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.

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"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])

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.

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"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])

On August 14, 2026 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor, reported financial results and provided an update on operational highlights for the second quarter ended June 30, 2026.

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"The second quarter was a highly productive period for Allarity. During the quarter, the USPTO granted the key U.S. patent covering our stenoparib-specific DRP companion diagnostic, providing exclusivity to develop stenoparib with its DRP into April 2042. This establishes a critical, long-term intellectual property foundation for stenoparib development and commercialization and reinforces our confidence in the long-term potential of our approach to pairing anticancer therapeutics with drug-specific companion diagnostics," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics.

"Subsequent to quarter-end, we also successfully completed our manufacturing campaign for stenoparib, securing drug supply in accordance with the more stringent standards required for late-stage clinical development. Completion of this campaign represents an important step as we prepare for a pivotal, registrational trial. We have also secured CLIA certification for our in-house laboratory, enabling us to do all of the necessary testing for the DRP in-house, which will further secure our ability to control and accelerate the advance of stenoparib toward FDA approval. I am particularly proud of these accomplishments as they position the company to drive stenoparib forward as rapidly as possible. Together with the presentation of our promising, durable Phase 2 clinical benefit data in advanced ovarian cancer patients at leading international oncology conferences, these achievements further strengthen the foundation for accelerating stenoparib toward FDA approval. Finally, I am pleased that we ended the quarter with almost $27 million in cash and restricted cash, providing us with the financial resources to continue the important work of advancing stenoparib."

Clinical and Drug Development Progress

Phase 3 manufacturing campaign milestone: During the second quarter, Allarity announced that its active pharmaceutical ingredient (API) manufacturing campaign for stenoparib was progressing in line with the planned timeline at its world-class contract development and manufacturing organization (CDMO). Subsequent to quarter-end, the campaign was successfully completed (July 2026), ahead of the originally planned completion by the third quarter of 2026. The campaign supports accelerating stenoparib toward FDA approval following its FDA Fast Track designation and was completed in anticipation of the generation of clinical benefit data from the ongoing Phase 2 trial in advanced ovarian cancer. All manufacturing-related payments were completed during the second quarter and are recorded as prepaid expenses, and no additional cash outlays for API manufacturing are anticipated.
Key U.S. patent granted for the stenoparib DRP companion diagnostic: The United States Patent and Trademark Office (USPTO) granted the key U.S. patent covering Allarity’s proprietary stenoparib-specific Drug Response Predictor (DRP) companion diagnostic, with a term extending into April 2042. The grant follows the USPTO’s Notice of Allowance announced in April 2026. The patent covers methods for predicting clinical benefit from stenoparib based on gene-expression profiles derived from tumor samples, as well as methods for selecting patients most likely to benefit from stenoparib treatment, and affords commercial exclusivity protection for stenoparib when used in concert with the stenoparib DRP.
AACR 2026 data linking DRP to enhanced overall survival in ovarian cancer: At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 (AACR 2026), Allarity presented Phase 2 clinical data showing extended overall survival benefit in advanced, platinum-resistant and refractory ovarian cancer patients, particularly in those patients whose tumors have the highest stenoparib DRP scores. These data reinforce the value of leveraging the DRP-based patient selection strategies to select patients most likely to benefit from stenoparib and to accelerate stenoparib’s advance to FDA approval.
AACR 2026 data highlighting stenoparib’s potential in colorectal cancer: In a second AACR (Free AACR Whitepaper) 2026 poster, the Company presented new findings demonstrating stenoparib’s mechanism of action—modulating the WNT/β-catenin signaling pathway and inhibiting the growth of human colorectal cancer cell lines at clinically relevant concentrations. The majority of colorectal cancers activate the WNT pathway, enabling cancer progression and metastatic spread. Accordingly, inhibition of the WNT pathway may provide an exciting new therapeutic option for colon and rectal cancers, which remain among the most prevalent and deadly cancers in the United States.
Poster presented at ESMO (Free ESMO Whitepaper) Gynaecological Cancers Congress: Allarity presented a Trial-in-Progress poster outlining the scientific background, study design, and clinical rationale for its ongoing Phase 2 trial evaluating stenoparib in patients with advanced platinum-resistant or platinum-ineligible ovarian cancer. The poster was presented by the study’s Principal Investigator, Kathleen N. Moore, M.D., an internationally recognized specialist in gynecologic oncology and a leading expert in advanced platinum-resistant and platinum-refractory ovarian cancer.
Ovarian cancer program continued under FDA Fast Track designation: Allarity continued enrollment in its Phase 2 clinical trial protocol evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The amended protocol is designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum-resistant patients and to accelerate the clinical development of stenoparib toward FDA approval.
SCLC combination trial continued enrollment: The Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC)—fully funded by the U.S. Department of Veterans Affairs (VA)—continued enrolling patients across multiple VA medical centers throughout the United States.
CLIA certification obtained: Allarity obtained a Certificate of Registration under the Clinical Laboratory Improvement Amendments (CLIA) for its in-house laboratory in Hørsholm, Denmark. The FDA requires that biomarker testing used to select patients for registration trials be performed in a CLIA-certified laboratory environment. For the first time, Allarity is now able to perform its DRP testing in-house in a CLIA-certified environment to support U.S. clinical trials, including a registrational trial of stenoparib in advanced ovarian cancer. This is expected to reduce reliance on external laboratories, may shorten turnaround times and reduce costs. It also may position the Allarity Therapeutics Medical Laboratory as a preferred CLIA-certified laboratory partner in Northern Europe for other companies seeking to conduct clinical trials in, or commercialize products for the U.S. market.
Corporate and Strategic Developments

Scientific visibility at Precision Medicine Forum Europe 2026: CEO Thomas Jensen presented at Precision Medicine Forum Europe 2026 in Stockholm, Sweden, discussing stenoparib’s dual mechanism of action and Allarity’s predictive biomarker, as well as the Company’s ongoing Phase 2 trials.
Second Quarter 2026 Financial Review

Results of Operations for the Three Months Ended June 30, 2026

Cash Position: As of June 30, 2026, cash and restricted cash totaled $26.9 million, compared to $14.7 million as of June 30, 2025. The Company used $2.6 million of cash in operating activities during the quarter.
R&D Expenses: Research and development (R&D) expenses were $1.3 million for the quarter ended June 30, 2026, compared to $2.3 million for the quarter ended June 30, 2025.
G&A Expenses: General and administrative (G&A) expenses were $1.3 million for the quarter ended June 30, 2026, compared to $1.8 million for the quarter ended June 30, 2025.
Total Comprehensive Loss: The total comprehensive loss attributable to common stockholders was $3.7 million for the quarter ended June 30, 2026, compared to $4.2 million for the quarter ended June 30, 2025. For the six months ended June 30, 2026, the loss was $6.5 million, compared to $7.2 million for the six months ended June 30, 2025.
About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers, especially drug-resistant cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, small cell lung cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has completed its first Phase 2 trial for stenoparib in advanced ovarian cancer patients. That trial showed promising and durable clinical benefit in ovarian cancer patients who had two or more lines of prior lines of therapy and recieved stenoparib twice daily. The updated data from this study were presented at the AACR (Free AACR Whitepaper) special conference on advances in ovarian cancer in September 2025. These analyses are subject to change as follow-up matures. A new protocol was designed expressly to capitalize on this emerging clinical experience with stenoparib in platinum-resistant patients and began enrolling patients in the summer of 2025. This amended protocol enrolls only platinum- resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval. In parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC) began enrolling patients in early 2026 and is currently enrolling patients across multiple VA sites in the U.S.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which Allarity believes may be useful in all cancer types and is patented for dozens of anticancer drugs, has been extensively published in the peer-reviewed literature.

(Press release, Allarity Therapeutics, AUG 14, 2026, View Source [SID1234670140])

On August 14, 2026 Replimune Group, Inc. (Nasdaq: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported financial results for the fiscal first quarter ended June 30, 2026 and provided a business update.

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On August 6, 2026, the Company announced the U.S. Food and Drug Administration (FDA) has approved TUDRIQEV (vusolimogene oderparepvec-wtpg), previously referred to as RP1, in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression with a PD-1 antibody-based regimen. The Company has begun launch preparations in the U.S. and anticipates having product in the market within 60 days. Replimune also recently completed a $150 million financing to support commercial launch and the ongoing IGNYTE-3 confirmatory trial.

The Company also announced today the appointment of Michelle DiNapoli as Chief Commercial Officer, effective August 18, 2026. Ms. DiNapoli brings more than 25 years of biopharmaceutical experience commercializing innovative oncology therapies and building high-performing commercial organizations. She joins Replimune after a seven-year tenure at Deciphera Pharmaceuticals. At Deciphera, she built the U.S. sales force, led the U.S. Commercial organization, and scaled infrastructure to drive launch execution as the company grew from a single product to a multi-product organization. Prior to Deciphera, Ms. DiNapoli spent 16 years at Genentech in commercial leadership roles spanning breast, lung, and colorectal cancer franchises as well as cancer immunotherapy, developing deep expertise in market access, lifecycle management, and cross-functional execution.

"The FDA’s approval of TUDRIQEV is a defining milestone for Replimune and, more importantly, for the patients facing advanced melanoma, where the need for safe and effective treatment options remains significant," said Sushil Patel, Ph.D., CEO of Replimune. "With this approval, we are now a fully integrated biotechnology company. We are completing the build out of our commercial infrastructure to enable a successful launch and bring TUDRIQEV to patients as quickly as possible."

Program Highlights & Milestones

RP1 (vusolimogene oderparepvec)

· IGNYTE-3 Confirmatory Study: The global Phase 3 trial assessing RP1 in combination with nivolumab versus physician’s choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment is actively enrolling. The primary endpoint, expected to readout in 2030, is overall survival, and key secondary endpoints are progression free survival and overall response rate.

RP2

· REVEAL Study: The registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. The trial is evaluating RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in approximately 280 patients. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. Phase 2/3 transition is expected in Q1 2027.

Financial Highlights

· Cash Position: As of June 30, 2026, cash, cash equivalents and short-term investments were $195.3 million, as compared to $268.9 million as of fiscal year ended March 31, 2026. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans.

Based on our current operating plan, we expect that our existing cash and cash equivalents and short-term investments, as of June 30, 2026, in addition to the $141.0 million of net proceeds from the issuance of our common stock in August 2026, will enable us to fund operations for greater than twelve months from the issuance of the condensed consolidated financial statements, which includes scale up for the commercialization of TUDRIQEV in advanced melanoma and for working capital and general corporate purposes.

· R&D Expenses: Research and development expenses were $49.3 million for the fiscal first quarter and $57.8 million for the fiscal first quarter ended June 30, 2025. This decrease was primarily due to a decrease in personnel related and other costs, as well as a decrease in direct research costs relating to the IGNYTE, ARTACUS and CERPASS studies. Research and development expenses included $3.6 million in stock-based compensation expenses for the fiscal first quarter ended June 30, 2026.

· S,G&A Expenses: Selling, general and administrative expenses were $19.0 million for the fiscal first quarter ended June 30, 2026, as compared to $32.6 million for the fiscal first quarter ended June 30, 2025. Selling, general and administrative expenses included $4.1 million in stock-based compensation expenses for the fiscal first quarter ended June 30, 2026.

· Net Loss: Net loss was $69.8 million for the fiscal first quarter ended June 30, 2026 and $86.7 million for the fiscal first quarter ended June 30, 2025.

About TUDRIQEVTM (vusolimogene oderparepvec-wtpg)

TUDRIQEV (vusolimogene oderparepvec-wtpg) is a genetically modified herpes simplex virus, type 1 (HSV-1) oncolytic viral therapy that encodes a fusogenic glycoprotein derived from gibbon ape leukemia virus with the R sequence deleted (GALV-GP-R–) and human granulocyte macrophage colony-stimulating factor (GM-CSF). The genes encoding the HSV-1 neurovirulence factor ICP34.5 and the transporter associated with antigen presentation inhibitor ICP47 are deleted from TUDRIQEV. TUDRIQEV preferentially replicates within the tumor leading to tumor lysis, release of tumor and viral antigens, proinflammatory molecules, and infiltration of T cells. The GALV-GP-R– expressed by TUDRIQEV increases direct tumor killing and the GM-CSF expressed by TUDRIQEV is intended to activate and mature dendritic cells and monocytes. In the anti-PD-1 resistant setting, TUDRIQEV and nivolumab in combination may promote anti-tumor immune response.

INDICATION

TUDRIQEV is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.

This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Accidental exposure of TUDRIQEV: Healthcare providers, caregivers, close contacts, pregnant women, newborns, and patients should avoid direct contact with injected tumors, dressings, or bodily fluids of patients.

Herpetic infection or reactivation: Patients with suspected herpetic infections should contact their healthcare provider for assessment and antiviral treatment of the suspected herpetic infection as clinically warranted.

Injection procedure complications: Complications related to injection procedure have occurred, including hemorrhage, infection, and visceral injury. Patients should be monitored for signs and symptoms of visceral injury (eg, pneumothorax) during and after TUDRIQEV administration and managed according to clinical practice.

Immune-mediated events: In clinical studies, immune-mediated events, including colitis, hepatitis, myocarditis, neuropathy, capillary leak syndrome, dermatitis, and vitiligo have been reported in patients treated with TUDRIQEV and nivolumab.

Adverse Reactions

Most common non-laboratory adverse reactions reported in more than 10% of patients were fatigue, pyrexia, infections, chills, musculoskeletal pain, nausea, diarrhea, injection site reaction, headache, cough, influenza like illness, rash, vomiting, pruritus, arthralgia, constipation, decreased appetite, dizziness, dyspnea, hemorrhage, edema, and abdominal pain.

Serious adverse reactions occurring in >1% patients include pleural effusion (n=3), acute kidney injury (n=2), arthralgia (n=2), atrial fibrillation (n=2), atrial flutter (n=2), cancer pain (n=2), hypophysitis (n=2), immune-mediated enterocolitis (n=2), pyrexia (n=2), sepsis (n=2), urinary tract infection (n=2), and myocardial infarction (n=2). Serious adverse reactions leading to death include myocardial infarction (n=1) and multiple organ dysfunction (n=1).

Drug Interactions

Patients receiving systemic antiviral treatment for herpetic infection should delay TUDRIQEV treatment for 72 hours after completion of antiviral therapy.

Special Populations

Advise females and males of reproductive potential to use effective contraception during treatment with TUDRIQEV and for 90 days after the last dose.

About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2

RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.

(Press release, Replimune, AUG 14, 2026, View Source [SID1234670129])

On August 14, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported financial results for the second quarter ended June 30, 2026, and highlighted continued progress in its pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in relapsed or refractory acute myeloid leukemia (AML).

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Moleculin continues to advance the pivotal Phase 2/3 MIRACLE trial following positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A, which showed complete remission rates at least three times greater than the control arm. Enrollment remains on track to reach the 90-patient milestone in September with the data readout in the December 2026 to February 2027 timeframe. These data are expected to support selection of the optimal Annamycin dose and the planned initiation of Part B in the first half of 2027.

Walter Klemp, Chairman and Chief Executive Officer of Moleculin, commented, "In addition to the positive interim MIRACLE results, we are just as excited by the feedback we are receiving from investigators about Annamycin and their enthusiasm for participating in the study. Their response reflects both the significant unmet need in relapsed or refractory AML and growing recognition of Annamycin’s potential, with its encouraging data generated to date and differentiated cardiac safety profile, to play an important role in the treatment landscape. As we advance toward the 90-patient milestone and next unblinded efficacy readout, this strong investigator engagement adds to our confidence in the program and the potential for Annamycin to meaningfully improve outcomes for patients."

Recent Highlights

Reported positive interim results from the Phase 2/3 MIRACLE trial, with both Annamycin treatment arms demonstrating complete remission (CR) rates at least three times higher than the control arm in patients with relapsed or refractory AML. The interim analysis demonstrated a clear efficacy advantage for both Annamycin treatment arms, 190 mg/m² plus cytarabine and 230 mg/m² plus cytarabine, over the cytarabine control arm. CR reached 43% and 36% in the respective Annamycin cohorts, compared with 12% for control, while composite complete remission (CRc) reached 50% and 57%, respectively, versus 29% for the control arm. The n=45 population contained 75.6% over 60 years of age, 55.6% 7+3 and 31.1% venetoclax regimens for first line (1L) therapies.
Announced independent market research indicating strong physician intent to prescribe Annamycin based on its potential efficacy, transplant-bridging potential and favorable cardiac safety profile.
Presented data at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrating no detectable cardiotoxicity with Annamycin despite cumulative exposure levels exceeding conventional anthracycline limits, further supporting its differentiated safety profile.
Chairman and Chief Executive Officer Walter Klemp discussed the positive preliminary MIRACLE interim results during a Virtual Investor "What This Means" segment, providing additional context on the Company’s clinical progress and anticipated next milestones.
Enrollment continued in Part A of the MIRACLE trial, with more than 80% of the planned 90 patients enrolled as of the interim analysis.
Cash on hand and cash equivalents as of June 30, 2026, together with $9.3 million in financing proceeds raised subsequent to the quarter, expected to support planned operations into the first quarter of 2027.
Clinical Development Update

Annamycin – MIRACLE Trial
Moleculin continues to advance the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial, a pivotal adaptive-design Phase 2/3 study evaluating Annamycin in combination with cytarabine (AnnAraC) for the treatment of adults with relapsed or refractory acute myeloid leukemia.

During the second quarter, the Company reported positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A of the trial. Both Annamycin treatment arms demonstrated substantially higher complete remission rates than the control arm, while maintaining the encouraging safety profile previously observed in clinical studies. Activity in the MIRACLE trial continues to demonstrate no evidence of cardiotoxicity. The Company continues to enroll patients in Part A and expects to use these data to select the optimal dose for advancement into Part B.

Expected Milestones for the Annamycin Development Program

September 2026: Completion of enrollment in Part A of MIRACLE
December 2026 to February 2027 timeframe: MIRACLE – data unblinding for Part A 90 subjects completed
2H 2026: Atlantic Health pancreatic cancer clinical trial begins
1H 2027: MIRACLE – Start of Part B
2027: Begin 3rd line R/R AML subject trial
2027: Begin pediatric AML clinical study
2028: End recruitment of Part B
2028: Primary efficacy data for MIRACLE 2nd line subjects
2028: Begin submission of a Rolling New Drug Application (NDA) for the treatment of R/R AML for accelerated approval on primary endpoint of CR from MIRACLE
2029: NDA submission complete
Additional Pipeline Programs

Moleculin continues to support development activities for WP1066 through investigator-sponsored and externally funded studies, while maintaining its focus on advancing Annamycin as the Company’s lead clinical program.

Second Quarter 2026 Financial Results

Research and development expenses were $5.5 million and $3.6 million for the three months ended June 30, 2026 and 2025, respectively. The increase of $1.9 million is mainly related to the MIRACLE clinical trial of $1.1 million, additional nonclinical studies of $0.4 million, and $0.4 million in other research costs during the current quarter as compared to the prior year quarter.

General and administrative expenses for the quarter ended June 30, 2026 were approximately $2.1 million, compared with approximately $2.1 million for the same period in 2025.

As of June 30, 2026, the Company had cash and cash equivalents of approximately $7.3 million. Management believes that its cash on hand and cash equivalents as of June 30, 2026, together with $9.3 million in financing proceeds raised subsequent to the quarter, will support planned operations into the first quarter of 2027.

(Press release, Moleculin, AUG 14, 2026, View Source [SID1234670128])