On August 6, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy (Press release, Jazz Pharmaceuticals, AUG 6, 2025, View Source [SID1234654889]). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the Phase 3 ACTION confirmatory trial.

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Modeyso is the first and only treatment option approved by the FDA for this ultra-rare and aggressive brain tumor that affects an estimated 2,000 people in the U.S. each year, many of whom are children and young adults.2 The disease is characterized by rapid progression and historically has had no effective systemic treatment options.3 To address this urgent unmet patient need, Modeyso is expected to be commercially available in the coming weeks.

"This is a major turning point in neuro-oncology," said Patrick Wen, M.D., Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute and Professor of Neurology, Harvard Medical School. "For the first time, we have an FDA-approved therapy for patients with recurrent H3 K27M-mutant diffuse midline glioma. While outcomes remain challenging for many patients, the objective responses observed with dordaviprone, including durable benefit in some patients, represent a meaningful advancement. This therapy was developed with the underlying biology of the tumor in mind and introduces a new treatment option for a population with historically limited choices."

Modeyso is administered as an oral capsule once weekly. The FDA’s decision was based on an integrated efficacy analysis of 50 patients with recurrent H3 K27M-mutant diffuse midline glioma, selected from five open-label clinical studies based on prespecified eligibility criteria. The overall response rate (ORR), as assessed by blinded independent central review (BICR) using Response Assessment in Neuro-Oncology (RANO) 2.0 criteria, was 22% (95% CI: 12 to 36), with an additional responder identified by integrated RANO 2.0. Among responders, the median duration of response was 10.3 months (95% CI: 7.3 to 15.2), with 73% maintaining their response for at least six months and 27% for at least 12 months.1

"The FDA approval of Modeyso is a milestone moment for the patients and families who have long needed new options, the clinicians who have tirelessly searched for solutions, and the researchers and advocates who never gave up," said Joshua E. Allen, Ph.D., Chief Scientific Officer, Chimerix, a Jazz Pharmaceuticals Company. "We’re proud to deliver precisely the kind of transformative innovation we strive for, and we congratulate our combined Chimerix and Jazz team, and the community who worked together tirelessly to bring this treatment forward. This approval not only equips clinicians with the first targeted option for this disease but also signals a meaningful shift in what patients and families can expect after diagnosis. We would like to extend our thanks to the patients, advocates, clinicians, principal investigators, scientists, regulators and partner institutions who made this possible."

"This approval represents a long-awaited treatment option for families affected by H3 K27M-mutant diffuse midline glioma," said David F. Arons, President and Chief Executive Officer of the National Brain Tumor Society. "This is a fast-moving, devastating disease that turns families’ lives upside down. For years, this diagnosis has lacked an approved treatment and today, that changes. Families finally have a treatment option, and a reason to believe in more time together to make memories that might not have otherwise been possible."

The safety of Modeyso was evaluated in 376 adult and pediatric patients with glioma across four open-label clinical studies. Serious adverse reactions occurred in 33% of patients. Serious adverse reactions reported in more than 2% of patients included hydrocephalus (5%), vomiting (4.3%), headache (3.2%), seizure (2.4%) and muscular weakness (2.1%). The most common adverse reactions in patients who received Modeyso (≥20%) were fatigue, headache, vomiting, nausea and musculoskeletal pain.1 See additional safety information below and full prescribing information: View Source

About the Phase 2 Clinical Trial Program
The efficacy and safety of Modeyso were evaluated in adult and pediatric patients with glioma across five open-label, non-randomized clinical studies (ONC006, ONC013, ONC014, ONC016, and ONC018). A pre-specified integrated efficacy analysis included 50 patients with recurrent H3 K27M-mutant diffuse midline glioma who had measurable disease per Response Assessment in Neuro-Oncology (RANO) criteria. Tumor response was assessed every eight weeks by blinded independent central review (BICR). The primary efficacy endpoint was objective response rate (ORR). Safety was evaluated across four of the clinical studies.1

More information about Modeyso, the Full Prescribing Information, and Patient Information, is available here.

Investor Webcast on August 27, 2025
The company will host a webcast on August 27, 2025, at 4:30 p.m. ET / 9:30 p.m. IST to provide investors an overview of clinical data, patient need and commercialization strategy for Modeyso. The webcast will include commentary from a leading neuro-oncology expert and the company’s senior management.

A live webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. An archive of the webcast will be available for at least one week following the presentation on the Investors section of the company’s website at www.jazzpharmaceuticals.com.

About H3 K27M-Mutant Diffuse Midline Glioma
H3 K27M-mutant diffuse midline glioma is a rare and highly aggressive brain tumor that primarily affects the midline structures of the brain and spinal cord.4,5 It is characterized by a specific genetic mutation (H3 K27M) that disrupts epigenetic regulation and drives tumor growth.6 Most commonly diagnosed in children and young adults, patients with this type of glioma often face an extremely poor prognosis, with limited therapeutic options and very low survival rates following recurrence.7 Median survival is approximately one year from diagnosis and less than six months after progressing following frontline therapy.7

About Modeyso (dordaviprone)
Modeyso (dordaviprone) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.1 Modeyso is an orally administered small molecule given once weekly. Modeyso is a protease activator of the mitochondrial caseinolytic protease P (ClpP) and also inhibits dopamine D2 receptor (DRD2). In vitro, dordaviprone activates the integrated stress response, induces apoptosis, and alters mitochondrial metabolism, leading to restored histone H3 K27 trimethylation in H3 K27M-mutant diffuse glioma.1

Modeyso received accelerated approval based on a pre-specified integrated efficacy analysis of 50 adult and pediatric patients with recurrent H3 K27M-mutant diffuse midline glioma enrolled across five open-label clinical studies (ONC006, ONC013, ONC014, ONC016, and ONC018). Continued approval may be contingent upon verification and description of clinical benefit in the ongoing Phase 3 ACTION trial (NCT05580562), which is evaluating the safety and clinical benefit of Modeyso in newly diagnosed patients with H3 K27M-mutant diffuse glioma following radiotherapy.6 Modeyso was developed by Chimerix prior to its acquisition by Jazz Pharmaceuticals in April 2025.

Modeyso (dordaviprone) is not approved anywhere else in the world.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Hypersensitivity
MODEYSO can cause severe hypersensitivity reactions.

In the pooled safety population, Grade 3 hypersensitivity reactions occurred in 0.3% of patients receiving MODEYSO. Signs and symptoms of hypersensitivity may include rash, hives, fever, low blood pressure, wheezing, or swelling of the face or throat.

Inform patients about the signs and symptoms of hypersensitivity reactions and instruct them to seek immediate medical attention if symptoms occur.

If clinically significant hypersensitivity or anaphylaxis occur, immediately interrupt MODEYSO and initiate appropriate medical treatment and supportive care. Based on the severity of the adverse reaction, temporarily interrupt or permanently discontinue MODEYSO.

QTc Interval Prolongation
MODEYSO causes concentration-dependent QTc interval prolongation, which can increase the risk for ventricular tachyarrhythmias (e.g. torsades de pointes) or sudden death.

In patients who received MODEYSO and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 6% and 1.2% of patients, respectively.

Monitor ECGs and electrolytes prior to initiation and periodically during treatment, as clinically indicated. Increase the frequency of monitoring in patients with congenital long QT syndrome, existing QTc prolongation, a history of ventricular arrhythmias, electrolyte abnormalities, heart failure, or who are taking strong or moderate CYP3A4 inhibitors.

Avoid concomitant use with other agents known to prolong the QT interval. If concomitant use cannot be avoided, increase the frequency of monitoring and separate administration of MODEYSO and QT-prolonging product.

Interrupt or reduce the dose of MODEYSO in patients who develop QT prolongation; permanently discontinue in patients with signs of life-threatening arrhythmias.

Embryo-Fetal Toxicity
MODEYSO can cause fetal harm when administered to a pregnant woman.
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with MODEYSO and for 1 month after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with MODEYSO and for 1 month after the last dose.

ADVERSE REACTIONS
Serious adverse reactions occurred in 33% of the 376 patients who received MODEYSO. Serious adverse reactions in >2% of patients included hydrocephalus (5%), vomiting (4.3%), headache (3.2%), seizure (2.4%), and muscular weakness (2.1%). Fatal adverse reactions occurred in 1% of patients who received MODEYSO, including cardiac arrest (0.5%), intracranial hemorrhage (0.3%), and encephalopathy (0.3%).

The most common adverse reactions (≥20%) reported in clinical trials with MODEYSO were fatigue (34%), headache (32%), vomiting (24%), nausea (24%), and musculoskeletal pain (20%). The most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (7%), decreased calcium (2.7%), and increased alanine aminotransferase (2.4%).

DRUG INTERACTIONS
Strong and Moderate CYP3A4 Inhibitors
Avoid concomitant use of MODEYSO with strong and moderate CYP3A4 inhibitors. If concomitant use cannot be avoided, reduce the MODEYSO dose as recommended and monitor for toxicity.

Strong and Moderate CYP3A4 Inducers
Avoid concomitant use of strong and moderate CYP3A4 inducers with MODEYSO.

USE IN SPECIFIC POPULATIONS
Lactation
There are no data on the presence of MODEYSO in human milk because of the potential for serious adverse reactions from MODEYSO in breastfed children, advise women not to breastfeed during treatment with MODEYSO and for 1 week after the last dose.

Pediatric Use
The safety and effectiveness of MODEYSO have not been established in patients less than 1 year of age. Dosing has not been established for patients weighing less than 22 pounds (10 kg).

Please refer to the full Prescribing Information, including both Patient Information and Instructions for Use, for complete safety and administration information.

On August 6, 2025 Amplia Therapeutics (ASX: ATX) reported it has released new topline data from an ongoing trial of its best-in-class selective FAK inhibitor narmafotinib on advanced pancreatic cancer (Press release, Amplia Therapeutics, AUG 6, 2025, View Source [SID1234654810]).

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The ACCENT clinical trial is investigating the safety, tolerability, pharmacokinetics and preliminary efficacy of narmafotinib when used in combination with standard-of-care chemotherapies gemcitabine and Abraxane.

Latest data to 20 July has shown a progression free survival (PFS) of 7.6 months in trial participants, representing a two-month improvement over chemotherapy alone, and superior to the PFS obtained with the more aggressive (but less tolerated) FOLFIRINOX chemotherapy combination that attacks cancer cells in different ways.

Objective Response Rate
Narmafotinib’s objective response rate currently sits at 31%, significantly better compared to chemotherapy alone (23%), whilehe drug has also demonstrated a strong tolerability profile with adverse events being very similar in type and occurrence to those observed for chemotherapy.

Durability of response has been strong with seven patients having stayed on the trial for more than 12 months.

The mean days on trial for evaluable patients is 202 days and is substantially better than the 117 days the benchmark MPACT study reported for chemotherapy alone.

At the data cut-off date, 17 patients remained on trial.

Leading Cause of Death
Pancreatic cancer is the eighth most-diagnosed cancer in Australia and the nation’s third leading cause of cancer death.

While survival rates are increasing, it remains a serious diagnosis with an extremely poor prognosis.

Amplia is developing Narmafotinib as an inhibitor of FAK — a protein overexpressed in pancreatic cancer — and the treatment is gaining increasing attention for its role in solid tumours.

Quarterly Developments
The latest ACCENT results follow significant developments achieved in the trial during the three months to end June, with Amplia reporting a key activity threshold of 15 confirmed partial responses (PRs), demonstrating that the combination of narmafotinib with chemotherapy was superior to chemotherapy alone.

The company also announced that two trial participants had achieved pathological complete responses, with one patient experiencing a decrease in cancer lesion size over the course of treatment to the point where the lesions were no longer detectable.

Pathology showed a presumed residual tumour surgically removed from the second patient to be non-malignant tissue, meaning that the patient had achieved a pathological complete response.

This finding is extremely rare in metastatic pancreatic cancer sufferers, resulting in significant media attention for the patient and the hospital that had delivered the treatment.

Impressive Results
Amplia chief executive officer Dr Chris Burns said the trial continued to deliver impressive results.

"Data from our ACCENT trial of narmafotinib combined with chemotherapy continues to outperform chemotherapy alone across a variety of measures," he said.

"A PFS of 7.6 months at this interim stage is a significant improvement on existing chemotherapy regimens and we expect to provide further positive updates as the trial matures."

Dr Burns said the company was progressing a second trial of narmafotinib combined with FOLFIRINOX, with ethics approval for trial sites in the US and Australia received from the US Institutional Review Board during the June quarter.

Capital Raising
Post-quarter, Amplia launched a $27.5 million capital raising to support ongoing clinical activities and additional planned activities through to 2027.

The raising took the form of a $25m institutional placement and $2.5m share purchase plan and was supported by existing and new institutional and sophisticated investors in Australia and overseas.

Amplia finished the June quarter with a cash position of $7m, compared to $10.9m in the previous quarter, while net operating cash outflow totalled $3.9m, comprising $900,000 in administrative costs and $3m for research and development (R&D) activities primarily related to the ACCENT trial.

The company expects to receive a $3.8m R&D tax incentive refund in the next quarter, for the year ended March 2025.

On August 6, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (OTC: APTOF, TSX: APS), a clinical-stage precision oncology company developing the tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed AML, reported that the Cohort Safety Review Committee (CSRC) monitoring Aptose’s Phase 1/2 TUSCANY trial of TUS in combination with standard of care dosing of venetoclax and azacitidine (TUS+VEN+AZA triplet) has approved escalating from 120 mg TUS dose to 160 mg TUS dose based on its favorable review of safety and efficacy data from patients in the first three cohorts (40 mg, 80 mg, and 120 mg TUS dose levels) of the trial (Press release, Aptose Biosciences, AUG 6, 2025, View Source [SID1234654855]). Enrollment is open for dosing subjects at the 160 mg TUS dose level.

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Aptose also announced that it has received an additional advance of US$1.1M from Hanmi Pharmaceutical Co. Ltd. ("Hanmi"), as part of a US$8.5M loan facility agreement with Hanmi (the "Loan Agreement") announced prior on June 20, 2025 (press release here: View Source). To date, Aptose has received an aggregate of US$5.6M under the Loan Agreement.

The TUS+VEN+AZA triplet is being developed as a one-of-a-kind, safe and mutation agnostic frontline therapy to treat large, mutationally diverse populations of newly diagnosed AML patients who are ineligible to receive induction chemotherapy. Aptose reports that at the 120 mg TUS dose level, as with the prior reported 40 mg and 80 mg dose cohorts, no significant safety concerns or dose limiting toxicities (DLTs) have been reported in the TUSCANY trial, including no prolonged myelosuppression in Cycle 1 of subjects in remission.

All patients treated in the 120 mg dose cohort remain on study while enrollment is open for the 160 mg dose cohort. Aptose previously reported that the first two dose cohorts have demonstrated safety, CRs, and minimal residual disease (MRD) negativity across patients with diverse mutations in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA 2025) in June (press release here: View Source).

"Data from three cohorts, with a 40, 80 or 120 mg dose of TUS in the TUS+VEN+AZA triplet, continue to build a strong case for TUS as a therapeutic option for some of the most difficult to treat AML populations," said Rafael Bejar, M.D., Ph.D., Chief Medical Officer of Aptose. "In particular, patients with adverse biallelic TP53 or FLT3-ITD mutations, and those without FLT3 mutations, were able to safely achieve complete remissions with MRD negativity. After review of the most recent safety and efficacy data, our CSRC recommended that we continue to escalate dosing."

TUSCANY: TUS+VEN+AZA Triplet Phase 1/2 Study

The tuspetinib-based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 trial with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations, durable, and well tolerated. Earlier APTIVATE trials of TUS as a single agent and in combination as TUS+VEN demonstrated favorable safety and broad activity in diverse relapsed or refractory (R/R) AML populations that went beyond the more prognostically favorable NPM1 and IDH mutant subgroups. Indeed, responses were also noted in R/R AML patients with highly adverse TP53 and RAS mutations, and those with mutated or unmutated (wildtype) FLT3 genes.

The TUSCANY triplet Phase 1/2 study, being conducted at 10 leading U.S. clinical sites by elite clinical investigators, is designed to test various doses and schedules of TUS in combination with standard dosing of AZA and VEN for patients with AML who are ineligible to receive induction chemotherapy. A convenient, once daily oral agent, TUS is being administered in 28-day cycles. Multiple U.S. sites are enrolling in the TUSCANY trial with anticipated enrollment of 18-24 patients by late 2025. Data will be released as it becomes available.

More information on the TUSCANY Phase 1/2 study can be found on www.clinicaltrials.gov (here: View Source).

On August 6, 2025 Royalty Pharma plc (Nasdaq: RPRX) reported financial results for the second quarter of 2025 and raised full year 2025 guidance for Portfolio Receipts (Press release, Royalty Pharma , AUG 6, 2025, View Source [SID1234654871]).

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"We delivered excellent second quarter 2025 results, as the strength of our diversified portfolio drove 20% growth in Portfolio Receipts, and raised our full year guidance," said Pablo Legorreta, Royalty Pharma’s founder and Chief Executive Officer. "Additionally, we closed the acquisition of our external manager, enabling Royalty Pharma to become an integrated company, which is an important milestone in our evolution. Furthermore, we announced a groundbreaking funding agreement with Revolution Medicines, which enables our partner to retain operational control over their pipeline development and global commercialization, and exemplifies a new funding paradigm for innovative biotech companies. Guided by our dynamic capital allocation framework, we repurchased $1 billion of our Class A ordinary shares in the first half of this year, highlighting our attractive fundamental outlook. The prospects for the royalty market and our business have never been stronger and we look forward to sharing more details at our upcoming Investor Day on September 11th."

Strong double-digit growth in Royalty Receipts and Portfolio Receipts

•
Royalty Receipts grew 11% to $672 million, primarily driven by Voranigo, Trelegy, Evrysdi, and Tremfya.

•
Portfolio Receipts increased by 20% to $727 million.

Flexible and scaled synthetic royalty deal underpins Capital Deployment in the second quarter of 2025

•
Capital Deployment of $595 million; announced innovative partnership with Revolution Medicines of up to $2 billion including a synthetic royalty of up to $1.25 billion on daraxonrasib (in Phase 3 for RAS-addicted cancers).

•
Repurchased eight million Class A ordinary shares for $277 million in the second quarter, with total repurchases of $1 billion in the first half 2025.

Positive clinical updates across royalty portfolio

•
Positive Phase 3 results for Gilead’s Trodelvy in first-line metastatic triple-negative breast cancer.

Completed acquisition of external manager, RP Management, LLC, to become an integrated public company

•
Acquisition closed in May 2025 and combines Royalty Pharma’s portfolio with the intellectual capital of the manager; transaction received overwhelming support from shareholders with 99.9% of votes cast in favor.

Raising financial guidance for full year 2025 (excludes contribution from future transactions)

•
Royalty Pharma expects 2025 Portfolio Receipts to be between $3,050 million and $3,150 million (previously $2,975 to $3,125), representing expected growth of 9% to 12% (previously 6% to 12%).

Financial & Liquidity Summary

Three Months Ended June 30,
(unaudited)
($ and shares in millions) 2025 2024 Change
Portfolio Receipts

727 608 20%
Net cash provided by operating activities

364 658 (45)%
Adjusted EBITDA (non-GAAP)*

633 560 13%
Portfolio Cash Flow (non-GAAP)*

641 574 12%
Weighted average Class A ordinary shares outstanding – diluted

562 597 (6)%

Portfolio Receipts Highlights

Three Months Ended June 30,
(unaudited)
($ in millions) 2025 2024 Change
Products:

Marketers: Therapeutic Area:
Cystic fibrosis franchise

Vertex Rare disease 194 195 0%
Trelegy

GSK Respiratory 57 48 17%
Tysabri

Biogen Neuroscience 56 64 (13)%
Imbruvica

AbbVie, J&J Cancer 44 49 (11)%
Xtandi

Pfizer, Astellas Cancer 42 39 8%
Tremfya

Johnson & Johnson Immunology 37 30 24%
Evrysdi

Roche Rare disease 33 25 32%
Promacta

Novartis Hematology 33 30 7%
Voranigo

Servier Cancer 26 — n/a
Cabometyx/Cometriq

Exelixis, Ipsen, Takeda Cancer 20 17 22%
Spinraza

Biogen Rare disease 12 10 25%
Erleada

Johnson & Johnson Cancer 10 9 10%
Trodelvy

Gilead Cancer 10 10 (4)%
Other products(5)

98 79 25%

Royalty Receipts

672 605 11%
Milestones and other contractual receipts

56 3 n/a

Portfolio Receipts

727 608 20%
Amounts shown in the table may not add due to rounding.

Royalty Receipts was $672 million in the second quarter of 2025, an increase of 11% compared to $605 million in the second quarter of 2024. The increase was primarily driven by Voranigo, Trelegy, Evrysdi, and Tremfya.

Portfolio Receipts was $727 million in the second quarter of 2025, an increase of 20% compared to $608 million in the second quarter of 2024, primarily driven by the same Royalty Receipts increases noted above and a one-time payment included in Milestones and other contractual receipts.

Liquidity and Capital Resources

Royalty Pharma’s liquidity and capital resources are summarized below:

As of June 30, 2025, Royalty Pharma had cash and cash equivalents of $632 million and total debt with principal value of $8.2 billion.

In January 2025, Royalty Pharma announced a new share repurchase program under which it may repurchase up to $3.0 billion of its Class A ordinary shares. During the second quarter of 2025, Royalty Pharma repurchased approximately eight million Class A ordinary shares for $277 million. During the first half of 2025, Royalty Pharma repurchased approximately 31 million Class A ordinary shares for $1 billion. During the second quarter and first half of 2024, Royalty Pharma repurchased approximately three million Class A ordinary shares for $84 million. The weighted-average number of diluted Class A ordinary shares outstanding for the second quarter of 2025 was 562 million as compared to 597 million for the second quarter of 2024.Liquidity Summary

Three Months Ended June 30,
(unaudited)
($ in millions) 2025 2024
Portfolio Receipts

727 608
Payments for operating and professional costs

(94) (48)

Adjusted EBITDA (non-GAAP)

633 560
Interest received, net

8 14

Portfolio Cash Flow (non-GAAP)

641 574
  Amounts may not add due to rounding.

•
Adjusted EBITDA (non-GAAP) was $633 million in the second quarter of 2025. Adjusted EBITDA is calculated as Portfolio Receipts minus payments for operating and professional costs.

•
Portfolio Cash Flow (non-GAAP) was $641 million in the second quarter of 2025. Portfolio Cash Flow is calculated as Adjusted EBITDA minus interest paid or received, net. This measure reflects the cash generated by Royalty Pharma’s business that can be redeployed into value-enhancing royalty acquisitions, used to repay debt, returned to shareholders through dividends or share purchases, or utilized for other discretionary investments.

Refer to Table 4 for Royalty Pharma’s reconciliation of each non-GAAP measure to the most directly comparable GAAP financial measure, net cash provided by operating activities.

Capital Deployment reflects cash payments during the period for new and previously announced transactions. Capital Deployment was $595 million in the second quarter of 2025, consisting primarily of funding for daraxonrasib, a milestone payment related to Adstiladrin and research and development funding for litifilimab.

In April 2025, Ferring Pharmaceuticals announced U.S. Food and Drug Administration (FDA) approval of a new manufacturing hub in Parsippany, NJ for Adstiladrin, its novel gene therapy for bladder cancer. The approval triggered a $200 million milestone payment that was paid in the second quarter of 2025.

The table below details Capital Deployment by category:

Capital Deployment

Three Months Ended June 30, Six Months Ended June 30,
(unaudited) (unaudited)
($ in millions) 2025 2024 2025 2024
Purchases of available for sale debt securities

(75) (150) (75) (150)
Acquisitions of financial royalty assets

(1) (729) (2) (815)
Acquisitions of other financial assets

— (18) — (18)
Development-stage funding payments

(301) (1) (351) (1)
Milestone payments

(219) (50) (269) (50)
Investments in equity method investees

— (4) — (11)
Contributions from legacy non-controlling interests – R&D

0 0 0 0

Capital Deployment

(595) (951) (696) (1,044)

Royalty Transactions

During 2025, Royalty Pharma has announced new transactions of up to $2.25 billion. The announced transactions amount reflects the entire amount of capital committed for new transactions year to date, including potential future milestones.

Recent transactions include:

•
In June 2025, Royalty Pharma entered into a two part $2 billion funding arrangement with Revolution Medicines. The funding arrangement includes up to $1.25 billion ($250 million upfront) to purchase a synthetic royalty on daraxonrasib and a senior secured term loan of up to $750 million. The first tranche of the senior secured term loan must be drawn following FDA approval of daraxonrasib. Daraxonrasib is in Phase 3 development for the treatment of RAS mutant pancreatic cancer and non-small cell lung cancer.

The information in this section should be read together with Royalty Pharma’s reports and documents filed with the SEC at www.sec.gov and the reader is also encouraged to review all other press releases and information available in the Investors section of Royalty Pharma’s website at www.royaltypharma.com.

Internalization Transaction

In January 2025, Royalty Pharma agreed to acquire its external manager, RP Management, LLC ("RPM"). In May 2025, Royalty Pharma completed the internalization transaction and became an integrated company as employees of RPM became employees of Royalty Pharma. The acquisition received overwhelming support from Royalty Pharma’s shareholders, with 99.9% of votes cast in favor of the transaction.

Key Developments Relating to the Portfolio

The key developments related to Royalty Pharma’s royalty interests are discussed below based on disclosures from the marketers of the products.

CF Franchise
In the second quarter of 2025, Royalty Pharma did not receive from Vertex the full amount of Royalty Receipts on Alyftrek net sales to which it is contractually entitled. Accordingly, Royalty Pharma has commenced the dispute resolution procedures contemplated by the agreements relating to our royalties on Vertex’s cystic fibrosis products.

In July 2025, Vertex announced that the European Commission (EC) approved Alyftrek for people with cystic fibrosis (CF) ages 6 years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

In April 2025, Vertex announced EC approval for the label expansion of Kaftrio in combination with ivacaftor for CF patients ages 2 years and older who have at least one non-class I mutation in the CFTR gene.

Cabometyx In July 2025, Ipsen announced that the EC has approved Cabometyx for previously treated advanced neuroendocrine tumors.
Skytrofa In July 2025, Ascendis announced that the U.S. FDA approved Skytrofa for the replacement of endogenous growth hormone in adults with growth hormone deficiency.
deucrictibant In July 2025, Pharvaris announced that it anticipates topline data for the Phase 3 study (RAPIDe-3) evaluating deucrictibant for the on-demand treatment of hereditary angioedema attacks in the fourth quarter of 2025 and, pending positive data, expects to submit an New Drug Application (NDA) with the FDA in the first half of 2026.
Xtandi In July 2025, Pfizer and Astellas Pharma announced topline results from the overall survival (OS) analysis from the Phase 3 EMBARK study evaluating Xtandi, in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer. For patients treated with Xtandi plus leuprolide versus placebo plus leuprolide, EMBARK met the key secondary endpoint with a statistically significant and clinically meaningful improvement in OS. Results also showed a favorable trend towards improved OS for patients treated with Xtandi monotherapy versus placebo plus leuprolide, however the difference did not reach statistical significance.

Trodelvy
In May 2025, Gilead Sciences announced positive topline results from the Phase 3 ASCENT-03 study. The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are ineligible to receive immunotherapy. Overall survival, was not mature at the time of PFS primary analysis. Gilead will continue to monitor OS outcomes, with ongoing patient follow-up and further analysis planned.

In April 2025, Gilead announced positive topline results from the Phase 3 Ascent-04/Keynote-D19 study, demonstrating that Trodelvy plus Keytruda significantly improved PFS compared to Keytruda and chemotherapy in patients with previously untreated PD-L1+ mTNBC. Overall survival, a key secondary endpoint, was not mature at the time of the PFS primary analysis. However, there was an early trend in improvement for OS with Trodelvy plus Keytruda and Gilead will continue to monitor OS outcomes.

Promacta In May 2025, Camber Pharmaceuticals announced the U.S. launch of eltrombopag, the AB-rated generic for Promacta.
Tremfya
In May 2025, Johnson & Johnson announced that the EC approved Tremfya for the treatment of adult patients with moderately to severely active Crohn’s disease.

In April 2025, Johnson & Johnson announced that the EC approved Tremfya for the treatment of adult patients with moderately to severely active ulcerative colitis.

In April 2025, Johnson & Johnson announced that the Phase 3b APEX study achieved both its primary endpoint of reducing signs and symptoms and its major secondary endpoint of reducing progression of structural damage as measured by radiographic progression at 24 weeks, in adults living with active psoriatic arthritis, compared to placebo.

Airsupra In May 2025, AstraZeneca announced positive BATURA Phase 3b results that showed Airsupra demonstrated statistically significant and clinically meaningful improvements in all primary and secondary endpoints compared to albuterol in patients with mild asthma.
aficamten
In May 2025, Cytokinetics announced positive topline results from MAPLE-HCM, a Phase 3 trial comparing aficamten to metoprolol in patients with symptomatic obstructive hypertrophic cardiomyopathy. The study met its primary endpoint, demonstrating a statistically significant improvement in peak oxygen uptake from baseline to Week 24 for aficamten with a favorable safety profile.

In May 2025, Cytokinetics announced that the FDA extended the Prescription Drug User Fee Act action date for the NDA for aficamten to December 26, 2025. The FDA required additional time to conduct a full review of the company’s proposed Risk Evaluation and Mitigation Strategy. No additional clinical data or studies have been requested by the FDA.

olpasiran In May 2025, Amgen announced that a Phase 3 cardiovascular (CV) outcomes study in patients with elevated Lp(a) and at a high risk for a first CV event is expected to be initiated in the second half of 2025 or first half of 2026.
Cobenfy In April 2025, Bristol Myers Squibb announced that topline results from the Phase 3 ARISE trial evaluating Cobenfy as an adjunctive treatment to atypical antipsychotics in adults with schizophrenia did not reach the threshold for a statistically significant difference compared to placebo with an atypical antipsychotic for the primary endpoint of the change from baseline to Week 6 in the Positive and Negative Syndrome Scale total score.
trontinemab In April 2025, Roche announced that new trontinemab data continue to support rapid and deep, dose-dependent reduction of amyloid plaques in Phase 1b/2a Brainshuttle AD study. Roche expects to initiate a Phase 3 program for trontinemab at the end of 2025.

2025 Financial Outlook

Royalty Pharma has provided guidance for full year 2025, excluding new transactions and borrowings announced after the date of this release, as follows:

Provided August 6, 2025

Previous

Portfolio Receipts

$3,050 million to $3,150 million

(Growth of ~+9% to 12% year/year)

$2,975 million to $3,125 million

(Growth of ~+6% to 12% year/year)

Payments for operating and professional costs ~9% to 9.5% of Portfolio Receipts Approximately 10% of Portfolio Receipts
Interest paid

$275 million $260 million
The above Portfolio Receipts guidance represents expected growth of 9% to 12% in 2025. Royalty Pharma’s full year 2025 guidance reflects a negligible estimated foreign exchange impact to Portfolio Receipts, assuming current foreign exchange rates prevail for the rest of 2025.

Payments for operating and professional costs in the second half of 2025 are expected to decrease due to extinguishment of the management fee following the completion of the internalization transaction on May 16, 2025. Payments for operating and professional costs include one-time payments amounting to approximately $70 million (>2% of 2025 Portfolio Receipts), comprised of transaction costs for the Internalization and the sale of the MorphoSys Development Funding Bonds.

Total interest paid is based on the semi-annual interest payment schedule of Royalty Pharma’s existing notes and the quarterly interest payment schedule for the term loan assumed as part of the internalization transaction. In 2025, total interest paid(7) is anticipated to be approximately $275 million, including $126 million in the third quarter of 2025 and $8 million in the fourth quarter of 2025. These projections assume no additional debt financing in 2025, including no drawdown on the revolving credit facility. In the second quarter of 2025, Royalty Pharma collected interest of $9 million on its cash and cash equivalents, which partially offset interest paid.

Royalty Pharma today provides this guidance based on its most up-to-date view of its prospects. This guidance assumes no major unforeseen adverse events or changes in foreign exchange rates and excludes the contributions from transactions announced subsequent to the date of this press release.

Financial Results Call

Royalty Pharma will host a conference call and simultaneous webcast to discuss its second quarter 2025 results today at 8:00 a.m., Eastern Time. Please visit the "Investors" page of the company’s website at View Source to obtain conference call information and to view the live webcast. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days.

On August 5, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported financial results for the three-month and six-month periods ended June 30, 2025, and highlighted recent business updates, including progress in advancing Phase 3 clinical development of its lead candidate IMNN-001 in newly diagnosed advanced ovarian cancer (Press release, IMUNON, AUG 5, 2025, View Source [SID1234654789]).

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"IMUNON continues to make significant progress in advancing its mission to transform cancer treatment," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "With groundbreaking IMNN-001 clinical data, a clear clinical development and regulatory strategy, including a Phase 3 trial currently in progress, and significant unmet patient need, IMUNON is well positioned to potentially deliver an innovative therapy for women with newly diagnosed advanced ovarian cancer who urgently need new treatment options."

"Our clinical success has attracted increasing interest from potential institutional investors and from potential partners, reflecting confidence in our technology and business strategy. As we advance the Phase 3 OVATION 3 Study, which will evaluate IMNN-001 in women with stage IIIC or IV ovarian cancer, we are committed to funding this pivotal trial strategically. We have taken steps to conserve cash and align our critical needs with available capital on hand, while securing the resources needed to advance this potentially transformative therapy with select financing opportunities," Dr. Lindborg continued.

RECENT DEVELOPMENTS

IMNN-001 Immunotherapy

First Patient Dosed in the Phase 3 OVATION 3 Study of IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer – On July 30, 2025, the Company announced treatment of the first patient in the OVATION 3 Study and is working with trial investigators to expand clinical sites and accelerate enrollment. Three sites have been activated and are open for patient enrollment, with a corporate goal of having 20 sites activated by the end of 2025.

The Phase 3 OVATION 3 trial will assess the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard of care (SoC) N/ACT alone. Study participants will be randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage 3C or 4) who are eligible for neoadjuvant therapy, the intent-to-treat (ITT) population, with a sub-group of women positive for homologous recombination deficiency (HRD), including BRCA1 or BRCA2 mutations. Participants who are HRD positive will receive poly ADP-ribose polymerase (PARP) inhibitors as part of standard maintenance therapy. The primary endpoint of the study is overall survival (OS), and secondary endpoints are surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints.

Oral Presentation of Phase 2 OVATION 2 Study at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting Reinforces Unprecedented Overall Survival IMNN-001 Data in Advanced Ovarian Cancer – During an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois on June 3, 2025, the Company presented positive data from its Phase 2 OVATION 2 Study showing that treatment with IMNN-001 in women with newly diagnosed advanced ovarian cancer resulted in consistent, clinically meaningful improvements in several key endpoints across treatment groups, including OS, progression-free survival (PFS), chemotherapy response score and surgical response. Treatment with IMNN-001 also showed a favorable safety profile, with no elevation in immune-related adverse events. The review of full data was simultaneously published in the peer-reviewed journal Gynecologic Oncology, titled OVATION-2: A Randomized Phase I/II study Evaluating the Safety and Efficacy of IMNN-001 (IL-12 gene therapy) with Neo/Adjuvant Chemotherapy in Patients Newly- Diagnosed with Advanced Epithelial Ovarian Cancer.

The data presented at ASCO (Free ASCO Whitepaper) 2025 and published in Gynecologic Oncology demonstrated consistent results across all treatment groups, with the following key highlights:

Patients in the intent-to-treat (ITT) population administered IMNN-001 plus SoC N/ACT achieved a median increase in OS of 13 months compared to SoC N/ACT alone (46 vs. 33 months), with a hazard ratio of 0.69.
Better therapeutic effect observed with IMNN-001 treatment compared to the control arm (p=0.0375), as shown by mean 6.5-month extension of time free of progression or death (PFS + OS) captured in totality of treatment effect.
Use of PARP inhibitors as part of maintenance therapy further enhanced outcomes, with median OS not yet reached in IMNN-001 treatment arm after more than five years (vs. 37 months in the control arm), with a hazard ratio of 0.38.

For additional details, please refer to our press release (Press Release). The OVATION 2 Study oral presentation and journal manuscript are both available on the "Scientific Presentations" page of IMUNON’s website at View Source

Positive Phase 2 Translational Data of IMNN-001 in Advanced Ovarian Cancer Presented at ESMO (Free ESMO Whitepaper) Gynaecological Cancers Congress 2025 – On June 18, 2025, at the ESMO (Free ESMO Whitepaper) Gynaecological Cancers Congress 2025, the Company presented new positive translational data from the Phase 2 OVATION 2 Study of IMNN-001, its investigational gene-based interleukin-12 (IL-12) immunotherapy based on its proprietary TheraPlas technology platform, for the treatment of newly diagnosed advanced ovarian cancer. The data demonstrated that IMNN-001 creates a "hot" anti-tumor microenvironment by recruiting CD8+ T cells, macrophages and dendritic cells into the tumor microenvironment and decreasing Treg suppressor cells. This biomarker research further validates IMNN-001’s mechanism of action and selective immune activation at the tumor site.

PlaCCineDNA Vaccine Technology

Six-Month Data Show Durability of Protection for Next-Generation DNA Vaccine Platform in Phase 1 Clinical Trial in COVID-19 – On May 15, 2025, we announced six-month data from the Phase 1 proof-of-concept trial of IMNN-101, our investigational DNA plasmid vaccine based on the Company’s proprietary PlaCCine platform. In 24 healthy volunteers previously vaccinated against the Omicron XBB1.5 variant, a single dose targeting this antigen induced up to a 3-fold median increase in serum neutralizing antibody (NAb) titers from baseline at six months, with stronger responses in the higher dose cohorts (2.0 mg and 1.0 mg) compared to the lower dose (0.5 mg). The highest observed individual increase was 8-fold from baseline among the participating volunteers. Modest T-cell response increases were also observed in trial participants who received multiple immunizations prior to the study. IMNN-101 remained safe and well-tolerated, with no serious adverse events reported.

These results build on February 2025 data showing a persistent 2- to 4-fold NAb titer increase through week 4, with further gains between weeks 2 and 4, and cross-reactivity against XBB1.5 and newer variants. The findings align with preclinical data demonstrating more than 95% protection in non-human primates, comparable to mRNA vaccines. PlaCCine’s demonstrated advantages include durability of protection, simplified manufacturing, and stability (up to one year at 4°C and one month at 37°C), positioning it as a potential alternative to mRNA vaccines. Given our strategic deprioritization of this program, the Company plans to seek partners for further development of IMNN-101.

Corporate Highlights

IMUNON Announces Stock Dividend Boosting Shareholder Value – On July 28, 2025, the Company announced a 15% stock dividend, 0.15 shares of common stock per share of common stock and per each common stock equivalent with dividend rights. This stock grant reflects IMUNON’s confidence in its clinical programs, long-term growth strategy, and its dedication to rewarding shareholders. The stock dividend program will distribute a total of approximately 448,000 shares of additional shares of IMUNON common stock for each share (or common stock equivalent) held, payable to such holders of record as of August 7, 2025. The distribution is expected to occur on August 21, 2025.

Up To $9.75 Million Private Placement Offering Priced At-The-Market – On May 28, 2025, the Company announced the sale of common stock and short-term warrants at a purchase price of $0.45 per share in a private placement priced at-the-market under Nasdaq rules. The aggregate gross proceeds to the Company from the private placement was approximately $3.25 million, before deducting placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the short-term warrants, if fully exercised on a cash basis, will be approximately $6.50 million. The Company intends to use the net proceeds from the offering for working capital focused on the pivotal Phase 3 OVATION 3 Study of IMNN-001 and general corporate purposes. The short-term warrants became exercisable on July 11, 2025, the effective date of stockholder approval of the issuance of the shares of common stock upon exercise of the warrants and have a three-year term.

Continued Listing Extension Granted by Nasdaq to Complete Compliance Plan – On July 15, 2025, the Company announced that the Nasdaq Hearing Panel has granted its request for an exception to complete its compliance plan, allowing the Company to maintain its listing on the Nasdaq Stock Market. Following a comprehensive review of IMUNON’s strategies to regain compliance, the Nasdaq Hearing Panel stated that IMUNON has already achieved compliance with the Equity Rule through recent fundraising activities. To ensure sustained compliance with the minimum shareholder equity requirement and to regain compliance with the minimum bid price requirement, the Company will implement the compliance plan recently presented to the Hearing Panel. The Panel has approved an exception tailored to the time needed for IMUNON to regain compliance, rather than the full 180-day period initially requested. The Company is committed to meeting these requirements within the designated timeframe. Should additional time be necessary, IMUNON may submit a request for an extension to the Panel.

Effected Reverse Stock Split and Increase in Authorized Shares – On July 25, 2025, the Company announced a 15-for-1 reverse stock split of its common stock, which was made effective for trading purposes as of 12:01 a.m. ET on July 25, 2025. All shares have been restated to reflect the effects of the 15-for-1 reverse stock split. Immediately prior to the reverse stock split, the Company had 31,828,425 shares of common stock outstanding which consolidated into 2,121,895 shares of the Company’s common stock. The reverse stock split did not impact the total authorized number of shares of common or preferred stock or the par value thereof. The number of outstanding options, stock awards and warrants were adjusted accordingly, with outstanding options and stock awards being reduced from approximately 1.9 million to approximately 0.1 million and outstanding warrants being reduced from approximately 12.7 million to approximately 0.8 million.

Also at the Company’s 2025 Annual Meeting of Stockholders held on July 11, 2025, IMUNON stockholders approved an amendment to the Company’s Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 112,500,000 shares to 350,000,000 shares, and to make a corresponding change to the number of authorized shares of capital stock.

SECOND QUARTER 2025 FINANCIAL RESULTS

Please note: All share amounts and per share amounts in this press release have been adjusted to reflect a 15-for-1 reverse split of our common stock, which we effected on July 25, 2025.

Net loss for the second quarter of 2025 was $2.7 million, or $2.15 per share, compared with a net loss of $4.8 million, or $7.64 per share, for the second quarter of 2024. Operating expenses were $2.8 million for the second quarter of 2025, a decrease of $2.2 million or 45% from $5.0 million for the second quarter of 2024.

Research and development (R&D) expenses were $1.2 million for the second quarter of 2025, a decrease of $1.6 million from $2.8 million for the second quarter of 2024. The decrease was due primarily to lower costs associated with the OVATION 2 Study, the Phase 1 proof-of-concept PlaCCine DNA vaccine trial, and development of the PlaCCine DNA vaccine technology platform.

General and administrative (G&A) expenses were $1.5 million for the second quarter of 2025, compared with $2.2 million for the second quarter of 2024. This decrease was primarily attributable to lower employee-related and legal expenses.

Investment income from short-term investments was $27,000 for the second quarter of 2025 compared to $225,000 for the same period in 2024 due to lower cash balances.

As of June 30, 2025, cash and cash equivalents were $4.7 million. During July 2025, the Company received $3.1 million in net proceeds from the exercise of warrants and sales under its ATM facility. The Company believes it has sufficient capital resources to fund its planned operations into the fourth quarter of 2025.

FIRST HALF OF 2025 FINANCIAL RESULTS

Please note: All share amounts and per share amounts in this press release have been adjusted to reflect a 15-for-1 reverse split of our common stock, which we effected on July 25, 2025.

For the six months ended June 30, 2025, the Company reported a net loss of $6.8 million, or $6.08 per share, compared with a net loss of $9.7 million, or $15.51 per share, for the same six-month period of 2024. Operating expenses were $6.9 million for the six months ended June 30, 2025, a decrease of $3.1 million or 31% from $10.0 million for the same period in 2024.

Net cash used for operating activities was $5.8 million for the first six months of 2025, compared with $10.4 million for the same period in 2024. This decrease was due to lower operating costs coupled with higher accounts payable and accrued liabilities.

R&D expenses were $3.4 million in the first half of 2025, compared with $6.1 million in the same period of 2024. Clinical costs associated with the OVATION program were $0.4 million in the first half of 2025 compared to $0.7 million in the same period of 2024. Clinical costs associated with the PlaCCine vaccine trial were $83,000 in the first half of 2025 compared to $0.9 million in the first half of 2024. R&D costs associated with the development of IMNN-001 to support the OVATION program were $1.5 million in the first half of 2025 compared to $0.7 million in same period of 2024. The development of the PlaCCine DNA vaccine technology platform was $2.0 million in the first half of 2024. CMC costs were $0.5 million in the first half of 2025 compared to $0.8 million in the same period of 2024.

G&A expenses were $3.5 million in the first half of 2025, compared with $3.9 million in the same period of 2024. The decrease was primarily attributable to lower employee-related expenses and lower legal and travel expenses.

Other non-operating income was $70,000 in the first half of 2025, compared with $307,000 in the same period of 2024. This decrease is due to lower cash and investment balances.

Conference Call and Webcast

The Company is hosting a conference call to review second quarter 2025 financial results and provide a business update today, August 5, 2025, at 11:00 a.m. ET. To participate in the call, please dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON Second Quarter 2025 Financial Results Call. A live webcast of the call will also be available here.

The call will be archived for replay until August 19, 2025. The replay can be accessed at 877-344-7529 (U.S. Toll Free), 855-669-9658 (Canada Toll Free) or 412-317-0088 (International Toll) using replay access code 9465184. An audio replay of the call will also be available here for 90 days.