On August 4, 2025 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition" or the "Company"), a multi-national epigenetics company, reported that it has entered into definitive agreements for the purchase and sale of (i) 156,250 shares of its common stock to certain directors and executive officers of the Company (collectively, the "Insiders") at an offering price of $0.64 per share, and (ii) 1,734,375 shares of its common stock, together with common stock purchase warrants to purchase up to 1,734,375 shares of common stock (individually, a "Warrant" and collectively, the "Warrants"), to certain other existing stockholders of the Company at a combined offering price of $0.64 per share and accompanying Warrant (Press release, VolitionRX, AUG 4, 2025, View Source [SID1234654733]). Each Warrant has an exercise price per share of $0.768, and is exercisable immediately upon issuance, and expires five years from the issuance date.

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The Insiders (purchasers of 156,250 shares) will not receive any Warrants in the offering.

The securities will be issued and sold in the offering by the Company directly to the investors and without a placement agent. The offering is expected to close on or about August 5, 2025, subject to the satisfaction of customary closing conditions.

The aggregate gross proceeds from the offering to the Company are expected to be $1.21 million, before deducting estimated offering expenses payable by the Company, assuming no exercise of the Warrants. The additional gross proceeds to the Company from the Warrants, if such Warrants are fully exercised, will be approximately $1.3 million. However, no assurance can be given that any of these Warrants will be exercised. Volition expects to use the net proceeds of the offering for research and continued product development, clinical studies, product commercialization, working capital and other general corporate purposes, including potential strategic acquisitions.

The securities described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-283088) that was filed with the Securities and Exchange Commission (the "SEC") on November 8, 2024, as amended on April 11, 2025, and declared effective by the SEC on April 18, 2025. The offering is being made only by means of a prospectus supplement and accompanying base prospectus relating to the offering that form a part of the shelf registration statement. The prospectus supplement and accompanying base prospectus relating to the offering will be filed with the SEC and may be obtained, when filed, on the SEC’s website located at www.sec.gov.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 4, 2025 TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) reported its financial results for the second quarter of 2025, along with recent company developments, and provided an update on 2025 revenue guidance (Press release, TG Therapeutics, AUG 4, 2025, View Source [SID1234654732]).

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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "We’re incredibly proud of the continued momentum behind BRIUMVI, which we believe is establishing itself as a leading anti-CD20 therapy in adults with relapsing MS. The strong uptake we’re seeing, combined with deepening physician confidence and compelling patient experiences, underscores the strength of our launch strategy and gives us confidence in reaching our updated 2025 full year BRIUMVI U.S. net revenue guidance of $570 to $575 million. With important innovations like our subcutaneous formulation and combined day one and day fifteen IV dosing currently being studied, we believe BRIUMVI is well positioned to lead the class and redefine treatment expectations for people living with MS."

Recent Highlights & Developments

BRIUMVI (ublituximab-xiiy) Commercialization

BRIUMVI U.S. net product revenue of $138.8 million for the second quarter of 2025, representing 91% growth over the same period last year and 16% growth over Q1 2025
Expansion of commercialization outside of the U.S. with our partner, Neuraxpharm, with BRIUMVI approved in the European Union, United Kingdom, Switzerland and Australia
BRIUMVI Publications

Published two articles in medical journals:
"Switching to Ublituximab from Prior anti-CD20 Monoclonal Antibody Therapy: A Case Report Series", published in Frontiers in Immunology, demonstrating a retrospective case series of seven individuals with multiple sclerosis (MS) treated in private practice or at an MS clinic who switched to ublituximab from a different anti-CD20 monoclonal antibody therapy due to efficacy or tolerability concerns, published in Frontiers in Immunology
"The Evolution of Anti-CD20 Treatment in Multiple Sclerosis", published in CNS DRUGS, demonstrating the differentiating characteristics within the anti-CD20 monoclonal antibody class used to treat MS, published in CNS DRUGS
Pipeline Development Goals Achieved

Commenced patient enrollment into the randomized Phase 3 pivotal program to evaluate a consolidated Day 1 and Day 15 dosing regimen for IV BRIUMVI in the ongoing ENHANCE trial
Dosed the first patient with progressive multiple sclerosis in the Phase 1 clinical trial evaluating azer-cel for the treatment of autoimmune diseases
2025 Financial Guidance

Raises BRIUMVI U.S. net product revenue target to $570 – $575 million for the full year 2025 (prior guidance of $560 million for full year 2025)
Raises total global revenue target to approximately $585 million for the full year 2025 (prior guidance of $575 million for full year 2025)
2025 Remaining Pipeline Development Goals

Commence patient enrollment into the Phase 3 pivotal program for subcutaneous BRIUMVI
Continue enrollment into the Phase 3 pivotal program based on the streamlined dosing regimens evaluated in the ENHANCE trial, evaluating a single Day 1 600 mg IV dose of BRIUMVI
Continue enrollment of participants into the ongoing clinical trial evaluating BRIUMVI in Myasthenia Gravis (MG)
Continue enrollment of participants into the Phase 1 clinical trial evaluating azer-cel for the treatment of autoimmune diseases, beginning with progressive forms of MS
Present updated data at major medical conferences throughout the year
Financial Results for Second Quarter 2025

Product Revenue, net: Product revenue, net was $138.8 million and $258.5 million for the three and six months ended June 30, 2025, respectively, compared to $72.6 million and $123.1 million for the three and six months ended June 30, 2024, respectively. Product revenue, net for both the three and six months ended June 30, 2025 and 2024, consisted of net product sales of BRIUMVI in the United States.
License, milestone, royalty and other revenue: License, milestone, royalty and other revenue was approximately $2.3 million and $3.5 million for the three and six months ended June 30, 2025, respectively, compared to approximately $0.9 million and $13.9 million for the three and six months ended June 30, 2024. License, milestone, royalty and other revenue for the six months ended June 30, 2024 is predominantly comprised of a $12.5 million milestone payment under the Neuraxpharm Commercialization Agreement for the first key market commercial launch of BRIUMVI in the European Union (EU) which occurred in the first quarter of 2024.
R&D Expenses: Total research and development (R&D) expense was approximately $31.8 million and $78.1 million for the three and six months ended June 30, 2025, respectively, compared to $17.6 million and $50.3 million for the three and six months ended June 30, 2024, respectively. The increase in R&D expense during the three and six months ended June 30, 2025 was primarily attributable to manufacturing and development costs incurred in connection with our ublituximab subcutaneous development work during the period.
SG&A Expenses: Total selling, general and administrative (SG&A) expense was approximately $55.6 million and $105.9 million for the three and six months ended June 30, 2025, respectively, compared to $38.8 million and $73.4 million for the three and six months ended June 30, 2024, respectively. The increase in selling, general and administrative costs, was primarily due to an increase in marketing, personnel and external costs associated with the commercialization of BRIUMVI.
Net Income (Loss): Net income was $28.2 million and $33.2 million for the three and six months ended June 30, 2025, respectively, compared to net income (loss) of $6.9 million and $(3.8) million for the three and six months ended June 30, 2024 respectively.
Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $278.9 million as of June 30, 2025. We anticipate that our cash, cash equivalents and investment securities as of June 30, 2025, combined with the projected revenues from BRIUMVI, will be sufficient to fund our business based on our current operating plan.
CONFERENCE CALL INFORMATION
The Company will host a conference call today, August 4, 2025, at 8:30 AM ET, to discuss the Company’s financial results from second quarter 2025.

To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for a period of 30 days after the call.

ABOUT BRIUMVI (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.

BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in the EU and UK for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.

A list of authorized specialty distributors can be found at www.briumvi.com.

IMPORTANT SAFETY INFORMATION
Contraindications: BRIUMVI is contraindicated in patients with:

Active Hepatitis B Virus infection
A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS

Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.

Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.

Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.

Progressive Multifocal Leukoencephalopathy (PML): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JC virus infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies.

If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.

If PML is confirmed, treatment with BRIUMVI should be discontinued.

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.

Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.

Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.

Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.

The full Summary of Product Characteristics approved in the European Union (EU) for BRIUMVI can be found here Briumvi | European Medicines Agency (europa.eu).

ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.

ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.

On August 4, 2025 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported its financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Syndax, AUG 4, 2025, View Source [SID1234654731]).

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"Syndax reported another remarkable quarter. With strong Revuforj and Niktimvo sales momentum along with our expectation for stable expenses over the next few years and more than $500 million in cash, we are well on our way to becoming a profitable company with two blockbuster products," said Michael A. Metzger, Chief Executive Officer. "Notably, Revuforj net revenue increased 43% quarter-over-quarter, even with approximately a third of patients pausing treatment to receive a stem cell transplant. Revuforj is poised for continued growth as we further penetrate the KMT2A population and as patient recontinuations following stem cell transplantation build meaningfully. Importantly, we are nearing another major inflection point with the anticipated approval of Revuforj as the first therapy for R/R mNPM1 AML. Longer-term, our leadership in the menin space positions us to be first to the frontline and meaningfully expand the franchise."

Mr. Metzger continued, "Additionally, Niktimvo is off to a very fast start generating $50 million in net revenue in just the first five months of the launch. It is already profitable to Syndax and we expect increasing profitability margins as revenues continue to grow. The impressive results demonstrate the benefit of delivering a novel approach to treating chronic GVHD and the potential for Niktimvo to transform patient care and make a substantial financial impact for Syndax."

Recent Business Highlights and Anticipated Milestones

Revuforj (revumenib)

Revuforj achieved $28.6 million in net revenue in the second quarter of 2025, representing a 43% increase over the first quarter of 2025. Revuforj was launched in the U.S. in November 2024 for the treatment of relapsed or refractory (R/R) acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older.
Announced that the U.S. FDA granted Priority Review to the Company’s supplemental New Drug Application (sNDA) for Revuforj for the treatment of R/R mutant NPM1 (mNPM1) acute myeloid leukemia (AML). The sNDA is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025.
Presented new Revuforj data in R/R mNPM1 and NUP98-rearranged (NUP98r) AML from the AUGMENT-101 trial at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress Meeting in June 2025.
Additional results from all efficacy-evaluable R/R mNPM1 AML patients in the pivotal Phase 2 portion of the AUGMENT-101 trial of revumenib (n=77) show an overall response rate (ORR)1 of 48% (37/77). The complete remission (CR) plus complete remission with partial hematologic recovery (CRh) rate was 26% (20/77). Median duration of CR/CRh response was 4.7 months. Among patients with CR/CRh assessed for measurable residual disease (MRD), 63% (12/19) were MRD negative. Subpopulation analysis showed that a median overall survival (OS) of 23.3 months (95% CI: 8.4-NR) was observed among the 37 patients who achieved an overall response, based on a Kaplan-Meier estimate from this single-arm trial.
Among patients with R/R NUP98r AML included in the Phase 1 portion of AUGMENT-101, the ORR was 60% (3/5). One patient who proceeded to transplant resumed revumenib post-transplant and was in maintenance cycle 10 as of the data cutoff date. The safety profile of revumenib in patients with R/R NUP98r AML was consistent with previous reports observed in KMT2Ar or mNPM1 AML.
Published pivotal data from patients with R/R mNPM1 AML in the Phase 2 portion of the AUGMENT-101 trial in the journal Blood in May 2025. The results published from the primary efficacy analysis (n=64) are consistent with the data presented at the EHA (Free EHA Whitepaper) Annual Congress Meeting in June 2025 from the larger efficacy-evaluable population (n=77).
Multiple trials evaluating revumenib in mNPM1 and KMT2Ar acute leukemia across the treatment landscape are ongoing. These trials include:
EVOLVE-2: A pivotal, Phase 3, randomized, double-blind, placebo-controlled trial evaluating revumenib in combination with venetoclax and azacitidine in newly diagnosed mNPM1 AML patients who are unfit for intensive chemotherapy. The trial is being conducted in collaboration with the HOVON network, a leading cooperative clinical trial group with extensive experience studying novel therapies for hematologic malignancies.
BEAT AML: A Phase 1 trial evaluating the combination of revumenib with venetoclax and azacitidine in newly diagnosed older adults (≥60 years) with mNPM1 or KMT2Ar AML. The trial is being conducted as part of the Leukemia & Lymphoma Society’s Beat AML Master Clinical Trial. Updated data that showed a 67% (29/43) CR rate and 100% (37/37) flow-MRD negativity rate among evaluable responders were published in the Journal of Clinical Oncology and simultaneously presented in an oral presentation at the EHA (Free EHA Whitepaper) Annual Congress Meeting in June 2025.
SAVE: A Phase 1/2 trial evaluating an all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in pediatric and adult patients with R/R AML or mixed-lineage acute leukemia (MPAL) harboring either mNPM1, KMT2Ar, or NUP98r alterations. The trial is being conducted by investigators from MD Anderson Cancer Center. Updated data that showed an ORR of 82% (27/33) and a CR/CRh rate of 48% (16/33) were presented at the 66th ASH (Free ASH Whitepaper) Annual Meeting. The trial is now enrolling a cohort of newly diagnosed patients.
Intensive chemotherapy: A Phase 1 trial evaluating the combination of revumenib with intensive chemotherapy (7+3) followed by revumenib maintenance treatment in newly diagnosed mNPM1 or KMT2Ar acute leukemia patients. The Company expects to report data in the fourth quarter of 2025 supporting pivotal dose selection.
Break Through Cancer: A Phase 2 trial studying whether the combination of revumenib and venetoclax can eliminate MRD in patients with AML and extend progression-free survival. The trial is being conducted by Break Through Cancer, a collaboration between leading U.S. cancer research centers.
INTERCEPT: A Phase 1 trial evaluating the use of novel therapies, including revumenib, to target MRD and early relapse in AML. The trial is being conducted by the Australasian Leukaemia and Lymphoma Group as part of the INTERCEPT AML master clinical trial. Data that showed 54% (6/11) of patients had MRD reduction at any time, including 36% (4/11) who achieved MRD negativity, were presented at the 66th ASH (Free ASH Whitepaper) Annual Meeting.
Start-up activities are underway for two trials, known as the REVEAL trials, that will evaluate revumenib in combination with standard of care regimens in newly diagnosed acute leukemia patients with mNPM1 or KMT2A-rearranged AML who are fit to receive intensive chemotherapy, with trial initiation expected in the fourth quarter of 2025.
The Company is evaluating revumenib in patients with R/R metastatic microsatellite stable (MSS) colorectal cancer (CRC). The Company expects to report data from the trial by the end of 2025.

Niktimvo (axatilimab-csfr)

Niktimvo achieved $36.2 million in net revenue in the second quarter of 2025, the first full quarter of the U.S. launch, representing significant growth compared to the $13.6 million in net revenue in the first quarter of 2025. Niktimvo was launched in the U.S. in late January 2025 for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs). Syndax and Incyte are co-commercializing Niktimvo. Syndax records 50% of the Niktimvo net commercial profit/loss, defined as net product revenue minus the cost of sales and commercial expenses. For the second quarter of 2025, Syndax’s share of the Niktimvo product contribution, reported as Collaboration revenue, was $9.4 million.
Presented data at the EHA (Free EHA Whitepaper) Annual Congress Meeting in June 2025 highlighting the robust and rapid responses observed in different organs and subgroups of patients with chronic GVHD in the pivotal AGAVE-201 trial that supported the FDA approval of Niktimvo.
Two trials evaluating axatilimab in combination with standard of care therapies in newly diagnosed chronic GVHD patients are ongoing, including:
A Phase 2, open-label, randomized, multicenter trial of axatilimab in combination with ruxolitinib in patients ≥ 12 years of age with newly diagnosed chronic GVHD.
A pivotal Phase 3, randomized, double-blind, placebo-controlled, multi-center trial of axatilimab in combination with corticosteroids in patients ≥ 12 years of age with newly diagnosed chronic GVHD.
Enrollment is ongoing in MAXPIRe, a Phase 2, 26-week randomized, double-blinded, placebo-controlled trial of axatilimab on top of standard of care in patients with idiopathic pulmonary fibrosis (IPF). The Company expects to complete enrollment in the trial in the fourth quarter of 2025 with topline data anticipated in the second half of 2026.
Corporate Updates

In May 2025, the Company announced the appointment of Dr. Nick Botwood as Head of Research and Development and Chief Medical Officer. Dr. Botwood brings 25 years of industry experience leading drug development, R&D strategy, and global commercialization of novel oncology therapeutics.
In June 2025, the Company announced the resignation of William Meury from its Board of Directors after seven years of service due to his acceptance of the role of President and Chief Executive Officer and a member of the Board of Directors at Incyte, the Company’s collaboration partner for Niktimvo.
Second Quarter 2025 Financial Results

As of June 30, 2025, Syndax had cash, cash equivalents, and short and long-term investments of $517.9 million and 86.3 million common shares and prefunded warrants outstanding.

Total revenue for the second quarter of 2025 was $38.0 million, which consisted of $28.6 million in Revuforj net product revenue and $9.4 million in Niktimvo collaboration revenue. The collaboration revenue is derived from the $36.2 million in Niktimvo net revenue that was previously reported by the Company’s partner Incyte. Syndax records 50% of the Niktimvo net commercial profit/loss, defined as net product revenue (recorded by Incyte) minus the cost of sales and commercial expenses.

Second quarter 2025 research and development expenses increased to $62.2 million from $48.7 million for the comparable prior year period. The increase was due to an increase in revumenib-related costs primarily driven by multiple trials evaluating revumenib in mNPM1 and KMT2Ar acute leukemia across the treatment landscape, milestone paid to AbbVie upon submission of the sNDA, and medical affairs activities supporting Revuforj as well as increased personnel costs to help support commercialization.

Second quarter 2025 selling, general and administrative expenses increased to $43.8 million from $29.1 million for the comparable prior year period. The increase was primarily due to increased employee-related expenses and professional fees to support increased sales and marketing-related expenses related to the U.S. commercial launch of Revuforj.

For the three months ended June 30, 2025, Syndax reported a net loss attributable to common stockholders of $71.8 million, or $0.83 per share, compared to a net loss attributable to common stockholders of $68.1 million, or $0.80 per share, for the comparable prior year period.

Financial Guidance

For the third quarter of 2025, the Company expects total research and development plus selling, general and administrative expenses to be $95 to $100 million, excluding non-cash stock compensation expense. For the full year of 2025, the Company expects total research and development plus selling, general and administrative expenses to be $370 to $390 million, excluding non-cash stock compensation expense. The full year 2025 guidance represents no change to prior guidance, which was $415 to $435 including $45 million in estimated non-cash stock compensation expense. The Company is not providing revenue guidance at this time.

Syndax expects that its operating expense base will remain stable over the next few years. As a result, Syndax expects that its cash, cash equivalents and short- and long-term investments, combined with its anticipated product revenue and interest income, will enable the company to reach profitability.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, August 4, 2025.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website. Alternatively, the conference call may be accessed through the following:

Conference ID: Syndax2Q25
Domestic Dial-in Number: 800-590-8290
International Dial-in Number: 240-690-8800
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website at www.syndax.com approximately 24 hours after the conference call and will be available for 90 days following the call.

About Revuforj (revumenib)

Revuforj (revumenib) is an oral, first-in-class menin inhibitor that is FDA approved for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older.

The FDA has granted Priority Review to Syndax’s supplemental New Drug Application (sNDA) seeking the approval of revumenib for the treatment of R/R mNPM1 AML. The sNDA is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which allows for a more efficient review and close engagement between the sponsor and FDA. The sNDA is supported by positive pivotal data from the AUGMENT-101 trial of revumenib in patients with R/R mNPM1 AML. Results from this population were published in the journal Blood and presented at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress Meeting.

Additionally, multiple trials of revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with mNPM1 or KMT2Ar AML.

Revumenib was previously granted Orphan Drug Designation for the treatment of AML, ALL and acute leukemias of ambiguous lineage (ALAL) by the U.S. FDA and for the treatment of AML by the European Commission. The U.S. FDA also granted Fast Track designation to revumenib for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation and Breakthrough Therapy Designation for the treatment of adult and pediatric patients with R/R acute leukemia harboring a KMT2A rearrangement.

About Niktimvo (axatilimab-csfr)

Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD, including a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774). Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

About the Real-Time Oncology Review Program (RTOR)

RTOR provides a more efficient review process for oncology drugs to ensure that safe and effective treatments are available to patients as early as possible, while improving review quality and engaging in early iterative communication with the applicant. Specifically, it allows for close engagement between the sponsor and the FDA throughout the submission process and it enables the FDA to review individual sections of modules of a drug application rather than requiring the submission of complete modules or a complete application prior to initiating review. Additional information about RTOR can be found at: View Source

On August 4, 2025 Mural Oncology plc (Nasdaq: MURA), reported its financial results for the second quarter of 2025 and provided a business update (Press release, Mural Oncology, AUG 4, 2025, View Source [SID1234654729]). On April 15, 2025, Mural announced that it was discontinuing all clinical development of its lead product candidate, nemvaleukin alfa, and was commencing the exploration of strategic alternatives focused on maximizing shareholder value. The Company is continuing to explore strategic alternatives.

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Following its announcement on April 15, 2025, Mural has taken steps to conserve its remaining cash, including the implementation of a reduction in workforce by approximately 90%, the discontinuation of the clinical development of nemvaleukin alfa, and the termination of its other research and development activities, including the research and development of its IL-18 and IL-12 programs. As of June 30, 2025, the company had approximately $77.1 million in cash and cash equivalents. The company estimates that, if it has not consummated a transaction or other strategic alternative by December 31, 2025, its cash and cash equivalents as of such date will total approximately $43 to $48 million. This estimate reflects anticipated costs to be incurred in connection with finalization of the discontinuation of the company’s remaining activities and expected residual operating expenses (e.g. lease expense, salary and benefits for remaining employees, insurance costs). This cash guidance is subject to a number of assumptions and actual cash balances may differ materially, particularly if the Company consummates a transaction or other strategic alternative prior to December 31, 2025. Mural has not included in its cash guidance, additional costs that may be incurred as a result of, or in connection with, any strategic alternative it may pursue, including, but not limited to, an offer for or other acquisition of the company, merger, business combination or other transaction, including a possible wind-down and liquidation of the company (e.g., legal and financial advisor fees and severance costs for remaining employees).

Further updates and developments will be disclosed as appropriate or where necessary under regulatory requirements. There can be no assurance that the company’s exploration of strategic alternatives will result in the company pursuing a transaction or that any acquisition or other transaction involving the company will be completed, nor as to the terms on which any acquisition or other transaction will occur, if at all.

Financial Results for the Quarter Ended June 30, 2025

Cash Position: As of June 30, 2025, cash and cash equivalents were $77.1 million.

R&D Expenses: Research and development expenses were $23.3 million for the second quarter of 2025 compared to $27.5 million for the second quarter of 2024. This decrease was primarily due to decreased employee-related expenses following the reduction-in-force implemented by the company during the second quarter of 2025 and the decreased spend on the ARTISTRY-7 clinical trial of nemvaleukin due to the termination of the development of nemvaleukin. These decreases were partially offset by an increase in spend on early discovery programs upon completion of certain manufacturing activities and on the ARTISTRY-6 trial of nemvaleukin related to the top-line read-out and wind-down of the trial during the second quarter of 2025.

G&A Expenses: General and administrative expenses were $8.1 million for the second quarter of 2025 compared to $6.7 million for the second quarter of 2024. This increase in G&A expenses was primarily due to increased employee-related expenses associated with employee termination and retention benefits and increased legal expenses associated with corporate activities, partially offset by decreased share-based compensation expense resulting from an increase in the awards that were forfeited or were expected to be forfeited following the reduction-in-force.

Restructuring and Impairment Expenses: Mural incurred $17.5 million in restructuring and impairment charges during the second quarter of 2025, consisting of severance and termination benefits related to the reduction-in-force, an impairment charge related to lab equipment sold during the second quarter of 2025 and contract termination and write-offs related to the termination of the company’s research and development programs.

Net Loss: Net loss was $48.0 million for the second quarter of 2025 compared to $31.6 million for the second quarter of 2024. The increase in net loss was primarily driven by the restructuring and impairment charges incurred during the second quarter of 2025.

Cash Guidance: Mural estimates that its cash and cash equivalents will be approximately $43.0 million – $48.0 million as of December 31, 2025, if it has not consummated a transaction or other strategic alternative by such date.

On August 4, 2025 XOMA Royalty Corporation ("XOMA Royalty") (NASDAQ: XOMA) and LAVA Therapeutics N.V. ("LAVA") (NASDAQ: LVTX) reported they have entered a definitive share purchase agreement (the "Purchase Agreement" and the transactions set forth in the Purchase Agreement, the "Transactions") whereby XOMA Royalty will acquire LAVA for (i) USD between $1.16 and $1.24 per share in cash, consisting of (A) USD $1.16 (the "Base Price Per Share") in cash per share (the "LAVA common stock"), plus (B) an additional amount of cash of up to $0.08 per Share (such amount as finally determined in accordance with the Purchase Agreement, the "Additional Price Per Share," and together with the Base Price Per Share, the "Cash Amount"), plus (ii) a non-transferable contingent value right ("CVR") per share representing the right to receive 75% of the net proceeds related to LAVA’s two partnered assets and 75% of any net proceeds from any out license or sale of LAVA’s unpartnered programs (Press release, Lava Therapeutics, AUG 4, 2025, View Source [SID1234654728]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We believe the structure of this transaction has the potential to benefit both LAVA and XOMA Royalty shareholders over time," stated Owen Hughes, Chief Executive Officer of XOMA Royalty. "We are adding economics related to LAVA’s partnered programs investigating the utility of gamma delta bispecific antibodies, which hold significant promise for patients."

"The Purchase Agreement with XOMA Royalty announced today is the result of a thorough and wide-ranging strategic review process, conducted with the support of our legal and financial advisors, aimed at maximizing shareholder value while participating in the sustained success of LAVA’s business," said Steve Hurly, Chief Executive Officer of LAVA.

In accordance with its fiduciary duties under Dutch law, LAVA’s Board of Directors (the "Board") has unanimously determined that the Transactions are in the best interests of LAVA and the sustainable success of its business, having carefully considered the interests of LAVA shareholders, employees, and all other relevant stakeholders and has approved the Purchase Agreement. The Board unanimously recommends that shareholders support the Offer, accept the Offer and vote in favor of the resolutions to be proposed to LAVA’s shareholders’ meeting, as noted below.

Transaction Terms

Pursuant and subject to the terms of the Purchase Agreement, XOMA Royalty will commence a tender offer (the "Offer") by August 15, 2025, to acquire all outstanding shares of LAVA common stock. The closing of the Offer is subject to certain conditions, including the tender of LAVA common stock representing at least 80% (or, in certain cases, 75%) of LAVA’s issued and outstanding shares, the condition that certain resolutions are adopted by LAVA’s shareholders meeting; a minimum cash balance at closing, and other customary closing conditions. Following a subsequent offering period, LAVA will undergo a corporate reorganization designed to result in XOMA Royalty acquiring 100% of the shares in LAVA’s successor and all then-remaining LAVA shareholders (other than XOMA Royalty) receiving the same cash and CVR consideration per share as is provided in the tender offer, subject to applicable withholding taxes. LAVA will hold a shareholder’s meeting in connection with the Transactions. The closing of the Transactions is expected in the fourth quarter of 2025.

In connection with the Transactions, the Company plans to discontinue its Phase 1 clinical trial of LAVA-1266 for acute myeloid leukemia and myelodysplastic syndrome and initiate the wind-down of the LAVA-1266 program.

Advisors

XOMA Royalty was represented by Gibson, Dunn & Crutcher LLP and Loyens & Loeff N.V, who acted as U.S. and Dutch legal advisors, respectively. Leerink Partners is acting as exclusive financial advisor to LAVA, Cooley LLP is acting as U.S. legal advisor to LAVA and NautaDutilh N.V. is acting as Dutch legal advisor to LAVA.