On August 6, 2025 OmniAb, Inc. (NASDAQ: OABI) reported financial results for the three and six months ended June 30, 2025, and provided operating and partner program updates (Press release, OmniAb, AUG 6, 2025, View Source [SID1234654882]).

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"Our business is performing very well as we continued our momentum in partner additions in the second quarter, reaching 100 active partners. This is a testament to the strength of our innovative technology platform and to our team’s execution, and puts us on pace for one of our strongest years ever in partner adds. Additionally, a recent further streamlining of our operations enhances the scalability and long-term value of our business," said Matt Foehr, Chief Executive Officer of OmniAb. "Our recent launch of the xPloration Partner Access Program demonstrates our commitment to innovation, customer service and value creation. We are excited about this new offering for our partners and for its potential to expand and diversify our revenue streams."

Second Quarter 2025 Financial Results

Revenue for the second quarter of 2025 was $3.9 million, compared with $7.6 million for the same period in 2024. License and milestone revenue decreased primarily due to a $1.8 million decline in milestone revenue. Service revenue declined primarily due to the discontinuation of a small-molecule ion channel program and the related acceleration of non-cash revenue in the prior year period. These decreases were offset by $0.6 million in xPloration revenue as a result of the sale of an instrument and related consumables.

Cost of xPloration revenue was $0.3 million for the second quarter of 2025 and consists of direct costs associated with the sale of the xPloration instrument and associated consumables. Research and development expense was $10.9 million for the second quarter of 2025, compared with $13.9 million for the same period in 2024, with the decrease primarily due to lower share-based compensation expense and reduced headcount, and lower external expenses associated with the small-molecule ion channel programs. General and administrative expense was $7.7 million for the second quarter of 2025, compared with $8.0 million for the same period in 2024, with the decrease primarily due to lower legal fees and share-based compensation expense. Other operating income, net was $1.9 million, which included a gain of $3.0 million from the sale of a small molecule program to Angelini Pharma partially offset by a $1.0 million contingent liability adjustment associated with that program. Other operating income, net for the prior-year period was $2.5 million, which included a $2.6 million reduction in contingent liabilities attributed to changes in partner small molecule ion channel programs.

Net loss for the second quarter of 2025 was $15.9 million, or $0.15 per share, compared with a net loss of $13.6 million, or $0.13 per share, for the same period in 2024.

Cash use in the second quarter of 2025 was $2.0 million.

Year-to-Date Financial Results

Revenue for the first half of 2025 was $8.1 million, compared with $11.4 million for the same period in 2024. License and milestone revenue decreased primarily due to a $0.8 million decline in milestone revenue, partially offset by a $0.2 million increase in license revenue. Service revenue declined primarily due to the discontinuation of a small-molecule ion channel program and the related acceleration of non-cash revenue in the prior year period. These decreases were offset by $0.7 million in xPloration revenue as a result of the sale of an instrument and related consumables.

Cost of xPloration revenue was $0.3 million for the first half of 2025 and consists of direct costs associated with the sale of the xPloration instrument and associated consumables. Research and development expense was $23.5 million for the first half of 2025, compared with $28.5 million for the same period in 2024, primarily due to lower share-based compensation expense and reduced headcount, and lower external expenses associated with the small-molecule ion channel programs and screening technology development. General and administrative expense was $15.6 million for the first half of 2025, compared with $16.3 million for the same period in 2024 with the decrease primarily due to lower legal fees and share-based compensation expense. Other operating income, net for the first half of 2025 reflected a gain of $3.0 million from the sale of a small molecule program to Angelini Pharma, partially offset by a $1.0 million contingent liability adjustment associated with that program, whereas the prior-year period included a $2.6 million reduction in contingent liabilities attributed to changes in partner small molecule ion channel programs.

Net loss for the first half of 2025 was $34.1 million, or $0.32 per share, compared with a net loss of $32.6 million, or $0.32 per share, for the same period in 2024.

As of June 30, 2025, OmniAb had cash, cash equivalents and short-term investments of $41.6 million.

2025 Financial Guidance

OmniAb affirms guidance for 2025 revenue to be in the range of $20 million to $25 million, and for costs and operating expense to be in the range of $85 million to $90 million. In addition, OmniAb continues to expect 2025 cash use to be lower than cash use in 2024. Cash use in 2024 was $38.9 million, excluding the 2024 ATM issuance. The 2025 full year effective tax rate is expected to be approximately 0%.

Second Quarter 2025 and Recent Business Highlights

During the second quarter of 2025, OmniAb entered into six new license agreements, including with Veraxa Biotech, AG, Duke-NUS, University of Strathclyde, University of Maryland, AB-Ray Bio and an undisclosed global clinical research organization, and one asset-based sale. The asset-based sale was with Angelini Pharma for the small molecule Kv7.2 program. OmniAb received an upfront payment of $3 million and is entitled to receive potential milestones of over $170 million and royalties.

As of June 30, 2025, the Company had 100 active partners and 381 active programs, including 32 OmniAb-derived programs in clinical development or being commercialized.

Business and partner highlights from the second quarter of 2025 and recent weeks included the following:

xPloration

In May, OmniAb launched the xPloration Partner Access Program. xPloration is a high-throughput single B-cell screening instrument that leverages machine learning and artificial intelligence to address challenges in primary B-cell screening with traditional methods. xPloration’s competitive edge includes unmatched screening throughput, superior hit recovery, exceptional ease-of-use and reliability.
OmniAb highlighted case studies utilizing xPloration in a presentation titled "xPloration: Simplifying Deep Antibody Mining for Maximum Impact" at the 21 st Annual PEGS Boston Conference and Expo, where xPloration was awarded 2025 Best of Show. The presentation illustrated the platform’s capabilities across various assay formats, including multiplex cell surface binding and cross-blocking assays.
IMVT-1402

In May, Immunovant started recruitment of a randomized, placebo-controlled, double-blind Phase 3 study to assess the efficacy and safety of IMVT-1402 in patients with mild-to-severe generalized myasthenia gravis.
Immunovant is also enrolling patients in potentially registrational trials of IMVT-1402 in chronic inflammatory demyelinating polyneuropathy, Graves’ disease, difficult-to-treat rheumatoid arthritis and Sjogren’s disease. Additionally, a proof-of-concept study has been initiated in a sixth indication, cutaneous lupus erythematosus.
TEV-53408

Teva Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for investigational TEV-53408, an anti-IL15 antibody, for the treatment of people with celiac disease on a gluten-free diet. TEV-53408 is currently being evaluated in Phase 2a and Phase 1 clinical trials to assess the efficacy and safety in adults with celiac disease and vitiligo, respectively.
TEV-56278

Teva Pharmaceutical and Shanghai Fosun Pharmaceutical announced that the companies, through their respective subsidiaries, entered into a strategic partnership for the development of investigational TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy. Teva’s proprietary ATTENUKINE technology provides a new mechanism of action, potentially offering high efficacy and low toxicity in a broad array of oncology indications
JNJ-5322

At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Johnson & Johnson presented initial Phase 1 results of JNJ-5322, a next-generation trispecific T-cell redirecting antibody targeting BCMA x GPRC5D x CD3, in patients with relapsed or refractory multiple myeloma. JNJ-5322 demonstrated a 100% overall response rate (ORR) at the recommended Phase 2 dose of 100 mg in anti-BCMA/-GPRC5D naïve patients, with convenient dosing every four weeks. Initial data with JNJ-5322 suggest a paradigm shift, offering ORRs similar to CAR-Ts but as an off-the-shelf therapy intended for outpatient dosing.
M9140

At the ASCO (Free ASCO Whitepaper) Annual Meeting, Merck KGaA presented data on M9140, a novel antibody-drug conjugate with topoisomerase 1 inhibitor payload targeting tumors that express carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5). In the Phase 1 PROCEADE-CRC-01 study, M9140 showed a predictable, manageable safety profile and promising early clinical activity in heavily pretreated metastatic colorectal cancer (mCRC) patients. The ORR of 31% (17.2% confirmed) and median progression free survival (mPFS) of 6.9 months at 2.8 mg/kg every three weeks compares favorably with current monotherapy standard of care (ORRs 1-2%, mPFS 1.9-3.7 months) and recent Phase 3 data with trifluridine–tipiracil + bevacizumab (ORR 6.1%, mPFS 5.6 months) in 3L+ mCRC. These results suggest 2.8 mg/kg as the recommended Phase 2 dose for further development in colorectal cancer, and other solid tumors.
Merck KGaA also presented the PROCEADE PanTumor Phase 1b/2 clinical trial study design at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper). This study will assess the antitumor activity, tolerability, safety and pharmacokinetics of M9140 either as monotherapy or in combination with other anticancer agents in patients with advanced/metastatic gastric cancer, non-small cell lung cancer (NSCLC) and pancreatic adenocarcinoma.
Sugemalimab

CStone Pharmaceuticals announced the publication of long-term survival data from its Phase 3 GEMSTONE-302 trial in The Lancet Oncology. This study evaluates sugemalimab combined with platinum-based chemotherapy as a first-line treatment for both squamous and non-squamous, non-oncogene-addicted metastatic NSCLC. This marks the trial’s third publication in a top-tier journal, following earlier publications of final progression-free survival results in The Lancet Oncology(2022) and interim overall survival results in Nature Cancer(2023).
CStone Pharmaceuticals also announced an exclusive partnership with Istituto Gentili, a European biopharmaceutical company with a century-long heritage in oncology, to commercialize sugemalimab across Western Europe and the UK. Under the agreement, Gentili received exclusive commercialization rights for sugemalimab in 23 European countries, as well as the UK and other geographies.
BC3195

At the ASCO (Free ASCO Whitepaper) Annual Meeting, BioCity presented data on BC3195, a first-in-human antibody-drug conjugate targeting CDH3. BC3195 demonstrated a manageable safety profile and favorable pharmacokinetics, with impressive preliminary antitumor activity in heavily pretreated NSCLC patients – most of whom had EGFR mutations – achieving an ORR of 50%. Dose optimization and expansion are ongoing.
Conference Call and Webcast

OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (800) 549 8228 using the conference ID 93102. Slides, as well as the live and replay webcast, are available at View Source

On August 6, 2025 Galapagos NV (Euronext & NASDAQ: GLPG) reported that the United States Food and Drug Administration (FDA) has granted RMAT designation to GLPG5101, a second generation anti-CD19/4-1BB CAR-T product candidate for the treatment of relapsed/refractory mantle cell lymphoma (R/R MCL) (Press release, Galapagos, AUG 6, 2025, View Source [SID1234654864]).

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The RMAT designation was established under the U.S. 21st Century Cures Act to accelerate development and review of promising cell and gene therapies for serious or life-threatening conditions. To qualify for RMAT designation, GLPG5101 demonstrated preliminary clinical evidence suggesting it has the potential to treat, modify, reverse, or cure a serious or life-threatening disease.

Clinical data derived from the ongoing ATALANTA-1 study with GLPG5101 in patients with R/R B-cell Non-Hodgkin Lymphoma (B-NHL), including a subset of patients with MCL, supported the RMAT designation. These data1 demonstrated both high objective and high complete response rates, with a manageable safety profile, including low rates of high-grade cytokine release syndrome (CRS), immune effector cell associated neurotoxicity syndrome (ICANS) and low dropout rates.

"This designation reflects the promising clinical activity and safety profile observed in our ongoing Phase 1/2 study and supports our commitment to delivering an effective and timely treatment option to patients in need," said Omotayo Fasan, M.D., Clinical Development Program Head at Galapagos. "With RMAT status allowing for closer collaboration with the FDA, this will enable additional opportunities for accelerated development and assessment timelines."

Benefits of RMAT designation include increased FDA guidance and more frequent interactions during development, eligibility for accelerated approval based on surrogate or intermediate endpoints, all Fast Track and Breakthrough Therapy advantages such as priority review and rolling submissions, and early discussions of potential study endpoints.

Galapagos intends to report updated data from the ATALANTA-1 study at a future medical conference.

About GLPG5101 and ATALANTA-1

GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The safety, efficacy and feasibility of decentralized manufactured GLPG5101 are currently being evaluated in the ATALANTA-1 Phase 1/2 study in eight hematological malignancies with high unmet need. The primary objective of the Phase 1 part of the study is to evaluate safety and to determine the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment of efficacy and feasibility of decentralized manufacturing of GLPG5101. The dose levels that were evaluated in Phase 1 are 50×106 (DL1), 110×106 (DL2) and 250×106 (DL3) CAR+ viable T-cells. The primary objective of the Phase 2 part of the study is to evaluate the Objective Response Rate (ORR) while the secondary objectives include Complete Response Rate (CRR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of decentralized manufacturing. Each enrolled patient will be followed for 24 months. The ATALANTA-1 study is currently enrolling patients in the U.S. and Europe.

About relapsed/refractory mantle cell lymphoma

Mantle cell lymphoma is a rare and aggressive subtype of non-Hodgkin lymphoma originating from B cells. Patients with relapsed or refractory disease have progressed after standard therapies and face limited treatment options and reduced survival rates.

On August 6, 2025 Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma Inc. (NASDAQ: LTRN), reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase Ib/2a clinical trial to evaluate STAR-001 (LP-184) in combination with spironolactone for patients with glioblastoma multiforme (GBM) at first progression (Press release, Lantern Pharma, AUG 6, 2025, View Source;Food-and-Drug-Administration-Clearance-of-IND-for-Phase-Ib2a-Glioblastoma-Multiforme-GBM-Trial/default.aspx [SID1234654883]).

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The planned Phase Ib/2a clinical trial (IND 178511) is designed to investigate the safety, tolerability, and preliminary efficacy of STAR-001 in combination with spironolactone in patients with recurrent GBM, one of the deadliest and most aggressive forms of brain cancer. GBM represents approximately 15% of all brain tumors and has a median survival of approximately 12 months from initial diagnosis, with fewer than 5% of patients surviving beyond five years.

"This FDA clearance represents a significant milestone for Starlight Therapeutics and our mission to bring innovative treatment options to patients facing the most challenging forms of brain and CNS cancers," said Dr. Marc Chamberlain, Chief Medical Officer of Starlight Therapeutics. "GBM remains one of the most difficult cancers to treat, with virtually no meaningful therapeutic advances in nearly 17 years. We believe our unique combination approach has the potential to offer new hope for patients and their families while advancing a novel mechanism to challenge these recurrent brain cancers."

Targeting GBM Through Innovative Synthetic Lethality

STAR-001 (also referred to as LP-184 when focused on other solid tumor indications) is a synthetically lethal, brain-penetrant, novel DNA-damaging agent that has demonstrated promising preclinical activity against various solid tumors, including pediatric and adult brain cancers. Lantern Pharma has previously been awarded both FDA Orphan Drug Designation and FDA Fast Track Designation for STAR-001 in GBM, underscoring the significant unmet medical need and the drug’s potential to address it. An existing Phase 1a trial to determine safety, dosing, the maximum tolerated dose (MTD) and tolerability across a range of solid tumors, including GBM, is currently underway and expected to complete enrollment in the current quarter. This trial is expected to help establish a baseline dosing level and expectations of drug-concentration in tumor and plasma for future clinical trials, including those being planned by Starlight Therapeutics.

The combination of STAR-001 with spironolactone, an existing FDA approved drug, represents a scientifically rational approach to treating GBM. STAR-001 is a blood-brain barrier permeable small molecule that leverages synthetic lethality to exploit DNA damage repair (DDR) deficiencies, particularly those overexpressing PTGR1. Approximately 60% of GBM cells overexpress PTGR1 levels sufficient to activate STAR-001. Spironolactone significantly enhances this therapeutic effect by inducing degradation of ERCC3, a critical protein involved in nucleotide excision repair (NER). This mechanism leads to NER deficiency (NERD), making GBM cells significantly more sensitive to STAR-001 and less capable of repairing the DNA damage caused by the administration of STAR-001. This synergistic approach is particularly promising in GBM which has often become resistant to therapies in the recurrent setting.

AI-Driven Drug Development Platform

Starlight Therapeutics was formed to pursue the focused clinical development of central nervous system (CNS) oncology indications developed and advanced through Lantern Pharma’s proprietary artificial intelligence drug development platform, RADR. This AI-driven approach enables the identification of optimal drug-cancer combinations and patient populations most likely to benefit from treatment, significantly reducing the time and cost typically associated with traditional drug development.

"The clearance of this IND demonstrates the power of our efficient, data-driven drug development model in identifying promising therapeutic opportunities in areas of high unmet medical need," said Panna Sharma, President and CEO of Lantern Pharma. "Through Starlight Therapeutics, we are positioned to dedicate focused resources and expertise to advancing treatments for some of the most challenging cancers affecting the brain and central nervous system in both adults and children, while developing meaningful therapies that can reach patients in an accelerated timeline compared to traditional drug development processes."

Market Opportunity and Next Steps

With GBM representing an annual market opportunity of $3 to $5 billion globally and case numbers accelerating worldwide, there is an urgent need for innovative treatment approaches. The current standard of care has remained largely unchanged for over 15 years, highlighting the critical importance of novel therapeutic strategies like the STAR-001 combination.

Starlight is targeting commencement of the Phase Ib/2a trial in late 2025 or early 2026, subject to additional funding, and plans to provide regular updates on trial preparation, patient enrollment progress, and preliminary data as they become available.

About Glioblastoma Multiforme (GBM)

Glioblastoma multiforme is the most common and aggressive form of primary brain tumor in adults, accounting for approximately 15% of all brain tumors. Despite aggressive multimodal treatment including surgery, radiation, and chemotherapy, the prognosis remains extremely poor, with a median survival of only 12 months and a five-year survival rate of less than 5%. The blood-brain barrier presents a significant challenge in treating GBM, as most therapeutic agents cannot effectively penetrate brain tissue.

On August 6, 2025 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported financial results for the second quarter of 2025 and recent business highlights (Press release, Geron, AUG 6, 2025, View Source [SID1234654865]). In a separate press release today, the Company announced the appointment of Harout Semerjian as incoming President and CEO.

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"We are pleased that our sharpened sales strategy is demonstrating signs of commercial success as evidenced by solid U.S. sales and increased demand across a broadening group of treating physicians," said Dawn Carter Bir, Interim President and Chief Executive Officer of Geron. "Last quarter, we set out to increase our commercial sales team by 20% and double our medical science liaisons and I’m pleased to say we have accomplished both of these goals. We believe our investments in commercial and medical affairs will help to bolster awareness and adoption of RYTELO, our first-in-class telomerase inhibitor, and with the leadership experience Harout brings to the company, we look forward to further progress over time."

Recent Business Highlights

RYTELO

Net product revenue of $49.0 million in the second quarter of 2025, an increase of 24% compared to the first quarter.
Quarter-over-quarter demand for RYTELO in the second quarter of 2025 increased by 17%, compared to 1% in the first quarter, driven by increased demand from new patient starts.
Number of ordering accounts is now over 1,000, an increase of approximately 400 year-to-date.
Geron is continuing preparatory activities for the anticipated launch of RYTELO in select EU countries, following approval earlier this year.
IMpactMF Phase 3 Clinical Trial Evaluating imetelstat in relapsed/refractory myelofibrosis

Reached over 95% enrollment as of end of July, with full enrollment expected by year-end 2025.
Interim analysis readout for overall survival expected in the second half of 2026 (when approximately 35% of patient events have occurred), and final analysis expected in the second half of 2028 (when approximately 50% of patient events have occurred).
Recent Medical and Scientific Presentations

Presented multiple presentations at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress.
Together, these presentations support the potential benefits of the first-in-class oligonucleotide telomerase inhibitor RYTELO (imetelstat) for a range of patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia and showcase the progress Geron is making with the ongoing IMpactMF and IMproveMF trials of imetelstat in myelofibrosis.
Second Quarter 2025 Financial Results

Cash and Marketable Securities

As of June 30, 2025, Geron had approximately $432.6 million in cash, cash equivalents, restricted cash and marketable securities, compared to $502.9 million as of December 31, 2024.

Net Loss

For the three and six months ended June 30, 2025, the Company reported a net loss of $16.4 million, or $0.02 per share and $36.2 million, or $0.05 per share, compared to $67.4 million, or $0.10 per share and $122.8 million, or $0.19 per share, for the three and six months ended June 30, 2024.

Revenues

Total product revenue, net for the three and six months ended June 30, 2025, was $49.0 million and $88.4 million, compared to $780,000 for the three and six months ended June 30, 2024, as RYTELO was approved by the FDA in June 2024.

Total net revenue for the three and six months ended June 30, 2025, was $49.0 million and $88.6 million, compared to $882,000 and $1.2 million for the three and six months ended June 30, 2024. Total net revenue includes license fees and royalties in addition to any product revenue, net. The increase in revenue is due to product revenue from U.S. sales of RYTELO, which was approved by the FDA in June 2024.

Operating Expenses

Total operating expenses for the three and six months ended June 30, 2025, were $61.5 million and $117.8 million, compared to $70.2 million and $126.7 million for the three and six months ended June 30, 2024.

Cost of goods sold was approximately $1.2 million and $2.4 million for the three and six months ended June 30, 2025, compared to $17,000 for the three and six months ended June 30, 2024, which consisted of costs to manufacture and distribute RYTELO.

Research and development expenses for the three and six months ended June 30, 2025, were $21.7 million and $36.8 million, compared to $30.8 million and $60.2 million for the same periods in 2024. The decrease in research and development expenses for the three and six months ended June 30, 2025, compared to the same periods in 2024, was primarily due to decreased clinical trial costs associated with a decrease of activity in our Phase 3 IMerge LR-MDS study after FDA approval of RYTELO in 2024, as well as manufacturing and quality costs that were capitalized in the current period now that RYTELO is approved, compared to being expensed in the prior period.

Selling, general and administrative expenses for the three and six months ended June 30, 2025, were $38.6 million and $78.6 million, compared to $39.4 million and $66.5 million for the same periods in 2024. The decrease in selling, general and administrative expenses for the three months ended June 30, 2025, compared to the same period in 2024, is attributed to initial RYTELO launch costs in 2024. The increase in the six months ended June 30, 2025 is primarily due to higher personnel-related expenses from increased headcount to support the commercialization of RYTELO.

2025 Financial Guidance

For fiscal year 2025, the Company maintains its previously announced expectations of total operating expenses to be in the range of approximately $270 million to $285 million, which includes non-cash items such as stock-based compensation expense, amortization of debt discounts and issuance costs, and depreciation and amortization.

Based on current operating plans and assumptions, the Company believes that existing cash, cash equivalents, and marketable securities, together with anticipated net revenues from U.S. sales of RYTELO, will be sufficient to fund projected operating requirements for the foreseeable future.

Conference Call

Geron will host a conference call at 8:00 a.m. ET on Wednesday, August 6, 2025, to discuss business updates and second quarter 2025 financial results.

A live webcast of the conference call and accompanying presentation will be available on the "Investors & Media" page of the Company’s website at www.geron.com. A replay of the webcast will be archived and available on the Company’s website for 30 days.

About RYTELO (imetelstat)

RYTELO is an oligonucleotide telomerase inhibitor approved in the U.S. for the treatment of adult patients with LR-MDS with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). It is indicated to be administered as an intravenous infusion over two hours every four weeks.

In addition, RYTELO is approved in the European Union as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.

RYTELO is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In LR-MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. Developed and exclusively owned by Geron, RYTELO is the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration and the European Commission.

Please see RYTELO (imetelstat) full Prescribing Information, including Medication Guide, available at View Source

About IMpactMF Phase 3

IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with intermediate-2 or high-risk myelofibrosis (MF) who are relapsed after or refractory to prior treatment with a JAK inhibitor, also referred to as relapsed/refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete remission, partial remission, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes. IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations and current status, visit clinicaltrials.gov/study/NCT04576156.

On August 6, 2025 Merus N.V. (Nasdaq: MRUS), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), reported that Bill Lundberg, M.D., President, Chief Executive Officer of Merus, will participate in a fireside chat at the Canaccord Genuity 45th Annual Growth Conference on Wednesday, August 13, 2025 at 1:30 p.m. ET (Press release, Merus, AUG 6, 2025, View Source [SID1234654884]).

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The webcast of the presentation will be contemporaneously available on the Investors page of the Company’s website. The archived presentation will also be available there for a limited time after the event.