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Bio-Techne Releases Fourth Quarter Fiscal 2025 Results

On August 6, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported its financial results for the fourth quarter ending June 30, 2025 (Press release, Bio-Techne, AUG 6, 2025, View Source [SID1234654886]).

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Fourth Quarter FY2025 Highlights

Fourth quarter organic revenue increased by 3% (4% reported) to $317.0 million. Full year organic revenue increased 5% (5% reported) to $1.2 billion.
GAAP earnings per share (EPS) was $ (0.11) versus $0.25 one year ago. Delivered adjusted EPS of $0.53 compared to $0.49 one year ago. Full year GAAP EPS was $0.46 versus $1.05 one year ago. Full year adjusted EPS was $1.92 versus $1.77 one year ago.
Strong performance in our proteomic analytic and cell therapy growth pillars drove 4% organic growth (6% reported) in the Protein Sciences segment for the quarter, and 5% organic and reported growth for the full year.
Announced divestiture of the Exosome Diagnostics business including the ExoDx Prostate test (EPI) as the Company emphasizes investment and commercial priorities on non-CLIA based product lines in their growth pillars.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted diluted EPS, adjusted net earnings, adjusted gross margin, adjusted operating income, adjusted tax rate, organic revenue, adjusted operating margin, earnings before interest, taxes, depreciation, and amortization (EBITDA), and adjusted EBITDA are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"Bio-Techne delivered a solid fourth quarter that was in-line with our expectations, despite ongoing market uncertainty," said Kim Kelderman, President and Chief Executive Officer of Bio-Techne. "We achieved strong performance in our cell therapy and protein analysis instrumentation growth pillars, supported by a resilient pharma market. Our fiscal year 2025 results reflect the outstanding execution by our team and the meaningful impact our innovative solutions continue to deliver for customers, which include accelerating development timelines and driving scientific breakthroughs."

Kelderman added, "Last night, we announced the divestiture of our Exosome Diagnostics business. This strategic decision will immediately strengthen our profitability and allow us to increase our focus on high-growth areas, particularly tools for research and precision diagnostics."

Kelderman concluded, "While market uncertainties persist, I have full confidence in our team’s ability to navigate the evolving landscape and continue delivering meaningful value to all our stakeholders."

Bio-Techne will host an earnings conference call today, August 6, 2025, at 8:00 a.m. CDT. To listen, please dial 1-800-274-8461 or 1-203-518-9814 (for international callers), and reference conference ID TECHQ4. The earnings call can also be accessed via webcast through the following link View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512- 2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 11159590. The replay will be available from 11:00 a.m. CDT on Wednesday, August 6, 2025, until 11:00 p.m. CDT on Saturday, September 6, 2025.

Fourth Quarter Fiscal 2025

Revenue

Net sales for the fourth quarter increased 4% to $317.0 million. Organic revenue increased 3% compared to the prior year. Foreign currency exchange had a favorable impact of 2%, and non-recurring prior year revenue from a business held-for-sale had an unfavorable impact of 1%.

GAAP Earnings Results

GAAP EPS was ($0.11) per diluted share, versus $0.25 in the same quarter last year. GAAP operating income for the fourth quarter of fiscal 2025 decreased 152% to ($23.9) million, compared to $45.8 million in the fourth quarter of fiscal 2024. GAAP operating margin was (7.5)%, compared to 15.0% in the fourth quarter of fiscal 2024. Current quarter GAAP operating margin was unfavorably impacted by impairment of the Exosome Diagnostics business.

Non-GAAP Earnings Results

Adjusted EPS increased to $0.53 per diluted share compared to $0.49 in the same quarter last year. Adjusted operating income of $101.3 million in the fourth quarter of fiscal 2025 remained relatively consistent with fourth quarter of fiscal 2024 adjusted operating income of $101.8 million. Adjusted operating margin was 32.0% for the fourth quarter of fiscal 2025 compared to 33.5% in the fourth quarter of fiscal 2024. Adjusted operating margin was impacted by unfavorable product mix, especially within the Diagnostic Solutions segment.

Full Year Fiscal 2025

Revenue

Net sales for the full year fiscal 2025 increased 5% to $1.2 billion. Organic revenue increased 5%. Foreign currency exchange and a business held-for-sale did not have a material impact.

GAAP Earnings Results

GAAP EPS was $0.46 per diluted share, compared to $1.05 last fiscal year. GAAP operating income for full year fiscal 2025 decreased 51% to $102.3 million, compared to $206.7 million in the full year fiscal 2024. GAAP operating margin was 8.4%, compared to 17.8% in the full year fiscal 2024. GAAP operating margin was unfavorably impacted by impairment of assets held-for-sale, restructuring and restructuring-related costs, and a non-recurring arbitration award.

Non-GAAP Earnings Results

Adjusted EPS increased to $1.92 per diluted share, compared to $1.77 last fiscal year. Adjusted operating income for fiscal 2025 increased 4% to $383.6 million, compared to $370.2 million for fiscal 2024. Adjusted operating margin for full year fiscal 2025 decreased to 31.6%, compared to 32.1% in full year fiscal 2024. Adjusted operating margin was impacted by reinstatement of incentive compensation accruals as well as unfavorable product mix.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biopharma and academic research communities. Additionally, the segment provides multiple platforms useful in various areas of protein analysis. In fiscal year 2024, a business within the Protein Sciences Segment met the criteria of held-for-sale; the held-for-sale business has been excluded from the segment’s operating results. Protein Sciences segment’s fourth quarter fiscal 2025 net sales were $226.5 million, an increase of 6% from $214.0 million for the fourth quarter of fiscal 2024. Organic revenue growth was 4% for the fourth quarter of fiscal 2025, with foreign currency exchange having a favorable impact of 2%. The Protein Sciences segment’s operating margin increased to 43.6% in the fourth quarter of fiscal 2025 compared to 43.0% in the fourth quarter of fiscal 2024. The segment’s operating margin increased primarily due to favorable volume leverage and ongoing profitability initiatives.

Protein Sciences segment’s full year fiscal 2025 net sales were $870.2 million, an increase of 5% from $830.9 million for full year fiscal 2024. Organic revenue for the segment increased 5% for the fiscal year, with foreign currency exchange and a business held-for-sale not having a material impact on revenue. Protein Sciences segment’s operating margin was 42.6% in fiscal 2025 compared to 42.7% in fiscal 2024.

Diagnostics and Spatial Biology Segment

The Company’s Diagnostics and Spatial Biology segment develops and provides spatial biology products, carrier screening and oncology kits, as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Spatial Biology segment also provides blood chemistry and blood gas quality controls, hematology instrument controls, immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Exosome Diagnostics business met the held-for-sale criteria at June 30, 2025 and incurred an impairment loss of $83.1 million during the quarter. The Diagnostics and Spatial Biology segment’s fourth quarter fiscal 2025 net sales were $89.7 million, a decrease of 1% from $90.7 million for the fourth quarter of fiscal 2024. Organic revenue decreased 1% for the fourth quarter of fiscal 2025, with foreign exchange not having a material impact. The Diagnostics and Spatial Biology segment’s operating margin of 6.0% in the fourth quarter of fiscal 2025 compared to 12.5% in the fourth quarter of fiscal 2024. The segment’s operating margin was impacted by unfavorable product mix.

The Diagnostics and Spatial Biology segment’s full year fiscal 2025 net sales were $346.3 million, an increase of 6% from $326.4 million for full year fiscal 2024. Organic growth for the segment was 6% with foreign currency exchange not having a material impact on revenue growth. The Diagnostics and Spatial Biology segment’s operating margin was 6.2% in fiscal 2025 compared to 7.5% in fiscal 2024. The segment’s operating margin was impacted by the reinstatement of incentive compensation accruals as well as unfavorable product mix.

Compugen Reports Second Quarter 2025 Results

On August 6, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in predictive computational target discovery powered by AI/ML, reported financial results for the second quarter of 2025 and provided a corporate update (Press release, Compugen, AUG 6, 2025, View Source [SID1234654885]).

"We continued to advance our immuno-oncology (IO) clinical and early-stage pipeline programs," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We dosed the first patient in MAIA-ovarian, our global adaptive platform trial evaluating COM701 as a single agent for maintenance therapy in patients with relapsed platinum sensitive ovarian cancer (sub-trial 1). In addition, we are looking forward to presenting a pooled analysis of previously presented data from our three Phase 1 trials evaluating COM701 in heavily pretreated platinum resistant ovarian cancer at ESMO (Free ESMO Whitepaper) 2025 in October. We are also progressing the Phase 1 trial for GS-0321 a potential first-in-class anti-IL18BP antibody licensed to Gilead."

Dr. Cohen-Dayag continued, "We are excited to see the progress our partner AstraZeneca is making with its rilvegostomig program, with ten active Phase 3 trials. Rilvegostomig is an Fc reduced PD-1/TIGIT bispecific antibody, the TIGIT component of which is derived from our COM902, and which AstraZeneca has specifically designed and engineered with a unique mechanism of action to harness co-operative binding of both PD-1 and TIGIT to drive enhanced immune responses. At ASCO (Free ASCO Whitepaper) in June this year, AstraZeneca presented encouraging early data from trials evaluating rilvegostomig in combination with TROP2 ADC, Datroway, in NSCLC and in combination with chemotherapy in hepatobiliary cancer. The totality of this data along with data presented in 2024 highlight rilvegostomig as a potential IO backbone for future drug combinations. At the upcoming ESMO (Free ESMO Whitepaper) 2025 conference, AstraZeneca plans to share follow up data from ARTEMIDE-01 in NSCLC as a poster presentation and first data from TROPION-PanTumor03 in bladder cancer as a mini oral session. AstraZeneca’s broad development strategy for rilvegostomig to replace existing PD(L)-1 inhibitors represents a significant potential revenue source for Compugen as we are eligible for both future milestone payments and mid-single digit tiered royalties on future sales."

Dr. Cohen-Dayag added, "Our solid financial position with a cash runway expected to fund operations into 2027 allows us to advance our pipeline of differentiated IO therapies and to leverage Unigen – our validated AI/ML-powered computational target discovery platform to discover novel mechanisms to activate the immune system against cancer. I look forward to transitioning leadership to Dr. Eran Ophir in September and the opportunity of stepping into the newly established role of Executive Chair. With this enhanced leadership expansion, a strategically differentiated pipeline and operational focus, Compugen is well positioned for growth."

Next Planned Milestones

ESMO 2025: poster presentation of a pooled analysis of three Phase 1 trials from previously presented data evaluating COM701 in heavily pretreated platinum resistant ovarian cancer
ESMO 2025: Compugen’s partner, AstraZeneca, plans to present:
updated data from Phase 2 ARTEMIDE-01 evaluating rilvegostomig in metastatic NSCLC as a poster presentation
first data from TROPION-PanTumor03 evaluating rilvegostomig in combination with TROP 2 ADC Datroway in bladder cancer as a mini oral session
H2 2026: data from projected interim analysis of single agent COM701 sub-trial 1 as maintenance therapy in relapsed platinum sensitive ovarian cancer
Second Quarter 2025 Financial Highlights

Cash: As of June 30, 2025, Compugen had approximately $93.9 million in cash, cash equivalents, short-term bank deposits, and investment in marketable securities.

Compugen expects that its cash and cash-related balances will be sufficient to fund its operating plans into 2027. This does not include any cash inflows. The Company has no debt.

Revenue: Compugen reported approximately $1.3 million in revenues for the second quarter ended June 30, 2025, compared to approximately $6.7 million in revenues for the comparable period in 2024. The revenues reported in the second quarter of 2025 reflect recognition of a portion of both the upfront payment and the IND milestone payment from the license agreement with Gilead. The revenues reported in the second quarter of 2024 reflect recognition of portions of the upfront payment from the license agreement with Gilead and the clinical milestone from the license agreement with AstraZeneca.

R&D expenses for the second quarter of 2025 were approximately $5.6 million compared to approximately $6.2 million for the comparable period in 2024.

G&A expenses were approximately $2.2 million for the second quarters of 2025 and 2024.

Net loss for the second quarter of 2025 was approximately $7.3 million, or $0.08 per basic and diluted share, compared with a net loss of approximately $2.1 million, or $0.02 per basic and diluted share, in the second quarter of 2024.

Full financial tables are included below

Conference Call and Webcast Information

The Company will hold a conference call today, August 6, 2025, at 8:30 AM ET to review its second quarter 2025 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

Merus to Present at the Canaccord Genuity 45th Annual Growth Conference

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]).

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.

Lantern Pharma’s Subsidiary, Starlight Therapeutics, Announces U.S. Food and Drug Administration Clearance of IND for Phase Ib/2a Glioblastoma Multiforme (GBM) Trial

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]).

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.

OmniAb Reports Second Quarter 2025 Financial Results and Business Highlights

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]).

"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