On November 4, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported its financial results for the fiscal quarter and nine months ended September 30, 2025.

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In the third quarter of 2025, ImmunityBio reported $31.8 million of product revenue, representing a 434% increase from $6.0 million in the third quarter of 2024. This growth reflects continued commercial traction of ANKTIVA in combination with BCG in BCG-unresponsive NMIBC with CIS with or without papillary tumors. The first three quarters of 2025 sales totaling $74.7 million represents a 467% increase in unit volume during the first three quarters of 2025 versus the last three quarters of 2024. The Company ended the quarter with $257.8 million in cash, cash equivalents, and marketable securities as of September 30, 2025.

"We are pleased with the continued strong demand for ANKTIVA in NMIBC CIS. Unit sales grew nearly 6X year-to-date compared with full-year 2024, reflecting adoption both at leading research centers and in community urology clinics, including rural areas," said Richard Adcock, President and CEO of ImmunityBio. "ANKTIVA’s total response rate continues to gain momentum with payors as it was recently added as the preferred drug in its indication by a large medication contracting organization covering ~80 million lives. Additionally, enrollment in the rBCG EAP nearly doubled this quarter, underscoring the urgent need to address the BCG shortage. On the clinical side of the business, our BCG-naïve study is enrolling well, and we are optimistic about the potential to expand ANKTIVA’s reach to an even broader population of bladder cancer patients in the near future."

"We continue to achieve compelling results with the core components of our BioShield platform, demonstrated by sustained demand for ANKTIVA in bladder cancer and encouraging data this quarter showing its potential to reverse lymphopenia in non-small cell lung cancer," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer, of ImmunityBio. "ANKTIVA also showed strong data in achieving disease control in glioblastoma, an extremely difficult to treat cancer. We are excited about the growth opportunities for our science and its potential to address many more unmet needs."

Third-Quarter Ended September 30, 2025 Financial Summary and Comparison to Prior Year Quarter

Product Revenue, Net

Product revenue, net increased $25.8 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.

Research and Development Expense

Research and development (R&D) expense increased $0.8 million to $51.2 million during the three months ended September 30, 2025, as compared to $50.4 million during the three months ended September 30, 2024. The increase was due to higher manufacturing costs and higher distribution costs driven by more production and clinical trial activities, and higher license fees, partially offset by fewer sponsored research agreements.

Selling, General and Administrative Expense

Selling, general and administrative (SG&A) expense increased $0.4 million to $36.3 million during the three months ended September 30, 2025, as compared to $35.9 million during the three months ended September 30, 2024. The increase was due to higher costs related to headcount, partially offset by lower costs related to litigation settlements and commercial consulting activities.

Net Loss Attributable to ImmunityBio Common Stockholders

Net loss attributable to ImmunityBio common stockholders was $67.3 million during the three months ended September 30, 2025, compared to $85.7 million during the three months ended September 30, 2024. The reduction of loss was primarily driven by increased product revenue and lower related-party interest expense, partially offset by an increase in interest expense related to the revenue interest liability, and changes in the fair value of warrant liabilities, a related-party convertible note and derivative liabilities.

Nine Months Ended September 30, 2025 Financial Summary and Comparison to Prior Year Nine Months

Product Revenue, Net

Product revenue, net increased $67.8 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.

Research and Development Expense

R&D expense decreased $0.2 million to $154.7 million during the nine months ended September 30, 2025, as compared to $154.9 million during the nine months ended September 30, 2024. The decrease was mainly due to a reduction in outside service costs, CMO fees and drug materials purchased and used in manufacturing, partially offset by an increase in clinical trial costs and by higher manufacturing costs driven by increased production activities.

Selling, General and Administrative Expense

SG&A expense decreased $15.8 million to $111.3 million during the nine months ended September 30, 2025, as compared to $127.1 million during the nine months ended September 30, 2024. The decrease was primarily driven by lower costs related to litigation settlements and commercial consulting activities, partially offset by higher stock-based compensation expense, recruiting and training expenses, salaries, benefits and commissions, and travel expenses due to growing sales and marketing activities.

Net Loss Attributable to ImmunityBio Common Stockholders

Net loss attributable to ImmunityBio common stockholders was $289.5 million during the nine months ended September 30, 2025, compared to $354.4 million during the nine months ended September 30, 2024. This reduction of loss was primarily driven by increased product revenue, lower SG&A expense described above, lower related-party interest expense, and changes in the fair value of warrant liabilities, partially offset by changes in the fair value of derivative liabilities and a related-party convertible note, an increase in interest expense related to the revenue interest liability, and lower interest and investment income.

(Press release, ImmunityBio, NOV 4, 2025, View Source [SID1234659359])

On November 4, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it will present at the Guggenheim Securities Healthcare Innovation Conference to take place on November 10-12, 2025.

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Guggenheim Securities Innovation Conference

Date / Time: November 11, 2025 at 10:30 AM ET
Format: Presentation and 1×1 investor meetings
Location: Boston, MA
Webcast Link: here

Webcasts from the conferences will also be available on UroGen’s Investor Relations website. A replay will be available on the site for approximately 90 days.

(Press release, UroGen Pharma, NOV 4, 2025, View Source [SID1234659375])

On November 4, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in predictive computational drug target discovery powered by AI/ML, reported that Compugen management will participate in a fireside chat at the upcoming Stifel 2025 Healthcare Conference in New York City. The fireside chat will take place on Tuesday November 11, 2025, at 3:20-3:50 PM ET.

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A live webcast will be accessible on the Investor Relations section of the Compugen website at www.cgen.com. A replay will also be available following the live event.

(Press release, Compugen, NOV 4, 2025, View Source [SID1234659393])

On November 4, 2025 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported financial results for the third quarter ended September 30, 2025, and provided a business update.

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"Our intent to separate our wholly owned biopharma programs from our royalty assets provides investors with the opportunity to realize and enhance the potential value of two distinct sets of assets. Jemperli sales grew to $785 million YTD with GSK indicating dMMR endometrial market share is now ~5% greater than Keytruda1, reflecting Jemperli’s differentiated overall survival data and supporting GSK’s peak sales guidance of far more than $2.7 billion2 in monotherapy indications," said Daniel Faga, president and chief executive officer of Anaptys. "Our biopharma portfolio is strategically positioned with multiple attractive, high-potential assets, including rosnilimab, ANB033 and ANB101. Rosnilimab’s transformational profile was highlighted in a late-breaking presentation of Phase 2b data in RA at ACR Convergence 2025 and we anticipate reporting top-line Phase 2 data through Week 12 in ulcerative colitis in November or December."

INTENT TO SEPARATE BUSINESS

Announced intent to separate biopharma operations from substantial royalty assets by YE 2026
Designed to unlock potential value by creating two independent, publicly traded companies with different business objectives and opportunities
The royalty management company will manage royalties and milestone payments from financial collaborations, including Jemperli with GSK and imsidolimab with Vanda, with a focus on protecting and returning their value to shareholders
The biopharma operations company will focus on development and potential commercialization of innovative immunology therapeutics for autoimmune and inflammatory diseases, including rosnilimab, ANB033 and ANB101
ROYALTY MANAGEMENT CO

GSK Jemperli Financial Collaboration

GSK announced strong commercial performance for Jemperli ($303 million/£230 million in Q3 2025 sales; $785 million/£600 million in YTD 2025 sales) with >16% USD and >17% GBP quarter-over-quarter growth1
In Q4 2025, Anaptys anticipates accruing a one-time $75 million commercial sales milestone from GSK once Jemperli achieves $1 billion in worldwide net sales
>$390 million in annualized Jemperli royalties payable to Anaptys at GSK’s peak sales guidance of >$2.7 billion2, which Anaptys expects to be achieved before 2031
Estimate Sagard will have accrued ~$250 million in royalties and sales milestones through year-end 2025 and now anticipate full paydown of $600 million non-recourse debt monetization between Q2 2027 and Q2 20283
Substantial GSK investment in additional monotherapy and potential combination trials for Jemperli including –
AZUR-1 – pivotal Phase 2 – dostarlimab monotherapy in untreated stage II/III dMMR/MSI-H locally advanced rectal cancer
Top-line data expected in H2 2026; U.S. FDA Breakthrough Therapy Designation
AZUR-2 – pivotal Phase 3 – dostarlimab versus standard of care in untreated TN40 or stage III dMMR/ MSI-H resectable colon cancer
AZUR-4 – Phase 2 – dostarlimab plus chemotherapy versus standard of care (chemotherapy) in untreated stage III MMRp/MSS resectable colon cancer
JADE – pivotal Phase 3 – dostarlimab monotherapy versus placebo in locally advanced unresected head and neck squamous cell carcinoma (PD-L1 high) post chemoradiation
Vanda Imsidolimab Financial Collaboration

Vanda anticipates FDA BLA submission for imsidolimab in generalized pustular psoriasis (GPP) in Q4 2025
BIOPHARMA CO

Rosnilimab (Pathogenic T Cell Depleter)

Presented Phase 2b data for rosnilimab, a pathogenic T cell depleter, in rheumatoid arthritis as a late-breaking oral presentation at American College of Rheumatology (ACR) Convergence 2025
In both the overall and b/tsDMARD-experienced populations, response rates across multiple higher-order endpoints, including ACR50, ACR70, CDAI LDA, CDAI remission, and patient-reported outcomes increased between Week 12 and Week 28 and are maintained off-drug for at least 3-months through Week 38
Regardless of prior therapy, including JAKs, similar responses were observed on more stringent endpoints, such as ACR50, ACR70, CDAI LDA and CDAI remission
Safety data through Week 38 demonstrate rosnilimab was well-tolerated, including no malignancies and no deaths
The presentation is available for download on the Anaptys website here
Top-line data through Week 12 of global Phase 2 trial in moderate-to-severe UC (N=136, ~50% advanced therapy experienced) on track for November/December 2025
Assessing Q2W and Q4W dose levels of subcutaneously administered rosnilimab vs. placebo (randomized 1:1:1)
Will report data on primary statistical analysis at Week 12 on well-established endpoints, including the primary endpoint of change from baseline in modified Mayo Score (mMS) and key secondary endpoints, such as clinical response and remission on mMS
All patients in all three study arms treat-through to Week 24 and remain blinded to treatment arm. Placebo-treated patients who achieved clinical response on partial mMS (pmMS) at Week 12 remain on placebo, while placebo-treated patients who are non-responders are crossed over to the high dose Q2W rosnilimab treatment arm
Patients who are in clinical response on pmMS at Week 24 are eligible for an additional 26-week (50 weeks of total treatment) blinded treatment extension period (TEP)
Blinded surveillance data to date suggest a favorable safety and tolerability profile consistent with prior rosnilimab trials
ANB033 (CD122 antagonist)

Hosted virtual investor event on ANB033 including preclinical and Phase 1a data
Webcast and presentation are available for viewing on the Anaptys website here
Phase 1b cohort in celiac initiated
Top-line Phase 1b data anticipated in Q4 2026
Plan to initiate an additional Phase 1b trial in a second inflammatory disease in 2026
Exploring eosinophilic esophagitis as a potential indication
ANB101 (BDCA2 modulator)

Phase 1 trial ongoing in healthy volunteers
FINANCIAL UPDATES

Stock Repurchase Program and Cash Runway

Company has repurchased a total of 3,344,064 shares of common stock (10.9% shares outstanding) with $65.2 million as of Sept. 30, 2025, from its $75.0 million Stock Repurchase Program
Cash and investments of $256.7 million as of Sept. 30, 2025
Anticipate ending 2025 with approximately $300 million, including an anticipated accrual of a one-time $75 million commercial sales milestone in Q4 2025 from GSK once Jemperli achieves $1 billion in worldwide net sales
Upon completion of the separation, Biopharma Co will launch with adequate capital to fund operations for at least two years through significant potential corporate milestones
Third Quarter 2025 Financial Results

Cash, cash equivalents and investments totaled $256.7 million as of September 30, 2025, compared to $420.8 million as of December 31, 2024, for a decrease of $164.1 million due primarily to $113.9 million used for operating activities and $65.2 million in shares repurchased offset by $15 million upfront payment received from Vanda Pharmaceuticals for the license of imsidolimab.
Collaboration revenue was $76.3 million and $126.4 million for the three and nine months ended September 30, 2025, compared to $30.0 million and $48.2 million for the three and nine months ended September 30, 2024. The increase was due primarily to Jemperli total sales for 2025 exceeding $750 million which earned a $50 million commercial sales milestone in Q3 under the license agreement. Jemperli royalties increased 80% from $13.8 million to $24.9 million and 110% from $30.1 million to $63.2 million for the three and nine months ended September 30, 2025, and $9.7 million in revenue recognized for the Vanda license agreement.
Research and development expenses were $31.4 million and $110.4 million for the three and nine months ended September 30, 2025, compared to $42.2 million and $121.3 million for the three and nine months ended September 30, 2024. The decrease for the three and nine months ended September 30, 2025, was primarily due to lower development costs for ANB032 and imsidolimab, offset by higher costs relating to the Phase 1 trials for ANB033 and ANB101. The R&D non-cash, stock-based compensation expense was $4.5 million and $13.3 million for the three and nine months ended September 30, 2025, as compared to $4.0 million and $10.9 million in the same period in 2024.
General and administrative expenses were $10.2 million and $34.9 million for the three and nine months ended September 30, 2025, compared to $10.6 million and $32.2 million for the three and nine months ended September 30, 2024. The increase was due primarily to transaction costs associated with the Vanda Pharmaceuticals license agreement. The G&A non-cash, stock-based compensation expense was $4.7 million and $14.2 million for the three and nine months ended September 30, 2025, as compared to $4.2 million and $14.9 million in the same period in 2024.
Net income was $15.1 million for the three months ended September 30, 2025, or a net income per share of $0.54 and a net loss of $62.8 million for the nine months ended September 30, 2025, or a net loss per share of $2.16, compared to a net loss of $32.9 million and $123.4 million for the three and nine months ended September 30, 2024, or a net loss per share of $1.14 and $4.46.

(Press release, AnaptysBio, NOV 4, 2025, View Source [SID1234659344])

On November 4, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported that it will host an R&D Day for investors at the Harvard Club (35 West 44th Street) in New York City on November 10, 2025, beginning at 8:00 a.m. ET.

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The investor event will feature ovarian cancer thought leaders, principal investigators from the Company’s Phase 3 OVATION 3 Study and Phase 2 minimal residual disease (MRD) clinical trial, conducted in partnership with Break Through Cancer Foundation, statistical experts and members of IMUNON’s management team, delivering updates on new IMNN-001 data and discussing progress with the OVATION 3 Study and IMNN-001’s potential role in transforming the treatment landscape for women with advanced ovarian cancer. There will be a live Q&A session and networking opportunities with the speakers and IMUNON management team following the formal presentations.

Featured Presentations and Speakers:

Title: Advancing Ovarian Cancer Care: IMNN-001’s Potential to Transform the Microtumor Environment from Cold to Hot in Phase 3
Presenter: Premal H. Thaker, M.D., David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Chief of Gynecologic Oncology, Director of Gynecologic Oncology Clinical Research, Professor in Gynecologic Oncology, Washington University School of Medicine
Title: Unveiling Progress: Safety, Tolerability, and Translational Insights for IMNN-001
Presenter: Amir Jazaeri, M.D., Vice Chair for Clinical Research, Director, Gynecologic Cancer Immunotherapy Program, Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center

Title: OVATION 3 Probability of Success & the Statistical Properties of Phase 3 Trial Design
Presenter: Giorgio Paulon, Ph.D., Director & Senior Statistical Scientist, Berry Consultants, LLC

Title: Phase 3 OVATION 3 Trial Update
Presenter: Douglas V. Faller, M.D., Ph.D., Chief Medical Officer, IMUNON

(Press release, IMUNON, NOV 4, 2025, View Source [SID1234659360])