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 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, reported a business update and announced financial results for the third quarter ended September 30, 2025.

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"This quarter we continued to make significant progress across the pipeline and broader business, including the partnership with Servier that extends our runway into 2030 and enables potential commercialization of darovasertib outside of the United States. We have also provided multiple major medical conference clinical data updates at WCLC, ESMO (Free ESMO Whitepaper) and SMR, and completed our third IND filing in 2025 to further extend our industry leadership in precision medicine oncology," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

Selected Pipeline Developments and Upcoming Milestones

Darovasertib

•
Metastatic uveal melanoma (mUM)
o
Median progression-free survival (PFS) data from the Phase 2/3 trial (OptimUM-02) of darovasertib in combination with crizotinib in first line (1L) HLA*A2:01-negative mUM is on track to be reported by year-end 2025 to 1Q 2026; this data has the potential to enable an accelerated approval filing in the United States. The trial is nearing full enrollment, which remains on track to be completed by year-end.
o
In October 2025, data from the single-arm, Phase 2 trial (OptimUM-01) of darovasertib in combination with crizotinib were presented at the Society for Melanoma Research (SMR) Congress in Amsterdam, Netherlands. Data were from a total of 44 1L mUM patients, including both HLA*A2:01-negative and HLA*A2:01-positive patient subsets. Highlights include:
▪
21.1 month median overall survival (OS) and 7.0 month median progression free survival (PFS) across all patients
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In 41 efficacy-evaluable patients, confirmed overall response rate (ORR) of 34% (14/41) with a 9.0 month median duration of response (mDOR)
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Disease control rate (DCR) of 90% (37/41), with 85% (35/41) of patients achieving ‘any reduction’ in target lesions
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The combination continued to be well-tolerated with the most common treatment-related adverse events (TRAEs >30%) of diarrhea, nausea, edema, vomiting, dermatitis, hypoalbuminemia, and fatigue
•
Neoadjuvant therapy for primary uveal melanoma (UM)
o
In October 2025, the company presented positive data from the randomized Phase 2 trial (OptimUM-09) in a Proffered Paper Oral Presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in Berlin, Germany. Data were from a total of 95 patients, including 56 recommended for enucleation (EN) and 39 eligible for plaque brachytherapy (PB). Highlights include:
▪
Ocular tumor shrinkage in ~83% (78/94) of patients assessed, the majority of whom achieved ≥20% tumor shrinkage
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Among evaluable EN patients, the eye preservation rate was 57% (24/42), which increased to 95% (19/20) in patients achieving ≥20% tumor shrinkage
▪
In evaluable PB eligible patients, ~70% (26/37) achieved a reduction in predicted radiation dose to the eye from baseline, resulting in ~65% (24/37) having lower predicted risk of vision loss 3-years post-PB treatment
▪
During neoadjuvant treatment with darovasertib, ~55% (29/53) of EN and ~61% (23/38) of PB patients showed an improvement in baseline visual acuity scores (VAS), with a mean gain of 17 and 10 letters, respectively

▪
Darovasertib continued to be well-tolerated, with a low rate of serious adverse events and TRAEs leading to discontinuation
o
IDEAYA has initiated a randomized Phase 3 registration-enabling trial of darovasertib as a single-agent in the neoadjuvant setting of primary UM. The trial, referred to as OptimUM-10, will enroll a total of approximately 450 patients in two cohorts of PB- and EN-recommended patients.
▪
Target enrollment was revised downward from our previous estimate of 520 patients due to a reduction of 70 patients in the PB cohort (prior guidance of 400, now 330 patients) based on additional FDA feedback on the statistical plan (alpha usage) across the two cohorts.
•
Adjuvant therapy for primary UM
o
In collaboration with Servier, IDEAYA plans to initiate a global Phase 3 combination trial of darovasertib and crizotinib as an adjuvant therapy for primary UM in the first half of 2026.
IDE397 (MAT2A)

•
Positive data were reported from the ongoing Phase 1/2 trial of IDE397 in combination with Gilead’s Trodelvy (sacituzumab govitecan-hziy), a Trop2-directed antibody-drug conjugate (ADC), in patients with MTAP-deleted urothelial cancer (UC).
o
57% ORR (4/7; 4cPR) at 30 mg IDE397 plus 7.5mg/kg Trodelvy (Dose level 2).
o
Median PFS and mDOR were not yet reached.
o
Manageable safety profile consistent with known adverse events of both drugs as single agents.
•
IDEAYA has selected Dose level 2 as the go-forward dose for the IDE397 and Trodelvy clinical combination in MTAP-deleted UC and has achieved first-patient-in (FPI) in NSCLC. The next clinical update from the combination trial is planned for a medical conference in the first half of 2026.
IDE849 (DLL3 TOP1i ADC)

•
IDEAYA’s partner, Hengrui Pharma, presented clinical safety and efficacy data from over 70 small-cell lung cancer (SCLC) patients from their Phase 1 clinical trial at the 2025 International Association for the Study of Lung Cancer ("IASLC") World Conference on Lung Cancer (WCLC) in Barcelona, Spain. Data included 87 patients with small-cell lung cancer (SCLC) and 13 patients with other neuroendocrine carcinomas (NEC) as of a cut-off date of June 20, 2025. A total of 71 refractory (2L+) SCLC patients were evaluated for efficacy at doses of IDE849 between 2.4mg/kg and 4.2 mg/kg. Highlights include:
o
At the 2.4 mg/kg expansion dose of IDE849, 2L patients demonstrated an 80.0% (8/10) ORR and 70.0% (7/10) confirmed ORR; across all lines of therapy (2L+) at this dose the ORR and confirmed ORR decreased modestly to 73.7% (14/19) and 57.9% (11/19) (1 pending confirmation), respectively.
o
Across all doses of IDE849 tested, 2L patients showed a 77.1% (27/35) ORR and 60.0% (21/35) confirmed ORR (4 pending confirmation) whereas a 73.2% (52/71) ORR and 47.9% (34/71) confirmed ORR (10 pending confirmation) was observed across all lines of therapy at all doses (≥2.4 mg/kg).
o
Patients with baseline brain metastases had an 83.3% (5/6) confirmed ORR at the 2.4 mg/kg dose and a 66.7% (12/18) confirmed ORR (1 pending confirmation) across all doses (≥2.4 mg/kg).
o
6.7 month median PFS achieved across all lines and all doses (≥2.4 mg/kg); the median PFS was not reached in 2L patients.
•
In May 2025, IDEAYA initiated a global Phase 1 trial of IDE849 and has achieved FPI in the United States. The company continues to enroll SCLC patients with plans to expand into patients with neuroendocrine tumors (NETs) and other DLL3-overexpressing tumors by the end of 2025.
Other programs

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IDE161, a potential first-in-class small molecule poly-(ADP-ribose) glycohydrolase, or PARG, inhibitor is currently in Phase 1 dose optimization to inform future combination studies with IDE849 and other TOP1i-based ADCs where PARG inhibition may synergize with the payload to deepen responses. IDEAYA plans to initiate a Phase 1 combination trial of IDE849 and IDE161 by the end of 2025.
•
IDE275 (GSK959), a potential first-in-class small molecule inhibitor of Werner Helicase, is being developed in collaboration with GlaxoSmithKline (GSK). A Phase 1 dose escalation in patients with MSI-High solid tumors is ongoing.
•
IDE705 (GSK101), a potential first-in-class small molecule inhibitor of DNA Polymerase Theta Helicase, or Pol Theta, is being developed in collaboration with GSK. A Phase 1 dose escalation in combination with niraparib, GSK’s small molecule inhibitor of PARP, is ongoing in patients with solid tumors.
o
Phase 2 dose expansion in BRCA-mutant solid tumors would trigger a $10 million milestone payment from GSK.
•
IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, is being developed for patients with MTAP-deleted lung cancer and other high priority MTAP-deleted solid tumor indications. IDEAYA received IND clearance from the FDA in the third quarter and expects to begin a Phase 1 dose escalation trial by the end of the year with the goal of advancing into combination trials with IDE397 in the first half of 2026.

In the fourth quarter IDEAYA submitted an IND for IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1i ADC, and is on track to file an IND for IDE574, a potential first-in-class KAT6/7 dual inhibitor, by the end of the year.
License agreement with Servier

•
IDEAYA entered into an exclusive license agreement with Servier for rights to darovasertib outside the United States. The company received an upfront payment of $210 million, and is eligible for up to $100 million in regulatory approval-based milestone payments and up to $220 million in commercial milestone payments, as well as double-digit royalties on net sales in all territories outside of the United States. IDEAYA and Servier will collaborate on the development of darovasertib and share the associated costs. IDEAYA retains all rights to darovasertib in the United States.
Financial Results for the Quarter Ended September 30, 2025

As of September 30, 2025, IDEAYA had cash, cash equivalents and marketable securities of approximately $1.14 billion, compared to $991.9 million as of June 30, 2025. The increase was primarily driven by the $210.0 million upfront payment received from Servier related to the exclusive license agreement for darovasertib, offset by the net cash used in operations.

Collaboration revenue for the three months ended September 30, 2025, totaled $207.8 million compared to zero for the three months ended June 30, 2025. Collaboration revenue was recognized for the performance obligations satisfied through September 30, 2025 related to the development and commercialization license recognized upon execution and the research and development services that will be recognized over time under the Servier exclusive license agreement for darovasertib. As of September 30, 2025, the remaining balance for the research and development services performance obligations is $143.1 million related to the clinical development cost reimbursements anticipated under the license agreement that will be recognized as IDEAYA collaboration revenue over time as the research and development services are completed.

Research and development (R&D) expenses for the three months ended September 30, 2025 totaled $83.0 million compared to $74.2 million for the three months ended June 30, 2025. The increase was primarily driven by higher clinical trial and CMC manufacturing expenses to support our programs.

General and administrative (G&A) expenses for the three months ended September 30, 2025 totaled $16.4 million compared to $14.6 million for the three months ended June 30, 2025. The increase was primarily due to higher legal expenses to support company growth and commercial expenses to support the darovasertib commercial preparation activities.

The net income for the three months ended September 30, 2025, was $119.2 million compared to the net loss of $77.5 million for the three months ended June 30, 2025. Total stock compensation expense for the three months ended September 30, 2025, was $12.2 million compared to $11.9 million for the three months ended June 30, 2025.

(Press release, Ideaya Biosciences, NOV 4, 2025, View Source [SID1234659358])

On November 4, 2025 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported financial results for the three and nine months ended September 30, 2025 and recent corporate updates.

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"There were a number of new initiatives launched in the third quarter, and we’re encouraged by the early signs that they’re positively impacting our commercial execution and driving increased demand for our products," said Craig Collard, Chief Executive Officer of Heron.

Financial Guidance for 2025

2025 Full-Year Guidance for Net Revenue and Adjusted EBITDA (in millions)
Item Original Q1 Updated
Guidance Q2 Updated
Guidance Q3 Reiterated
Guidance
Net Revenue $153.0 to $163.0
Adjusted EBITDA $0 – $8.0 $4.0 – $12.0 $9.0 – $13.0 $9.0 – $13.0

Business Highlights

Heron’s Acute Care franchise delivered revenue growth of 67.2% year-over-year in Q3 2025 and 69.2% year-over-year for the first nine months of 2025, reflecting continued commercial acceleration.
ZYNRELEF Updates:
ZYNRELEF Net Revenue increased $3.1 million or 49% in the three months ended September 30, 2025, compared to the same period in 2024, and increased $8.5 million or 49% in the nine months ended September 30, 2025 compared to the same period in 2024.
Commercial initiatives include launch of a reorganized, dedicated ZYNRELEF sales team in Q3 2025, and enhanced distributor incentives in select accounts – including both formulary and high potential non formulary accounts – to drive growth and accelerate adoption.
Following a phased roll-out, transition to the VAN is complete, and every unit of ZYNRELEF now includes this enhanced device – optimizing product preparation, handling and operating field sterility with ZYNRELEF in hospitals and ambulatory surgical centers across U.S.
The permanent, product specific J-code for ZYNRELEF, granted by the Centers for Medicare and Medicaid Services, went live effective October 1, 2025 – streamlining reimbursement and improving billing clarity across payer types and settings of care.
The ZYNRELEF Prefilled Syringe program is progressing. Stability for this proposed market presentation has commenced and, if successful, approval is anticipated in 2027.
APONVIE Updates:
APONVIE Net Revenue increased $1.9 million or 173% in the three months ended September 30, 2025, compared to the same period in 2024, and increased $5.2 million or 200% in the nine months ended September 30, 2025 compared to the same period in 2024.
We enter Q4 2025 with a seasoned and fully trained APONVIE team leveraging the full range of Heron’s resources to drive adoption within the many health systems and accounts achieved since launch.
Oncology Updates:
CINVANTI unit demand and Net Revenue increased 6% in Q3 as compared to Q3 2024, continuing to hold consistent revenue year-over-year.
Cash, cash equivalents, and short-term investments were $55.5 million as of September 30, 2025.

Net Revenue Performance – Three Months Ended September 30 (in thousands)

2025 2024 Dollar Change Percentage Change

Acute Care $ 12,347 $ 7,385 $ 4,962 67.2%
APONVIE $ 3,034 $ 1,140 $ 1,894 166.1%
ZYNRELEF $ 9,313 $ 6,245 $ 3,068 49.1%

Oncology $ 25,866 $ 25,425 $ 441 1.7%
CINVANTI $ 23,955 $ 22,662 $ 1,293 5.7%
SUSTOL $ 1,911 $ 2,763 $ (852) (30.8%)

Total Net Revenue $ 38,213 $ 32,810 $ 5,403 16.5%

Net Revenue Performance – Nine Months Ended September 30 (in thousands)

2025 2024 Dollar Change Percentage Change

Acute Care $ 33,300 $ 19,676 $ 13,624 69.2%
APONVIE $ 7,758 $ 2,587 $ 5,171 199.9%
ZYNRELEF $ 25,542 $ 17,089 $ 8,453 49.5%

Oncology $ 81,016 $ 83,828 $ (2,812) (3.4%)
CINVANTI $ 73,841 $ 73,205 $ 636 0.9%
SUSTOL $ 7,175 $ 10,623 $ (3,448) (32.5%)

Total Net Revenue $ 114,316 $ 103,504 $ 10,812 10.4%

Conference Call and Webcast

Heron will host a conference call and live webcast on Tuesday, November 4, 2025, at 8:30 a.m. ET. The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. The investor presentation to be used for the conference call and webcast can be accessed from Heron’s website prior to the conference call and webcast. An archive of the teleconference, webcast, and investor presentation will also be made available on Heron’s website for sixty days following the call.

About ZYNRELEF for Postoperative Pain

ZYNRELEF is the first and only extended-release dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF’s indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.

About APONVIE for Prevention of Postoperative Nausea and Vomiting ("PONV") Prevention

APONVIE is a substance P/neurokinin 1 (NK1) Receptor Antagonist (RA), indicated for the prevention of post operative nausea and vomiting (PONV) in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron’s approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023.

Please see full prescribing information at www.APONVIE.com.

About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL for CINV Prevention

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

Please see full prescribing information at www.SUSTOL.com.

(Press release, Heron Therapeutics, NOV 4, 2025, View Source [SID1234659357])

On November 4, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the European Patent Office (EPO) has communicated its intent to grant Genprex a patent for the use of Reqorsa Gene Therapy (quaratusugene ozeplasmid) in combination with PD-1 antibodies for the treatment of cancer.

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"We are pleased to continue bolstering our patent estate, which includes multiple patents for the use of REQORSA in combination with both PD-1 and PD-L1 antibodies across many markets," said Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing at Genprex. "This European patent will further strengthen our intellectual property portfolio and the patent protection around REQORSA in order to safeguard our gene therapy with target-specific combination therapy."

This patent will expand on the previously granted patents for REQORSA in combination with PD-1 antibodies, which have been granted in the U.S., Japan, Mexico, Russia, Australia, Chile, China, and Singapore.

REQORSA is initially being developed in combination with prominent, approved cancer drugs to treat lung cancer. In preclinical studies, REQORSA has been shown to be complementary with targeted drugs and immunotherapies. The Company believes REQORSA’s unique attributes position it to provide potential treatments that improve on these current therapies for patients with lung cancer and possibly other cancers.

According to Eurostat, in 2021, nearly a quarter of a million people died from lung cancer in the EU, accounting for almost a fifth of all cancer deaths and accounting for 4.3% of the total number of deaths. According to the European Commission, it is estimated that in the EU-27 countries in 2020, lung cancer accounted for 11.9% of all new cancer diagnoses (excluding non-melanoma skin cancers) and 20.4% of all deaths due to cancer. In addition, lung cancer was the fourth most frequently occurring cancer (after prostate, breast, and colorectal cancers) and the leading cause of cancer death.

According to data from GLOBOCAN 2022, lung cancer stood as the most frequently diagnosed cancer and the primary cause of cancer-related deaths on a global scale with approximately 2.48 million new cases and 1.8 million deaths, respectively. If the incidence and mortality rates remain stable as in 2022, the burden of lung cancer is projected to increase to 4.62 million new cases and 3.55 million deaths by 2050.

(Press release, Genprex, NOV 4, 2025, View Source [SID1234659356])

On November 4, 2025 FORE Biotherapeutics reported that the Company will participate at the following investor conferences:

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Stifel 2025 Healthcare Conference. The Company will attend on Tuesday, November 11, and will provide a corporate presentation at 10:40 a.m. – 11:10 a.m. ET.
Jefferies London Global Healthcare Conference. The Company will attend and participate in one-on-one meetings on Monday, November 17 – Wednesday, November 19.
Management will host and participate in one-on-one meetings. Please contact Argot Partners to schedule one-on-one meetings with the management team.

(Press release, Fore Biotherapeutics, NOV 4, 2025, View Source [SID1234659355])