On November 5, 2025 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, reported a business update and announced third quarter 2025 financial results.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We have made significant progress advancing our promising ADC programs," said Michael Richman, NextCure’s president and CEO. "We recently began U.S. enrollment in the Phase 1 trial for SIM0505, our CDH6 ADC, initiating at a mid-tier dose range where multiple clinical responses were observed in China by our partner Simcere Zaiming. We expect to advance into higher-dose cohorts in the US shortly, as is currently occurring in China. We believe the ability to dose at levels that match or exceed competitor CDH6-targeting ADCs should demonstrate the promise of this program. We also received FDA clearance for our LNCB74 protocol amendment, giving us the ability to add higher dose escalation cohorts. We plan to provide proof of concept data readouts on SIM0505 and LNCB74 in the first half of 2026."

Business Highlights and Near-Term Milestones

SIM0505 (CDH6 ADC)

● A novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window.
● Acquired global rights in June 2025, excluding greater China where Simcere Zaiming retained rights.
● First U.S. patient dosed in October 2025 at a mid-tier dose level where multiple responses have been observed along with good tolerability in the ongoing Chinese trial.
● Proof of concept data readout, including data from Simcere Zaiming’s ongoing Phase 1 trial, in the first half of 2026.

LNCB74 (B7-H4 ADC)

● A novel ADC directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload.
● Co-developed with LigaChem Biosciences Inc. in a 50-50 cost share arrangement.
● Received Food and Drug Administration (FDA) acceptance of a protocol amendment giving us the ability to add higher dose escalation cohorts.
● Proof of concept data readout in the first half of 2026.

Financial Results for Quarter Ended September 30, 2025

● Cash, cash equivalents, and marketable securities as of September 30, 2025 were $29.1 million as compared to $68.6 million as of December 31, 2024. The decrease of $39.5 million was primarily due to cash used to fund operations, including the $12.0 million upfront license fee to Simcere Zaiming. We expect current financial resources to be sufficient to fund operating expenses and capital expenditures into mid-2026.
● Research and development expenses were $6.1 million for the three months ended September 30, 2025, as compared to $8.8 million for the three months ended September 30, 2024. The decrease of $2.6 million was due to lower costs related to deprioritized programs, lower preclinical development costs and lower personnel-related costs.
● General and administrative expenses were $2.8 million for the three months ended September 30, 2025, as compared to $3.7 million for the three months ended September 30, 2024. The decrease of $0.9 million was primarily related to lower personnel costs.
● Net loss was $8.6 million for the three months ended September 30, 2025, as compared to a net loss of $11.5 million for the three months ended September 30, 2024 due to the lower research and development costs and lower general and administrative costs as described above, partially offset by lower other income.

(Press release, NextCure, NOV 5, 2025, View Source [SID1234659467])

On November 5, 2025 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported the presentation of updated preclinical data for MaaT034, its next generation drug candidate to be evaluated to improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors at the 40th Society for Immunotherapy Cancer Annual Meeting in National Harbor, MD held from November 5 to 9, 2025. The SITC (Free SITC Whitepaper) Annual Meeting is one of the world’s leading scientific and medical conferences focused on cancer immunotherapy. The dataset demonstrates compelling anti-tumor efficacy results and immune activation in germ-free mouse models. New analyses of multi-omic data from these models amplify the results previously presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

MaaT034, the first-in-class co-cultured full ecosystem product, is designed to optimize intestinal microbiome functions and improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors (ICIs). MaaT034 is part of the Company’s MET-C platform, which leverages AI-driven co-culture technology to create donor-independent synthetic microbiome ecosystems at industrial scale, targeting specific disease indications.

To guide further development of MaaT034 in immuno-oncology, and in addition to its preclinical program, MaaT Pharma is also participating in two exploratory, investigator-sponsored clinical trials evaluating its donor-derived drug candidates (MaaT013 and MaaT033), respectively in metastatic melanoma and in non-small cell lung cancer (NSCLC).

Key findings from the presentation at SITC (Free SITC Whitepaper) include:

Metagenomic analysis shows that MaaT034 successfully engrafts in the gut of germ-free mice and reproduces the microbial functions of native-based microbiome ecosystems.
MaaT034 improves dendritic cell (DC)-mediated T cell activation and potentiates anti-tumor effects mediated by anti-PD-1 checkpoint blockade in vitro.
70% of MaaT034 microbial species engraft in mice, ensuring an enduring presence of beneficial bacteria in the gut environment.In human FMT studies, the level of engraftment is significantly associated with positive clinical outcomes across multiple indications, as shown by a recent comprehensive meta-analysis[1].
MaaT034 increases the production of key microbial-derived metabolites such as short-chain fatty acids, secondary bile acids, and tryptophan metabolites in germ-free mice. This translates into an improved gastrointestinal physiology as evidenced by gut mucosal restoration.
MaaT034 optimizes anti-PD1 mediated activity in tumor-bearing, germ-free mice. While anti-PD1 alone reduced tumor growth by 10%, the combination of anti-PD1 and MaaT034 resulted in a 83.7% tumor growth reduction (compared to a 24.2% reduction when using a single strain of Akkermansia muciniphila[2] bacteria). These results demonstrate that improved tumor control is achieved with anti-PD1 in combination with MaaT034, as compared to PD-1 alone or in combination with a reference single bacterial strain.
"With MaaT034, we are entering a new phase in our drug platform development, one that leverages our deep experience in the development of complex microbiome therapies and cutting-edge computational analysis to build a next-generation drug candidate capable of enhancing patient response to immunotherapy," said Sheri Simmons, PhD, Acting Chief Scientific Officer, MaaT Pharma. "These findings strongly support advancing our donor-independent, synthetic microbiome therapy and we look forward to bringing MaaT034 into clinical development."

Details of poster presentation:

Abstract number: 1150
Title: MaaT034, a new co-cultured microbiome ecosystem therapy candidate, potentiates anti-PD1 mediated antitumoral activity in germ-free mice
Presentation Day: Saturday, Nov. 8, 2025
Primary Category: Microbiome and Other Environmental Factors
Upcoming investor and medical conferences participation

November 19-21, 2025 – Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) annual meeting in Geneva, Switzerland
November 25, 2025 – Investir Day event in Paris, France
December 6-9, 2025 – 67th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in Orlando, Fl, USA
[1] Ianiro, G., Punčochář, M., Karcher, N. et al. Variability of strain engraftment and predictability of microbiome composition after fecal microbiota transplantation across different diseases. Nat Med 28, 1913–1923 (2022). View Source
[2] Akkermansia muciniphila is a commensal bacterium naturally present in large quantities in the gut microbiota of healthy people.

About MaaT034

MaaT034, currently in preclinical development, is a next-generation donor-independent full ecosystem synthetic microbiome therapy, dedicated to improving patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors. Developed using the Company’s co-culturing proprietary MET-C platform, MaaT034 is optimized for large-scale production in oncology. Previous presented preclinical data showed that MaaT034 produced key metabolites, recognized as promoting gut barrier restoration and modulating immune responses, such as Short-Chain Fatty Acids (SCFA), secondary bile acids, and tryptophan derivatives. These data support the role of MaaT034 in gut barrier repair and in T cell reactivation either in combination with anti-PD1 or with anti-PD-L1. By enhancing gut barrier repair and modulating immune responses, MaaT034 is expected to complement the action of these immunotherapeutic agents, potentially improving their efficacy in treating solid tumors cancer.

(Press release, MaaT Pharma, NOV 5, 2025, View Source [SID1234659466])

On November 5, 2025 Keros Therapeutics, Inc. ("Keros" or the "Company") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ("TGF-ß") family of proteins, reported financial results for the quarter ended September 30, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are excited that our partner Takeda plans to advance elritercept into a Phase 3 clinical trial to evaluate elritercept in the first-line setting in myelodysplastic syndromes," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. "We are pleased with the continued progress of both our partner and our internal pipeline, as we advance toward initiating a Phase 2 clinical trial of KER-065 in patients with Duchenne muscular dystrophy."

Third Quarter 2025 Financial Results

Keros reported a net loss of $7.3 million in the third quarter of 2025 as compared to a net loss of $53.0 million in the third quarter of 2024. The decrease of $45.7 million was largely due to revenue recognized related to Keros’ license agreement with Takeda Pharmaceuticals U.S.A., Inc. ("Takeda"), partially offset by research and development efforts as well as additional investments to support the achievement of Keros’ clinical and corporate goals.

Research and development expenses were $19.5 million for the third quarter of 2025 as compared to $49.2 million for the same period in 2024. The decrease of $29.7 million was primarily due to the transition of elritercept-related research and development expenses to Takeda.

General and administrative expenses were $10.1 million for the third quarter of 2025 as compared to $9.8 million for the same period in 2024. The increase of $0.3 million was primarily due to an increase in other external expenses partially offset by a decrease in compensation costs, including stock-based compensation costs, in connection with a reduction in headcount.

Keros’ cash and cash equivalents as of September 30, 2025 was $693.5 million compared to $559.9 million as of December 31, 2024. Based on current operating assumptions, Keros expects that its cash and cash equivalents as of September 30, 2025, less $375.0 million of excess capital that the Company’s Board of Directors has determined to return to stockholders, will enable Keros to fund its operating expenses and capital expenditure requirements into the first half of 2028.

(Press release, Keros Therapeutics, NOV 5, 2025, View Source [SID1234659465])

On November 5, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the third quarter of 2025 and updated financial guidance for 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Achieving the highest revenue quarter in Jazz’s history speaks to the strength of our diversified portfolio and the outstanding performance of our team. We were pleased to once again deliver solid execution across our sleep, epilepsy and oncology portfolios, led by double-digit percentage growth from Epidiolex and Xywav," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "In addition, we achieved several key milestones that will enhance our commercial portfolio, including receiving FDA approvals for Modeyso as well as the Zepzelca and atezolizumab first-line maintenance combination. We remain confident in the opportunity presented by zanidatamab and look forward to sharing the top-line data readout from the Phase 3 HERIZON-GEA-01 trial before the end of the year. With a proven portfolio and strong financial foundation, we are well-positioned to accelerate our evolution and deliver meaningful value for patients and shareholders alike."

Key Highlights

•Modeyso received accelerated approval from the FDA ahead of its PDUFA date; initiated commercial launch in August 2025 with strong initial uptake and sales of $11.0 million in 3Q25.
•Zepzelca and atezolizumab combination received FDA approval for 1L maintenance treatment of ES-SCLC based on positive data from the Phase 3 IMforte trial.
•Top-line PFS data from zanidatamab in Phase 3 1L GEA expected in 4Q25; updated intent-to-treat population for PFS to include all patients enrolled in the trial.
•Narrowed 2025 total revenue guidance range to $4.175 – $4.275 billion from $4.150 – $4.300 billion.
•Announced the appointment of Dr. Ted Love to the Board of Directors.

Business Updates

Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Net product sales increased 11% to $431.4 million in 3Q25 compared to 3Q24.
•Meaningful net patient adds in 3Q25 of approximately 450 patients. There were approximately 15,675 active patients exiting the quarter comprised of approximately 10,725 narcolepsy patients and approximately 4,950 idiopathic hypersomnia (IH) patients.

Epidiolex/Epidyolex (cannabidiol):
•Net product sales increased 20% to $302.6 million in 3Q25 compared to 3Q24.
•In 3Q25, volumes increased by 10%, driven by demand, and net product sales benefitted from lower gross to net deductions in the U.S.

Rylaze/Enrylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
•Net product sales increased 1% to $99.9 million in 3Q25 compared to 3Q24.

Zepzelca (lurbinectedin):
•Net product sales decreased 8% to $79.3 million in 3Q25 compared to 3Q24.
•Zepzelca and atezolizumab combination was included in National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as a preferred regimen for patients whose disease has not progressed following four cycles of platinum-based chemotherapy and atezolizumab induction.

Ziihera (zanidatamab-hrii):
•Net product sales were $8.3 million in 3Q25 following product launch in December 2024.
•Updated the intent-to-treat population for the primary PFS (progression-free survival) and interim overall survival analyses of the HERIZON-GEA-01 trial to include the full patient population enrolled in the trial.

Modeyso (dordaviprone):
•Net product sales were $11.0 million in 3Q25 following product launch in August 2025.
•Modeyso was made commercially available quickly following FDA accelerated approval on August 6, ensuring patients with H3 K27M-mutant diffuse midline glioma (DMG) had access to the first and only targeted drug therapy for this ultra-rare and aggressive brain tumor.
•Modeyso was included in the NCCN Clinical Practice Guidelines in Oncology.

Corporate Development:
•The Company announced a global licensing agreement with Saniona to develop and commercialize SAN2355, a highly differentiated, subtype selective Kv7.2/Kv7.3 activator in preclinical development for epilepsy and other potential indications.

Financial Highlights
Three Months Ended
September 30, Nine Months Ended
September 30,
(In thousands, except per share amounts) 2025 2024 2025 2024
Total revenues $ 1,126,107 $ 1,054,969 $ 3,069,660 $ 2,980,777
GAAP net income (loss) $ 251,412 $ 215,055 $ (559,599) $ 369,005
Non-GAAP adjusted net income1
$ 500,653 $ 412,359 $ 101,037 $ 951,445
GAAP earnings (loss) per share $ 4.08 $ 3.42 $ (9.18) $ 5.63
Non-GAAP adjusted earnings per share1
$ 8.13 $ 6.54 $ 1.63 $ 14.25

(Press release, Jazz Pharmaceuticals, NOV 5, 2025, View Source [SID1234659464])

On November 5, 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 third quarter of 2025 and recent business highlights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"The high unmet need in lower-risk MDS is well known, and RYTELO is a therapy with a novel mechanism of action and the potential to significantly impact the treatment paradigm. There is work ahead of us to fully maximize the value of this therapy and ensure RYTELO reaches more patients," said Harout Semerjian, President and Chief Executive Officer of Geron. "Geron is positioned, with our realigned leadership team, to strengthen commercial execution, increase both physician and patient awareness, and drive RYTELO sales in the U.S. We look forward to presenting meaningful data at ASH (Free ASH Whitepaper), enhancing our partnerships with the MDS community and conducting the interim analysis for the IMpactMF trial. Our actions are focused on creating value for our patients and shareholders."

Recent Business Highlights

RYTELO

Achieved net product revenue of $47.2 million in the third quarter of 2025.
Demand was down 3% quarter-over-quarter, with opportunities to elevate brand awareness and clinical value communications.
Number of ordering accounts is now approximately 1,150, an increase of approximately 150 quarter-over-quarter.
Increased RYTELO presence at major hematology forums, such as the Society of Hematologic Oncology (SOHO) 2025 Annual Meeting.
Announced that two abstracts highlighting data from the IMerge clinical trial in lower-risk MDS were accepted for presentation at the ASH (Free ASH Whitepaper) 2025 Annual Meeting, including one oral presentation on the potential correlation between imetelstat clinical response rates and treatment-emergent cytopenias.
Clinical Pipeline

Completed enrollment of 320 patients in the IMpactMF Phase 3 clinical trial evaluating imetelstat in relapsed/refractory myelofibrosis in September 2025.
Expect IMpactMF interim analysis readout for overall survival in the second half of 2026 (when approximately 35% of patient events have occurred), and final analysis in the second half of 2028 (when approximately 50% of patient events have occurred).
Announced three abstracts were accepted at the ASH (Free ASH Whitepaper) 2025 Annual Meeting highlighting clinical data from Geron’s IMbark and IMproveMF clinical trials and the investigator-sponsored IMpress clinical trial.
Corporate Updates

Announced the appointment of Ahmed ElNawawi ("Nawawi") as Executive Vice President, Chief Commercial Officer to advance the company’s strategic priorities, including driving growth, maximizing the potential of RYTELO, and strengthening the foundation for potential future portfolio expansion.
Appointed three additional executives with expertise across technical operations, investor relations and corporate affairs, and portfolio management, further strengthening the company’s commercial, operational and development capabilities.
Third Quarter 2025 Financial Results

Cash and Marketable Securities

As of September 30, 2025, Geron had approximately $421.5 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 months ended September 30, 2025, the Company reported a net loss of $18.4 million, or $0.03 per share, compared to $26.4 million, or $0.04 per share, for the three months ended September 30, 2024.

Revenues

Total product revenue, net for the three months ended September 30, 2025, was $47.2 million, compared to $28.2 million for the three months ended September 30, 2024.

Total revenues for the three months ended September 30, 2025 was $47.2 million, compared to $28.3 million for the three months ended September 30, 2024. Total revenues include license fees and royalties in addition to product revenue, net.

Costs and Operating Expenses

Total costs and operating expenses for the three months ended September 30, 2025 were $61.1 million, compared to $56.5 million for the three months ended September 30, 2024.

Cost of goods sold was approximately $1.0 million for the three months ended September 30, 2025, compared to $456,000 for the three months ended September 30, 2024, which consisted of costs to manufacture and distribute RYTELO.

Research and development expenses for the three months ended September 30, 2025 were $21.1 million, compared to $20.2 million for the same period in 2024. The increase in research and development expenses for the three months ended September 30, 2025, compared to the same period in 2024, was primarily due to increased chemistry, manufacturing, and controls (CMC) and personnel-related expenses. Geron expects research and development expenses to increase in the remaining quarter of 2025 over 2024 levels, primarily due to ongoing investments to support the Company’s CMC strategy.

Selling, general and administrative expenses for the three months ended September 30, 2025 were $39.0 million, compared to $35.9 million for the same period in 2024. The increase in selling, general and administrative expenses was primarily due to an increase in sales and marketing full-time employees and additional investment in marketing programs.

2025 Financial Guidance

For fiscal year 2025, the Company expects total operating expenses will be between $250 million and $260 million, compared to previously announced guidance of approximately $270 million to $285 million. Total operating expenses include 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 its 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, November 5, 2025, to discuss business updates and third 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.

(Press release, Geron, NOV 5, 2025, View Source [SID1234659463])