On November 13, 2025 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, reported pipeline progress and business updates and reported financial results for the third quarter ended September 30, 2025.

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"As we advance our robust pipeline of innovative masked immunotherapies, we continue to provide additional validation of our proprietary masking technology and ability to deliver differentiated molecules across a wide range of targets and design formats," said René Russo, Pharm.D., president and chief executive officer of Xilio. "At SITC (Free SITC Whitepaper), we presented compelling data across our clinical and preclinical programs, including data supporting the best-in-class potential of our masked T cell engager programs to meaningfully widen the therapeutic window relative to non-masked T cell engagers as well as our unique ability to incorporate co-stimulation to substantially improve the durability of T cell response."

Dr. Russo added, "For our clinical-stage programs, we continue to be encouraged by the promising data for both vilastobart and efarindodekin alfa, which have each shown differentiated clinical efficacy and safety for patients with high unmet need. In particular, new data for vilastobart leveraging plasma TMB as a predictive biomarker showed a 40% response rate in patients with MSS mCRC without liver metastases, supporting the significant opportunity for vilastobart as a combination therapy. As we look ahead to 2026, we are focused on execution across our clinical programs, while rapidly advancing XTX501, our bispecific PD-1/IL-2, toward a planned IND submission in mid 2026 and our masked T cell engager programs into IND-enabling studies."

Pipeline and Business Updates

Vilastobart: tumor-activated, Fc-enhanced anti-CTLA-4

Vilastobart is currently being evaluated in combination with atezolizumab (Tecentriq) in Phase 1C combination dose escalation in patients with advanced solid tumors and in a Phase 2 clinical trial in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC).

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In November 2025, Xilio announced new late-breaking data from its ongoing Phase 2 clinical trial at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting. These data demonstrated a 40% objective response rate (ORR) in heavily pre-treated, plasma tumor mutational burden (TMB) high patients (≥10 mutations/Mb) with MSS mCRC without liver metastases and showed a statistically significant correlation (p=0.05) between plasma TMB status and response. Approximately 55% of patients with MSS mCRC are estimated to have high plasma TMB, representing a meaningful patient population with high unmet need. For more information, read the press release here, and watch a replay of the webcast with leading colorectal cancer experts here.

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In November 2025, Xilio announced additional new Phase 2 data presented at SITC (Free SITC Whitepaper), which demonstrated the potential for circulating tumor DNA (ctDNA) as an early predictive biomarker for response to treatment with vilastobart in combination with atezolizumab in patients with MSS mCRC. For more information, read the press release here.

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Based on the promising clinical activity and safety profile demonstrated by vilastobart as a combination therapy, including in patients who had high plasma TMB, Xilio is actively seeking a partner to develop vilastobart in combination with PD-(L)1 or PD1-VEGF in MSS CRC and other tumor types.

Efarindodekin Alfa: tumor-activated IL-12

Xilio is evaluating efarindodekin alfa as a monotherapy in an ongoing Phase 1/2 clinical trial in patients with advanced solid tumors.

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In November 2025, Xilio presented Phase 1 monotherapy dose escalation data for efarindodekin alfa at SITC (Free SITC Whitepaper) demonstrating promising monotherapy anti-tumor activity in patients with advanced solid tumors as well as a generally well-tolerated safety profile at doses over 100-fold greater than the maximum tolerated dose of recombinant human IL-12. For more information, read the press release here.

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In September 2025, Xilio announced the selection of an initial recommended phase 2 dose (RP2D) and schedule for efarindodekin alfa and initiated patient dosing in the Phase 2 portion of the clinical trial. In connection with the initiation of Phase 2, Xilio achieved a development milestone of $17.5 million under its license agreement with Gilead Sciences, Inc. (Gilead). For more information, read the press release here.

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Xilio has completed enrollment in the Phase 1A monotherapy dose escalation and Phase 1B monotherapy dose expansion portions of the ongoing Phase 1/2 clinical trial, and evaluation of those patients is ongoing.

XTX501: bispecific PD-1 / masked IL-2

XTX501 is a novel, bispecific PD-1 / masked IL-2 designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function. XTX501 incorporates masking designed to overcome IL-2 receptor-mediated clearance and peripheral activity. In preclinical studies, XTX501 demonstrated robust monotherapy activity (including in settings insensitive to PD-1) and tumor-selective pharmacodynamics consistent with its intended mechanism of action.

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XTX501 is currently advancing through investigational new drug (IND)-enabling studies, and Xilio plans to submit an IND application for XTX501 in the middle of 2026.

Masked T Cell Engager Programs

Xilio is leveraging its proprietary, clinically validated tumor-activation platform to advance multiple preclinical programs for masked T cell engagers, including wholly owned programs targeting tumor-associated antigens for PSMA (prostate cancer), CLDN18.2 (gastric, pancreatic, esophageal and lung cancers) and STEAP1 (prostate, colorectal and lung cancers), as well as an additional program in collaboration with AbbVie Group Holdings Limited (AbbVie).

Xilio’s masked T cell engager programs include bispecific molecules designed using its advanced tumor-activated cell engager (ATACR) format, which consists of a T cell engager with a masked CD3 targeting domain, and tri-specific molecules designed using its selective effector-enhanced cell engager (SEECR) format. The SEECR format builds upon the ATACR format by adding co-stimulatory signaling designed to further enhance potency and durability of T cell activation.

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In November 2025, Xilio presented new preclinical data at SITC (Free SITC Whitepaper) highlighting the potential for the company’s masking technology to significantly expand the therapeutic window for T cell engagers and overcome the challenges associated with current, systemically active non-masked T cell engagers. Xilio’s masked T cell engager molecules demonstrated potent anti-tumor activity with evidence of reduced systemic toxicity in murine models, supporting its broad applicability and potential best-in-class profile across a diverse range of targets, and the incorporation of co-stimulatory signaling in Xilio’s proprietary SEECR format enhanced durability of anti-tumor activity compared with T cell engager molecules that lacked co-stimulation. For more information, read the press release here.

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In the third quarter of 2025, Xilio nominated a development candidate for its PSMA program (ATACR format).

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Xilio anticipates nominating development candidates for its CLDN18.2 program (ATACR format) in the fourth quarter of 2025 and for its STEAP1 program (SEECR format) in the first half of 2026.

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Xilio anticipates advancing at least two of these programs into IND-enabling studies and submitting IND applications for those programs in 2027.

Third Quarter 2025 Financial Results

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Cash Position: Cash and cash equivalents were $103.8 million as of September 30, 2025, compared to $55.3 million as of December 31, 2024. The increase was primarily driven by $52.0 million in total upfront payments under the collaboration, license and option agreement and stock purchase agreement entered into in February 2025 with AbbVie and $47.0 million in net proceeds received from Xilio’s June 2025 follow-on public offering, partially offset by cash used for operating activities.

In the fourth quarter of 2025, Xilio received the $17.5 million development milestone payment under its license agreement with Gilead.
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Collaboration and License Revenue: Collaboration and license revenue was $19.1 million for the quarter ended September 30, 2025, compared to $2.3 million for the quarter ended September 30, 2024. Collaboration and license revenue for the quarter ended September 30, 2025 consisted of revenue recognized in connection with Xilio’s collaborations with AbbVie and Gilead, and collaboration and license revenue for the quarter ended September 30, 2024 consisted of revenue recognized in connection with Xilio’s collaboration with Gilead.

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Research & Development (R&D) Expenses: R&D expenses were $14.3 million for the quarter ended September 30, 2025, compared to $10.8 million for the quarter ended September 30, 2024. The increase was primarily driven by increased clinical development activities related to efarindodekin alfa, manufacturing activities related to IND-enabling studies and preclinical development activities for XTX501, increased costs related to early-stage programs and indirect research and development and increased personnel-related costs.

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General & Administrative (G&A) Expenses: G&A expenses were $6.7 million for the quarter ended September 30, 2025, compared to $6.3 million for the quarter ended September 30, 2024. The increase was primarily driven by an increase in professional and consulting fees, including legal fees and other professional costs, which were partially offset by a decrease in costs related to directors’ and officers’ liability insurance.

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Net Loss: Net loss was $16.3 million for the quarter ended September 30, 2025, compared to $14.0 million for the quarter ended September 30, 2024.

Financial Guidance

Based on its current operating plans, Xilio anticipates that its cash and cash equivalents as of September 30, 2025, together with the $17.5 million development milestone received under its license agreement with Gilead, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the first quarter of 2027.

About Vilastobart

Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety of the combination in Phase 1C dose escalation in patients with advanced solid tumors and the efficacy and safety of the combination in Phase 2 in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) with and without liver metastases. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.

About Efarindodekin Alfa

Efarindodekin alfa (XTX301) is an investigational tumor-activated IL-12 designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment (TME) of poorly immunogenic "cold" tumors towards an inflamed or "hot" state. Xilio is currently evaluating the safety and tolerability of efarindodekin alfa as a monotherapy in patients with advanced solid tumors in the Phase 1 portion of a first-in-human, multi-center, open-label Phase 1/2 clinical trial and the safety and efficacy of efarindodekin alfa as a monotherapy in the Phase 2 portion in patients with advanced solid tumors. The Phase 2 portion of the trial is anticipated to enroll approximately 40 patients in specific tumor types at multiple sites in the United States. Please refer to NCT05684965 on www.clinicaltrials.gov for additional details.

In March 2024, Xilio entered into an exclusive global license agreement with Gilead to develop and commercialize efarindodekin alfa and specified other molecules directed to IL-12.Xilio is responsible for conducting clinical development for efarindodekin alfa through the initial Phase 2 portion of the ongoing Phase 1/2 clinical trial. Following the delivery by Xilio of a specified clinical data package for efarindodekin alfa related to the Phase 1/2 clinical trial, Gilead can elect to transition responsibilities for the development and commercialization of efarindodekin alfa to Gilead, subject to the terms of the license agreement and payment by Gilead of a $75.0 million transition fee. If Gilead exercises its option for efarindodekin alfa, Xilio will be eligible to receive up to $500.0 million in specified development, regulatory and sales-based milestones and will be eligible to receive tiered royalties ranging from high single digits to mid-teens on annual global net product sales.

(Press release, Xilio Therapeutics, NOV 13, 2025, View Source [SID1234659919])

On November 13, 2025 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported its financial results for the third quarter 2025.

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"We are steadily building the foundation for potentially transformative progress in the oncology treatment paradigm as we advance our systemic DNase I program in combination with established cancer therapies," commented James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic. "The partnerships we’ve formed continue to generate critical data that we believe will help us guide our development and regulatory strategies to fully realize the promise of our DNase technology. The underwritten public offering we completed in October 2025 extends our cash runway and provides us additional capital to continue to invest in pre-clinical efforts and exploratory studies and advance our technology toward an IND submission and Phase 1 initiation."

Xenetic continues to advance its DNase-based technology towards Phase 1 clinical development for the treatment of pancreatic carcinoma and other locally advanced or metastatic solid tumors. Preclinical proof-of-concept studies combining DNase I with chemotherapy, immunotherapies, and CAR-T therapy in hematological and solid tumor and metastatic cancer models have been completed. Building on proof-of-concept success, the program has now advanced to mechanism-of-action and translational studies in preparation for a Phase 1 clinical trial.

Additionally, as previously announced in December 2024, Xenetic entered into a Clinical Trial Services Agreement with PeriNess, under which PeriNess will lead in the regulatory approval, operational execution and management of potential exploratory, investigator initiated studies of recombinant DNase as an adjunctive treatment in patients with pancreatic carcinoma and other locally advanced or metastatic solid tumors receiving chemotherapy and immunotherapy in Israeli medical centers.

Summary of Financial Results for Third Quarter 2025
Net loss for the quarter ended September 30, 2025 was approximately $0.5 million. Research & development expenses for the three months ended September 30, 2025 increased by approximately $0.4 million, or 105.6%, to approximately $0.8 million from $0.4 million in the comparable quarter in 2024 primarily due to increased manufacturing development efforts and pre-clinical research as well as increased consulting costs. General and administrative expenses for the three months ended September 30, 2025 increased by approximately $0.1 million, or 9.3%, to approximately $0.8 million from approximately $0.7 million in the comparable quarter in 2024 primarily due to increased legal costs in connection with the Company’s strategic review process.

Revenue for the three months ended September 30, 2025 increased by approximately $0.4 million, or 67.2%, to approximately $1.0 million from approximately $0.6 million for the three months ended September 30, 2024. This increase represented an increase in royalty revenue related to Xenetic’s sublicense agreement with Takeda Pharmaceuticals Co. Ltd. as compared to the same period in 2024 primarily due to royalties recognized from certain countries during the third quarter of 2025 compared to the same period in 2024.

The Company ended the quarter with approximately $4.1 million cash. Subsequent to quarter end, the Company closed an underwritten offering for net proceeds of approximately $3.9 million.

(Press release, Xenetic Biosciences, NOV 13, 2025, View Source [SID1234659918])

On November 13, 2025 Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, reported that its senior leadership team will present at the prestigious Jefferies London Healthcare Conference.

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Chief Executive Officer Ivor Elrifi and Chief Operating Officer/Chief Financial Officer Keeren Shah will deliver a corporate overview highlighting the Company’s innovative pipeline and recent clinical milestones. The session will include an update on the lead candidate foralumab, the only fully human anti-CD3 monoclonal antibody in clinical development administered intranasally for neurodegenerative diseases such as non-active secondary progressive multiple sclerosis (SPMS), Alzheimer’s disease (AD), multiple system atrophy (MSA) and amyotrophic lateral sclerosis (ALS).

The Jefferies London Healthcare Conference is one of Europe’s premier investor forums, attracting leading global healthcare companies, institutional investors, and industry thought leaders. Tiziana’s participation underscores its growing visibility within the biotechnology investment community and its commitment to advancing transformative therapies for patients with high unmet medical needs.

Presentation Details

Event: Jefferies London Healthcare Conference

Date: Wednesday, November 19, 2025

Time: 12:30 p.m. – 12:55 p.m. GMT (25-minute presentation)

Location: London, UK

Presenters:

● Ivor Elrifi, Chief Executive Officer

● Keeren Shah, Chief Operating Officer and Chief Financial Officer

Management will also be available for one-on-one meetings throughout the conference. Interested parties may request meetings through the Jefferies conference portal or by contacting Tiziana’s investor relations team.

(Press release, Tiziana Life Sciences, NOV 13, 2025, View Source [SID1234659917])

On November 13, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported new and updated data from its hematology portfolio and pipeline will be shared across 14 abstracts at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 Annual Meeting, taking place from December 6-9 in Orlando, FL. Presentations highlight the next wave of potential novel approaches across a range of blood cancers and disorders.

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"This has been a landmark year for our Hematology program with U.S. and international regulatory approvals and launches for our blood cancer medicines," said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President and Hematology Clinical Development Unit Head at Regeneron. "At ASH (Free ASH Whitepaper), our momentum continues with oral presentations on Lynozyfic as well as odronextamab in the frontline setting, which showcase how earlier interventions with our innovative approaches have the potential to benefit even more patients. We will also share updated results across our blood disorders pipeline, which reinforce our strategy of translating our deep expertise in hematology into meaningful progress where unmet needs remain."

Notable presentations from the Lynozyfic (linvoseltamab-gcpt) development program include an oral presentation on the Phase 1/2 LINKER-MM4 trial, which is the first to investigate the use of a bispecific monotherapy in newly diagnosed multiple myeloma (MM). New results will also be shared from the multicohort Phase 1b LINKER-MM2 trial evaluating linvoseltamab with two different anti-CD38 monoclonal antibodies in patients with relapsed/refractory (R/R) MM.

Progress on the odronextamab development program will be featured in six abstracts including an oral presentation on the first results of odronextamab plus chemotherapy from OLYMPIA-3 in previously untreated diffuse large B-cell lymphoma (DLBCL). Other presentations include the first results from Part 1 of two Phase 3 trials evaluating odronextamab in follicular lymphoma (FL) – odronextamab plus chemotherapy in frontline FL (OLYMPIA-2) as well as odronextamab plus lenalidomide in R/R FL (OLYMPIA-5).

Additional presentations include updated results for the novel combination of cemdisiran with pozelimab (cemdi-poze) compared to ravulizumab in paroxysmal nocturnal hemoglobinuria as well as the first-in-human evaluation of REGN7257 in severe aplastic anemia.

The full list of Regeneron presentations at ASH (Free ASH Whitepaper) includes:

Abstract Title Presentation ID Presenter Session Date/Time (ET)
Lynozyfic
Safety and efficacy of linvoseltamab as a simplified monotherapy first-line regimen in NDMM: Initial Results from the window of opportunity Phase 1/2 LINKER-MM4 trial​ #697

Oral Presentation Session 654 Robert Orlowski Sunday,
December 7 at 4:30 – 6:00 pm

West Hall E1
Safety and efficacy of linvoseltamab (LINVO) combined with anti-CD38 monoclonal antibodies (mAbs) daratumumab (DARA) or isatuximab (ISA) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): Initial results from the multicohort, Phase 1b LINKER-MM2 trial
#2254

Poster Session 654 Meletios Dimopoulos Saturday,
December 6 at 5:30 – 7:30 pm

West Halls B3-B4
Odronextamab
Odronextamab plus chemotherapy in patients with previously untreated diffuse large B-cell lymphoma (DLBCL): First Results from part 1 of the Phase 3 Olympia-3 study #65

Oral Presentation
Session 629
Jean-Marie Michot
Saturday, December 6

at 9:30 – 11:00 am

Tangerine Ballroom F2

Efficacy and safety of long-term odronextamab treatment in patients with relapsed/refractory follicular lymphoma: 3-year follow-up from the Phase 2 ELM-2 study #3588

Poster Session 623

Jose Villasboas Bisneto
Sunday, December 7

at 6:00 – 8:00 pm

West Halls B3-B4

Odronextamab plus chemotherapy in patients with previously untreated follicular lymphoma: First results from part 1 of the Phase 3 Olympia-2 study #3600

Poster
Session 623
Kitsada Wudhikarn
Sunday, December 7

at 6:00 – 8:00 pm

West Halls B3-B4

Odronextamab (Odro) plus lenalidomide (+Len) in patients with relapsed/refractory (R/R) follicular lymphoma (FL): First results from part 1 (safety lead-in) of the Phase 3 OLYMPIA-5 study #5381

Poster
Session 623 Umberto Vitolo
Monday, December 8

at 6:00 – 8:00 pm

West Halls B3-B4

Phased variant circulating tumor DNA (ctDNA) tracking provides limited additional power in predicting progressive disease compared with duplex variant tracking in patients with Relapsed/Refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) treated with odronextamab #5309

Poster Session 621 Jon Arnason Monday,
December 8 at 6:00 – 8:00 pm

West Halls B3-B4
Odronextamab treatment for patients with rare subtypes of relapsed/refractory (R/R) aggressive B-cell non-Hodgkin lymphoma (B-NHL): Updated efficacy and safety analyses from a dedicated cohort of the ELM-2 study #5523

Poster
Session 629

Farrukh Awan Monday,
December 8 at 6:00 – 8:00 pm

West Halls B3-B4
Cemdisiran and Pozelimab ("cemdi-poze")*
Efficacy and safety of pozelimab plus cemdisiran versus ravulizumab in patients with paroxysmal nocturnal hemoglobinuria who received prior C5 therapy #1420

Poster Session 508 Jun Ho Jang Saturday,
December 6 at
5:30 – 7:30 pm

West Halls B3-B4
Study design of A phase 3, open-label trial for pozelimab and cemdisiran combination therapy in patients with paroxysmal nocturnal hemoglobinuria with inadequate control of intravascular hemolysis #4988

Poster Session 508 Jun Ho Jang Monday,
December 8 at 6:00 – 8:00 pm

West Halls B3-B4
REGN7257
First-in-human evaluation of IL2RG blockade in patients with severe aplastic anemia that is refractory to or relapsed on immunosuppressive therapy #27

Oral Presentation
Session 508

Regis Peffault De Latour Saturday,
December 6 at
9:30 – 11:00 am

Hyatt – Plaza Int’l HIJK

Multiple Myeloma
Health care resource utilization in patients with multiple myeloma receiving bispecific antibody therapy with teclistamab: A Medicare claims database analysis in the US #3975

Poster
Session 653 Sikander Ailawadhi Sunday,
December 7 at 6:00 – 8:00 pm

West Halls B3-B4
Aplastic Anemia
Comprehensive multiproteomic analysis reveals an inflammatory phenotype in immune aplastic anemia characterized by broad activation of antigen presenting cells and t helper/cytotoxic 1.17 immune responses #3190

Poster Session 508 Audrey Le Floch-Ramondou
Sunday, December 7

at 6:00 – 8:00 pm

West Halls B3-B4

Longitudinal multiproteomic analysis reveals persistent underlying inflammation in acute graft-versus-host disease patients responding to corticosteroid treatment #2456

Poster Session 722 Audrey Le Floch-Ramondou
Saturday, December 6

at
5:30 – 7:30 pm

West Halls B3-B4

*Agreement with Alnylam Pharmaceuticals, Inc.

Cemdi-poze as well as REGN7257 are investigational, and the uses of linvoseltamab described above and of odronextamab in rare subtypes of R/R aggressive B-cell non-Hodgkin lymphoma are also investigational and have not been approved by any regulatory authority. Odronextamab is approved in the European Union as Ordspono for the treatment of R/R FL or DLBCL after two or more lines of systemic therapy, although its safety and efficacy have not been fully evaluated by any other regulatory authority.

(Press release, Regeneron, NOV 13, 2025, View Source [SID1234659916])

On November 13, 2025 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, reported third quarter 2025 financial results and business updates.

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"FDA approval of PAPZIMEOS in August marked the beginning of a new era for adults living with RRP," said Helen Sabzevari, PhD, President and CEO of Precigen. "PAPZIMEOS is the first and only treatment for adults with RRP, with an excellent safety profile and unmatched efficacy based on the groundbreaking pivotal study that supported full FDA approval, granted ahead of the PDUFA action date. PAPZIMEOS is already available to prescribers, and demand from both physicians and patients has been exceptional. For the first time, adults with RRP have access to an emerging standard of care—the first therapy capable of breaking the relentless cycle of surgeries by targeting the root cause of the disease."

"We are very encouraged by the strong early interest in PAPZIMEOS and the rapid pace of activation since approval in August and the deployment of our sales force in September," said Phil Tennant, Chief Commercial Officer of Precigen. "Patient identification has been outstanding, with prescribers and institutions actively working to bring PAPZIMEOS to their patients. To date, over 100 patients have already been registered in the PAPZIMEOS Patient Hub. In addition, a significantly larger number of patients have been identified through institutional patient hubs as potential candidates for treatment with PAPZIMEOS. Our team has swiftly mobilized the market: engaging over 90% of target institutions, advancing payer and formulary access, and driving broad educational and promotional outreach. These efforts have laid a firm foundation for PAPZIMEOS as the new standard of care for adults with RRP."

"PAPZIMEOS represents a monumental shift in how we care for adults with RRP," said Dr. Simon R. Best, MD, Associate Professor of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine. "For the first time, we can offer adult patients a safe and effective treatment that addresses the underlying disease rather than repeatedly managing symptoms through endless surgeries. The durable patient outcomes from the pivotal trial are nothing short of remarkable, and it’s clear PAPZIMEOS is poised to become the new standard of care for this debilitating condition."

KEY PROGRAM AND COMPANY HIGHLIGHTS

PAPZIMEOSTM (zopapogene imadenovec-drba) AdenoVerse Immunotherapy for Adults with RRP

· PAPZIMEOS full approval: In August 2025, the US Food and Drug Administration (FDA) granted full approval of PAPZIMEOS with a broad label and no requirement for a confirmatory trial for the treatment of adults with recurrent respiratory papillomatosis (RRP). Approval was supported by the groundbreaking results from the Phase 1/2 pivotal study—the only study in RRP ever conducted with a prospectively defined statistical primary endpoint.
· PAPZIMEOS now available: Following FDA approval in August 2025, PAPZIMEOS is now commercially available and commercial product is shipping to prescribers in the US for the treatment of adults with RRP.
· Early adoption momentum: Rapid commercial launch execution underway with over 90% of target institutions engaged since full deployment of the sales team in September. To date, over 100 patients have been registered in the PAPZIMEOS Patient Hub.
· Positive payer coverage: Private health insurance coverage is progressing rapidly with more than 100 million lives covered to date; PAPZIMEOS is also now available through Medicare and Medicaid.
· Long-term durability data published: The Company announced long-term follow-up results highlighting ongoing durable complete responses after treatment with PAPZIMEOS at the American Academy of Otolaryngology–Head and Neck Surgery Foundation (AAO-HNSF) 2025 Annual Meeting and the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting 2025. As of the September 19, 2025 data cutoff:

o 15 out of 18 complete responders (83%) demonstrated continued complete response without any additional treatment interventions with a median follow-up of 36 months (range 27 to 37). Median duration of complete response has yet to be reached.
o Reduction in surgeries compared to the year prior to treatment with PAPZIMEOS was observed in 86% of patients in Year 1, 91% in Year 2, and 95% in Year 3.
o No new safety events observed during long-term follow-up.
· Healthcare resource utilization data published: The Company announced new data at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Europe 2025 showing that, above and beyond the impact of surgery, healthcare resource utilization is substantially higher in adults with RRP with significantly higher emergency and healthcare visits, opioid use, and mental health service needs, reflecting the substantial burden on the healthcare system.
· Quality of life data published: The Company announced new data at ISPOR Europe 2025 showing results from a survey of adult RRP patients highlighting the substantial impact of RRP on the patient journey and quality of life. RRP patients reported a substantial physical and mental health burden that impacts overall well-being, results in job losses and productivity declines, and lowers overall quality of life.
· Geographic expansion: The Company submitted a Marketing Authorization Application (MAA) for zopapogene imadenovec for the treatment of adults with RRP to the European Medicines Agency (EMA) in November 2025.

PRGN-2009 AdenoVerse Immunotherapy in HPV-associated Cancers
PRGN-2009 is an investigational off-the-shelf AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-associated cancers.

· PRGN-2009 Phase 2 clinical trials, under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in newly diagnosed HPV-associated oropharyngeal cancer, are ongoing.
· The Phase 2 randomized, open-label study of PRGN-2009 in combination with pembrolizumab in patients with HPV-associated recurrent/metastatic cervical cancer is ongoing with two additional clinical sites active in addition to NCI.

FINANCIAL HIGHLIGHTS

· Cash, cash equivalents, and investments totaled $123.6 million as of September 30, 2025, which is expected to fund the Company’s operations to cash flow break-even.
· In September 2025, the Company entered into a credit facility that provides up to $125 million of non-dilutive financing and received the first tranche of $100 million.

"In the third quarter of 2025, we significantly increased investment in commercialization efforts to support the successful launch of PAPZIMEOS," said Harry Thomasian Jr., Chief Financial Officer of Precigen. "With the launch now underway, we are confident that we are well-equipped to maximize the impact of the historic PAPZIMEOS launch, drive ongoing commercialization of PAPZIMEOS, and support sustainable growth. Importantly, based upon our present forecast, we expect our current cash position to fund operations through cash flow break-even, representing a strong financial foundation as we continue to execute on our commercial and strategic objectives."

Third Quarter 2025 Financial Results Compared to Prior Year Period

Total revenues increased by $2.0 million compared to the three months ended September 30, 2024. This increase was primarily driven by the increase in collaboration and licensing revenue as a result of the recognition of the remaining deferred revenue associated with the termination of an exclusive channel collaboration agreement.

Research and development expenses increased by $1.0 million, or 9%, compared to the three months ended September 30, 2024. The increase was primarily driven by increased manufacturing expenses and lab supplies related to commercial manufacturing of PAPZIMEOS prior to its FDA approval, professional fees incurred in connection with regulatory filing procedures as well as employee-related costs. These increases were partially offset by the capitalization of inventory-related costs subsequent to the FDA’s approval of PAPZIMEOS.

Selling, General and Administrative (SG&A) expenses increased by $14.2 million, or 144%, compared to the three months ended September 30, 2024. This increase was primarily due to a $9.0 million increase in costs incurred related to PAPZIMEOS commercial readiness, including sales and marketing efforts as well as professional and consulting fees. Other employee-related costs increased approximately $4.0 million, and professional and legal fees increased by $1.0 million.

Total other expense, net, increased by $109.2 million compared to the three months ended September 30, 2024. This change was primarily due to a non-cash $111.5 million increase in the fair value of warrant liabilities related to the convertible preferred transaction from 2024.

The Company recorded a one-time $179.0 million non-cash deemed dividend on preferred stock in the third quarter of 2025 as a reduction to additional paid-in capital (and an increase in net loss attributable to common shareholders when computing net loss per share) in accordance with Generally Accepted Accounting Principles (GAAP). On September 15, 2025, all of the outstanding Preferred Shares were converted into common shares.

Net loss attributable to common shareholders was $325.3 million, or $(1.06) per basic and diluted share for the three months ended September 30, 2025, compared to a net loss of $24 million, or $(0.09) per basic and diluted share, for the three months ended September 30, 2024. The increase in net loss was significantly impacted by non-cash items including the increase in the fair value of the warrant liabilities and the deemed dividend on preferred shares (combined impact of $0.95 per share for the three months ended September 30, 2025).

(Press release, Precigen, NOV 13, 2025, View Source [SID1234659915])