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])

On November 13, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company developing therapeutics using its proprietary INTASYL siRNA gene silencing technology to eliminate cancer, reported its financial results for the quarter ended September 30, 2025 and provided a business update.

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Recent Corporate Updates

PH-762 Clinical Progress

Phio’s ongoing Phase 1b dose escalation clinical trial (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma. Per the trial’s protocol, patients receive four injections of PH-762 at weekly intervals and pathologic response is assessed on day 36 after the initial injection of PH-762. To date, pathologic results for the fifth and final cohort were as follows: 100% tumor clearance in one of three patients, > 90% clearance in the second patient, and > 50% clearance in the third patient at Day 36.

To date, a total of 18 patients with cutaneous carcinomas have completed treatment across five dose escalating cohorts in the Phase 1b trial. The cumulative pathologic response in 16 patients with cSCC include six with a complete response (100% clearance), two with a near complete response (> 90% clearance) and two with a partial response (> 50% clearance). A single patient with metastatic Merkel cell carcinoma had a partial response (> 50% clearance). Six patients with cSCC and one patient with metastatic melanoma had a pathologic non-response (< 50% clearance). No patients in the study, however, exhibited clinical progression of disease.

To date, there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. Phio may continue to screen and treat additional patients as part of the fifth cohort.

In July 2025, the Company entered into a comprehensive drug substance development services agreement with a U.S. manufacturing company pursuant to which the manufacturer will provide analytical and process development and cGMP manufacture of Phio’s lead development compound, PH-762.

Scientific and Investor Presentations

In September 2025, Phio delivered podium presentations for its INTASYL self-delivering siRNA technology at the Wainwright Global Investment Conference and the Life Sciences PA Life Sciences Future Conference. The Company presented its Phase 1b clinical trial results to date. The Company also delivered virtual presentations on its INTASYL compounds PH-762 and PH-894 in October 2025 at the Renmark Video Non Deal Roadshow. A poster highlighting an update on the ongoing clinical study for PH-762 was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting in National Harbor, MD. In addition, a podium presentation entitled "Synthesized INTASYL siRNA Technology Downregulating Gene Expression" will be held at the Advanced Therapies USA conference 2025 in Philadelphia, PA.

Warrant Inducements

On July 25, 2025, the Company entered into warrant inducement agreements with certain holders of certain of the Company’s existing common stock warrants to exercise such warrants for an aggregate of 928,596 shares of the Company’s common stock. In consideration for the exercise of such warrants and the payment of an additional $0.125 per new warrant, the Company agreed to issue to such holders new unregistered common stock warrants to purchase an aggregate of up to 1,857,192 shares of common stock with an exercise price of $2.485 per share. In connection with this financing, the Company raised approximately $2.1 million after expenses.

On November 3, 2025, the Company entered into warrant inducement agreements with certain holders of certain of the Company’s existing common stock warrants to exercise such warrants for an aggregate of 5,663,182 shares of the Company’s common stock. In consideration for the exercise of such warrants and the payment of an additional $0.125 per new warrant, the Company agreed to issue to such holders new unregistered common stock warrants to purchase an aggregate of up to 11,326,364 shares of common stock with an exercise price of $2.05 per share. In connection with this financing, the Company expects to raise approximately $12.1 million, of which $11.5 million has been received by the Company, with the remainder expected by November 18, 2025.

Third Quarter 2025 Financial Results

Cash Position

At September 30, 2025, the Company had cash and cash equivalents of approximately $10.7 million as compared with approximately $5.4 million at December 31, 2024.

As of the date of this release, the Company had estimated cash and cash equivalents of approximately $21.3 million, which is projected to sustain operations into the first half of 2027.

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2025 were $1.2 million compared to $0.6 million for the same period in 2024. The increase in research and development expenses was primarily driven by higher clinical trial costs and chemistry, manufacturing and controls (CMC) costs in connection with advancing our PH-762 program, as well as an increase in R&D employee personnel-related costs.

General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2025 were $1.3 million compared to $0.9 million for the same period in 2024. The increase in general and administrative expenses was primarily driven by an increase in outsourced professional fees related to accounting and legal services as well as employee stock compensation expense.

Net Loss

Net loss was $2.4 million for the three months ended September 30, 2025 compared with $1.5 million for the same period in 2024. The increase in net loss was due to the changes in research and development and general and administrative expenses as described above.

(Press release, Phio Pharmaceuticals, NOV 13, 2025, View Source [SID1234659914])

On November 13, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported a business update, announced financial results for the third quarter ended September 30, 2025, and provided a clinical programs update.

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"Our request to meet with the FDA to propose an amendment to our ongoing VERSATILE-003 Phase 3 trial represents the culmination of the encouraging data from our now completed VERSATILE-002 trial", said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We believe the positive PFS data offers an important opportunity to shorten the trial duration and time to regulatory submission while maintaining mOS as the endpoint for full FDA approval. Importantly, we believe this approach may also accelerate the availability of this promising treatment to patients in need."

Clinical and Corporate Update

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Announced final topline survival data from the VERSATILE-002 Phase 2 clinical trial. VERSATILE-002 evaluated PDS0101 + Keytruda (pembrolizumab) in patients with HPV16+ HNSCC

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The median overall survival (mOS) is 39.3 months in patients with CPS ≥ 1. The lower limit of the 95% confidence interval is 23.9 months, and the upper limit is not yet estimable.

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The progression-free survival is 6.3 months in patients with CPS ≥ 1.

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Announced plan to seek accelerated approval pathway in the VERSATILE-003 Phase 3 randomized trial for PDS0101 in combination with pembrolizumab versus pembrolizumab monotherapy.

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Increased mOS suggests the potential for fewer death events in a specified time that will likely result in an extended trial duration.

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The increase in mOS is the basis for a proposed amendment to the statistical analysis plan based on the earlier mOS. The proposed amendment could reduce trial size while maintaining statistical power.

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Due to the positive final PFS result, the proposed amendment would change the PFS endpoint to become a surrogate primary endpoint that can be evaluated earlier with high statistical power and potentially form the basis for accelerated approval.

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mOS will remain as the primary endpoint for full approval as originally recommended by FDA.

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National Cancer Institute (NCI) presented new clinical data at the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting

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The NCI presented three abstracts highlighting emerging clinical and translational findings from PDS Biotechnology’s novel investigational immunotherapy platforms, including the tumor-targeting IL-12 fused antibody drug conjugate (PDS01ADC) and PDS0101, the Company’s lead Phase 3 clinical stage HPV-targeted immunotherapy. The presented translational biomarker studies demonstrated the unique immunological properties of PDS0101 and PDS01ADC leading to anti-tumor immune responses and the predictability of clinical responses.

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Announced Preliminary Results from Colorectal Cancer Cohort of Phase 2 Clinical Trial with PDS01ADC.

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Met Criteria for Expansion to Stage 2 Following Positive Stage 1 Results

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Metastatic colorectal cancer cohort in study led by the National Cancer Institute met high objective response rate bar for continuation of study of at least 6 of 9 confirmed objective responses by RECIST v1.1. This triggered enrollment expansion under the Simon Two-Stage study design

Third Quarter 2025 Financial Results

Reported net loss was $9.0 million, or $0.19 per basic and diluted share, for the three months ended September 30, 2025, compared to $10.7 million, or $0.29 per basic share and diluted share, for the three months ended September 30, 2024. The decrease in net loss was primarily due to lower operating expenses.

Research and development expenses were $4.6 million for the three months ended September 30, 2025, compared to $6.8 million for the three months ended September 30, 2024. The decrease was primarily due to lower manufacturing and clinical expenses and personnel costs.

General and administrative expenses were $3.6 million, for the three months ended September 30, 2025, compared to $3.4 million for the three months ended September 30, 2024. The increase was primarily due to higher professional fees, partially offset by lower personnel costs.

Total operating expenses were $8.1 million for the three months ended September 30, 2025, compared to $10.2 million for the three months ended September 30, 2024.

Net interest expense was $0.9 million for the three months ended September 30, 2025, compared to $0.5 million for the three months ended September 30, 2024. The increase was primarily due to lower interest income from the Company’s cash deposits.

The Company’s cash balance as of September 30, 2025 was $26.2 million, compared to $41.7 million as of December 31, 2024.

On November 12, 2025, the Company sold 5,800,000 common stock (or prefunded warrants in lieu thereof), as well as 5,800,000 accompanying warrants, for gross proceeds of approximately $5.3 million.

Conference Call Details

Date: November 13, 2025
Time: 8:00 a.m. Eastern Time
Dial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International)
Webcast Registration: Click Here
Call MeTM Registration: Click Here (Available 15 minutes prior to call)

(Press release, PDS Biotechnology, NOV 13, 2025, View Source [SID1234659913])

On November 13, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and provided clinical and operational updates for the quarter ended September 30, 2025.

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"In the first nine months of 2025, we continued to advance toward the potential initiation of Phase 3 trials for ORIC-944 in prostate cancer and enozertinib in lung cancer. The ORIC-944 Phase 1b data announced today further support its potential best-in-class efficacy and safety profile, and we look forward to sharing clinical data for enozertinib later this year that will highlight its best-in-class potential," said Jacob M. Chacko, M.D., president and chief executive officer. "Backed by compelling clinical data and a strong cash position, we remain focused on rapidly advancing these programs to registrational studies and, ultimately, commercialization."

Third Quarter 2025 and Other Recent Highlights

ORIC-944: a potent and selective allosteric inhibitor of PRC2

Announced the completion of the dose exploration portion of the Phase 1b trial and the selection of provisional recommended Phase 2 doses (RP2Ds) of ORIC-944 to be tested in combination with the approved doses of darolutamide and apalutamide in the dose optimization portion of the Phase 1b trial: 400 mg and 600 mg once daily of ORIC-944 in combination with 600 mg twice daily of darolutamide; and 600 mg, 800 mg and 1,200 mg once daily of ORIC-944 in combination with 240 mg once daily of apalutamide.
Reported preliminary efficacy and safety data from the Phase 1b dose exploration trial of ORIC-944 in combination with androgen receptor (AR) inhibitors in 20 patients with metastatic castration-resistant prostate cancer (mCRPC), which includes 17 patients previously reported in May 2025. Circulating tumor DNA (ctDNA) was assessed for 17 patients with mCRPC who had available ctDNA samples and evidence of ctDNA at baseline prior to study entry. The data reported as of September 22, 2025 demonstrated:
PSA responses and ctDNA reductions across all ORIC-944 dose levels and at comparable rates in combination with apalutamide or with darolutamide.
Broad and deep PSA responses, with 55% of patients (11/20) achieving a PSA50 response (confirmed in 40%), and 20% of patients (4/20) achieving a PSA90 response (all confirmed).
Rapid and deep ctDNA responses across a breadth of AR mutations and other gene alterations, with 76% (13/17) achieving > 50% ctDNA reduction, and 59% (10/17) achieving ctDNA clearance, which is greater than clearance rates observed in precedent trials with standard of care agents in comparable mCRPC patient populations.
Both combination regimens demonstrated a safety profile compatible with long-term dosing, with the vast majority of treatment-related adverse events (TRAEs) Grade 1 or 2 in severity and consistent with PRC2 and AR inhibition. Only one patient experienced a Grade 3 TRAE, and there were no Grade 4 or Grade 5 AEs attributed to ORIC-944, apalutamide or darolutamide.
Presented two posters at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics. In castration-sensitive prostate cancer models, ORIC-944 combined with AR inhibition synergistically suppressed tumor growth, extended survival, and prolonged response duration by limiting cellular plasticity and delaying tumor adaptation. In KRAS G12C-mutant NSCLC and colorectal cancer models, ORIC-944 plus KRAS inhibition improved efficacy and progression-free survival, suggesting PRC2 inhibition may deepen and extend responses by preventing or delaying resistance to KRAS inhibitors.

Enozertinib: a brain-penetrant inhibitor that selectively targets EGFR exon 20, EGFR atypical, and HER2 exon 20 mutations

The World Health Organization International Nonproprietary Names (INN) expert committee approved "enozertinib" as the nonproprietary (generic) name for ORIC-114.
Announced publication in Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), detailing preclinical data demonstrating enozertinib’s exquisite selectivity, strong potency, brain-penetrance, and anti-tumor activity across a broad range of EGFR atypical mutant models, including intracranial lung cancer xenografts.
Continue to enroll Phase 1b trial of enozertinib as a single-agent in patients with advanced NSCLC with EGFR exon 20, EGFR atypical, and HER2 exon 20 mutations, including patients with CNS metastases that are either treated or untreated but asymptomatic, across our 1L expansion cohorts; 2L+ dose optimization cohorts now fully enrolled.
Continue to enroll Phase 1b trial of enozertinib in combination with subcutaneous (SC) amivantamab in 1L NSCLC patients with EGFR exon 20 mutations.

Corporate Highlights:

Announced the appointment of Kevin Brodbeck, PhD, to the newly established role of Chief Technical Officer (CTO).
As previously disclosed, the company raised $108.7 million in net proceeds under the ATM (at-the-market) program in the third quarter, including participation from healthcare specialist funds.

Anticipated Program Milestones:

ORIC anticipates the following upcoming data milestones:

ORIC-944 (mCRPC):
1Q 2026: Combination dose optimization data with AR inhibitor(s)
Enozertinib (NSCLC):
December 2025: 1L EGFR exon 20, 2L EGFR exon 20, 2L+ EGFR atypical, and 2L+ HER2 exon 20 data to be presented at ESMO (Free ESMO Whitepaper) Asia 2025
Mid-2026: 1L EGFR atypical data and 1L EGFR exon 20 combination with SC amivantamab data

Third Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $413.0 million as of September 30, 2025, which includes proceeds from the $125.0 million private placement financing in May 2025 and $117.6 million in net proceeds raised during the year under the ATM program. The company expects its cash and investments to fund the operating plan into 2H 2028.
R&D Expenses: Research and development (R&D) expenses were $28.8 million for the three months ended September 30, 2025, compared to $31.2 million for the three months ended September 30, 2024, a decrease of $2.4 million. The decrease was due to lower ORIC-944 drug manufacturing costs and lower costs from discontinued programs, offset by higher personnel costs, including additional non-cash stock-based compensation, and costs related to the advancement of enozertinib. For the nine months ended September 30, 2025, R&D expenses were $84.0 million, compared to $82.1 million for the nine months ended September 30, 2024, an increase of $1.9 million. The increase was due to higher personnel costs, including additional non-cash stock-based compensation, and costs related to the advancement of enozertinib, offset by lower ORIC-944 drug manufacturing costs and lower costs from discontinued programs.
G&A Expenses: General and administrative (G&A) expenses were $7.9 million for the three months ended September 30, 2025, compared to $7.1 million for the three months ended September 30, 2024, an increase of $0.8 million. For the nine months ended September 30, 2025, G&A expenses were $24.5 million, compared to $21.2 million for the nine months ended September 30, 2024, an increase of $3.3 million. The increases were primarily due to higher personnel costs and professional services, including additional non-cash stock-based compensation.

(Press release, ORIC Pharmaceuticals, NOV 13, 2025, View Source [SID1234659912])

On November 13, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported additional efficacy and safety data from the Phase 1b trial of once daily ORIC-944 in combination with androgen receptor (AR) inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC).

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"We continue to be encouraged by ORIC-944 combination data, which further demonstrate its potential as a best-in-class PRC2 inhibitor that may benefit a broad range of patients with prostate cancer," said Jacob M. Chacko, M.D., president and chief executive officer. "The tolerability and efficacy data to date provide compelling validation for the doses we’ve selected for the dose optimization portion of the Phase 1b trial. We look forward to sharing dose optimization data in 1Q 2026 ahead of initiating our first global Phase 3 registrational trial in mCRPC in the first half of next year."

ORIC-944 Phase 1b Dose Exploration Data
Patients were previously treated with a median of three prior lines of therapy, including abiraterone acetate, up to one prior line of chemotherapy, and a variety of other approved and investigational treatment regimens. This median does not include background androgen deprivation therapy or first-generation AR inhibitors that the patients may have received. Patients were treated once daily with 400 mg, 600 mg, 800 mg, or 1,200 mg of ORIC-944 in combination with 240 mg of apalutamide once daily or with 600 mg of darolutamide twice daily. PSA data for 20 patients with mCRPC includes 17 patients previously reported in May 2025. Circulating tumor DNA (ctDNA) was assessed for 17 patients with mCRPC who had available ctDNA samples and evidence of ctDNA at baseline prior to study entry. PSA response data and ctDNA data are as of September 22, 2025.

Preliminary antitumor activity analysis
PSA responses and ctDNA reductions were observed across all ORIC-944 dose levels and were also observed at comparable rates in combination with apalutamide or with darolutamide.

PSA activity

55% of patients (11/20) achieved a PSA50 response, confirmed in 40% (8/20).
20% of patients (4/20) achieved a PSA90 response (all confirmed).

ctDNA activity
ctDNA serves as a useful biomarker to predict the duration of treatment benefit and survival in prostate cancer. Detectable ctDNA at baseline is associated with poor prognosis, and non-detectable ctDNA at baseline or upon treatment is associated with longer progression-free survival and overall survival. In the Phase 1b trial, 88% of patients had detectable ctDNA at baseline (higher than precedent trials with standard of care agents in comparable mCRPC patient populations), and ORIC-944 in combination with apalutamide or with darolutamide demonstrated:

Rapid and deep ctDNA responses across a breadth of AR mutations and other gene alterations, with 76% of patients (13/17) achieving >50% ctDNA reduction.
59% of patients (10/17) achieved ctDNA clearance, which is greater than clearance rates observed in precedent trials with standard of care agents in comparable mCRPC patient populations.

Preliminary safety analysis
ORIC-944 in combination with apalutamide or with darolutamide continues to be well tolerated to date. Both combination regimens demonstrated a safety profile compatible with long-term dosing, with the vast majority of treatment-related adverse events (TRAEs) Grade 1 or 2 in severity and consistent with PRC2 and AR inhibition. As of the September 22, 2025 cutoff date, only one patient experienced a Grade 3 TRAE, and there were no Grade 4 or Grade 5 AEs attributed to ORIC-944, apalutamide or darolutamide.

Next Steps
Based on these efficacy and safety results, ORIC has selected provisional recommended Phase 2 doses (RP2Ds) of ORIC-944 to be tested in combination with the approved doses of darolutamide and apalutamide in the dose optimization portion of the Phase 1b trial: 400 mg and 600 mg once daily of ORIC-944 in combination with 600 mg twice daily of darolutamide; and 600 mg, 800 mg and 1,200 mg once daily of ORIC-944 in combination with 240 mg once daily of apalutamide. Enrollment in the dose optimization portion of the trial is ongoing, and the company plans to announce preliminary dose optimization data in 1Q 2026. Data from the dose optimization portion of the trial will inform the choice of ORIC-944 dose to advance in combination with apalutamide or with darolutamide in the first global Phase 3 registrational trial in mCRPC, which the company expects to initiate in 1H 2026.

ORIC-944 Phase 1b Trial Design
ORIC-944 is being evaluated in a Phase 1b dose optimization trial in combination with ERLEADA (apalutamide), Johnson & Johnson’s AR inhibitor, and NUBEQA (darolutamide), Bayer’s AR inhibitor, in patients with mCRPC. Patients are eligible if they have received prior treatment with an androgen receptor pathway inhibitor (ARPI) and up to one prior chemotherapy. The primary objective of the trial is to determine the recommended Phase 2 dose (RP2D), and additional objectives include safety, tolerability, pharmacokinetics, and preliminary clinical activity.

(Press release, ORIC Pharmaceuticals, NOV 13, 2025, View Source [SID1234659911])