On November 13, 2025 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported it has signed a definitive merger agreement for Day One to acquire Mersana Therapeutics, Inc. ("Mersana").

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The transaction positions the Company for continued success and expansion of its oncology portfolio, adding Emi-Le, a potential first-in-class monotherapy for patients with ACC, an aggressive cancer with a well-defined patient population and high unmet need, most often arising from the salivary gland. The early anti-tumor activity observed with Emi-Le in an ongoing Phase 1 study, in a disease with a clear unmet medical need, may support a fast path to registration. Emi-Le represents an innovative and differentiated ADC directed against B7-H4, a well-characterized target in certain cancers. B7-H4 is highly expressed in ACC as well as in other adult and pediatric cancers. As a novel targeted investigational agent with monotherapy anti-tumor activity intended for a well-defined patient population without any approved therapies or a clear standard of care, the Company believes that Emi-Le is well positioned for potential rapid development and commercialization.

"This acquisition will add a potential game-changing new medicine to the Day One portfolio and, if approved, will broaden our opportunities for patient impact and for continued growth and value creation," said Jeremy Bender, Ph.D., chief executive officer of Day One. "The addition of the Emi-Le program to our portfolio allows us to leverage the research and development expertise, and the commercial capabilities, that already exist within Day One to address underserved, rare and life-threatening cancers in patients of all ages."

Terms of the Agreement

Under the terms of the definitive merger agreement, Day One will promptly commence a tender offer to acquire all of the outstanding shares of Mersana common stock at a price of $25 per share in cash at closing plus one non-tradable CVR per share to receive certain potential milestone payments of up to an aggregate of $30.25 per CVR in cash, for total consideration of up to $55.25 per share in cash, representing a total equity value of approximately $129 million at closing and representing a total deal value of up to approximately $285 million. The CVR is payable subject to certain terms and conditions of achievement of the following milestones:

Clinical Milestones

· A development milestone related to an existing partnership agreement: $1.25 per share

· Breakthrough Therapy Designation for ACC granted by FDA: $1.00 per share

· First dosing of a participant in a registrational trial of Emi-Le for ACC-1: $4.00 per share

Regulatory/Sales Milestones

· Regulatory approval granted by FDA in Emi-Le for ACC-1: $9.00 per share

· First commercial sale of Emi-Le in a major EMA market: $2.00 per share

· First commercial sale of Emi-Le in Japan: $1.00 per share

· Annual net sales of Emi-Le exceed $100 million by 2032: $2.00 per share

· Annual net sales of Emi-Le exceed $200 million by 2035: $4.00 per share

· Annual net sales of Emi-Le exceed $300 million by 2037: $6.00 per share

Day One expects to finance the acquisition with existing cash resources. Day One’s strong cash position and financial profile is expected to enable development of Emi-Le through potential approval with no additional financing required.

The transaction is expected to close by the end of January 2026, subject to receipt of applicable regulatory approvals and the satisfaction of other customary conditions.

Advisors

Gordon Dyal & Co., LLC is acting as the exclusive financial advisor to Day One, with Fenwick & West LLP serving as legal counsel. TD Cowen is acting as financial advisor to Mersana, with Wilmer Cutler Pickering Hale and Dorr LLP serving as legal counsel.

Conference Call

Day One will host a conference call and webcast today, Nov. 13 at 8:00 am Eastern Time. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13757215. Live audio webcast will be accessible from the Events page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events section of the Day One Media & Investors page for 30 days following the event.

(Press release, Day One, NOV 13, 2025, View Source [SID1234659896])

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 Kiyatec, a leader in functional oncology testing with its proprietary 3D Predict platform, reported it has closed a strategic investment round led by MBD, a South Korea-based technology leader. This new investment solidifies a strategic commercial partnership aimed at leveraging MBD’s automated platform technology to rapidly scale Kiyatec’s U.S. testing capabilities and accelerate the launch of its diagnostic panels for multiple cancer types along with new AI tools.

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The partnership represents a significant step in Kiyatec’s mission to provide clinicians with essential drug response data for cancer patients worldwide. MBD’s state-of-the-art automation will be integrated into Kiyatec’s CLIA/CAP laboratory operations in Greenville, SC, dramatically enhancing throughput and quality control as the company expands its commercial footprint.

"This strategic investment marks a pivotal moment for Kiyatec," said Eric Perreault, CEO of Kiyatec. "MBD is not just a financial partner; they are a technological force multiplier. By integrating their advanced automated platform, we can immediately enhance our scale, reduce turnaround times, and solidify our path to providing drug response results to thousands of glioblastoma patients. Crucially, this partnership will accelerate the validation and launch of our testing panels for other high-incidence cancers, including ovarian, breast, and non-small cell lung cancer."

The immediate integration of MBD’s technology is designed to optimize Kiyatec’s operational efficiency, enabling the company to meet the growing demand from physicians across the United States.

Bosung Ku, CEO of MBD, commented on the partnership: "Kiyatec’s 3D Predict technology and its compelling clinical performance data—particularly in glioblastoma—represent the future of personalized oncology. Our investment reflects our firm commitment to supporting global leaders who are advancing patient care. We look forward to seeing the immediate impact of our automated platform integration as Kiyatec scales its commercial operations and moves swiftly to bring vital functional diagnostic information to patients with brain, lung, breast and gynecological cancers."

The investment will primarily be utilized to fund the company’s commercial expansion, AI tool integration and further drive clinical evidence generation necessary for broad reimbursement coverage.

(Press release, Kiyatec, NOV 13, 2025, View Source [SID1234659941])

On November 13, 2025 Delcath Systems, Inc. (Nasdaq: DCTH), ("Delcath" or the "Company") an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported the publication of results from a retrospective analysis conducted by researchers at the University of Tubingen, Germany. The study, titled "Characterization of long-term survivors with liver metastases from uveal melanoma diagnosed between 2005 and 2021," was published in the International Journal of Cancer and highlights the potential benefits of early use of liver-directed therapies, including chemosaturation (also known as percutaneous hepatic perfusion or PHP), in achieving long-term survival for patients with metastatic uveal melanoma (mUM) and liver metastases. The analysis underscores PHP’s advantages in disease control compared to other therapies, supporting its early integration potentially ahead of systemic options or in combination with systemic therapies.

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The retrospective analysis evaluated 167 patients with mUM who developed liver metastases between 2005 and 2021, focusing on the 33 long-term survivors (20% of the cohort) who lived three or more years following the initial diagnosis of liver metastases. Key findings include:

The majority of long-term survivors (82%) received liver-directed therapy as their first-line treatment in the metastatic setting
90% of long-term survivors received at least one liver-directed therapy at any time, with 85% also receiving immune checkpoint inhibitors (ICI) at some point
In patients who received first line liver-specific therapy, response evaluation showed a disease control rate of 93% (complete response, partial response, or stable disease) versus 63% for patients who received first line systemic therapy
52% percent of long-term survivors received PHP at any time point, achieving a median overall survival of 37.35 months and progression-free survival of 10.28 months
"The retrospective analysis from the University of Tubingen provides compelling real-world evidence supporting the early integration of liver-directed therapies such as PHP into the treatment of metastatic uveal melanoma. This potentially contributes to long-term survival in a disease with historically poor outcomes-particularly through PHP’s demonstrated 100% disease control rate when used as first line liver-specific therapy, outperforming other options," said Gerard Michel, Chief Executive Officer of Delcath Systems. "Building on the positive results from the CHOPIN trial, which demonstrated significant improvements in progression-free and overall survival when combining PHP with immune checkpoint inhibitors in first-line treatment of patients with metastatic uveal melanoma, the results reinforce the value of HEPZATO KIT and CHEMOSAT as foundational components of multimodal treatment strategies, including initiating PHP as part of a first line treatment strategy that includes immune checkpoint inhibitors."

Notably, all patients (100%) who received PHP as their first liver-directed therapy achieved disease control, with 69% experiencing partial tumor response – demonstrating superior efficacy compared to other liver-directed therapies.

The authors highlight the combination of PHP for hepatic metastases control and ICI for extrahepatic metastases control appears reasonable and shows association with better outcomes, with 15 patients in the cohort of long-term survivors receiving both therapies. They suggest initiating PHP first in multimodal strategies to potentially enhance ICI efficacy, especially given the liver’s role in inducing tumor immune tolerance to ICI therapy.

The study utilized chemosaturation with Delcath’s CHEMOSAT Hepatic Delivery System, which employs the same proprietary technology as the U.S. Food and Drug Administration (FDA) approved HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System). This analysis builds on prior publications from the same research group, including Wiens et al. (2024) in Therapeutic Advances in Medical Oncology, which reported significantly improved melanoma-specific survival (28 months) with first-line liver-directed therapies compared to systemic therapies (10 months), and a poster presentation by Laukhuf et al. at the European Association of Dermato-Oncology (EADO) Congress in April 2025, which initially characterized long-term survivors in this cohort.

(Press release, Delcath Systems, NOV 13, 2025, View Source [SID1234659897])

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])