On November 6, 2025 Coherus Oncology, Inc. (Nasdaq: CHRS), reported financial results for the third quarter ended September 30, 2025 and provided an overview of recent business highlights.

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"In Q3 2025, we gained significant momentum on our strategy to develop innovative oncology therapies that substantially increase patient survival," said Denny Lanfear, Coherus Chairman and Chief Executive Officer. "The vast majority of our study sites are enrolling, driving towards multiple data readouts in 2026 across a number of tumor types. We have now expanded our CHS-114 CCR8 Treg depleter clinical program to include colorectal cancer, an area of growing unmet need, impacting even younger patients."

"The importance of CCR8 as a cancer target is highlighted by the 2025 Nobel Prize in Physiology or Medicine, which recognized the pivotal role of Treg cells in peripheral immune tolerance and their pathological role in autoimmunity and cancer," said Theresa LaVallee, PhD, Coherus Chief Scientific and Development Officer. Coherus Oncology was recently honored to present our clinical data on CHS-114 showing the cytolytic antibody’s potency and selectively, with robust tumoral Treg depletion, immune activation and a good safety profile at a SITC (Free SITC Whitepaper) presentation focused on a deep dive into development of antibodies targeting CCR8 Tregs, reflecting our scientific leadership in this rapidly evolving field."

"Our clinical programs target tumor types where there is a clear biological rationale and a significant unmet medical need with available therapies," said Rosh Dias, MD, Chief Medical Officer. "We have previously shown encouraging data for both casdozokitug and CHS-114, and we expect maturing datasets from our ongoing studies throughout 2026."

RECENT BUSINESS HIGHLIGHTS

LOQTORZI (toripalimab-tpzi) Commercial Updates

LOQTORZI remains the only FDA-approved and available treatment in the U.S. for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC), in all patient subsets and across all lines of therapy.
LOQTORZI net revenue for Q3 2025 was $11.2 million, a 12% increase over $10.0 million in Q2 2025 and a 92% increase over LOQTORZI net revenue of $5.8 million in Q3 2024. Growth in Q3 2025 was driven largely by higher patient demand from both increasing new account starts as well as repeat use in existing accounts. Average duration of treatment among existing patients also continues to grow.
Increasing awareness of the revised National Comprehensive Cancer Network (NCCN) guidelines granting LOQTORZI preferred status within the NPC indication continues to drive strong demand growth among head & neck cancer specialists. The Company’s focus remains on deepening adoption within general oncologists in the community setting by driving education on clinical data and updated NCCN guidelines. While half of all NPC patients in the U.S. are managed in this setting, market penetration will continue at a steady and gradual pace due to the rarity of patients seen by these oncologists.

ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION ONCOLOGY PIPELINE

LOQTORZI is a next-generation PD-1 marketed in the U.S. in two indications.

Coherus plans to maximize the value of this medicine by combining LOQTORZI with internal pipeline candidates, CHS-114 and casdozokitug, for additional solid tumor indications and entering into capital-efficient external partnerships for label expansions.
In October 2025, the Cancer Research Institute announced the first patient enrolled in the third cohort of the ongoing Immunotherapy Platform Study in Platinum-Resistant High-Grade Serous Ovarian Cancer (IPROC) (NCT04918186). The third cohort of the Phase 2 trial is evaluating LOQTORZI in combination with ENB Therapeutics’ ENB-003 for the treatment of ovarian cancer.

CHS-114 is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding.

Updated biomarker data from the Phase 1b study dose expansion study in 2L+ head and neck squamous cell carcinoma (HNSCC) will be presented on Saturday, November 8, 2025 at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).
Phase 1b CHS-114/toripalimab combination dose optimization studies in 2L HNSCC and 2L gastric cancers are underway, with initial data readouts for HNSCC expected in 1H 2026.
A Phase 1b study evaluating the CHS-114/toripalimab combination, with and without chemotherapy, in 1L and 2L esophageal squamous cell carcinoma (ESCC), respectively, is underway with a first data readout expected in mid-2026.
A Phase 1b/2a study evaluating CHS-114/toripalimab combination in 4L+ colorectal cancer is enrolling patients and initial data is expected in 2H 2026.

Casdozokitug is a first-in-class, clinical-stage IL-27 antagonist, with demonstrated monotherapy activity in treatment-refractory non-small cell lung cancer (NSCLC) and clear cell renal cell carcinoma (ccRCC) and combination activity in hepatocellular carcinoma (HCC).

Enrollment is ongoing in the Phase 2 randomized trial of casdozokitug/toripalimab/bevacizumab in 1L HCC, with the first data readout expected in mid-2026.
On November 2, 2025, new data was presented at the Cytokines 2025 annual meeting demonstrating casdozokitug promotes NK and T cell activity, and antitumor response in patients with advanced solid tumors. These biomarker data continue to support treatment with casdozokitug which leads to inhibition of IL-27 signaling and enhanced cytolytic immune activity (by NK and T cells). The new data reveal these biomarker changes following treatment of HCC patients with casdozokitug and standard of care are associated with clinical response (and thus, support an important contribution of casdozokitug).

THIRD QUARTER 2025 FINANCIAL RESULTS

Net revenue from continuing operations was $11.6 million and $6.1 million during the three months ended September 30, 2025 and 2024, respectively, and $29.4 million and $18.7 million during the nine months ended September 30, 2025 and 2024, respectively. LOQTORZI net product revenue increased $5.3 million and $16.9 million compared to the three and nine months ended September 30, 2024, respectively, driven primarily by volume growth of LOQTORZI, which launched in December 2023. The increase in the nine-month period was partially offset by a decrease in other revenue primarily driven by a $6.1 million upfront fee recognized in the prior year for the out-license of rights to commercialize toripalimab within Canada.

Cost of goods sold (COGS) from continuing operations was $3.7 million and $2.7 million during the three months ended September 30, 2025 and 2024, respectively, and $9.8 million and $6.0 million during the nine months ended September 30, 2025 and 2024, respectively. The increases were primarily due to volume growth of LOQTORZI.

Research and development (R&D) expenses from continuing operations were $27.3 million and $22.1 million for the three months ended September 30, 2025 and 2024, respectively, and $77.9 million and $71.1 million during the nine months ended September 30, 2025 and 2024, respectively. The increases were primarily due to increased costs for development of casdozokitug and CHS-114, partially offset by savings from reduced activities related to other programs, reduced headcount, and lower infrastructure costs.

Selling, general and administrative (SG&A) expenses from continuing operations were $24.9 million and $28.1 million during the three months ended September 30, 2025 and 2024, respectively, and $77.0 million and $95.9 million during the nine months ended September 30, 2025 and 2024, respectively. The decreases were driven primarily by lower headcount and decreased operating costs following Coherus’ recent divestitures, partially offset by a $1.6 million net impairment charge in the third quarter of 2025 for the write-off of an intangible asset and associated contingent value right ("CVR") liability related to GSK4381562, acquired in the Surface Oncology, Inc. acquisition. The decrease in the nine-month period was further due to a net $6.8 million charge in the first quarter of 2024 for the write-off of an intangible asset and associated CVR liability related to NZV930, which was also acquired in the Surface Oncology, Inc. acquisition.

Interest expense from continuing operations was $2.3 million and $2.8 million during the three months ended September 30, 2025 and 2024, respectively, and $6.8 million and $8.8 million during the nine months ended September 30, 2025 and 2024, respectively. The decrease in the nine-month period was primarily due to the prepayment of the remaining $75.0 million of the principal amount due under the 2027 Term Loans on May 8, 2024, partially offset by interest on the $38.7 million senior secured term loan facility and the LOQTORZI portion of the Revenue Participation Right Purchase and Sale Agreement, each commencing May 8, 2024.

Net loss from continuing operations for the third quarter of 2025 was $44.5 million, or $(0.38) per share on a diluted basis, compared to a net loss of $47.6 million, or $(0.41) per share on a diluted basis, for the same period in 2024. Net loss for the nine months ended September 30, 2025 was $136.8 million, or $(1.18) per share on a diluted basis, compared to net loss of $169.3 million, or $(1.48) per share on a diluted basis, for the same period in 2024.

Non-GAAP net loss from continuing operations for the third quarter of 2025 was $38.9 million, or $(0.33) per share on a diluted basis, compared to $40.0 million, or $(0.35) per share for the same period in 2024. Non-GAAP net loss for the nine months ended September 2025 was $118.8 million, or $(1.02) per share on a diluted basis, compared to a net loss of $127.1 million, or $(1.11) per share for the same period in 2024. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss from continuing operations and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and marketable securities totaled $191.7 million as of September 30, 2025, compared to $126.0 million as of December 31, 2024. A majority of the $67.0 million in accrued rebates, fees and reserves reflected on the September 30, 2025 balance sheet were UDENYCA-related obligations that did not transfer in the divestiture and are expected to be settled in a front-weighted fashion over the remainder of the year and into 2026.

Conference Call Information

When: Thursday, November 6, 2025, starting at 5:00 p.m. Eastern Standard Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: View Source

Webcast: View Source

A live and archived webcast will be available on the "Investors" section of the Coherus website at View Source

Please dial in 15 minutes early to ensure a timely connection to the call.

(Press release, Coherus Oncology, NOV 6, 2025, View Source [SID1234659561])

On November 6, 2025 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, reported financial results for the third quarter ended September 30, 2025, and provided a business update.

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"With enrollment ongoing in the JANX007 and JANX008 clinical trials and multiple new drug candidates expected to enter the clinic next year, we remain confident in our ability to advance these programs, supported by a strong balance sheet that enables continued execution," said David Campbell, Ph.D., President and CEO of Janux.

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

•
JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449).

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JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622).

Additional data from JANX007 and JANX008 will be presented at future Janux events in the fourth quarter of 2025.

THIRD QUARTER 2025 FINANCIAL RESULTS:

•
Cash and cash equivalents and short-term investments: As of September 30, 2025, Janux reported cash and cash equivalents and short-term investments of $989.0 million, compared to $1.03 billion at December 31, 2024.

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Research and development expenses: Research and development expenses for the quarter ended September 30, 2025 were $34.6 million, compared to $18.6 million for the comparable period in 2024.

•
General and administrative expenses: General and administrative expenses for the quarter ended September 30, 2025 were $10.6 million, compared to $17.7 million for the comparable period in 2024. With respect to the quarter ended September 30, 2024, $9.5 million of the general and administrative expense incurred was due to stock-based compensation expense associated with equity modifications.

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Net loss: For the quarter ended September 30, 2025, Janux reported a net loss of $24.3 million, compared to a net loss of $28.1 million for the comparable period in 2024.

Janux’s TRACTr, TRACIr and ARM Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials. Janux is also generating a number of additional TRACTr, TRACIr and ARM programs for potential future development.

(Press release, Janux Therapeutics, NOV 6, 2025, View Source [SID1234659577])

On November 6, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported financial results for the third quarter of 2025, along with recent product highlights and corporate updates.

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"Zai Lab is entering the next phase of our growth, powered by the rapid advancement of our global pipeline and supported by a commercially profitable and scalable business in China," said Dr. Samantha Du, Founder, Chairperson, and CEO of Zai Lab. "With zoci moving into pivotal development less than two years after IND and multiple differentiated global programs progressing in parallel, we are demonstrating the speed, scientific rigor, and global ambition of our R&D engine. At the same time, our commercial platform in China remains strong, with new products and indications – including KarXT, povetacicept and VYVGART – broadening our long-term growth profile. Together, we are building a company that will make a lasting difference for patients and create long-term value for our shareholders."

"This quarter, we continued to deepen the foundations of the VYVGART launch," said Josh Smiley, President and COO of Zai Lab. "In gMG, we are seeing steady new patient starts and increasing treatment duration, supported by updated treatment guidelines and real-world experience. While adoption is building gradually, physician confidence continues to grow and reinforces the long-term potential of VYVGART as a new standard of care in the treatment of this chronic disease. Looking ahead, we are preparing for our next expected launch for KarXT in schizophrenia. We remain focused on disciplined execution as we position for the significant opportunities ahead, supported by a growing regional business and a rapidly progressing, global pipeline."

Recent Pipeline Highlights

Below are key product updates since our last earnings release:

Oncology Pipeline

•Zocilurtatug Pelitecan (zoci, DLL3 ADC) (formerly ZL-1310):

–In October 2025, Zai Lab initiated a global registrational study of zocilurtatug pelitecan monotherapy in second-line+ extensive-stage small cell lung cancer (ES-SCLC).

–In October 2025, Zai Lab presented updated Phase 1 results at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference, demonstrating a best overall response rate of 68% at the 1.6 mg/kg dose in second-line extensive-stage small cell lung cancer. The estimated median duration of response (DoR) of 6.1 months across all doses and all lines of therapy is highly encouraging for a monotherapy in this heavily pre-treated and difficult-to-treat patient population. Meaningful activity in patients with brain metastases was also observed, including an 80% response rate in patients with untreated brain metastases. The data also demonstrated a well-tolerated safety profile at 1.6 mg/kg, with Grade ≥ 3 treatment-related adverse events of 13%, no Grade ≥2 interstitial lung disease, and no drug discontinuations. Together, these results reinforce zoci’s best-in-class potential and support the initiation of the global registrational study.

•Tumor Treating Fields (TTFields): In August 2025, Zai Lab announced that the China National Medical Products Administration (NMPA) has granted Innovative Medical Device Designation for TTFields for patients with pancreatic cancer based on the positive results from the Phase 3 PANOVA-3 trial. We plan to submit for regulatory approval in China in the fourth quarter of 2025.

•Bemarituzumab (FGFR2b): In November 2025, Zai Lab partner Amgen announced FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab in patients with first-line gastric cancer, was stopped.

Immunology Pipeline

•ZL-1503 (IL-13/IL-31R): In November 2025, Zai Lab initiated a global Phase 1/1b study to evaluate safety, tolerability and pharmacokinetics of ZL-1503 in healthy volunteers and participants with moderate to severe atopic dermatitis.

•Efgartigimod (FcRn):

–Sjogren’s disease: In September 2025, Zai Lab joined the registrational UNITY study of efgartigimod subcutaneous given by prefilled syringe in Sjogren’s disease in Greater China (mainland China, Hong Kong, Macau and Taiwan, collectively).

–Seronegative gMG: In August 2025, Zai Lab partner argenx announced topline data from the pivotal ADAPT SERON study of VYVGART in patients with AChR-Ab seronegative gMG. The study met its primary endpoint (p-value=0.0068) and it is the first global phase 3 study to demonstrate clinically meaningful improvements in disease activity across all three subtypes – MuSK+, LRP4+, triple seronegative. Zai Lab participated in the global Phase 3 study in Greater China, enabling a potential China regulatory submission.

•Xanomeline-Trospium (or KarXT) (M1/M4-agonist): In September 2025, the "China Schizophrenia Prevention and Treatment Guidelines (2025 Edition)" were officially released, and KarXT was included for the first time, marking the first national-level guideline globally to include KarXT. The guidelines emphasize KarXT’s broad efficacy across all three symptom domains (positive, negative, and cognitive symptoms) and its unique safety profile, supporting long-term adherence and functional recovery. China’s NMPA accepted the New Drug Application (NDA) for the treatment of schizophrenia in January 2025.

•Povetacicept: In September 2025, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to povetacicept for the treatment of IgA nephropathy (IgAN). Subsequently, the FDA also granted a rolling review of the Biologics License Application (BLA) submission for povetacicept for this indication. Vertex has completed full enrollment of the Phase 3 study, including the interim analysis cohort for potential accelerated approval in the U.S. Zai Lab participated in the global Phase 3 RAINIER study in patients with IgAN in Greater China.

Third Quarter 2025 Financial Results

•Product revenue, net was $115.4 million in the third quarter of 2025, compared to $101.8 million for the same period in 2024, representing 13% y-o-y growth, 14% y-o-y growth at constant exchange rate (CER). This increase was primarily driven by increased sales for NUZYRA and XACDURO, partially offset by softer sales for ZEJULA:

–VYVGART and VYVGART Hytrulo were $27.7 million in the third quarter of 2025 which includes a $2.4 million reduction following a voluntary price adjustment on Hytrulo ahead of National Reimbursement Drug List (NRDL) negotiation, compared to $26.5 million in the second quarter of 2025. Sales grew 4.6% quarter over quarter driven by an extension of duration of therapy and increased market penetration.

–ZEJULA was $42.4 million in the third quarter of 2025, compared to $48.2 million for the same period in 2024. Sales were softer due to evolving competitive dynamics within the PARPi class.

–XACDURO, which was launched in the fourth quarter of 2024, was $6.4 million in the third quarter of 2025.

–NUZYRA was $15.4 million in the third quarter of 2025, compared to $10.0 million for the same period in 2024. This growth was supported by increased market coverage and penetration.

•Research and Development (R&D) expenses were $47.9 million in the third quarter of 2025, compared to $66.0 million for the same period in 2024, primarily due to a decrease in licensing fees in connection with upfront and milestone payments.

•Selling, General and Administrative expenses were $70.1 million in the third quarter of 2025, compared to $67.2 million for the same period in 2024. This increase was primarily driven by higher general selling expenses to support the growth of NUZYRA and VYVGART, partially offset by decreases in selling expenses related to ZEJULA.

•Loss from operations was $48.8 million in the third quarter of 2025, $28.0 million when adjusted to exclude certain non-cash expenses including depreciation, amortization, and share-based compensation. A reconciliation of loss from operations (GAAP) to adjusted loss from operations (non-GAAP) is included at the end of this release.

•Net loss was $36.0 million in the third quarter of 2025, or a loss per ordinary share attributable to stockholders of $0.03 (or loss per American Depositary Share (ADS) of $0.33), compared to a net loss of $41.7 million for the same period in 2024, or a loss per ordinary share of $0.04 (or loss per ADS of $0.42). These decreases in net loss were primarily due to increased product revenue and decreased operating expenses.

•Cash and cash equivalents, short-term investments, and current restricted cash totaled $817.2 million as of September 30, 2025, compared to $832.3 million as of June 30, 2025.

Anticipated Major Milestones in the Fourth Quarter of 2025 and Full Year 2026

Expected Clinical Developments and Data Readouts

Global Pipeline

Zocilurtatug Pelitecan (zoci, DLL3 ADC) (formerly ZL-1310)

•Second-Line+ ES-SCLC: Zai Lab to present updated data on intracranial activity from the ongoing Phase 1 study in the first half of 2026.

•First-Line ES-SCLC: Zai Lab to provide data readout from the Phase 1 study evaluating zoci combination therapy (with atezolizumab and/or chemotherapy) in the first half of 2026 and advance into a registrational study in 2026 based on emerging data. Zai Lab also plans to initiate a Phase 1 study to explore zoci in a novel combination in 2026.

•Other neuroendocrine carcinomas: Zai Lab to provide data readout from the global Phase 1/2 study in patients with selected solid tumors in the first half of 2026 and advance into a registrational-enabling cohort in 2026.

ZL-1503 (IL-13/IL-31R)

•Zai Lab to provide the initial data readout from the global Phase 1/1b study in healthy volunteers and participants with moderate to severe atopic dermatitis in 2026.

ZL-6201 (LRRC15 ADC)

•Zai Lab to submit an Investigational New Drug application to the FDA for a global Phase 1 study for patients with sarcoma and potentially other LRRC15-positive solid tumors in the fourth quarter of 2025.

Upcoming Potential NMPA Submissions

•Tumor Treating Fields (TTFields) in first-line pancreatic cancer in the fourth quarter of 2025

•Efgartigimod (FcRn) for prefilled syringe in generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) in the fourth quarter of 2025

Upcoming Potential NMPA Approvals

•Xanomeline-Trospium (or KarXT) (M1/M4-agonist) in schizophrenia

•Tisotumab Vedotin (Tissue Factor ADC) in recurrent or metastatic cervical cancer following progression on or after chemotherapy

•Repotrectinib (ROS1/TRK) in NTRK+ solid tumors

Regional Pipeline

Efgartigimod (FcRn)

•Ocular myasthenia gravis: Zai Lab partner argenx to provide topline results from the global Phase 3 ADAPT-OCULUS study in the first half of 2026. Zai Lab participated in the study in Greater China.

•Myositis: Zai Lab partner argenx to provide topline results from the global Phase 2/3 ALKIVIA study evaluating three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS) and dermatomyositis (DM)) in the second half of 2026. Zai Lab participated in the study in Greater China.

•Thyroid eye disease (TED): Zai Lab partner argenx to provide topline results from two registrational UplighTED studies in the second half of 2026. Zai Lab participated in the studies in Greater China.

Povetacicept (APRIL/BAFF)

•Primary membranous nephropathy (pMN): Zai Lab to join the global pivotal Phase 2/3 OLYMPUS study of povetacicept in pMN in Greater China in the fourth quarter of 2025.

•IgAN: Zai Lab partner Vertex will conduct an interim analysis of the global Phase 3 RAINIER study following 36 weeks of treatment. Vertex expects to submit the first module of the IgAN BLA to the FDA before the end of 2025 and plans to complete the full BLA submission in the first half of 2026 for potential accelerated approval in the U.S.

VRDN-003 (anti-IGF-1R, subcutaneous)

•Zai Lab to initiate a registrational study in TED in Greater China in the fourth quarter of 2025.

•Viridian to provide topline results from global registrational REVEAL-1 study in active TED patients in the first quarter of 2026 and global registrational REVEAL-2 study in chronic TED in the second quarter of 2026. Zai Lab, through its license agreement with Zenas, obtained a sublicense to the Viridian anti-IGF-1R antibody and is proceeding with clinical development.

Full-Year 2025 Outlook

Zai Lab is revising total revenue guidance for the full year 2025 to at least $460 million.

Conference Call and Webcast Information

Zai Lab will host a live conference call and webcast today, November 6, 2025, at 8:00 a.m. ET (9:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at View Source Participants must register in advance of the conference call.

Details of registration links are as follows:

•For webcast (preferred): View Source
•For dial-in: View Source

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

(Press release, Zai Laboratory, NOV 6, 2025, View Source [SID1234659593])

On November 6, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company"), reported the pricing of $650 million aggregate principal amount of 0% convertible senior notes due 2031 (the "2031 Notes") and $650 million aggregate principal amount of 0.875% convertible senior notes due 2032 (the "2032 Notes" and, together with the 2031 Notes, the "Convertible Notes"). The Company also granted a 13-day option to the initial purchasers to purchase up to an additional $100 million aggregate principal amount of the 2031 Notes and up to an additional $100 million aggregate principal amount of the 2032 Notes. The Convertible Notes are being offered and sold only to persons reasonably believed to be "qualified institutional buyers" pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act").

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The 2031 Notes will be senior, unsecured obligations of the Company. The 2031 Notes will not bear regular interest, and the principal amount of the 2031 Notes will not accrete. The 2032 Notes will be senior, unsecured obligations of the Company and will accrue interest payable semi-annually in arrears at an annual rate of 0.875%. The 2031 Notes have an initial conversion rate of 11.4683 shares of the Company’s common stock per $1,000 principal amount of 2031 Notes (which is equivalent to an initial conversion price of approximately $87.20 per share of the Company’s common stock, representing an initial conversion premium of approximately 27.5% above the closing price of $68.39 per share of the Company’s common stock on November 6, 2025). The 2032 Notes have an initial conversion rate of 11.4683 shares of the Company’s common stock per $1,000 principal amount of 2031 Notes (which is equivalent to an initial conversion price of approximately $87.20 per share of the Company’s common stock, representing an initial conversion premium of approximately 27.5% above the closing price of $68.39 per share of the Company’s common stock on November 6, 2025). Each conversion rate for the 2031 Notes and 2032 Notes, respectively, is subject to adjustment in some events but will not be adjusted for any accrued and unpaid special and additional interest with respect to the 2031 Notes and accrued and unpaid interest with respect to the 2032 Notes. Holders of the Convertible Notes will have the right to require the Company to repurchase all or a portion of their Convertible Notes upon the occurrence of a fundamental change (as defined in each indenture governing the Convertible Notes) at a cash repurchase price of 100% of their principal amount plus any accrued and unpaid special and additional interest with respect to the 2031 Notes and accrued and unpaid interest with respect to the 2032 Notes. The 2031 Notes will mature on February 15, 2031, and the 2032 Notes will mature on November 15, 2032, in each case, unless earlier redeemed, repurchased or converted in accordance with their respective terms prior to such dates. Prior to the close of business on the business day immediately preceding August 15, 2030, the 2031 Notes will be convertible only upon the satisfaction of certain conditions and during certain periods, and on and after August 15, 2030, at any time prior to the close of business on the second scheduled trading day immediately preceding the maturity date of the 2031 Notes, the 2031 Notes will be convertible regardless of these conditions. Prior to the close of business on the business day immediately preceding May 15, 2032, the 2032 Notes will be convertible only upon the satisfaction of certain conditions and during certain periods, and on and after May 15, 2032, at any time prior to the close of business on the second scheduled trading day immediately preceding the maturity date of the 2032 Notes, the 2032 Notes will be convertible regardless of these conditions. The Company will settle conversions in cash and, if applicable, shares of the Company’s common stock, at the Company’s election. The Company expects to close the offering on November 12, 2025, subject to the satisfaction of various customary closing conditions.

In connection with the pricing of the Convertible Notes, the Company entered into privately negotiated capped call transactions relating to each series of Convertible Notes with one or more financial institutions, which may include one or more of the initial purchasers of the Convertible Notes and/or their respective affiliates (collectively, the "Capped Call Counterparties"). The capped call transactions relating to the 2031 Notes initially cover, subject to customary adjustments, the number of shares of the Company’s common stock that will initially underlie the 2031 Notes, and the capped call transactions relating to the 2032 Notes initially cover, subject to customary adjustments, the number of shares of the Company’s common stock that will initially underlie the 2032 Notes. The cap price of the capped call transactions relating to the 2031 Notes is initially $136.78 per share of the Company’s common stock, representing a premium of 100% above the last reported sale price of $68.39 per share of the Company’s common stock on November 6, 2025, and is subject to certain adjustments under the terms of the capped call transactions. The cap price of the capped call transactions relating to the 2032 Notes is initially $136.78 per share of the Company’s common stock, representing a premium of 100% above the last reported sale price of $68.39 per share of the Company’s common stock on November 6, 2025, and is subject to certain adjustments under the terms of the capped call transactions.

The Company will receive net proceeds from the offering of approximately $1.274 billion (or approximately $1.47 billion if the initial purchasers exercise their option to purchase additional Convertible Notes in full), after deducting the initial purchasers’ discounts and commissions and the Company’s estimated offering expenses. The Company expects to use approximately $182.7 million of the net proceeds of the offering to fund the cost of entering into the capped call transactions. The Company also expects to use approximately $1.020 billion of the net proceeds of the offering to enter into privately negotiated agreements with certain holders of its outstanding 0.25% convertible senior notes due 2027 (the "2027 Notes") and 1.00% convertible senior notes due 2028 (the "2028 Notes" and, together with the 2027 Notes, the "Existing Convertible Notes") to repurchase their Existing Convertible Notes for cash through privately negotiated transactions entered into concurrently with or shortly after the offering (the "Note Repurchases"). In connection with the Note Repurchases, the Company expects to pay approximately $1.019 billion in cash, which includes accrued interest, to repurchase the Existing Convertible Notes.

The Company intends to use the remainder of the net proceeds from the offering for general corporate purposes, including working capital, capital expenditures, potential acquisitions and strategic transactions, and, potentially, future note repurchases including repurchases of the Existing Convertible Notes from time to time following the offering or for the repayment of the Notes at maturity. If the initial purchasers exercise their option to purchase additional notes, the Company intends to use a portion of the net proceeds from the sale of additional notes to fund the cost of entering into additional capped call transactions.

The Note Repurchases could increase (or reduce the size of any decrease in) the market price of the Company’s common stock or the Convertible Notes. The Company also expects that some existing noteholders may purchase or sell shares of the Company’s common stock in the market to hedge their exposure in connection with these transactions. The Note Repurchases and any associated hedging by holders could have affected or affect the market price of the Company’s common stock prior to, concurrently with or shortly after the pricing of the Convertible Notes, and could have also resulted in a higher effective conversion price for the Convertible Notes.

The capped call transactions relating to each series of Convertible Notes are generally expected to reduce the potential dilution to the Company’s common stock upon conversion of the relevant series of Convertible Notes and/or offset the amount of any potential cash payments the Company may be required to make in excess of the principal amount of converted Convertible Notes of such series, as the case may be, in the event that the market price per share of the Company’s common stock, as measured under the terms of the capped call transactions, is greater than the strike price of the capped call transactions, which initially corresponds to the conversion price of the Convertible Notes and is subject to anti-dilution adjustments substantially similar to those applicable to the conversion rate of the Convertible Notes. If, however, the market price per share of the Company’s common stock, as measured under the terms of the capped call transactions, exceeds the cap price of the capped call transactions, there would nevertheless be dilution and/or there would not be an offset of such potential cash payments, in each case, to the extent that such market price exceeds the cap price of the capped call transactions.

The Company has been advised that, in connection with establishing their initial hedges of the capped call transactions, the option counterparties or their respective affiliates expect to enter into various derivative transactions with respect to the Company’s common stock and/or purchase shares of the Company’s common stock concurrently with or shortly after the pricing of the Convertible Notes. This activity could increase (or reduce the size of any decrease in) the market price of the Company’s common stock or the Convertible Notes at that time.

In addition, the Company has been advised that the Capped Call Counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to the Company’s common stock and/or purchasing or selling the Company’s common stock or selling the Company’s common stock or other securities of the Company in secondary market transactions following the pricing of the Convertible Notes and from time to time prior to the maturity of the Convertible Notes (and (x) are likely to do so during any observation period related to a conversion of the Convertible Notes, following any redemption of the Convertible Notes by the Company, or following any repurchase of the Convertible Notes by the Company in connection with any fundamental change and (y) are likely to do so following any repurchase of Convertible Notes by the Company other than in connection with any such redemption or any fundamental change if the Company elects to unwind a corresponding portion of the capped call transactions in connection with such repurchase). This activity could also cause or avoid an increase or decrease in the market price of the Company’s common stock or the Convertible Notes, which could affect a holder’s ability to convert its Convertible Notes and, to the extent the activity occurs during any observation period related to a conversion of a series of Convertible Notes, it could affect the number of shares of the Company’s common stock and value of the consideration that a holder will receive upon conversion of its Convertible Notes.

This press release is neither an offer to sell nor a solicitation of an offer to buy the Convertible Notes or the shares of the Company’s common stock issuable upon conversion of the Convertible Notes, if any, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Any offer of these securities will be made only by means of a private offering memorandum.

The offer and sale of the Convertible Notes and the shares of the Company’s common stock issuable upon conversion of the Convertible Notes, if any, have not been registered under the Securities Act, or the securities laws of any other jurisdiction, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

(Press release, Halozyme, NOV 6, 2025, View Source;Announces-Pricing-of-Private-Offering-of-650-Million-of-Convertible-Senior-Notes-due-2031-and-650-Million-of-Convertible-Senior-Notes-due-2032/default.aspx [SID1234659646])

On November 6, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the third quarter ended September 30, 2025.

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"September 25, 2025 was a historic day for Crinetics with the approval of Palsonify for the treatment of people with acromegaly," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "For years, acromegaly patients have endured significant challenges with existing therapies. Since approval, our team has executed seamlessly to get Palsonify to patients and the launch is off to a very good start. Healthcare providers both at pituitary centers and in the community have written prescriptions, and we are seeing uptake in patients switching from prior therapies and in those newly initiating medical therapy. With the approval milestone, we are now a fully integrated pharmaceutical company. Five clinical trials across our deep pipeline are advancing and our financial position remains robust. We are executing with speed and focus on our mission to bring life-changing treatments to the patients who need them most."

Third Quarter 2025 and Recent Highlights:
PALSONIFY was approved by the U.S. Food and Drug Administration (FDA) on September 25, 2025 for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Crinetics’ field force has called on over 95% of the top priority healthcare provider targets. Additionally, approximately 95% of filled prescriptions are from switch patients and 5% are from naïve patients, reflecting the demographics of the acromegaly population. Payer reimbursement has not been a barrier to treatment, with approximately 50% of filled prescriptions reimbursed.
Presented three abstracts from clinical development programs at North American Neuroendocrine Tumor Society Annual Meeting (NANETS 2025), highlighting neuroendocrine tumor research progress. Crinetics shared data showing investigator-assessed progression free survival rate of 74% following one year of treatment with paltusotine and details from the first-in-human study of the nonpeptide drug conjugate (NDC) candidate CRN09682 in patients with somatostatin receptor 2-expressing tumors.
Key Upcoming Milestones:
Crinetics expects the first patients to randomize in the CAREFNDR Phase 3 trial of paltusotine in carcinoid syndrome in the fourth quarter of 2025.
Crinetics is making continued progress on the development program for atumelnant across multiple trials. Crinetics expects the first patients to randomize in the CALM-CAH Phase 3 study in adults with congenital adrenal hyperplasia (CAH) and the BALANCE-CAH Phase 2/3 study in pediatrics in the fourth quarter of 2025. Glucocorticoid reduction data from Cohort 4 of the Phase 2 study and 13-week data from the Phase 2 open-label extension study will be shared early in 2026.
Planning, including regulatory interactions, for the next study of atumelnant in ACTH-dependent Cushing’s syndrome (ADCS) is underway. Initiation of the Phase 2/3 study is expected to begin in the first half of 2026.
Crinetics expects the first patient to receive CRN09682 in the dose escalation phase of a Phase 1/2 study in the fourth quarter of 2025. This is the first candidate from the NDC platform and the study will include an expansion phase for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors (NETs) and other SST2-expressing solid tumors.
Based on emerging data from Investigational New Drug (IND)-enabling studies, focus of the thyroid stimulating hormone receptor (TSHR) antagonist program has shifted to bringing forward an alternative candidate with a superior profile. There is also follow-up preclinical work needed on the IND-enabling studies for the SST3 program that will postpone its IND submission.
Third Quarter 2025 Financial Results:
Revenues were $0.1 million for the quarter ended September 30, 2025. All revenues were derived from the paltusotine licensing agreement with Sanwa Kagaku Kenkyusho Co., Ltd. There were no revenues for the same period in 2024.
Research and development expenses were $90.5 million for the quarter ended September 30, 2025, compared to $61.9 million for the same period in 2024. The increases were primarily attributable to an increase in personnel costs of $10.9 million and increased clinical and manufacturing activities costs of $10.2 million, driven by the advancement of our clinical programs and the expansion of our preclinical portfolio.
Selling, general and administrative expenses were $52.3 million for the quarter ended September 30, 2025, compared to $25.9 million for the same period in 2024. The increases were primarily driven by an increase in personnel costs of $10.2 million primarily due to the increase in headcount and an increase in outside services costs of $12.0 million to support our overall growth and the commercial launch of PALSONIFY.
Net loss for the quarter ended September 30, 2025, was $130.1 million, compared to a net loss of $76.8 million for the same period in 2024.
Cash, cash equivalents, and investments totaled $1.1 billion as of September 30, 2025, compared to $1.4 billion as of December 31, 2024. Based on current projections, Crinetics expects that its cash, cash equivalents and investments will be sufficient to fund its current operating plan into 2029. For 2025, Crinetics continues to anticipate cash used in operations to be between $340 and $370 million.
Conference Call and Webcast Details
Management will hold a live conference call and webcast today, Thursday, November 6 at 4:30 p.m. ET. To participate, please dial 1-833-470-1428 (domestic) or 1-646-844-6383 (international) and refer to Access Code 166837. To access the webcast, the direct link (here) or visit the Events page of the Crinetics website. Following the live event, the webcast will be archived on the Investor Relations section of www.crinetics.com.

Upcoming Investor Events
Crinetics management will be attending the following events in the coming months:

2025 Stifel Healthcare Conference, November 11-13 in New York, NY.
Piper Sandler 37th Annual Healthcare Conference, December 2-4 in New York, NY.
Citi’s 2025 Global Healthcare Conference, December 2-4 in Miami, FL.
8th Annual Evercore Healthcare Conference, December 2-4 in Coral Gables, FL.
Please check the website for updates regarding the timing of the live presentation webcasts, if any, and for replay information.

(Press release, Crinetics Pharmaceuticals, NOV 6, 2025, View Source [SID1234659562])