On November 10, 2025 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs) to profoundly improve people’s lives, reported financial results for the third quarter ended September 30, 2025, and highlighted recent progress.

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"In October, we announced that Avidity entered into a definitive merger agreement with Novartis, which we believe maximizes value for our investors, accelerates the global reach of our innovative neuroscience pipeline, and advances even more possibilities for our innovative science," said Sarah Boyce, president and chief executive officer of Avidity. "This important transaction, alongside compelling del-zota data and a successful pre-BLA meeting with the FDA in the third quarter, underscores the remarkable consistency of our AOC platform and the significant potential of del-zota, del-desiran, and del-brax to transform outcomes for people living with serious rare diseases. These achievements are possible because of our incredibly talented Avidity team and the close collaboration of the dedicated patient and clinical communities we serve."

Company Announcements, Highlights and Upcoming Milestones

▪Definitive Merger Agreement with Novartis AG

•In October 2025, Avidity announced it had entered into a definitive merger agreement with Novartis AG ("Novartis") which was unanimously approved by the Boards of Directors of both Avidity and Novartis. The closing of the acquisition will follow the separation of Avidity’s early-stage precision cardiology programs into SpinCo, which is expected to be a publicly traded company. SpinCo will be led by Kathleen Gallagher, currently Avidity’s chief program officer, as chief executive officer. Sarah Boyce, currently Avidity’s chief executive officer, will serve as chair of the board.
•Novartis will acquire Avidity’s programs and pipeline in neuroscience and gain access to its differentiated RNA-targeting delivery platform, which includes three late-stage clinical development programs: delpacibart zotadirsen (del-
zota) for the treatment of Duchenne muscular dystrophy (DMD), delpacibart etedesiran (del-desiran) for the treatment of myotonic dystrophy type 1 (DM1) and delpacibart braxlosiran (del-brax) for the treatment of facioscapulohumeral muscular dystrophy (FSHD).
•Expected closing is in the first half of 2026, subject to completion of the separation of SpinCo from Avidity and other customary closing conditions.
▪Delpacibart zotadirsen (del-zota) for the treatment of people living with Duchenne muscular dystrophy with mutations amenable to exon 44 skipping (DMD44):
•Clear path forward aligned with FDA following October 2025 pre-BLA meeting. The BLA submission is planned for 2026 for accelerated approval.
•In September 2025, Avidity shared positive topline and functional del-zota data from EXPLORE44 and EXPLORE44-OLE trials demonstrating consistent, clinically meaningful improvements across functional endpoints at approximately one year of treatment. Data demonstrated reversal of disease progression and unprecedented improvement compared to baseline and natural history across multiple functional measures. Del-zota continued to demonstrate a favorable long-term safety and tolerability profile.
•In July 2025, Avidity announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to del-zota.
▪Delpacibart etedesiran (del-desiran) for the treatment of myotonic dystrophy type 1 (DM1):
•In July 2025, Avidity announced completion of enrollment for the Phase 3 HARBOR trial, the first global Ph3 trial of del-desiran for the treatment of DM1.
•Expected publication of data analyses from the completed Phase 1/2 MARINA trial in the fourth quarter of 2025.
•54-week topline data readout from global Phase 3 HARBOR study expected in the second half of 2026.
▪Delpacibart braxlosiran (del-brax) for the treatment of facioscapulohumeral muscular dystrophy (FSHD):
•Topline data from FORTITUDE biomarker cohort expected in the second quarter of 2026.
•Alignment with FDA on accelerated and full approval pathways for del-brax, and initiated global, confirmatory Phase 3 study, FORTITUDE-3, intended to support global approval strategy for del-brax.
•Phase 3 FORTITUDE-3 readout and global regulatory submissions expected in 2028.

▪Collaboration Progress:
•In the third quarter of 2025, Avidity received collaboration revenue of a $10.0 million clinical development milestone under Avidity’s research collaboration and license agreement with Eli Lilly and Company.
Third Quarter 2025 Financial Results

▪Cash, cash equivalents and marketable securities totaled approximately $1.9 billion as of September 30, 2025, which reflects net proceeds of $651.4 million from a public offering and $185.5 million from the sale of common stock under the Company’s sales agreement.

•The Company expects that its cash, cash equivalents and marketable securities as of September 30, 2025, will be sufficient to fund its operations to mid-2028.

▪Collaboration revenues of $12.5 million for the third quarter of 2025 and $17.9 million for the first nine months of 2025, primarily relate to a $10.0 million clinical development milestone under Avidity’s research collaboration and license agreement with Eli Lilly and Company, as well as additional revenues under Avidity’s research collaboration and license agreement with Bristol Myers Squibb. Collaboration revenues of $2.3 million for the third quarter of 2024 and $7.9 million for the first nine months of 2024, primarily relate to revenues under Avidity’s research collaboration and license agreement with Bristol Myers Squibb.

▪Research and development expenses for the third quarter of 2025 were $154.9 million, compared to $77.2 million for the same period of 2024. Research and development expenses for the nine months ended September 30, 2025 were $392.6 million, compared to $208.0 million for the same period of 2024. The increases were primarily driven by increased costs associated with the advancement of del-desiran, del-brax and del-zota, higher manufacturing costs, and higher personnel costs.

▪General and administrative expenses for the third quarter of 2025 were $46.3 million, compared to $23.3 million for the same period of 2024. General and administrative expenses for the nine months ended September 30, 2025 were $116.8 million, compared to $57.9 million for the same period of 2024. The increases were primarily due to higher personnel and commercial infrastructure costs to support the company’s expanded operations.

(Press release, Avidity Biosciences, NOV 10, 2025, View Source [SID1234659735])

On November 10, 2025 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company developing a potentially first-in-class WEE1 inhibitor for patients with ovarian cancer and other tumor types, reported financial results for the third quarter 2025 and highlighted recent operational progress.

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"We are pleased with our continued disciplined execution of the DENALI clinical trial this quarter, supporting late-stage development of azenosertib as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer, and positioning us for an anticipated topline data readout by year end 2026. Our engagement with trial investigators and presence at medical conferences is very encouraging and continues to support our development strategy," said Julie Eastland, Chief Executive Officer of Zentalis. "With $280.7 million in cash providing runway into late 2027, we maintain a robust financial foundation to deliver on our azenosertib objectives."

Business Updates

•Phase 2 DENALI clinical trial remains on track and has the potential to support an accelerated approval, subject to FDA feedback.
◦Enrollment is ongoing in DENALI Part 2a of the Phase 2 DENALI clinical trial (NCT05128825) of azenosertib in patients with Cyclin E1-positive PROC. DENALI Part 2a is designed to confirm the primary dose-of-interest with a target enrollment of up to approximately 30 patients at each of two dose levels: 400mg QD 5:2 (intermittent daily dosing with a five days on, two days off dosing schedule) and 300mg QD 5:2. DENALI Part 2b is designed to enroll approximately 70 patients at a single dose, the selection of which will be informed by the Part 2a results.

◦The Company expects to disclose topline data from DENALI Part 2 (Part 2a and Part 2b) by year end 2026. We believe that DENALI Part 2, if successful, has the potential to support an accelerated approval, subject to FDA review.

•Poster Presentations at AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) support Cyclin E1 biomarker-driven strategy for azenosertib.
◦Presentations feature data from first-in-human Phase 1 study, including Cyclin E1 biomarker findings, supporting late-stage development of azenosertib.

•TETON Phase 2 trial in uterine serous carcinoma (USC) completed enrollment.
◦Consistent with the Company’s previously announced strategic prioritization of azenosertib for the treatment of patients with Cyclin E1-positive PROC, further development in USC will be limited to partnering or the Company’s ability to allocate capital to this indication.

◦The Company will continue to support an ongoing investigator-initiated study to explore potential biomarker enrichment strategy in USC.
◦Results from the TETON trial are planned for publication in the first half of 2026.

Third Quarter 2025 Financial Results

•Cash, Cash Equivalents and Marketable Securities Position: As of September 30, 2025, the Company had cash, cash equivalents and marketable securities of $280.7 million. The Company believes that its existing cash, cash equivalents and marketable securities as of September 30, 2025 will be sufficient to fund its operating expenses requirements into late 2027.

•Research and Development Expenses: Research and development (R&D) expenses for the three months ended September 30, 2025 were $23.0 million, compared to $36.8 million for the three months ended September 30, 2024. The decrease of $13.8 million was primarily due to decreases of $7.6 million for personnel expenses, of which $2.7 million was non-cash stock-based compensation. Decreases of $4.2 million for lab services, $1.2 million for clinical expenses, and $0.8 million for supplies, overhead, and other expense also contributed to the overall reduction in research and development expenses.

•General and Administrative Expenses: General and administrative expenses for the three months ended September 30, 2025 were $10.8 million, compared to $14.6 million during the three months ended September 30, 2024. This decrease of $3.8 million was attributable to a decrease of $3.8 million in personnel expense, of which $2.8 million was non-cash stock-based compensation.
•Operating Expenses: Total operating expenses were $33.7 million for the three months ended September 30, 2025, compared to $51.4 million for the three months ended September 30, 2024.

About Azenosertib
Azenosertib is an investigational, novel, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated as a monotherapy and combination clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

About DENALI Clinical Trial
DENALI is a multi-part Phase 2 clinical trial studying azenosertib in platinum-resistant ovarian cancer (PROC) patients. Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg 5:2 (intermittent daily dosing with a five days on, two days off dosing schedule). Interim results from Part 1b were presented at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting. Part 2 is ongoing and is enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis’ proprietary immunohistochemistry cutoff. Part 2 includes Part 2a, a dose confirmation portion evaluating two doses, 300mg 5:2 and 400mg 5:2, and Part 2b, a portion designed to complete enrollment at the selected dose. Part 2, in total, is designed for accelerated approval, pending study outcome and discussions with the U.S. Food and Drug Administration.

(Press release, Zentalis Pharmaceuticals, NOV 10, 2025, View Source [SID1234659731])

On November 10, 2025 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported that company management will participate at multiple upcoming investor conferences:

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TD Cowen Immunology and Inflammation Virtual Summit
Date: Wednesday, November 12, 2025
Presentation Time: 3:00 p.m. ET / 12:00 p.m. PT
Piper Sandler 37th Annual Healthcare Conference
Date: Tuesday, December 2, 2025
Presentation Time: 2:00 p.m. ET / 11:00 a.m. PT

Live webcasts of the presentations will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. Replays of the events will be available on the Xencor website for at least 30 days following the presentations.

(Press release, Xencor, NOV 10, 2025, View Source [SID1234659730])

On November 10, 2025 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage oncology company, reported financial results for the third quarter ended September 30, 2025, and provided corporate updates.

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"We’re thrilled with the positive momentum of the CARDINAL program generated by the unprecedented Phase 1 MMR achievement rate and encouraging safety/tolerability profile published in the recent ASH (Free ASH Whitepaper) abstract. These data continue to reinforce our view of the potential of TERN-701 to become a best-in-disease treatment for patients with chronic myeloid leukemia (CML)," said Amy Burroughs, chief executive officer of Terns Pharmaceuticals. "Our team continues to execute with precision and focus towards an updated and expanded CARDINAL readout at ASH (Free ASH Whitepaper), with an ultimate goal of bringing this important new therapy to CML patients."

Recent Pipeline Developments and Anticipated Milestones

TERN-701: Novel investigational allosteric BCR::ABL1 inhibitor for chronic myeloid leukemia (CML)

•
In November 2025, Terns announced that an abstract with updated data from the ongoing Phase 1 CARDINAL trial evaluating TERN-701 in patients with relapsed/refractory CML had been selected for oral presentation at the 67th ASH (Free ASH Whitepaper) Annual Meeting and Exposition
•
The abstract reported data from the ongoing dose escalation and dose expansion parts of the CARDINAL trial. Highlights include from the abstract include:
o
Overall (cumulative) major molecular response (MMR) rate of 75% by 24 weeks, with 64% achieving MMR and 100% maintaining MMR
o
Overall (cumulative) MMR by 24 weeks in difficult to treat patient subgroups
•
69% in patients with lack of efficacy to last tyrosine kinase inhibitor (TKI)
•
60% in patients who had prior asciminib
•
67% in patients with prior asciminib / ponatinib / investigational TKI
o
No patients had lost MMR at the time of data cutoff
o
Encouraging safety and tolerability profile at all doses evaluated
•
A more expansive and updated dataset from the CARDINAL trial will be presented at the ASH (Free ASH Whitepaper) Annual Meeting:
o
Session Name: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Therapeutic agents to enhance patient outcomes
o
Session Date: December 8, 2025
o
Session Time: 2:45 – 4:15pm ET
o
Presentation Time: 2:45 – 3:00pm ET
•
The Company will host a conference call to review the data on December 8, 2025 at 4:30pm ET. The event can be accessed live on the investor relations section of Terns’ website, where it will also be archived

TERN-601: Oral, small-molecule glucagon-like peptide-1 receptor agonist (GLP1-RA) for obesity

•
In October 2025, Terns announced top-line 12-week data from the Phase 2 study of TERN-601 for the treatment of obesity, which showed maximum placebo-adjusted weight loss of 4.6% with 12% treatment discontinuation due to adverse events
•
Asymptomatic, reversible grade 3 liver enzyme elevations occurred in three participants during post-treatment follow-up period, two of which were deemed drug related
•
The results of the Phase 2 study did not support the Company’s further development of TERN-601 in obesity
•
Terns had previously announced its decision to no longer invest in metabolic disease

Pipeline and Partnering Programs

"As we continue to sharpen our strategic focus in oncology, earlier this year we decided we would discontinue internal clinical development of our metabolic programs. While these metabolic assets have shown promise, we believe their full potential can best be realized through external partnerships," noted Andrew Gengos, chief financial officer of Terns.

TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist

•
Based on non-clinical studies, THR-β is a complementary mechanism to GLP-1, potentially providing broader metabolic and liver benefits in addition to increased weight loss
•
Terns is seeking a strategic partner to advance this program

TERN-801: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist

•
In the third quarter of 2025, Terns nominated TERN-801, an oral small-molecule GIPR antagonist as a development candidate from the TERN-800 series discovery effort
•
Terns is seeking a strategic partner to advance this program

Third Quarter 2025 Financial Results

Cash Position: As of September 30, 2025, cash, cash equivalents and marketable securities were $295.6 million, as compared with $358.2 million as of December 31, 2024. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2028.

Research and Development (R&D) Expenses: R&D expenses were $19.9 million for the quarter ended September 30, 2025, as compared with $15.2 million for the quarter ended September 30, 2024.

General and Administrative (G&A) Expenses: G&A expenses were $7.8 million for the quarter ended September 30, 2025, as compared with $9.8 million for the quarter ended September 30, 2024.

Net Loss: Net loss was $24.6 million for the quarter ended September 30, 2025, as compared with $21.9 million for the quarter ended September 30, 2024.

(Press release, Terns Pharmaceuticals, NOV 10, 2025, View Source [SID1234659729])

On November 10, 2025 Rakovina Therapeutics Inc. ("Rakovina" or the "Company") (TSX-V: RKV)(FSE: 7JO0) a biopharmaceutical company advancing cancer therapies through AI-enabled drug discovery, reported that new data will be presented in two posters at the Society for Neuro-Oncology (SNO) Annual Meeting, taking place November 19–23, 2025, in Honolulu, Hawaii.

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The presentations will highlight Rakovina’s AI-driven programs to discover and develop next-generation DNA-damage response (DDR) inhibitors engineered for central nervous system (CNS) penetration, supporting the development of potential new treatment options for primary and metastatic brain cancers.

Presentation Details:

Title: Discovery and development of a novel CNS-penetrating ATR inhibitor
Session: Poster Session – DNA Repair (DNAR-05)
Date/Time: November 21, 2025 | 11:30 a.m.–12:45 p.m. (HST)

Title: Discovery and development of novel CNS-penetrating PARP1-selective inhibitors
Session: Poster Session – DNA Repair (DNAR-06)
Date/Time: November 21, 2025 | 11:30 a.m.–12:45 p.m. (HST)

The first poster presents results from Rakovina Therapeutics’ kt-5000AI ATR inhibitor program, developed in collaboration with Variational AI. The program leverages the ENKI generative AI platform to design and optimize CNS-penetrant ATR inhibitors with favorable pharmacologic properties for the potential treatment of brain cancers. The data highlight the discovery of potent, selective ATR inhibitors that demonstrate activity against treatment-resistant tumor phenotypes.

The second poster presents progress from the Company’s kt-2000AI PARP inhibitor program, developed using the Deep Docking AI-accelerated drug discovery platform. The program applies ultra-large-scale virtual screening to evaluate billions of compounds in silico, rapidly identifying and optimizing PARP1-selective, CNS-penetrant inhibitors with desirable pharmacologic properties. The data illustrate how this approach enables deep exploration of chemical space and efficient discovery of next-generation candidates designed to address the limitations of first-generation PARP inhibitors.

"The Society for Neuro-Oncology Annual Meeting is a premier global forum for advances in brain cancer research, and we’re proud to share our latest data at this year’s conference," said Prof. Mads Daugaard, President and Chief Scientific Officer of Rakovina Therapeutics. "Our participation reflects Rakovina’s ongoing efforts to develop first-in-class DNA-damage response inhibitors designed to reach the brain. By combining AI-accelerated medicinal chemistry with the world-class infrastructure at the University of British Columbia’s Vancouver Prostate Centre, we are advancing next-generation therapies targeting ATR and PARP1 pathways aimed at improving outcomes for patients with aggressive and treatment-resistant brain cancers."

(Press release, Rakovina Therapeutics, NOV 10, 2025, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-to-present-new-data-highlighting-cns-penetrant-atr-and-parp1-inhibitors-at-the-2025-society-for-neuro-oncology-annual-meeting [SID1234659728])