On May 13, 2025 Stylus Medicine, Inc. ("Stylus"), a biotechnology company dedicated to developing transformative in vivo genetic medicines, reported to have emerged from stealth with $85 million in financing (Press release, Stylus Medicine, MAY 13, 2025, View Source [SID1234653000]). Stylus’ funding includes a $45 million Series A extension financing with participation from RA Capital Management, Khosla Ventures, and six new investors including Chugai Venture Fund, Eli Lilly and Company, and Johnson & Johnson Innovation – JJDC. This financing follows a $40 million Series A investment from founding investors RA Capital and Khosla Ventures.

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Stylus will use this financing to advance its in vivo genetic medicines platform and pipeline of in vivo therapeutic programs. The company’s powerful and elegant engineering platform combines sequence-specific genome integration with cell-targeted lipid nanoparticle (LNP) delivery. The platform is based on Stylus-designed therapeutic-grade recombinases capable of encoding polyfunctional multi-kb payloads with high efficiency, high specificity, and high fidelity. This system enables durable, flexible, and scalable in vivo cell engineering, overcoming major limitations of ex vivo cell therapy manufacturing and expanding the reach of transformative genetic medicines.

"Stylus was established to reimagine how genetic medicines reach patients. At the core of our approach are three defining features of an ideal therapy: safe and targeted in vivo delivery, specific integration, and durable expression of a therapeutic payload," said Emile Nuwaysir, Ph.D., Chairman and Chief Executive Officer of Stylus. "By removing the complexity of ex vivo and viral manufacturing, we will dramatically simplify patient treatment. Our goal is to bring the life-saving promise of genetic medicines to every patient in need, starting with CAR-T therapies."

"Stylus was created in 2022 by Raven, RA Capital’s healthcare incubator, and Khosla Ventures to solve the fundamental challenges holding back genetic medicines," said Joshua Resnick, M.D., Partner at RA Capital and President of Raven. "The Stylus system is incredibly elegant, and Stylus has the right team, capital, and strategy to succeed. The company has the potential to vastly expand the availability of life-changing therapies, while creating a scalable, efficient model that is attractive from both a clinical and commercial perspective."

Leadership and Organization

The Company’s leadership includes Emile Nuwaysir, Ph.D., Chairman and Chief Executive Officer, and Jason Fontenot, Ph.D., Chief Scientific Officer.

Dr. Nuwaysir brings more than 25 years of experience in executive leadership positions in the cell and gene therapy field to the role. As a serial entrepreneur and operator, he has launched and led multiple biotechnology companies from inception to exit, including senior leadership roles at BlueRock Therapeutics (acquired by Bayer), Cellular Dynamics (acquired by FujiFilm), and NimbleGen (acquired by Roche). He was most recently the CEO of Ensoma and the CEO and Chairman of BlueRock Therapeutics. Dr. Nuwaysir is also the past Chairman of the Alliance for Regenerative Medicine.

Dr. Fontenot, Stylus’ Chief Scientific Officer (CSO), brings more than two decades of experience in senior scientific roles and a track-record of leadership in cell and gene therapy. He was most recently the CSO of Sangamo Therapeutics and the CSO of Immusoft Corporation. He led the Exploratory Research group at Juno Therapeutics and was a group leader in Immunology Research at Biogen. Dr. Fontenot’s academic research was focused on lineage specification in the immune cells. His seminal discoveries in regulatory T cell biology established the molecular basis for dominant immune tolerance with broad implications in autoimmunity and oncology.

"The genetic medicines revolution began decades ago, but despite the immense therapeutic potential we’ve treated a limited number of patients because of manufacturing and delivery challenges, and the inability to deliver large genetic payloads. Most genetic medicines available today are an important proof-of-concept, but not a practical solution," said Nessan Bermingham, Ph.D., Operating Partner at Khosla Ventures. "Stylus set out with a bold vision to solve those challenges. Achieving this vision requires exceptional leadership, and with Emile and Jason at the helm, Stylus is optimally positioned to realize our goal to bring transformative genetic medicines to the millions of patients who desperately need them."

Drs. Nuwaysir and Fontenot are part of an accomplished leadership team, and an experienced Board of Directors comprised of industry veterans and scientific innovators, including:

Board of Directors

Emile Nuwaysir, Ph.D., Chairman and Chief Executive Officer
Nessan Bermingham, Ph.D., Operating Partner at Khosla Ventures, formerly Chief Executive Officer at Intellia Therapeutics
John Gustofson, President at Chugai Venture Fund, formerly Managing Director at AbbVie Ventures
Patrick Hsu, Ph.D., Scientific Founder of Stylus Medicine, Co-Founder of the Arc Institute, and Assistant Professor of Bioengineering and Deb Faculty Fellow at the University of California, Berkeley
Joshua Resnick, M.D., Partner at RA Capital Management and President of Raven, RA Capital’s healthcare incubator
Scientific Founders

Patrick Hsu, Ph.D., Co-Founder of the Arc Institute and Assistant Professor of Bioengineering and Deb Faculty Fellow at the University of California, Berkeley
Ami S. Bhatt, M.D., Ph.D., Professor of Medicine & Genetics at Stanford University
Michael C. Bassik, Ph.D., Associate Professor of Genetics at Stanford University
Lacramioara Bintu, Ph.D., Assistant Professor of Bioengineering at Stanford University
"Recombinases are ideal enzymes for integrating large genetic payloads into the genome. Stylus’ unique approach centers on an extensive, proprietary library of therapeutic-grade recombinases, optimized through computational design and machine learning for protein engineering," said Patrick Hsu, Ph.D. "By developing engineered recombinases for in vivo genetic medicines, Stylus is unlocking a new era of therapeutic possibilities."

On May 13, 2025 Invenra Inc., a pioneer in multispecific antibody discovery and development, announces the launch of its T-Body trispecific antibody platform, a next-generation technology designed to reliably direct correct chain pairing and afford high expression and assembly efficiency in a variety of antibody constructs, including complex trispecific constructs (Press release, Invenra, MAY 13, 2025, View Source [SID1234652999]). Building on the success of Invenra’s B-Body bispecific platform, the T-Body platform expands the company’s capabilities to address complex therapeutic targets with enhanced developability.

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"Trispecific antibodies represent a major leap forward in therapeutic design, and our T-Body platform offers a unique approach to unlock their potential," said Roland Green, Ph.D., CEO and Chairman of Invenra. "By integrating proprietary CH3 domains, streamlining purification, and achieving strong expression yields, we’re empowering partners to rapidly discover and advance a new class of multispecific therapeutics."

Designed for Versatility and Manufacturability

The T-Body platform features an IgG-like architecture with proprietary CH3 domain pairs that substitute for traditional CH1/CL domains in two Fab arms. This configuration improves chain pairing, reduces mispairing, and supports efficient expression and assembly in mammalian cells. The design also enables "Plug & Play" variable domain compatibility, allowing insertion of VH/VL pairs from diverse sources—including phage libraries, humanized mice, and AI-designed antibodies.

Invenra’s T-Body platform features include:

Proprietary CH3 Design: Improves heavy/light chain pairing and overall assembly.
Streamlined Purification: One-step purification with Protein A and anti-CH1 resin compatibility.
Robust Expression: High yields in multiple transient expression systems.
Flexible Targeting: Supports multivalent and/or multispecific formats with both kappa and lambda light chains.
Manufacturing-Ready: Compatible with standard IgG production processes for rapid scale-up.
Expanding the Future of Multispecific Antibodies

With the T-Body platform, Invenra continues its mission to accelerate next-generation multispecific antibody discovery in areas such as oncology, autoimmune disease, and immunotherapy. The platform’s modularity and developability profile position it for internal programs and strategic partnerships aimed at addressing complex biology through engineered multispecific formats.

"This platform is a natural extension of our antibody engineering leadership," Green added. "We’re excited to work with partners to move trispecific candidates from concept to clinic."

Invenra is highlighting the T-Body platform at the 21st Annual PEGS Boston May 12-16, with details available at its poster (A051), booth (612), and online at invenra.com.

On May 13, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported the presentation of six posters, including one oral presentation, at the 2025 annual meeting of the Professional Society for Health Economics and Outcomes Research (ISPOR), taking place May 13-16 in Montreal, Canada (Press release, Tempus, MAY 13, 2025, View Source [SID1234652998]). Tempus researchers are showcasing scientific and clinical studies highlighting the impact of AI and real-world data on health economics and outcomes research.

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"The research we’re presenting at ISPOR 2025 underscores the powerful potential of integrating clinical, molecular, and claims data to unlock actionable insights that drive more personalized and effective cancer care," said Emilie Scherrer, Senior Director and Head of Outcomes Research, at Tempus. "At Tempus, we share ISPOR’s deep focus on empowering providers and health systems with the real-world data they need to optimize treatment strategies and improve outcomes for their patients."

Research highlights include:

Oral Presentation: Oncology Trial Emulation Using Real-World Electronic Health Record Data: Results of the Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation (CARE) Initiative
Date/Time: Thursday, May 15; 10:15 AM – 11:15 AM ET

Overview: The Coalition to Advance Real-World Evidence through Randomized Controlled Trial (RCT) Emulation (CARE) Initiative seeks to advance understanding of when real-world data (RWD) can generate valid treatment effectiveness estimates by emulating RCTs. This study presents findings from three oncology emulations. The KEYNOTE-189 (metastatic NSCLC) and PALOMA-2 (advanced breast cancer) trials were emulated using electronic health record datasets. Trial entry criteria were applied, and treatment status was based on first-line medications. Inverse probability of treatment weighting controlled for baseline confounding, and Kaplan-Meier and Cox models estimated primary outcomes. In the KEYNOTE-189 emulation, the real-world progression-free survival (rwPFS) hazard ratio (HR) in one dataset was similar to the RCT finding, while the other was closer to the null. PALOMA-2’s rwPFS HR was also closer to the null. Real-world overall survival estimates in KEYNOTE-189 also varied across datasets. The researchers conclude that RWD oncology emulation conclusions depend on dataset features, route of administration, and real-world follow-up characteristics.
Poster Presentation: Impact of Adverse Event Definitions on Real-World Detection of Immune-Related Adverse Events
Date/Time: Thursday, May 15; 10:30 AM – 1:30 PM ET

Location: Exhibit Hall 220B-E, Poster #6044
Overview: Researchers investigated the impact of varying definitions on the identification of immune-related adverse events (irAEs) in real-world data (RWD) from non-small cell lung cancer (NSCLC) patients treated with immune checkpoint blockade (ICB). The research utilized Tempus clinico-genomic data linked to Komodo Health’s claims to analyze irAEs within one year of ICB treatment in patients with stage 3C+ NSCLC. Three peer-reviewed irAE definitions—differing in included irAEs, ICD-10 codes, and pre-treatment washout periods—were applied to the cohort of 4,831 patients. The overall prevalence of irAEs varied significantly across definitions: 41.0% (n=1,981) for Study A (9 irAEs), 75.4% (n=3,849) for Study B (10 irAEs), and 5.4% (n=264) for Study C (3 irAEs). This study demonstrates that irAE identification in RWD varies based on the definitions used, which can affect post-market surveillance, clinical practice guidelines, and patient care. The authors emphasize the need for researchers to accurately communicate the definitions used and conduct sensitivity analyses.
Poster Presentation: Comparison of Demographics and Clinical Characteristics using Real World Data from Tempus Multimodal Database and SEER Cancer Registry Across 17 Solid Cancer Cohorts
Date/Time: Thursday, May 15; 4:00 PM – 7:00 PM ET
Location: Exhibit Hall 220B-E, Poster #6019

Overview: This study benchmarked the Tempus multimodal database — a real-world data source with clinical and biomarker data from cancer patients — against the SEER cancer registry. Analyzing data from 63,520 patients with solid tumors diagnosed between 2016 and 2021, researchers compared baseline demographic, clinical, and treatment characteristics against the SEER database. The proportion of cancer types of new cancer cases were similar among the two databases. The Tempus database showed a larger representation of patients from the Midwest, whereas the SEER database had a heavy representation from the West. Tempus patients were younger on average but had more advanced cancer staging. Additionally, the Tempus database had more racial diversity based on self-reported race and more complete treatment data. In conclusion, the Tempus and SEER databases show general comparability in demographics and clinical characteristics, but the Tempus database provides greater treatment data granularity and captures more late-stage disease, attributable to sequencing patterns in clinical care.
Poster Presentation: Assessing the Completeness of Oncology Treatment Data from Administrative Claims: A Benchmarking Study Against Abstracted EHRs Using Patient-Level Linkages
Date/Time: Thursday, May 15; 4:00 PM – 7:00 PM ET
Location: Exhibit Hall 220B-E, Poster #6041

Overview: This study benchmarked oncology treatment data from administrative claims against abstracted electronic health records (EHR) for 6,487 stage 4 lung adenocarcinoma patients diagnosed between 2020 and 2023. Claims data (open and closed) were linked using de-identified patient tokens, with EHR data considered the ground truth. Sensitivities and positive predictive values (PPVs) were calculated for 13 infusional and 3 oral medications. Closed claims showed greater sensitivities (50.0-95.3%) than open claims (14.3-54.8%), with infusions having higher sensitivities than orals. PPVs were high for both infusions (closed: 79.1-98.3%; open: 61.5-99.1%) and orals (closed: 84.5-94.2%; open: 91.8-96.8%). Exact matches for abstracted infusion start dates in claims ranged from 45.5-82.5% for closed claims, while 27.6-65.9% of oral start dates matched within 7 days. The team concludes that while EHR remains the gold standard, individual claims may be sufficient for identifying patients receiving specific treatments, and closed claims may be suitable for constructing comprehensive treatment journeys.
Poster Presentation: Impact of NGS Testing Timing on Treatment Patterns and Clinical Outcomes in Colorectal Cancer
Date/Time: Thursday, May 15; 4:00 PM – 7:00 PM ET
Location: Exhibit Hall 220B-E, Poster #6013

Overview: Researchers evaluated the impact of next-generation sequencing (NGS) timing on real-world overall survival (rwOS) in 2,293 colorectal cancer (CRC) patients using the Tempus real-world multimodal database. The median age at diagnosis was 58.4 years, with most patients having stage 3 (23%) or stage 4 (68%) disease and receiving first-line (1L) chemotherapy without NGS-informed therapy. Time from biopsy to NGS test order was analyzed, revealing a notable delay in ordering NGS tests post-biopsy. A random forest classifier identified the timeline from biopsy to NGS results receipt as key in determining 1L treatment. Notably, stage 4 patients receiving NGS results within approximately two months of biopsy had a significant survival advantage. The study demonstrates that NGS testing may be associated with increased rwOS in CRC, highlighting the importance of timely NGS for guiding treatment decisions and improving outcomes.
Poster Presentation: Integrating Next Generation Sequencing, EHR, and Claims Data to Extend Follow-Up in a Real-World Advanced Lung Adenocarcinoma Biomarker-Treatment Landscape
Date/Time: Friday, May 16; 9:00 AM – 11:30 AM ET
Location: Exhibit Hall 220B-E, Poster #6046

Overview: The research team explored the use of closed claims data to enhance electronic health record (EHR)-derived treatment histories for stage 4 lung adenocarcinoma patients with comprehensive genomic profiling (CGP) and a diagnosis between 2020 and 2023. By linking closed claims data to EHRs, researchers extended abstracted lines of therapy (LOTs), defining new LOTs based on treatment gaps, persistent treatments, and follow-up duration. Integrating claims data increased the number of patients in LOT1, LOT2, and LOT3 and extended LOTs previously lost to follow-up. The integrated LOTs reflected NCCN guidelines, with EGFR inhibitors frequently used in EGFR-mutated patients and immunotherapy and KRAS inhibitors used in KRAS p.G12C patients. The study concludes that using closed claims to extend EHR-abstracted treatment data is valuable for real-world treatment pattern and outcome analyses.

On May 13, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that new data from a matching-adjusted indirect comparison study evaluating taletrectinib versus entrectinib in ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) will be presented in a poster session at ISPOR 2025, the Professional Society for Health Economics and Outcomes Research’s annual conference, taking place May 13-16, 2025 in Montreal, QC, Canada (Press release, Nuvation Bio, MAY 13, 2025, View Source [SID1234652997]).

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Presentation Overview:

Title: Taletrectinib vs Entrectinib in ROS1-Positive (ROS1+) Non-Small Cell Lung Cancer (NSCLC): A Matching-Adjusted Indirect Comparison (MAIC)
Presenter: Misako Nagasaka, M.D., Ph.D., Associate Professor – Division of Hematology and Oncology, UCI School of Medicine
Date: Wednesday, May 14
Session Time: 10:30 a.m. – 1:30 p.m. ET
Session: Poster Session 1
Presentation Number: CO151
The materials will be made available in the Publications section of Nuvation Bio’s website after the presentation.

About Taletrectinib

Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.

Based on results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted and granted Priority Review to Nuvation Bio’s NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) and assigned a PDUFA goal date of June 23, 2025. The U.S. FDA previously granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. In January 2025, China’s NMPA approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC.

On May 13, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, reported its financial results for the first quarter ended March 31, 2025 and provided an update on recent company developments (Press release, Atossa Therapeutics, MAY 13, 2025, View Source [SID1234652996]).

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First Quarter 2025 Highlights:

Announced Strategic Decision to Pursue Metastatic Breast Cancer Indication: Atossa announced plans to target metastatic breast cancer as its lead program for (Z)-endoxifen. The decision reflects its commitment to addressing the persistent unmet medical need in metastatic breast cancer and the potential for a more streamlined regulatory pathway to deliver (Z)-endoxifen to these patients. Current treatment options for metastatic breast cancer often provide limited durability of response and substantial side effects. In previous clinical trials, (Z)-endoxifen has been shown to be well-tolerated as a selective estrogen receptor modulator (SERM), which Atossa believes supports its potential to fill this critical gap in treatment.
Significantly Strengthened (Z)-endoxifen Patent Portfolio with Three New U.S. Patents: Atossa continued to bolster the intellectual property portfolio of (Z)-endoxifen with the grant of three new U.S. patents covering 31 claims directed at: sustained release compositions of (Z)-endoxifen (U.S. Patent No. 12,201,591); enteric oral formulations of (Z)-endoxifen and salts thereof as well as their use in treating hormone-dependent breast and reproductive tract disorders (U.S. Patent No. 12,275,684); and 58 claims covering (Z)-endoxifen formulations, including various levels of purity and stability as well as methods of using those formulations (U.S. Patent No. 12,281,056). Atossa’s robust patent portfolio now encompasses more than 200 patent claims related to (Z)-endoxifen formulations and their clinical applications.
"Our focus remains firmly on advancing (Z)-endoxifen as a next-generation therapy for breast cancer patients across the full spectrum of care—including a strategic emphasis on metastatic breast cancer, where therapeutic innovation is urgently needed," said Steven Quay, M.D., Ph.D., President and Chief Executive Officer of Atossa. "Across multiple clinical trials involving hundreds of patients, (Z)-endoxifen has consistently demonstrated strong tolerability and therapeutic versatility, which we believe shows its potential as a therapy for breast cancer from early-stage disease to more advanced stages. We are committed to unlocking the full potential of (Z)-endoxifen for patients while delivering value to our shareholders. A cornerstone of this strategy is the robust intellectual property portfolio we are building in an effort to protect our programs globally. As we look ahead to the remainder of 2025 and beyond, we are energized by the many opportunities to position (Z)-endoxifen as a potentially safer, more effective endocrine therapy for breast cancer patients worldwide."

Comparison of Three Months Ended March 31, 2025 and 2024

Revenue and Cost of Revenue. For the three months ended March 31, 2025 and 2024, we had no source of revenue and no associated cost of revenue.

Operating Expenses. Total operating expenses were $7.4 million for the three months ended March 31, 2025, which was an increase of $0.4 million, from the three months ended March 31, 2024 of $7.0 million. Factors contributing to the increased operating expenses in the three months ended March 31, 2025 are explained below.

Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the three months ended March 31, 2025 and 2024, together with the dollar change and percentage change in those categories (dollars in thousands):

For the Three Months Ended March 31,

2025

2024

Increase (Decrease)

% Increase (Decrease)

Research and Development Expenses

Clinical and pre-clinical trials

$

2,747

$

2,884

$

(137)

(5) %

Compensation

880

626

254

41 %

Professional fees and other

530

238

292

123 %

Research and Development Expenses Total

$

4,157

$

3,748

$

409

11 %

Clinical and pre-clinical trial expenses decreased $0.1 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024, due to a slight decrease in spend related to our (Z)-endoxifen trials, including drug development costs.
The increase in R&D compensation expenses of $0.3 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 was due to an increase in headcount.
The increase in R&D professional fees and other of $0.3 million was due to an increase in spending on regulatory consulting services.
General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the three months ended March 31, 2025 and 2024, together with the dollar change and percentage change in those categories (dollars in thousands):

For the Three Months Ended March 31,

2025

2024

Increase (Decrease)

% Increase (Decrease)

General and Administrative Expenses

Compensation

$

1,462

$

1,325

$

137

10 %

Professional fees and other

1,614

1,680

(66)

(4) %

Insurance

181

227

(46)

(20) %

General and Administrative Expenses Total

$

3,257

$

3,232

$

25

1 %

The increase in G&A compensation expenses of $0.1 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 was due to an increase in headcount quarter over quarter.
Interest Income. Interest income was $0.7 million for the three months ended March 31, 2025, a decrease of $0.4 million from interest income of $1.1 million for the three months ended March 31, 2024. The decrease was due to a decrease in the balance in our money market account.

About (Z)-Endoxifen
(Z)-endoxifen is a highly potent SERM with demonstrated ability to inhibit—and potentially degrade—estrogen receptors. It has shown activity even in tumors that have developed resistance to other endocrine therapies. Beyond its anti-estrogenic properties, (Z)-endoxifen also targets protein kinase C beta 1 (PKCβ1), an oncogenic signaling protein, at clinically achievable blood levels. Importantly, (Z)-endoxifen seems to deliver comparable or superior bone-protective effects relative to tamoxifen, while exhibiting minimal or no endometrial proliferative activity—which we believe addresses key limitations of current standard-of-care therapies. Atossa is developing a proprietary oral formulation of (Z)-endoxifen that is enteric-coated to bypass stomach acid, which would otherwise convert the active (Z)-isomer to its inactive (E)-form. We believe this innovation allows for optimal bioavailability and therapeutic integrity. Clinical studies have shown Atossa’s (Z)-endoxifen to be well tolerated in both healthy women and those with breast cancer. Atossa is prioritizing the development of (Z)-endoxifen for the treatment of metastatic breast cancer, where novel therapeutic options are urgently needed. The compound is currently being evaluated in three Phase 2 trials: one in women with ductal carcinoma in situ (DCIS) and two in women with estrogen receptor positive (ER+) / human epidermal growth factor receptor 2 negative (HER2-) breast cancer, including the EVANGELINE study and an I-SPY study. Atossa’s (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including three recently issued U.S. patents and numerous pending applications worldwide.