On May 5, 2026 Aura Biosciences, Inc. ("Aura") (Nasdaq: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, reported the closing of its previously announced underwritten public offering. In the offering, Aura sold (i) 46,099,650 shares of common stock, which includes 6,508,650 shares sold upon exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering, and (ii) in lieu of common stock to certain investors, pre-funded warrants to purchase an aggregate of up to 3,800,000 shares of its common stock at an exercise price of $0.00001 per pre-funded warrant. The shares of common stock were sold at a public offering price of $6.00 per share and the pre-funded warrants were sold at a public offering price of $5.99999 per share. The gross proceeds to Aura from the offering were approximately $299.4 million, before deducting underwriting discounts and commissions and other offering expenses. All of the securities sold in the offering were offered by Aura.

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Leerink Partners, TD Cowen and Evercore ISI acted as joint bookrunning managers for the offering. LifeSci Capital also acted as a bookrunning manager in the offering. Citizens Capital Markets acted as a co-manager for the offering.

The offering was made pursuant to the Company’s registration statement on Form S-3 (No. 333-278253), which was previously filed with the Securities and Exchange Commission (the "SEC") on March 27, 2024 and declared effective by the SEC on April 5, 2024, and a related registration statement on Form S-3MEF (File No. 333-295515) effective as of May 4, 2026 and filed with the SEC pursuant to Rule 462(b) under the Securities Act of 1933, as amended (collectively, the "Registration Statement"), and a final prospectus supplement related to and describing the terms of the offering described above was filed with the SEC on May 5, 2026 and is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus related to the offering may also be obtained by contacting: Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at [email protected]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Aura Biosciences, MAY 5, 2026, View Source [SID1234665153])

On May 5, 2026 Assertio Holdings, Inc. ("Assertio" or the "Company") (Nasdaq: ASRT), reported that it has reached a mutual agreement with Garda Therapeutics, Inc. ("Garda") to postpone the commencement of the previously announced tender offer to acquire all outstanding shares of Assertio to May 8, 2026.

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As previously announced on May 4, 2026, Assertio has entered into an amended and restated merger agreement (the "Garda Agreement") to be acquired by Garda for $21.80 per share in cash, or total cash consideration of $153.2 million. The Company expects to file a Schedule 14D-9 in connection with the tender offer on May 8, 2026. In addition, Assertio will postpone the commencement of the previously announced tender offer for all outstanding Convertible Senior Notes until May 8, 2026.

(Press release, Assertio Holdings, MAY 5, 2026, View Source [SID1234665152])

On May 5, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported financial results for the quarter ended March 31, 2026.

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Revenue of $348.1 million, up 36.1% year-over-year
Diagnostics revenue of $261.1 million, representing 34.7% growth year-over-year, driven by Oncology volume growth of 28%
MRD volume was ~6,500 tests in Q1 2026, up ~500% year-over-year
Data and Applications revenue of $87.0 million, representing 40.5% year-over-year growth, with Insights (data licensing and modeling) growing 44.1%
$643.8 million in cash and marketable securities as of March 31, 2026
Increasing revenue guidance to $1.59 to $1.60 billion for 2026 and expect full year 2026 Adjusted EBITDA of approximately $65 million
"Our strong financial and operational performance this quarter underscores the accelerating demand for our AI-driven diagnostic platform and the immense value of our multimodal data and corresponding AI models," said Eric Lefkofsky, Founder and CEO of Tempus. "We continue to see strong momentum as we deploy more sophisticated algorithms across our platform, driving 36% revenue growth year-over-year, with particular strength in our Oncology diagnostic business and data and modeling business."

First Quarter Summary Results

Revenue increased 36.1% year-over-year to $348.1 million.
Diagnostics generated $261.1 million of revenue, representing 34.7% year-over-year growth, driven by Oncology volume growth of 28% and Hereditary volume growth of 54% (7% growth when accounting for Ambry’s 2025 pre-acquisition volumes given February’s closing date).
Data and Applications revenue generated $87.0 million of revenue, representing 40.5% year-over-year growth, with Insights growing 44.1%.
Gross profit increased 43.1% year-over-year to $222.0 million, led by growth in Data and Applications.
Net loss was ($125.9 million), which included $56.3 million of stock compensation expense and related employer payroll taxes in the first quarter and $32.3 million in unrealized losses on marketable securities, compared to a net loss of ($68.0 million) in the first quarter of 2025 and a net loss of ($54.2 million) in the fourth quarter of 2025.
Adjusted EBITDA was ($2.8 million), compared to ($16.2 million) in the first quarter of 2025 and $12.9 million in the fourth quarter of 2025.
Recent Operational Highlights

Established a multi-year, strategic collaboration with Merck to accelerate biomarker discovery and development by leveraging Tempus’ multimodal data and Lens analytical platform.
Expanded our collaboration with Gilead to provide enterprise-wide access to our AI-driven Lens platform and multimodal datasets, aimed at advancing their oncology pipeline through real-world evidence and AI-driven insights.
Selected by Northwestern Medicine to expand genomic testing access to oncology patients across the health system, leveraging Tempus’ full suite of DNA, RNA, liquid biopsy, and MRD tests to enable more personalized cancer care and clinical trial design.
Entered a multi-year strategic collaboration with NYU Langone Health, centered on a prospective observational study that uses serial molecular profiling to track cancer evolution and treatment resistance, with the goal of developing AI-powered diagnostic tools and personalized therapies.
Entered strategic collaboration with Blood Cancer United to develop one of the largest real-world data registries for pediatric acute myeloid leukemia, aimed at accelerating research and improving treatment options for young patients.
Announced study results from the ALERT trial in collaboration with Medtronic showing that Tempus’ AI-driven EHR notifications increased life-saving heart valve procedures by 40% for patients with significant disease.
Published a study in JCO Precision Oncology demonstrating that Tempus’ advanced features including tumor-normal matching and RNA sequencing identified actionable findings in 12% of patients that were missed by standard testing.
Announced the launch of a first-of-its-kind pan-cancer algorithm that utilizes RNA expression data to identify Homologous Recombination Deficiency (HRD), expanding the number of patients who may benefit from PARP inhibitors beyond those identified by traditional DNA testing.
First Quarter Financial Results

Three Months Ended March 31,

2026

2025

Change

(in thousands, except percentages and per share amounts)

(unaudited)

Revenue

$

348,116

$

255,737

36.1

%

Gross profit

$

222,041

$

155,203

43.1

%

Loss from operations

$

(84,711

)

$

(68,689

)

23.3

%

Non-GAAP loss from operations

$

(11,580

)

$

(25,777

)

(55.1

)%

Net loss

$

(125,919

)

$

(68,037

)

85.1

%

Non-GAAP net loss

$

(22,612

)

$

(41,561

)

(45.6

)%

Adjusted EBITDA

$

(2,833

)

$

(16,174

)

82.5

%

Net loss per share, basic

$

(0.70

)

$

(0.40

)

75.0

%

Non-GAAP net loss per share, basic

$

(0.13

)

$

(0.24

)

(45.8

)%

Financial Outlook and Guidance

Tempus is increasing full year 2026 revenue guidance to $1.59 billion – $1.60 billion, which represents ~25% annual growth. We continue to expect 2026 Adjusted EBITDA to be ~$65 million.

For additional information on the quarter, including a letter from our CEO and CFO, please visit our investor relations site at investors.tempus.com.

Webcast and Conference Call Information

A conference call and webcast will begin today, May 5, 2026 after market close at 4:30 p.m. Eastern Time. Interested parties may access details at:

Conference ID: 4294068
Domestic Dial-in Number: (646) 307-1963
International Dial-in Number: (800) 715-9871
Live webcast: View Source

The webcast may be accessed on the company’s investor relations website at investors.tempus.com. For those unable to listen to the live webcast, a recording will be made available on the company’s website after the event and will be accessible for one year. Visit the investor relations website to find the company’s latest deck, and commentary on the quarter by Eric Lefkofsky, Founder and CEO and Jim Rogers, CFO, which will be discussed on the conference call and webcast.

(Press release, Tempus, MAY 5, 2026, View Source [SID1234665151])

On May 5, 2026 Factor Bioscience Inc., a Cambridge-based biotechnology company focused on using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported its participation in the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 29th Annual Meeting to be held in Boston, MA from May 11-15, 2026. Factor will deliver seven presentations covering the latest preclinical data from Factor’s engineered cell therapy programs, as well as recent advances in Factor’s cell engineering platforms.

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"We are excited to report the last data from our pipeline programs as well as several new innovations at ASGCT (Free ASGCT Whitepaper) 2026," said Dr. Matt Angel, Co-Founder, Chairman and CEO of Factor. "From next-generation CAR-T approaches to RNA-enabled cell engineering and off-the-shelf cell therapies, the seven presentations we will present reflect the strength and versatility of the platforms that we have developed at Factor over the past 15 years."

Dr. Kyle Garland, Vice President of Research & Development at Factor, commented, "Over the past year, we have made significant progress developing next-generation therapeutics that have the potential to treat some of the most intractable diseases by overcoming the limitations of conventional therapies. We look forward to engaging with the scientific community in Boston at the ASGCT (Free ASGCT Whitepaper) Annual Meeting and sharing how our recent advancements are moving us closer to transformative patient care."

Details of the presentations are below:

"In vivo CAR-T platform incorporating high-fidelity synthetic RNA enables selective protein expression in CD8+ T cells (1095)" -to be presented by Joseph Pisano on Tuesday, May 12 from 5:00-6:30 pm, in the "Topic C: Gene Addition: Non-Viral Vectors" Poster Session.
"TCR-replaced CAR T cells with a mutant CD28 co-stimulatory domain containing TRAF-binding motifs demonstrate enhanced memory phenotype and reduced exhaustion following tumor rechallenge assays (1260)" -to be presented by Ian Hay on Tuesday, May 12 from 5:00-6:30 pm, in the "Topic F: Pre-Clinical Models for Gene and Cell Therapies of Cancer and Autoimmune Disease" Poster Session.
"Transplant-ready IL-12-engineered iPSC-derived macrophages with solid-tumor killing activity cryopreserved under optimized xeno-free conditions maintain viability post thaw (2179)" -to be presented by Lindsey Sabo on Wednesday, May 13 from 5:00-6:30 pm, in the "Topic G: CMC and Regulatory" Poster Session.
"Engineered iPSC-derived mesenchymal stromal cells improve muscle function and pathology in the mdx mouse model of muscular dystrophy (2501)" -to be presented by Christopher B. Rohde on Wednesday, May 13 from 5:00-6:30 pm, in the "Topic E: Gene-Based Therapies in Pre-Clinical Models of Genetic Disease" Poster Session.
"IL12-secreting macrophages enhance cytotoxic T cell activity against a spheroid glioblastoma multiforme model and overcome the immunosuppressive tumor microenvironment (3289)" -to be presented by Katherine Klosterman on Thursday, May 14 from 5:00-6:30 pm, in the "Topic F: Pre-Clinical Models for Gene and Cell Therapies of Cancer and Autoimmune Disease" Poster Session.
"Efficient RNA-based reprogramming of human fibroblasts without strand slippage-inducing modified nucleotides (3312)" -to be presented by Cassandra Ng on Thursday, May 14 from 5:00-6:30 pm, in the "Topic D: Gene Correction and Modulation" Poster Session.
"Engineered iPSC-derived MSCs expressing serine protease HTRA1 reduce Tau fibrils (3486)" -to be presented by Taeyun Kim on Thursday, May 14 from 5:00-6:30 pm, in the "Topic E: Gene-Based Therapies in Pre-Clinical Models of Genetic Disease" Poster Session.
For more information about the American Society of Genetic & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, visit annualmeeting.asgct.org.

(Press release, Factor Bioscience, MAY 5, 2026, View Source;cell-therapy-asgct-29th-annual-meeting-302763089.html [SID1234665150])

On May 5, 2026 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company reported the initiation of a global, multi-center clinical trial. The Company has also submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), marking a key milestone in Senhwa’s global clinical development.

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The study will evaluate Senhwa’s first-in-class investigational drug, Pidnarulex (CX-5461), in combination with BeOne Medicines’ marketed PD-1 inhibitor, tislelizumab, across multiple advanced or metastatic solid tumors, including pancreatic cancer, colorectal cancer, and melanoma—areas with significant unmet medical needs. The global multi-center design is expected to accelerate clinical validation while enhancing the asset’s visibility, supporting future out-licensing and commercialization opportunities.

The Company aims to leverage combination therapy approaches to enter the rapidly expanding immuno-oncology market and build sustainable long-term growth momentum.

CX-5461 features a differentiated dual mechanism of action. In addition to inhibiting ribosomal RNA synthesis and suppressing tumor cell proliferation, it stabilizes G-quadruplex structures, inducing DNA damage and activating the cGAS–STING pathway. This unique mechanism not only confers direct anti-tumor activity but also enhances tumor immunogenicity, creating strong synergy with immune checkpoint inhibitors. Preclinical and translational studies have demonstrated that CX-5461 can effectively remodel the tumor microenvironment, increase tumor-infiltrating lymphocytes (TILs), and upregulate PD-L1 expression. These findings suggest its potential to overcome resistance and improve response rates in patients with limited benefit from current immunotherapies, positioning CX-5461 as a promising backbone agent in combination immunotherapy strategies.

According to market research analyses, the global cancer immunotherapy market exceeded US$150 billion in 2025 and is projected to grow at a double-digit compound annual growth rate, potentially surpassing US$300 billion by 2035. Within this expanding landscape, combination therapies have emerged as a central focus for the pharmaceutical industry, serving as a key driver for lifecycle extension and next-generation revenue growth.

At the same time, the pharmaceutical sector is facing increasing pressure from patent expirations of blockbuster drugs, driving strong demand for innovative assets with differentiated mechanisms and clinical potential. Strategic licensing and M&A activities have become primary pathways for large pharmaceutical companies to secure high-value pipeline assets, intensifying competition for early-stage opportunities.

Against this backdrop, the current clinical trial is expected to serve as a critical validation point for CX-5461. Pending positive efficacy and safety outcomes, the asset has the potential to attract strong interest from global pharmaceutical companies for licensing or acquisition, significantly enhancing its commercial prospects and overall market value.

(Press release, Senhwa Biosciences, MAY 5, 2026, View Source [SID1234665149])