Atossa Therapeutics to Host Virtual KOL Event Featuring Dr. Laura Esserman to Discuss Development of (Z)-Endoxifen in ER-Positive Breast Cancer

On May 14, 2026 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of significant unmet medical need, reported that it will host a virtual key opinion leader event focused on the evolving clinical and translational data supporting the development of (Z)-endoxifen, the Company’s investigational selective estrogen receptor modulator/degrader, or SERM/D, as a potential next-generation endocrine therapy backbone across multiple estrogen receptor ("ER") -positive breast cancer settings.

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The event will feature internationally recognized surgical oncologist and breast cancer expert Dr. Laura Esserman. Dr. Esserman serves as Director of the University of California San Francisco Breast Care Center and is the founder and principal investigator of the I-SPY Trials, an innovative platform designed to accelerate the development of personalized breast cancer therapies.

"Dr. Esserman has been at the forefront of innovation in breast cancer clinical research, adaptive trial design, and precision oncology for decades," said Dr. Steven Quay, M.D., Ph.D., Chairman and Chief Executive Officer of Atossa Therapeutics. "We believe (Z)-endoxifen has the potential to become more than a single-indication therapy; it may serve as an endocrine therapy platform across multiple ER-positive breast cancer settings. Dr. Esserman’s leadership in translational breast cancer research makes her an ideal expert to discuss the emerging clinical and biomarker data supporting this opportunity."

The discussion is expected to address several topics of interest to clinicians, investors, and potential strategic partners, including:

Recent data from the I-SPY2 Endocrine Optimization Pilot study evaluating (Z)-endoxifen as monotherapy in newly diagnosed ER-positive breast cancer patients
Translational biomarker data, including Ki-67 reduction, MRI functional tumor volume changes, and circulating tumor DNA dynamics
Data supporting (Z)-endoxifen activity across clinically relevant ESR1 mutations, including Y537N, Y537S, and D538G
The rationale for (Z)-endoxifen as a potential next-generation endocrine therapy backbone
Combination strategies, including CDK4/6 inhibitor combinations
Development opportunities in premenopausal breast cancer and endocrine therapy optimization
Event Details

Date: Tuesday, May 19, 2026
Time: 1:00 to 2:00 p.m. PT
Moderator: Michael King, Managing Director at Rodman & Renshaw
Registration: View Source

Attendees may submit questions to [email protected] up to 24 hours prior to the event.

A replay of the webcast will be available on the Company’s "Investors" portion of its website for at least 60 days following the live event.

About (Z)-Endoxifen

(Z)-endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader, or SERM/D, with demonstrated activity across multiple mechanisms of action. Atossa is evaluating its potential applications in oncology and rare diseases. The Company’s proprietary oral formulation has shown a favorable safety profile and pharmacology distinct from tamoxifen, including ER-targeted effects and PKC inhibition. Atossa’s (Z)-endoxifen is not approved for any indication.

(Press release, Atossa Therapeutics, MAY 14, 2026, View Source [SID1234665732])

Gilead Prices $3 Billion of Senior Unsecured Notes

On May 14, 2026 Gilead Sciences, Inc. (Nasdaq: GILD), a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, reported the pricing of senior unsecured notes in an aggregate principal amount of $3 billion, in an underwritten, registered public offering, consisting of $500 million of 4.250% senior notes maturing in 2028, $1 billion of 4.400% senior notes maturing in 2029, $1 billion of 4.600% senior notes maturing in 2031 and $500 million of 4.900% senior notes maturing in 2034. The offering is expected to close on May 20, 2026, subject to customary closing conditions.

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Gilead intends to use the net proceeds from this offering for general corporate purposes, which may include funding for acquisitions, investments, strategic transactions or other business opportunities.

Barclays Capital Inc., BofA Securities, Inc. and Citigroup Global Markets Inc. are acting as lead joint book-running managers in the offering. The offering of the securities is being made only by means of a prospectus supplement and the accompanying base prospectus, which is filed as part of Gilead’s effective shelf registration statement on Form S-3 (File No. 333-273745), copies of which may be obtained from:

Barclays Capital Inc.

c/o Broadridge Financial Solutions,

1155 Long Island Avenue

Edgewood, NY 11717

(888) 603-5847

Email: [email protected]

BofA Securities, Inc.

NC1-022-02-25

201 North Tryon Street

Charlotte, NC 28255

(800) 294-1322

Email: [email protected]

Citigroup Global Markets Inc.

c/o Broadridge Financial Solutions,

1155 Long Island Avenue

Edgewood, NY 11717

(800) 831-9146

Email: [email protected]

An electronic copy of the prospectus supplement and the accompanying base prospectus and other documents Gilead has filed with the U.S. Securities and Exchange Commission (the "SEC") may also be obtained at no charge at the SEC’s website at www.sec.gov. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Gilead Sciences, MAY 14, 2026, View Source [SID1234665731])

EDAP | Focal One and Telix Announce Collaboration Focused on Robotic HIFU and Theranostics in Prostate Cancer

On May 14, 2026 EDAP TMS S.A. (Nasdaq: EDAP) reported that it has entered into a letter of intent with Telix Pharmaceuticals Limited ("Telix") to explore joint clinical research activities and physician education focused on the combination of EDAP’s Focal One Robotic HIFU and Telix’s PSMA PET imaging products in the management of prostate cancer.

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The initial area of investigational focus is expected to study the combination of PSMA PET diagnostic imaging scans within the Focal One HIFU treatment workflow to optimize treatment planning, deliver a precise, image-guided focal therapy treatment, and monitor responses after treatment and during subsequent patient follow-up. This collaboration will be investigated in both the primary treatment setting as well as the salvage treatment setting after radiation therapy.

Based on early clinical experience integrating PSMA PET with Focal One HIFU and with the recently published prospective HIFI-2 study showing positive patient outcomes using Focal One to treat patients with recurrence after radiation therapy, this combination with Telix holds the promise to further improve patient outcomes.

"We are uniquely designed to enable the integration of PSMA PET imaging with Focal One’s real-time ultrasound and fully robotic energy delivery to optimize treatment efficacy while minimizing side effects," said Ryan Rhodes, EDAP Chief Executive Officer. "As the market leader in robotic focal therapy, with a growing global installed base, this collaboration will accelerate the development and standardization of treatment strategies to further personalize focal therapy treatments using Telix’s PSMA PET imaging agents and Focal One Robotic HIFU."

"Precision medicine requires precision treatment strategies," said Kevin Richardson, Telix Precision Medicine Chief Executive Officer. "As disruptive technologies continue to transform prostate cancer care, we believe PSMA PET imaging has the potential to play an important role in helping clinicians better inform treatment decisions across a range of minimally invasive and image-guided treatment approaches. We are excited to explore a collaboration with Focal One that may further advance personalized care for patients."

The parties may also explore clinician educational programs such as webinars, symposia, and training initiatives and clinical studies involving mutual customers managing patients with Telix PSMA PET imaging products and Focal One Robotic HIFU.

The parties may enter into more definitive agreements in the future. There can be no assurance that any specific initiatives or programs will result from this initial collaboration, and the letter of intent imposes no obligation on either party to enter into any such agreement. The parties have not made any financial commitments under the letter of intent, and the collaboration is not expected to have a material impact on EDAP’s financial results.

(Press release, EDAP TMS, MAY 14, 2026, View Source [SID1234665730])

NuCana Reports First Quarter 2026 Financial Results and Provides Business Update

On May 14, 2026 NuCana plc (NASDAQ: NCNA) ("NuCana" or the "Company") reported financial results for the first quarter ended March 31, 2026 and provided an update on its clinical development program with its two lead anti-cancer medicines.

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"We are pleased to report continued progress in the first quarter of 2026 as NUC-7738 advances towards important clinical and regulatory milestones," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "During the quarter, we continued to advance enrollment for our Phase 2 NuTide:701 expansion study evaluating NUC-7738 in combination with Keytruda (pembrolizumab) in patients with PD-1 inhibitor-resistant metastatic melanoma. The clinical activity and favorable safety profile previously reported, including confirmed objective responses and prolonged disease control, continue to support the therapeutic potential of NUC-7738 in this patient population, and we look forward to reporting final data from this study, which is expected later in 2026."

"We are also delighted to announce that the U.S. Food and Drug Administration (the "FDA") cleared our Investigational New Drug application ("IND") for NUC-7738 in April 2026. This important milestone enables clinical investigation of NUC-7738 in the United States and we expect our initial focus will be in patients with melanoma. We look forward to advancing our dialogue with the FDA to determine the optimal pathway toward a potential registrational strategy for NUC-7738 in melanoma."

Mr. Griffith continued, "Beyond our near-term, anticipated milestones in melanoma, we are actively exploring opportunities to broaden the clinical utility of NUC-7738 through additional indications and combination strategies. The mechanism of action of NUC-7738, disrupting RNA polyadenylation and targeting multiple aspects of the tumor microenvironment, positions it as a potentially versatile agent across a range of tumor types, and we are encouraged by the scientific rationale supporting its evaluation in new settings. We believe these efforts have the potential to significantly expand the long-term value of NUC-7738 for patients and for NuCana."

Mr. Griffith concluded, "Our strong balance sheet, with cash resources expected to fund operations into 2029, provides us with the financial flexibility to execute on our strategic priorities and advance our pipeline. We look forward to achieving important anticipated milestones throughout the remainder of 2026."

2026 Anticipated Milestones

NUC-7738
Complete patient recruitment in the Phase 2 expansion study (NuTide:701) evaluating NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant melanoma;
Announce final data from the Phase 2 expansion study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant melanoma;
Obtain regulatory guidance from the FDA regarding a potential registrational strategy for NUC-7738 in melanoma; and
Advance evaluation of additional indications and combination strategies.
NUC-3373
Complete evaluation of optimal combinations and indications to inform potential future clinical studies of NUC-3373.

First Quarter 2026 Financial Highlights and Cash Position

As at March 31, 2026, NuCana had cash and cash equivalents of £21.5 million compared to £24.3 million at December 31, 2025. NuCana anticipates its cash and cash equivalents at March 31, 2026 will be sufficient to fund its planned operations into 2029.

NuCana reported a net loss of £3.9 million for the quarter ended March 31, 2026, as compared to a net loss of £2.5 million for the quarter ended March 31, 2025. The net loss for the quarter ended March 31, 2026 included non-cash share-based payment expenses of £1.9 million (2025: £0.3 million).

Basic and diluted loss per ordinary share was £0.00 for the quarter ended March 31, 2026, as compared to a loss per ordinary share of £0.02 for the comparable quarter ended March 31, 2025.

(Press release, Nucana, MAY 14, 2026, View Source [SID1234665728])

Cue Biopharma Reports First Quarter 2026 Financial Results and Recent Strategic Developments

On May 14, 2026 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical stage therapeutics company focused on developing transformative therapies targeting functional cures for immunological disorders, reported first quarter 2026 financial results and highlighted recent corporate progress and upcoming milestones.

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"We are excited to advance our enhanced portfolio targeting the potential for functional cures for allergic and autoimmune diseases with high unmet need. Our newly expanded pipeline reflects our strengthened strategy and position in anticipation of significant value-driving milestones in the second half of 2026," said Shao-Lee Lin, M.D., Ph.D., president and chief executive officer of Cue Biopharma. "With the recent financing, we believe our current cash runway will be sufficient to support the execution of our expected clinical milestones for CUE-221 and CUE-401. As a team, we look forward to leveraging our strength in precision immunoengineering to advance these assets and create long-term shareholder value to provide transformative therapies for patients."

Business Highlights
Pipeline and Strategy


Enhanced pipeline with CUE-221 (formerly known as Ascendant-221), a late-stage novel clinical anti-IgE asset with a dual-mechanism through an exclusive license from Ascendant Health Sciences Ltd (Ascendant Health).

Hosted a virtual R&D Day focused on CUE-401, a potential first-in-class bifunctional cytokine designed to induce tolerance in autoimmune and inflammatory diseases.

Financial and Corporate


Completed a private placement of pre-funded warrants and accompanying common warrants for gross proceeds of approximately $30 million, before placement agent fees and offering expenses, and aggregate net proceeds of approximately $28 million, to support the company’s clinical pipeline, including advancing CUE-221.


Received a $7.5 million preclinical milestone payment under the Boehringer Ingelheim collaboration and license agreement for the selection and approval of Boehringer Ingelheim’s first compound for lead optimization.

Leadership


Appointed a new President and CEO, Shao-Lee Lin, M.D., Ph.D., a biopharmaceutical executive and physician scientist with 25 years of experience in core immunology experience who has helped build multi-billion-dollar portfolios, built strong teams, and taken a company from inception to IPO. Additional executives join Cue’s legacy team in forming a growing complement of clinical and preclinical expertise across the company.

Upcoming Milestones
CUE-221:


Cue expects to submit an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA) to expand development into food allergy in the second half of 2026.


Results from Ascendant Health’s ongoing China Phase 2 placebo-and active-controlled dose-ranging study in Chronic Spontaneous Urticaria are expected in the second half of 2026.


Plan to initiate global, Phase 2b trial in food allergy pending Cue’s review of results from Ascendant Health’s ongoing the China Phase 2 CSU study results.

CUE-401:


Cue expects to submit an IND to the FDA in the second half of 2026

Phase 1 first-in-human study expected to be initiated by year-end 2026.

First Quarter 2026 Financial Results

First quarter revenue was $5.7 million compared to $0.4 million in the first quarter of 2025. The revenue earned during the three months ended March 31, 2026 was related to the Boehringer Ingelheim collaboration and license agreement. The revenue earned during the three months ended March 31, 2025 was related to the agreement with Ono Pharmaceutical, which was terminated in March 2025.

Research and development expenses were $6.9 million for the three months ended March 31, 2026 compared to $8.5 million in 2025. The decrease was primarily due to lower clinical trial costs for the company’s CUE-100 series, as well as decreases in expenditure for total employee compensation due to attrition.

General and administrative expenses were $4.2 million for both the three months ended March 31, 2026 and 2025.

Net loss for the three months ended March 31, 2026 was $5.2 million compared to $12.3 million in 2025.

As of March 31, 2026, the Company had $16.4 million in cash and cash equivalents. Subsequent to March 31, 2026, the Company has completed a $30 million private placement financing and also received a milestone payment of $7.5 million from Boehringer Ingelheim.

(Press release, Cue Biopharma, MAY 14, 2026, View Source [SID1234665727])