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Aktis Oncology Initiates Phase 1b Clinical Trial for AKY-2519, a B7-H3 Miniprotein Radioconjugate, in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

On May 4, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) (Aktis or the Company), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, reported the initiation of a Phase 1b clinical trial of AKY-25191 in patients with metastatic castration-resistant prostate cancer (mCRPC). The mCRPC-dedicated Phase 1b trial is part of Aktis’ clinical development strategy to develop AKY-2519 broadly in B7-H3 expressing tumors. Aktis plans to initiate a Phase 1b basket trial in lung, colorectal, and other high B7-H3 expressing solid tumors in the second half of 2026.

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"We see an opportunity to advance broad clinical development of AKY-2519 given the high expression of B7-H3 across multiple solid tumor types and associated poor prognosis. We are excited to advance a two-trial strategy, which enables us to evaluate AKY-2519 broadly in multiple patient subsets and to efficiently generate indication-relevant data for actionable, data-driven decision-making," said Akos Czibere, MD, PhD, Chief Medical Officer at Aktis. "This strategy was informed by insights from our clinical advisory boards and reflects the distinct treatment patterns and clinical needs of patients with mCRPC compared to other solid tumor patients. Importantly, this allows us to generate data in mCRPC in both PLUVICTO-naïve and -experienced patients to maximize the potential impact of AKY-2519."

"Prostate cancer is one of the most important indications for therapeutic radiopharmaceuticals; however, many unmet needs persist," said Oliver Sartor, MD, LCMC Health, Director, Transformational Prostate Cancer Research Center, New Orleans, LA. "A substantial number of mCRPC patients are ineligible for PSMA-targeted therapy due to low target expression and even more importantly, many patients have a sub-optimal response to PSMA targeted therapy. We all agree that further improvements are needed. Given high expression in mCRPC, B7-H3 represents a promising new target. The Phase 1b mCRPC AKY-2519 clinical study is a critical step in learning more about the safety and efficacy of a promising new next-generation B7-H3 targeted radiopharmaceutical. We look forward to learning more from these investigations."

The first Phase 1b open label trial will enroll patients with mCRPC, including both PLUVICTO-naïve and PLUVICTO-experienced cohorts, at multiple prostate-specific radioligand therapy centers in the U.S. The study will explore three dose levels in each cohort. Following dose escalation, the trial will expand enrollment at selected dose levels to generate additional clinical data. Preliminary data are expected in 2027. The second Phase 1b multi-center, open label trial will enroll patients in the U.S. with lung, colorectal, and other high B7-H3 expressing solid tumors. The protocol for this basket trial has been finalized and is currently under regulatory review.

AKY-2519 is the second miniprotein Aktis has advanced to the clinic in the past 12 months. Aktis’ lead program, AKY-1189, a miniprotein radioconjugate protein targeting Nectin-4 expressing tumors, is currently enrolling patients in an ongoing Phase 1b trial, with preliminary data anticipated in the first quarter of 2027.

Conference Call and Webcast Information
Aktis will host a live conference call and webcast tomorrow, Tuesday, May 5, 2026, at 8 a.m. ET to discuss its clinical development strategy for AKY-2519. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. A live webcast of the call will be available under "Events" in the Investors section of the Aktis Oncology website at investors.aktisoncology.com. The archived webcast will be available for 90 days following the call.

PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) is a registered trademark of Novartis Pharmaceuticals Corporation.

About Aktis’ miniprotein radioconjugate platform
Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anti-cancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end supply chain, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.

(Press release, Aktis Oncology, MAY 4, 2026, View Source [SID1234665074])

Aura Biosciences Announces Pricing of $260 Million Public Offering of Common Stock and Pre-funded Warrants

On May 4, 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 pricing of an underwritten public offering consisting of (i) 39,591,000 shares of its common stock 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. In addition, Aura has granted the underwriters a 30-day option to purchase up to an additional 6,508,650 shares of its common stock on the same terms and conditions. The offering price of each share of common stock is $6.00. The offering price of each pre-funded warrant is $5.99999.

All of the shares and pre-funded warrants in the offering are being sold by Aura. The gross proceeds from the offering to Aura are expected to be $260.3 million, before deducting underwriting discounts and commissions and other offering expenses and excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about May 5, 2026, subject to customary closing conditions.

Aura intends to use $205.1 million of the net proceeds from the offering, together with existing cash, cash equivalents and marketable securities, to advance its clinical programs, including in early choroidal melanoma, and for registration-enabling activities for bel-sar, as well as for general corporate purposes. Aura plans to use the remaining net proceeds from the offering to repurchase up to 6,922,870 shares from its stockholder, Matrix Capital Management Master Fund, LP ("Matrix"), which represents all shares of Aura’s common stock held by Matrix, at $5.64 per share, which is the price per share at which the underwriters will purchase shares of Aura’s common stock from Aura in the offering.

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

A shelf registration statement relating to the shares of common stock and pre-funded warrants offered in the public offering described above was 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 that was filed with the SEC on May 4, 2026 pursuant to Rule 462(b) under the Securities Act of 1933, as amended (and became automatically effective upon filing). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC on May 4, 2026, and are available on the SEC’s website located at www.sec.gov. A final prospectus supplement containing additional information relating to the offering and an accompanying prospectus will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this 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 4, 2026, View Source [SID1234665073])

NextCure and Simcere Zaiming Initiate Dose Optimization for SIM0505 (CDH6 ADC) in Gynecologic Cancers

On May 4, 2026 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer and Simcere Zaiming Pharmaceutical Co., Ltd., (Simcere) an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), reported initiation of the dose optimization portion of the Phase 1 study of SIM0505, focusing on patients with platinum-resistant ovarian cancer. SIM0505 is an investigational antibody drug conjugate (ADC) comprised of an antibody that targets Cadherin-6 (CDH6) and a proprietary topoisomerase 1 inhibitor (TOPOi) payload.

"Initiation of dose optimization highlights the promise of our novel CDH6-directed ADC and our focus on bringing SIM0505 to patients as quickly as possible. The dose optimization study is intended to help finalize dose selection and further de-risk advancement toward registrational studies. Additionally, we are accelerating development of the program by increasing the number of U.S. and China trial sites and expanding our clinical site footprint into Canada and Europe," said Michael Richman, President and CEO of NextCure. "We look forward to presenting Phase 1 data at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference as we continue to build momentum in the program."

About SIM0505

SIM0505 is a novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study (NCT06792552) for the potential treatment of advanced solid tumors, including ovarian cancer with an emphasis on platinum resistant ovarian cancer. The Food and Drug Administration granted Fast Track to SIM0505 for platinum-resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd.

About NextCure, Inc.

NextCure is a clinical-stage biopharmaceutical company focused on advancing innovative medicines to treat cancer patients through the use of targeted therapies including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells within and beyond the tumor microenvironment, and the role each interaction plays in a biologic response.

Fortress Biotech to Participate in the H.C. Wainwright 2nd Annual Royalty Company Virtual Conference

On May 4, 2026 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 2nd Annual Royalty Company Virtual Conference, taking place on Wednesday, May 6, 2026. The fireside chat is scheduled to begin at 12:30pm ET.

To register for the conference, visit View Source

(Press release, Fortress Biotech, MAY 4, 2026, View Source [SID1234665071])

CPTx to present preclinical proof-of-principle of its DNA-based in vivo CAR T platform at ASGCT Annual Meeting

On May 4, 2026 CPTx, a company developing next-generation non-viral in vivo CAR T therapies, reported that it will deliver an oral presentation showing in vivo proof-of-principle of its immune-quiet, single-stranded DNA-based delivery platform, as well as present two poster presentations at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place in Boston, MA, from May 11-15.

The oral presentation, by Head of Strategy and R&D Matthias Bozza, will include early readouts from preclinical testing of the company’s proprietary immune-quiet DNA + targeted lipid nanoparticle (tLNP) delivery system, which comprises a fully non-viral, systemically administered platform for in vivo generation of chimeric antigen receptor (CAR) T cells.

The therapeutic relevance of this approach was evaluated in a mouse model. Upon systemic administration, tLNPs loaded with CAR-encoding DNA achieved more durable tumor control relative to mRNA-based particles, consistent with the expectation that DNA-based payloads can provide a more sustained and controllable expression profile compared to transient mRNA-driven transgene expression.

"These data being presented at ASGCT (Free ASGCT Whitepaper) demonstrate strong progress towards efficient in vivo CAR T engineering using our immune-quiet DNA vectors, delivered via a targeted LNP platform. We are establishing a translational path toward off-the-shelf, in vivo-generated cell therapies that eliminate the need for individualized manufacturing. By shifting CAR T therapy from an ex vivo product to an in vivo medicine using our unique DNA-based vectors, this platform has the potential to substantially expand patient access, and we are excited to be advancing it towards first-in-human clinical evaluation." said Hendrik Dietz, CEO of CPTx.

Details of the presentations:

Oral Presentation 341: Programming CAR T cells in vivo with immune-silent ssDNA
Session: In vivo engineering of CAR T cells for autoimmune disease
Presenter: Matthias Bozza
Time: Thursday, May 14, 11:00 AM – 11:15 AM ET
Location: Westin Seaport Grand Ballroom CDE (Concourse Level)

Poster 3084: Targeted lipid nanoparticles deliver immune-silent ssDNA to generate CAR T cells
Time: Thursday, May 14, 05:00 PM – 06:30 PM ET
Location: MCEC Exhibit and Poster Hall (Halls B2-C, Exhibit Level)

Poster 3124: ssDNA vectors mitigate DNA-induced inflammation to support non-viral gene delivery
Time: Thursday, May 14, 05:00 PM – 06:30 PM ET
Location: MCEC Exhibit and Poster Hall (Halls B2-C, Exhibit Level)

(Press release, CPTx Bio, MAY 4, 2026, View Source [SID1234665070])