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.

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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.

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"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.

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(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.

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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])

Valerio Therapeutics Announces the Launch of InVimmune, a New Company Dedicated to Developing Differentiated in Vivo Cell Therapy Approaches

On May 4, 2026 Valerio Therapeutics (FR0010095596 – ALVIO), a biotechnology company specializing in the development of technology platforms dedicated to the targeted delivery of innovative therapies (the "Company"), reported the launch of InVimmune, a new company dedicated to developing differentiated in vivo cell therapy approaches with potential applications across oncology, fibrosis, autoimmune diseases and additional indications. InVimmune’s first indication is in oncology, addressing an area of high unmet medical need.

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"Through InVimmune, we are adding a new strategic pillar to Valerio and expanding the reach of our platform into in vivo cell therapy. Our differentiated approach has the potential to be applied across several therapeutic areas, including oncology, fibrosis and autoimmune diseases, with a first indication in oncology where unmet medical need remains high. We continue to strengthen our team and broaden the network of experts surrounding the Company to accelerate the development of our technologies and pipeline. We believe that the quality of our talent, combined with the exceptional scientific advisors supporting Valerio and InVimmune, provides a strong foundation to execute our strategy and deliver on our ambitions." said Julien Miara, Chief Executive Officer of the Company.

InVimmune has been established to extend the reach of Valerio’s technology platforms into in vivo cell therapy through a novel immune reprogramming approach. InVimmune will leverage Valerio’s proprietary single-domain antibody platform together with targeted-delivery capabilities to develop differentiated programs across multiple therapeutic areas, with an initial focus on oncology.
To support InVimmune’s first oncology program, Valerio has established a dedicated Oncology Scientific Advisory Board, chaired by Professor Eric Vivier. The Board also includes Frederick Ramsdell, PhD, 2025 Nobel Prize in Physiology or Medicine laureate and Chair of the Scientific Advisory Board at Sonoma Biotherapeutics; Alan Korman, PhD, Chief Scientific Officer and Board Member at BlueSphere Bio; Matteo Iannacone, MD, PhD, Director of the Division of Immunology, Transplantation and Infectious Diseases, Professor of Pathology, and Head of the Dynamics of Immune Responses laboratory at the San Raffaele Scientific Institute and University in Milan; and François Romagné, Former CSO of Innate pharma, Professor of Immunotechnology.

In parallel, Olivier Demaria, PhD, will serve as Chief Scientific Officer of both Valerio and InVimmune and will also sit on InVimmune’s Oncology Scientific Advisory Board, ensuring scientific continuity and close alignment across both organizations. Wael Jdey, PhD, will be promoted to Chief Technical Officer of Valerio.

Valerio Therapeutics will provide further updates on InVimmune’s development in due course.

Professor Eric Vivier, Chair of the Oncology Scientific Advisory Board, added:
"InVimmune is built around an innovative concept with the potential to open new therapeutic avenues across multiple disease areas. By combining targeted delivery with a differentiated immune reprogramming approach, the company aims to advance novel in vivo cell therapy programs. Its first indication in oncology addresses a setting of high unmet medical need and is supported by a strong scientific foundation."

(Press release, Valerio Therapeutics, MAY 4, 2026, View Source [SID1234665069])