Natera to Present Clinical and Economic Utility of Signatera at ESMO GI, Highlights Innovations in MRD

On July 1, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported new data that will be presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI) in Barcelona, Spain (Press release, Natera, JUL 1, 2025, View Source [SID1234654202]). These presentations reinforce the strong clinical and economic utility of Signatera monitoring across colon and rectal cancers (CRC), as well as new clinical validation data on its tissue-free MRD assay.

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Signatera in CRC surveillance

Data on >3,000 CRC patients will be shared in an oral presentation, concluding that adding Signatera ctDNA* monitoring to the current standard of care in surveillance can better identify patients who are candidates for metastasis-directed therapy (MDT). Results indicated that Signatera-positive patients were up to 20x more likely to receive curative-intent MDT than Signatera-negative patients. By comparison, CEA positivity led to only a 2x increase, with no added value in stage IV.

Signatera Genome in rectal cancer

An analysis will be presented from the MD Anderson INTERCEPT study (n=31) that used serial Signatera Genome testing in patients with locally advanced rectal cancer after neoadjuvant therapy. Results demonstrated 100% specificity/PPV, with surveillance sensitivity of 100% in the surgical cohort and 88% (7/8) overall.

Economic utility of Signatera-guided therapy in adjuvant CRC

A budget impact model from BUPA, a multinational health insurance provider with over 60 million customers, will outline a 43% expected reduction in healthcare costs using Signatera-guided adjuvant treatment versus standard of care in stage II-III CRC.

"We’re excited to present these new findings that continue to support the utility of Natera’s products across GI cancers," said Adham Jurdi, M.D., senior medical director of oncology at Natera. "These data highlight our commitment to improving outcomes and driving innovation in MRD detection."

Full list of data featuring Natera’s technology at ESMO (Free ESMO Whitepaper) GI:

July 4, 16:40-16:50 CET | FPN: 20 | Signatera (Oral Presentation)
Presenter: Arvind Dasari, M.D., MS
Clinical utility of including circulating tumor DNA (ctDNA) monitoring in standard of care (SoC) colorectal cancer (CRC) surveillance

July 4, 16:50-17:00 CET | FPN: 30 | Signatera (Oral Presentation)
Presenter: Hideaki Bando, M.D.
Association of ctDNA Clearance with Disease-Free Survival and Safety and Quality of Life from ctDNA-Directed Therapy: Findings from the ALTAIR Study

July 4, 15:30-16:30 CET | FPN: 102P | Signatera (Poster Presentation)
Presenter: Christos Mikropoulos, MBBS, MSc, M.D. (Res), MRCP, FRCR
Direct cost of healthcare analysis of Signatera ctDNA testing in the adjuvant setting for a hypothetical cohort of stage II and stage III colorectal cancer (CRC) patients: a UK private payer perspective

July 4, 15:30-16:30 CET | FPN: 243P | Signatera Genome (Poster Presentation)
Presenter: Arvind Dasari, M.D., MS
Clinical performance of Signatera Genome assay in a sub-cohort of locally advanced rectal cancer (LARC) patients (pts) in the MD Anderson INTERCEPT program

July 4, 15:30-16:30 CET | FPN: 93P | Tissue-free MRD (Poster Presentation)
Presenter: Yoshiaki Nakamura, M.D., Ph.D.
Clinical validation of a methylation-based, tissue-free colorectal cancer test for the detection of molecular residual disease by circulating tumor DNA

July 4, 15:30-16:30 CET | FPN: 89P | Early Cancer Detection (Poster Presentation)
Presenter: John P.Y. Shen, M.D.
Development of methylation-based biomarkers to predict metastases, treatment effect, and microsatellite status in colorectal cancer

Lixte Biotechnology Holdings, Inc. Announces $5.0 Million Private Placement Priced at the Market

On July 1, 2025 Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT) (the "Company"), a clinical stage pharmaceutical company, reported that, on June 30, 2025 intraday, it entered into a definitive agreement with accredited investors on the purchase and sale of approximately $5.0 million of shares of Common Stock (or Pre-Funded Warrants), Series B Convertible Preferred Stock and Common Warrants (Press release, Lixte Biotechnology, JUL 1, 2025, View Source [SID1234654236]). The offering was priced at the market under Nasdaq rules.

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The offering consists of the sale of an aggregate of 2,382,084 shares of Common Stock (or Pre-funded Warrants in lieu thereof), 3,573,130 shares of Series B Convertible Preferred Stock and 6,355,214 Common Warrants. The Pre-Funded Warrants will be immediately exercisable at an exercise price of $0.00001 and may be exercised at any time until exercised in full. The initial exercise price of each Common Warrant is $1.00 per share of Common Stock. The Common Warrants are exercisable immediately and expire 60 months after the resale registration statement registering the underlying shares is declared effective.

Aggregate gross proceeds to the Company are expected to be approximately $5.0 million, $4.0 million of which will be paid at closing and $1.0 million of which will be paid when the resale registration statement registering Common Stock and the underlying shares is declared effective. The transaction is expected to close on or about July 2, 2025, subject to the satisfaction of customary closing conditions. The Company expects to use the net proceeds from the offering, together with its existing cash, for general corporate purposes and working capital.

Spartan Capital Securities, LLC is acting as exclusive placement agent for the private placement. TroyGould PC is acting as counsel to the Company. Kaufman & Canoles, P.C. is acting as counsel to Spartan Capital Securities, LLC.

The securities described above are being sold in a private placement transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The securities were offered only to accredited investors. Pursuant to a registration rights agreement with the investors, the Company has agreed to file one or more registration statements with the SEC covering the resale of the Common Stock and the Shares issuable upon exercise of the pre-funded warrants and warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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.

MonTa announces completion of phase I does-escalation

On July 1, 2025 MonTa reported completion of its phase I dose-escalation study with completion of the last cohort of patients after treating 85 patients in total. We look forward to design the expansion phase also called phase IB to move towards patients with less advanced cancer with unmed medical need (Press release, MonTa Biosciences, JUL 1, 2025, View Source [SID1234654187]).

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MAIA Biotechnology to Present Two Posters Featuring Cancer Telomere-Targeting Agents at FEBS 2025 Congress

On July 1, 2025 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported two upcoming poster presentations at the 49th Federation of European Biochemical Societies (FEBS) 2025 Congress, hosted by the Turkish Biochemical Society, to be held July 5-9, 2025, in Istanbul, Turkey (Press release, MAIA Biotechnology, JUL 1, 2025, View Source [SID1234654203]). The poster presentations highlight MAIA’s lead telomere-targeting agent and next-generation treatments. The first presentation will be delivered by MAIA Scientific Advisory Board member, Z. Gunnur Dikmen, M.D., Ph.D., Hacettepe University, Faculty of Medicine, Department of Biochemistry in Ankara, Turkey.

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Poster Presentation 1

Abstract title: "Telomere-targeting therapeutics RiboTHIO and THIO synergize with radiotherapy and immune checkpoint blockade to suppress lung tumor growth"

Abstract number:

62164

Abstract notation:

LB-R-32-12

Session title:

Cancer Therapy

Session date and time:

July 7, 2025, from 12:30pm to 2:30pm TRT

Presenter:

Z. Günnur Dikmen, M.D., Ph.D.

Abstract access:

Available at FEBS Open Bio Journal after the Congress

Poster Presentation 2

Abstract title: "The effects of telomerase mediated telomere-targeting novel drug candidate compounds on oxidative DNA damage and DNA repair on A549 cells"

Abstract number:

60494

Abstract notation:

P-32-095

Session title:

Cancer Therapy
Session date and time:

July 7, 2025, from 12:30pm to 2:30pm TRT
Presenter:

Gamze Tuna

Abstract access:

Available at FEBS Open Bio Journal after the Congress

"We appreciate the opportunity to participate at the FEBS Congress where the outstanding merits of our first-in-class cancer telomere targeting agents will be featured before a gathering of the top European academic researchers and scientists." said MAIA Chairman and CEO Vlad Vitoc, M.D. "These scientific findings further illustrate the potential of our current and next-generation treatments to synergize with therapies used in several cancer indications."

The most recent data from MAIA’s THIO-101 pivotal Phase 2 clinical trial of ateganosine as a treatment for non-small cell lung cancer (NSCLC) showed median overall survival (OS) of 17.8 months1 in a heavily pre-treated population.

Abeona Therapeutics® Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On July 1, 2025 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported it has granted equity awards to new non-executive employees who joined the Company (Press release, Abeona Therapeutics, JUL 1, 2025, View Source [SID1234654188]). The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

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On June 30, 2025, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to 21 individuals hired by Abeona, which equity awards relate to, in the aggregate, up to 48,715 restricted shares of Abeona common stock. One-third of the shares subject to such restricted stock awards will vest yearly on each anniversary of the Grant Date, such that the shares subject to such restricted stock awards granted to each employee will be fully vested on the third anniversary of the Grant Date, in each case, subject to each employee’s continued employment with Abeona on the applicable vesting dates.