Regierungen füllen ihre Lager nach dem Krieg – und ein Micro-Cap sitzt mittendrin (NASDAQ: MDWD) (FSE: M8W)

Drei Jahre Krieg in der Ukraine und im Nahen Osten haben Regierungen genau gelehrt, was sie bevorraten müssen. Die erste Lektion war kinetisch – und Aktien aus den Bereichen Drohnen, Raketen und Aufklärung schossen nach oben. Die zweite Lektion trifft nun möglicherweise ein, und sie scheint die Aufmerksamkeit auf ein kleines Biotech-Unternehmen zu lenken, das die wenigsten kennen dürften: MediWound* (NASDAQ: MDWD) (FSE: M8W) (ISIN: IL0011316309) (WKN: A110TG)

Read >> https://www.boersennews.de/community/blog/regierungen-fuellen-ihre-lager-nach-dem-krieg-und-ein-micro-cap-sitzt-mittendrin-nasdaq-mdwd-fse-m8w/8725/

*Anzeige – Bezahlte Werbemitteilung. Bitte lesen Sie die vollständigen Offenlegungen zu Interessenkonflikten und Risikohinweisen am Ende dieses Beitrags.

Jeder moderne Krieg lehrt Regierungen, was zu bevorraten ist

Die erste Lektion der vergangenen drei Jahre – Ukraine, Gaza, Libanon, Iran – lautete, dass die kinetische Seite der Verteidigung ein Jahrzehnt lang unterfinanziert war. Drohnen, Raketen, KI-gestützte Aufklärung, integrierte Luftverteidigung. Die Märkte haben diese Lektion hart eingepreist. Palantir (NASDAQ: PLTR) hat sich rund verzehnfacht. Lockheed, RTX, Elbit (NASDAQ: ESLT), Kratos (NASDAQ: KTOS) – allesamt Multibagger gegenüber ihren Tiefstständen vor dem Ukraine-Krieg.

Doch Generäle führen den nächsten Krieg mit den Lehren aus dem letzten. Und die Lektion, die nun in den Fokus rückt – nach drei Jahren realer Gefechtsdaten aus zwei aktiven Kriegsschauplätzen –, ist, dass die medizinische Versorgungsebene nach der Explosion der Engpass ist, für den niemand Vorräte angelegt hat.

Ein verändertes Verletzungsprofil

Das Verletzungsprofil hat sich in einer Weise verschoben, die von Bedeutung ist. Berichte von der Front aus der Ukraine beschreiben einen Krieg, der von Explosionen, Splittern und Schrapnell geprägt ist statt von konventionellen Schussverletzungen. Medizinische Daten der israelischen Streitkräfte (IDF), veröffentlicht im Journal of Burn Care & Research, dokumentierten 249 Brandverletzte unter 2.627 erfassten Soldaten während der Bodenoffensive in Gaza – ein Anteil von rund 9,5 % Verbrennungen und damit deutlich höher als in historischen Konflikten. Fachlich begutachtete militärische Verbrennungsmedizin-Analysen (darunter Daten des U.S. Army Institute of Surgical Research) verorten Verbrennungen durchgängig bei 5 bis 20 % der Gefechtsverletzungslast in jüngeren Konflikten, wobei die Rate der Gaza-Bodenoffensive in der oberen Hälfte dieser Spanne liegt. Doch Verbrennungen sind nur ein Teil des modernen Kriegsverletzungsbildes. Schrapnell- und Explosionsverletzungen zusammengenommen machen rund 61 % der Gefechtsverluste aus. Eine prospektive Studie, im Dezember 2025 im Journal of Burn Care & Research veröffentlicht und am National Burn Center des Sheba Medical Center an 15 Patienten mit traumatischen Tätowierungen infolge von Reibungs- und Explosionsverletzungen durchgeführt, berichtete von einer Reduktion der pigmentierten Wundoberfläche um 92,5 % nach Anwendung von NexoBrid innerhalb von 24 Stunden nach der Verletzung. Diese Fälle machen – gemeinsam mit schweren Verbrennungen – allesamt mögliche Anwendungsgebiete für NexoBrid aus und stehen für über 70 % der modernen Gefechtsverletzungen.

Regierungen handeln bereits nach dem, was diese Zahlen nahelegen

Die Europäische Kommission stellte Ende 2023 690 Millionen Euro bereit, um strategische rescEU-Reserven an medizinischen und CBRN-Abwehrgütern aufzubauen. Die EU legte im Juli 2025 eine formelle Bevorratungsstrategie (Stockpiling Strategy) auf. Der NATO-Gipfel in Den Haag setzte ein neues Verteidigungsziel von 3,5 % des BIP – und der aktualisierte NATO-Rahmen erlaubt es nun, Ausgaben für zivile Vorsorge und Resilienz auf diese Verpflichtungen anzurechnen, was das adressierbare Budget für die medizinische Bevorratung dramatisch erweitert. Das Basisbudget der BARDA – der US-Behörde für die fortgeschrittene Entwicklung biomedizinischer Abwehrmaßnahmen – ist von rund 670 Millionen US-Dollar im Geschäftsjahr 2014 auf über 1 Milliarde US-Dollar heute gewachsen, und COVID zeigte, dass die Behörde mehr als 32 Milliarden US-Dollar einsetzen kann, wenn die Bedrohung real ist.

Im April handelten die USA entschlossen. Die BARDA vergab einen einzigen Zehnjahresvertrag im Wert von bis zu 197 Millionen US-Dollar, um ein bestimmtes Medikament für die Vorsorge bei Massenanfällen von Brandverletzten zu beschaffen, zu bevorraten und weiterzuentwickeln. Kein Impfstoff. Kein Antikörper. Ein topisches enzymatisches Gel, das abgestorbenes Verbrennungsgewebe in einer vierstündigen Anwendung auflöst – ohne Operationssaal. Bei einem Massenanfall, in dem die chirurgische Kapazität den Engpass bildet, ist das der Unterschied zwischen der Behandlung aller und der Triage jener, die man nicht retten kann.

Das Medikament ist NexoBrid. Das Unternehmen dahinter ist MediWound (NASDAQ: MDWD).

Ein staatlich gestütztes Standbein, das keine Theorie mehr ist

Im Laufe des vergangenen Jahrzehnts steckte die BARDA rund 120 Millionen US-Dollar an nicht verwässernder Finanzierung in die Entwicklung von NexoBrid. Das US-Verteidigungsministerium finanzierte darüber hinaus eine bei Raumtemperatur stabile Formulierung, die für die Bedingungen auf dem Schlachtfeld konzipiert ist. Das Medikament ist Teil des US-amerikanischen Strategic National Stockpile. Die Vergabe im April fügt weitere 197 Millionen US-Dollar hinzu – verteilt auf Beschaffung, den Aufbau einer US-Fertigung, eine feldtaugliche Formulierung und eine Indikation für Explosionstraumata. MediWound hat sein Engagement in der europäischen Vorsorge-Infrastruktur ausgeweitet. Das Unternehmen teilte kürzlich mit, dass es in das Joint Industrial Cooperation Forum (ICF) der europäischen Behörde HERA aufgenommen wurde – ein Industriegremium, das Unternehmen und öffentliche Akteure zusammenbringt, um Europas Vorsorge bei medizinischen Gegenmaßnahmen, die Versorgungsresilienz und die Notfallplanung zu unterstützen. Und in seiner Telefonkonferenz zu den Quartalszahlen am 7. Mai hob MediWounds US-Partner Vericel (NASDAQ: VCEL) die Umsatzprognose für die Verbrennungsversorgung an und führte mehrere Millionen des Anstiegs unmittelbar auf zusätzliche BARDA-finanzierte NexoBrid-Beschaffung zurück, die in der zweiten Jahreshälfte 2026 eintreffen soll. Die staatliche Franchise hat aufgehört, theoretisch zu sein. Sie ist nun eine Zahl in der veröffentlichten Prognose eines börsennotierten Partners.

Ein zweites Standbein mit noch größerem Markt

Würde die Geschichte hier enden, wäre MediWound bereits als potenziell einer der interessantesten Werte auf der Welle der medizinischen Vorsorge positioniert, die Verteidigungsinvestoren noch nicht neu bewertet haben. Doch das zweite Standbein von MediWound zielt auf einen noch größeren Markt.

Der größere Vermögenswert ist EscharEx – dieselbe enzymatische Plattform, jedoch auf chronische Wunden ausgerichtet. Der adressierbare US-Markt beläuft sich auf rund 2,5 Milliarden US-Dollar und wird derzeit von einem einzigen FDA-zugelassenen enzymatischen Medikament bedient, dessen letzte Zulassung aus dem Jahr 1965 stammt. Eine fachlich begutachtete Post-hoc-Analyse aus MediWounds Phase-II-Studie ChronEx, veröffentlicht in Wounds, ergab, dass 63 % der mit EscharEx behandelten Patienten innerhalb von zwei Wochen ein vollständiges Débridement erreichten. Bei Patienten derselben Studie, die die etablierte Kollagenase (SANTYL) erhielten, waren es null. Die Phase III rekrutiert derzeit; eine Zwischenbewertung des Stichprobenumfangs sowie der Abschluss der Rekrutierung werden bis zum Ende des ersten Quartals 2027 erwartet, und nahezu jeder große Name der modernen Wundversorgung – Mölnlycke, Solventum, MIMEDX, Coloplast/Kerecis, Convatec, Essity, B. Braun, Medline – ist bereits als Forschungskooperationspartner beteiligt. B. Braun und Essity gehören dabei zu den bekannten Namen der Branche im deutschsprachigen Raum.

Warum diese Ausgangslage selten ist

Ein schwaches erstes Quartal – bedingt durch die zeitliche Taktung des BARDA-Vertrags und durch Lieferverzögerungen im Zusammenhang mit dem regionalen Konflikt – zog die Aktie von den Höchstständen des Jahresbeginns zurück. Die Lieferungen sind abgeschlossen. Der Vertrag fließt. Der Zwischenbericht liegt weniger als ein Jahr entfernt, was diesen Katalysator in ein Zeitfenster rückt, das der breitere Markt möglicherweise noch nicht neu bewertet hat.

Fazit

Nichts davon garantiert ein Ergebnis – Studien können scheitern, regulatorische Entscheidungen können sich verzögern, und staatliche Aufträge können sich in ihrer zeitlichen Taktung verschieben. Drohnen bekamen die erste Welle. Die medizinische Versorgungsebene könnte die zweite sein. Das Biotech-Unternehmen, das im Zentrum davon positioniert erscheint, wird für weniger gehandelt als der Schlagzeilenwert eines einzigen der staatlichen Aufträge, die es bereits gewonnen hat.

Noch kennen viele Investoren den Namen MediWound nicht. Genau das ist oft der Moment, in dem sich entscheidet, wer früh hinschaut – und wer erst reagiert, wenn der Markt es längst getan hat.

Aktuelle Unternehmensmeldungen von MediWound (FSE: M8W)

MediWound berichtet Finanzergebnisse für das erste Quartal 2026 und gibt ein Unternehmensupdate

MediWound kündigt Veröffentlichung der Finanzergebnisse für das erste Quartal 2026 an

Neu veröffentlichter US-Expertenkonsens deckt sich mit MediWounds Strategie zum Débridement chronischer Wunden

MediWound präsentiert neue EscharEx-Daten auf führenden Wundversorgungs-Kongressen

MediWound meldet BARDA-Vertragsvergabe an Vericel für NexoBrid im Wert von bis zu 197 Millionen US-Dollar

MediWound reicht Jahresbericht auf Form 20-F ein

As with all biotech companies, further development remains largely dependent on clinical results, regulatory decisions and commercial implementation.

Read more >>  DA Davidson upgrades Palantir stock due to demand for AI orchestration (NASDAQ: PLTR)

^(Disclaimer des Autors:) ^(*Wichtige Hinweise und Offenlegungen: Wall Street Wire ist eine Content- und Medientechnologieplattform und weder Broker-Dealer noch registrierter Anlageberater. Dieser Beitrag stellt eine bezahlte Werbemitteilung dar. Wall Street Wire hat von MediWound Ltd. eine Vergütung für Marketing- und Awareness-Dienstleistungen erhalten. Aufgrund dieser Vergütung besteht ein Interessenkonflikt, der die Objektivität der Inhalte beeinflussen kann. Die Inhalte dienen ausschließlich allgemeinen Informationszwecken und stellen weder Anlageberatung noch eine Anlageempfehlung oder Aufforderung zum Kauf oder Verkauf von Wertpapieren dar. Sie können auf öffentlichen Quellen, Unternehmensangaben oder Informationen Dritter beruhen und wurden nicht in allen Fällen unabhängig überprüft. Eine Gewähr für Richtigkeit, Vollständigkeit oder Aktualität wird nicht übernommen. Wall Street Wire sowie deren Betreiber und Autoren halten keine Positionen in den genannten Wertpapieren und betreiben keinen Handel in diesen. Investitionen, insbesondere in Micro- oder Small-Cap-Unternehmen, sind mit erheblichen Risiken verbunden und können zum vollständigen Verlust des eingesetzten Kapitals führen. Zukunftsgerichtete Aussagen sind mit Unsicherheiten verbunden und können erheblich von der tatsächlichen Entwicklung abweichen. Dieser Beitrag ist keine offizielle Mitteilung des Emittenten oder des dargestellten Unternehmens und wurde nicht notwendigerweise von diesem autorisiert, geprüft oder freigegeben. Weitere Hinweise und Offenlegungen: https://wallstwire.ai/disclosures. Diese deutschsprachige Version wurde unter Einsatz automatisierter Übersetzung erstellt und kann Abweichungen enthalten. Maßgeblich ist im Zweifel die englische Originalfassung (https://markets.businessinsider.com/news/currencies/three-years-of-war-changed-what-governments-buy-one-player-is-already-winning-contracts-nasdaq-mdwd-1036294000).)

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▲ 18 r/Qtrex_Quantum+10 crossposts

$QTEX - QTREX Engineers Conductivity Itself to Address Quantum Computing's Cryogenic Heat-Load Barrier (NASDAQ: QTEX)

QTREX Engineers Conductivity Itself to Address Quantum Computing's Cryogenic Heat-Load Barrier

The Company Filed a U.S. Provisional Patent Application Covering a Potentially Dominant Approach to the Critical Cryogenic Signal Pathway, Designed to Overcome Limitations of Traditional Manufacturing

July 01, 2026 08:40 ET | Source: QTREX Quantum Ltd.

Nes Ziona, Israel, July 01, 2026 (GLOBE NEWSWIRE) — QTREX Quantum Ltd. (Nasdaq: QTEX) ("QTREX" or the "Company"), a company focused on advancing Additively Manufactured Electronics ("AME") for quantum computing infrastructure today announced the development of a controlled-conductivity cryogenic microwave interconnect architecture designed to reduce heat conduction while preserving microwave signal performance in quantum computing systems. The Company filed a U.S. Provisional Patent Application with the United States Patent and Trademark Office ("USPTO") and the underlying technology is patent pending.

The Company's architecture is based on the intentional use of the Wiedemann–Franz Law, a fundamental law of physics linking electrical conductivity and electronic thermal conductivity in metallic conductors, with particular relevance at cryogenic temperatures. By applying this law at the materials-design level, The Company is turning conductivity into an engineering parameter for cryogenic quantum infrastructure, enabling conductive materials to be designed not only for signal transmission, but also for thermal behavior in ultra-low-temperature environments.

This capability is enabled by QTREX's control over the full materials-to-component process, from the chemistry and engineering of its manufacturing materials, through the additive manufacturing process, and into the final quantum-infrastructure component. This vertical control allows the Company to design material behavior for the specific requirements of quantum environments.

In superconducting quantum computing systems, microwave control and readout signals must travel from room-temperature electronics to quantum processors operating at millikelvin temperatures inside dilution refrigerators. Each interconnect line can also become a thermal pathway, conducting unwanted heat into the coldest stages of the system. This is already a significant constraint in today's cryogenic quantum systems and becomes increasingly critical as systems scale.

"Our ability to dictate material properties from the chemical formulation through to the final component gives us a unique competitive advantage in the quantum sector", said Dagi Ben-Noon, CEO of QTREX. "This architecture is a direct result of our vertically integrated approach, demonstrating how our advanced manufacturing capabilities has the potential of solving complex infrastructure challenges that traditional methods simply cannot address."

QTREX has seen strong interest from industry participants exposed to this development, reflecting the fact that this approach introduces a new way of thinking about cryogenic quantum infrastructure. This interest is already moving into near-term technical evaluation, with one of the Company's current industry collaborators expected to begin reviewing the architecture as early as next week.

About QTREX Quantum

QTREX Quantum Ltd. (Nasdaq: QTEX) is a technology company focused on advanced connectivity and electronics manufacturing solutions for next-generation hardware markets. Following its acquisition of the AME platform, the Company is developing high-density, thermally optimized quantum connectivity solutions for dilution cryostats and advancing AME applications for defense, aerospace, missile, space, and other mission-critical environments. The Company also continues to advance its medical technology portfolio, including respiratory support and blood monitoring platforms, while actively working to monetize certain parts of the medical business.

For more information, please visit: www.q-trex.com

Forward-Looking Statement Disclaimer

This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. These forward-looking statements are based on the current expectations of the management of the Company only and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. For example, the Company is using forward-looking statements when it discusses Conductivity's ability to address quantum computing's cryogenic heat-load barrier; the Company's ability to enable conductive materials to be designed also for thermal behavior in ultra-low-temperature environments; the capabilities of the Company's controlled-conductivity cryogenic microwave interconnect architecture; approval of the Company's pending patents; the Company's ability to design material behavior for the specific requirements of quantum environments; the belief that constraints in today's cryogenic quantum systems become increasingly critical as systems scale; the belief that the Company has a unique competitive advantage in the quantum sector and how its advanced manufacturing capabilities has the potential of solving complex infrastructure challenges; any interest from industry participants; and the belief that the Company's approach may introduces a new way of thinking about cryogenic quantum infrastructure. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements. More detailed information about the risks and uncertainties affecting the Company is contained under "Risk Factors" in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission.

Company Contact

QTREX Quantum
Email: info@q-trex.com
Phone: +972-9-9664485

https://www.globenewswire.com/news-release/2026/07/01/3320608/0/en/QTREX-Engineers-Conductivity-Itself-to-Address-Quantum-Computing-s-Cryogenic-Heat-Load-Barrier.html

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u/MarketNewsFlow — 5 days ago

$NVCT - Nuvectis Pharma Announces Pricing of $100 Million Public Offering of Common Stock (NASDAQ: NVCT)

Nuvectis Pharma Announces Pricing of $100 Million Public Offering of Common Stock

FORT LEE, N.J., June 29, 2026 (GLOBE NEWSWIRE) — Nuvectis Pharma, Inc. (Nasdaq: NVCT), a clinical stage biopharmaceutical company focused on the development of innovative therapies for the treatment of immune complement-related conditions and oncology, today announced the pricing of its previously announced underwritten public offering of 5,000,000 shares of its common stock at a price of $20.00 per share, with expected gross proceeds to Nuvectis of $100 million. Nuvectis has also granted the underwriters a 30-day option to purchase up to 750,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about July 1, 2026, subject to satisfaction of customary closing conditions.

Cantor is acting as sole book runner for the offering. H.C. Wainwright & Co., Laidlaw & Company (UK) Ltd., Lucid Capital Markets, Maxim Group LLC, Roth Capital Partners and Titan Partners, a division of American Capital Partners are acting as co-managers for the offering.

Nuvectis intends to use the net proceeds from the offering to continue to advance the development programs of NXP100, NXP200, and NXP900 or any future product candidate, hiring of additional personnel, capital expenditures, costs of operating as a public company and other general corporate purposes.

The shares of common stock described above are being offered by Nuvectis pursuant to its shelf registration statement on Form S-3 (File No. 333-293459) filed with the U.S. Securities and Exchange Commission ("SEC") on February 13, 2026 and declared effective by the SEC on February 20, 2026. The preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC's web site at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to these shares of common stock may also be obtained, when available, by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at prospectus@cantor.com.

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.

About Nuvectis Pharma

Nuvectis Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development of innovative therapies for the treatment of immune complement-related conditions and oncology. The Company's pipeline includes NXP100, a complement Factor B inhibitor in development for the treatment of complement-mediated diseases, and the oncology drug candidates NXP900 and NXP200, in development for the treatment of advanced cancers.

NXP100 is a late-stage Factor B inhibitor with best-in-class potential as an effective therapy in multiple complement-mediated diseases and provide a convenience advantage as the only once-daily oral treatment option for these diseases requiring life-long treatment.

NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases, including SRC and YES1 intended to inhibit the catalytic and scaffolding functions of the SRC kinase, providing comprehensive shutdown of the signaling pathway.

NXP200 is an oral, brain penetrant, paradox-breaker BRAF inhibitor for the treatment of BRAF V600X-mutated and Class II/III non-V600-mutated solid tumor malignancies, including central nervous system cancer, colorectal cancer, melanoma, and non-small cell lung cancer, with best-in-class potential.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the U.S. federal securities laws, which are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate", "believe", "contemplate", "could", "estimate", "expect", "intend", "seek", "may", "might", "plan", "potential", "predict", "project", "target", "aim", "should", "will", "would", or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements include, but are not limited to, statements regarding future events, including statements about the timing for completion of the public offering, and the use of proceeds and anticipated total gross proceeds from the public offering. Forward looking statements are based on Nuvectis' current expectations and interpretations of data and information available, including preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for its pipeline products NXP100, NXP200, and NXP900, and estimates and projections regarding Nuvectis' financial condition. The outcomes of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties may also be subject to market and other conditions and described more fully in the section titled "Risk Factors" in Nuvectis' first quarter 2026 Form 10-Q and Nuvectis' other public filings with the U.S. Securities and Exchange Commission ("SEC"). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Nuvectis' expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Other than statements of historical fact, all statements are considered forward-looking statements and are based on Nuvectis' interpretations of past events as well as current expectations, estimates, and projections.

Company Contact

Ron Bentsur
Chairman, Chief Executive Officer and President
Tel: 201-614-3151
rbentsur@nuvectis.com

Media Relations Contact

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

https://www.globenewswire.com/news-release/2026/06/30/3319364/0/en/Nuvectis-Pharma-Announces-Pricing-of-100-Million-Public-Offering-of-Common-Stock.html

u/MarketNewsFlow — 6 days ago

$NVCT - Nuvectis Pharma Announces Proposed Public Offering of Common Stock (NASDAQ: NVCT)

Nuvectis Pharma Announces Proposed Public Offering of Common Stock

FORT LEE, NJ, June 29, 2026 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (Nasdaq: NVCT), a clinical stage biopharmaceutical company focused on the development of innovative therapies for the treatment of immune complement-related conditions and oncology, today announced that it has commenced an underwritten public offering of its common stock. All of the shares to be sold in the offering will be offered by Nuvectis. In addition, Nuvectis intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Cantor is acting as sole book runner for the offering.

Nuvectis intends to use the net proceeds from this offering to continue to advance the development programs of NXP100, NXP200, and NXP900 or any future product candidate, hiring of additional personnel, capital expenditures, costs of operating as a public company and other general corporate purposes.

The securities described above are being offered by Nuvectis pursuant to its shelf registration statement on Form S-3 (File No. 333-293459) filed with the U.S. Securities and Exchange Commission ("SEC") on February 13, 2026 and declared effective by the SEC on February 20, 2026. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at https://www.sec.gov/. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained, when available, by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at prospectus@cantor.com. The final terms of the proposed offering will be disclosed in a final prospectus supplement to be filed with the SEC.

The offering of these securities is being made under an effective shelf registration statement on file with the SEC. 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.

About Nuvectis Pharma

Nuvectis Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development of innovative therapies for the treatment of immune complement-related conditions and oncology. The Company's pipeline includes NXP100, a complement Factor B inhibitor in development for the treatment of complement-mediated diseases, and the oncology drug candidates NXP900 and NXP200, in development for the treatment of advanced cancers.

NXP100 is a late-stage Factor B inhibitor with best-in-class potential as an effective therapy in multiple complement-mediated diseases and provides a convenience advantage as the only once-daily oral treatment option for these diseases requiring life-long treatment.

NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases, including SRC and YES1 intended to inhibit the catalytic and scaffolding functions of the SRC kinase, providing comprehensive shutdown of the signaling pathway.

NXP200 is an oral, brain penetrant, paradox-breaker BRAF inhibitor for the treatment of BRAF V600X-mutated and Class II/III non-V600-mutated solid tumor malignancies, including central nervous system cancer, colorectal cancer, melanoma, and non-small cell lung cancer, with best-in-class potential.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the U.S. federal securities laws, which are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate", "believe", "contemplate", "could", "estimate", "expect", "intend", "seek", "may", "might", "plan", "potential", "predict", "project", "target", "aim", "should", "will", "would", or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements include, but are not limited to, statements regarding future events, including statements about market conditions, statements relating to the completion, timing, size, use of proceeds from the proposed public offering on the anticipated terms or at all and the grant of the option to the underwriters to purchase additional shares of common stock. Forward-looking statements are based on Nuvectis' current expectations and interpretations of data and information available, including preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for its pipeline products NXP100, NXP200, and NXP900, and estimates and projections regarding Nuvectis' financial condition. The outcomes of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties may also be subject to market and other conditions and described more fully in the section titled "Risk Factors" in Nuvectis' first quarter 2026 Form 10-Q and other public filings with the U.S. Securities and Exchange Commission ("SEC"). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for Nuvectis to predict all risks and uncertainties that could have an impact on the forward looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. Nuvectis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Nuvectis' expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and Nuvectis claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Other than statements of historical fact, all statements are considered forward-looking statements and are based on Nuvectis' interpretations of past events as well as current expectations, estimates, and projections.

Company Contact

Ron Bentsur
Chairman, Chief Executive Officer and President
Tel: 201-614-3151
rbentsur@nuvectis.com

Media Relations Contact

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

https://www.globenewswire.com/news-release/2026/06/29/3319274/0/en/Nuvectis-Pharma-Announces-Proposed-Public-Offering-of-Common-Stock.html

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u/MarketNewsFlow — 6 days ago

Entera Bio Receives Positive FDA Feedback on 12-Month Registrational Phase 3 Study for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with Osteoporosis (NASDAQ: ENTX)

The planned Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of total hip bone mineral density (BMD) at Month 12, would support Entera’s plan to submit a New Drug Application (NDA) for EB613

Entera expects to submit its NDA for EB613 based on 12-month data, with an open-label extension study to follow patients through 24 months to supplement EB613’s safety, durability of effect and sequence data

Phase 3 initiation is planned for late 2026 with topline data anticipated in the second half of 2028

TEL AVIV, June 22, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today announced that it has received positive feedback from the U.S. Food and Drug Administration (FDA) on its Phase 3 registrational protocol for EB613 (oral PTH(1-34), teriparatide), the first oral anabolic (bone-building) tablet in development for the treatment of osteoporosis. The FDA feedback is in response to a Clinical Amendment submitted by Entera to its Investigational New Drug (IND) application, as announced in March 2026.

The FDA accepted Entera’s plan to conduct a single, randomized, double-blind, placebo-controlled, Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of percent change from baseline in total hip BMD at Month 12 to support a potential New Drug Application (NDA) submission for EB613 for the treatment of women with post-menopausal osteoporosis. The proposed NDA package will also include Entera’s scientific bridge analysis with Forteo® (teriparatide SC injection, Eli Lilly) under the 505(b)(2) pathway, and a transiliac crest bone biopsy sub-study in a subset of patients.

The FDA also agreed with Entera’s proposal to continue following the randomized patients out to 24 months in an open-label extension study under a separate protocol. Entera will plan to submit data through up to 18 months as part of the 120-day safety update to its NDA. Additionally, Entera will submit the complete 2-year data upon completion of the open-label extension study to characterize further the durability of the treatment effect, safety, and sequence data for EB613 followed by a standard anti-resorptive therapy for 12 months.

The registrational study is powered to demonstrate EB613’s clinical effectiveness with projected increases in total hip BMD that are comparable to reported outcomes for Forteo® at 12 months, changes associated with a 60% to 80% relative reduction in vertebral fracture risk.

Entera completed a placebo-controlled, 6-month, Phase 2 study of EB613 in 161 postmenopausal women. The study met its primary (PD/bone turnover biomarker) and secondary (BMD) endpoints, with statistically significant increases in BMD at the lumbar spine, total hip, and femoral neck (JBMR 2024). The increase in total hip BMD in this study was comparable to what has been reported for Forteo® at 6-months. Most recently, at ENDO 2026, comparative Phase 1 data presented as a Late-Breaking Oral Presentation demonstrated that the single tablet of EB613 achieved a pharmacokinetic and pharmacodynamic profile comparable to both the multi-tablet EB613 evaluated in the Phase 2 study and Forteo®.

The Company plans to initiate the registrational Phase 3 study in late 2026, with topline results anticipated in the second half of 2028.

"We are grateful to the FDA for their support of our program.  Entera has a clear and optimized registrational path with the aim of getting EB613 to women with osteoporosis,” said Miranda Toledano, Chief Executive Officer of Entera. "Our goal with EB613 is to democratize anabolic treatment and enable millions of women and men to protect their bones and potentially prevent the catastrophic consequences of fracture. In a silent and asymptomatic disease, access and ease of administration matter."

About EB613

Substantial evidence supports the efficacy of anabolic therapies over bisphosphonates for lowering fracture risk in osteoporosis patients at high risk. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. Entera’s EB613 program (oral PTH(1-34), teriparatide) is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis. Entera completed a Phase 2, 6-month, 161-patient, placebo-controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increases in lumbar spine, total hip, and femoral neck BMD. The effects of EB613 on trabecular and cortical bone using 3D-DXA showed increases with EB613 compared to placebo on a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. Mechanistically, the findings suggest that bone strengthening and fracture resistance may occur rapidly with EB613. Furthermore, the data are consistent with that of published subcutaneous teriparatide at the 6-month time point.

About Osteoporosis

Osteoporosis is a chronic, progressive disorder in which bone resorption exceeds formation, resulting in decreased bone strength and increased susceptibility to fracture. Osteoporosis is a major and growing public health issue, responsible for over 2 million fractures annually in the US. After age 50, one in three women and one in five men will suffer an osteoporosis-related fracture in their remaining lifetime. Osteoporotic fractures lead to chronic pain, decreased quality of life, and increased disability, and contribute to premature death. Studies show that up to 20-24% of hip fracture patients die within one year of the fracture. The total medical cost of osteoporotic fractures is projected to increase from $57 billion in 2018 to $95 billion by 2040, largely related to the aging population. Postmenopausal women are at higher risk of developing osteoporosis-related fractures, particularly in the hip, spine, and wrist. The mechanism for low BMD in postmenopausal women is primary estrogen deficiency, which leads to accelerated bone loss, especially in the first 5-10 years after menopause. Forteo^(®) (Eli Lilly) was first approved by FDA in 2002 for the treatment of postmenopausal women with osteoporosis and subsequently for treatment of men with primary or hypogonadal osteoporosis at high risk of fracture, and for osteoporosis associated with sustained systemic glucocorticoid therapy.

About Entera 

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages a disruptive and proprietary technology platform (N-Tab^(®)) and its pipeline of first-in-class oral peptide programs. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet for osteoporosis. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n = 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is also developing the first oral Long Acting PTH(1-34) tablet as a replacement therapy for patients with hypoparathyroidism (EB612), the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide tablet for the treatment of obesity and metabolic syndromes; and the first oral GLP-2 tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health, Inc. For more information on Entera, visit www.enterabio.com or follow us on LinkedInTwitter, and Facebook.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy, clinical development activities, collaboration arrangements and expected financial and operational results are forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

https://www.globenewswire.com/news-release/2026/06/22/3315282/0/en/Entera-Bio-Receives-Positive-FDA-Feedback-on-12-Month-Registrational-Phase-3-Study-for-EB613-the-First-Oral-Anabolic-Tablet-in-Development-for-Postmenopausal-Women-with-Osteoporosi.html

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u/MarketNewsFlow — 12 days ago
▲ 4 r/MetalsOnReddit+1 crossposts

$ENTX - Entera Bio Receives Positive FDA Feedback on 12-Month Registrational Phase 3 Study for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with Osteoporosis (NASDAQ: ENTX)

Seem Interesting - Entera Bio Receives Positive FDA Feedback on 12-Month Registrational Phase 3 Study for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with Osteoporosis (NASDAQ: ENTX).

The planned Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of total hip bone mineral density (BMD) at Month 12, would support Entera’s plan to submit a New Drug Application (NDA) for EB613

Entera expects to submit its NDA for EB613 based on 12-month data, with an open-label extension study to follow patients through 24 months to supplement EB613’s safety, durability of effect and sequence data

Phase 3 initiation is planned for late 2026 with topline data anticipated in the second half of 2028

TEL AVIV, June 22, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today announced that it has received positive feedback from the U.S. Food and Drug Administration (FDA) on its Phase 3 registrational protocol for EB613 (oral PTH(1-34), teriparatide), the first oral anabolic (bone-building) tablet in development for the treatment of osteoporosis. The FDA feedback is in response to a Clinical Amendment submitted by Entera to its Investigational New Drug (IND) application, as announced in March 2026.

The FDA accepted Entera’s plan to conduct a single, randomized, double-blind, placebo-controlled, Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of percent change from baseline in total hip BMD at Month 12 to support a potential New Drug Application (NDA) submission for EB613 for the treatment of women with post-menopausal osteoporosis. The proposed NDA package will also include Entera’s scientific bridge analysis with Forteo® (teriparatide SC injection, Eli Lilly) under the 505(b)(2) pathway, and a transiliac crest bone biopsy sub-study in a subset of patients.

The FDA also agreed with Entera’s proposal to continue following the randomized patients out to 24 months in an open-label extension study under a separate protocol. Entera will plan to submit data through up to 18 months as part of the 120-day safety update to its NDA. Additionally, Entera will submit the complete 2-year data upon completion of the open-label extension study to characterize further the durability of the treatment effect, safety, and sequence data for EB613 followed by a standard anti-resorptive therapy for 12 months.

The registrational study is powered to demonstrate EB613’s clinical effectiveness with projected increases in total hip BMD that are comparable to reported outcomes for Forteo® at 12 months, changes associated with a 60% to 80% relative reduction in vertebral fracture risk.

Entera completed a placebo-controlled, 6-month, Phase 2 study of EB613 in 161 postmenopausal women. The study met its primary (PD/bone turnover biomarker) and secondary (BMD) endpoints, with statistically significant increases in BMD at the lumbar spine, total hip, and femoral neck (JBMR 2024). The increase in total hip BMD in this study was comparable to what has been reported for Forteo® at 6-months. Most recently, at ENDO 2026, comparative Phase 1 data presented as a Late-Breaking Oral Presentation demonstrated that the single tablet of EB613 achieved a pharmacokinetic and pharmacodynamic profile comparable to both the multi-tablet EB613 evaluated in the Phase 2 study and Forteo®.

The Company plans to initiate the registrational Phase 3 study in late 2026, with topline results anticipated in the second half of 2028.

"We are grateful to the FDA for their support of our program.  Entera has a clear and optimized registrational path with the aim of getting EB613 to women with osteoporosis,” said Miranda Toledano, Chief Executive Officer of Entera. "Our goal with EB613 is to democratize anabolic treatment and enable millions of women and men to protect their bones and potentially prevent the catastrophic consequences of fracture. In a silent and asymptomatic disease, access and ease of administration matter."

About EB613

Substantial evidence supports the efficacy of anabolic therapies over bisphosphonates for lowering fracture risk in osteoporosis patients at high risk. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. Entera’s EB613 program (oral PTH(1-34), teriparatide) is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis. Entera completed a Phase 2, 6-month, 161-patient, placebo-controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increases in lumbar spine, total hip, and femoral neck BMD. The effects of EB613 on trabecular and cortical bone using 3D-DXA showed increases with EB613 compared to placebo on a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. Mechanistically, the findings suggest that bone strengthening and fracture resistance may occur rapidly with EB613. Furthermore, the data are consistent with that of published subcutaneous teriparatide at the 6-month time point.

About Osteoporosis

Osteoporosis is a chronic, progressive disorder in which bone resorption exceeds formation, resulting in decreased bone strength and increased susceptibility to fracture. Osteoporosis is a major and growing public health issue, responsible for over 2 million fractures annually in the US. After age 50, one in three women and one in five men will suffer an osteoporosis-related fracture in their remaining lifetime. Osteoporotic fractures lead to chronic pain, decreased quality of life, and increased disability, and contribute to premature death. Studies show that up to 20-24% of hip fracture patients die within one year of the fracture. The total medical cost of osteoporotic fractures is projected to increase from $57 billion in 2018 to $95 billion by 2040, largely related to the aging population. Postmenopausal women are at higher risk of developing osteoporosis-related fractures, particularly in the hip, spine, and wrist. The mechanism for low BMD in postmenopausal women is primary estrogen deficiency, which leads to accelerated bone loss, especially in the first 5-10 years after menopause. Forteo^(®) (Eli Lilly) was first approved by FDA in 2002 for the treatment of postmenopausal women with osteoporosis and subsequently for treatment of men with primary or hypogonadal osteoporosis at high risk of fracture, and for osteoporosis associated with sustained systemic glucocorticoid therapy.

About Entera 

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages a disruptive and proprietary technology platform (N-Tab^(®)) and its pipeline of first-in-class oral peptide programs. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet for osteoporosis. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n = 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is also developing the first oral Long Acting PTH(1-34) tablet as a replacement therapy for patients with hypoparathyroidism (EB612), the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide tablet for the treatment of obesity and metabolic syndromes; and the first oral GLP-2 tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health, Inc. For more information on Entera, visit www.enterabio.com or follow us on LinkedInTwitter, and Facebook.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy, clinical development activities, collaboration arrangements and expected financial and operational results are forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

https://www.globenewswire.com/news-release/2026/06/22/3315282/0/en/Entera-Bio-Receives-Positive-FDA-Feedback-on-12-Month-Registrational-Phase-3-Study-for-EB613-the-First-Oral-Anabolic-Tablet-in-Development-for-Postmenopausal-Women-with-Osteoporosi.html

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u/MarketNewsFlow — 12 days ago
▲ 8 r/MicroCapNews+5 crossposts

$DUKR - Duke Robotics Announces New Order for the Bird of Prey Weapon Drone System Through Leading Defense Company Elbit (NASDAQ: DUKR)

Duke Robotics Announces New Order for the Bird of Prey Weapon Drone System Through Leading Defense Company Elbit

Leading Global Defense Technology Company Elbit Received New Order for the Battle-Tested Bird of Prey; Deliveries Expected Later This Year

Duke Robotics to Participate in Sales Through Its Royalty Arrangement with Elbit Under the Parties' Long-Term Collaboration Agreement

FT. LAUDERDALE, FL, June 23, 2026 (GLOBE NEWSWIRE) — Duke Robotics Corp. (Nasdaq: DUKR; DUKRW) ("Duke Robotics" or the "Company"), a leader in advanced robotics and drone-based solutions for civilian and defense markets, today announced that it has received confirmation from Elbit Systems Land Ltd. ("Elbit") that Elbit has received a new order for the Bird of Prey stabilized weapons drone system (formerly known as TIKAD), with deliveries expected to take place later this year.

The Bird of Prey is an agile, fully stabilized remote weapon system designed for non-line-of-sight and stand-off engagements. Built on Duke Robotics' proprietary stabilization technology, the system is engineered to deliver precise engagement capability from a moving aerial platform — a long-standing technical challenge for weaponized drones. The Company believes the confirmation of a new order further validates the operational relevance of the system and the strength of its collaboration with Elbit, one of the world's leading defense companies.

The Bird of Prey is marketed and sold globally by Elbit, one of the world's leading defense technology companies, under the parties' collaboration agreement, pursuant to which Duke Robotics is entitled to royalties on Elbit's sales of the system. Consistent with the structure of that collaboration, and as the Company has previously described, Duke Robotics expects to recognize any royalty revenue associated with these orders in connection with Elbit's delivery of the systems and receipt of the related proceeds, rather than at the time orders are placed or confirmed.

"We believe that Elbit's confirmation of a new order for the Bird of Prey is a meaningful validation of the system and of our long-term collaboration with one of the world's leading defense companies," said Yossef Balucka, Chief Executive Officer of Duke Robotics. "The Bird of Prey has previously been reported with respect to its operational use by the Israel Defense Forces, and we believe demand for stabilized, drone-based engagement capabilities continues to increase as militaries around the world draw lessons from recent conflicts. We believe this development reflects the growing commercial momentum behind our defense technology and reinforces the value of the defense offering Duke Robotics is building."

The new order comes at a time of accelerating global investment in drone-based combat systems. Militaries across NATO, the Middle East, and beyond are reshaping procurement around autonomous and remotely operated aerial platforms, drawing on lessons from recent conflicts in Ukraine and the Middle East,¹ while global defense budgets continue to rise.² The Company believes that demand for precise, stabilized, drone-mounted engagement capabilities is growing, and that the Bird of Prey is well positioned within this category through Elbit's extensive international marketing and distribution reach.

About Duke Robotics

Duke Robotics Corp. (Nasdaq: DUKR; DUKRW) develops advanced stabilization and autonomous robotic drone systems for both civilian and defense markets. The Company's Insulator Cleaning Drone (IC Drone) is a first-of-its-kind, drone-enabled system for cleaning and monitoring high-voltage electric utility insulators. Leveraging Duke's technologies, the IC Drone provides a safer, more efficient, and cost-effective alternative method. AEROTRACE™ is the Company's AI-powered aerial monitoring and intelligence platform for infrastructure operators, designed to deliver actionable insights for asset assessment and proactive maintenance. In defense, through a collaboration agreement with Elbit Systems Land Ltd. ("Elbit"), the Bird of Prey weapons drone system is an agile, fully stabilized remote weapon system designed for non-line-of-sight and stand-off engagements, marketed by Elbit under the brand name Bird of Prey (formerly known as TIKAD). For additional Company information, please visit https://dukeroboticsys.com and follow us on Twitter (X) and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements. Words such as "future" and similar expressions, or future or conditional verbs such as "will," are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs, assumptions, and information currently available to us. For example, we are using forward-looking statements when we discuss the new order for the Bird of Prey confirmed by Elbit, the anticipated timing of deliveries, the Company's expectation that it will recognize royalty revenue in connection with Elbit's delivery of the systems and receipt of the related proceeds under the parties' collaboration agreement, the anticipated demand for drone-based combat systems and stabilized weaponized drone capabilities, the strength and continued momentum of the Company's collaboration with Elbit, the validation provided by confirmed operational use of the Bird of Prey, and the Company's positioning across its civilian and defense business lines. Our actual results may differ materially from those expressed or implied due to known or unknown risks and uncertainties. These include, but are not limited to, risks related to the possibility that the orders may be modified, delayed, reduced, or cancelled; that deliveries may not occur within the expected timeframe or at all; that the amount and timing of any royalty revenue to the Company will depend on Elbit's completion of sales and collection of proceeds and may differ materially from current expectations; the successful market adoption of our technologies, the continued development and refinement of our technology, our ability to effectively collaborate with Elbit Systems, fluctuations in foreign currency exchange rates, operational challenges associated with marketing activities in new markets, economic conditions that may affect defense spending and infrastructure investment, geopolitical factors that could impact business operations, regulatory challenges in various regions, and competition from technological advances. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and any subsequent filings with the Securities and Exchange Commission. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Company Contact:
Duke Robotics Corp.
invest@dukeroboticsys.com

Investor Relations Contact:
Arx Investor Relations
North American Equities Desk
duke@arxhq.com

¹ NATO Parliamentary Assembly, Science and Technology Committee, "Uncrewed Warfare" (023 STCTTS), 2025. https://www.nato-pa.int/document/2025-uncrewed-warfare-report-clement-023-stctts

² SIPRI, "Unprecedented rise in global military expenditure as European and Middle East spending surges," 28 April 2025. https://www.sipri.org/media/press-release/2025/unprecedented-rise-global-military-expenditure-european-and-middle-east-spending-surges

https://www.globenewswire.com/news-release/2026/06/23/3315964/0/en/Duke-Robotics-Announces-New-Order-for-the-Bird-of-Prey-Weapon-Drone-System-Through-Leading-Defense-Company-Elbit.html

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u/MarketNewsFlow — 13 days ago
▲ 22 r/AlphaTauMedical+7 crossposts

$DRTS - Alpha Tau Successfully Treats First Recurrent Glioblastoma Patient Outside of the United States with Alpha DaRT® at Hadassah University Medical Center in Israel (NASDAQ: DRTS)

Alpha Tau Successfully Treats First Recurrent Glioblastoma Patient Outside of the United States with Alpha DaRT® at Hadassah University Medical Center in Israel

- First glioblastoma patient ever treated with Alpha DaRT® outside of the United States, and the first in Israel - performed at Hadassah University Medical Center in Jerusalem, one of the world's premier academic neurosurgical institutions -

- The procedure marks the first international clinical application of Alpha DaRT's brain-specific proprietary delivery system -

- Glioblastoma is the most common and aggressive primary brain cancer, with approximately 160,000 new cases diagnosed globally each year; with recurrence occurring in virtually all patients, typically within 6-9 months, for which there is no established standard of care -

- The patient was treated under the ALL clinical protocol, Alpha Tau's broad-access study at Hadassah University Medical Center open to patients with solid tumors in any location of the body amenable to Alpha DaRT source delivery -

JERUSALEM, June 23, 2026 (GLOBE NEWSWIRE) — Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced the successful treatment with Alpha DaRT of the first glioblastoma patient in Israel, and the first ever outside of the United States, performed at Hadassah University Medical Center in Jerusalem. The procedure was carried out by a multidisciplinary team led by Prof. Yigal Shoshan, Professor of Neurosurgery at Hadassah University Medical Center. Using the Company's proprietary brain applicator under real-time stereotactic neuro-navigation, Alpha DaRT sources were precisely delivered to the recurrent tumor through a single, minimally-invasive burr hole entry point into the brain. The procedure was completed safely and without unexpected complications.

Glioblastoma (GBM) is the most common and most lethal primary brain tumor in adults, with approximately 160,000 new cases diagnosed globally each year. Following standard first-line treatment, typically consisting of a combination of surgery, radiation, and chemotherapy, recurrence is virtually inevitable, occurring in nearly all GBM patients within 6 to 9 months of initial treatment. It is at this stage that the disease becomes most unforgiving: median overall survival from the time of recurrence is only an additional 6 to 9 months, there is no standard of care, and the majority of patients are ineligible for repeat surgical resection — leaving them with severely limited therapeutic options. It is precisely this population, facing progression with nowhere left to turn, that Alpha DaRT aims to reach.

Uzi Sofer, CEO of Alpha Tau, stated: "Today's announcement marks a significant milestone for Alpha Tau's glioblastoma program: the first-ever treatment of a GBM patient outside of the United States, delivered at an institution as scientifically rigorous and globally respected as Hadassah. Israel is the birthplace of Alpha DaRT, and bringing this technology to Israeli brain tumor patients — patients who today have so few options — is a moment of deep pride and significance for our entire team."

Prof. Yigal Shoshan, Professor of Neurosurgery at Hadassah University Medical Center, stated: "I am proud that this first Israeli case has advanced the field not just by a geography, but by a genuine technical step forward. My involvement in Alpha DaRT for brain tumors began in the laboratory, through our preclinical study, in which we demonstrated that stereotactic implantation of Alpha DaRT sources in the swine brain was both safe and technically feasible. That work laid the scientific and procedural groundwork for today's clinical milestone. The procedure was completed successfully, without unexpected complications, and represents an important proof of concept for how the flexibility of Alpha DaRT's delivery system can be adapted to the complexity of individual brain tumor anatomy. The patient — male, 77 years old, with recurrent glioblastoma following surgery and radiation therapy — tolerated the procedure well."

Dr. Robert Den, CMO of Alpha Tau, commented: "Treating a patient with glioblastoma who has no remaining standard of care — under a protocol designed precisely to reach that population — is exactly what this program is built for. The treatment of the first patient in Israel adds to the momentum of our multicenter US Recurrent GBM REGAIN trial, which is continuing to recruit patients swiftly following the fantastic interim results last month and the FDA clearance to proceed to full enrollment with the addition of two new leading U.S. academic centers. Together, these milestones are building a genuine clinical foundation for Alpha DaRT in one of oncology's most challenging and underserved diseases. We look forward with genuine anticipation to learning from Prof. Shoshan and his team as this work progresses, and above all, we look forward to following this patient's progress."

About Alpha Tau Medical Ltd.

Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company focused on the research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.

About Alpha DaRT®

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to primarily affect the tumor and to spare healthy tissue surrounding it. For intracranial use, Alpha DaRT sources are delivered via a specialized stereotactic delivery system that interfaces with standard real-time neuronavigation platforms, enabling precise, image-guided source placement through minimally invasive burr-hole access without requiring open craniotomy.

About the ALL Protocol

The ALL protocol is a broad-access clinical trial conducted at Hadassah University Medical Center in Jerusalem, Israel. The protocol is open to patients with a wide range of solid tumor types to which Alpha DaRT sources can be delivered, who do not qualify for participation in other existing Alpha Tau clinical trials or who have no remaining standard treatment alternatives according to the treating physician. To date, patients have been treated under the ALL protocol across multiple indications, including pancreatic cancer, recurrent glioblastoma, rectal cancer, liver cancer, oral cavity cancer, and skin cancer.

Forward-Looking Statements

This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, including with respect to clinical trials, the ALL clinical protocol and the safety, feasibility, and efficacy of Alpha DaRT for the treatment of glioblastoma, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Alpha Tau's current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau's ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau's limited operating history; (iii) Alpha Tau's incurrence of significant losses to date; (iv) Alpha Tau's need for additional funding and ability to raise capital when needed; (v) Alpha Tau's limited experience in medical device discovery and development; (vi) Alpha Tau's dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau's clinical studies to predict final study results; (viii) failure of Alpha Tau's early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau's ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau's Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau's exposure to patent infringement lawsuits; (xii) Alpha Tau's ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq's listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption "Risk Factors" in Alpha Tau's annual report filed on form 20-F with the SEC on March 9, 2026, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau's views as of any date subsequent to the date of this press release.

Investor Relations Contact:
IR@alphatau.com

https://www.globenewswire.com/news-release/2026/06/23/3315968/0/en/Alpha-Tau-Successfully-Treats-First-Recurrent-Glioblastoma-Patient-Outside-of-the-United-States-with-Alpha-DaRT-at-Hadassah-University-Medical-Center-in-Israel.html

u/MarketNewsFlow — 13 days ago
▲ 11 r/MicroCapNews+7 crossposts

$QUCY - Quantum Cyber Unveils Quantum Station: A Battlefield Operating System for Multi-Domain Autonomous Warfare (NASDAQ: QUCY)

Quantum Cyber Unveils Quantum Station: A Battlefield Operating System for Multi-Domain Autonomous Warfare

Purpose-Built Ruggedized Command-and-Control Platform Delivers a Single Pane of Glass Across Air, Land, and Sea Drone Operations; Integrates Hardware, Software, and Communications as a Unified Battlefield System; To be Manufactured in the United States; Positions Quantum Cyber as Operator-First Defense Architecture Company

WEST PALM BEACH, Florida, June 23, 2026 (GLOBE NEWSWIRE) — Quantum Cyber N.V. (Nasdaq: QUCY) ("Quantum Cyber" or the "Company"), a Nasdaq-listed autonomous defense technology company assembling an AI-powered System-of-Systems platform for drone warfare, counter-UAS, and border security applications, today unveiled Quantum Station, the Company's purpose-built battlefield command-and-control platform engineered to serve as the central nervous system of multi-domain autonomous operations.

We intend to build AI and Autonomous features within our Quantum Station in order to eliminate human error when operating Drones. We believe that the future of Drone warfare will need to be built this way.

From Makeshift to Mission-Ready: The Problem Quantum Station Solves

Across active theaters of operation today, drone operators frequently work from improvised command setups: consumer monitors, off-the-shelf laptops, mismatched cabling, and fragmented software tools that were never designed to work together. The result is operator cognitive overload, degraded situational awareness, and mission-critical latency at the worst possible moment.

Quantum Station was built to end that. It replaces every piece of that improvised stack with a single IP67-rated, backpack-portable tactical suitcase containing everything a drone crew needs to command, observe, record, debrief, and disseminate from insertion to mission close. The system is the hardware, software, and communications layer. All three are unified under one architecture designed for the today's operator who cannot afford for any of them to fail.

A Single Pane of Glass Across All Platforms

Quantum Station is built around open architecture and universal drone compatibility. Supporting ArduPilot, PX4, and custom platforms through native Pixhawk flight-controller integration with CAN bus and telemetry passthrough, the system is designed to command any drone in any inventory, not just the drones it was sold with originally.

The operator interface centers on a 15.6-inch QLED capacitive touchscreen primary display running a cyber-secure Linux operating system with system-wide AES-256 encryption. Up to four additional external field monitors can be connected simultaneously, enabling multi-channel video management, live debrief, and real-time mission analysis across an entire drone swarm. Event logging supports complete timeline reconstruction. An Android ground control application and a cloud layer for fleet management and mission archiving extend command reach beyond the tactical edge.

This is not a display with a drone app loaded on it. Quantum Station is a battle-management system with a display built in.

Communications Architecture Built for Contested Environments

Quantum Station integrates a full communications stack engineered for degraded and denied environments. The primary control link operates over ELRS 900 MHz with a range of 10 to 50 kilometers, sub-50 millisecond latency, and dual TX/RX full-duplex capability. A 2.4 GHz option is commonly available for closer-range operations. A BLE layer handles close-range configuration, calibration, and mission planning without breaking the primary link.

Dedicated video telemetry (VRX/VTX) operates with simultaneous telemetry over UART. When tactical communications infrastructure is available, 4G LTE failover and fiber-optic backhaul for tethered or fixed-site operations extend the command reach. The architecture is Starlink-ready, ensuring the system is positioned for the next generation of low-earth-orbit communications that the U.S. military is actively integrating across all domains.

Looking further ahead, Quantum Station is architected to integrate with Quantum Cyber's quantum antenna technology currently in development, which the Company anticipates will enable secure, frequency-agile photonic communications that eliminate dependence on conventional RF links entirely — positioning Quantum Station as the command hub of a truly RF-independent battlefield network.

Power and Endurance for Sustained Battlefield Operations

Quantum Station is engineered for sustained operations without resupply. Hot-swap dual military-standard batteries deliver 6.5 or more hours of continuous operation. The system accepts 220V AC wall power and 6S LiPo battery input, and integrates XT60 charging ports for drone batteries directly — eliminating the need for a separate charging station in the field. A 25W integrated USB-C port charges drone remote controllers from the same unit. Active cooling via metal heat sinks and dual fans supports reliable operation from 0 to 50 degrees Celsius.

The complete system weighs approximately 10 kilograms and measures 15 by 40 by 48.5 centimeters — a form factor that fits in a backpack and deploys from a vehicle without ground support equipment.

The Command Layer of a System-of-Systems Platform

Quantum Station represents the command-and-control tier of Quantum Cyber's growing System-of-Systems platform, which also encompasses autonomous drone warfare, counter-UAS perimeter defense, autonomous naval mine countermeasures, EMP-shielded drone manufacturing, anti-drone ammunition, and quantum antenna communications technology currently in development. Every planned autonomous system in the Company's portfolio — across air, land, and sea — is being designed to operate from a single Quantum Station.

The Trump Administration is seeking approximately $55 billion for drone and autonomous warfare programs in the fiscal year 2027 defense budget, the largest single-year autonomous warfare allocation in U.S. history. Executive Order 14307 establishes American drone dominance as an explicit national security and industrial priority. The global counter-UAS market is projected to grow from $3.1 billion to $10.6 billion by 2030, representing a 27.2 percent compound annual growth rate (Grand View Research, 2025). Quantum Cyber believes the defining competitive advantage in this market will not be the drone. It will be the operator's ability to command it.

"The modern battlefield runs on information, and the operator who can see it clearest and act on it fastest wins," said David Lazar, Chief Executive Officer of Quantum Cyber. "Quantum Station is not a hardware product. It is a battlefield operating system. We built it because every drone in our platform needs a command layer worthy of what it can do. Quantum Station is that layer — open, ruggedized, interoperable, and designed by people who understand what operators actually need when the mission is live."

About Quantum Cyber N.V.

Quantum Cyber N.V. (Nasdaq: QUCY) is assembling an AI-powered, quantum-accelerated System-of-Systems autonomous defense platform that integrates drone warfare, counter-UAS, autonomous naval mine countermeasures, EMP shielding, anti-drone ammunition, command-and-control, and quantum antenna applications under a single Nasdaq-listed company. The Company acquires, licenses, and develops combat-proven autonomous technologies, deploying them as a coordinated, multi-domain portfolio across air, land, and sea. For more information, visit www.quantum-cyber.ai.

Forward-Looking Statements

Certain statements made in this press release are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements relate to, among other things, the commercial development and deployment of the Quantum Station platform; the Company's anticipated integration of Quantum Station within its System-of-Systems platform; the platform's compatibility with third-party drone systems and communications infrastructure; the anticipated integration of quantum antenna technology into the Quantum Station platform and the elimination of conventional RF communications dependency; the anticipated market opportunity in drone warfare and counter-UAS; and the Company's broader business strategy and technology pipeline. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company's expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to complete development or achieve commercial deployment of Quantum Station; (ii) the failure to achieve interoperability with third-party platforms; (iii) changes in applicable laws or regulations; (iv) an inability to successfully pursue new initiatives; and (v) other risks and uncertainties discussed from time to time in other reports and public filings with the Securities and Exchange Commission (the "SEC") by the Company. Additional information concerning these and other factors may be found in the Company's filings with the SEC, including its Annual Report on Form 10-K filed on March 31, 2026, its Quarterly Report on Form 10-Q filed on May 15, 2026, and subsequent filings. The Company's SEC filings are available publicly on the SEC's website at www.sec.gov. Any forward-looking statement made in this press release speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as required by law.

Investor Relations Contact:
Arx Investor Relations
North American Equities Desk
qucy@arxhq.com

https://www.globenewswire.com/news-release/2026/06/23/3315841/0/en/Quantum-Cyber-Unveils-Quantum-Station-A-Battlefield-Operating-System-for-Multi-Domain-Autonomous-Warfare.html

u/MarketNewsFlow — 13 days ago
▲ 13 r/pennystocks_No_Rules+10 crossposts

$ENTX - Entera Bio Receives Positive FDA Feedback on 12-Month Registrational Phase 3 Study for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with Osteoporosis (NASDAQ: ENTX)

The planned Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of total hip bone mineral density (BMD) at Month 12, would support Entera’s plan to submit a New Drug Application (NDA) for EB613

Entera expects to submit its NDA for EB613 based on 12-month data, with an open-label extension study to follow patients through 24 months to supplement EB613’s safety, durability of effect and sequence data

Phase 3 initiation is planned for late 2026 with topline data anticipated in the second half of 2028

TEL AVIV, June 22, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today announced that it has received positive feedback from the U.S. Food and Drug Administration (FDA) on its Phase 3 registrational protocol for EB613 (oral PTH(1-34), teriparatide), the first oral anabolic (bone-building) tablet in development for the treatment of osteoporosis. The FDA feedback is in response to a Clinical Amendment submitted by Entera to its Investigational New Drug (IND) application, as announced in March 2026.

The FDA accepted Entera’s plan to conduct a single, randomized, double-blind, placebo-controlled, Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of percent change from baseline in total hip BMD at Month 12 to support a potential New Drug Application (NDA) submission for EB613 for the treatment of women with post-menopausal osteoporosis. The proposed NDA package will also include Entera’s scientific bridge analysis with Forteo® (teriparatide SC injection, Eli Lilly) under the 505(b)(2) pathway, and a transiliac crest bone biopsy sub-study in a subset of patients.

The FDA also agreed with Entera’s proposal to continue following the randomized patients out to 24 months in an open-label extension study under a separate protocol. Entera will plan to submit data through up to 18 months as part of the 120-day safety update to its NDA. Additionally, Entera will submit the complete 2-year data upon completion of the open-label extension study to characterize further the durability of the treatment effect, safety, and sequence data for EB613 followed by a standard anti-resorptive therapy for 12 months.

The registrational study is powered to demonstrate EB613’s clinical effectiveness with projected increases in total hip BMD that are comparable to reported outcomes for Forteo® at 12 months, changes associated with a 60% to 80% relative reduction in vertebral fracture risk.

Entera completed a placebo-controlled, 6-month, Phase 2 study of EB613 in 161 postmenopausal women. The study met its primary (PD/bone turnover biomarker) and secondary (BMD) endpoints, with statistically significant increases in BMD at the lumbar spine, total hip, and femoral neck (JBMR 2024). The increase in total hip BMD in this study was comparable to what has been reported for Forteo® at 6-months. Most recently, at ENDO 2026, comparative Phase 1 data presented as a Late-Breaking Oral Presentation demonstrated that the single tablet of EB613 achieved a pharmacokinetic and pharmacodynamic profile comparable to both the multi-tablet EB613 evaluated in the Phase 2 study and Forteo®.

The Company plans to initiate the registrational Phase 3 study in late 2026, with topline results anticipated in the second half of 2028.

"We are grateful to the FDA for their support of our program.  Entera has a clear and optimized registrational path with the aim of getting EB613 to women with osteoporosis,” said Miranda Toledano, Chief Executive Officer of Entera. "Our goal with EB613 is to democratize anabolic treatment and enable millions of women and men to protect their bones and potentially prevent the catastrophic consequences of fracture. In a silent and asymptomatic disease, access and ease of administration matter."

About EB613

Substantial evidence supports the efficacy of anabolic therapies over bisphosphonates for lowering fracture risk in osteoporosis patients at high risk. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. Entera’s EB613 program (oral PTH(1-34), teriparatide) is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis. Entera completed a Phase 2, 6-month, 161-patient, placebo-controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increases in lumbar spine, total hip, and femoral neck BMD. The effects of EB613 on trabecular and cortical bone using 3D-DXA showed increases with EB613 compared to placebo on a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. Mechanistically, the findings suggest that bone strengthening and fracture resistance may occur rapidly with EB613. Furthermore, the data are consistent with that of published subcutaneous teriparatide at the 6-month time point.

About Osteoporosis

Osteoporosis is a chronic, progressive disorder in which bone resorption exceeds formation, resulting in decreased bone strength and increased susceptibility to fracture. Osteoporosis is a major and growing public health issue, responsible for over 2 million fractures annually in the US. After age 50, one in three women and one in five men will suffer an osteoporosis-related fracture in their remaining lifetime. Osteoporotic fractures lead to chronic pain, decreased quality of life, and increased disability, and contribute to premature death. Studies show that up to 20-24% of hip fracture patients die within one year of the fracture. The total medical cost of osteoporotic fractures is projected to increase from $57 billion in 2018 to $95 billion by 2040, largely related to the aging population. Postmenopausal women are at higher risk of developing osteoporosis-related fractures, particularly in the hip, spine, and wrist. The mechanism for low BMD in postmenopausal women is primary estrogen deficiency, which leads to accelerated bone loss, especially in the first 5-10 years after menopause. Forteo^(®) (Eli Lilly) was first approved by FDA in 2002 for the treatment of postmenopausal women with osteoporosis and subsequently for treatment of men with primary or hypogonadal osteoporosis at high risk of fracture, and for osteoporosis associated with sustained systemic glucocorticoid therapy.

About Entera 

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages a disruptive and proprietary technology platform (N-Tab^(®)) and its pipeline of first-in-class oral peptide programs. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet for osteoporosis. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n = 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is also developing the first oral Long Acting PTH(1-34) tablet as a replacement therapy for patients with hypoparathyroidism (EB612), the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide tablet for the treatment of obesity and metabolic syndromes; and the first oral GLP-2 tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health, Inc. For more information on Entera, visit www.enterabio.com or follow us on LinkedInTwitter, and Facebook.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy, clinical development activities, collaboration arrangements and expected financial and operational results are forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

https://www.globenewswire.com/news-release/2026/06/22/3315282/0/en/Entera-Bio-Receives-Positive-FDA-Feedback-on-12-Month-Registrational-Phase-3-Study-for-EB613-the-First-Oral-Anabolic-Tablet-in-Development-for-Postmenopausal-Women-with-Osteoporosi.html

u/MarketNewsFlow — 14 days ago
▲ 12 r/NuvectisPhama+10 crossposts

$NVCT - Nuvectis Announces Strategic Portfolio Expansion via License Agreement for Ex-China Rights with Haisco Pharmaceutical Group for Two Potentially Best-In Class Clinical-Stage Compounds (NASDAQ: NVCT)

  • The transaction transforms Nuvectis into a late-stage clinical development company by expanding its pipeline into complement-mediated diseases with the in-licensing of a Complement Factor B inhibitor (CFBi [NXP100]) and also enhances the oncology product pipeline with the in-licensing of a paradox breaker BRAF inhibitor (BRAFi [NXP200]) for the treatment of BRAF-mutated malignancies.
  • NXP100 (HSK39297): A once-daily, oral CFBi in late-stage development for the treatment of complement-mediated diseases. Current development status in China includes: Two Marketing Authorization Applications (MAAs) are under review for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH); The applications seek approvals for NXP100 for the treatment of PNH in treatment-naive patients and in patients who failed treatment with a Complement protein 5 (C5) inhibitor. Successful completion of a Phase 2 and ongoing Phase 3 trial in Immunoglobulin A Nephropathy (IgAN). Ongoing Phase 2 trial in Lupus Nephritis (LN). NXP200 (HSK42360): An oral, brain penetrant, paradox-breaker BRAF inhibitor for the treatment of BRAF V600X-mutated and Class II/III non-V600-mutated malignancies.
  • NXP200 has generated single agent durable responses in several tumor types including CNS, colorectal, melanoma, non-small-cell lung cancer, papillary thyroid and others. Paradox breaking represents a next generation approach to targeting BRAF. A Phase 1b study in China is ongoing. Strong intellectual property protection for both compounds. Nuvectis will hold a conference call today at 8:30 AM ET to introduce its newly in-licensed products.

Fort Lee, NJ, June 22, 2026 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) (“Nuvectis” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of complement-related conditions and oncology, today announced a strategic portfolio expansion via a license agreement for exclusive ex-China rights with Haisco Pharmaceutical Group (“Haisco”) to two potentially best in-class clinical-stage compounds. Nuvectis will hold a conference call today at 8:30 AM ET to introduce its newly in-licensed products.

Haisco (SHE ticker code: 002653) is a leading fully-integrated pharmaceutical company with approximately 50 marketed products and 70 research programs, most recently recognized for successfully executing licensing deals with Eli Lilly and AbbVie (both in 2Q2026), and the phase 3 success of envudeucitinib in plaque psoriasis (1Q2026), a compound which Haisco discovered and advanced through development until it was licensed to Alumis, Inc.

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “The in-licensing of the two clinical stage drug candidates with best-in-class potential represents an expansion of Nuvectis’ pipeline and strategy.” Mr. Bentsur continued, “NXP100 is a late-stage Factor B inhibitor with the potential to become an effective therapy in multiple complement-mediated diseases and provide a convenience advantage as a once-daily oral treatment option for these diseases requiring life-long treatment. With regards to NXP200, the paradox-breaker BRAF inhibitor, the ability to overcome the limitations of older generation BRAF inhibitors, a validated pharmaceutical class, is an area of great interest and we are very pleased to add NXP200 to our oncology pipeline, in which NXP900, our incumbent drug candidate, is progressing toward important clinical inflection points from the ongoing Phase 1b starting in this summer.” Mr. Bentsur concluded, “With tremendous in-house drug development capabilities and two recently completed licensing deals with Eli Lilly and AbbVie, Haisco is recognized as a premier drug development company with global reach. We are thankful for this opportunity and are privileged to partner with Haisco as we look forward to our collaboration and advancing these development programs.”

Dr. Pangke Yan, Chief Executive Officer of Haisco, commented, “This licensing deal, in addition to our recently completed deals, further strengthens Haisco’s global research and development presence and we are excited to collaborate with Nuvectis on these two projects. We believe that Nuvectis has the relevant experience and capabilities required to advance these projects and that together we can accelerate and offer high-quality treatment options to patients worldwide.”

Clinical / Regulatory Status in China and Key Data Summaries for NXP100 and NXP200

NXP100 (HSK39297)

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Two MAAs for NXP100 have been submitted to the Chinese National Medical Products Administration (NMPA) and are currently under review:

The first MAA is based on positive data from a completed randomized, open-label, active comparator-controlled, Phase 3 study (clinicaltrials.gov NCT06799546). In this study, 73 adult Chinese treatment naïve PNH patients were randomized 1:1 to receive either NXP100 or Soliris® (eculizumab), a Complement C5 inhibitor, for a 24-week treatment period. The primary efficacy endpoint was to evaluate the proportion of patients achieving hemoglobin (Hgb) levels ≥ 12 g/dL on at least three out of four measurements between Week 18 and Week 24 in the absence of red blood cell (RBC) transfusions. Treatment with NXP100 was superior to treatment with eculizumab in the primary and all key secondary endpoints (overall increase in Hgb levels, reducing the requirement for RBC transfusions, and avoiding extravascular hemolysis).

Parameter NXP100 (n=37) Eculizumab (N=36) Primary Endpoint Proportion of participants achieving Hgb levels ≥12 g/dL without RBC transfusion % (95% CI) 59.5 (43.2, 75.7) 8.3 (2.8, 19.4) p-Value < 0.001 The second MAA is based on positive data from a completed single-arm, Phase 3 study (clinicaltrials.gov NCT07052838). In this study, 36 adult Chinese patients with PNH and persistent anemia who failed treatment with C5 inhibitors were treated with NXP100 for a 24-week treatment period. The primary efficacy endpoint was to evaluate the proportion of patients achieving Hgb levels ≥ 12 g/dL on at least three out of four measurements between Week 18 and Week 24 in the absence of RBC transfusions from Week 2, with efficacy prospectively defined as having the lower bound of the 95% CI for the response rate exceeding 20%. The study met the primary and all key secondary endpoints (overall increase in Hgb levels, reducing the requirement for RBC transfusions, and avoiding extravascular hemolysis).

Parameter NXP100 (n=36) Primary Endpoint Proportion of participants achieving Hgb levels ≥12 g/dL without RBC transfusion % (95% CI) 52.8 (35.5, 69.6) Immunoglobulin A Nephropathy (IgAN)

In China, a Phase 3 clinical trial (NCT07390123) is ongoing in IgAN following positive data from a randomized, placebo-controlled Phase 2 (NCT06670352). In the Phase 2 study, the efficacy of treatment with NXP100 was investigated in a 24-week treatment period versus placebo with efficacy defined as reduction in the ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 12 weeks of treatment. Treatment with NXP100 resulted in clinically meaningful reduction in 24h-UPCR after 4 weeks, and the magnitude of the treatment effect increased over time. NXP100 also demonstrated excellent estimated Glomerular Filtration Rate (eGFR) control (a secondary endpoint) vs placebo in the study.

Parameter Week 4 Week 12 (Primary Endpoint) Week 24 Reduction in 24h-UPCR relative to baseline vs. placebo

NXP100 N=24 Placebo N=21 -33% -45.3% -57.7% In addition, a Phase 2 of NXP100 for the treatment of LN is also ongoing in China.

NXP100 Competitive Landscape and Market Analysis

The PNH market size is expected to be >$5.0BN in 2026 with the injectable C5 inhibitor drugs Soliris® and Ultomiris®, marketed by Alexion/AstraZeneca Rare Disease, projected to be approximately $4.5BN of the total market. The PNH market is expected to more than double to >$10BN within 8 years. Soliris and Ultomiris were the centerpiece of Astra Zeneca’s acquisition of Alexion in 2021 for $39BN. Fabhalta (iptacopan, launched in 2024), marketed by Novartis, is the only FDA approved Complement Factor B inhibitor with approvals in PNH, IgAN and C3G. Fabhalta®is administered orally, twice per day, vs NXP100 which is administered once a day. Fabhalta® is currently also being investigated in several clinical trials, including LN, Myasthenia Gravis (MG) and dry Age-related Macular Degeneration (dAMD). Fabhalta® peak annual revenue in the currently approved indications is projected by analysts to reach $5B to $10B. The PNH and IgAN markets are estimated to reach >$20BN combined within the next 10 years. In randomized Phase 3 clinical trials in patients with PNH, treatment with either NXP100 or Fabhalta® was superior to treatment with C5 inhibitors, with comparable treatment effect for NXP100 and Fabhalta across studies, positioning CFBis to potentially dominate the PNH market over time. In IgAN, the Phase 2 data suggests that NXP100 has the potential to be comparable to the best injectable APRIL/BAFF inhibitors on the key renal function endpoints, including 24-hour UPCR and eGFR control. In cross study comparisons, the observed safety profile of NXP100 appears to be similar to that of Fabhalta®. NXP200 (HSK42360)

Overview, Competitive Landscape and Market Analysis

BRAF is a validated therapeutic target in oncology with first generation drugs such as Tafinlar® (dabrafenib, marketed by Novartis) and Braftovi® (encorafenib, marketed by Pfizer) approved in multiple indications. These first-generation BRAF inhibitors effectively inhibit the V600-mutated BRAF, which results in initial antitumor activity, but also leads to paradoxical activation through stimulation of the MAPK signaling pathway, causing treatment resistance and development of secondary malignancies, primarily skin squamous cancer and other skin-related side effects. The current solution to the paradoxical activation problem is concomitant administration of MEK inhibitors, but while the skin side effects are reduced, they are not eliminated and acquired resistance still emerges. In addition, Class II and III BRAF mutations are not inhibited by first generation BRAF inhibitors. Designed to overcome this paradoxical activation, paradox-breaking BRAF inhibitors represent the next generation approach to targeting BRAF. There are currently several paradox breakers BRAF inhibitors in clinical development, none are FDA approved.

Available data to date suggests that NXP200 is the only paradox-breaker BRAF inhibitor that has consistently demonstrated single agent activity in CNS tumors but, importantly, also in additional solid tumor types that harbor BRAF mutations. In a completed dose escalation study of NXP200 as monotherapy in heavily pre-treated patients with BRAF V600-mutated solid tumors, including ones previously treated with BRAF/MEK inhibitors, NXP200 demonstrated an acceptable safety profile and single-agent durable clinical activity in various tumor types, including a >40% response rate in low- and high-grade adult glioma, including one Complete Response. Durable responses were also demonstrated in non-small cell lung cancer (NSCLC), colorectal and papillary thyroid cancers.

In this dose escalation program, treatment with a first-generation, free base form of NXP200 was used. A second-generation salt form of NXP200 was recently developed to enhance the pharmacokinetic (PK) profile of NXP200, and early data indeed demonstrate a marked improved PK and greater single agent clinical activity. Thus, with favorable pharmacology, promising early clinical data and possible applicability across V600, Class I and Class II-altered solid tumors, NXP200 could emerge as a best-in-class next-generation BRAF inhibitor. NXP200 is currently in a Phase 1b study in China.

The combined annual revenue for the first-generation BRAF inhibitors, typically administered in combination with a MEK inhibitor to overcome paradoxical activation, is estimated at approximately $4BN.

Of note, in April 2026, Servier acquired Day One Biopharmaceuticals for $2.5BN with its only FDA approved drug, Ojemda (tovorafenib), a first generation BRAF inhibitor which is indicated for the treatment of relapsed or refractory pediatric in BRAF-altered low-grade glioma. With projected 2026 sales of $225-250M, sales of Ojemda represent only 6% of the current BRAF market.

Intellectual Property

Both compounds have strong intellectual property protection including composition of matter patents for NXP100 and NXP200 which expire in 2043 and 2042, respectively.

Transaction Terms

Nuvectis in-licensed exclusive worldwide Ex-China rights for two drug candidates from Haisco. Haisco also retains rights for NXP100 in India and certain Southeast Asia territories. Haisco will receive upfront and near-term payments totaling up to USD $40 million and is eligible to receive up to USD $1.421BN in additional development, regulatory, and commercial milestone payments, as well as tiered royalties on future net sales. The agreement is subject to certain financing conditions which Nuvectis is required to meet to ensure sufficient capital for the development of the licensed products.

Conference Call and Webcast Information

Date: Monday, June 22, 2026, at 8:30 AM ET Participant Dial-in (U.S.): 1-877-407-0752 Participant Dial-in (International): 1-201-389-0912 Webcast Access: Click Here A replay of the webcast will be available on the Investors section of the Nuvectis website at: https://nuvectis.com/investors/

Third-party products mentioned herein are the trademarks of their respective owners.

About Nuvectis Pharma, Inc.

Nuvectis Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development of innovative therapies for the treatment of immune complement-related conditions and oncology. The Company’s pipeline includes NXP100, a complement Factor B inhibitor in development for the treatment of complement-mediated diseases, and the oncology drug candidates NXP900 and NXP200, in development for the treatment of advanced cancers.

NXP100 is a late-stage Factor B inhibitor with best-in-class potential as an effective therapy in multiple complement-mediated diseases and provide a convenience advantage as the only once-daily oral treatment option for these diseases requiring life-long treatment.

NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1 intended to inhibit the catalytic and scaffolding functions of the SRC kinase, providing comprehensive shutdown of the signaling pathway.

NXP200 is an oral, brain penetrant, paradox-breaker BRAF inhibitor for the treatment of BRAF V600X-mutated and Class II/III non-V600-mutated solid tumor malignancies, including CNS, colorectal cancer CRC, melanoma, and NSCLC, with best-in-class potential.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. federal securities laws, which are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate”, “believe”, “contemplate”, “could”, “estimate”, “expect”, “intend”, “seek”, “may”, “might”, “plan”, “potential”, “predict”, “project”, “target”, “aim”, “should”, “will”, “would”, or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward looking statements are based on Nuvectis Pharma, Inc.’s current expectations and interpretations of data and information available, including preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for its pipeline products NXP100, NXP200, and NXP900, and estimates and projections regarding our financial condition. The outcomes of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties may also be subject to market and other conditions and described more fully in the section titled “Risk Factors” in our first quarter 2026 Form 10-Q and our other public filings with the U.S. Securities and Exchange Commission (“SEC”). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Other than statements of historical fact, all statements are considered forward-looking statements and are based on our interpretations of past events as well as current expectations, estimates, and projections.

  • The transaction transforms Nuvectis into a late-stage clinical development company by expanding its pipeline into complement-mediated diseases with the in-licensing of a Complement Factor B inhibitor (CFBi [NXP100]) and also enhances the oncology product pipeline with the in-licensing of a paradox breaker BRAF inhibitor (BRAFi [NXP200]) for the treatment of BRAF-mutated malignancies.
  • NXP100 (HSK39297): A once-daily, oral CFBi in late-stage development for the treatment of complement-mediated diseases. Current development status in China includes:
  • Two Marketing Authorization Applications (MAAs) are under review for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH); The applications seek approvals for NXP100 for the treatment of PNH in treatment-naive patients and in patients who failed treatment with a Complement protein 5 (C5) inhibitor.
  • Successful completion of a Phase 2 and ongoing Phase 3 trial in Immunoglobulin A Nephropathy (IgAN).
  • Ongoing Phase 2 trial in Lupus Nephritis (LN).
  • NXP200 (HSK42360): An oral, brain penetrant, paradox-breaker BRAF inhibitor for the treatment of BRAF V600X-mutated and Class II/III non-V600-mutated malignancies. NXP200 has generated single agent durable responses in several tumor types including CNS, colorectal, melanoma, non-small-cell lung cancer, papillary thyroid and others. Paradox breaking represents a next generation approach to targeting BRAF. A Phase 1b study in China is ongoing.
  • Strong intellectual property protection for both compounds.
  • Nuvectis will hold a conference call today at 8:30 AM ET to introduce its newly in-licensed products.

Fort Lee, NJ, June 22, 2026 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) (“Nuvectis” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of complement-related conditions and oncology, today announced a strategic portfolio expansion via a license agreement for exclusive ex-China rights with Haisco Pharmaceutical Group (“Haisco”) to two potentially best in-class clinical-stage compounds. Nuvectis will hold a conference call today at 8:30 AM ET to introduce its newly in-licensed products.

Haisco (SHE ticker code: 002653) is a leading fully-integrated pharmaceutical company with approximately 50 marketed products and 70 research programs, most recently recognized for successfully executing licensing deals with Eli Lilly and AbbVie (both in 2Q2026), and the phase 3 success of envudeucitinib in plaque psoriasis (1Q2026), a compound which Haisco discovered and advanced through development until it was licensed to Alumis, Inc.

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “The in-licensing of the two clinical stage drug candidates with best-in-class potential represents an expansion of Nuvectis’ pipeline and strategy.” Mr. Bentsur continued, “NXP100 is a late-stage Factor B inhibitor with the potential to become an effective therapy in multiple complement-mediated diseases and provide a convenience advantage as a once-daily oral treatment option for these diseases requiring life-long treatment. With regards to NXP200, the paradox-breaker BRAF inhibitor, the ability to overcome the limitations of older generation BRAF inhibitors, a validated pharmaceutical class, is an area of great interest and we are very pleased to add NXP200 to our oncology pipeline, in which NXP900, our incumbent drug candidate, is progressing toward important clinical inflection points from the ongoing Phase 1b starting in this summer.” Mr. Bentsur concluded, “With tremendous in-house drug development capabilities and two recently completed licensing deals with Eli Lilly and AbbVie, Haisco is recognized as a premier drug development company with global reach. We are thankful for this opportunity and are privileged to partner with Haisco as we look forward to our collaboration and advancing these development programs.”

Dr. Pangke Yan, Chief Executive Officer of Haisco, commented, “This licensing deal, in addition to our recently completed deals, further strengthens Haisco’s global research and development presence and we are excited to collaborate with Nuvectis on these two projects. We believe that Nuvectis has the relevant experience and capabilities required to advance these projects and that together we can accelerate and offer high-quality treatment options to patients worldwide.”

Clinical / Regulatory Status in China and Key Data Summaries for NXP100 and NXP200

NXP100 (HSK39297)

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Two MAAs for NXP100 have been submitted to the Chinese National Medical Products Administration (NMPA) and are currently under review:

The first MAA is based on positive data from a completed randomized, open-label, active comparator-controlled, Phase 3 study (clinicaltrials.gov NCT06799546). In this study, 73 adult Chinese treatment naïve PNH patients were randomized 1:1 to receive either NXP100 or Soliris® (eculizumab), a Complement C5 inhibitor, for a 24-week treatment period. The primary efficacy endpoint was to evaluate the proportion of patients achieving hemoglobin (Hgb) levels ≥ 12 g/dL on at least three out of four measurements between Week 18 and Week 24 in the absence of red blood cell (RBC) transfusions. Treatment with NXP100 was superior to treatment with eculizumab in the primary and all key secondary endpoints (overall increase in Hgb levels, reducing the requirement for RBC transfusions, and avoiding extravascular hemolysis).

Parameter NXP100(n=37) Eculizumab(N=36)
Primary Endpoint
Proportion of participants achieving Hgb levels ≥12 g/dL without RBC transfusion% (95% CI) 59.5 (43.2, 75.7) 8.3 (2.8, 19.4)
p-Value < 0.001

The second MAA is based on positive data from a completed single-arm, Phase 3 study (clinicaltrials.gov NCT07052838). In this study, 36 adult Chinese patients with PNH and persistent anemia who failed treatment with C5 inhibitors were treated with NXP100 for a 24-week treatment period. The primary efficacy endpoint was to evaluate the proportion of patients achieving Hgb levels ≥ 12 g/dL on at least three out of four measurements between Week 18 and Week 24 in the absence of RBC transfusions from Week 2, with efficacy prospectively defined as having the lower bound of the 95% CI for the response rate exceeding 20%. The study met the primary and all key secondary endpoints (overall increase in Hgb levels, reducing the requirement for RBC transfusions, and avoiding extravascular hemolysis).

Parameter NXP100(n=36)
Primary Endpoint
Proportion of participants achieving Hgb levels ≥12 g/dL without RBC transfusion % (95% CI) 52.8 (35.5, 69.6)

Immunoglobulin A Nephropathy (IgAN)

In China, a Phase 3 clinical trial (NCT07390123) is ongoing in IgAN following positive data from a randomized, placebo-controlled Phase 2 (NCT06670352). In the Phase 2 study, the efficacy of treatment with NXP100 was investigated in a 24-week treatment period versus placebo with efficacy defined as reduction in the ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 12 weeks of treatment. Treatment with NXP100 resulted in clinically meaningful reduction in 24h-UPCR after 4 weeks, and the magnitude of the treatment effect increased over time. NXP100 also demonstrated excellent estimated Glomerular Filtration Rate (eGFR) control (a secondary endpoint) vs placebo in the study.

Parameter Week 4 Week 12(Primary Endpoint) Week 24
Reduction in 24h-UPCR relative to baseline vs. placebo  NXP100 N=24  Placebo N=21 -33% -45.3% -57.7%

In addition, a Phase 2 of NXP100 for the treatment of LN is also ongoing in China.

NXP100 Competitive Landscape and Market Analysis

  • The PNH market size is expected to be >$5.0BN in 2026 with the injectable C5 inhibitor drugs Soliris® and Ultomiris®, marketed by Alexion/AstraZeneca Rare Disease, projected to be approximately $4.5BN of the total market. The PNH market is expected to more than double to >$10BN within 8 years. Soliris and Ultomiris were the centerpiece of Astra Zeneca’s acquisition of Alexion in 2021 for $39BN.
  • Fabhalta (iptacopan, launched in 2024), marketed by Novartis, is the only FDA approved Complement Factor B inhibitor with approvals in PNH, IgAN and C3G.
    • Fabhalta®is administered orally, twice per day, vs NXP100 which is administered once a day.
    • Fabhalta® is currently also being investigated in several clinical trials, including LN, Myasthenia Gravis (MG) and dry Age-related Macular Degeneration (dAMD).
    • Fabhalta® peak annual revenue in the currently approved indications is projected by analysts to reach $5B to $10B. The PNH and IgAN markets are estimated to reach >$20BN combined within the next 10 years.
  • In randomized Phase 3 clinical trials in patients with PNH, treatment with either NXP100 or Fabhalta® was superior to treatment with C5 inhibitors, with comparable treatment effect for NXP100 and Fabhalta across studies, positioning CFBis to potentially dominate the PNH market over time.
  • In IgAN, the Phase 2 data suggests that NXP100 has the potential to be comparable to the best injectable APRIL/BAFF inhibitors on the key renal function endpoints, including 24-hour UPCR and eGFR control.
  • In cross study comparisons, the observed safety profile of NXP100 appears to be similar to that of Fabhalta®.

NXP200 (HSK42360)

Overview, Competitive Landscape and Market Analysis

BRAF is a validated therapeutic target in oncology with first generation drugs such as Tafinlar® (dabrafenib, marketed by Novartis) and Braftovi® (encorafenib, marketed by Pfizer) approved in multiple indications. These first-generation BRAF inhibitors effectively inhibit the V600-mutated BRAF, which results in initial antitumor activity, but also leads to paradoxical activation through stimulation of the MAPK signaling pathway, causing treatment resistance and development of secondary malignancies, primarily skin squamous cancer and other skin-related side effects. The current solution to the paradoxical activation problem is concomitant administration of MEK inhibitors, but while the skin side effects are reduced, they are not eliminated and acquired resistance still emerges. In addition, Class II and III BRAF mutations are not inhibited by first generation BRAF inhibitors. Designed to overcome this paradoxical activation, paradox-breaking BRAF inhibitors represent the next generation approach to targeting BRAF. There are currently several paradox breakers BRAF inhibitors in clinical development, none are FDA approved.

Available data to date suggests that NXP200 is the only paradox-breaker BRAF inhibitor that has consistently demonstrated single agent activity in CNS tumors but, importantly, also in additional solid tumor types that harbor BRAF mutations. In a completed dose escalation study of NXP200 as monotherapy in heavily pre-treated patients with BRAF V600-mutated solid tumors, including ones previously treated with BRAF/MEK inhibitors, NXP200 demonstrated an acceptable safety profile and single-agent durable clinical activity in various tumor types, including a >40% response rate in low- and high-grade adult glioma, including one Complete Response. Durable responses were also demonstrated in non-small cell lung cancer (NSCLC), colorectal and papillary thyroid cancers.

In this dose escalation program, treatment with a first-generation, free base form of NXP200 was used. A second-generation salt form of NXP200 was recently developed to enhance the pharmacokinetic (PK) profile of NXP200, and early data indeed demonstrate a marked improved PK and greater single agent clinical activity. Thus, with favorable pharmacology, promising early clinical data and possible applicability across V600, Class I and Class II-altered solid tumors, NXP200 could emerge as a best-in-class next-generation BRAF inhibitor. NXP200 is currently in a Phase 1b study in China.

The combined annual revenue for the first-generation BRAF inhibitors, typically administered in combination with a MEK inhibitor to overcome paradoxical activation, is estimated at approximately $4BN.

Of note, in April 2026, Servier acquired Day One Biopharmaceuticals for $2.5BN with its only FDA approved drug, Ojemda (tovorafenib), a first generation BRAF inhibitor which is indicated for the treatment of relapsed or refractory pediatric in BRAF-altered low-grade glioma. With projected 2026 sales of $225-250M, sales of Ojemda represent only 6% of the current BRAF market.

Intellectual Property

Both compounds have strong intellectual property protection including composition of matter patents for NXP100 and NXP200 which expire in 2043 and 2042, respectively.

Transaction Terms

Nuvectis in-licensed exclusive worldwide Ex-China rights for two drug candidates from Haisco. Haisco also retains rights for NXP100 in India and certain Southeast Asia territories. Haisco will receive upfront and near-term payments totaling up to USD $40 million and is eligible to receive up to USD $1.421BN in additional development, regulatory, and commercial milestone payments, as well as tiered royalties on future net sales. The agreement is subject to certain financing conditions which Nuvectis is required to meet to ensure sufficient capital for the development of the licensed products**.**

Conference Call and Webcast Information

  • Date: Monday, June 22, 2026, at 8:30 AM ET
  • Participant Dial-in (U.S.): 1-877-407-0752
  • Participant Dial-in (International): 1-201-389-0912
  • Webcast Access: Click Here

A replay of the webcast will be available on the Investors section of the Nuvectis website at: https://nuvectis.com/investors/

Third-party products mentioned herein are the trademarks of their respective owners.

About Nuvectis Pharma, Inc.

Nuvectis Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development of innovative therapies for the treatment of immune complement-related conditions and oncology. The Company’s pipeline includes NXP100, a complement Factor B inhibitor in development for the treatment of complement-mediated diseases, and the oncology drug candidates NXP900 and NXP200, in development for the treatment of advanced cancers.

NXP100 is a late-stage Factor B inhibitor with best-in-class potential as an effective therapy in multiple complement-mediated diseases and provide a convenience advantage as the only once-daily oral treatment option for these diseases requiring life-long treatment.

NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1 intended to inhibit the catalytic and scaffolding functions of the SRC kinase, providing comprehensive shutdown of the signaling pathway.

NXP200 is an oral, brain penetrant, paradox-breaker BRAF inhibitor for the treatment of BRAF V600X-mutated and Class II/III non-V600-mutated solid tumor malignancies, including CNS, colorectal cancer CRC, melanoma, and NSCLC, with best-in-class potential.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. federal securities laws, which are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate”, “believe”, “contemplate”, “could”, “estimate”, “expect”, “intend”, “seek”, “may”, “might”, “plan”, “potential”, “predict”, “project”, “target”, “aim”, “should”, “will”, “would”, or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward looking statements are based on Nuvectis Pharma, Inc.’s current expectations and interpretations of data and information available, including preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for its pipeline products NXP100, NXP200, and NXP900, and estimates and projections regarding our financial condition. The outcomes of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties may also be subject to market and other conditions and described more fully in the section titled “Risk Factors” in our first quarter 2026 Form 10-Q and our other public filings with the U.S. Securities and Exchange Commission (“SEC”). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Other than statements of historical fact, all statements are considered forward-looking statements and are based on our interpretations of past events as well as current expectations, estimates, and projections.

u/MarketNewsFlow — 14 days ago
▲ 12 r/MicroCapNews+8 crossposts

$QUCY - Quantum Cyber Issues Letter to Shareholders (NASDAQ: QUCY)

Quantum Cyber Issues Letter to Shareholders

Capitol Hill Meetings with Rep. McCormick and Senior Officials | Pentagon City Defense Conference | Connecticut Facility Purchase Agreement in Progress | Strong Financial Position

June 22, 2026 07:30 ET | Source: Quantum Cyber

WEST PALM BEACH, Florida, June 22, 2026 (GLOBE NEWSWIRE) --

Dear Fellow Shareholders,

I am writing to update you on a series of significant developments that have taken shape over the past several weeks. Together, they reflect a company that is executing with purpose: deepening its relationships in Washington, progressing its manufacturing buildout, and operating from a position of financial strength.

Washington, D.C. Engagement: Capitol Hill and Senior Government Officials

Over the past several days, our leadership delegation traveled to Washington, D.C. for a series of high-level government engagements. I had the opportunity to meet directly with Representative Rich McCormick to discuss the evolving homeland security needs facing the United States and the role that autonomous defense technology can play in addressing them. We also held meetings with senior-ranked government officials across the fields of cyber security and homeland security.

I was joined on this delegation by members of Quantum Cyber's technology and business leadership team. These were substantive conversations, and I believe they reflect growing recognition at the federal level that domestically manufactured, AI-powered autonomous platforms are central to the United States' near-term defense and security posture. We plan to continue cultivating these relationships as we advance our platform.

Pentagon City: Defense and Military Conference

While in the Washington area, we hosted a conference at Pentagon City with military stakeholders and officials from the Department of War. These discussions centered on the operational requirements, procurement priorities, and deployment scenarios most relevant to our System-of-Systems platform. The level of engagement we received reinforces our conviction that the Company is building capabilities that are directly aligned with where federal defense spending and doctrine are headed.

Connecticut Manufacturing Facility: Advancing Toward a Definitive Purchase Agreement

As previously announced on June 8, 2026, our wholly owned subsidiary Quantum Drones Corporation signed a Letter of Intent to acquire an approximately 43,000-square-foot manufacturing facility located in Bridgeport, Connecticut, from Arcade Technology LLC for an aggregate purchase price of $3,200,000. I am pleased to report that we are actively working toward the execution of a definitive purchase agreement and are making meaningful progress in that process.

This facility, which includes industrial manufacturing equipment such as stamping presses, CNC machining centers, lathes, milling machines, surface grinders, and metal fabrication tooling, is intended to serve as the operational foundation for our domestic defense manufacturing complex. Our plans for the complex include drone airframe assembly, an 80-unit 3D-printing drone production farm, our Advanced Filament Manufacturing Division producing both standard and patented EMP-hardened composite filament, and dedicated quality assurance infrastructure. Once operational, this facility is designed to allow Quantum Cyber to deliver combat-ready autonomous systems at the scale that the Pentagon and our government customers require. We look forward to providing further updates as the transaction progresses.

Executing From Financial Strength

We have significantly strengthened our financial position following the recent receipt of over $15 million in warrant exercise proceeds in May 2026. Our capital structure is also currently debt-free, with no exercisable warrants outstanding.

Management believes the existing cash position provides sufficient runway to fund the continued build-out of our autonomous defense platform, including our disclosed technology licensing pipeline, ongoing patent prosecution, and the strategic acquisition activity currently in progress. We intend to maintain this financial discipline as we move into the next phase of the Company's development.

Closing Remarks

The past several weeks have been among the most productive in Quantum Cyber's short history as an autonomous defense company. We have engaged with the officials who shape federal defense and homeland security policy. We have hosted high-level conferences with the military and the Department of War. We are steps away from acquiring the U.S.-based manufacturing infrastructure we need to deliver hardware at scale. And we are doing all of this from a debt-free balance sheet with cash in hand.

We are building this company with urgency, with discipline, and with a clear view of where the defense procurement market is heading. Thank you for your continued confidence and support.

Sincerely,
David Lazar
Chief Executive Officer
Quantum Cyber N.V. (Nasdaq: QUCY)

Forward-Looking Statements

Certain statements made in this letter are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "expect," "estimate," "plan," "outlook," and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. The signing of a Letter of Intent does not guarantee the execution of a definitive purchase agreement or the consummation of the proposed transaction, and there can be no assurance that the transaction will close on the terms described or at all. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company's expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to execute a definitive purchase agreement or satisfy closing conditions for the Connecticut facility; (ii) the failure to meet projected development and operational targets; (iii) changes in applicable laws or regulations; (iv) an inability to successfully execute on the Company's acquisition and technology pipeline; and (v) other risks and uncertainties discussed from time to time in other reports and public filings with the Securities and Exchange Commission (the "SEC") by the Company. The Company's SEC filings are available publicly on the SEC's website at www.sec.gov. Any forward-looking statement made in this letter speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, except as required by law.

Investor Relations Contact
Arx Investor Relations
North American Equities Desk
qucy@arxhq.com

https://www.globenewswire.com/news-release/2026/06/22/3315200/0/en/Quantum-Cyber-Issues-Letter-to-Shareholders.html

u/MarketNewsFlow — 7 days ago

$QTEX - QTREX Announces Management Share Purchase Plan (NASDAQ: QTEX)

QTREX Announces Management Share Purchase Plan

Nes Ziona, Israel, June 22, 2026 (GLOBE NEWSWIRE) -- QTREX Quantum Ltd. (Nasdaq: QTEX) ("QTREX" or the "Company") a company focused on advancing Additively Manufactured Electronics ("AME") for quantum computing infrastructure today announced that Dagi Ben-Noon, Chief Executive Officer of QTREX, Tal Parnas, Chairman of the Company's Board of Directors, and members of the Company's senior management team have informed QTREX's Board of Directors of their intention to use personal funds to purchase up to an aggregate of 2,000,000 of the Company's ordinary shares, no par value per share (the "Ordinary Shares") over the next 12 months from June 22, 2026, pursuant to and subject to applicable rules and regulations as well as the Company's insider trading policy.

The actual share purchases under the repurchase plan will commence following the release of the Company's financial results for the period ending June 30, 2026 and will remain subject to applicable rules and regulations, the Company's insider trading policy, blackout periods, reporting obligations and any applicable trading plan requirements.

The Company's management share purchases are expected to be made primarily through open-market transactions at prevailing market prices and may also be made from time to time in privately negotiated transactions, block trades and/or other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations.

QTREX continues to advance its AME-based quantum connectivity strategy across cryogenic interconnect applications, cryogenic chip carrier development, advanced materials and strategic industry collaborations. The Company will continue to update shareholders on material business milestones as appropriate.

About QTREX Quantum

QTREX Quantum Ltd. (Nasdaq: QTEX) is a technology company focused on advanced connectivity and electronics manufacturing solutions for next-generation hardware markets. Following its acquisition of the AME platform, the Company is developing high-density, thermally optimized quantum connectivity solutions for dilution cryostats and advancing AME applications for defense, aerospace, missile, space, and other mission-critical environments. The Company also continues to advance its medical technology portfolio, including respiratory support and blood monitoring platforms, while actively working to monetize certain parts of the medical business.

For more information, please visit: http://q-trex.com/

Forward-Looking Statement Disclaimer

This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. These forward-looking statements are based on the current expectations of the management of the Company only and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. For example, the Company is using forward-looking statements when it discusses the repurchase plan and the ability of the Company's management to implement it. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements. More detailed information about the risks and uncertainties affecting the Company is contained under "Risk Factors" in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission.

Company Contact

QTREX Quantum
Email: info@q-trex.com
Phone: +972-9-9664485

https://www.globenewswire.com/news-release/2026/06/22/3315180/0/en/QTREX-Announces-Management-Share-Purchase-Plan.html

u/MarketNewsFlow — 14 days ago
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$QTEX - QTREX Expands into Quantum Processor Interface with Single-Build Cryogenic Chip Carrier (NASDAQ: QTEX)

QTREX Expands into Quantum Processor Interface with Single-Build Cryogenic Chip Carrier

Based on a design supplied by a major U.S.-based technology company active in quantum computing, the milestone extends QTREX's AME platform into the processor-interface layer, expanding its role within future quantum computing architectures

June 18, 2026 07:30 ET | Source: QTREX Quantum Ltd.

Nes Ziona, Israel, June 18, 2026 (GLOBE NEWSWIRE) -- QTREX Quantum Ltd. (Nasdaq: QTEX) ("QTREX" or the "Company") a company focused on advancing Additively Manufactured Electronics ("AME") for quantum computing infrastructure, today announced a major technical and strategic milestone: the Company has successfully produced a cryogenic chip carrier using its proprietary single-build AME process, based on a design supplied by one of the world's largest U.S.-based technology companies developing full-stack quantum computing systems.

The achievement expands QTREX's role within the quantum hardware stack into the processor-interface layer, demonstrating that the Company's AME platform can address both signal transport and critical carrier-level functions around the quantum processor. By enabling these capabilities within a single AME architecture, QTREX believes it is opening a new category of quantum computing components and expanding its addressable opportunity across future quantum system architectures.

A cryogenic chip carrier supports the quantum processor and manages signal fan-out between the processor interface and the cryogenic I/O stack. As quantum systems scale, this interface becomes increasingly important. Higher channel counts require denser routing, stronger shielding, lower thermal load, controlled signal integrity and repeatable manufacturing inside highly constrained cryogenic environments.

QTREX's carrier uses a Kapton-class polyimide architecture adapted for very low-temperature environments. The single-build AME process is designed to integrate the cryogenic chip carrier and interconnect structure into one monolithic architecture, enabling conductive pathways, dielectric structures, shielding features and direct interconnect transitions to be produced together rather than assembled through separate connectors and manual steps. By reducing connectorized transitions, the architecture is intended to lower potential failure points, simplify the signal path and support substantially higher routing density. Because shielding can be engineered directly into the carrier, and because AME enables 3D routing geometries, this approach can open a new integration path for high-channel-count quantum processors that conventional connector-based architectures are not designed to support.

"Following engagement with multiple quantum computing companies and the evaluation of this capability with one of the industry's leading players, we view this milestone as representing a meaningful expansion of our position within the quantum hardware ecosystem," said Dagi Ben-Noon, CEO of QTREX. "By enabling the cryogenic chip carrier and interconnect structure to be produced within the same single-build AME architecture, we are expanding our quantum connectivity platform to include processor-interface functions. This capability further strengthens QTREX's role in addressing one of the fundamental scaling challenges facing the quantum computing industry."

Following interest from multiple quantum hardware companies and strategic technology customers, the next phase is expected to focus on customer-specific cryogenic chip carrier designs tailored to each processor architecture, chip design and system-level requirement.

QTREX plans to present the chip carrier sample during private meetings in Boston around Quantum.Tech World 2026, taking place on June 25–26, 2026. Industry participants, research institutions and strategic partners interested in viewing the sample or discussing customer-specific processor-interface designs may contact Yoav Rozanovich, Chief Business Officer, at yoavr@q-trex.com or info@q-trex.com to request a meeting.

About QTREX Quantum

QTREX Quantum Ltd. (Nasdaq: QTEX) is a technology company focused on advanced connectivity and electronics manufacturing solutions for next-generation hardware markets. Following its acquisition of the AME platform, the Company is developing high-density, thermally optimized quantum connectivity solutions for dilution cryostats and advancing AME applications for defense, aerospace, missile, space, and other mission-critical environments. The Company also continues to advance its medical technology portfolio, including respiratory support and blood monitoring platforms, while actively working to monetize certain parts of the medical business.

For more information, please visit: www.q-trex.com

Forward-Looking Statement Disclaimer

This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. These forward-looking statements are based on the current expectations of the management of the Company only and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. For example, the Company is using forward-looking statements when it discusses the benefits, advantages and capabilities of its AME platform and cryogenic quantum chip carrier; that the achievement expands its role within the quantum hardware stack into the processor-interface layer, demonstrating that its AME platform can address both signal transport and critical carrier-level functions around the quantum processor, that the milestone represents a meaningful expansion of its position within the quantum hardware ecosystem; that this new capability further strengthens its role in addressing one of the fundamental scaling challenges facing the quantum computing industry and that its next phase is expected to focus on customer-specific cryogenic chip carrier designs tailored to each processor architecture, chip design and system-level requirement; potential customer, partner and commercial discussions; and its plans to present the sample in Boston. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements. More detailed information about the risks and uncertainties affecting the Company is contained under "Risk Factors" in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission.

Company Contact:
QTREX Quantum
Email: info@q-trex.com
Phone: +972-9-9664485

Investor Relations Contact:
Arx Investor Relations
North American Equities Desk
Email: QTREX@arxhq.com

https://www.globenewswire.com/news-release/2026/06/18/3314085/0/en/qtrex-expands-into-quantum-processor-interface-with-single-build-cryogenic-chip-carrier.html

reddit.com
u/MarketNewsFlow — 14 days ago
▲ 11 r/MicroCapNews+9 crossposts

$SEGN.V - Seegnal Successfully Initiates First U.S. Pilot Program (TSXV: SEGN)

Seegnal Successfully Initiates First U.S. Pilot Program

Pilot now underway with U.S.-based long-term care provider following the previously announced letter of intent

CALGARY, AB, June 19, 2026 (GLOBE NEWSWIRE) -- Seegnal Inc. (TSXV: SEGN) ("Seegnal" or the "Company"), a developer of innovative healthcare technology focused on mitigating medication risks, is pleased to announce that it has successfully initiated its first pilot program in the U.S., following the letter of intent, announced on May 19, 2026.

The pilot program is being conducted with a U.S.-based long-term care provider and is expected to run between 8 and 12 weeks from the receipt of data, followed by a potential extended evaluation period.

Approximately 1.2 million Americans live in CMS-certified nursing facilities,¹ a population characterized by advanced age, multiple chronic conditions, and high rates of polypharmacy. Adverse drug events are a significant and often preventable source of hospitalization in this population: an estimated 99,628 emergency hospitalizations each year in U.S. adults aged 65 and older are attributable to adverse drug events.²

"Initiating this pilot is an important step in executing on our U.S. commercial strategy," said Elad Bibi-Aviv, Chief Executive Officer of Seegnal. "Long-term care is a setting where medication complexity, polypharmacy, and the need for individualized prescribing decisions converge. These are areas where our platform was designed to add value." "We look forward to working with our pilot partner and to reporting on progress in due course."

About Seegnal

Seegnal Inc. (TSXV: SEGN) is an innovative healthcare technology company dedicated to reducing medication-related harm where care begins. The Company's SaaS-based clinical decision support platform is designed to help clinicians prescribe with greater precision by integrating patient-specific data at the point of care, including medications, laboratory results, renal function, allergies, age, and other relevant risk factors. By delivering more targeted, context-aware medication alerts within existing clinical workflows, Seegnal aims to reduce alert fatigue, support safer prescribing, and advance a more personalized standard of patient care. Seegnal's technology is deployed across healthcare settings and is used by more than 15,000 clinicians in daily practice. For additional Company information, please visit https://www.seegnal.com/ and follow us on LinkedIn.

Company Contact:
Elad Bibi-Aviv
Chief Executive Officer
+1 (929) 248 4652

Investor Relations Contact:
North American Equities Desk
seegnal@arxhq.com

Forward-Looking Information

This news release includes certain "forward-looking information" as defined under applicable Canadian securities legislation, including statements regarding the plans, intentions, beliefs, and current expectations of the Company with respect to future business activities and operating performance. Forward-looking information is often identified by the words "may", "would", "could", "should", "will", "intend", "plan", "anticipate", "believe", "estimate", "expect" or similar expressions and includes information regarding: the conduct, scope, duration, and outcomes of the pilot of Seegnal's clinical decision support platform; the potential for an extended evaluation period or any subsequent commercial agreement; and the Company's U.S. commercial expansion strategy. Forward-looking information is necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such risks and uncertainties include, without limitation: the pilot may be paused, suspended, modified, or terminated; the pilot may not be completed on the anticipated timeline or at all; technical, integration, data-availability, clinician-participation, regulatory, and privacy-related conditions may not continue to be satisfied; the pilot may not produce the clinical, operational, or economic outcomes contemplated; the parties may not enter into an extended evaluation or any subsequent commercial agreement; and the Company's broader U.S. commercial expansion may proceed more slowly than anticipated, or not at all. Accordingly, readers should not place undue reliance on forward-looking information, which speaks only as of the date of this news release. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by law.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

¹ KFF, "A Look at Nursing Facility Characteristics in 2025," December 17, 2025. Available at: https://www.kff.org/medicaid/a-look-at-nursing-facility-characteristics/

² Budnitz DS, Lovegrove MC, Shehab N, Richards CL. "Emergency Hospitalizations for Adverse Drug Events in Older Americans." New England Journal of Medicine. 2011;365(21):2002-2012. Available at: https://www.nejm.org/doi/full/10.1056/NEJMsa1103053

https://www.globenewswire.com/news-release/2026/06/19/3314728/0/en/Seegnal-Successfully-Initiates-First-U-S-Pilot-Program.html

u/MarketNewsFlow — 8 days ago
▲ 11 r/pennystocks_No_Rules+9 crossposts

$SCAI - SalesCloser Launches Self-Serve Multimodal AI Website Agent, Expanding Its Platform Beyond Sales Teams to Any Business With a Website (TSXV: SCAI)

SalesCloser Launches Self-Serve Multimodal AI Website Agent, Expanding Its Platform Beyond Sales Teams to Any Business With a Website

New product aims to bring SalesCloser's conversational AI directly onto customer websites, combining text chat and live audio-visual conversation in a single agent, with a free-to-start, usage-based model designed to lower barriers to adoption

New product aims to further expand SalesCloser's commercial user base by providing a new and frictionless way to experience its technology in a major bottleneck many potential customers experience

Vancouver, BC, June 16, 2026 (GLOBE NEWSWIRE) -- SalesCloser Technologies Ltd. ("SalesCloser" or the "Company") (TSXV: SCAI) (FSE: MJ5), a pioneer in autonomous AI sales technology, today announced the launch of a new self-serve, multimodal AI website agent that businesses can deploy directly on their websites to engage, qualify, and assist visitors in real time. The product is now live and available to sign up for without a sales call or a credit card.

The new agent operates across two modes that effortlessly hand off to each other within a single conversation: text-based chat and live audio-visual conversation with a digital avatar, voice, and shared-screen capability. A visitor can begin with a simple chat question and move to a face-to-face audio-visual conversation, or start audio-visual and drop back to text, with conversation context preserved across the transition. The agent can present its own screen to walk a visitor through a product tour or documentation, and a visitor can share their screen or camera to receive hands-on help. The agent is designed to operate around the clock, across desktop and mobile, in more than 30 languages.

Unlike SalesCloser's existing products, which are deployed through a sales-assisted process, the website agent is the Company's first product built for self-serve adoption. Businesses can get started at no cost, with a monthly allotment of free usage credit, and pricing thereafter is usage-based, so customers pay in proportion to how actively the agent is engaged. Each deployment carries a "Powered by SalesCloser" attribution, which the Company intends to use as a channel for broader awareness across the websites on which the agent runs. The new product operates on the Company's conversational AI platform and its owned model-serving infrastructure, which the Company has previously described as part of its strategy to manage the cost, latency, and scalability of its AI workloads.

"Most websites lose the large majority of their visitors without those visitors completing a desired action, such as making a purchase or submitting a form,¹ and we believe a key reason is the lack of a scalable way to greet and engage everyone who views a website," said Ali Tajskandar, Chief Executive Officer of SalesCloser. "We built this product to change that. It brings a real conversation — chat or face-to-face, the visitor's choice — to every website, and we made it initially free to start so that any business, not only large enterprises, can put it to work. We believe lowering the barrier to entry for this new product is the right way to introduce more of the market to what our technology can do. The new product aims to further expand our commercial user base by providing a frictionless way to experience our technology in a manner that has the potential to address a major bottleneck for many companies."

The launch is intended to extend SalesCloser's platform from products built primarily for sales teams toward AI agents that work directly on a business's website, broadening the Company's potential applicability from organizations with dedicated sales functions and budgets toward the substantially larger universe of businesses that operate a website. That universe sits within the conversational AI market, which, according to a report by Grand View Research, is projected to reach approximately US$41.39 billion in 2030, growing at a compound annual growth rate of approximately 23.7% from 2025 to 2030.² The Company believes the website agent is additive to, rather than a replacement for, its existing subscription business: its demonstration, discovery, and voice calling agents remain available through the existing sales-assisted process and are unchanged by this launch, while the self-serve product is designed to address businesses that want an AI agent on their website without an upfront commitment, and may in turn generate inbound interest for the Company's more advanced, higher-volume offerings as users' needs grow.

The Company intends for the website agent to support visitors across the full customer journey through a single deployment. Before a sale, the agent can greet visitors, ask qualifying questions, identify higher-intent prospects, capture lead information, and walk prospects through features and pricing using its screen-presentation capability. After a sale, it can assist with guided onboarding and configuration questions and handle common support inquiries, including by sharing its screen or accepting a customer's screen share to help diagnose an issue.


About SalesCloser

SalesCloser.ai is a Vancouver-based AI software company focused on automating and scaling revenue generation through conversational AI. The Company's platform enables businesses to deploy AI-powered virtual sales agents that engage prospects and customers across the sales lifecycle. SalesCloser's agents conduct real-time, personalized interactions across voice, video, and digital channels, including lead qualification, product demonstrations, follow-ups, and meeting scheduling. By augmenting core sales functions, the platform helps organizations increase capacity, accelerate pipeline velocity, and improve conversion rates without a corresponding increase in headcount. The platform integrates with existing CRM and business systems, supports multilingual deployment, and delivers consistent, high-quality customer interactions across industries. SalesCloser operates under a subscription-based SaaS model, generating recurring revenue with strong visibility and high gross margins while continuously enhancing its AI capabilities. The Company's technology is supported by a growing portfolio of patent applications focused on improving the performance of AI-driven conversational workflows. SalesCloser.ai is listed on the TSX Venture Exchange under the ticker "SCAI". For more information, visit the SalesCloser investor site at: https://investors.salescloser.ai


Corporate Contact: Adrian Lim, CFO Email: investors@salescloser.ai Phone: 778 655 4329

Investor Relations Contact: Arx Investor Relations North American Equities Desk SCAI@arxhq.com


Forward-Looking Statements

Statements that are not reported financial results or other historical information are forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, "forward-looking statements"). This press release includes forward-looking statements regarding the Company, its subsidiaries and the industries in which they operate, including statements about and references to the anticipated features, capabilities, availability and benefits of the Company's new self-serve multimodal AI website agent, expected adoption of the new product and the effect of a free-to-start, usage-based model on adoption, the expectation that the new product will be additive to and not a replacement for existing subscription revenue, the expectation that the self-serve product may generate inbound interest for the Company's sales-assisted product line, the anticipated expansion of the Company's addressable market, the size and growth of the conversational AI market, the future growth of the Company's products and platforms, the future development and increased use of products incorporating artificial intelligence, the Company's owned model-serving infrastructure and the anticipated benefits thereof, the Company's ability to scale operations, expectations regarding revenue growth and customer acquisition, technology development and platform advancement initiatives, commercial expansion and go-to-market strategies, future profitability, business and acquisition strategies, opportunities, objectives, prospects, the impact of broader economic factors on the Company, and future events and performance. Sentences and phrases containing or modified by words such as "expect", "anticipate", "plan", "continue", "estimate", "intend", "expect", "may", "will", "project", "predict", "potential", "targets", "projects", "is designed to", "strategy", "should", "believe", "contemplate" and similar expressions, and the negative of such expressions, are not historical facts and are intended to identify forward-looking statements. Readers are cautioned to not place undue reliance on forward-looking statements. Actual results and developments may differ materially from those contemplated by forward-looking statements. Although the Company believes that the expectations reflected in forward-looking statements in this press release are reasonable and are based on, among other things, the expectations and analysis of current market trends and opportunities of management of the Company, such forward-looking statements have been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond the Company's control, including, but not limited to, risks associated with the adoption and monetization of new products, the uncertainty of customer uptake of a free-to-start, usage-based offering, the risk that anticipated additive revenue or inbound demand does not materialize, risks associated with changes to SalesCloser and other product's revenue and profitability, changes to customer preferences, competition, use cases for SalesCloser and other products, risks relating to the Company's reliance on third-party service providers and infrastructure, economic uncertainty and instability as a result of the ongoing inflation and supply chain issues, higher interest rate climate, tightening of credit availability and recessionary risks, pandemic related risks, wars, tariffs, instability in global commodity and securities markets, shifts in consumer and institutional spending and marketing strategies, risks related to data breaches and privacy, the changing global market and competition for the products and services supplied by the Company, and the additional risk factors discussed in the continuous disclosure materials of the Company which are available under the Company's profile on SEDAR+ at www.sedarplus.ca. The forward-looking statements contained in this press release are expressly qualified by this cautionary statement and are made as of the date hereof. The Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.


¹ Source: Contentsquare, "Digital Experience Benchmark Report 2026" (average website conversion rate in the low single digits, measured as the share of visits that include a conversion event such as a purchase or form fill).

² Source: Grand View Research, Inc., "Conversational AI Market to be Worth $41.39 Billion by 2030 at CAGR 23.7%" (May 12, 2025).

https://www.globenewswire.com/news-release/2026/06/16/3313078/0/en/salescloser-launches-self-serve-multimodal-ai-website-agent-expanding-its-platform-beyond-sales-teams-to-any-business-with-a-website.html

u/MarketNewsFlow — 15 days ago
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$ENTX - Entera Reports Robust Preclinical Data for EB612 (Oral LA-PTH(1-34)) for Hypoparathyroidism and EB618 (Oral GLP-1/Glucagon) for Obesity at ENDO 2026 (Nasdaq: ENTX)

Entera Reports Robust Preclinical Data for EB612 (Oral LA-PTH(1-34)) for Hypoparathyroidism and EB618 (Oral GLP-1/Glucagon) for Obesity at ENDO 2026

EB612, a first-in-class long-acting PTH(1-34) oral peptide for hypoparathyroidism, produced robust bioavailability and sustained increases in calcium across three preclinical models; IND is expected in late 2026

EB618, a first-in-class dual GLP-1/glucagon oral receptor agonist (oxyntomodulin) for obesity and metabolic disorders, showed dose-proportional pharmacokinetics and a robust effect on blood glucose in non-human primates

TEL AVIV, June 16, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera"), a leader in the development of oral peptides, reported preclinical data at ENDO 2026, the annual meeting of the Endocrine Society, for its EB612 and EB618 pipeline programs. Both EB612 and EB618 programs are being co-developed with OPKO Health Inc. (NASDAQ: OPK).

"The strength of these results underscores the consistency of our N-Tab® platform to develop proprietary oral peptides across a myriad of targets and indications," said Miranda Toledano, Chief Executive Officer of Entera.


EB612: First-in-Class Oral Long-Acting PTH(1-34) Peptide Tablet for Hypoparathyroidism

EB612 is a proprietary first-in-class long-acting PTH(1-34) analog formulated with Entera's N-Tab® oral peptide platform. As the first oral peptide replacement therapy, EB612 aims to provide patients with an oral alternative to currently approved or development-stage peptides that require injections.

In a poster presentation entitled "Pre-Clinical Results for EB612: First-in-Class Oral Long-Acting PTH(1-34) Analog as Hormone Replacement Tablet for Patients with Hypoparathyroidism," Entera highlighted the following data for EB612:

  • In the thyroparathyroidectomized (TPTx) rat model, the established and widely used preclinical model of hypoparathyroidism, the long-acting PTH(1-34) analog, dosed daily for 7 days, restored serum calcium and reduced phosphate to levels comparable to sham control animals.
  • In a minipig model, a single oral dose of EB612 reached maximal plasma levels 2 to 3 hours post-dose, with drug remaining detectable in plasma for more than three days. This sustained pharmacokinetic exposure was associated with a rapid and long-lasting increase in serum Ca in all study animals. The calcemic effect lasted for approximately three days.
  • In a non-human primate model, a single oral dose of EB612 produced a robust and sustained increase in serum calcium for approximately three days, accompanied by a correlating suppression of endogenous PTH levels.

EB612 was well tolerated, with no safety concerns identified, and the calcemic effects were consistent with those reported for clinically validated injectable PTH-replacement therapies for hypoparathyroidism.

Ongoing studies are advancing EB612 toward first-in-human clinical evaluation. As announced in February 2026, Entera and OPKO expanded their collaboration to advance EB612 on a 50/50 basis, with an intention to file an investigational new drug (IND) application in late 2026.


EB618: First-in-Class Oral Dual GLP-1/Glucagon Receptor Agonist (Oxyntomodulin) Tablet for Obesity and Metabolic Disorders

Oxyntomodulin (OXM) is a naturally occurring dual GLP-1/glucagon receptor agonist hormone that regulates appetite and glucose metabolism and promotes weight loss, with additional cardioprotective and anti-fibrotic properties; its therapeutic potential as a native hormone is limited by a short plasma half-life.

The EB618 tablet is a proprietary long-acting OXM analog formulated with Entera's N-Tab® platform.

In a poster presentation at ENDO 2026 entitled "EB618, First-In-Class Oral Tablet of Dual GLP-1/Glucagon Receptor Agonist for Patients with Obesity and Metabolic Disorders: Results from PK-PD Study in Non-Human Primates," Entera reported a single dose pharmacokinetic-pharmacodynamic study in non-human primates:

  • EB618 exhibited robust bioavailability, with dose-proportional systemic exposure across three tested tablet strengths and low variability.
  • A dose-proportional pharmacologic effect on postprandial blood glucose levels was observed.
  • EB618 was well tolerated, with no safety concerns identified, at doses exceeding the anticipated clinical dose range by more than tenfold.

These data support the continued clinical development of EB618 as a potential first-in-class oral once-daily GLP-1/glucagon receptor agonist for the treatment of obesity and metabolic disorders.


About Entera

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages a disruptive and proprietary technology platform (N-Tab®) and its pipeline of first-in-class oral peptide programs. The Company's most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet for osteoporosis. A placebo-controlled, dose-ranging phase 2 study of EB613 tablets (n = 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is also developing the first oral Long Acting PTH(1-34) tablet as a replacement therapy for patients with hypoparathyroidism (EB612), the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide tablet for the treatment of obesity and metabolic syndromes; and the first oral GLP-2 tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health, Inc. For more information on Entera, visit www.enterabio.com or follow us on LinkedIn, Twitter, and Facebook.


Cautionary Statement Regarding Forward-Looking Statements

Various statements in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy, clinical development activities, collaboration arrangements and expected financial and operational results are forward-looking statements. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera's forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's ability to establish and maintain development and commercialization collaborations; Entera's operation as a development stage company with limited operating history; Entera's competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the "Cautionary Statement Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's most recent Annual Report on Form 10-K filed with the SEC, as well as Entera's subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Company Contact: IR@enterabio.com

https://www.globenewswire.com/news-release/2026/06/16/3312598/0/en/entera-reports-robust-preclinical-data-for-eb612-oral-la-pth-1-34-for-hypoparathyroidism-and-eb618-oral-glp-1-glucagon-for-obesity-at-endo-2026.html

u/MarketNewsFlow — 17 days ago