r/nasdaq

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Investor Weekly Report 061 | FF EAI Robotics Exceeds Expectations with 242 Units Delivered, Raises 2026 Target to 2,000

Investor Weekly Report 061 | FF EAI Robotics Exceeds Expectations with 242 Units Delivered, Raises 2026 Target to 2,000

① FF EAI Robotics Achieves 105 June Sales, Shipments and Deliveries, Reaches 242 Units from March–June, Raises 2026 Target to 2,000 Units

② FF Robotics Becomes the Star of Automate and Heads to ISTE Live 2026

Full Script

For Weekly Report Issue #61, I’d like to start with two important bits of progress: FF EAI robots reached another record-high month of sales, shipments, and deliveries, and we are raising our full-year target once again. This is also an early result that the team and I are proud to share, nearly two months after I returned as FF Global CEO and began driving our five new transformations.  

In June, sales, shipments, and deliveries of FF EAI robots reached 105 units. From March through June, cumulative volume reached 242 units, exceeding our original target of 220 units.  

At the same time, we have decided to raise our full-year shipment target to 2,000 units. This marks the second increase to our full-year target, following our April adjustment from 1,000 units to 1,500 units.  

So why has FF’s robotics business continued to exceed expectations, and what gives us the confidence to keep raising our delivery targets?  

First, our five unique strengths are beginning to show. Our robot device capability, in particular, is already becoming a real competitive advantage. With the six major series of the Full-Form FF EAI Robot World now complete, our “one brain, multiple forms” all-star robot super group is demonstrating unique value. At the same time, our other four strengths — the EAI Brain, Data Factory, Industry Bridge, and ecosystem flywheel — are also being gradually unleashed.  

Second, our products and technologies continue to evolve. We are building a full-stack EAI solution built on “VLA + World Model,” centered on the EAI Brain, and supported by our developer platform and Data Factory. Our first-stage goal is to build the No. 1 EAI Brain and No. 1 foundation model for the EAI robotics education ecosystem in the U.S. and, eventually, globally.  

Third, our sales capability and vertical industry ecosystem are gaining market validation and strong recognition from partners, schools, and government stakeholders. I will share more progress on this front in next week’s weekly report.  

Fourth, our team and organizational capabilities continue to strengthen. With the ultimate return of the founding team, our “Human + AI Agent” organizational model has significantly improved both decision-making and execution efficiency.  

Another piece of good news this week came from Automate. As the largest robotics and automation trade show in North America, Automate gave FF a powerful stage for our first appearance at the event. The Full-Form FF EAI Robot World drew tremendous attention, becoming “the star of the show” and one of the most popular must-visit booths at this year’s show. It attracted large crowds, potential customers, and ecosystem partners, and received focused coverage from mainstream media, including FOX, ABC, NBC, NPR, and others. LA Weekly even described FF as trying to build the Apple of robotics.  

The strong momentum on the show floor showed that FF brought consumer-electronics-level excitement to a professional robotics trade show. To me, this points to three important signals:  

No.1, Physical AI is accelerating toward real-world applications and mass adoption.   

No.2, as a U.S.-based EAI robotics company, FF is leveraging its Three-in-One ecosystem strategy and five unique strengths to help move the industry beyond single-product competition and into a new stage defined by practical applications, ecosystem development, and scaled deployment.  

No.3, this is not only recognition of FF’s product power, but also recognition of FF’s role in accelerating the arrival of the EAI robotics era through disruptive Physical AI innovation.  

Next week, from June 29 to July 1, FF will also take part in ISTE Live 2026 in Orlando, the largest education technology conference in North America. We will use this opportunity to advance collaboration with K–12 schools, educational institutions, FF Par partners, developers, and ecosystem partners. On the B2B side, we will accelerate the adoption of EAI robotics education products and solutions across more schools, educational institutions, and FF Par partners. On the B2C side, we will continue to use family education as the first-stage entry point into the consumer robotics market. Our goal is to build an EAI education ecosystem for children, schools, and the future talent pipeline, and to open the door to the Physical AI world for children at an earlier age.  

On the capital side, this Friday, the company filed a new S-3 registration statement with the SEC in accordance with applicable rules. This is a renewal filing ahead of the expiration of the original S-3 registration statement, which became effective in June 2023. The purpose is to maintain financing flexibility during this critical phase of implementing our Three-in-One strategy. Over the past three years, the company has used the S-3 very prudently. Of the original $300 million registered amount, only approximately $28 million was actually issued. Going forward, the company will continue to practice “Stockholders First,” gradually reduce its reliance on convertible debt financing, and move toward a healthier financing structure centered on operating cash flow, mid- to long-term financial investors, and strategic investment.  

On the EAI EV side, the U.S. Patent and Trademark Office recently granted FF a patent for its AIHER range-extending hybrid transmission system. FF’s first-of-its-kind technology featuring a “range-extension-first, hybrid-assist” architecture will provide the industry with a more efficient powertrain solution. It preserves the refueling advantages of traditional internal combustion vehicles while delivering an electric-motor-driven experience and reducing mechanical complexity. This further strengthens FF’s technical barriers and competitive moat in the Physical AI era.  

That’s all for this week. See you next week!” 

u/Etraderbanker — 5 days ago
▲ 19 r/nasdaq+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

reddit.com
u/MarketNewsFlow — 5 days ago
▲ 33 r/nasdaq+1 crossposts

Galaxy joins Russell 1000 Index

Galaxy has been added to the Russell 1000 Index, a benchmark tracking roughly 1,000 of the largest U.S. companies by market cap.

The milestone marks Galaxy's leadership across digital assets and AI infrastructure. Galaxy operates at institutional scale in crypto markets while rapidly building and operating one of the largest data center campuses in the country.

u/GalaxyHQOfficial — 7 days ago
▲ 12 r/nasdaq+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
▲ 17 r/nasdaq+5 crossposts

MRAM Stock News: Everspin Shareholder Meeting Puts AI-Memory Hype -

As of the latest quoted market data from the supplied draft, MRAM traded around $28.94, down sharply from recent highs but still far above where the stock began its 2026 rally. The stock has become one of the most controversial small-cap semiconductor names of the year as AI-memory hype, defense demand and short-seller pressure collide.

stockmarketloop.com
u/Major_Access2321 — 12 days ago
▲ 1 r/nasdaq+2 crossposts

Saw a glitch and a dream aswell lmao 💔

Woke up with this and started rooting all of this was true and real, until the app refreshed few mins later. Even placed a sell order at that rate😔💔😭😂

u/HotTransportation874 — 10 days ago
▲ 4 r/nasdaq+4 crossposts

$PLSM Turns $1,000 Into $5,100 As Retail Frenzy Continues

NEW YORK — June 24, 2026 — Pulsenmore Ltd. (NASDAQ: PLSM) became a fresh example of how quickly speculative retail flow can move through a thinly traded health-tech name after traders linked the stock’s rally to an earlier Making Easy Money Discord alert from Grandmaster-OBI.

According to trader-circulated alert history, $PLSM was flagged on June 17 at $3.77. One week later, the stock reached a reported high of $19.52, turning into a roughly 5.18x move from the alert price.

The rally is not just about one ticker. It highlights a market structure question now showing up repeatedly in low-priced stocks: when a catalyst, a tight trading float, scanner activity and retail attention arrive at the same time, how much of the move is fundamentals — and how much is flow?

stockmarketloop.com
u/Major_Access2321 — 12 days ago
▲ 13 r/nasdaq+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
▲ 11 r/nasdaq+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
▲ 12 r/nasdaq+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
▲ 17 r/nasdaq+12 crossposts

$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

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u/MarketNewsFlow — 14 days ago