r/BreakoutStocks

TL;DR: ICE wants ~100k detention beds (from ~70k). Plan A — $1.1B on 11 warehouse conversions — is stalled: 0 of 11 sites operating, and DHS Secretary Mullin told House Appropriations on Jun 25 that DHS is "evaluating all 11" purchased warehouse sites while acknowledging a bed shortage. Plan B: buy ~10 turnkey centers from CoreCivic ($CXW) and GEO ($GEO) — 20k+ idle beds combined, with active DHS sale talks per both companies' Q1 calls and Axios reporting. The Secure America Act (~$70B through FY2029) was signed Jun 10. Benchmark raised CXW PT $28 → $36 on Jun 26, citing 80% probability of 2 facility sales → ~$680M after-tax (debt paydown + buybacks). Long CXW and GEO — GEO looks like the laggard on the same thesis.

 

The administration's stated target is ~100,000 ICE detention beds.

Plan A: buy warehouses and convert them (~$1.1B across 11 sites).

Public reporting says that plan is failing:

- None of the 11 warehouse sites operate as detention centers ([Axios, May 7, 2026](https://www.axios.com/2026/05/07/ice-immigrant-detention-private-contractors))
- Local pushback, litigation, and officials blocking sites in multiple jurisdictions
- At the Jun 25, 2026 House Appropriations DHS oversight hearing, Mullin said DHS is "evaluating all 11" purchased warehouse sites and acknowledged a bed shortage ([C-SPAN](https://www.c-span.org/event/house-committee/homeland-security-secretary-mullin-testifies-on-dhs-oversight/444301))

Plan B: ICE buys turnkey facilities from private operators that already own built capacity. Axios (May 7) reported ICE is in talks to purchase ~10 turnkey facilities from its largest vendors, with GEO CEO Zoley citing a possible Q2–Q3 2026 sales window.

## Why $CXW and $GEO

CXW (CoreCivic)
- Largest non-government owner of correctional/detention facilities
- ~7,066 idle beds across 5 facilities (Q1 2026 call)
- CEO Swindle: active DHS sale discussions
- Benchmark $36 PT (Jun 26, 2026; was $28)
- ~+54% YTD per Investing.com/Benchmark coverage

GEO (Geo Group)
- Hosts ~25k ICE beds (~25% of ICE network)
- ~6,000+ idle beds across 6 former federal prisons (Q1 2026 call)
- CEO Zoley: multi-facility sale discussions
- Same thesis — read-through if CXW closes sales first
- Check live quote (moves with detention-policy beta)

Both companies have said they would sell turnkey assets at depreciated replacement cost (per Q1 earnings calls and Axios).

 Recent catalysts (Jun 2026)

- Jun 4 — ICE sole-source notice for Prairie/CoreCivic, up to 1,600 beds (SAM.gov / procurement reporting)
- Jun 10 — Secure America Act signed (PL 119-98), ~$70B for ICE/CBP/DHS through FY2029 ([Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/2))
- Jun 25 — Mullin Appropriations testimony: warehouse sites under review, bed shortage cited ([C-SPAN](https://www.c-span.org/event/house-committee/homeland-security-secretary-mullin-testifies-on-dhs-oversight/444301))
- Jun 26 — Benchmark raises CXW PT $28 → $36 (Buy maintained); 80% / ~$680M facility-sale scenario ([Investing.com](https://www.investing.com/news/analyst-ratings/benchmark-raises-corecivic-stock-price-target-on-detention-demand-93CH-4762738))

Funding (Jun 10): multi-year appropriations reduce the recurring "will Congress fund detention beds this year?" uncertainty that slowed procurement during the earlier DHS shutdown period.

Procurement (Jun 4): sole-source toward existing CoreCivic capacity — consistent with buying turnkey beds instead of new warehouse conversions.

 Congressional calendar (archived)

From publicly archived House Appropriations pages:

- Jun 11, 2026: the main Appropriations [hearings schedule](https://web.archive.org/web/20260611135716/https://appropriations.house.gov/schedule/hearings) did not yet list the DHS oversight hearing
- Jun 25, 2026: Mullin testified at the [DHS oversight hearing](https://appropriations.house.gov/schedule/hearings/oversight-hearing-department-homeland-security-0) — warehouse rethink and bed pressure discussed; no CXW/GEO facility sale announcements at the hearing
- Jun 26, 2026: Benchmark published its $36 PT on CXW

Management on both Q1 calls guided facility sales on a Q2–Q3 2026 timeline. No SEC 8-K announcing completed facility sales has been filed as of Jun 26.

Benchmark math (Jun 26, 2026):

From [Investing.com's summary of the Benchmark note](https://www.investing.com/news/analyst-ratings/benchmark-raises-corecivic-stock-price-target-on-detention-demand-93CH-4762738):

- Buy maintained, PT $36 (was $28) — 8.5× FY2027 EBITDA
- 80% probability of 2 CXW facility sales → ~$680M after-tax proceeds → debt paydown + share repurchases
- Cites >20k combined idle beds (CXW + GEO) and active DHS discussions

CXW was already up ~50% YTD before the note published — the Benchmark headline is fresh; the detention thesis is not hidden.

 Bull case

1. Bed demand — 100k target vs ~70k active implies a large capacity gap
2. Warehouse failure — DHS reassessing all 11 purchased sites pushes demand toward existing private facilities
3. Funding locked — Secure America Act covers enforcement spending through FY2029
4. Asset sales — one-time cash to CXW/GEO plus ongoing management revenue if deals close
5. GEO read-through — if CXW closes sales first, GEO trades on the same customer and Plan B logic

 Bear case

- Political risk — Jun 25 hearing included heated exchanges on detention deaths and overcrowding
- ESG / headline risk — limited institutional buyer pool; negative press can hit both names
- Deals not signed — "discussions" and Benchmark's 80% scenario are not closed transactions
- Valuation — CXW already up sharply YTD; same Investing.com article flags fair-value concerns
- Plan A revival — if DHS revives warehouse conversions, turnkey purchases could slip
- Legal friction — state/local opposition (including California AB 1801 dynamics for GEO assets)
- Policy reversal — future administration, court orders, or appropriations changes

Not financial advice. Do your own research.

Sources

- Benchmark PT raise (Jun 26): https://www.investing.com/news/analyst-ratings/benchmark-raises-corecivic-stock-price-target-on-detention-demand-93CH-4762738
- Axios — ICE Plan B, 10 facilities, 0/11 warehouses operating: https://www.axios.com/2026/05/07/ice-immigrant-detention-private-contractors
- Jun 25 Mullin hearing: https://www.c-span.org/event/house-committee/homeland-security-secretary-mullin-testifies-on-dhs-oversight/444301
- Jun 11 Appropriations schedule (Wayback): https://web.archive.org/web/20260611135716/https://appropriations.house.gov/schedule/hearings
- Secure America Act: https://www.congress.gov/bill/119th-congress/senate-bill/2
- CXW Q1 2026 transcript: https://www.theglobeandmail.com/investing/markets/stocks/CXW/pressreleases/1778854/corecivic-cxw-q1-2026-earnings-transcript/

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

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

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 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.

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

• 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.