Regentis Biomaterials Reports 2025 Financial Results and Provides Business Update

Rhea-AI Summary

Regentis Biomaterials (NYSE:RGNT) reported 2025 results and a corporate update. Key items: a successful IPO raising $10.0 million, $7.4 million cash as of December 31, 2025, operating expenses of $7.0 million (including $5.3 million non-cash), and a going concern qualification in the 2025 audit.

Clinical progress includes >50% enrollment in the pivotal Phase III GelrinC knee trial, establishment of new U.S. and European sites, publication showing durable MRI cartilage repair, and a 27th patent for a liquid, ready-to-use GelrinC formulation.

Positive

• IPO raised $10.0 million on December 5, 2025
• Cash of $7.4 million as of December 31, 2025
• Pivotal Phase III enrollment surpassed 50%
• Published MRI data showing native-like cartilage at 2 years
• Granted 27th patent covering liquid ready-to-use GelrinC

Negative

• Audit included a going concern qualification for 2025
• Operating expenses were $7.0 million in 2025

Key Figures

Cash and equivalents: $7.4 million IPO gross proceeds: $10 million Operating expenses: $7.0 million +5 more

8 metrics

Cash and equivalents $7.4 million As of December 31, 2025; expected runway for Phase III enrollment and site expansion

IPO gross proceeds $10 million IPO closed December 5, 2025 on NYSE American

Operating expenses $7.0 million Operating expenses for year ended December 31, 2025

Non-cash expenses $5.3 million Portion of 2025 operating expenses that were non-cash

U.S. clinical sites 7 sites New U.S. sites added to support pivotal Phase III GelrinC trial

European clinical sites 6 sites New European sites established to support 2026 commercial plans

Phase III enrollment Surpassed 50% Patient enrollment status in pivotal Phase III GelrinC trial

Gelrin platform patents 27 patents Most recent U.S. patent covers liquid, ready-to-use GelrinC version

Market Reality Check

Price: $4.00 Vol: Volume 3,910 is light at ...

low vol

$4.00 Last Close

Volume Volume 3,910 is light at 0.29x the 20-day average of 13,610 shares. low

Technical Shares trade below the 200-day MA at $6.19, with the stock at $3.70 ahead of this release.

Peers on Argus

No peers with momentum data are listed; today’s -9.42% move in RGNT screens as s...

No peers with momentum data are listed; today’s -9.42% move in RGNT screens as stock-specific rather than sector-driven.

Historical Context

5 past events · Latest: Feb 19 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 19	Leadership appointment	Positive	+0.3%	Appointment of Chief Medical Officer to advance GelrinC strategy and approvals.
Feb 17	Clinical expansion	Positive	-10.5%	Expansion of European clinical site network ahead of 2026 commercial launch.
Feb 04	Leadership appointment	Positive	-0.2%	Appointment of new CFO/CBO as GelrinC advances toward launch and Phase III progress.
Jan 29	Clinical expansion	Positive	-4.8%	U.S. Phase III site expansion to accelerate enrollment and strengthen data quality.
Jan 20	Clinical data update	Positive	+0.0%	MRI data showing GelrinC-generated cartilage similar to native hyaline cartilage.

Pattern Detected

Recent news has been clinically and strategically positive, but the stock more often sold off or was flat, showing frequent divergence between headlines and price.

Recent Company History

Over the last few months, Regentis has focused on advancing GelrinC and building its leadership team. Updates included U.S. and European clinical site expansion, long-term MRI data supporting cartilage regeneration, and appointments of a new CEO and senior executives. Despite these clinically and strategically positive milestones, share reactions were often negative or muted following announcements on Jan 20, Jan 29, Feb 4, and Feb 17. Against this backdrop, the current earnings update, combined with a disclosed going concern qualification, fits into an already volatile narrative.

Market Pulse Summary

This announcement combines 2025 financials with a business update on GelrinC, emphasizing a cash pos...

Analysis

This announcement combines 2025 financials with a business update on GelrinC, emphasizing a cash position of $7.4 million, progress toward completing enrollment in a pivotal Phase III trial, and expanded U.S. and European clinical networks ahead of a planned 2026 roll-out in Europe. At the same time, the company discloses an audit opinion containing a going concern qualification. Investors may track future cash disclosures, Phase III milestones, and any changes in auditor language as key indicators of execution and balance sheet strength.

Key Terms

Phase III, hyaline cartilage, CE Mark, Form 20-F, +2 more

6 terms

Phase III medical

"pivotal Phase III FDA trial for GelrinC"

A Phase III trial is the late-stage clinical study that tests whether a medical treatment works and is safe in a large group of patients, often comparing it to standard care. Think of it as a final dress rehearsal or full-scale road test before regulators decide on approval; positive or negative results strongly influence a drug maker’s chance to sell the treatment, future revenue, and investment risk.

hyaline cartilage medical

"architecture similar to native hyaline cartilage, widely regarded as the gold standard"

A smooth, rubbery type of connective tissue that covers the ends of bones in joints and lines some airways; it acts like a low-friction cushion and shock absorber so bones glide smoothly during movement. Investors track hyaline cartilage because it has limited ability to heal on its own, making treatments, implants, and regenerative therapies for arthritis and joint injuries a major commercial opportunity—think of it as the worn part of a machine that many companies aim to repair or replace.

CE Mark regulatory

"Already approved in Europe, GelrinC is expected to be rolled out"

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

Form 20-F regulatory

"more detailed information can be found in the Company's Annual Report on Form 20-F"

Form 20-F is the standardized annual disclosure that non-U.S. companies must file with the U.S. securities regulator when their shares are traded in the U.S.; it contains audited financial statements, a plain-language description of the business, management discussion, governance details and key risk factors. It matters to investors because it provides a consistent, comparable company “report card” and rulebook, helping buyers assess financial health, governance and risks before investing.

audit opinion regulatory

"the audit opinion for such fiscal year contained a going concern qualification"

An audit opinion is a professional accountant’s conclusion about whether a company’s financial statements are accurate and free of major errors, similar to a report card on the company’s books. Investors use it to judge how much they can trust reported revenue, profits and liabilities — a clean opinion boosts confidence like a healthy check-up, while a qualified or adverse opinion raises red flags about potential problems or undisclosed risks.

NYSE American financial

"Regentis listed on the NYSE American exchange through a successful IPO"

NYSE American is a stock exchange where companies can list their shares to be bought and sold by investors. It functions like a marketplace, helping businesses raise money and providing investors with opportunities to buy ownership in these companies. Its role is important because it facilitates the trading of smaller or emerging companies, offering investors access to a broader range of investment options.

AI-generated analysis. Not financial advice.

$7.4 million in cash expected to provide runway to complete site expansion process and patient enrollment as part of pivotal Phase III FDA trial for GelrinC

Already approved in Europe, GelrinC is expected to be rolled out in clinics across the continent in 2026

GelrinC is positioned to be the first ready-to-use, off-the-shelf product in the U.S. for knee cartilage repair

HERZLIYA, IL / ACCESS Newswire / February 24, 2026 / Regentis Biomaterials Ltd. ("Regentis" or the "Company"), a regenerative medicine company focused on innovative tissue repair solutions, today reported financial results for the year ended December 31, 2025 and provided an update on corporate and clinical developments.

"2025 was a transformational year for Regentis, marked by our successful IPO and a strengthened balance sheet with more than $7 million in cash, positioning us to potentially complete patient recruitment and treatment in our pivotal Phase III study for GelrinC by mid-year 2026," said Dr. Ehud Geller, CEO and Executive Chairman of Regentis. "This financial strength also provides the runway to begin marketing GelrinC in clinics across Europe in 2026, where we believe early physician adoption will help build meaningful demand and attract a strong commercial partner. With GelrinC positioning to become the first ready-to-use, off-the-shelf regenerative product in the U.S. for knee cartilage repair, we are excited about its potential to establish a new gold standard of care. At the same time, we see significant opportunity to expand our Gelrin platform technology into broader cartilage indications, including osteoarthritis and other joint injuries, further advancing our mission to deliver durable regenerative solutions for patients worldwide."

Financial Highlights:

• Regentis listed on the NYSE American exchange through a successful IPO which closed on December 5, 2025, raising gross proceeds of $10 million.

• With $7.4 million in cash and equivalents as of December 31, 2025, Regentis has a cash runway to potentially complete its site expansion process and patient enrollment of its pivotal Phase III trial for GelrinC in knee cartilage repair.

• The Company's operating expenses for the year ended December 31, 2025 were $7.0 million, $5.3 million of which was for non-cash expenses, demonstrating prudent cash management while continuing to execute on clinical advancements.

Corporate and Clinical Highlights:

• Regentis established 7 new clinical sites across the U.S. including leading orthopedic centers to support its pivotal Phase III trial of GelrinC as well as future clinical programs. The new sites are expected to further accelerate the pivotal study's patient enrollment, which surpassed 50%.

• In Europe, 6 new clinical sites were established to support engagement with leading orthopedic surgeons and centers of excellence in key European markets, strengthening Regentis' positioning for eventual commercial launch and broader clinical adoption in 2026.

• Data published in the peer-reviewed scientific journal Cartilage established GelrinC as a leader in long-term durable cartilage repair, using the objective, quantitative MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) assessment to demonstrate morphologic outcomes that consistently outperformed other treatment modalities. Regentis is the first company to extensively use MOCART as a secondary endpoint in a clinical study, and to have the U.S. Food and Drug Administration's (FDA) acceptance of this approach.

• New data from the published Cartilage study additionally demonstrated that GelrinC has achieved a breakthrough in regenerating native-like cartilage structure in knee repair based on MRI results. Two years after treatment, GelrinC-treated patients demonstrated layered cartilage architecture similar to native hyaline cartilage, widely regarded as the gold standard for durable joint function.

• Regentis was granted its 27^th patent for the Gelrin platform technology. The U.S. Patent and Trademark Office issued Regentis' most recent patent for GelrinC, covering the liquid, ready to use version of the product that also improved processes for its production by avoiding the use of organic solvents. The liquid ready-to-use formulation reflects Regentis' focus on simplifying procedures for surgeons while improving patient experience.

More detailed information can be found in the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2025, a copy of which has been filed with the Securities and Exchange Commission (SEC) on February 24, 2026 (the "Annual Report"). The Annual Report, which contains the Company's audited consolidated financial statements, can be accessed on the SEC's website at http://www.sec.gov/ as well as via the Company's investor relations website at https://investors.regentis.co.il/. The Company will deliver a hard copy of its Annual Report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Regentis Investor Relations at 60 Medinat Hayehudim Street, 4676652, Israel or by phone at +972 (9) 960-1917.

In addition, on February 24, 2026, the Company announced that, as disclosed in its Annual Report, the audit opinion for such fiscal year contained a going concern qualification from the Company's independent registered public accounting firm. This announcement is being made solely to comply with the NYSE American Company Guide Sections 401(h) and 610(b), which require separate disclosure of receipt of an audit opinion that contains a going concern qualification. This announcement does not represent any change or amendment to the Company's 2025 audited financial statements or to the Annual Report.

About GelrinC^®

Regentis' lead product, GelrinC^®, is a cell-free, off-the-shelf hydrogel synchronized erosion and resorbable implant for the treatment of painful injuries to focal articular knee cartilage. As an innovative regenerative medical product, GelrinC® offers an unprecedented solution that gives surgeons and payers an off-the-shelf, ready to use, simple to perform, reliable, and cost-effective procedure that provides patients with a single, 10-minute procedure, faster recovery, sustained pain relief, and functional improvement for more than 4 years, based on clinical study results to date. No effective off-the-shelf, ready to use treatment for focal knee cartilage defects is currently available on the market. GelrinC^® has CE Mark approval in the European Union and is now being evaluated in a pivotal U.S. Food and Drug Administration (FDA) study, which has completed over 50% enrollment.

About Regentis Biomaterials

Regentis Biomaterials Ltd is a regenerative medicine company dedicated to developing innovative tissue repair solutions that restore health and enhance quality of life. With an initial focus on orthopedic treatments, Regentis' Gelrin platform technology, based on synchronized, degradable hydrogel implants, regenerates damaged or diseased tissue including inflamed cartilage and bone. Regentis' lead product GelrinC^®, is a cell-free, off-the-shelf hydrogel that is eroded and resorbed in the knee, allowing the surrounding cells to regenerate the cartilage in a controlled and synchronous process. GelrinC^® aims to address a market of approximately 470,000 cases for cartilage knee repair annually in the U.S. where no off-the-shelf treatment is available.

Forward Looking Statements

This press release contains "forward-looking statements" that 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, and include beliefs regarding Regentis' advancement towards commercialization and its cash runway. Forward-looking statements are based on Regentis' current expectations and are subject to inherent uncertainties, risks and assumptions 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. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: the ability of our clinical trials to demonstrate safety and efficacy of GelrinC or any future product candidate, and other positive results; the timing and focus of our preclinical studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for of GelrinC or any future product candidate, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to accurately identify demand for product candidates; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain FDA approval for of GelrinC or any future product candidate and obtain and maintain regulatory approval; our ability to obtain market acceptance of of GelrinC or any future product candidate from the medical community and third-party payors; our plans relating to the further development of GelrinC or any future product candidate, including additional disease states or indications we may pursue; existing regulations and regulatory developments in the United States and other jurisdictions; our plans and ability to obtain or protect intellectual property rights, including extensions of patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; our dependence on third parties; our financial performance and our ability to repay our loans and debts; and our ability to negotiate favorable terms in any collaboration, licensing or other arrangements into which we may enter and perform our obligations under such collaborations. For a more detailed description of the risks and uncertainties affecting Regentis, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the section titled "Risk Factors" in our Annual Report on Form 20-F filed with the SEC on February 24, 2026 and other public reports filed with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Regentis undertakes no duty to update such information except as required under applicable law.

Contact:

acarlquist@medicavp.com

SOURCE: Regentis Biomaterials Ltd

View the original press release on ACCESS Newswire

FAQ

How much cash did Regentis (RGNT) report on December 31, 2025?

Regentis reported $7.4 million in cash and equivalents as of December 31, 2025. According to the company, this cash position is expected to provide runway to complete site expansion and patient enrollment for the pivotal Phase III GelrinC trial.

What did Regentis announce about its 2025 IPO and proceeds for RGNT?

Regentis completed an IPO on December 5, 2025, raising $10.0 million in gross proceeds. According to the company, the IPO strengthened the balance sheet to support clinical execution and European commercial rollout plans for GelrinC in 2026.

What clinical progress did Regentis report for the GelrinC Phase III trial (RGNT)?

The company reported pivotal Phase III patient enrollment surpassed 50% and added seven new U.S. sites. According to Regentis, new sites and site expansion are intended to accelerate enrollment and complete pivotal study recruitment by mid-2026.

What did the published MRI data say about GelrinC durability and structure?

Published data in Cartilage showed GelrinC produced layered, native-like cartilage architecture two years after treatment. According to the company, MOCART assessments demonstrated morphologic outcomes that consistently outperformed other treatment modalities.

Did Regentis disclose any audit or accounting concerns for 2025 (RGNT)?

Regentis disclosed that its 2025 audited financial statements included a going concern qualification from the independent auditor. According to the company, this disclosure is made to comply with NYSE American listing requirements and does not amend the audited statements.

What intellectual property and formulation developments did Regentis report for GelrinC (RGNT)?

Regentis received its 27th patent, covering the liquid ready-to-use GelrinC and solvent-free production improvements. According to the company, the formulation simplifies surgical procedure and supports planned European clinic rollout in 2026.