RGNT 6-K
Regentis Biomaterials Ltd. (RGNT)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of September
Commission file number:
(Translation of registrant’s name into English)
60 Medinat Hayehudim Street, 4676652, Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Explanatory Note
Attached are the Company’s press release providing a business update for the first half of 2026, condensed interim unaudited financial statements and a summary of its operating and financial review and prospects, each as of June 30, 2026, furnished herewith as Exhibits 99.1, 99.2 and 99.3, respectively.
This Report on Form 6-K (including the six bullet points following “Corporate and Clinical Highlights:” in Exhibit 99.1 and Exhibits 99.2 and 99.3 ) is hereby incorporated by reference into the registrant’s Registration Statement on Form F-1 (File No. 333-297320), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
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Exhibit Index
| Exhibit No. | Description | |
| 99.1 | Press Release dated September 11, 2026 | |
| 99.2 | Condensed Interim Unaudited Financial Statements as of June 30, 2026 | |
| 99.3 | Operating and Financial Review and Prospects as of June 30, 2026 | |
| 101.INS | Inline XBRL Instance Document | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
| 101.DEF | Inline XBRL Taxonomy Extension Label Linkbase Document | |
| 101.LAB | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
| 101.PRE | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
| 104 | Cover Page Interactive Data File formatted as Inline XBRL and contained in Exhibit 101 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Regentis Biomaterials Ltd. | ||
| Date: September 11, 2026 | By: | /s/ Ori Gon |
| Ori Gon | ||
| Chief Financial Officer | ||
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Exhibit 99.1
Regentis Biomaterials Reports First Half 2026 Financial Results and Provides Corporate Update
Advances GelrinC® U.S. pivotal trial with 43 patients treated; Completion of enrollment expected by approximately year end 2026
Expands European commercialization readiness, including surgeon training and regulatory approval of new manufacturing process that improves production yield 400%
Strengthened balance sheet with $6.5 million private placement in June 2026
HERZLIYA, Israel, September 11, 2026 - Regentis Biomaterials Ltd. (“Regentis” or the “Company”) (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, today reported financial results for the six months ended June 30, 2026 and provided a corporate and clinical update.
“During the first half of 2026, we continued to advance GelrinC® on multiple fronts as we build toward important clinical and commercial milestones in the U.S. and Europe,” said Ehud Geller, CEO and Executive Chairman of Regentis. “Interest in GelrinC® from physicians, patients and clinical centers continues to build, and we are encouraged by the engagement we are seeing as we expand the number of active clinical sites in the United States and Europe. Based on the current pace of enrollment, we now expect to complete full enrollment of 80 patients in our U.S. pivotal trial on or around the end of this year, compared with our previous expectation of the third quarter. This timing reflects the practical pace of site activation and patient recruitment in the U.S. and Europe.”
“Enthusiasm for GelrinC® is building in Europe, where we have CE Mark approval, as we prepare for commercialization. We are engaging with physicians and clinical centers and advancing surgeon training through our European Centers of Excellence to support adoption of the procedure. Progress in both the U.S. and Europe reinforces our confidence in GelrinC®’s potential to provide a simple, off-the-shelf regenerative treatment for patients suffering from painful articular cartilage injuries.”
Corporate and Clinical Highlights
| · | Advanced pivotal Phase III GelrinC® clinical trial and expanded U.S. clinical site network. To date, Regentis has recruited and treated 43 of 80 patients. The Company expanded its U.S. clinical network during the first half of 2026, adding leading orthopedic centers across the country. |
| · | Expanded European clinical network and advanced preparations for GelrinC® commercialization. Regentis added clinical sites in Italy, Germany, Serbia, Slovenia and Romania, expanding its network of European orthopedic centers. With CE Mark approval, the Company continued preparations for commercialization, including physician engagement and surgeon training through its growing network of European Centers of Excellence. |
| · | Advanced manufacturing capabilities with a 400% increase in production yield to support commercialization. Regentis developed and filed patents for a new solvent-free manufacturing process that increases GelrinC® production yield by 400%. In July, the Company received regulatory approval for the new manufacturing process from the European Notified Body, supporting manufacturing scale-up for anticipated European commercial requirements and future market expansion. |
| · | Expanded IP protection for GelrinC®. The Japan Patent Office issued a Notice of Allowance for Regentis’ patent application titled “Organic Solvent Free Compositions Comprising Protein-Polymer Conjugates and Uses Thereof,” extending protection in Japan for the Company’s proprietary solvent-free technology used in the manufacture of GelrinC®. |
| · | Reported long-term MRI data demonstrating native-like cartilage regeneration with GelrinC®. At 24 months, GelrinC®-treated patients demonstrated layered cartilage architecture comparable to native hyaline cartilage. The analysis used validated MRI methodologies accepted by U.S. and European regulators and showed progressive maturation and organization of regenerated cartilage over time. |
| · | Published peer-reviewed data demonstrating long-term durability of cartilage repair. Results published in the peer-reviewed journal Cartilage used quantitative MOCART assessment of the complete follow-up dataset from the GelrinC® Phase II study, demonstrating durable morphological cartilage repair through two years and supporting the quality and durability of regenerated tissue. |
First Half 2026 Financial Highlights
| · | Research and development expenses were approximately $1.2 million for the six months ended June 30, 2026, compared with $180,000 for the same period in 2025. The increase primarily reflected advancement of the Company’s ongoing pivotal clinical study, including personnel, production and material costs and outsourced services. |
| · | General and administrative expenses were approximately $1.2 million, compared with $259,000 for the first six months of 2025. The increase primarily reflected higher personnel-related expenses and costs associated with operating as a public company following Regentis’ December 2025 initial public offering. |
| · | Operating loss was approximately $2.4 million, compared with $439,000 in the first six months of 2025. |
| · | Net loss improved to approximately $2.6 million, or $0.44 per share, compared with a net loss of approximately $3.2 million, or $1.17 per share, for the first six months of 2025. The improvement primarily reflected a significant reduction in finance expenses, partially offset by increased research and development and general and administrative expenses. |
| · | Completed $6.5 million private placement. In June 2026, Regentis completed a private placement with aggregate gross proceeds of approximately $6.5 million. |
| · | Cash and cash equivalents totaled approximately $9.0 million as of June 30, 2026. Net cash used in operating activities was approximately $2.8 million during the first six months of 2026. As of June 30, 2026, the Company has repaid its debt entirely. |
More detailed information can be found in the Company’s Form 6-K, a copy of which has been filed with the Securities and Exchange Commission (SEC) on September 11, 2026 and 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/sec-filings.
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About GelrinC®
Regentis’ lead product, GelrinC®, is a cell-free, off-the-shelf hydrogel implant having synchronized erosion and resorption for the treatment of painful and debilitating 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 5 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’ plans to commence European surgeon activities and the timing thereof. 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 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:
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Exhibit 99.2
REGENTIS BIOMATERIALS LTD.
INTERIM CONDENSED FINANCIAL STATEMENTS
AS OF AND FOR THE SIX MONTHS ENDED JUNE 30, 2026
(UNAUDITED)
U.S. DOLLARS IN THOUSANDS
INDEX
- - - - - - - - - - - - - - -
F-1
REGENTIS BIOMATERIALS LTD.
INTERIM CONDENSED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
| As of June 30, |
As of December 31, |
||||||||||
| Note | 2026 | 2025 | |||||||||
| Unaudited | Audited | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | $ | | ||||||||
| Other current assets | |||||||||||
| Total current assets | |||||||||||
| Long-term assets: | |||||||||||
| Operating lease right of use assets | |||||||||||
| Property and equipment, net | |||||||||||
| Total long term assets | |||||||||||
| Total assets | $ | $ | |||||||||
| Liabilities and shareholders’ equity | |||||||||||
| Current liabilities: | |||||||||||
| Trade accounts payable | $ | $ | |||||||||
| Other accounts payable | 3 | ||||||||||
| Current maturity of operating lease liability | |||||||||||
| Short-term loans | 4 | ||||||||||
| Total current liabilities | |||||||||||
| Long - term operating lease liability | |||||||||||
| Total liabilities | |||||||||||
| Commitments and contingencies | 6 | ||||||||||
| Shareholders’ equity: | |||||||||||
| Ordinary shares, par value; Authorized: | |||||||||||
| Additional paid-in capital | |||||||||||
| Accumulated deficit | ( | ) | ( | ) | |||||||
| Total shareholders’ equity | |||||||||||
| Total liabilities and shareholders’ equity | $ | $ | |||||||||
The accompanying notes are an integral part of the unaudited condensed financial statements.
F-2
REGENTIS BIOMATERIALS LTD.
INTERIM CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)
U.S. dollars in thousands (except share and per share data)
| Six months ended June 30, |
|||||||||||
| Note | 2026 | 2025 | |||||||||
| Unaudited | |||||||||||
| Operating expenses: | |||||||||||
| Research and development expenses: | $ | ( | ) | $ | ( | ) | |||||
| General and administrative expenses | ( | ) | ( | ) | |||||||
| Operating loss | ( | ) | ( | ) | |||||||
| Financial income (expenses), net: | |||||||||||
| Change in fair value of convertible notes | ( | ) | |||||||||
| Change in fair value of warrant liability | |||||||||||
| Other financing expenses, net | ( | ) | ( | ) | |||||||
| Net loss | $ | ( | ) | $ | ( | ) | |||||
| Basic and diluted net loss per share | 2d | $ | ( | ) | $ | ( | ) | ||||
| Weighted average number of ordinary shares used in computing basic and diluted net loss per share | 2d | ||||||||||
The accompanying notes are an integral part of the unaudited condensed financial statements.
F-3
REGENTIS BIOMATERIALS LTD.
INTERIM CONDENSED STATEMENTS OF TEMPORARY EQUITY AND SHAREHOLDERS’ EQUITY (DEFICIT)
U.S. dollars in thousands (except share data)
| Ordinary shares | Additional paid-in |
Accumulated | Total shareholders’ |
|||||||||||||||||
| Number | Amount | capital | deficit | equity | ||||||||||||||||
| Balance as of December 31, 2025 (Audited) | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Issuance of ordinary shares and warrants, net of issuance costs, | ||||||||||||||||||||
| Share based payment | - | |||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance as of June 30, 2026 (Unaudited) | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Convertible preferred shares |
Ordinary shares | Additional paid-in |
Accumulated | Total shareholders’ |
||||||||||||||||||||||||
| Number | Amount | Number | Amount | capital | deficit | deficit | ||||||||||||||||||||||
| Balance as of December 31, 2024 (Audited) | $ | $ | $ | | $ | ( | ) | $ | ( | ) | ||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
| Balance as of June 30, 2025 (Unaudited) | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
The accompanying notes are an integral part of the unaudited condensed financial statements.
F-4
REGENTIS BIOMATERIALS LTD.
INTERIM CONDENSED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
| Six months ended June 30, |
||||||||
| 2026 | 2025 | |||||||
| Unaudited | ||||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Revaluation of convertible notes | ||||||||
| Share based payment | ||||||||
| Revaluation of warrant liability | ( | ) | ||||||
| Accrued interest and amortization of short-term loans’ premium risk | ||||||||
| Change in: | ||||||||
| Other current assets | ( | ) | ||||||
| Trade accounts payables | ( | ) | ( | ) | ||||
| Decrease in operating lease liability | ( | ) | ||||||
| Other accounts payable | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities | ||||||||
| Increase in Operating lease right of use assets | ( | ) | ||||||
| Purchase of property and equipment | ( | ) | ||||||
| Net cash used in investing activities | ( | ) | ||||||
| Cash flows from financing activities | ||||||||
| Issuance of ordinary shares, net of issuance costs | ||||||||
| Receipt (repayment) of a short-term loan | ( | ) | ||||||
| Net cash provided by financing activities | ||||||||
| Net change in cash and cash equivalents | ( | ) | ||||||
| Cash and cash equivalents at the beginning of the period | ||||||||
| Cash and cash equivalents at the end of the period | $ | $ | ||||||
| Supplemental disclosure of non-cash investing and financing activities: | ||||||||
| Issuance costs accrued and charged to additional paid in capital | $ | $ | ||||||
| Lease liabilities arising from obtaining right-of-use-assets | $ | $ | ||||||
| Accrued expenses recorded against prepaid expenses | $ | $ | ||||||
The accompanying notes are an integral part of the unaudited condensed financial statements.
F-5
REGENTIS BIOMATERIALS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| NOTE 1: | GENERAL |
| a. | Regentis Biomaterials Ltd. (the “Company”) commenced operations in September 2004. The Company develops innovative tissue repair solutions that seek to restore health and enhance the quality of life of patients. The Company’s current efforts are focused on orthopedic treatments using our Gelrin platform based on degradable hydrogel implants to regenerate damaged or diseased tissue. Gelrin is a unique hydrogel matrix of polyethylene glycol diacrylate and denatured fibrinogen. The Company’s lead product candidate is GelrinC, a cell-free, off-the-shelf hydrogel that is cured into an implant in the knee for the treatment of painful injuries to articular knee cartilage. |
| b. | Initial Public Offering |
On December 5, 2025, the Company closed its initial public offering (the “IPO”) of
| c. | Going concern and management plans |
The accompanying condensed unaudited financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since its inception, the Company has devoted substantially all of its efforts to research and development, clinical trials, and raising capital. The Company is still in its development and clinical stage and has not yet generated revenues. The extent of the Company’s future operating losses and the timing of becoming profitable are uncertain. The Company has incurred loss of $
F-6
REGENTIS BIOMATERIALS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| NOTE 1: | GENERAL (Cont.) |
While the Company has been successful in raising financing in the past, it is not probable that the Company will be able to successfully obtain additional financing on a timely basis on terms acceptable to the Company or will provide the Company with sufficient funds to meet its objective.
Such conditions raise substantial doubts about the Company’s ability to continue as a going concern. Management’s plans include, but are not limited to additional fund raising in the United States.
If such sufficient financing is not received timely, the Company would then need to pursue a plan to license or sell its assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy protection. The Company’s financial statements do not reflect any adjustments that might result from the outcome of this uncertainty.
| d. | Impact of the “Iron Swords” War on Israel |
In October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Following the attack, Israel’s security cabinet declared war against Hamas and commenced a military campaign against Hamas and other terrorist organizations in parallel to their continued rocket and terror attacks. In addition, Hezbollah have attacked military and civilian targets in Northern Israel, to which Israel has responded, including through increased air and ground operations in Lebanon. Since the war broke out, the Company’s operations have not been adversely affected by this situation, and we have not experienced disruptions to our development. On June 13, 2025, in light of continued nuclear threats and intelligence assessments indicating imminent attacks, Israel launched a pre-emptive strike directly targeting military and nuclear infrastructure inside Iran aimed to disrupt Iran’s capacity to coordinate or launch further hostilities against Israel, as well as disrupt its nuclear program. On June 25, 2025, a ceasefire between Israel and Iran took effect. Nonetheless, hostilities between Israel and Iran may resume and further escalate, with both sides launching attacks against one another. On February 28, 2026, Israel and the United States launched a second, larger-scale offensive against Iran. Iran has retaliated with sustained attacks across the Middle East and was joined by renewed Hezbollah attacks on Israel. The conflict is ongoing with no ceasefire in place and the situation remains volatile, with the potential for escalation into a broader regional conflict involving additional terrorist organizations and possibly other countries.
| NOTE 2: | SIGNIFICANT ACCOUNTING POLICIES |
| a. | Unaudited interim condensed financial statements: |
These unaudited condensed financial statements have been prepared as of June 30, 2026 and for the six months period then ended. Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been omitted. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and the accompanying notes of the Company for the year ended December 31, 2025 that are included in the Company’s Annual Report on Form 20-F, filed with the Securities and Exchange Commission on February 24, 2026 (the “Annual Report on Form 20-F”). The results of operations presented are not necessarily indicative of the results to be expected for the year ending December 31, 2026.
F-7
REGENTIS BIOMATERIALS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| NOTE 2: | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
| b. | Use of estimates in preparation of financial statements: |
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company evaluates on an ongoing basis its assumptions. The Company’s management believes that the estimates, judgments and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements, and the reported amounts of expenses during the reporting periods. Actual results could differ from those estimates.
| c. | Significant Accounting Policies: |
The significant accounting policies followed in the preparation of these unaudited interim condensed financial statements are applied consistently with the significant accounting policies applied in the Company’s latest annual financial statements as of and for the period ended December 31, 2025.
Recently adopted accounting standards
Lease:
In accordance with ASU No. 2016-02, “Leases (Topic 842)”, the Company determines if an arrangement is a lease and the classification of that lease at inception based on: (1) whether the contract involves the use of a distinct identified asset, (2) whether the Company obtains the right to substantially all the economic benefits from the use of the asset throughout the period, and (3) whether the Company has a right to direct the use of the asset. The Company elected to not recognize a lease liability and a right-of-use (“ROU”) asset for leases with a term of twelve months or less. The Company also elected the practical expedient to not separate lease and non-lease components for its leases.
ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make minimum lease payments arising from the lease.
ROU assets are initially measured at amounts, which represents the discounted present value of the lease payments over the lease, plus any initial direct costs incurred. The lease liability is initially measured at lease commencement date based on the discounted present value of minimum lease payments over the lease term. The implicit rate within the operating leases is generally not determinable, therefore the Company uses its Incremental Borrowing Rate (“IBR”) based on the information available at commencement date in determining the present value of lease payments. The Company’s IBR is estimated to approximate the interest rate for collateralized borrowing with similar terms and payments and in economic environments where the leased asset is located. Certain leases include options to extend or terminate the lease. An option to extend the lease is considered in connection with determining the ROU asset and lease liability when it is reasonably certain that the Company will exercise that option. An option to terminate is considered unless it is reasonably certain that the Company will not exercise the option.
F-8
REGENTIS BIOMATERIALS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| NOTE 2: | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
Property, plant and equipment:
Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets at the following annual rates:
| % | Mainly % | |||||
| Laboratory equipment | ||||||
| Computers, office furniture and equipment |
Impairment of long-lived assets:
Property and equipment and ROU assets are reviewed for impairment in accordance with ASC 360, “Property, Plant and Equipment,” whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets (assets group) to be held and used is measured by a comparison of the carrying amount of an asset (assets group) to the future undiscounted cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. As of June 30, 2026, impairment indicators have been identified.
Warrants to purchase ordinary shares:
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance. The assessment considers whether the warrants are freestanding financial instruments, meet the definition of a liability under ASC 480, are indexed to the Company’s own stock and whether the warrants are eligible for equity classification under ASC 815-40. This assessment is conducted at the time of warrant issuance and as of each subsequent reporting period end date while the warrants are outstanding.
Warrants that meet all the criteria for equity classification, are required to be recorded as a component of additional paid-in capital. Warrants that do not meet all the criteria for equity classification, are required to be recorded as liabilities at their initial fair value on the date of issuance and remeasured to fair value through earnings at each balance sheet date thereafter.
| d. | Basic and diluted loss per share: |
The Company’s convertible preferred shares are participating securities. As the Company has participating securities, the Company compute earnings per share using the two-class method. Under the two-class method, net income (loss) is allocated between ordinary shares and other participating securities based on their participating rights. The Company’s participating securities do not contractually require the holders of such shares to participate in the Company’s losses.
F-9
REGENTIS BIOMATERIALS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| NOTE 2: | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
As such, net loss for the period presented were not allocated to the Company’s participating securities.
For purposes of the diluted net income (loss) per share calculation, options and warrants are considered to be ordinary share equivalents. In the calculation of the basic and diluted net loss, the Company included options that would be exercised for no or little consideration and are exercisable with no contingencies.
Net loss and weighted average number of ordinary shares used in computing basic and diluted net loss per share is as follows:
| Six months ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Numerator: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Interest accrued on convertible preferred shares | ( | ) | ||||||
| Net loss available for allocation | ( | ) | ( | ) | ||||
| Net loss attributed to Ordinary Shares | ( | ) | ( | ) | ||||
| Net loss attributed to preferred shares | ( | ) | ||||||
| Denominator: | ||||||||
| Number of Ordinary Shares | ||||||||
| Number of convertible preferred shares | ||||||||
| Net loss per share of Ordinary Share, basic and diluted | $ | ( | ) | $ | ( | ) | ||
| Net loss per share of preferred share, basic and diluted | $ | $ | ( | ) | ||||
For the purposes of the diluted net loss per share attributable to ordinary shareholders’ calculation, stock options and warrants are considered to be Ordinary Shares equivalents. The number of Ordinary Shares equivalents presented below were excluded from the computation of diluted net loss per share attributable to ordinary shareholders for the periods presented because the exercise prices were greater than the average market price of the Ordinary Shares as a result of applying the treasury stock method, and therefore including them would have been anti-dilutive.
F-10
REGENTIS BIOMATERIALS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| NOTE 2: | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
| Six months ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Options with an exercise price of $1.46 | ||||||||
| Options with an exercise price of $4.0 | ||||||||
| Warrants with an exercise price of $10.0 | ||||||||
| Warrants with an exercise price of $5.0 | ||||||||
| Warrants with an exercise price of $4.20 | ||||||||
| Warrants with an exercise price of $4.375 | ||||||||
| e. | Accounting pronouncements not yet adopted: |
In November 2024, the Financial Accounting Standards Board (“FASB”) issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which expands disclosures about specific expense categories presented on the face of the income statement. In January 2025, the FASB issued ASU 2025-01, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40), which clarifies the effective date of ASU 2024-03. The ASU will be effective for us beginning with our annual reporting for fiscal year 2028 and interim periods thereafter. The Company is evaluating the impact of the adoption of this update on the Company’s condensed interim financial statements and related disclosures.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements (“ASU 2025-11”). ASU 2025-11 clarifies the applicability of the interim reporting guidance, the types of interim reporting, and the form and content of interim financial statements in accordance with GAAP. The ASU is not intended to change the fundamental nature of interim reporting or expand or reduce current interim disclosure requirements but rather provide clarity and improve navigability of the existing interim reporting requirements. This guidance is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the impact of ASU 2025-11 on its financial statements and related disclosures.
In December 2025, the FASB issued ASU 2025-10 Accounting for Government Grants Received by Business Entities, to establish guidance on the recognition, measurement, presentation and disclosure requirements for government grants received by business entities, including guidance for grants related to an asset and grants related to income. ASU 2025-10 is effective for fiscal years beginning after December 15, 2028, and interim reporting periods within those annual reporting periods. The Company is currently evaluating the impact of this amendment on its financial statements and related disclosures.
F-11
REGENTIS BIOMATERIALS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| NOTE 3:- | OTHER ACCOUNT PAYABLE |
| June 30, 2026 | December 31, 2025 | |||||||
| Accrued expenses | $ | $ | ||||||
| Accrued employee compensation | ||||||||
| Total | $ | $ | ||||||
| NOTE 4:- | SHORT-TERM LOANS |
The Company’s short-term loans consist of a series of unsecured loans obtained between 2023 and 2025 from shareholders, officers, directors and other investors, each bearing interest at
The following table presents the movement in short-term loans:
| Balance as of December 31, 2025 | $ | |||
| Repayment of short-term loans | ( | ) | ||
| Balance as of June 30, 2026 | $ |
F-12
REGENTIS BIOMATERIALS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| NOTE 5:- | SHAREHOLDERS’ EQUITY |
Issuance of shares and warrants
On June 23, 2026, the Company closed private placement of ordinary shares together with warrants, at a purchase price of $
The Company issued a combination of
On February 23, 2026, Company’s Board of Directors, approved the below:
| 1. | Grant of options to employees and consultants share options to purchase an aggregate of |
| 2. | Grant of options to a director and consultant share options to purchase an aggregate of |
| 3. | Grant of |
On May 28, 2026, the Company granted directors share options to purchase an aggregate of
On June 4, 2026, the Company granted directors share options to purchase an aggregate of
F-13
REGENTIS BIOMATERIALS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| NOTE 5:- | SHAREHOLDERS’ EQUITY (Cont.) |
The fair value of the share options granted was estimated using the Black-Scholes option pricing model using the following range assumptions:
| Description | 2026 | |||
| Risk-free interest rate | % | |||
| Expected volatility | % | |||
| Dividend yield | ||||
| Expected term (in years) | ||||
| Exercise price (in USD) | ||||
The fair value of the share options and warrants granted with an exercise price effectively zero, is in substance reflects grant of ordinary shares. As such, the fair value of such options and warrants equals to Company’s share price on the date of grant.
Expenses recognized in the condensed financial statements:
| Six months ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Research and development expenses | $ | $ | ||||||
| General and administrative expenses | ||||||||
| Finance expense, net | ||||||||
| Total | $ | $ | ||||||
F-14
REGENTIS BIOMATERIALS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| NOTE 6:- | COMMITMENTS AND CONTINGENCIES |
| 1. | Between September 2004 and December 2015, the Company received funding from the Israeli Innovation Authority (“IIA”) for its participation in certain research and development activities, based on budgets approved by the IIA, subject to the fulfillment of specified milestones. The Company is committed to pay royalties to the IIA on proceeds from sale of products related to research and development activities of which the IIA participates by way of grants. According to the funding terms, royalties between |
| 2. | In February 2018, the Company entered into a services agreement with Baxter Healthcare Corporation (the “Baxter Services Agreement” and “Baxter”, respectively), pursuant to which the Company agreed to purchase certain services from Teva Medical (Marketing) Ltd. (“Teva”) in connection with GelrinC. In April 2022, we amended the Baxter Services Agreement to replace Teva as the supplier of Tisseel under the Supply Agreement for GelrinC with Baxter as Teva ceased to distribute Tisseel in Israel. |
Under the Baxter Services Agreement, Baxter provides the Company with quality, regulatory and technical support, for up to a maximum aggregate of 40 man-hours per year for all such support. In consideration for receiving such support, the Company pays Baxter $
| 3. | In July 2008, the Company entered into a Supply Agreement with Baxter and Teva which was amended and restated on January 6, 2009, pursuant to which the Company agreed to purchase Tisseel VHSD fibrin sealant Kit (the “Tisseel”), from Teva, with Teva being Baxter’s exclusive distribution agent in Israel for Tisseel, for manufacture of GelrinC. The Supply Agreement was amended and restated. |
F-15
REGENTIS BIOMATERIALS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| NOTE 6:- | COMMITMENTS AND CONTINGENCIES (Cont.) |
The Supply Agreement had an initial term of
| 4. | In January 2026, the Company renewed its facility lease agreement until December 2026. The monthly rental obligations under non-cancellable leases are approximately $ |
Future minimum lease payments under non-cancelable operating leases as of June 30, 2026 are as follows:
| USD | ||||
| 2026 | ||||
| $ | ||||
The Company has elected to utilize the practical expedient in ASC 842 for short-term leases (less than 12 months) whereby a lease liability and right of use asset will not be recorded for short-term leases.
F-16
REGENTIS BIOMATERIALS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| NOTE 6:- | COMMITMENTS AND CONTINGENCIES (Cont.) |
| 5. | In 2019, a disagreement has arisen between the Company and CSL Behring GmbH, or CSL, whether certain unshipped minimum purchase commitments for fibrinogen from 2018 to 2020 are to be paid by the Company pursuant to a Framework Supply Agreement dated March 8, 2016, or Framework Supply Agreement, by and between the Company and CSL, whereby CSL agreed to supply the Company with fibrinogen. On January 14, 2020, the Company received a termination letter, or CSL Termination Letter. In the CSL Termination Letter, CSL demanded a total amount of $ |
The Company’s product has yet to be approved by FDA and is still in clinical trials and in any event, is not using CSL’s fibrinogen.
F-17
REGENTIS BIOMATERIALS LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| NOTE 6:- | COMMITMENTS AND CONTINGENCIES (Cont.) |
From time to time, the Company has been and may be in the future subject to other legal proceedings, claims, investigations, and government inquiries (collectively, “Legal Proceedings”) in the ordinary course of business. There are no currently pending legal proceedings that the Company believes will have a material adverse impact on the business or financial statements.
| NOTE 7: | SEGMENT REPORTING |
ASC 280, “Segment Reporting,” establishes standards for reporting information about operating segments.
The Company’s CODM is its (“CEO”), who reviews financial information.
The CODM performs the assessment of the segment performance by using net income (loss) to monitor budget versus actual results. Segment assets that are reviewed by the CODM are reported within the Company’s balance sheet as total assets.
The table below summarizes the significant expense categories regularly reviewed by the CODM:
| Six months ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Salaries ,contractors and material for research and development | $ | ( | ) | $ | ( | ) | ||
| Corporate general and administrative cost | ( | ) | ( | ) | ||||
| Other segments items* | ( | ) | ( | ) | ||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| (*) |
| NOTE 8:- | SUBSEQUENT EVENTS |
On July 9, 2026, Company’s shareholders meeting approved the grant of options and warrants to Directors of the Company, see also Note 5.
F-18
Exhibit 99.3
OPERATING AND FINANCIAL REVIEW AND PROSPECTS
You should read the following selected financial data and discussion of our operating and financial condition and prospects in conjunction with the financial statements and the notes thereto included elsewhere in this 6-K. Our financial statements are prepared in conformity with United States of America generally accepted accounting principles, or U.S. GAAP. Unless otherwise designated, the “Company,” “Regentis,” “we,” “us,” “our” and other similar designations refer to Regentis Biomaterials Ltd. The terms “shekel,” “Israeli shekel” and “NIS” refer to New Israeli Shekels, the lawful currency of the State of Israel, and the terms “dollar,” “U.S. dollar” or “$” refer to United States dollars, the lawful currency of the United States of America. All references to “shares” in this prospectus refer to Ordinary Shares of Regentis Biomaterials Ltd., no par value. Unless derived from our financial statements or otherwise indicated, U.S. dollar translations of NIS amounts presented in this exhibit are translated using the rate of NIS 2.978 to $1.00, based on the representative exchange rate reported by the Bank of Israel on June 30, 2026.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:
| ● | our cash and liquidity position and our ability to fund our operations, including our anticipated capital requirements and our need for additional financing; |
| ● | the ability of our clinical trials to demonstrate safety and efficacy of our future product candidates, and other positive results; | |
| ● | the timing and focus of our future preclinical studies and clinical trials, and the reporting of data from those studies and trials; | |
| ● | the size of the market opportunity for our future product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; | |
| ● | our ability to accurately identify demand for our Gelrin hydrogel platform or any future product candidates; | |
| ● | the success of competing therapies that are or may become available; | |
| ● | the beneficial characteristics, safety, efficacy and therapeutic effects of our future product candidates; | |
| ● | our ability to obtain FDA approval for our GelrinC product and obtain and maintain regulatory approval of our future product candidates; | |
| ● | our ability to obtain market acceptance of our Gelrin hydrogel platform and any future product candidates from the medical community and third-party payors; |
| ● | our plans relating to the further development of our future product candidates, 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; | |
| ● | the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; | |
| ● | our ability to generate revenue and profit margin under our anticipated contracts which is subject to certain risks; | |
| ● | difficulties in our and our partners’ ability to recruit and retain qualified physicians and other healthcare professionals, and enforce our non-compete agreements with our physicians; | |
| ● | our ability to restructure our operations to comply with future changes in government regulation; | |
| ● | our ability to address any competing technological and market developments that impact our Gelrin hydrogel platform and any future product candidates or their prospective usage by medical professionals; | |
| ● | 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; | |
| ● | our ability to maintain, protect and expand our portfolio of intellectual property rights, including patents, patent applications, trade secrets and know-how; | |
| ● | our expectations regarding having our Ordinary Shares continued listing on the NYSE American; and | |
| ● | statements as to the impact of the political and security situation in Israel on our business, including due to war or conflicts between Israel, Hamas, Hezbollah, and on other fronts from various extremist groups in the region, such as the Houthis in Yemen and various rebel militia groups in Syria and Iraq. |
Readers are urged to carefully review and consider the various disclosures made throughout this 6-K which are designed to advise interested parties of the risks and factors that may affect our business, financial condition, results of operations and prospects.
2
You should not put undue reliance on any forward-looking statements. Any forward-looking statements in this prospectus are made as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this prospectus. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
The forward-looking statements and opinions contained in this exhibit are based upon information available to us as of the date of the 6-K that accompanies this exhibit and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. The forward-looking statements contained in this exhibit speak only as of the date of the 6-K that accompanies this exhibit, and unless otherwise required by law, we do not undertake any obligation to update them in light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events.
You should read this exhibit, and the documents that we reference herein, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
Overview
We are a regenerative medicine company dedicated to developing innovative tissue repair solutions that restore the health and enhance the quality of life of patients. Our current efforts are focused on orthopedic treatments using our Gelrin platform based on degradable hydrogel implants to regenerate damaged or diseased tissue (inflamed cartilage and bone tissue). Gelrin is a unique hydrogel matrix of polyethylene glycol diacrylate (a polymer involved in tissue engineering) and denatured fibrinogen (a biologically inactivated protein that normally has a role in blood clotting). Our lead product is GelrinC, a cell-free, off-the-shelf hydrogel that is cured into an implant in the knee for the treatment of painful injuries to articular knee cartilage.
To our knowledge, there is currently no approved off-the-shelf product in the United States for the cartilage repair market. GelrinC potentially offers a solution that, we believe, gives surgeons a cost-effective product and a simple-to-perform procedure providing patients with sustained pain relief and functional improvement. GelrinC is already approved as a device with a Conformité Européenne, or CE mark in Europe, and we plan to look for strategic partners in Europe in connection therewith. With GelrinC, we aim to develop a product for the treatment of an unmet need for the market of cartilage injuries in the knee. We believe our product offers a simple and economic procedure, allowing patients a comparatively quick recovery with potentially long-term outcomes. In addition, we have 27 granted patents and 5 pending patent applications of which 2 are allowed, covering, in a large number of countries, compositions, delivery device, surgical and manufacturing features.
In the Pilot Study, 56 patients were treated with GelrinC for articular cartilage injuries. The improvements observed in the Knee Injury and Osteoarthritis Outcome Score, or KOOS, and Visual Analog Scale, or VAS, pain measurement scores taken over two years were superior (100% greater improvement) to those seen with the traditional microfracture (the current “gold standard”) procedure. Additionally, patients continued to report further improvement and greater pain reduction of their knee and associated problems using GelrinC for four years.
Based on these results, the Food and Drug Administration, or FDA, granted Regentis an investigational device exemption, or IDE, for our pivotal trial, permitting pre-market approval application, or PMA, submission with two-year follow up data of 80 patients, with an additional 40 patients to be treated thereafter. The pivotal trial is currently being conducted in the United States and Europe. So far, we have recruited and treated 47 patients out of the required 80 initial patients, under the FDA sanctioned protocol. The protocol is an open label study, with one arm only (treatment), using our own historical control (microfracture). 43 patients out of the 47 patients recruited so far have completed the two-year follow up in this trial. We expect to complete the recruitment of patients approximately by year end 2026.
3
Components of Operating Results
Revenues
We have not recognized any revenue to date, and we do not expect to generate revenue from the sale of products in the near future.
Research and Development Expenses
Research and development activities are our primary focus. We do not believe that it is possible at this time to accurately project total expenses required for us to reach the point at which we will be ready to out-license our technologies. Development timelines, the probability of success and development costs can differ materially from expectations. In addition, we cannot forecast whether and when collaboration arrangements will be entered into, if at all, and to what degree such arrangements would affect our development plans and capital requirements. We also received a non-royalty bearing grant from the European Union through the European Commission Executive Agency for Small and Medium-sized Enterprises as part of the Horizon 2020 Research and Innovative Framework Programme, or the Horizon 2020 Grant. The Horizon 2020 Grant was fully recognized in the year ended December 31, 2024, as a reduction in research and development expense. We expect our research and development expenses to increase over the next several years as our development program progresses. We would also expect to incur increased research and development expenses if we were to identify and develop additional technologies.
Research and development expenses include the following:
| ● |
employee-related expenses, such as salaries; | |
| ● | Expenses related to our ongoing phase III clinical study |
| ● | expenses relating to outsourced and contracted services, such as consulting, research and advisory services; |
| ● | supply and development costs; and |
| ● |
expenses incurred in operating our small-scale equipment. |
We recognize research and development expenses as we incur them.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel costs, facility costs and maintenance expenses, and external professional service costs, including legal, accounting, audit, finance, business development, investor relations and human resource services, and other consulting fees.
We anticipate that our general and administrative expenses will increase in the future as we increase our administrative headcount and infrastructure to support our continued research and development programs and the potential commercialization of our products. We also have incurred increased expenses related to audit, legal, regulatory and tax related services associated with maintaining compliance with NYSE American and SEC requirements, director and officer insurance premiums, director compensation, and other costs associated with being a public company.
Finance Income (expenses), Net
Our finance income (expense), net consists primarily of changes in fair value of convertible notes, change in fair value of warrant liability, bank management fees and commissions and exchange rate differences expenses. The financial income recorded from the change in fair value of convertible notes and change in fair value of warrant liability was mainly due to the change in the Company’s assumptions used in the valuation of these instruments.
Income Taxes
We have yet to generate taxable income in Israel. As of June 30, 2026, our operating tax loss carryforwards were approximately $53 million. We anticipate that we will continue to generate tax losses for the foreseeable future and that we will be able to carry forward these tax losses indefinitely to future taxable years. Accordingly, we do not expect to pay taxes in Israel until we have taxable income after the full utilization of our carry forward tax losses.
4
Results of Operations
Our results of operations have varied in the past and can be expected to vary in the future due to numerous factors. We believe that period-to-period comparisons of our operating results are not necessarily meaningful and should not be relied upon as indications of future performance.
Our results of operations for the six months ended June 30, 2026 and 2025 were as follows:
| Six Months Ended June 30, | ||||||||
| (in thousands of USD, except share and per share data) | 2026 | 2025 | ||||||
| Statements of comprehensive loss: | ||||||||
| Research and development expenses | (1,203 | ) | (180 | ) | ||||
| General and administrative expenses | (1,196 | ) | (259 | ) | ||||
| Operating loss | (2,399 | ) | (439 | ) | ||||
| Financial income (expenses), net: | ||||||||
| Changes in fair value of convertible notes | - | (2,740 | ) | |||||
| Changes in fair value of warrant liability | - | 160 | ||||||
| Other financing expenses, net | (201 | ) | (209 | ) | ||||
| Net loss | (2,600 | ) | (3,228 | ) | ||||
| Basic and diluted net income (loss) per share | (0.44 | ) | (1.17 | ) | ||||
| Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share | 5,954,122 | 2,765,850 | ||||||
Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025
Research and development expenses
Research and development expenses increased by approximately $1.0 million, or 568%, to $1.2 million for the six months ended June 30, 2026, compared to $180 thousand for the six months ended June 30, 2025. The increase resulted mainly from the advancement of our ongoing pivotal Phase III clinical study with employee and employee-related costs, production and material costs, and outsourced service costs.
General and administrative expenses
General and administrative expenses increased by $937 thousand, or 362%, to $1.2 million for the six months ended June 30, 2026, compared to $259 thousand for the six months ended June 30, 2025. The increase resulted mainly from higher employee and employee-related costs and corporate costs associated with operating as a public company.
Financial income (expenses), net
Finance expenses, net decreased by approximately $2.6 million, or 93%, to $201 thousand for the six months ended June 30, 2026, compared to finance expenses, net of $2.8 million for the six months ended June 30, 2025. The decrease resulted mainly from the absence of fair value remeasurement of our convertible notes, which were converted upon the closing of our initial public offering in December 2025.
5
Net loss
Net loss decreased by $628 thousand to a net loss of $2.6 million for the six months ended June 30, 2026, compared to a net loss of $3.2 million for the six months ended June 30, 2025. The decrease resulted mainly from lower finance expenses, partially offset by higher research and development and general and administrative expenses.
Emerging Growth Company Status
We qualify as an “emerging growth company” as defined in the JOBS Act. An emerging growth company may take advantage of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. These provisions include:
| ● | a requirement to present only two years of audited financial statements in addition to any required interim financial statements and correspondingly reduced Operating and Financial Review and Prospects disclosure; |
| ● | to the extent that we no longer qualify as a foreign private issuer, (i) reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and (ii) exemptions from the requirement to hold a non-binding advisory vote on executive compensation, including golden parachute compensation; |
| ● | an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002; and |
| ● | an exemption from compliance with the requirement that the Public Company Accounting Oversight Board has adopted regarding a supplement to the auditor’s report providing additional information about the audit and the financial statements. |
We may take advantage of these exemptions for up to five years or until such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company upon the earliest to occur of: (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (ii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; (iii) the date on which we are deemed to be a large accelerated filer under the rules of the SEC; or (iv) the last day of the fiscal year following the fifth anniversary of this offering. We may choose to take advantage of some but not all of these exemptions. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. This means that an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the extended transition period to comply with new or revised accounting standards and to adopt certain of the reduced disclosure requirements available to emerging growth companies. As a result of the accounting standards election, we will not be subject to the same implementation timing for new or revised accounting standards as other public companies that are not emerging growth companies which may make comparison of our financials to those of other public companies more difficult.
Liquidity and Capital Resources
Since our inception, we have incurred losses and negative cash flows from our operations. For the six months ended June 30, 2026, we had a net loss of $2.6 million, net cash of $2.8 was used in our operating activities and accumulated deficit of $58.4 million. As of June 30, 2026, our cash and cash equivalents totaled $9.0 million. Based on our current plans, we believe that our existing cash and cash equivalents will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through September 2027.
6
Through June 30, 2026, we have financed our operations primarily through convertible loans and short-term loans, other than our initial public offering and subsequent private placement, each as discussed below. Total invested capital as of each June 30, 2026 was $52.7 million, which included Ordinary Shares and warrants to purchase Ordinary Shares.
On December 5, 2025, we closed our initial public offering, or IPO, of 1,250,000 ordinary shares. The ordinary shares were sold at an initial public offering price of $8.00 per ordinary share. In connection with the IPO, we received aggregate gross proceeds of approximately $10 million, before deducting underwriting discounts, commissions and before offering expenses.
On June 17, 2026, we entered into securities purchase agreements pursuant to which we agreed to sell and issue in a private placement, or the Private Placement, 1,844,543 Ordinary Shares, pre-funded warrants to purchase up to 12,600 Ordinary Shares, or Pre-Funded Warrants, and ordinary warrants to purchase up to 1,857,143 Ordinary Shares, or Ordinary Warrants, at a combined purchase price of $3.50 per Ordinary Share and accompanying Ordinary Warrant, and $3.4999 per Pre-Funded Warrant and accompanying Ordinary Warrant. The Pre-Funded Warrants have an exercise price of $0.0001 per Ordinary Share, are immediately exercisable upon issuance and will not expire until exercised in full. The Ordinary Warrants have an exercise price of $4.20 per Ordinary Share, are immediately exercisable upon issuance and will expire on the five-year anniversary from the date of issuance. The aggregate gross proceeds from the Private Placement were approximately $6.5 million, prior to deducting placement agent fees and estimated offering expenses payable by the Company. On June 25, 2026, the Private Placement closed.
We also entered into the Placement Agent Agreement dated June 17, 2026, with ThinkEquity LLC, or the Placement Agent, pursuant to which the Placement Agent agreed to serve as the exclusive placement agent for us in connection with the Private Placement. We paid the Placement Agent a placement agent fee equal to 7.0% of the gross proceeds from the sale of the Ordinary Shares (or pre-funded warrants in lieu thereof) in the Private Placement, a non-accountable expense allowance equal to 1.0% of the gross proceeds from the sale of the Ordinary Shares (or pre-funded warrants in lieu thereof) in the Private Placement, and an expense reimbursement for accountable out-of-pocket expenses up to $180,000. Designees of the Placement Agent also received warrants to purchase an aggregate of up to 92,857 Ordinary Shares at an exercise price of $4.375 per share as compensation for the Placement Agent’s services in connection with the Private Placement.
The following table summarizes our statement of cash flows for the six months ended June 30, 2026 and 2025:
| For the Six Months Ended June 30, | ||||||||
| (U.S. dollars in thousands except share and per share data) | 2026 | 2025 | ||||||
| Net cash used in operating activities | (2,807 | ) | (340 | ) | ||||
| Net cash used in investing activities | (37 | ) | - | |||||
| Net cash provided by financing activities | 4,418 | 300 | ||||||
| Increase (Decrease) in cash and cash equivalents | 1,574 | (40 | ) | |||||
Net cash used in operating activities
Net cash used in operating activities
Net cash used in operating activities for the six months ended June 30, 2026 was $2.8 million, compared to net cash used in operating activities of $340 thousand for the six months ended June 30, 2025. The increase resulted mainly from the expansion of labor, production and subcontracting activities related to our clinical study as well as higher general and administrative spending following our initial public offering.
Net cash used in investing activities
Net cash used in investing activities was $37 thousand for the six months ended June 30, 2026. There was no net cash used in investing activities during the six months ended June 30, 2025.
7
Net cash provided by financing activities
Net cash provided by financing activities increased by $4.1 million, to $4.4 million for the six months ended June 30, 2026 compared to net cash provided by financing activities of $300 thousand for the six months ended June 30, 2025. The increase resulted mainly from $5.6 million of net proceeds from the issuance of Ordinary Shares in the Private Placement, partially offset by $1.2 million of repayments of a short-term loan.
Funding Requirements
We have incurred losses from operations since the inception, resulting in an accumulated deficit on June 30, 2026 of $58.4 million. We anticipate that we will continue to incur net losses for the foreseeable future. We believe that our existing cash and cash equivalents, without giving effect to the proceeds from this offering, will be sufficient to fund our projected cash needs through September 2027. To meet future capital needs, we would need to raise additional capital through equity or debt financing or other strategic transactions. However, any such financing may not be on favorable terms or even available to us. Our failure to obtain sufficient funds on commercially acceptable terms when needed would have a material adverse effect on our business, results of operations and financial condition. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and the actual amount of our expenses could vary materially and adversely as a result of a number of factors. We have based our estimates on assumptions that may prove to be wrong, and our expenses could prove to be significantly higher than we currently anticipate.
Our future capital requirements will depend on many factors, including, but not limited to:
| ● | the progress and costs of our research and development activities; |
| ● | the costs of development and expansion of our operational infrastructure; |
| ● | our ability, or that of our collaborators, to achieve development milestones and other events or developments under potential future licensing agreements; |
| ● | the amount of revenues and contributions we receive under future licensing, collaboration, development and commercialization arrangements with respect to our technologies; |
| ● | the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; |
| ● | the costs of contracting with third parties to provide sales and marketing capabilities for us or establishing such capabilities ourselves, once our technologies are developed and ready for commercialization; |
| ● | the costs of acquiring or undertaking development and commercialization efforts for any future products or technology; |
| ● | the magnitude of our general and administrative expenses; and |
| ● | any additional costs that we may incur under future in- and out-licensing arrangements relating to our technologies and future products. |
Until we can generate significant recurring revenues, we expect to satisfy our future cash needs through capital raising or by out-licensing and/or co-developing applications of one or more of our product candidates. We cannot be certain that additional funding will be available to us on acceptable terms, if at all. If funds are not available on favorable terms, or at all, we may be required to delay, reduce the scope of or eliminate research or development efforts or plans for commercialization with respect to our technologies and make necessary changes to our operations to reduce the level of our expenditures in line with available resources.
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We are a development-stage technology company and it is not possible for us to predict with any degree of accuracy the outcome of our research and development efforts. As such, it is not possible for us to predict with any degree of accuracy any significant trends, uncertainties, demands, commitments or events that are reasonably likely to have a material effect on our net loss, liquidity or capital resources, or that would cause financial information to not necessarily be indicative of future operating results or financial condition. However, to the extent possible, certain trends, uncertainties, demands, commitments and events are described herein.
Quantitative and Qualitative Disclosures About Market Risk
Liquidity Risk
Liquidity risk is the risk that we will encounter difficulty in meeting the obligations associated with our financial liabilities that are settled in cash. Cash flow forecasting is performed in our operating entities and aggregated at a consolidated level. We monitor forecasts of our liquidity requirements to ensure we have sufficient cash to meet operational needs. We may be reliant on our ability to raise additional investment capital from the issuance of both debt and equity securities to fund our business operating plans and future obligations.
Credit risk
Credit risk is the risk of financial loss to us if a debtor or counterparty to a financial instrument fails to meet its contractual obligations, and arises mainly from our receivables.
We restrict exposure to credit risk in the course of our operations by investing only in bank deposits.
Equity price risk
As we have not invested in securities riskier than short-term bank deposits, we do not believe that changes in equity prices pose a material risk to our holdings. However, decreases in the market price of our Ordinary Shares could make it more difficult for us to raise additional funds in the future or require us to raise funds at terms unfavorable to us.
Inflation risk
We do not believe that inflation has had a material effect on our business, financial condition or results of operations in the reporting period. If our costs were to become subject to significant inflationary pressures, we may not be able to fully offset such higher costs through hedging transactions. Our inability or failure to do so could harm our business, financial condition and results of operations.
Foreign Currency Exchange Risk
Our results of operations are affected by fluctuations in currency exchange rates, primarily due to the fact that a significant portion of our operating expenses, such as employee salaries and subcontractors, are incurred in New Israeli Shekels (NIS), while our presentation currency is the U.S. Dollar. During the six months ended June 30, 2026, the appreciation of the NIS against the U.S. Dollar resulted in an increase in our NIS-denominated operating expenses when translated into U.S. Dollars, thereby adversely impacting our results of operations.
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