# EDGAR Filing Document

**Accession Number:** 0001611747
**File Stem:** 0001213900-25-083373
**Filing Date:** 2025-9
**Character Count:** 75262
**Document Hash:** 6bc2c9580af97601f9774a00a5ac3bc3
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-25-083373.hdr.sgml**: 20250902

**ACCESSION NUMBER**: 0001213900-25-083373

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 54

**CONFORMED PERIOD OF REPORT**: 20250630

**FILED AS OF DATE**: 20250902

**DATE AS OF CHANGE**: 20250902

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Scinai Immunotherapeutics Ltd.
- **CENTRAL INDEX KEY:** 0001611747
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** L3
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37353
- **FILM NUMBER:** 251285682

**BUSINESS ADDRESS:**
- **STREET 1:** JERUSALEM BIOPARK, 2ND FLOOR
- **STREET 2:** HADASSAH EIN KEREM CAMPUS
- **CITY:** JERUSALEM
- **STATE:** L3
- **ZIP:** 00000
- **BUSINESS PHONE:** 972-8-9302529

**MAIL ADDRESS:**
- **STREET 1:** JERUSALEM BIOPARK, 2ND FLOOR
- **STREET 2:** HADASSAH EIN KEREM CAMPUS
- **CITY:** JERUSALEM
- **STATE:** L3
- **ZIP:** 00000

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** BiondVax Pharmaceuticals Ltd.
- **DATE OF NAME CHANGE:** 20140624

?xml version='1.0' encoding='ASCII'?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 6-K**

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 2025

Commission File Number: 001-37353

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

**SCINAI IMMUNOTHERAPEUTICS LTD.**

(Translation of registrant's name into English)

**Jerusalem BioPark, 2nd Floor**

**Hadassah Ein Kerem Campus**

**Jerusalem, Israel**

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒&nbsp;&nbsp;&nbsp;&nbsp; Form 40-F ☐

**EXPLANATORY NOTE**

Attached are the Company's press release providing a business update for the first half of 2025, condensed interim unaudited financial statements and a summary of its operating and financial review and prospects, each as of June 30, 2025, furnished herewith as Exhibits 99.1, 99.2 and 99.3, respectively

This Report on Form 6-K (including Exhibits 99.1, 99.2 and 99.3) is hereby incorporated by reference into the registrant's Registration Statements on Form S-8 (File No. [333-271293](http://www.sec.gov/Archives/edgar/data/1611747/000121390023030288/ea176534-s8_biondvaxpharma.htm) and File No. [333-239344](http://www.sec.gov/Archives/edgar/data/1611747/000121390020015429/ea123060-s8_biondvaxpharma.htm)) and Form F-3 (File No. [333-274078](http://www.sec.gov/Archives/edgar/data/1611747/000121390023068963/ea183844-f3_biondvaxpharma.htm) and File No. [333-276767](http://www.sec.gov/Archives/edgar/data/1611747/000121390024007939/ea192382-f3_scinaiimmun.htm)), 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.

**Exhibit Index**

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [Press Release dated September 2, 2025](ea025545201ex99-1_scinai.htm) |
| 99.2 | [Condensed Consolidated Unaudited Financial Statements as of June 30, 2025](ea025545201ex99-2_scinai.htm) |
| 99.3 | [Operating and Financial Review and Prospects as of June 30, 2025](ea025545201ex99-3_scinai.htm) |
| 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 |

---

**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.

---

| | | |
|:---|:---|:---|
|  | **Scinai Immunotherapeutics Ltd.** | **Scinai Immunotherapeutics Ltd.** |
| Date: September 2, 2025 | By: | /s/ Amir Reichman |
|  |  | Amir Reichman |
|  |  | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**Scinai Reports Six-Month 2025 Financial Results Highlighting Continued CDMO Revenue Growth and Strengthened Balance Sheet**

JERUSALEM, Sept. 2, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company focused on developing novel and innovative biological drug candidates for the treatment of inflammation and immunology (I&I) related diseases and on providing CDMO services through its Scinai Bioservices business unit, today announced its financial results for the six months ended June 30, 2025.

![](ex99-1_001.jpg)

**Six-Month 2025 Financial Summary** 

● **Revenues** for the six months ended June 30, 2025, totaled $773 thousand, compared to $284 thousand for the six months ended June 30, 2024. The increase reflects the continued growth of the Company's CDMO business, which generated contract revenues.

● **R&D expenses** for the six months ended June 30, 2025, amounted to $1,237 thousand, compared to $2,788 thousand for the same period in 2024, primarily due to lower allocation of wages and facilities to R&D activities.

● **Marketing, general and administrative** expenses were $1,256 thousand in the six months ended June 30, 2025, compared to $1,003 thousand in the same period of 2024. The increase was primarily due to share-based payments and due to an insurance reimbursement recorded in 2024.

● **Net loss** was $4,134 thousand, compared to $4,481 thousand in the six months ended June 30, 2024, reflecting higher revenues and lower R&D expenses.

● **Cash** - as of June 30, 2025, cash and cash equivalents totaled $989 thousand. Subsequently, in July and August 2025, the Company successfully raised an additional $4.2 million through its Standby Equity Purchase Agreement with Yorkville Advisors, significantly strengthening its cash position.

**Business Update**

**CDMO**

● Scinai Bioservices, the Company's CDMO business unit, continues to grow steadily, with its U.S. subsidiary contributing $421 thousand in revenues in the first half of 2025.

● As of August 31, 2025, total CDMO service orders for 2025 reached $1.0 million, net of raw materials and disposables, with invoiced revenues of $850 thousand.

**R&D**

● Scinai is advancing its anti-IL-17 NanoAb program with two product profiles in development: one focused on localized treatment of psoriasis patients with small but debilitating lesions, and another aimed at systemic treatment of moderate-to-severe plaque psoriasis through an innovative tri-specific antibody design.

● The Company plans to apply for up to €15 million in grant financing under the EU STEP program, with a decision expected in Q1 2026, to fund Phase 1/2a clinical trials.

● In 2025, Scinai filed patents for four additional NanoAbs from its collaboration with the Max Planck Society and University Medical Center Göttingen and is exercising its exclusive option to license them. By October 2025, the Company expects to apply for a European Funds for a Modern Economy (FENG) grant to support the development of a novel multi-specific antibody targeting TH2-related diseases such as asthma, atopic dermatitis, and COPD.

● In March 2025, Scinai signed an option agreement to acquire PinCell srl, an Italian biotech company developing PC111, a potential treatment for severe dermatological conditions. A related €12 million FENG grant application is under review, with a funding decision expected in Q3 2025.

**About Scinai Immunotherapeutics**

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked pipeline of VHH antibody fragments (nanoAbs) targeting diseases with large unmet medical needs, and the other a boutique CDMO providing biological drug development, analytical methods development, clinical cGMP manufacturing, and pre-clinical and clinical trial design and execution services for early stage biotech drug development projects.

Company website: www.scinai.com

**Company Contacts**

Investor Relations - Allele Capital Partners \| +1 978 857 5075 \| aeriksen@allelecapital.com Business Development \| +972 8 930 2529 \| bd@scinai.com

**Forward-Looking Statements**

 

*This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of Scinai Immunotherapeutics Ltd. Risks and uncertainties include, but are not limited to; the risk that the Company will otherwise be unable to remain compliant with the continued listing requirements of Nasdaq; lower than anticipated revenues of Scinai's CDMO business in 2025 and thereafter; failure to sign agreements with other potential clients of the CDMO business; the risk that the Company will not be awarded, or there will be delays in decisions with respect to, the potential grants from the FENG program, the EU Step program and/or the IIA; that the Company will not exercise its right to acquire PinCell; a delay in the commencement and results of pre-clinical and clinical studies, including the Phase 1/2a study for psoriasis, the risk of delay in, Scinai's inability to conduct, or the unsuccessful results of, its research and development activities, including the contemplated in-vivo studies and a clinical trial; the risk that Scinai will not be successful in expanding its CDMO business or in-license other nanoAbs; the risk that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of nanoAbs will not be met or that Scinai will not be successful in bringing the nanoAbs towards commercialization; the risk of a delay in the preclinical and clinical trials data for nanoAbs, if any; the risk that our business strategy may not be successful; Scinai's ability to acquire rights to additional product opportunities; Scinai's ability to enter into collaborations on terms acceptable to Scinai or at all; timing of receipt of regulatory approval of Scinai's manufacturing facility in Jerusalem, if at all or when required; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on May 7, 2025, and the Company's subsequent filings with the SEC. Scinai undertakes no obligation to revise or update any forward-looking statement for any reason.*

Logo: https://mma.prnewswire.com/media/2310190/Scinai_Immunotherapeutics_Logo.jpg

## Exhibit 99.2

?xml version='1.0' encoding='ASCII'?

**Exhibit 99.2**

**SCINAI IMMUNOTHERAPEUTICS LTD.**

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2025

Unaudited

**SCINAI IMMUNOTHERAPEUTICS LTD**

**CONSOLIDATED BALANCE SHEETS**

**U.S. dollars in thousands** 

---

| | | |
|:---|:---|:---|
|  | **June 30,**<br>**2025** | **December 31,**<br>**2024** |
|  | **Unaudited** | **Audited** |
| ASSETS |  |  |
| CURRENT ASSETS: |  |  |
| &nbsp;&nbsp;&nbsp;Cash and cash equivalents | $989 | $1964 |
| &nbsp;&nbsp;&nbsp;Restricted cash | 142 | 131 |
| &nbsp;&nbsp;&nbsp;Prepaid expenses and other receivables | 236 | 213 |
| &nbsp;&nbsp;&nbsp;Trade receivables | 139 | 83 |
| Total current assets | 1506 | 2391 |
| NON-CURRENT ASSETS: |  |  |
| &nbsp;&nbsp;&nbsp;Property, plant and equipment, net | 8497 | 9189 |
| &nbsp;&nbsp;&nbsp;Operating lease right-of-use assets | 1837 | 1868 |
| Total non-current assets | 10334 | 11057 |
| Total assets | $11840 | $13448 |

---

The accompanying notes are an integral part of the condensed consolidated financial statements.

**SCINAI IMMUNOTHERAPEUTICS LTD**

**CONSOLIDATED BALANCE SHEETS**

**U.S. dollars in thousands (except share data)**

---

| | | |
|:---|:---|:---|
|  | **June 30,**<br>**2025** | **December 31,**<br>**2024** |
|  | **Unaudited** | **Audited** |
| &nbsp;&nbsp;&nbsp;LIABILITIES AND EQUITY |  |  |
| CURRENT LIABILITIES: |  |  |
| &nbsp;&nbsp;&nbsp;Trade payables | $659 | $376 |
| &nbsp;&nbsp;&nbsp;Operating lease liabilities | 497 | 424 |
| &nbsp;&nbsp;&nbsp;Other payables | 964 | 1006 |
| Total current liabilities | 2120 | 1806 |
| NON-CURRENT LIABILITIES: |  |  |
| &nbsp;&nbsp;&nbsp;Warrants liability | 3 | 3 |
| &nbsp;&nbsp;&nbsp;Loan from others | 293 | 260 |
| &nbsp;&nbsp;&nbsp;Non-current operating lease liabilities | 1566 | 1402 |
| Total non-current liabilities | 1862 | 1665 |
| CONTINGENT LIABILITIES AND COMMITMENTS |  |  |
| SHAREHOLDERS' EQUITY: |  |  |
| Ordinary shares of no par value: Authorized: 40,000,000,000 shares at June 30, 2025 and at December 31, 2024; Issued and outstanding 6,056,623,584 shares at June 30, 2025 and 3,411,983,584 shares at December 31, 2024 | - | - |
| Preferred shares, no par value; Authorized: 1,000 shares at June 30, 2025 and 1,000 shares at December 31, 2024 (redemption amount of $34,000); Issued and outstanding: 1,000 shares at June 30, 2025 and 1,000 shares at December 31, 2024. | 5627 | 5627 |
| Additional paid-in capital | 125644 | 123629 |
| Accumulated deficit | (121673) | (117539) |
| Accumulated other comprehensive loss | (1740) | (1740) |
| Total shareholders' equity | 7858 | 9977 |
| Total liabilities and shareholders' equity | 11840 | $13448 |

---

The accompanying notes are an integral part of the condensed consolidated financial statements.

**SCINAI IMMUNOTHERAPEUTICS LTD**

**CONSOLIDATED STATEMENTS OF OPERATIONS**

**U.S. dollars in thousands (except share data)**

---

| | | |
|:---|:---|:---|
|  | **For the six months ended<br> June 30** | **For the six months ended<br> June 30** |
|  | **2025** | **2024** |
|  | **Unaudited** | **Unaudited** |
| Revenues | 773 | 284 |
| Cost of revenues | $(2043) | $(448) |
| Gross Income profit (loss) | (1270) | (164) |
| Research and development expenses, net | (1237) | (2788) |
| Marketing, general, and administrative expenses | (1256) | (1003) |
| Total operating expenses | (2493) | (3791) |
| Total operating profit (loss) | (3763) | (3955) |
| Total Financial Expenses net, | (371) | (526) |
| Net profit (loss) | $(4134) | $(4481) |
| Net loss per share attributable to ordinary shareholders, basic and diluted | (0.001) | (0.002) |
| Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, basic and diluted | 6364731650 | 2288278248 |

---

The accompanying notes are an integral part of the condensed consolidated financial statements.

**SCINAI IMMUNOTHERAPEUTICS LTD**

**CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY**

**U.S. dollars in thousands (except share data)**

---

| | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|
|  | **Ordinary shares** | **Ordinary shares** | **Preferred shares** | **Preferred shares** | | | | |
|  | **Number** | **Amount** | **Number** | **Amount** | **Additional<br> paid-in**<br>**capital** | **Accumulated<br> comprehensive**<br>**loss** | **Accumulated<br> equity**<br>**(deficit)** | **Total<br> shareholders'<br> equity**<br>**(deficit)** |
| Balance as of January 1, 2025 | 3411983584 | \* | 1000 | $5627 | $123629 | $(1740) | $(117539) | $9977 |
| Vested RSU's | 32816000 | - |  | - | - | - | - | - |
| Share-based compensation |  | &nbsp;&nbsp;&nbsp;&nbsp; - |  | - | 270 | - | &nbsp;&nbsp;&nbsp;&nbsp;- | 270 |
| Exercise of prefunded warrants | 322944000 | - |  | - | - | - | - | - |
| Issuance of ordinary shares | 2288880000 | - |  | - | 1745 | - | - | 1745 |
| Net loss |  | - | - | - | - | - | (4134) | (4134) |
| Balance as of June 30, 2025 | 6056623584 | - | 1000 | $5627 | $125644 | $(1740) | $(121673) | $7858 |

---

\* Ordinary shares have no par value

---

| | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|
|  | **Ordinary shares** | **Ordinary shares** | **Preferred shares** | **Preferred shares** | | | | |
|  | **Number** | **Amount** | **Number** | **Amount** | **Additional**<br> **paid-in**<br>**capital** | **Accumulated<br> comprehensive**<br>**loss** | **Accumulated<br> equity**<br>**(deficit)** | **Total<br> shareholders'<br> equity**<br>**(deficit)** |
| Balance as of January 1, 2024 | 1857169984 |  |  |  | $119506 | $&nbsp;&nbsp;&nbsp;&nbsp; (1740) | $(122335) | $(4569) |
| Issuance and exercise of warrants, net of issuance costs of $275 | 1491240800 |  |  |  | 1433 | - | - | 1433 |
| Vested RSU's | 1020800 |  |  |  | - | - | - | - |
| Share-based compensation |  |  |  |  | 333 | - | - | 333 |
| Net loss | - |  |  |  | - | - | (4481) | (4481) |
| Balance as of June 30, 2024 | 3349431584 |  |  |  | $121272 | $(1740) | $(126816) | $(7284) |

---

**SCINAI IMMUNOTHERAPEUTICS LTD.** 

**CONSOLIDATED STATEMENTS OF CASH FLOWS**

**U.S. dollars in thousands** 

---

| | | |
|:---|:---|:---|
|  | **For the six months ended**<br> **June 30,** | **For the six months ended**<br> **June 30,** |
|  | **2025** | **2024** |
|  | **Unaudited** | **Unaudited** |
| <u>Cash flows from operating activities:</u> |  |  |
| Net profit (loss) | $(4134) | $(4481) |
| Adjustments to reconcile net loss to net cash used in operating activities: |  |  |
| Depreciation of property, plant and equipment | 704 | 652 |
| Financial expense related to loan from others | 33 | 451 |
| Revaluation of warrants | - | (93) |
| Share-based compensation | 270 | 333 |
| Increase in receivables | (56) | (119) |
| Decrease (increase) in other receivables | (23) | 110 |
| Effect of exchange rate changes on cash, cash equivalents and restricted cash | (42) | - |
| SEPA commitment fees | 164 | - |
| Changes in operating lease right-of-use assets | 31 | 189 |
| Increase in trade payables | 283 | 125 |
| Changes in operating lease liabilities | 237 | (189) |
| Increase (decrease) in other payables | (42) | (199) |
| Net cash used in operating activities | (2575) | (3221) |
| <u>Cash flows from investing activities:</u> |  |  |
| Purchase of property, plant and equipment | (12) | (8) |
| Net cash used in investing activities | $(12) | $(8) |

---

The accompanying notes are an integral part of the condensed consolidated financial statements.

**SCINAI IMMUNOTHERAPEUTICS LTD**

**CONSOLIDATED STATEMENTS OF CASH FLOWS**

**U.S. dollars in thousands** 

---

| | | |
|:---|:---|:---|
|  | **For the six months ended<br> June 30,** | **For the six months ended<br> June 30,** |
|  | **2025** | **2024** |
|  | **Unaudited** | **Unaudited** |
| <u>Cash flows from financing activities:</u> |  |  |
| Proceed from issuance and exercise of warrants and shares, net | $- | $1433 |
| Proceeds from issuance of ordinary shares for SEPA holders, net | 1581 | - |
| Net cash provided by financing activities | 1581 | 1433 |
| Effect of exchange rate changes on cash, cash equivalents and restricted cash | 42 | 121 |
| Increase (decrease) in cash, cash equivalents and restricted cash | (964) | (1917) |
| Cash, cash equivalents and restricted cash at beginning of year | 2095 | 5010 |
| Cash, cash equivalents and restricted cash at end of six months period | $1131 | $3214 |
| <u>Supplementary disclosure of cash flows activities:</u> |  |  |
| (1) Cash paid during the year for: |  |  |
| Interest | $- | $143 |
| (2) Non-cash transactions: |  |  |
| Shares issued for SEPA financing agreement | 100 |  |
| <u>Reconciliation of cash, cash equivalents and restricted cash:</u> |  |  |
| Cash and cash equivalents | $989 | $3076 |
| Restricted cash | 142 | 138 |
| Cash, cash equivalents and restricted cash | $1131 | $3214 |

---

The accompanying notes are an integral part of the condensed consolidated financial statements.

**SCINAI IMMUNOTHERAPEUTICS LTD**

**NOTES TO CONSOLIDATED FINANCIAL STATEMENTS**

**U.S. dollars in thousands (except share and per share data and unless otherwise indicated)**

**NOTE 1:- GENERAL**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. Scinai Immunotherapeutics LTD (the "Company"), operations are divided between two business
units: (1) an innovative R&D business unit and (2) a Contract Development and Manufacturing Organization ("CDMO") business
unit (see section e). The R&D unit focuses on: (i) managing and guiding a research collaboration agreement with the Max Planck Society
("MPG"), the parent organization of the Max Planck Institute for Multidisciplinary Sciences ("MPI-MS"), and the
University Medical Center Gottingen ("UMG"), both located in Germany; and (ii) developing licensed drug candidates throughout
the pre-clinical and clinical steps required for drug approval. The CDMO unit focuses on providing drug development and manufacturing
services to small, early stage biotech companies. The Company was incorporated on July 21, 2003, in Israel and started its activity on
March 31, 2005. In June 2007, the Company completed an initial public offering of its ordinary shares on the Tel Aviv Stock Exchange (TASE)
and then voluntarily delisted from the TASE in January 2018. In May 2015, the Company completed an initial public offering of American
Depositary Shares ("ADS") on the Nasdaq Capital Market. The Company's principal executive offices and main laboratories
are located in Jerusalem, Israel.

Since October 2023, Israel has been in a state of war on multiple fronts involving the Gaza Strip and other countries and regions in the Middle East, including most recently the Islamic Republic of Iran. As a result of the conflict, some of the Company's employees were called to reserve military duty, leading to temporary workforce disruptions. In addition, the unstable environment made capital raising efforts more challenging.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. On March 23, 2022, the Company entered into a Research Collaboration Agreement ("RCA") with
MPG and UMG with an initial term of five years. The agreement covers the discovery, selection, and characterization of nanoAbs (single
domain VHH antibody fragments) directed at several molecular targets implicated in diseases where the Company believes there is significant
unmet need. The Company aims to address these unmet needs by harnessing the unique attributes of nanoAbs, such as their strong binding
affinity, stability at elevated temperatures, and ability to support more effective and convenient routes of administration. The molecular
targets and related diseases were identified through a consulting project with the global healthcare management firm L.E.K., and they
correspond to validated targets of currently marketed monoclonal antibodies for conditions such as psoriasis, asthma, macular degeneration,
and psoriatic arthritis. Under the RCA, the Company holds an exclusive option to enter into a license agreement with MPG and UMG for the
development and commercialization of each of the nanoAbs covered by the collaboration.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c. On June 5, 2023, the Company announced that as part of its ongoing broad-based collaboration with the Max Planck Society and the University Medical Center Gottingen (UMG), the Company signed an exclusive worldwide license agreement to develop and commercialize VHH antibodies (NanoAbs) targeting Interleukin-17 (IL-17) as treatments for all potential indications, starting with psoriasis and psoriatic arthritis.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;d. On September 6, 2023, the Company announced the launch of a new business named Scinai Bioservices to serve
as a CDMO, offering a multitude of drug development services to support small, early-stage biotech companies through drug development
as well as GMP manufacturing for clinical trials.

The CDMO business is still in its early stages, and its success is dependent on contracting with additional clients, which is not certain could take some time and may require additional funds to finance such operations in the interim. As detailed under g. below the Company also have liquidity issues. Accordingly, there is uncertainty regarding the Company's ability to generate future positive cash flows from such operations to support the carrying value of the CDMO facility. If the Company is not successful in generating positive cash flows from such operations, the carrying value of the CDMO plant may be considered impaired, which may result in significant charges to the Company's statement of operations

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;e. In December 2024, the Company established a U.S.-based subsidiary for the CDMO business unit operating
under the name Scinai Bioservices Inc. For the six-month period ended June 30, 2025, revenues of approximately $421 thousand were generated
from activities related to this subsidiary.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;f. On March 24, 2025, the Company acquired a Polish shell company without any operations or net assets, Scinai Immunotherapeutics
Spółka z ograniczoną odpowiedzialnością, for total consideration of $1 as to serve as its wholly-owned
subsidiary in Poland and as an applicant for potential grants under programs established by the Polish government.

On March 27, 2025, the Company signed an option agreement providing the Company with the exclusive right to acquire, subject to certain conditions being satisfied and the payment of certain sums, the Italian biotech company Pincell srl, which is developing PC111, a novel monoclonal antibody targeting the soluble form of Fas Ligand as a drug candidate for the treatment of severe dermatological conditions such as Pemphigus, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN). Concurrently, the Company's wholly owned Polish subsidiary submitted a €12 million non-dilutive grant application under the European Funds for a Modern Economy (FENG) program to fund ~ 80% of the costs of the next stage of PC111 development. PC111, which has received Orphan Drug Designation from the EMA for Pemphigus, is a fully human antibody with a non-immunosuppressive mechanism of action, addressing a significant unmet medical need in these life-threatening diseases.

**SCINAI IMMUNOTHERAPEUTICS LTD**

**NOTES TO CONSOLIDATED FINANCIAL STATEMENTS**

**U.S. dollars in thousands (except share and per share data and unless otherwise indicated)**

**NOTE 1:- GENERAL (Cont.)**

Under the terms of the binding option agreement, the Company was granted an exclusive and irrevocable option to acquire 100% of the fully diluted share capital of PinCell S.r.l. during a defined option period, for a total consideration of $200. The Company paid $50 upon signing. If the Company decides not to proceed with the acquisition, an amount of $50 will still be payable as cancellation fee. The upfront payment and the additional cancellation fee represent payments for in-process research and development ("IPR&D") acquired as part of an asset purchase. These payments are associated with asset that have not yet reached technological feasibility and lack alternative future use. Consequently, such payments are expensed as incurred and recognized as research and development expenses. Accordingly, the company expensed $100 in the Financial Statements and recognized a liability of $50 The option will expire on January 15, 2026, unless exercised earlier in accordance with the agreement's terms.

On June 5, 2025, the Company announced that the Italian government had granted clearance under the Golden Power regulation (Law Decree No. 21/2012) for the Company's option to acquire 100% of the share capital and voting rights of Pincell Srl, which was a condition to the acquisition. The clearance pertains to the transaction as presented in the notification submitted on April 5, 2025, which includes the granting of a license by Pincell to Scinai's Polish subsidiary for the use of Pincell's intellectual property rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;g. As of June 30, 3025, the Company's cash and cash equivalents totaled $989. For the six months ended
June 30, 2025, the Company had an operating loss of $3,763 and negative cash flows from operating activities of $2,575. The Company's
current cash and cash equivalents position is not sufficient to fund the Company's planned operations for at least a year beyond
the date of the filing date of the financial statements. Those factors raise substantial doubt about the Company's ability to continue
as a going concern. The ability to continue as a going concern is dependent upon the Company obtaining the necessary financing to meet
its obligations and repay its liabilities arising from normal business operations when they become due. While the Company has successfully
raised funds in the past, there is no guarantee that it will be able to do so in the future. The inability to borrow or raise sufficient
funds on commercially reasonable terms, would have serious consequences for the Company's financial condition and results of operations.

The Company's current operating budget includes various assumptions concerning the level and timing of cash receipts and cash outlays for operating expenses and capital expenditure. The Company is planning to finance its operations from its existing working capital resources and additional sources of capital and financing including public equity financing arrangements such as the SEPA agreement. However, there is no assurance that additional capital and/or financing will be available to the Company, and even if available, whether it will be on terms acceptable to the Company or in amounts required.

The accompanying financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and liabilities and commitments in the normal course of business. The financial statements for the six months ending June 30, 2025, do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to the Company's ability to continue as a going concern.

**NOTE 2: - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**a.** **Basis of Presentation** 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP") and applicable rules and regulations of the Securities and Exchange Commission ("SEC") for interim financial reporting.

Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. In our opinion, the information contained herein reflects all adjustments necessary for a fair statement of our results of operations, financial position, cash flows, and shareholders' equity. All such adjustments are of a normal, recurring nature.

**SCINAI IMMUNOTHERAPEUTICS LTD**

**NOTES TO CONSOLIDATED FINANCIAL STATEMENTS**

**U.S. dollars in thousands (except share and per share data and unless otherwise indicated)**

**NOTE 2: - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Cont.)**

The results of operations for the six months ended June 30, 2025, shown in these financial statements are not necessarily indicative of the results to be expected for the full year ending December 31, 2025. The unaudited condensed financial statements should be read in conjunction with the audited financial statements that were included in Form 20-F for the year ended December 31, 2024. The carrying value of cash and cash equivalents, account receivables, prepaid and other receivables and accounts payable (included in the condensed balance sheets) approximates their fair value because of their generally short maturities

There have been no material changes in our significant accounting policies as described in our financial statements for the year ended December 31, 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**b.** **New Accounting Pronouncements** 

Recently issued accounting pronouncements, not yet adopted:

**Improvements to Income Tax Disclosures**

In December 2023, the FASB issued ASU 2023-09 "Income Taxes (Topic 740): Improvements to Income Tax Disclosures". This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively. Early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.

**Disaggregation of Income Statement Expenses**

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income (Topic 220): Disaggregation of Income Statement Expenses. This ASU requires public business entities to provide enhanced disaggregation of certain income statement expense categories. Specifically, entities will be required to disclose, in tabular format, the amounts of employee compensation, depreciation, intangible asset amortization, and inventory procurement costs included in each relevant income statement expense line. The standard is effective for annual reporting periods beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of this guidance on its financial statements.

**NOTE 3: - COMMITMENTS**

Since 2006, the Company received approximately $6,160 in grants from the Israeli Innovation Authority (IIA). $4,573 of which grants were for research and development of M-001 and $1,587 of which grants were received to support the CDMO business, out of which grants for $64 were received during 2025.

In exchange for those grants, the Company undertook to pay royalties amounting to 3%-5% on the income deriving from a product (including know-how) which was developed, in whole or in part, directly or indirectly, in the framework of a research and development program that had benefited from IIA support, including any derivatives, and related services thereof. Royalty payments are capped at the amount of the grants received by the Company, plus Annual Interest for a File (as such term is defined in the IIA rules). However, on October 25, 2023, the IIA published a directive concerning changes in royalties to address the expiration of the LIBOR. Under such directive, regarding IIA grants approved by the IIA prior to January 1, 2024 but which are outstanding thereafter, as of January 1, 2024 the annual interest will be calculated at a rate based on 12-month Secured Overnight Financing Rate, the SOFR, or at an alternative rate published by the Bank of Israel plus 0.71513%; and, for grants approved on or following January 1, 2024 the annual interest will be the higher of (i) the 12 months SOFR interest rate, plus 1%, or (ii) a fixed annual interest rate of 4%. The maximum royalty amounts payable by the Company as of June 30, 2025 is approximately $5,161 which represents the total gross amount of grants actually received by the Company from the IIA including accrued interest. As of June 30, 2025, the Company had not paid any royalties to the IIA.

At the time the grants were received and as of June 30, 2025, successful development of the M-001 product was not assured and therefore the Company does not currently expect to make any royalty payments to the IIA.

**SCINAI IMMUNOTHERAPEUTICS LTD**

**NOTES TO CONSOLIDATED FINANCIAL STATEMENTS**

**U.S. dollars in thousands (except share and per share data and unless otherwise indicated)**

**NOTE 3: - COMMITMENTS (Cont.)**

The Company is also subject to various other restrictions pursuant to the grant, including limitations on transferring IP developed with grant funds. In light of the Company's new strategy, it does not expect these restrictions to be material to its ongoing operations.

**NOTE 4: - LOAN FROM OTHERS**

On August 21, 2024, the Company closed the Restructuring Agreement with the EIB, which included an amendment to the Finance Contract (the transactions contemplated by the Restructuring Agreement called the "EIB Restructuring Transaction"). In connection with the EIB Restructuring Transaction, an amount equal to approximately EUR 26.6 million (equal to approximately $29 million), including interest accrued to date, owed by the company to the EIB under the Finance Contract, was converted into 1,000 preferred shares, no par value per share. The company assessed the fair value of the preferred shares using the OPM model and the following assumptions, (1) expected term of three years, (2) risk-free rate of 3.8%, (3) STD of 110%.

Following such conversion, the total outstanding amount to the EIB is EUR 250,000 (equal to approximately $293,000 as of June 30, 2025). The outstanding amount has a maturity date of December 31, 2031, and no interest accrues or is due and payable on such amount. The Company is no longer required to pay to the EIB (i) royalties based on the Company's commercial sales exceeding EUR 5 million or (ii) a percentage (10%) of the gross proceeds from the Company's capital raises.

**NOTE 5: - SHAREHOLDERS' EQUITY**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. On March 3, 2025, the Company entered into the Standby Equity Purchase Agreement
("SEPA") with YA II PN, Ltd. ("YA"), pursuant to which YA has committed to purchase up to $10.0 million of ADSs,
or the Commitment Amount, at the Company's direction from time to time, subject to the restrictions and satisfaction of the conditions
in the SEPA, during the period commencing on the date of execution of the SEPA until the earlier of (i) the 36-month anniversary of the
date of execution of the SEPA, and (ii) YA's purchase of the total Commitment Amount under the SEPA, such period the Commitment
Period. Pursuant to the terms of the SEPA, the Company issued 28,784 ADSs (the "Commitment Shares") to YA as consideration
for its irrevocable commitment to purchase the Advance Shares under the SEPA. In connection with the SEPA, the Company recognized issuance-related
costs of approximately $100, which were recorded as finance costs.

The Company filed a registration statement on Form F-1 to register the resale of up to 3,022,796 ADSs issuable to YA under the SEPA from time to time during the Commitment Period (including the Commitment Shares), subject to the restrictions and satisfaction of the conditions in the Purchase Agreement, if and when the Company determine to sell additional ADSs to YA under the SEPA.YA has no right to require the Company to sell any ADSs to YA, but YA is obligated to make purchases of the ADSs as directed by the Company, subject to the restrictions and satisfaction of conditions set forth in the Purchase Agreement upon receipt of a notice sent by the Company to YA setting forth the number of ADSs that the Company desire to issue and sell to YA, or an Advance Notice. The purchase price of the ADSs that the Company may direct YA to purchase from time to time under the SEPA will be equal to 97% of the lowest daily volume weighted average price (VWAP) during the three consecutive trading day period commencing on the date that the Company delivers any Advance Notice to YA**.** The Company have the right to set a floor price in the Advance Notice that sets a lower limit of the ADS price at which the Company are willing to sell ADSs to YA.

In March 24, 2025, the Company delivered an Advance Notice for 31,746 ADSs and thereafter delivered the ADSs, and on March 27, 2025, the Company received gross proceeds of approximately $104.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. In June 2025, the Company raised $1,492 in gross proceeds through drawdowns under the Purchase Agreement.
The funding was executed at a volume-weighted average price of approximately $2.9 per ADS, reflecting a 3% discount to the market price
at the time. As part of this transaction, the Company issued 511,690 ADSs.

**SCINAI IMMUNOTHERAPEUTICS LTD**

**NOTES TO CONSOLIDATED FINANCIAL STATEMENTS**

**U.S. dollars in thousands (except share and per share data and unless otherwise indicated)**

**NOTE 6: - SHARE-BASED COMPENSATION**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. Option plans:

Options granted under the Company's 2005 Israeli Share Option Plan ("Plan") were exercisable in accordance with the terms of the Plan, within 10 years from the date of grant, against payment of an exercise price. The options generally vest over a period of three or four years.

In March 2018, the Company's Board of Directors approved the adoption of the Company's 2018 Israeli Share Option Plan ("2018 Plan") for the grant of options and restricted shares ("RSU") to employees, directors and service providers. The options are exercisable within 10 years from the date of grant, against payment of the exercise price, in accordance with the terms of the 2018 Plan. The options generally vest over a period of three or four years.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. The total share-based compensation expense related to all of the Company's equity-based awards, recognized
for the six months ended June 30, 2025, and 2024 is comprised as follows:

---

| | | |
|:---|:---|:---|
|  | **Six months ended**<br> **June 30,** | **Six months ended**<br> **June 30,** |
|  | **2025** | **2024** |
| Cost of revenues | 138 | - |
| Research and development expenses | $31 | $104 |
| Marketing, general and administrative expenses | 101 | 229 |
| Total share-based compensation | $270 | $333 |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c. During the six months ended June 30, 2024, the Company granted 55,725 RSUs to officers and employees,
These RSU's vest over three years and the fair value of said grant was $290.

During the six months ended June 30, 2025, the Company granted 900 RSUs to employees, These RSU's vest over three years and the fair value of said grant was $3.

As of June 30, 2025, there are $278 of total unrecognized costs related to share-based compensation that is expected to be recognized over a period of up to four years.

The fair value of the granted RSUs was determined based on the stock market price of the Company's ADS on the day of grant.

**NOTE 7: - BASIC AND DILUTED NET LOSS PER SHARE**

Basic net loss per share is computed by dividing net loss by the weighted average number of ordinary shares outstanding during the period, including pre-funded warrants and fully vested RSUs.

The Company applies the two-class method in calculating net income (loss) per ordinary shares. In order to determine the net income (loss) attributable to ordinary shares, the Company first considered the total income allocable to preferred shares. This is calculated using the total net income (loss) less undistributed income allocable to preferred shares due to their redemption feature.

Calculating diluted EPS incorporates the potential impact of dilution that could occur if outstanding dilutive securities were converted into Ordinary shares or exercised. These securities can include stock options, restricted stock units (RSUs), preferred shares and warrants.

**SCINAI IMMUNOTHERAPEUTICS LTD**

**NOTES TO CONSOLIDATED FINANCIAL STATEMENTS**

**U.S. dollars in thousands (except share and per share data and unless otherwise indicated**

**NOTE 7: - BASIC AND DILUTED NET LOSS PER SHARE (Cont.)**

Details of the number of shares and loss used in the computation of net loss per share:

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **For six months ended June 30** | **For six months ended June 30** | **For six months ended June 30** | **For six months ended June 30** |
|  | **2025** | **2025** | **2024** | **2024** |
|  | **Weighted<br> number of<br> shares** | **Net loss<br> attributable<br> to equity<br> holders of<br> the<br> Company** | **Weighted<br> number of<br> shares** | **Net loss<br> attributable<br> to equity<br> holders of<br> the<br> Company** |
| For the computation of basic and diluted loss | 6364731650 | 4134 | 2288278248 | 4481 |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. For the six months ended June 30, 2025, the following items have been excluded from the diluted weighted average number of shares
outstanding because they are anti-dilutive: 97,228,400 share options, 381,104,276 restricted share units 1,456,000,000 Preferred shares
and 2,231,316,096 warrants.

For the six months ended June 30, 2024, the following items have been excluded from the diluted weighted average number of shares outstanding because they are anti-dilutive: 98,171,200 share options, 254,893,245 restricted share units and 2,231,316,096 warrants.

**NOTE 8: - FAIR VALUE MEASUREMENTS**

In accordance with ASC No. 820, the Company measures warrants liability at fair value classified within Level 3.

The following table presents assets measured at fair value on a recurring basis as of December 31, 2024 and for the six months ended June 30, 2025:

---

| | | |
|:---|:---|:---|
|  | **June 30,**<br>**2025** | **December 31,**<br>**2024** |
|  | **Fair value measurement using<br> input Level 3** | **Fair value measurement using<br> input Level 3** |
| Non-current liabilities: |  |  |
| Warrants liability | $3 | $3 |
| Total liabilities | $&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 3 | $&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 3 |

---

The warrants fair value was established by management leveraging calculations by an independent expert using the binomial model.

**SCINAI IMMUNOTHERAPEUTICS LTD**

**NOTES TO CONSOLIDATED FINANCIAL STATEMENTS**

**U.S. dollars in thousands (except share and per share data and unless otherwise indicated**

**NOTE 9: - REVENUES** 

The Company recognized revenue from contracts with customers for the six months ended June 30, 2025 and 2024, as follows:

---

| | | |
|:---|:---|:---|
|  | **Six months ended**<br> **June 30,** | **Six months ended**<br> **June 30,** |
|  | **2025** | **2024** |
| Revenues from CDMO recognized Over time | $182 | $180 |
| Revenues from CDMO recognized Point in time | 591 | 104 |
| Revenues recognized from Licensing | - | - |
| Total | $773 | $284 |

---

During 2024, the Company recorded deferred revenues in the amount of $225 related to one customer. For the six months ended June 30, 2025, these deferred revenues were recognized as revenue upon meeting the revenue recognition criteria.

**NOTE 10: - SEGMENTS**

The Company operates as one operating segment. The Company's chief operating decision maker ("CODM") is its chief executive officer, who manages the Company's business activities as a single operating and reportable segment at the consolidated level. Accordingly, our CODM uses consolidated net loss to measure segment profit or loss, allocate resources and assess performance based on consolidated net loss which is consistent with the basis the consolidated statements of operations are presented. The CODM considers net loss in the annual forecasting process and reviews actual results when making decisions about allocating resources.

**NOTE 11: - SUBSEQUENT EVENTS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. In July 2025, the United States enacted tax reform through the One Big Beautiful Bill Act ("OBBBA").
Included in this legislation are significant corporate tax changes, including provisions that allow for the immediate expensing of research
and development conducted in the United States, immediate expensing of certain capital expenditures, and other changes to the U.S. taxation
of profits derived from foreign operations. The Company is assessing the impact that the new legislation will have on the consolidated
financial statements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. In July and August 2025, the Company raised $4,203 in proceeds through drawdowns
under the Standby Equity Purchase Agreement with Yorkville Advisors. The capital raising was executed at a volume-weighted average price
of approximately $2.57 per ADS, reflecting a 3% discount to market price at the time of sale. As part of this transaction, the Company
issued 1,638,062 ADSs .

## Exhibit 99.3

**Exhibit 99.3**

**OPERATING AND FINANCIAL REVIEW AND PROSPECTS**

**Operating Results**

*The information contained in this section should be read in conjunction with our unaudited condensed consolidated financial statements for the six months ended June 30, 2025 and related notes and the information contained elsewhere in this Form 6-K. Our financial statements have been prepared in accordance with United States generally accepted accounting principles (U.S. GAAP) as set forth in the Financial Accounting Standards Board (the FASB) Accounting Standards Codification (ASC). Unless the context otherwise requires, references to "Scinai," the "Company," "us," "we" and "our" refer to Scinai Immunotherapeutics Ltd. (the "Company"), an Israeli company; references to "ADS" refer to the Company's American Depositary Shares; references to "dollars," "U.S. dollars" and "$" are to United States Dollars; references to "CDMO business unit" refer to the Company's contract development and manufacturing services business unit; and references to "shekels" and "NIS" are to New Israeli Shekels, the Israeli currency.*

**Company Overview** 

We are a biopharmaceutical company with operations that are divided between two business units: (1) an innovative R&D business unit and (2) a Contract Development and Manufacturing Organization ("CDMO") business unit. The R&D unit focuses on: (i) managing and guiding a research collaboration agreement with the Max Planck Society ("MPG"), the parent organization of the Max Planck Institute for Multidisciplinary Sciences ("MPI-MS"), and the University Medical Center Gottingen ("UMG"), both located in Germany; and (ii) developing licensed drug candidates throughout the pre-clinical and clinical steps required for drug approval. The CDMO unit focuses on providing drug development and manufacturing services to small, early stage biotech companies. For financial reporting purposes, we treat our R&D business unit and our CDMO business unit as one reportable segment.

 

*Development of I&I biological therapeutic products* 

 

Since inception, we have executed eight clinical trials including a seven country, 12,400 participant phase 3 trial of our prior lead drug candidate, a universal influenza vaccine candidate ("M-001") and have built a GMP biologics manufacturing facility for biopharmaceutical products. After receiving the phase 3 trial results in Q3 2020, indicating that M-001 did not meet its clinical endpoints, we performed a turnaround process that included raising fresh capital, hiring new talent (including a new CEO), signing a research collaboration agreement with and in-licensing new intellectual property from world leading academic research institutes. Since then, we are in the process of developing a pipeline of diversified and commercially viable products built around the licensed innovative single domain VHH antibody fragments ("NanoAbs"). NanoAbs are derived from camelid animals and are also known as Nanobodies. "Nanobody" is a trademark registered by ABLYNX N.V., a wholly owned subsidiary of Sanofi. SCINAI has no affiliation with and is not endorsed by Sanofi.

As part of the abovementioned turnaround, on December 22, 2021, the Company signed a definitive exclusive, worldwide, License Agreement ("LA") with the Max Planck Society ("MPG"), the parent organization of the Max Planck Institute for Multidisciplinary Sciences ("MPI-MS"), and the University Medical Center Göttingen ("UMG"), both in Gottingen, Germany, for the development and commercialization of innovative NanoAbs for the treatment of COVID-19. The agreement provides for an upfront payment, development and sales milestones and royalties based on sales and sharing of sublicense revenues. In addition, the Company signed an accompanying Research Collaboration Agreement ("aRCA") with MPG and UMG in support of the abovementioned development of a COVID-19 NanoAb by MPI and UMG. The aRCA provided for monthly payments to MPG and UMG and had a term until the earlier of two years or the date the Company enters into first in-human clinical trials with the COVID-19 NanoAb.

On March 23, 2022, the Company signed a five-year Research Collaboration Agreement ("RCA" collectively, with the LA and aRCA, the "MPG/UMG Agreements") with MPG and UMG covering the discovery, selection and characterization of NanoAbs for up to nine molecular targets that have the potential to be further developed into drug candidates for the treatment of disease indications such as psoriasis, psoriatic arthritis, asthma and wet macular degeneration. These are all large and growing markets with underserved medical needs. In each case, the molecular target has been validated as an appropriate target for therapeutic intervention through inhibition by an antibody, thereby significantly reducing the discovery work that typically entails many years of research, high cost and high risk of failure. We believe that we can leverage our NanoAbs' unique and strong binding affinity, stability at high temperatures, and potential for more effective and convenient routes of administration towards competitive commercial viability. We believe that since these are clinical validated targets, we can develop NanoAb treatments with reduced risk and cost and accelerate the time from NanoAb selection to initiation of clinical development. Each NanoAb candidate is therefore positioned as a "biobetter" piggybacking on prior discoveries of others to mitigate risk but with significant potential advantages over existing therapeutics. In addition, while each NanoAb constitutes a novel molecule for which we file patent applications thereby creating a proprietary position, all of the developed NanoAbs when viewed together constitute a pipeline that is built around the same drug discovery, development and manufacturing platform allowing us to reduce risks and save costs. SCINAI has the exclusive option for an exclusive, pre-negotiated worldwide license agreement for the development and commercialization of each of the NanoAbs covered by the RCA with MPG and UMG.

On June 5, 2023, we announced that as part of our above-mentioned right for an exclusive worldwide license agreement for the development and commercialization of each of the NanoAbs covered by the RCA with MPG and UMG, we signed an exclusive worldwide license agreement to develop and commercialize VHH antibody fragments (NanoAbs) targeting Interleukin-17 (IL-17) as treatments for all potential indications, starting with psoriasis and psoriatic arthritis.

*CDMO services*

On September 6, 2023, we announced the launch of a new business unit named Scinai Bioservices to serve as a CDMO offering a multitude of services to support biotech companies through process development, as well as pilot and clinical GMP manufacturing. We seek to provide high quality, yet affordable CDMO services to accelerate the drug development processes of small biotech companies, including cGMP aseptic processing required for manufacturing of clinical batches.

We lease approximately 1,850 square meters (20,000 square feet) in the Jerusalem BioPark, located in the Ein Kerem Hadassah campus, next to Hadassah University Hospital and Hebrew University's Medical School. The facility includes laboratories, offices, and upstream and downstream manufacturing suites for bulk production and capacity for single-dose syringe filling for clinical supplies. We also have infrastructure to support future product manufacturing processes and equipment. The manufacturing facility features modular, single-use infrastructure, which enables us to adapt the facility to various manufacturing platforms (such as, for example, fermenters or bioreactors).

**Key Components of Statements of Operations** 

***Revenues***

*Sources of revenues.* Since our inception, we have generated significant losses in connection with our research and development, clinical trials and general administrative expenses in support of our operations. We started to generate revenues only from 2024 and during the six months ended June 30, 2025 from our CDMO business unit.

***Cost of Revenues***

Our Cost of Revenues consist primarily of salaries and related personnel expenses. These expenses represent the allocation of the cost of our manufacturing facilities, which are utilized to generate our CDMO revenues, over their estimated useful lives, and constitute a significant portion of our operational costs

***Operating Expenses***

Our operating expenses consist primarily of salary and related personnel expenses, Research Collaboration Agreement costs, depreciation and professional services.

 ****

 ****

***Research and development expenses.***

 

 Our research and development expenses consist primarily of Research Collaboration Agreement, fees paid to consultants, patent-related legal fees, costs of preclinical studies and clinical studies, drug and laboratory supplies, and costs for facilities and equipment. We charge all research and development expenses to operations as they are incurred. We expect our research and development expenses to remain a significant expense in the near future. Increases or decreases in research and development expenditures are attributable to the number and/or duration of the clinical studies that we conduct.

We expect that a large percentage of our research and development expenses in the future will be incurred in support of our future clinical development projects. Due to the inherently unpredictable nature of clinical development processes, we are unable to estimate with any certainty the costs we will incur. Clinical development timelines, the probability of success and development costs can differ materially from expectations.

Our future research and development expenses will depend on any Company product candidate's commercial potential. As we obtain results from clinical studies, we may elect to discontinue or delay clinical studies for any Company product candidate in certain indications in order to focus our resources on more promising product candidates. Completion of clinical studies may take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended use of a product candidate.

The lengthy process of completing clinical studies and seeking regulatory approval for any Company product candidate requires the expenditure of substantial resources. Any failure or delay in completing clinical studies, or in obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations. Because of the risk factors set forth in our Annual Report on Form 20-F for the year ended December 31, 2024, we are not able to estimate with any certainty when we would recognize any net cash inflows from our projects.

Developing bio-pharmaceutical products, conducting clinical trials, obtaining commercial manufacturing capabilities and commercializing products is expensive and we will need to raise substantial additional funds to achieve our strategic objectives. Our existing cash resources are not sufficient to fund our projected cash requirements at current monthly rates for at least the next 12 months, and we will require significant additional financing in the future to fund our operations, including if and when we conduct clinical trials, obtain regulatory approval and obtain commercial manufacturing capabilities for any Company product candidate and commercialize such product candidates. Our future capital requirements will depend on many factors, including:

● the progress and costs of our clinical trials and other research and development activities;

● the scope, prioritization and number of our clinical trials and other research and development programs;

● the amount of revenues and contributions we receive under future licensing, collaboration, development and commercialization arrangements with respect to our Company product candidates;

● the costs of the development and expansion of our operational infrastructure;

● the costs and timing of obtaining regulatory approvals for our Company product candidates;

● the ability of us, or our collaborators, to achieve development milestones, marketing approvals and other events or developments under our potential future licensing agreements;

● the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;

● the costs and timing of building and securing manufacturing arrangements for clinical or commercial production;

● the costs of contracting with third parties to provide sales and marketing capabilities for us or establishing such capabilities ourselves;

● the costs of acquiring or undertaking development and commercialization efforts for any Company product candidate or platforms;

● the magnitude of our general and administrative expenses; and

● any cost that we may incur under future in- and out-licensing arrangements relating to one or more of our Company product candidates.

Until we can generate significant recurring revenues, we expect to satisfy our future cash needs through the net proceeds received from future private or public equity raising, including the Standby Equity Purchase Agreement (SEPA) with Yorkville Advisors, grants from governmental agencies such as the Israel Innovation Authority ("IIA"), debt or equity or other non-dilutive financings, among other financing mechanisms. We cannot be certain that additional funding will be available to us on acceptable terms, if at all. If funds are not available, we may be required to delay, reduce the scope of or eliminate research or development plans for, or commercialization efforts with respect to any Company product candidate.

Since 2006, we received $6.2 million in IIA grants and Euro 24 million ($25.6 million) in EIB loans.

***Marketing, General and Administrative Expenses***

 

Our marketing, general, and administrative expenses primarily consist of salaries and employee benefit costs, including share-based compensation, for our general and administrative staff. This group includes employees in executive, operational, finance, and human resources roles. In addition, these expenses include consulting, legal, and other professional services related to general and administrative operations, business development, as well as costs associated with conferences and investor relations activities.

 **

***Financial Income and Expenses***

 **

Financial income consists primarily of interest income on our cash and cash equivalents, foreign currency exchange income. Financial expenses consist primarily of expenses related to bank charges foreign currency exchange expense, SEPA expenses and issuance costs.

 ****

***Participation by Third Parties***

Our research and development expenses are net of certain participations by third parties.

Research and development grants received from the OCS, today known as the IIA, are recognized upon receipt as a liability if future economic benefits are expected from the project that will result in royalty-bearing sales. The amount of the liability for the grant is first measured at fair value using a discount rate that reflects a market rate of interest that reflects the appropriate degree of risks inherent in our business. If no economic benefits are expected from the research activity, the grant receipts are recognized as a reduction of the related research and development expenses.

At the end of each reporting period, we evaluate whether there is reasonable assurance that the received grants will not be repaid based on its best estimate of future sales and, if so, no liability is recognized and the grants are recorded against a corresponding reduction in research and development expenses.

As a result of the failure of the Phase 3 clinical trial, the Company's management estimates that there will be no future revenues from M-001. Therefore, most likely, there will be no future royalty payments to the Israel Innovation Authority ("IIA").

The loan from the European Investment Bank ("EIB") was recorded in the Company's unaudited condensed financial statements for the six months ended June 30, 2025 as a liability in the amount of $0.29 million and as of June 30, 2024 as a liability in the amount of $19.8 million. On August 21, 2024, we announced that we had closed a restructuring agreement with EIB, which included an amendment to the amended Finance Contract with EIB. In connection with the EIB restructuring transaction, an amount equal to approximately EUR 26.6 million (equal to approximately $29 million), including interest accrued to date, owed by us to the EIB under the Finance Contract was converted into 1,000 of our preferred shares, no par value per share. Following such conversion, the total outstanding amount owed by us to the EIB is EUR 250,000 (equal to approximately $293,000 as of June 30, 2025). The outstanding amount has a maturity date of December 31, 2031, is not prepayable in advance, and no interest accrues or is due and payable on such amount.

Research and development grants received from the European Union and from the IIA are recorded against a corresponding reduction in research and development expenses.

***Taxes on Income***

Israeli resident companies, such as the Company, are generally subject to corporate tax at the rate of 23% as of 2024.

Capital gains derived by an Israeli resident company are generally subject to tax at the same rate as the corporate tax rate. Under Israeli tax legislation, a corporation will be considered as an "Israeli Resident" if it meets one of the following: (a) it was incorporated in Israel; or (b) the control and management of its business are exercised in Israel.

**Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024**

***Revenues***

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Our revenues for the six months ended June 30, 2025 amounted to $0.8 million, compared to $0.3 million for the six months ended June 30, 2024*.***

***Cost of Revenues***

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Our cost of revenues expenses for the six months ended June 30, 2025 amounted to $2 million, compared to $0.4 million for the six months ended June 30, 2024. The increase of $1.6 million was primarily due to allocation of the majority costs of employees and facilities to the CDMO business unit.

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***Research and Development Expenses, net***

Our research and development expenses for the six months ended June 30, 2025 amounted to $1.2 million, compared to $2.8 million for the six months ended June 30, 2024. The decrease of $1.6 million was primarily due to a decrease in allocation of costs of employees and facilities to the R&D business unit.

***Marketing, General and Administrative Expenses***

Our marketing, general and administrative expenses for the six months ended June 30, 2025 amounted to $1.2 million, compared to $1.0 million for the six months ended June 30, 2024. The increase of $0.2 million was primarily due to share-based payments and an insurance reimbursement recorded in 2024.

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***Financial Expenses, Net***

Our financial expenses, net for the six months ended June 30, 2025 amounted to $0.4 million compared to $0.5 million for the six months ended June 30, 2024. The decrease was mainly attributable to the absence of financing expenses in respect of loans from others.

***Net Loss***

Our net loss for the six months ended June 30, 2025 was $4.1 million, compared to our net loss for the six months ended June 30, 2024 of $4.5 million. The decrease in net loss was primarily due to an increase in revenues of $0.5 million, partially offset by an increase in total expenses of $0.1 million.

**Liquidity and Capital Resources** 

Since our inception, we have funded our operations primarily through public and private offerings of our equity securities in Israel and the U.S., grants from the OCS (today known as the IIA), grants received by the Israeli Ministry of Economy and European grants under the UNISEC consortium and the loan from the EIB.

As of June 30, 2025, we had cash and cash equivalents and short-term deposits of approximately $1 million as compared to $3.0 million as of June 30, 2024. Our cash and cash equivalents are denominated in US dollars. As noted below, in July and August 2025, we raised $4.2 million in proceeds through drawdowns under the Standby Equity Purchase Agreement with Yorkville Advisors.

Net cash used in operating activities was $2.6 million for the six months ended June 30, 2025, compared with net cash used in operating activities of $3.2 million for the six months ended June 30, 2024.

Net cash used by investing activities for the six months ended June 30, 2025 was $0.01 million compared with net cash used by investing activities of $0.01 million for the six months ended June 30, 2024, and primarily reflects purchase of property, plant and equipment.

Net cash provided by financing activities for the six months ended June 30, 2025 was $1.5 million, primarily from proceeds from issuance of ADSs under the Standby Equity Purchase Agreement with Yorkville Advisors compared to $1.4 million. For the six months ended June 30, 2024, mostly from proceeds from issuance of warrants and shares.

In the six months ended June 30, 2025, the Company had an operating loss of $3.7 million and negative cash flows from operating activities of $2.6 million. The Company's current cash and cash equivalents position is not sufficient to fund the Company's planned operations for at least a year beyond the date of the filing date of the financial statements. Those factors raise substantial doubt about the Company's ability to continue as a going concern. The ability to continue as a going concern is dependent upon the Company obtaining the necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they become due. While the Company has successfully raised funds in the past, there is no guarantee that it will be able to do so in the future. The inability to borrow or raise sufficient funds on commercially reasonable terms, would have serious consequences on our financial condition and results of operations.

The Company's current operating budget includes various assumptions concerning the level and timing of cash receipts and cash outlays for operating expenses and capital expenditures, including a cost-saving plan. The Company is planning to finance its operations from its existing working capital resources and additional sources of capital and financing. However, there is no assurance that additional capital and/or financing will be available to the Company, and even if available, whether it will be on terms acceptable to the Company or in amounts required, particularly if we are not able to maintain our listing on Nasdaq. Accordingly, the Company's board of directors approved a cost-saving plan to assist the Company in continuing its operations and meeting its cash obligations. As part of the cost-saving plan we have reduced our headcount costs through lay-offs and postponing and/or cancelling capital expenditures that would not be required for the implementation of the revised business plan.

The company financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and liabilities and commitments in the normal course of business. The unaudited condensed financial statements for the six months ended June 30, 2025, do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to the Company's ability to continue as a going concern.

On March 24, 2025, the Company delivered an Advance Notice for 31,746 ADSs and thereafter delivered the ADSs, and on March 27, 2025, the Company received gross proceeds of approximately $104,000.

In June 2025, the Company raised $1.5 million in gross proceeds through drawdowns under the Purchase Agreement. The funding was executed at a volume-weighted average price of approximately $2.9 per ADS, reflecting a 3% discount to market, and was completed without any warrants, fees, or additional dilution mechanisms. As part of this transaction, 511,690 ADSs were issued.

In July and August 2025, the Company raised $4.2 million in proceeds through drawdowns under the Standby Equity Purchase Agreement with Yorkville Advisors. The capital raising was executed at a volume-weighted average price of approximately $2.57 per ADS, reflecting a 3% discount to market price at the time of sale. As part of this transaction, the Company issued 1,638,062 ADSs.

Scinai operates a revenue-generating CDMO. The CDMO is a new business unit and currently operates at a loss because revenue does not yet cover base operating expenses and related costs required to provide CDMO services. In parallel, we continue to advance our research and development programs, which require continued investment and are not supported by product revenue at this stage. As a result, we expect to continue to incur operating losses in the near term and may need additional funding to support CDMO scale-up to breakeven and to continue our research and development activities.