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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported):
August 25, 2026
VYOME HOLDINGS, INC.
(Exact name of registrant as specified in its
charter)
| Delaware |
|
1-37897 |
|
26-1828101 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
Harvard Square, One Mifflin Place, Suite 400
Cambridge, MA |
|
02138 |
| (Address of principal executive offices) |
|
(Zip Code) |
(949) 429-6680
(Registrant’s telephone number, including
area code)
Not Applicable
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b)
of the Act:
| Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
| Common stock, par value $0.001 per share |
|
HIND |
|
The Nasdaq Capital Market |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition
On August 25, 2026, Vyome Holdings, Inc. issued
a press release announcing its financial results for its second fiscal quarter ended June 30, 2026. The full text of the press release
is furnished herewith as Exhibit 99.1.
The information disclosed under this Item 2.02,
including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be incorporated by reference into any registration statement
or other document pursuant to the Securities Act of 1933, as amended, or the Exchange Act except as expressly set forth in such filing.
Item 9.01 Financial Statements and Exhibits
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release dated August 25, 2026 |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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 hereunto duly authorized.
| |
VYOME HOLDINGS, INC. |
| |
|
| August 25, 2026 |
By: |
/s/ Venkat Nelabhotla |
| |
Name: |
Venkat Nelabhotla |
| |
Title: |
President & Chief Executive Officer |
Exhibit 99.1
Vyome Holdings Reports
Second Quarter 2026 Results Highlighted By Advancement Of Lead
VT-1953 Program, Pipeline Expansion And Strong Balance Sheet
CAMBRIDGE, Mass., August
25, 2026 — Vyome Holdings, Inc. (“Vyome”), a clinical-stage biopharmaceutical company focused on immuno-inflammatory
and rare disease conditions, today reports financial results for the second quarter ended June 30, 2026, and provides a corporate update.
Krishna Gupta, Chairman
of Vyome Holdings, said, “Vyome continues to execute with focus and discipline across its development programs while maintaining
a methodical and conservative approach to capital allocation. During the quarter, we advanced our lead VT-1953 program, broadened our
pipeline through the Impetis agreement and continued to strengthen our intellectual property portfolio. With a strong balance sheet and
disciplined capital structure, we believe Vyome is well positioned to pursue its development priorities and create long-term shareholder
value.”
Venkat Nelabhotla, Vyome
President and Chief Executive Officer, stated, “VT-1953 remains our lead priority. The Phase 2 data presented this year demonstrated
statistically significant improvements in malodor, the patient-reported impact of malodor on daily life, and lesion pain, with no treatment-emergent
adverse events reported. In March 2026, we submitted a pre-IND briefing package to the FDA that included our proposed pivotal clinical
study strategy for the treatment of malodor and other symptoms associated with malignant fungating wounds. During the second quarter of
2026, the Company received the FDA’s written response on the proposed clinical development program. The Company is incorporating
the FDA’s feedback, preparing the appropriate supporting package, and plans to continue its engagement with the FDA through a Type
C meeting to further advance the clinical development program.
“At the same time,
we are selectively building additional opportunities around our core immuno-inflammatory strategy. Our agreement with Impetis adds two
selective JAK inhibitor assets and provides potential access to important autoimmune and inflammatory disease categories. We intend to
advance these opportunities in a disciplined manner with non-dilutive methods while keeping VT-1953 as our primary development focus.
Importantly, we continue to maintain a clean capital structure with no debt, no preferred stock, and no toxic financing instruments. We
believe this combination of focused clinical execution, pipeline optionality, and financial discipline provides a strong foundation for
long-term shareholder value,” concluded Mr. Nelabhotla.
Second Quarter
2026 and Recent Corporate Highlights
| ● | In March 2026, submitted a pre-IND briefing package to the FDA including the proposed pivotal clinical
study strategy for VT-1953; received the FDA’s written response on the proposed clinical development program during the second quarter
is incorporating the FDA’s feedback, preparing the appropriate supporting package, and plans to continue its engagement with the
FDA through a Type C meeting to further advance the clinical development program. |
| ● | Presented Phase 2 clinical data on lead candidate VT-1953 topical gel for treatment of malignant fungating
wounds (MFW) at the American Association for Cancer Research (AACR), including: |
| o | Statistically significant reduction in malodor (primary endpoint) |
| o | Statistically significant improvement in patient-reported impact of malodor on daily life |
| o | Statistically significant improvement in lesion pain |
| o | No treatment-emergent adverse events |
| ● | Signed agreement with Impetis Biosciences Limited (“Impetis’) to in-license two selective
JAK inhibitor assets designed for higher selectivity to potentially treat autoimmune and inflammatory conditions |
| ● | Received a granted Chinese patent covering formulation and therapeutic use claims related to VB-1953 topical
gel program for treating inflammatory acne |
Financial Results
for the Quarter Ended June 30, 2026
| ● | Cash and cash equivalents were approximately
$7.9 million as of June 30, 2026, compared with approximately $5.0 million as of December 31, 2025 |
| ● | Total current assets were approximately $8.2
million as of June 30, 2026 |
| ● | Total stockholders’ equity was approximately
$7.3 million as of June 30, 2026 |
| ● | Total operating expenses for the quarter ended
June 30, 2026, were approximately $874,000, including approximately $507,000 in research and development expenses and approximately $365,000
in selling, general, and administrative expenses |
| ● | Net loss attributable to common shareholders
for the quarter ended June 30, 2026, was approximately $720,000, or approximately $0.10 per basic and diluted share |
Complete financial results
can be found in the Company’s
recent Quarterly Report on Form 10-Q available at sec.gov.
About Vyome Holdings,
Inc.:
Vyome is building the world’s premier platform
spanning the US-India innovation corridor. Vyome’s immediate focus is on leveraging its clinical-stage assets to transform the lives
of patients with immuno-inflammatory conditions. By applying groundbreaking science and its unique positioning, Vyome seeks to deliver
lasting value to shareholders in a hyper cost-efficient manner while upholding global standards of quality and safety.
To learn more, please visit www.vyometx.com
Forward-Looking Statements
Certain statements made in this press release
are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “target,” “believe,”
“expect,” “will,” “shall,” “may,” “anticipate,” “estimate,” “would,”
“positioned,” “future,” “forecast,” “intend,” “plan,” “project,”
“outlook”, and other similar expressions that predict or indicate future events or trends or that are not statements of historical
matters. Such statements include, but are not limited to, statements contained in this press release relating to Vyome’s business
strategy, Vyome’s clinical development plans and expected timelines, the expected therapeutic potential of Vyome’s product
candidates and pipeline assets, Vyome’s intellectual property strategy, Vyome’s future operating results, and Vyome’s
liquidity and capital resources outlook. Forward-looking statements are based on Vyome’s current expectations and assumptions regarding
Vyome’s business, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject
to inherent uncertainties, risks, and changes in circumstances that are difficult to predict. Vyome’s actual results may differ
materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of
assurance of future performance. Vyome cautions you, therefore, against relying on any of these forward-looking statements. Important
factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation,
Vyome’s ability to raise capital to fund continuing operations; the timing and outcome of Vyome’s interactions with the FDA;
our ability to successfully design, initiate, enroll, and complete clinical trials; our ability to protect Vyome’s intellectual
property rights; the impact of any infringement actions or other litigation brought against Vyome; competition from other providers and
products; Vyome’s ability to develop and commercialize products and services; changes in government regulation; and other factors
relating to Vyome’s industry, operations and results of operations described in the Vyome’s Annual Report on Form 10-K for
the year ended December 31, 2025, our Quarterly Reports on Form 10-Q, our Current Reports on Form 8-K and subsequent filings with the
SEC. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned. Factors or events
that could cause Vyome’s actual results to differ may emerge from time to time, and it is not possible for Vyome to predict all
of them. Vyome cannot guarantee future results, levels of activity, performance, or achievements. Vyome assumes no obligation to update
any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release, except as
may be required under applicable securities law.
Contacts
Media:
ir@vyometx.com
Visit
us on social media:
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SUMMARY FINANCIAL STATEMENTS
SUMMARY OF CONDENSED CONSOLIDATED BALANCE SHEETS AS OF
| | |
June 30,
2026 | | |
December 31,
2025 | |
| | |
| | |
| |
| Cash and cash equivalents | |
$ | 7,887,510 | | |
$ | 4,982,333 | |
| Other current assets | |
| 265,843 | | |
| 455,988 | |
| Long term assets | |
| 1,023,009 | | |
| 1,058,856 | |
| Total assets | |
$ | 9,176,362 | | |
$ | 6,497,177 | |
| | |
| | | |
| | |
| Liabilities | |
$ | 1,864,656 | | |
$ | 2,735,160 | |
| Total Stockholders’ equity (deficit) | |
| 7,311,706 | | |
| 3,762,017 | |
| Total liabilities and stockholders’ equity | |
$ | 9,176,362 | | |
$ | 6,497,177 | |
SUMMARY OF CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| | |
Six months
ended
June 30,
2026 | | |
Six months
ended
June
30,
2025 | |
| Revenues | |
$ | 58,546 | | |
$ | 248,535 | |
| Cost of goods sold | |
| (30,243 | ) | |
| (69,881 | ) |
| | |
| | | |
| | |
| Gross profit | |
| 28,303 | | |
| 178,654 | |
| | |
| | | |
| | |
| Operating expenses | |
| 2,020,809 | | |
| 701,839 | |
| Operating loss | |
| (1,992,506 | ) | |
| (523,185 | ) |
| | |
| | | |
| | |
| Interest and other expenses, net | |
| 287,302 | | |
| (79,547 | ) |
| | |
| | | |
| | |
| Net loss | |
$ | (1,705,204 | ) | |
$ | (602,732 | ) |
