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HIND on Nasdaq

Vyome Holdings, Inc

Vyome Holdings, Inc is an American pharmaceutical preparations company, incorporated in Delaware.1 It is headquartered in San Clemente, California.1 Its shares trade on Nasdaq under the symbol HIND.1

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Last updated Oct 21, 2026.

Overview

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  • TickerHIND on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersSan Clemente, California1
  • Incorporated inDE2
  • Business address1001 Calle Amanecer, San Clemente, Ca 926732
  • Filer category, Emerging growth company2

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Merger Agreement, Merger Sub merged with and into Vyome, with Vyome surviving the merger as a subsidiary of the Company (the “Merger”).4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

68.4%Gross margin5
-3269.4%Operating margin5
-3209.7%Net margin5
-96.0%Revenue growth, 20255
-272.8%Return on equity5

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Product brought in 55% of the revenue Vyome Holdings, Inc broke down this way in fiscal 2025.

  1. Product$174.6K555%up 30% from 2024
  2. License$116.9K537%
  3. Royalty$28.2K59%down 41% from 2024
Products and services by year
Products and services20242025
Product$134.4K$174.6K
License$116.9K
Royalty$47.4K$28.2K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue3¢$100.9K
  • Research and development19¢$588.3K
  • Selling, general and admin77¢$2.4M

Out of $319.7K in revenue.5 The company lost money this year.

Financial statements

Revenue6789105$319.7K in 2025−90% since 2019
0$5.0M$10.0M$15.0M2019: $3.3M$3.3M20192020: $11.3M$11.3M2020+244%2021: $13.6M$13.6M2021+20%2022: $11.2M$11.2M2022−17%2023: $8.7M$8.7M2023−23%2024: $8.0M$8.0M2024−8%2025: $319.7K$319.7K2025−96%
Gross profit6789105$218.8K in 2025−34% since 2019
0$2.5M$5.0M$7.5M$10.0M2019: $331.0K$331.0K20192020: $6.3M$6.3M2020+1792%2021: $8.3M$8.3M2021+33%2022: $6.8M$6.8M2022−19%2023: $5.5M$5.5M2023−18%2024: $195.0K$195.0K2024−96%2025: $218.8K$218.8K2025+12%
Operating income6789105-$10.5M in 2025−55% since 2019
-$60.0M-$40.0M-$20.0M02019: -$23.2M-$23.2M20192020: -$12.5M-$12.5M2020−46%2021: -$57.9M-$57.9M2021+365%2022: -$46.4M-$46.4M2022−20%2023: -$15.4M-$15.4M2023−67%2024: -$1.0M-$1.0M2024−93%2025: -$10.5M-$10.5M2025+939%
Net income6789105-$10.3M in 2025−57% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$23.7M-$23.7M20192020: -$21.6M-$21.6M2020−9%2021: -$63.1M-$63.1M2021+192%2022: -$46.2M-$46.2M2022−27%2023: -$11.4M-$11.4M2023−75%2024: -$1.4M-$1.4M2024−87%2025: -$10.3M-$10.3M2025+609%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Revenue$319.7K$256.9K
Cost of goods sold-$100.9K-$62.0K
Gross profit$218.8K$195.0K
Depreciation and amortization$12.0K$17.3K
Selling, general and administrative$2.4M$898.6K
Research and development$588.3K$285.4K
Transactional fees$7.7M
Total operating expenses$10.7M$1.2M
Operating loss-$10.5M-$1.0M
Interest expense-$146.6K-$206.0K
Other income(loss), net$91.0K$3.8K
Fair value adjustment$30.5K-$238.9K
Total other income (expense), net-$25.1K-$441.1K
Net loss attributable to non-controlling interest-$215.7K
Net loss attributable to owners of Vyome Holdings, Inc.-$10.3M-$1.4M
Net loss-$10.5M-$1.4M
Foreign currency translation adjustments-$25.7K$1.1K
Total comprehensive loss-$10.5M-$1.4M
Loss per share basic (in Dollars per share)-$4.86-$6,001.39
Loss per share diluted (in Dollars per share)-$4.86-$6,001.39
Weighted average number of shares outstanding basic (in Shares)2.2M shares241 shares
Weighted average number of shares outstanding diluted (in Shares)2.2M shares241 shares

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Corporate structure

Vyome Holdings, Inc sits at the top of its group. 6 entities, 5 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Vyome Holdings, Inc

  • Vyome Holdings, Inc San Clemente, California
    • LiveChain, Inc. Subsidiary · Nevada, United States
    • ReShape Costa Rica Sociedad de Responsabilidad Limited Subsidiary · Costa Rica
    • ReShape Lifesciences Australia Pty Ltd Subsidiary · Australia
    • ReShape Lifesciences Netherlands B.V. Subsidiary · Netherlands
    • Vyome Therapeutics Limited Subsidiary · India

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Vyome Holdings, Inc reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$570.7K5 Dec 31, 2025$606.9K5 Dec 31, 2024−6.0%
Accumulated depreciation$524.3K5 Dec 31, 2025$547.7K5 Dec 31, 2024−4.3%
Property and equipment, net$46.4K5 Dec 31, 2025$59.2K5 Dec 31, 2024−21.6%
Operating-lease assets (leased space)$29.4K5 Dec 31, 2025$59.4K5 Dec 31, 2024−50.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$5.0M5 Dec 31, 2025$101.9K5 Dec 31, 2024+4789.2%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$314.2K5 Dec 31, 2025$314.2K5 Dec 31, 20240%

Inventory

ItemLatestA year beforeChange
Inventory, total$2.5M10 Dec 31, 2024$3.7M10 Dec 31, 2023−34.2%
Raw materials$753.0K10 Dec 31, 2024$1.0M10 Dec 31, 2023−26.2%
Finished goods$683.0K10 Dec 31, 2024$1.3M10 Dec 31, 2023−49.1%
Supplies$1.0M10 Dec 31, 2024$1.4M10 Dec 31, 2023−25.7%

Properties, in its own words

We have approximately 110 square feet of office space in Princeton, New Jersey under an operating service agreement that expires on July 31, 2026. We also have approximately 150 square feet of office space in Cambridge, Massachusetts under two office service agreements that each expire on September 30, 2026.

We also lease approximately 3,000 square feet of office and laboratory in New Delhi, India under an operating lease that expires on December 31, 2026 and approximately 1,500 square feet of laboratory in New Delhi, India under an operating lease that expires on December 31, 2026.

Item 2 of the 10-K filed Mar 18, 2026.4

Leadership

Who has led Vyome Holdings, Inc, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Andrew P. Rasdal2016–2020
  2. Kelly Huang2019
  3. William J. Plovanic2019–2020
  4. Barton P. Bandy2021–2022
  5. Paul F. Hickey2022
  6. Venkateswarlu Nelabhotla2025–now

Chair

  1. Andrew P. Rasdal2019–2020

President

  1. Andrew P. Rasdal2016–2020
  2. William J. Plovanic2019–2020
  3. Barton P. Bandy2021–2022
  4. Paul F. Hickey2022
  5. Venkateswarlu Nelabhotla2025–now

Chief financial officer

  1. William J. Plovanic2016–2019
  2. Nooshin Hussainy2019–2020
  3. Thomas Stankovich2021–2024
  4. Jerry Leonard2026–now

Chief operating officer

  1. Kelly Huang2017–2018
20202025
Board members and other officers (32)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • LiveChain, Inc. Nevada3
  • ReShape Costa Rica Sociedad de Responsabilidad Limited Costa Rica3
  • ReShape Lifesciences Australia Pty Ltd Australia3
  • ReShape Lifesciences Netherlands B.V. Netherlands3
  • Vyome Therapeutics Limited India3
  • Vyome Therapeutics, Inc. Delaware3

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • ReShape Lifesciences Inc.Jun 22, 2021 to Aug 14, 20252
  • OBALON THERAPEUTICS INCFeb 13, 2008 to Jun 21, 20212

Timeline

  1. Aug 28, 20268-K Executive or director change52
  2. Aug 25, 20268-K Results of operations53
  3. May 29, 20268-K Results of operations54
  4. Apr 29, 20268-K Bylaws or fiscal year changed; Shareholder vote55
  5. Feb 25, 20268-K Entered a material agreement; Other events56
  6. Feb 13, 20268-K Regulation FD disclosure57
  7. Jan 28, 20268-K Regulation FD disclosure; Other events58
  8. Dec 23, 20258-K Entered a material agreement59
  9. Nov 19, 20258-K Results of operations60
  10. Oct 30, 20258-K Shareholder vote61
  11. Oct 3, 20258-K Other events62
  12. Sep 12, 20258-K Financial statements and exhibits63
  13. Sep 11, 2025New chief executive Venkateswarlu Nelabhotla becomes CEO13
  14. Aug 26, 2022New chief executive Paul F. Hickey becomes CEO14
  15. Sep 17, 2021New chief executive Barton P. Bandy becomes CEO15
  16. Oct 28, 2019New chief executive William J. Plovanic becomes CEO17
  17. Jan 4, 2019New chief executive Kelly Huang becomes CEO16
  18. Oct 5, 2016New chief executive Andrew P. Rasdal becomes CEO18

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($3.12) a share, on Nov 14, 2025.64

When it reported results

  1. Aug 25, 2026Reported quarterly or annual results53
  2. May 29, 2026Reported quarterly or annual results54
  3. Nov 19, 2025Reported quarterly or annual results60
  4. Nov 14, 2024Reported quarterly or annual results65
  5. Aug 14, 2024Reported quarterly or annual results66
  6. May 20, 2024Reported quarterly or annual results67
  7. Apr 4, 2024Reported quarterly or annual results68
  8. Nov 9, 2023Reported quarterly or annual results69

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

268 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 73 major events, 50 insider forms, 19 large holders, 106 other. The latest 20:

  1. Sep 3, 20264 EDGAR
  2. Sep 1, 20263 EDGAR
  3. Aug 28, 20268-K CURRENT REPORT EDGAR
  4. Aug 25, 20268-K CURRENT REPORT EDGAR
  5. Aug 12, 202610-Q QUARTERLY REPORT EDGAR
  6. May 29, 20268-K CURRENT REPORT EDGAR
  7. May 12, 202610-Q QUARTERLY REPORT EDGAR
  8. Apr 29, 20268-K CURRENT REPORT EDGAR
  9. Mar 31, 2026DEF 14A PROXY STATEMENT EDGAR
  10. Mar 20, 2026PRE 14A PRELIMINARY PROXY STATEMENT EDGAR
  11. Mar 18, 202610-K ANNUAL REPORT EDGAR
  12. Feb 25, 20268-K CURRENT REPORT EDGAR
  13. Feb 13, 20268-K CURRENT REPORT EDGAR
  14. Jan 28, 20268-K CURRENT REPORT EDGAR
  15. Dec 23, 20258-K CURRENT REPORT EDGAR
  16. Nov 26, 2025424B3 PROSPECTUS EDGAR
  17. Nov 19, 20258-K CURRENT REPORT EDGAR
  18. Nov 19, 20254 OWNERSHIP DOCUMENT EDGAR
  19. Nov 19, 20253 OWNERSHIP DOCUMENT EDGAR
  20. Nov 18, 20254 OWNERSHIP DOCUMENT EDGAR

The 268 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

46 open-market trades by officers, directors and large owners since October 2021: 3 buys and 43 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 31, 2024STANKOVICH THOMASChief Financial OfficerSale48$0.25$12Form 4
Feb 29, 2024STANKOVICH THOMASChief Financial OfficerSale43$0.17$7Form 4
Dec 31, 2023STANKOVICH THOMASChief Financial OfficerSale42$0.25$10Form 4
Nov 30, 2023STANKOVICH THOMASChief Financial OfficerSale39$0.23$9Form 4
Oct 25, 2023STANKOVICH THOMASChief Financial OfficerSale131$0.27$35Form 4
Oct 11, 2023STANKOVICH THOMASChief Financial OfficerSale39$0.93$36Form 4
Sep 1, 2023STANKOVICH THOMASChief Financial OfficerSale118$0.89$105Form 4
Aug 24, 2023STANKOVICH THOMASChief Financial OfficerSale39$1.42$55Form 4
Aug 4, 2023STANKOVICH THOMASChief Financial OfficerSale108$1.43$154Form 4
Jul 6, 2023STANKOVICH THOMASChief Financial OfficerSale106$1.47$156Form 4
Jun 30, 2023STANKOVICH THOMASChief Financial OfficerBuy17,702$1.52$26.9KForm 4
May 31, 2023STANKOVICH THOMASChief Financial OfficerSale98$2.41$236Form 4
Apr 30, 2023STANKOVICH THOMASChief Financial OfficerSale96$2.36$227Form 4
Mar 31, 2023STANKOVICH THOMASChief Financial OfficerSale109$2.60$283Form 4
Feb 28, 2023STANKOVICH THOMASChief Financial OfficerSale103$4.25$438Form 4
Feb 2, 2023STANKOVICH THOMASChief Financial OfficerSale157$13.29$2.1KForm 4
Jan 24, 2023STANKOVICH THOMASChief Financial OfficerSale158$7.49$1.2KForm 4
Dec 1, 2022STANKOVICH THOMASChief Financial OfficerSale7,357$0.15$1.1KForm 4
Nov 28, 2022STANKOVICH THOMASChief Financial OfficerSale364,756$0.17$62.0KForm 4
Nov 4, 2022STANKOVICH THOMASChief Financial OfficerSale8,393$0.27$2.3KForm 4

All 46 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Paul F. Hickey$200.0K$860.7K82
2025Venkat Nelabhotla65$260.0K$478.7K82
2025Thomas Stankovich$96.0K$106.1K82
2025Robert Dickey IV70$81.6K$100.8K82
2024Former Chief Financial Officer$148.7K82

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Citadel Advisors LLC25,972$55.8K0.0%New
Geode Capital Management, LLC25,793$55.5K0.0%No change
Focus Partners Wealth14,640$31.5K0.0%No change
Vanguard Fiduciary Trust Co12,195$26.2K0.0%No change
UBS Group AG11,908$25.6K0.0%−10,767
Susquehanna International Group, Llp10,058$21.6K0.0%New
Vanguard Capital Management LLC9,463$20.3K0.0%No change
Royal Bank Of Canada5,856$13.0K0.0%No change
Tower Research Capital LLC (TRC)1,808$3.9K0.0%+417
Barclays PLC26$560.0%New
Hrt Financial LP20,318$430.0%New
Caitong International Asset Management Co., Ltd3$60.0%+1

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Vyome Holdings, Inc is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARVyome Holdings, Inc1
  • CIK0001427570
  • Employer ID (EIN)26-18281014
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address1001 Calle Amanecer, San Clemente, CA 926731
  • Phone949-429-66801
  • Shares outstanding7,018,528 as of Aug 12, 202612
  • Public float$6.4M as of Jun 30, 20254
  • AuditorKreit and Chiu CPA LLP, Los Angeles, California PCAOB ID 6651; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceFeb 13, 20081
  • Filings693 in all: 4 (199), 8-K (150), 3 (42), 10-Q (30), CORRESP (29), 425 (20), SC 13G/A (19), UPLOAD (19)1
    All 49 form types

    EFFECT (16), S-1/A (16), 10-K (10), 424B3 (10), 424B5 (10), SC 13G (10), DEF 14A (9), S-8 (9), S-1 (8), S-3 (7), PRE 14A (6), S-4/A (6), SCHEDULE 13G (6), D (5), SC 13D/A (5), 424B4 (4), DEFA14A (4), SC 13D (4), SCHEDULE 13G/A (4), 8-K/A (3), NT 10-K (3), NT 10-Q (3), RW (3), 10-K/A (2), 4/A (2), DRS (2), FWP (2), S-1MEF (2), S-4 (2), 10-Q/A (1), 8-A12B (1), CERTNAS (1), CT ORDER (1), DEL AM (1), POS AM (1), PRER14A (1), REGDEX (1), RW WD (1), S-3/A (1), SCHEDULE 13D (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 18, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Mar 31, 2026
    Latest 8-K (8-K) Aug 28, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, $0.001 par value per shareHINDNasdaq

From the cover page of the 10-K filed Mar 18, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Vyome Holdings, Inc names in Item 1A of its 10-K filed Mar 18, 2026: 74 risks under these headings, as written.4

  • Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements
  • Risks Related to Our Product Development
  • Risks Related to Our Commercial Operations
  • Risks Related to Our Business and Operations
  • Risks Related to Our Intellectual Property
  • Risks Related to Government Regulations and Other Legal Compliance Matters
  • Risks Related to Ownership of Our Common Stock
  • We have a limited operating history and have not taken a product through to commercialization.
  • We have incurred losses since inception, and we expect to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future. We have not generated any revenue from the Vyome Assets and may never generate revenue or become profitable.
  • Our ability to use net operating losses (“NOL”) carryforwards may be limited.
  • Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and our financial condition and results of operations.
  • Previously, we recorded a non-cash indefinite-lived intangible and definite-lived assets impairment loss, which significantly impacted our results of operations, and we may be exposed to additional impairment losses that could be material.
The other 68 risks
  • If we are unable to raise capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our development programs or future commercialization efforts.
  • Due to the significant resources required for the development of VT-1953 and VT-1908, we must prioritize the pursuit of treatments for certain indications. We may expend our limited resources to pursue a particular indication and fail to capitalize on indications that may be more profitable or for which there is a greater likelihood of success.
  • We may in the future license additional assets, which may require us to expend additional resources and raise additional capital.
  • We may not realize all of the anticipated benefits of the Merger.
  • We have incurred substantial direct and indirect costs as a result of the Merger and expect to incur substantial direct and indirect costs following the Merger.
  • If the perceived benefits of the Merger do not meet the expectations of investors or securities analysts, the market price of our securities may decline.
  • Our operating results may fluctuate significantly.
  • If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our operating results could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of its common stock.
  • Certain of our directors and executive officers also work with other companies and organizations and such other positions may create conflicts of interest in the future.
  • We have never successfully completed the regulatory approval process for the Vyome Assets, and we may be unable to do so for any product candidates we acquire or develop.
  • We are substantially dependent on the success of VT-1953 and VT-1908, and our anticipated clinical trials of VT-1953 and VT-1908 may not be successful.
  • We may find it difficult to enroll patients in our clinical trials for Vyome Assets. If we experience delays or difficulties in the enrollment of patients in clinical trials, our successful completion of clinical trials or receipt of marketing approvals could be delayed or prevented.
  • The results of preclinical testing and early clinical trials of the Vyome Assets may not be predictive of the success of our later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA, EMA, or other comparable foreign regulatory authorities.
  • Preclinical and clinical development involves a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results.
  • Preliminary, interim data from our clinical trials that we announce or publish may change as more patient data become available and are subject to audit and verification procedures.
  • We may develop the Vyome Assets in combination with other therapies, which exposes us to additional risks related to other agents or active pharmaceutical or biological ingredients used in combination with the Vyome Assets.
  • If the FDA or other regulatory authorities revoke their approval of these other drugs or revoke their approval of, or if safety, efficacy, manufacturing or supply issues arise with, the drugs we choose to evaluate in combination with any product candidate we develop, we may be unable to obtain approval.
  • VT-1953 and VT-1908 may have a safety profile that could prevent regulatory approval, marketing approval or market acceptance, or limit its commercial potential.
  • We face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business. We may not be able to obtain adequate product liability insurance.
  • We face substantial competition, which may result in others discovering, developing, licensing or commercializing products before or more successfully than we do.
  • We have undertaken a cost reduction plan and reorganization, and may do so again in the future. The assumptions underlying these activities may prove to be inaccurate, or we may fail to achieve the expected benefits therefrom.
  • Public health crises such as pandemics or similar outbreaks have affected and could continue to seriously and adversely affect our preclinical studies and anticipated clinical trials, business, financial condition and results of operations.
  • Our business, operations, financial position and clinical development plans and timelines could be materially adversely affected by the ongoing conflicts in various parts of the world.
  • We are dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining qualified personnel, including consultants, we may not be able to successfully implement our business strategy.
  • We rely on third parties, including consultants, independent clinical investigators and CROs to conduct and sponsor some of the clinical trials of the Vyome Assets. Any failure by a third party to meet its obligations with respect to the clinical development of the Vyome Assets may delay or impair our ability to obtain regulatory approval for the Vyome Assets.
  • In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • Our internal computer systems, or those of any of our CROs, manufacturers, other contractors or consultants or potential future collaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations.
  • We generates all of our revenues from one customer, and loss of business from such customer could significantly harm our revenues and business.
  • We currently rely, and plan to rely in the future, on third parties to conduct and support our preclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize the Vyome Assets.
  • We intend to rely on third parties to produce and process the Vyome Assets. There can be no assurance that we will successfully negotiate agreements with third-party manufacturers to produce the Vyome Assets on acceptable terms or at all; and furthermore, we may fail to successfully transfer the manufacturing technology to these third-parties. Our business could be adversely affected if the third-party manufacturers are unable to produce the Vyome Assets, fail to provide us with sufficient quantities of the Vyome Assets or fail to do so at acceptable quality levels or prices.
  • We may, in the future, form or seek collaborations or strategic alliances or enter into licensing arrangements, and we may not realize the benefits of such collaborations, alliances or licensing arrangements.
  • The increasing use of social media platforms presents new risks and challenges.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired, which may adversely affect investor confidence in us and, as a result, the market price of our common stock.
  • We have identified material weaknesses in our internal control over financial reporting and any failure to maintain effective internal control over financial reporting, may have a material and adverse effect on our business, operating results, financial condition and prospects.
  • Our ability to protect our patents and other proprietary rights is uncertain, exposing us to the possible loss of competitive advantage.
  • We enjoy only limited geographical protection with respect to our licensed patents and may not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated if we fail to comply with these requirements.
  • Issued patents covering one or more of our drug candidates could be found invalid or unenforceable.
  • We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
  • Patent terms may be inadequate to protect our competitive position with respect to the Vyome Assets for an adequate amount of time.
  • If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of our marketing exclusivity for the Vyome Assets, our business may be materially harmed.
  • Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect the Vyome Assets.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market the Vyome Assets.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • We may be subject to patent infringement claims or may need to file claims to protect our intellectual property, which could result in substantial costs and liability and prevent us from commercializing the Vyome Assets.
  • We may not be able to effectively secure first-tier technologies when competing against other companies or investors.
  • Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.
  • If approved, the Vyome Assets that are regulated by FDA, EMA and other regulatory authorities may face competition from generics approved through an abbreviated regulatory pathway.
  • The regulatory approval processes of the FDA, EMA, and other comparable foreign regulatory authorities are complex, time-consuming and inherently unpredictable. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for the Vyome Assets, we may not be able to commercialize, or may be delayed in commercializing, the Vyome Assets, and our ability to generate revenue will be materially impaired.
  • Of the large number of drugs in development, only a small percentage successfully complete the FDA, EMA, or foreign regulatory approval processes and are commercialized. The lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market the Vyome Assets, which would significantly harm our business, results of operations and prospects.
  • We will be subject to extensive ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with the Vyome Assets.
  • Due to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, we may not be able to offer the Vyome Assets at competitive prices which would seriously harm our business.
  • The FDA, EMA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws in USA and India, which could expose us to penalties.
  • The size of the potential market for the Vyome Assets is difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for the Vyome Assets may be smaller than our estimates.
  • Healthcare legislative reform discourse and potential or enacted measures may have a material adverse impact on our business and results of operations and legislative or political discussions surrounding the desire for and implementation of pricing reforms may adversely impact our business.
  • Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the Affordable Care Act (“ACA”). It is unclear how other healthcare reform measures of the current administration or other efforts, if any, to amend or challenge the ACA, will impact our business.
  • We may be subject, directly or indirectly, to United States federal and state healthcare fraud and abuse and false claims laws and regulations. Prosecutions under such laws have increased in recent years and we may become subject to such litigation. If we are unable to, or have not fully complied with such laws, we could face substantial penalties.
  • If we fail to comply with environmental, health and safety laws and regulations in the USA, India or where we may have operations in future, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • We are subject to laws and regulations related to privacy, data protection, information security and consumer protection across different markets where we conduct our business. Our actual or perceived failure to comply with such obligations could harm our business.
  • We do not have a compliance program in place consistent with Federal agencies’ guidance’s on corporate compliance programs.
  • Political changes in the Government of India could delay or affect the further liberalization of the Indian economy and materially and adversely affect economic conditions in India, generally, and our business, in particular.
  • Our Indian subsidiary may not be in compliance with laws applicable to it, and it may face penalties and fines imposed by the Indian government.
  • The trading price of our common stock has been volatile and is likely to be volatile in the future.
  • We do not expect to pay cash dividends in the foreseeable future. Any return on investment may be limited to the capital appreciation, if any, of shares of our common stock.
  • Future sales of a substantial number of shares of our common stock may cause the price of our common stock to decline.

Legal proceedings

The Company is not aware of any pending or threatened litigation against it that could have a material adverse effect on the Company’s business, operating results or financial condition. The industry in which the Company operates is characterized by frequent claims and litigation, including claims regarding patent and other intellectual property rights as well as improper hiring practices. As a result, the Company may be involved in various legal proceedings from time to time.

The opening of Item 3, Legal Proceedings.4

Sources

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