Overview
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- TickerJUNS on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersJupiter, Florida1
- Incorporated inDE2
- Business address1001 North Us Hwy 1, Suite 504, Jupiter, Fl 334772
- Filer category, Emerging growth company2
- Legal formCorporation
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Nugevia PWR (“PWR”), which helps support mitochondrial function, which is a key for sustained growth and performance.3 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
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Cost of revenue0¢$4.2K
- Research and development23¢$2.1M
- Selling, general and admin77¢$6.8M
Out of $21.8K in revenue.4 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.4
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Product Revenues, net | $21.8K | $0 |
| Cost of goods sold | $4.2K | |
| Gross Profit | $17.6K | |
| Research and development | $2.1M | $492.7K |
| General and administrative | $6.8M | $2.6M |
| Total operating expenses | $8.9M | $3.1M |
| Operating loss | -$8.9M | -$3.1M |
| Interest income | $5.6K | |
| Loss on change in fair value of derivative liability | -$53.3K | |
| Gain on change in fair value of convertible notes | $281.9K | |
| Interest expense | -$66.0K | -$248.4K |
| Gain on extinguishment of debt | $857.7K | |
| Other income | $47.9K | $90.0K |
| Total other expenses, net | $263.8K | $651.7K |
| Net income (loss) | -$8.6M | -$2.4M |
| Basic | -$0.25 | -$0.08 |
| Diluted | -$0.25 | -$0.08 |
| Basic | 34.6M shares | 28.8M shares |
| Diluted | 34.6M shares | 28.8M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 5 fiscal years (annual) or 5 quarters (quarterly), latest first.4
| Period ending | 2025-12-31 | 2024-12-31 | 2024-05-31 | 2023-12-31 | 2022-01-31 |
|---|---|---|---|---|---|
| Cash | $3.8M | $3.8M | |||
| Account receivable | $2.6K | ||||
| Prepaid contracts | $766.7K | $766.7K | |||
| Inventory, net | $159.8K | ||||
| Other current assets | $106.5K | $114.1K | |||
| Total current assets | $4.8M | $4.7M | |||
| Operating lease right of use asset, net | $23.2K | $69.6K | |||
| Prepaid contracts, noncurrent | $712.1K | $1.5M | |||
| Other assets | $3.8K | $3.8K | |||
| Total assets | $5.6M | $6.2M | |||
| Accounts payable and accrued expenses | $638.6K | $396.5K | |||
| Accrued compensation | $1.4M | $1.4M | |||
| Accrued interest | $39.8K | $1.1K | |||
| Deferred revenue | $735 | ||||
| Current portion of operating lease liability | $21.2K | $50.1K | |||
| Convertible notes payable, fair value | $5.3M | ||||
| Total current liabilities | $7.4M | $2.0M | |||
| Operating lease liability, net of current portion | $21.2K | ||||
| Total liabilities | $7.4M | $2.0M | |||
| Common stock, par value $0.0001; 500,000,000 and 125,000,000 shares authorized, respectively; 34,446,455 and 33,103,860 issued and outstanding, respectively | $3.4K | $3.3K | |||
| Additional paid in capital | $32.8M | $30.2M | |||
| Accumulated deficit | -$34.7M | -$26.0M | |||
| Total stockholders deficit | -$1.8M | $4.2M | -$5.8M | ||
| Total liabilities and stockholders deficit | $5.6M | $6.2M | |||
| Series A preferred stock, par value | $0.00 | $0.00 | |||
| Series A preferred stock, shares authorized | 5.0M shares | 5.0M shares | |||
| Common stock, par value | $0.00 | $0.00 | $0.00 | ||
| Common stock, shares authorized | 500.0M shares | 125.0M shares | 125.0M shares | 45.0M shares | |
| Common stock, share issued | 34.4M shares | 33.1M shares | |||
| Common stock, share outstanding | 34.4M shares | 33.1M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2024-05-31 | 2023-12-31 | 2022-01-31 |
|---|---|---|---|---|---|
| Cash | $3.8M | $3.8M | |||
| Account receivable | $2.6K | ||||
| Prepaid contracts | $766.7K | $766.7K | |||
| Inventory, net | $159.8K | ||||
| Other current assets | $106.5K | $114.1K | |||
| Total current assets | $4.8M | $4.7M | |||
| Operating lease right of use asset, net | $23.2K | $69.6K | |||
| Prepaid contracts, noncurrent | $712.1K | $1.5M | |||
| Other assets | $3.8K | $3.8K | |||
| Total assets | $5.6M | $6.2M | |||
| Accounts payable and accrued expenses | $638.6K | $396.5K | |||
| Accrued compensation | $1.4M | $1.4M | |||
| Accrued interest | $39.8K | $1.1K | |||
| Deferred revenue | $735 | ||||
| Current portion of operating lease liability | $21.2K | $50.1K | |||
| Convertible notes payable, fair value | $5.3M | ||||
| Total current liabilities | $7.4M | $2.0M | |||
| Operating lease liability, net of current portion | $21.2K | ||||
| Total liabilities | $7.4M | $2.0M | |||
| Common stock, par value $0.0001; 500,000,000 and 125,000,000 shares authorized, respectively; 34,446,455 and 33,103,860 issued and outstanding, respectively | $3.4K | $3.3K | |||
| Additional paid in capital | $32.8M | $30.2M | |||
| Accumulated deficit | -$34.7M | -$26.0M | |||
| Total stockholders deficit | -$1.8M | $4.2M | -$5.8M | ||
| Total liabilities and stockholders deficit | $5.6M | $6.2M | |||
| Series A preferred stock, par value | $0.00 | $0.00 | |||
| Series A preferred stock, shares authorized | 5.0M shares | 5.0M shares | |||
| Common stock, par value | $0.00 | $0.00 | $0.00 | ||
| Common stock, shares authorized | 500.0M shares | 125.0M shares | 125.0M shares | 45.0M shares | |
| Common stock, share issued | 34.4M shares | 33.1M shares | |||
| Common stock, share outstanding | 34.4M shares | 33.1M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.4
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net Loss | -$8.6M | -$2.4M |
| Loss on change in fair value of derivative liability | $53.3K | |
| Gain on change in fair value of convertible notes | -$281.9K | |
| Amortization of debt discounts | $43.3K | |
| Loss (Gain) on extinguishment of debt | -$857.7K | |
| Gain on forgiveness of accrued compensation | -$40.0K | |
| Amortization of prepaid contracts | $766.7K | $54.6K |
| Non-cash financing cost | $200.0K | |
| Interest expense paid through sale of common stock | $22.5K | |
| Stock-based compensation | $2.4M | $1.8M |
| Increase in accounts receivable | -$2.6K | |
| Decrease (increase) in prepaid contracts | -$2.3M | |
| Increase in prepaid and other current assets | -$113.8K | |
| Increase in inventory | -$159.8K | |
| Increase in other current assets | $7.5K | |
| Decrease in operating lease right of use asset | -$3.7K | -$1.8K |
| Increase in deferred revenue | $735 | |
| Increase in accounts payable and accrued expenses | $242.2K | -$149.5K |
| Decrease in accrued compensation | -$17.7K | -$46.9K |
| Increase in accrued interest | $38.8K | $46.4K |
| Net cash used in operating activities | -$5.4M | -$3.9M |
| Proceeds from note payable, related parties | $138.5K | |
| Payment on convertible note payable | -$150.0K | |
| Proceeds from issuance convertible note payable, net | $5.6M | |
| Proceeds from offering, net of offering costs | $9.7M | |
| Proceeds from sale of common stock | $150.0K | |
| Net cash provided by financing activities | $5.4M | $7.7M |
| Net Change in Cash | $19.8K | $3.7M |
| Cash paid for interest | $38.4K | $147.8K |
| Restricted stock issued for forgiveness of salary | $10.0K | |
| Stock options issued for forgiveness of salary | $50.0K | |
| Notes payable, related party assign to Note payable | $266.7K | |
| Stock issued in connection with convertible promissory notes | $200.0K | $636.9K |
| Stock issued in connection interest payment | $22.5K |
No quarter-by-quarter statement was filed.
Corporate structure
JUPITER NEUROSCIENCES, INC. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of JUPITER NEUROSCIENCES, INC.
- PharmAla Biotech Holdings Inc. Filed SCHEDULE 13G on JUPITER NEUROSCIENCES, INC., latest Sep 22, 2026
- Orca Capital AG Filed SCHEDULE 13G/A on JUPITER NEUROSCIENCES, INC., latest Aug 28, 2026 (2 filings since Aug 28, 2026)
- Alexander Gustaf Erik Rosen Filed SC 13D on JUPITER NEUROSCIENCES, INC., latest Nov 15, 2024
- Christer Rosen Filed SC 13D on JUPITER NEUROSCIENCES, INC., latest Nov 15, 2024
- Claes Robert Wahlestedt Filed SC 13D on JUPITER NEUROSCIENCES, INC., latest Nov 15, 2024
- Marshall A. Hayward Filed SC 13D on JUPITER NEUROSCIENCES, INC., latest Nov 15, 2024
- Shaun Paul Brothers Filed SC 13D on JUPITER NEUROSCIENCES, INC., latest Nov 15, 2024
- JUPITER NEUROSCIENCES, INC. Jupiter, Florida
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What JUPITER NEUROSCIENCES, 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
| Item | Latest | A year before | Change |
|---|---|---|---|
| Operating-lease assets (leased space) | $23.2K4 Dec 31, 2025 | $69.6K4 Dec 31, 2024 | −66.7% |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $159.8K4 Dec 31, 2025 |
Properties, in its own words
Our corporate headquarters are located at 1001 North US Hwy 1, Suite 504, Jupiter, Florida 33477, where we lease approximately 1,206 rentable square feet of office space. This lease expires on May 31, 2026. Terms of the office lease provide for a base rent payment of $4,258 per month and a share of the building’s operating expenses, such as taxes and maintenance, of $600 per month. In September 2021, we added an additional office located at 127 Main Street, Boston, Massachusetts 02129 for 120 rentable square feet of office space for our Boston-based employees and scientist to utilize as necessary.
We believe that these facilities are adequate for our current and near-term future needs.
Item 2 of the 10-K filed Apr 1, 2026.3
Leadership
Who has led JUPITER NEUROSCIENCES, INC., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
Chief operating officer
- Chief executive officerChrister Rosen Nov 8, 2024 to now8
- ChairChrister Rosen Nov 8, 2024 to now8
- PresidentAlison D. Silva Jun 4, 2026 to now9
- Chief financial officerSaleem Elmasri Nov 8, 2024 to now10
- Chief operating officerAlison D. Silva Jun 4, 2026 to now9
Board members and other officers (11)
- Chief Administrative OfficerAlexander Gustaf Erik Rosen Nov 8, 2024 to now11
- Pres + Chief Business OfficerAlison D. Silva Nov 8, 2024 to now12
- Chief Scientific OfficerMarshall A. Hayward Nov 8, 2024 to now13
- Board memberTomas Jan Philipson Jul 1, 2026 to now14
- Board memberAndrew Jon Cutler Jul 22, 2026 to now15
- Board memberAlison D. Silva Nov 8, 2024 to now12
- Board memberAllison W. Brady Nov 8, 2024 to now16
- Board memberHolger Weis Nov 8, 2024 to now17
- Board memberJulie B. Kampf Nov 8, 2024 to now18
- Board memberMarshall A. Hayward Nov 8, 2024 to now13
- Board memberNicholas H. Hemmerly Nov 8, 2024 to now19
Named in SEC Form D filings
People the company listed in its private-offering notices.
- DirectorHolger Weiss named Sep 4, 202620
Former names
- Jupiter Orphan Therapeutics, Inc.Jul 15, 2016 to Dec 5, 20172
Timeline
- Sep 3, 20268-K Bylaws or fiscal year changed21
- Aug 28, 20268-K Listing notice or transfer; Other events22
- Aug 27, 20268-K Entered a material agreement; Executive or director change; Other events23
- Aug 24, 20268-K Entered a material agreement; Unregistered sale of shares; Other events24
- Aug 24, 20268-K Other events25
- Aug 6, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed; Other events26
- Jul 28, 20268-K Unregistered sale of shares; Other events27
- Jul 27, 20268-K Shareholder vote; Other events28
- Jul 21, 20268-K Entered a material agreement; Unregistered sale of shares29
- Jun 30, 20268-K Executive or director change30
- Jun 22, 20268-K Executive or director change31
- Jun 5, 20268-K Executive or director change32
- Nov 8, 2024New chief executive Christer Rosen becomes CEO8
Calendar
Coming up
- Nov 13, 2026Reports results for the quarter ending Sep/202633
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
199 filings to the SEC since October 2021: 2 annual reports, 6 quarterly reports, 28 major events, 36 insider forms, 8 large holders, 1 private raises, 118 other. The latest 20:
- Oct 13, 2026S-8 EDGAR
- Sep 25, 2026S-3 EDGAR
- Sep 22, 2026SCHEDULE 13G EDGAR
- Sep 4, 2026D EDGAR
- Sep 3, 20268-K EDGAR
- Aug 28, 2026SCHEDULE 13G/A EDGAR
- Aug 28, 2026SCHEDULE 13G EDGAR
- Aug 28, 20268-K EDGAR
- Aug 27, 20268-K EDGAR
- Aug 24, 20268-K EDGAR
- Aug 24, 20268-K EDGAR
- Aug 24, 2026424B5 EDGAR
- Aug 14, 202610-Q EDGAR
- Aug 6, 20268-K EDGAR
- Aug 5, 20264 EDGAR
- Jul 29, 2026424B3 EDGAR
- Jul 28, 20268-K EDGAR
- Jul 27, 2026424B3 EDGAR
- Jul 27, 20268-K EDGAR
- Jul 22, 20263 EDGAR
The 199 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
6 open-market trades by officers, directors and large owners since October 2021: 6 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Jul 1, 2025 | Silva Alison D.President and COO | Buy | 750 | $1.03 | $772 | Form 4 |
| Jul 1, 2025 | ROSEN CHRISTERCEO and Chairman | Buy | 3,600 | $1.02 | $3.7K | Form 4 |
| Jun 30, 2025 | Silva Alison D.President and COO | Buy | 950 | $1.03 | $980 | Form 4 |
| Jun 30, 2025 | ROSEN CHRISTERCEO and Chairman | Buy | 7,650 | $1.02 | $7.8K | Form 4 |
| Jun 27, 2025 | Silva Alison D.President and COO | Buy | 850 | $1.03 | $876 | Form 4 |
| Jun 27, 2025 | ROSEN CHRISTERCEO and Chairman | Buy | 166 | $1.06 | $176 | Form 4 |
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.
- PharmAla Biotech Holdings Inc.SCHEDULE 13G, 1 filing Sep 22, 202634
- Orca Capital AGSCHEDULE 13G/A, 2 filings Aug 28, 202635
- Alexander Gustaf Erik RosenSC 13D, 1 filing Nov 15, 202436
- Christer RosenSC 13D, 1 filing Nov 15, 202437
- Claes Robert WahlestedtSC 13D, 1 filing Nov 15, 202438
- Marshall A. HaywardSC 13D, 1 filing Nov 15, 202439
- Shaun Paul BrothersSC 13D, 1 filing Nov 15, 202440
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.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2025 | Christer Rosén | 74 | $441.0K | $671.4K41 |
| 2025 | Alison Silva | 47 | $315.0K | $632.1K41 |
| 2025 | Saleem Elmasri | 40 | $240.0K | $414.1K41 |
| 2025 | Alexander Rosén | 34 | $252.0K | $339.7K41 |
| 2025 | Marshall Hayward | $176.4K | $242.4K41 |
Funding
Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.
- Private raises (Form D) $774.8K
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2026 | $774.8K | $774.8K |
Private raises
Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.
SEC filer profile
How JUPITER NEUROSCIENCES, INC. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARJUPITER NEUROSCIENCES, INC.1
- CIK0001679628
- Employer ID (EIN)47-48283813
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; a shell company3
- Incorporated inDelaware3
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address1001 North Us Hwy 1, Suite 504, Jupiter, FL 334771
- Phone(561) 406-61541
- Shares outstanding770,081 as of Aug 14, 20267
- Public float$20.2M as of Jun 30, 20253
- AuditorCherry Bekaert LLP, Tampa, Florida PCAOB ID 677; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceJul 15, 20161
- Filings202 in all: CORRESP (40), 8-K (27), 4 (24), S-1/A (22), 424B3 (13), UPLOAD (13), 3 (12), 10-Q (6)1
All 31 form types
SC 13D (5), D (4), EFFECT (4), S-1 (3), 10-K (2), 424B5 (2), ARS (2), CERT (2), DEF 14A (2), DEFA14A (2), PRE 14A (2), S-3 (2), S-8 (2), SCHEDULE 13G (2), 424B4 (1), 8-A12B (1), 8-A12B/A (1), 8-K/A (1), DRS (1), NT 10-K (1), NT 10-Q (1), PRER14A (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Apr 1, 2026
Quarterly report (10-Q) Aug 14, 2026
Proxy statement (DEF 14A) Jun 22, 2026
Latest 8-K (8-K) Sep 3, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock | JUNS | Nasdaq |
From the cover page of the 10-K filed Apr 1, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks JUPITER NEUROSCIENCES, INC. names in Item 1A of its 10-K filed Apr 1, 2026: 74 risks under these headings, as written.3
- We may not be successful in preventing the material adverse effects that any of the following risks and uncertainties may cause. These potential risks and uncertainties may not be a complete list of the risks and uncertainties facing us. There may be additional risks and uncertainties that we are presently unaware of, or presently consider immaterial, that may become material in the future and have a material adverse effect on us. You could lose all or a significant portion of your investment due to any of these risks and uncertainties.
- Risks Related to Our Financial Position, Need for Additional Capital and Limited Operating History
- We are early in our development efforts, with a limited operating history, and we have no prescription products approved for commercial sale, which may make it difficult for you to evaluate our current business and likelihood of success and future viability.
- We have not generated any meaningful revenue from product sales to date, have incurred significant net losses since our inception, and expect to continue to incur significant net losses for the foreseeable future.
- Our management has concluded that factors raise substantial doubt about our ability to continue as a going concern and our auditor has included an explanatory paragraph relating to our ability to continue as a going concern in its audit report for the fiscal years ended December 31, 2025 and 2024.
- Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating to the discovery, development and commercialization of our product candidates, if approved.
- We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts.
- Raising additional capital may cause substantial dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
- The actual number of shares of common stock we will issue pursuant to the SEPA, if not terminated and if and when available, at any one time or in total, is uncertain.
- Low trading volume in our common stock may limit or prevent our ability to draw on the Standby Equity Purchase Agreement.
- Our substantial amount of indebtedness may adversely affect our cash flow and our ability to operate our business, remain in compliance with debt covenants and make payments on our indebtedness.
- Our ability to utilize our net operating loss carryforwards and certain other tax attributes to offset future taxable income may be limited.
The other 62 risks
- Changes in U.S. tax laws and regulations and those which we are subject to in various tax jurisdictions could adversely affect our business, financial condition and results of operations.
- Any shares of common stock we issue under the SEPA, if not terminated and if and when available, will further dilute our stockholders.
- Risks Related to the Launch of the Nugevia Brand
- The launch of the Nugevia brand exposes the Company to a number of business and operational risks that could materially and adversely impact its business
- Our business and future prospects with the Nugevia brand and our pharmaceutical products are significantly dependent on our exclusive, worldwide license agreement with Aquanova. Any adverse development related to this license agreement could materially and adversely affect our operations, financial condition, and results of operations.
- If the Company or its suppliers fails to comply with FDA or other regulations, it could result in enforcement actions or delays in the Nugevia brand product launch.
- The global nutraceutical market is highly competitive, with many brands offering products that are similar to Nugevia. Failure to differentiate from competitors could limit market penetration and revenue potential.
- The Company is dependent on certain proprietary supply-chain vulnerabilities with operational and supply chain risks.
- If there are intellectual property disputes relating to the JOTROL™ technology, it could threaten Nugevia’s market position
- Risks Related to the Discovery, Development and Commercialization of Our Product Candidate
- We are substantially dependent on the success of our lead product candidate, JOTROL™, which will be undergoing Phase II clinical trials, subject to FDA’s review and agreement. If we are unable to complete development of, obtain approval for and commercialize JOTROL™ for one or more indications in a timely manner, our business will be harmed.
- In addition to JOTROL™, our prospects depend in part upon discovering, developing and commercializing product candidates in future programs, which may fail or suffer delays that adversely affect their commercial viability.
- Clinical drug development involves a lengthy and expensive process with an uncertain outcome. The clinical trials of our product candidate may not demonstrate safety and efficacy to the satisfaction of the FDA, EMA or other comparable foreign regulatory authorities or otherwise produce positive results and the results of preclinical studies and early clinical trials may not be predictive of future results. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
- We have entered into Service Agreements with the Asian Partners with respect to services to be provided by the Asian Partners to us in Asia for the clinical development of JOTROL™ in the Southeast Asian territory immediately following the completion of the initial public offering; the shares issued by us in advance for the specific services could have a material negative impact on our business, financial condition and operating results in case the Asian Partners’ will not perform the services per the agreements.
- We entered into a Strategic Service Agreement with DOMINANT TREASURE HEALTH COMPANY LIMITED with respect to strategic services in Asia, the fees paid by the Company pursuant to which, are non-refundable and not tied to any milestones or performance, and the foregoing nature of such fees, could have a material negative impact on our business, financial condition and operating results.
- Our product candidates may cause serious adverse events, toxicities or other undesirable side effects when used alone or in combination with approved products or investigational new drugs that may result in a safety or risk profile that could prevent regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences.
- The outcome of preclinical testing and early clinical trials may not be predictive of the success of 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.
- If we experience delays or difficulties in the enrollment and/or maintenance of patients in clinical trials, our regulatory submissions or receipt of necessary marketing approvals could be delayed or prevented.
- We have limited resources and are currently focusing the majority of our efforts on developing JOTROL™ for particular indications. As a result, we may fail to capitalize on other indications or product candidates that may ultimately have proven to be more profitable.
- We face significant competition and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than the products we develop, our commercial opportunities will be negatively impacted.
- Interim, topline and preliminary 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 that could result in material changes in the final data.
- We may not be successful in our efforts to develop our proprietary drug delivery platform, JOTROL™, to build a pipeline of indications.
- We may develop JOTROL™ and potentially other programs in combination with other therapies, which would expose us to additional risks.
- The manufacture of drugs is complex, and our third-party manufacturers may encounter difficulties in production. If any of our third-party manufacturers encounter such difficulties, our ability to provide adequate supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented.
- Our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
- The patient population suffering from MPS I and MELAS syndrome is small and has not been established with precision. If the actual number of patients is smaller than we estimate, our potential revenue and ability to achieve profitability may be adversely affected. Because the target patient populations of our programs are small and the addressable patient population may be even smaller, we must be able to successfully identify patients and capture a significant market share to achieve profitability and growth.
- Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.
- Our business entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage, such inability could have an adverse effect on our business and financial condition. If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.
- Risks Related to Regulatory Approval and Other Legal Compliance Matters
- The regulatory approval processes of the FDA, EMA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval of our product candidates, we will be unable to generate product revenue and our business will be substantially harmed.
- The FDA, EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
- Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
- The regulatory approval processes for any product candidates that target rare diseases, including MPS I and MELAS are uncertain.
- Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight.
- We may not be able to obtain orphan drug designation or obtain or maintain orphan drug exclusivity for our product candidates and, even if we do, that exclusivity may not prevent the FDA, EMA or other comparable foreign regulatory authorities, from approving competing products.
- If our Nugevia nutritional supplement products do not have the effects intended or cause undesirable side effects, our business may suffer.
- Our competitors may develop nutritional supplement products that are less expensive, safer or otherwise more appealing, which may diminish or eliminate the commercial success of any potential product that we may commercialize.
- Our Nugevia products are subject to regulatory requirements and failure to comply with any regulations could lead to significant penalties or claims, which could materially harm our financial condition and operating results.
- We may face difficulties from changes to current regulations and future legislation.
- Risks Related to Data Privacy and Security
- We are subject to an evolving array of U.S. and foreign privacy, and data protection, and data security laws regulations, and standards, and any failure or perceived failure to comply could result in regulatory investigations, litigation, significant fines and penalties, operational restrictions, and reputational harm.
- Inadequate funding for the FDA, the U.S. Securities and Exchange Commission (SEC) and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- 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.
- If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.
- Our business activities may be subject to the U.S. Foreign Corrupt Practices Act and similar anti-bribery and anti-corruption laws of other countries in which we operate, as well as U.S. and certain foreign export controls, trade sanctions, and import laws and regulations. Compliance with these legal requirements could limit our ability to compete in foreign markets and subject us to liability if we violate them.
- Risks Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Business
- Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees.
- If we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to successfully sell or market our product candidates that obtain regulatory approval.
- 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.
- Risks Related to Cybersecurity and Information Technology Disruptions
- Our information technology systems and those of any of our CROs, clinical sites, manufacturers, vendors, and other partners are subject to cybersecurity threats and other disruptions that could adversely affect our operations and the development and commercialization of our product candidates.
- Our employees and executives may use artificial intelligence tools in ways that expose our confidential information, intellectual property, or clinical data to third parties, and the evolving regulatory and legal landscape around artificial intelligence could adversely affect our business.
- Our operations are vulnerable to interruption by fire, earthquakes, power loss, telecommunications failure, terrorist activity, pandemics and other events beyond our control, which could harm our business.
- A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
- The certificate of incorporation, as amended, and amended and restated bylaws provides that state or federal court located within the state of Delaware will be the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit its stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.
- By purchasing our common stock, you are bound by the fee-shifting provision contained in our amended and restated bylaws, which may discourage you to pursue actions against us and could discourage stockholder lawsuits that might otherwise benefit the Company and its stockholders.
- Risks Related to Our Intellectual Property
- Our worldwide exclusive license agreement with Aquanova for JOTROL™ is critical to our business. If we were to lose the license agreement, it could disrupt our ability to commercialize our Nugevia product line or pharmaceutical drug candidates.
- Our success depends on our ability to protect our intellectual property and our proprietary technologies.
- If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected.
- Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
- Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
- We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
- We may be involved in lawsuits to protect or enforce our patents or our licensor’s patents, which could be expensive, time consuming and unsuccessful. Further, our issued patents or our licensor’s patents could be found invalid or unenforceable if challenged in court.
- Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common stock to decline.
- Derivation proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to cease using the related technology or to attempt to license rights from the prevailing party.
- Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
- We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
Legal proceedings
From time to time, we are involved in various legal proceedings arising from the normal course of business activities. We are not presently a party to any litigation the outcome of which, we believe, if determined adversely to us, would individually or taken together have a material adverse effect on our business, operating results, cash flows or financial condition. Defending such proceedings is costly and can impose a significant burden on management and employees. The results of any current or future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.
The opening of Item 3, Legal Proceedings.3
Sources
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- 9SEC EDGARAlison D. Silva, President
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- 14SEC EDGARTomas Jan Philipson, Board member
- 15SEC EDGARAndrew Jon Cutler, Board member
- 16SEC EDGARAllison W. Brady, Board member
- 17SEC EDGARHolger Weis, Board member
- 18SEC EDGARJulie B. Kampf, Board member
- 19SEC EDGARNicholas H. Hemmerly, Board member
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- 21SEC EDGARBylaws or fiscal year changed
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- 25SEC EDGAROther events
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- 28SEC EDGARShareholder vote; Other events
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- 30SEC EDGARExecutive or director change
- 31SEC EDGARExecutive or director change
- 32SEC EDGARExecutive or director change
- 33NasdaqNasdaq calendar
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