MANE on NYSE
Veradermics, Inc
American pharmaceutical preparations company based in New Haven1
In its 2026 annual report the company says: “We are a dermatologist-founded, late clinical-stage biopharmaceutical company, or the “Company,” “we,” “us,” or “our”, focused on developing innovative therapeutics to address pervasive treatment challenges in highly prevalent aesthetic and dermatological conditions. Our initial focus is developing better treatments for PHL, a condition affecting approximately 50 million men and 30 million women in the United States.”3 Its shares trade on NYSE under the symbol MANE.1
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Last updated Oct 21, 2026.
Overview
- TickerMANE on NYSE1
- IndustryPharmaceutical Preparations1
- HeadquartersNew Haven, Connecticut1
- Incorporated inDE2
- Business address470 James Street, New Haven, Ct 065132
- Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company2
- Legal formCorporation
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We are a dermatologist-founded, late clinical-stage biopharmaceutical company, or the “Company,” “we,” “us,” or “our”, focused on developing innovative therapeutics to address pervasive treatment challenges in highly prevalent aesthetic and dermatological conditions. Our initial focus is developing better treatments for PHL, a condition affecting approximately 50 million men and 30 million women in the United States. Current PHL treatment options are limited and therefore are consistently plagued with high rates of treatment failure, patient dissatisfaction and treatment discontinuation. Patients and healthcare providers routinely identify the following shortcomings with currently available treatment options:3 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
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 |
|---|---|---|
| Research and development | $62.1M | $23.3M |
| General and administrative | $10.3M | $3.5M |
| Total operating expenses | $72.3M | $26.8M |
| Loss from operations | -$72.3M | -$26.8M |
| Interest income | $1.6M | $481.0K |
| Other income | $790.0K | $394.0K |
| Interest expense | $0 | -$585.0K |
| Total other income, net | $2.4M | $290.0K |
| Loss before income taxes | -$70.0M | -$26.5M |
| Income tax benefit | $0 | $0 |
| Net loss | -$70.0M | -$26.5M |
| Net loss attributable to common stock, basic | -$83.4M | -$27.3M |
| Net loss attributable to common stock, diluted | -$83.4M | -$27.3M |
| Net loss per share of common stock, basic (in usd per share) | -$111.91 | -$37.05 |
| Net loss per share of common stock, diluted (in usd per share) | -$111.91 | -$37.05 |
| Weighted average common stock outstanding, basic (in shares) | 745.0K shares | 736.9K shares |
| Weighted average common stock outstanding, diluted (in shares) | 745.0K shares | 736.9K shares |
| Net unrealized gains on marketable securities | $60.0K | $0 |
| Total other comprehensive income | $60.0K | $0 |
| Total comprehensive loss | -$69.9M | -$26.5M |
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 | 2024-11-30 | 2023-12-31 | 2023-03-31 |
|---|---|---|---|---|---|
| Cash and cash equivalents | $21.8M | $53.1M | |||
| Marketable securities at fair value | $120.1M | $0 | |||
| Prepaid expenses and other current assets | $10.6M | $2.5M | |||
| Total current assets | $152.5M | $55.5M | |||
| Property, plant and equipment, net | $22.0K | $0 | |||
| Right-of-use asset and other long-term assets | $103.0K | $0 | |||
| Total non-current assets | $125.0K | $0 | |||
| Total assets | $152.6M | $55.5M | |||
| Accounts payable | $2.1M | $2.2M | |||
| Accrued expenses | $7.0M | $2.5M | |||
| Other current liabilities and lease liabilities | $47.0K | $0 | |||
| Total current liabilities | $9.2M | $4.7M | |||
| Lease liabilities - non-current | $4.0K | $0 | |||
| Total liabilities | $9.2M | $4.7M | |||
| Subscription receivable | -$1.8M | -$3.8M | -$894.0K | ||
| Common stock, $0.00001 par value, 98,774,582 and 25,500,000 authorized as of December 31, 2024 and 2023, respectively and 7,418,740 shares issued and outstanding | $1.0K | $1.0K | |||
| Additional paid-in capital | $2.3M | $750.0K | |||
| Accumulated other comprehensive income | $60.0K | $0 | |||
| Accumulated deficit | -$123.4M | -$49.2M | |||
| Total stockholders deficit | -$121.0M | -$48.5M | -$22.2M | ||
| Total liabilities, redeemable convertible preferred stock, and stockholders deficit | $152.6M | $55.5M | |||
| Common stock, par value (in usd per share) | $0.00 | $0.00 | |||
| Common stock, authorized (in shares) | 267.5M shares | 98.8M shares | 98.8M shares | 18.0M shares | |
| Common stock, issued (in shares) | 749.8K shares | 736.9K shares | |||
| Common stock, outstanding (in shares) | 749.8K shares | 736.9K shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2024-11-30 | 2023-12-31 | 2023-03-31 |
|---|---|---|---|---|---|
| Cash and cash equivalents | $21.8M | $53.1M | |||
| Marketable securities at fair value | $120.1M | $0 | |||
| Prepaid expenses and other current assets | $10.6M | $2.5M | |||
| Total current assets | $152.5M | $55.5M | |||
| Property, plant and equipment, net | $22.0K | $0 | |||
| Right-of-use asset and other long-term assets | $103.0K | $0 | |||
| Total non-current assets | $125.0K | $0 | |||
| Total assets | $152.6M | $55.5M | |||
| Accounts payable | $2.1M | $2.2M | |||
| Accrued expenses | $7.0M | $2.5M | |||
| Other current liabilities and lease liabilities | $47.0K | $0 | |||
| Total current liabilities | $9.2M | $4.7M | |||
| Lease liabilities - non-current | $4.0K | $0 | |||
| Total liabilities | $9.2M | $4.7M | |||
| Subscription receivable | -$1.8M | -$3.8M | -$894.0K | ||
| Common stock, $0.00001 par value, 98,774,582 and 25,500,000 authorized as of December 31, 2024 and 2023, respectively and 7,418,740 shares issued and outstanding | $1.0K | $1.0K | |||
| Additional paid-in capital | $2.3M | $750.0K | |||
| Accumulated other comprehensive income | $60.0K | $0 | |||
| Accumulated deficit | -$123.4M | -$49.2M | |||
| Total stockholders deficit | -$121.0M | -$48.5M | -$22.2M | ||
| Total liabilities, redeemable convertible preferred stock, and stockholders deficit | $152.6M | $55.5M | |||
| Common stock, par value (in usd per share) | $0.00 | $0.00 | |||
| Common stock, authorized (in shares) | 267.5M shares | 98.8M shares | 98.8M shares | 18.0M shares | |
| Common stock, issued (in shares) | 749.8K shares | 736.9K shares | |||
| Common stock, outstanding (in shares) | 749.8K shares | 736.9K 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 | -$70.0M | -$26.5M |
| Stock-based compensation | $1.4M | $250.0K |
| Research and development expenses paid with convertible and promissory notes | $0 | $234.0K |
| Non-cash research and development services | $2.0M | $1.0M |
| Net accretion of discount/premium on debt securities | -$556.0K | $0 |
| Accrued interest earned | -$647.0K | $0 |
| Other | $43.0K | $573.0K |
| Prepaid expenses and other current assets | -$8.2M | -$1.2M |
| Accounts payable | -$122.0K | $646.0K |
| Accrued expenses | $4.5M | $1.3M |
| Other current liabilities and lease liabilities | -$39.0K | $0 |
| Net cash used in operating activities | -$71.6M | -$23.7M |
| Purchase of property, plant and equipment | -$24.0K | $0 |
| Purchases of marketable securities | -$143.9M | $0 |
| Maturities of marketable securities | $25.0M | $0 |
| Net cash used in investing activities | -$118.9M | $0 |
| Issuance of convertible notes | $0 | $8.5M |
| Payment of promissory note | $0 | -$845.0K |
| Preferred stock issuance costs | -$447.0K | -$283.0K |
| Exercise of stock options | $156.0K | $0 |
| Net cash provided by financing activities | $159.1M | $60.5M |
| Net increase (decrease) in cash and cash equivalents | -$31.3M | $36.8M |
| Cash paid during the year for interest | $0 | $95.0K |
| Cash paid during the year for income taxes | $0 | $0 |
| Right-of-use asset exchanged for lease liabilities | $90.0K | $0 |
| Unrealized gain on debt securities | $60.0K | $0 |
| Modification of Series B preferred stock | -$4.2M | $0 |
| Issuance of Series B preferred stock for contractual research and development services | $0 | $3.0M |
| Issuance of Series B preferred stock as payment for convertible notes | $0 | $10.4M |
| Issuance of convertible note for research and development services | $0 | $1.2M |
| Conversion of other receivable in exchange for research and development services to subscription receivable | $0 | $932.0K |
| Issuance of convertible note for accounts payable | $0 | $250.0K |
No quarter-by-quarter statement was filed.
Corporate structure
Veradermics, 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 Veradermics, Inc
- JPMorgan Chase Filed SCHEDULE 13G on Veradermics, Inc, latest Oct 13, 2026
- MONTANOVA CAPITAL, LLC Filed SCHEDULE 13D/A on Veradermics, Inc, latest Aug 21, 2026 (3 filings since Feb 11, 2026)
- SR ONE CAPITAL MANAGEMENT, LLC Filed SCHEDULE 13D/A on Veradermics, Inc, latest Aug 14, 2026 (2 filings since Feb 11, 2026)
- FMR LLC Filed SCHEDULE 13G on Veradermics, Inc, latest Aug 6, 2026
- VIKING GLOBAL INVESTORS LP Filed SCHEDULE 13G/A on Veradermics, Inc, latest May 15, 2026 (2 filings since Feb 12, 2026)
- CITADEL ADVISORS LLC Filed SCHEDULE 13G on Veradermics, Inc, latest May 7, 2026
- Longitude Capital Partners V, LLC Filed SCHEDULE 13D/A on Veradermics, Inc, latest May 5, 2026 (2 filings since Feb 12, 2026)
- Seven Fleet Capital Management LP Filed SCHEDULE 13D on Veradermics, Inc, latest May 5, 2026
- Veradermics, Inc New Haven, Connecticut
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Veradermics, 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 |
|---|---|---|---|
| Property and equipment, net | $22.0K4 Dec 31, 2025 | $04 Dec 31, 2024 | |
| Operating-lease assets (leased space) | $103.0K4 Dec 31, 2025 | $04 Dec 31, 2024 |
Real estate and locations
| Item | Latest | A year before | Change |
|---|---|---|---|
| Area of real estate | 1,202 sq ft4 Mar 31, 2025 |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $21.8M4 Dec 31, 2025 | $53.1M4 Dec 31, 2024 | −59.0% |
| Marketable securities, current | $120.1M4 Dec 31, 2025 | $04 Dec 31, 2024 |
Properties, in its own words
Our corporate headquarters is located at 470 James St, New Haven, CT 06513, where we lease and occupy approximately 1,200 square feet of office space. The term of this lease commenced in February 2025. To meet the future needs of our business, we entered into a new lease on the same premises at 470 James St., where we lease and will occupy approximately 6,300 square feet of office space. The lease will commence in the second quarter of 2026 and expires in 2029 and we have the option to extend the lease for an additional two years after the initial expiration. We believe our existing facilities are sufficient for our current needs.
Item 2 of the 10-K filed Mar 30, 2026.3
Leadership
Who has led Veradermics, Inc, and when. Pick a name to see everywhere that person has worked.
- Chief executive officerReid Alexander Waldman Feb 3, 2026 to now7
- Chief financial officerDominic Gabriel Carrano Feb 3, 2026 to now8
Board members and other officers (10)
- Chief Commercial OfficerMark Neumann Feb 3, 2026 to now9
- Chief Technical OfficerTimothy August Durso Feb 3, 2026 to now10
- Board memberDavid Matthew Friedman Feb 3, 2026 to now11
- Board memberJane M. Grant-Kels Feb 3, 2026 to now12
- Board memberKatarina Pance Feb 3, 2026 to now13
- Board memberPatrick G. Enright Feb 3, 2026 to now14
- Board memberReid Alexander Waldman Feb 3, 2026 to now7
- Board memberVlad Coric Feb 3, 2026 to now15
- Board memberAaron Cowen Feb 9, 2026 to now16
- General counselMichael Greco V. Feb 3, 2026 to now17
Named in SEC Form D filings
People the company listed in its private-offering notices.
Timeline
- Aug 11, 20268-K Results of operations21
- Jul 15, 20268-K Regulation FD disclosure; Other events22
- May 12, 20268-K Results of operations23
- May 1, 20268-K Entered a material agreement; Unregistered sale of shares24
- Apr 27, 20268-K Regulation FD disclosure; Other events25
- Apr 27, 20268-K Results of operations26
- Mar 30, 20268-K Results of operations27
- Feb 5, 20268-K Bylaws or fiscal year changed28
- Feb 3, 2026New chief executive Reid Alexander Waldman becomes CEO7
Calendar
Coming up
- Nov 10, 2026Reports results for the quarter ending Sep/202629
When it reported results
- Aug 11, 2026Reported quarterly or annual results21
- May 12, 2026Reported quarterly or annual results23
- Apr 27, 2026Reported quarterly or annual results26
- Mar 30, 2026Reported quarterly or annual results27
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
95 filings to the SEC since October 2021: 1 annual reports, 2 quarterly reports, 8 major events, 35 insider forms, 13 large holders, 6 private raises, 30 other. The latest 20:
- Oct 13, 2026SCHEDULE 13G EDGAR
- Sep 3, 20264 EDGAR
- Aug 21, 2026SCHEDULE 13D/A EDGAR
- Aug 21, 20264 EDGAR
- Aug 20, 20263 EDGAR
- Aug 19, 2026144 EDGAR
- Aug 19, 2026144 EDGAR
- Aug 18, 20264 EDGAR
- Aug 18, 20264 EDGAR
- Aug 17, 2026144 EDGAR
- Aug 17, 2026144 EDGAR
- Aug 14, 2026EFFECT EDGAR
- Aug 14, 2026144/A EDGAR
- Aug 14, 20264 EDGAR
- Aug 14, 2026424B3 EDGAR
- Aug 14, 2026SCHEDULE 13D/A EDGAR
- Aug 12, 2026144 EDGAR
- Aug 12, 2026144 EDGAR
- Aug 11, 202610-Q EDGAR
- Aug 11, 20268-K EDGAR
The 95 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
12 open-market trades by officers, directors and large owners since October 2021: 8 buys and 4 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Aug 19, 2026 | Averill Master Fund, Ltd.Director | Sale | 750,000 | $107.25 | $80.4M | Form 4 |
| Aug 17, 2026 | Durso Timothy AugustChief Technical Officer | Sale | 43,500 | $107.82 | $4.7M | Form 4 |
| Aug 17, 2026 | Waldman Reid AlexanderChief Executive Officer | Sale | 67,500 | $107.86 | $7.3M | Form 4 |
| Aug 12, 2026 | CHILDS JOHN WDirector | Sale | 100,000 | $107.12 | $10.7M | Form 4 |
| Feb 6, 2026 | SUVRETTA CAPITAL MANAGEMENT, LLCDirector | Buy | 30,521 | $36.34 | $1.1M | Form 4 |
| Feb 5, 2026 | Coric VladDirector | Buy | 117,646 | $17.00 | $2.0M | Form 4 |
| Feb 5, 2026 | CHILDS JOHN WDirector | Buy | 294,117 | $17.00 | $5.0M | Form 4 |
| Feb 5, 2026 | Longitude Venture Partners V, L.P.10% owner | Buy | 1,075,000 | $17.00 | $18.3M | Form 4 |
| Feb 5, 2026 | ENRIGHT PATRICK GDirector | Buy | 1,075,000 | $17.00 | $18.3M | Form 4 |
| Feb 5, 2026 | CHILDS JOHN WDirector | Buy | 294,117 | $17.00 | $5.0M | Form 4 |
| Feb 5, 2026 | SUVRETTA CAPITAL MANAGEMENT, LLCDirector | Buy | 96,200 | $37.99 | $3.7M | Form 4 |
| Feb 4, 2026 | SUVRETTA CAPITAL MANAGEMENT, LLCDirector | Buy | 155,953 | $37.05 | $5.8M | 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.
- JPMorgan ChaseSCHEDULE 13G, 1 filing Oct 13, 202630
- MONTANOVA CAPITAL, LLCSCHEDULE 13D/A, 3 filings Feb 11, 2026 to Aug 21, 202631
- SR ONE CAPITAL MANAGEMENT, LLCSCHEDULE 13D/A, 2 filings Feb 11, 2026 to Aug 14, 202632
- FMR LLCSCHEDULE 13G, 1 filing Aug 6, 202633
- VIKING GLOBAL INVESTORS LPSCHEDULE 13G/A, 2 filings Feb 12, 2026 to May 15, 202634
- CITADEL ADVISORS LLCSCHEDULE 13G, 1 filing May 7, 202635
- Longitude Capital Partners V, LLCSCHEDULE 13D/A, 2 filings Feb 12, 2026 to May 5, 202636
- Seven Fleet Capital Management LPSCHEDULE 13D, 1 filing May 5, 202637
Money raised
Private offerings the company reported to the SEC on Form D.
- May 1, 2026Raised $30 million in a private offering of securities Form D: 2 investors so far Form D
- Oct 14, 2025Raised $135 million in a private offering of equity Form D: $150 million offered in all Form D
- Nov 25, 2024Raised $66.6 million in a private offering of equity Form D: $75 million offered in all Form D
- Apr 25, 2023Raised $15 million in a private offering of equity Form D: 16 investors so far Form D
- Sep 22, 2021Raised $22.2 million in a private offering of equity Form D: 41 investors so far Form D
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Montanova Capital, LLC | 4,168,970 | $512.5M | 10.8% | No change |
| Fmr LLC | 3,204,981 | $394.0M | 0.0% | +1,412,072 |
| SR One Capital Management, LP | 2,401,868 | $295.3M | 28.4% | No change |
| Deep Track Capital, LP | 2,000,000 | $245.9M | 3.6% | +1,500,000 |
| Citadel Advisors LLC | 1,877,775 | $230.9M | 0.1% | +52,103 |
| Siren, L.L.C. | 1,655,374 | $203.5M | 4.1% | +150,000 |
| BlackRock, Inc. | 1,593,791 | $195.9M | 0.0% | +1,311,180 |
| Viking Global Investors LP | 1,561,494 | $192.0M | 0.5% | −129,061 |
| Jpmorgan Chase & Co | 1,165,584 | $144.2M | 0.0% | +189,418 |
| Aberdeen Group plc | 1,096,642 | $134.8M | 0.2% | +41,982 |
| D. E. Shaw & Co., Inc. | 1,013,643 | $124.6M | 0.1% | +879,424 |
| Vanguard Capital Management LLC | 869,212 | $106.9M | 0.0% | +169,567 |
| Maverick Capital Ltd | 789,980 | $97.1M | 0.9% | New |
| Jennison Associates LLC | 748,678 | $92.0M | 0.1% | +606,897 |
| Infinitum Asset Management, LLC | 731,149 | $89.9M | 9.1% | No change |
| UBS Group AG | 670,727 | $82.5M | 0.0% | +323,652 |
| Marshall Wace, Llp | 585,560 | $72.0M | 0.1% | −69,041 |
| Adage Capital Partners Gp, L.l.c. | 549,706 | $67.6M | 0.1% | −550,294 |
| State Street Corp | 544,369 | $66.9M | 0.0% | +469,969 |
| Geode Capital Management, LLC | 508,067 | $62.5M | 0.0% | +329,861 |
| Woodline Partners LP | 501,590 | $61.7M | 0.2% | +944 |
| Bank of New York Mellon Corp | 346,585 | $42.6M | 0.0% | +342,917 |
| Stifel Financial Corp | 294,117 | $36.2M | 0.0% | No change |
| Kalehua Capital Management LLC | 291,390 | $35.8M | 11.4% | +42,816 |
| Emerald Advisers, LLC | 288,370 | $35.5M | 0.8% | +155,834 |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Veradermics, Inc is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARVeradermics, Inc1
- CIK0001827635
- Employer ID (EIN)84-33044233
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not 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 address470 James Street, New Haven, CT 065131
- Phone228.372.33761
- Shares outstanding41,780,136 as of Aug 6, 20265
- Public float$0 as of Jun 30, 20254
- AuditorDeloitte & Touche LLP, Hartford, Connecticut PCAOB ID 34; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceOct 9, 20201
- Filings96 in all: 4 (19), 3 (15), 8-K (8), 144 (6), D (6), SCHEDULE 13D (4), SCHEDULE 13D/A (4), SCHEDULE 13G (4)1
All 27 form types
EFFECT (3), FWP (3), S-1 (3), 10-Q (2), 424B4 (2), CORRESP (2), DRS (2), S-1MEF (2), 10-K (1), 144/A (1), 4/A (1), 424B3 (1), 8-A12B (1), CERT (1), D/A (1), S-1/A (1), S-8 (1), SCHEDULE 13G/A (1), UPLOAD (1)
- Latest filingsAnnual report (10-K) Mar 30, 2026
Quarterly report (10-Q) Aug 11, 2026
Latest 8-K (8-K) Aug 11, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common stock, par value $.00001 per share | MANE | New York Stock Exchange |
From the cover page of the 10-K filed Mar 30, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Veradermics, Inc names in Item 1A of its 10-K filed Mar 30, 2026: 72 risks under these headings, as written.3
- Risks Related to Our Financial Position and Need for Capital
- We are a clinical-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale. We have incurred substantial losses since our inception, and we anticipate incurring substantial and increasing losses for the foreseeable future.
- We will require substantial additional financing to achieve our goals, and failure to obtain additional capital when needed, or on acceptable terms, would cause us to delay, limit, reduce or terminate our product development or commercialization efforts.
- Raising additional capital may cause dilution to our stockholders which may impose restrictions on our operations or require us to relinquish rights to our product candidates.
- Risks Related to the Development of Our Product Candidates
- We currently anticipate that our success will substantially depend on the approval and successful commercialization of VDPHL01, which is our lead product candidate. If we are unable to obtain regulatory approval for, and successfully commercialize, VDPHL01, or any of our other current or future product candidates, or experience significant delays in doing so, our business will be materially harmed.
- If the FDA does not conclude that VDPHL01 satisfies the requirements for the Section 505(b)(2) regulatory approval pathway, or if the requirements for VDPHL01 under Section 505(b)(2) are not as we expect, the approval pathway for those product candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.
- Any significant AEs or undesirable side effects caused by our product candidates may delay or prevent regulatory approval or market acceptance of our product candidates, or result in significant negative consequences following marketing approval, if any. Additionally, the clinical profile of VDPHL01 in female patients may differ from the clinical profile in male patients, and the outcomes observed to date in male patients may not be reflective or predictive of future outcomes for female patients.
- We operate in highly competitive markets and face competition from large, well-established companies with significant resources as well as other entities, and, as a result, we may not be able to compete effectively.
- Delays or difficulties in the enrollment and dosing of patients in clinical trials may delay or prevent receipt of necessary regulatory approvals.
- As an organization, we have only recently initiated registration-directed clinical trials, and may be unable to complete such trials for any product candidates we may develop, including VDPHL01.
- Interim, initial, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time are subject to audit and verification procedures and may differ materially from final data as more patient data become available.
The other 62 risks
- We intend to expend our resources to pursue VDPHL01 and therefore may fail to capitalize on, or identify product candidates that may be more profitable or for which there is a greater likelihood of success.
- The increasing use of social media platforms presents new risks and challenges.
- We may not be successful in our efforts to build a pipeline of additional product candidates.
- If we do not achieve our projected development goals in the timeframes we announce and expect, the commercialization of our products may be delayed.
- Product liability lawsuits against us or any of our licensing and collaboration partners could divert our resources and attention, cause us to incur substantial liabilities and limit commercialization of VDPHL01 or any of our other current or future product candidates.
- Risks Related to Commercialization of Our Product Candidates
- We currently have limited marketing, sales or distribution infrastructure. If we are unable to fully develop our sales, marketing and distribution capability on our own or through collaborations with marketing partners, we may not be successful in commercializing our product candidates.
- Even if we obtain regulatory approval for VDPHL01 or any other product candidates, such products may fail to achieve market acceptance which would adversely affect our efforts to commercialize any such product successfully.
- If we fail to generate sufficient market acceptance of our product candidates, if approved, our ability to obtain an appropriate return on investment on such products will be impacted.
- The commercial opportunity for VDPHL01 and any of our other current or future product candidates we may develop may be smaller than we expect.
- Our strategy of focusing on the cash-pay healthcare market for VDPHL01 may limit our ability to increase sales or achieve profitability
- If we fail to effectively maintain, promote, and enhance our reputation and VDPHL01 brand recognition in a cost-effective manner, our business and competitive advantage may be harmed.
- Our products rely on consumer discretionary spending and the purchasing decisions of our customers, both of which are sensitive to difficult to predict global economic conditions, including the imposition of tariffs, or changes in consumer or customer sentiment.
- Coverage and reimbursement by third-party payors may not be available or may be difficult to obtain for any product candidates for which we receive marketing approval. Failure to obtain or maintain coverage and adequate reimbursement for any such approved products could limit our ability to market those products and would decrease our ability to generate revenue.
- Risks Related to Our Business Operations, Employee Matters and Managing Growth
- We are dependent on the services of our senior management and other key personnel, and if we are not able to retain these individuals or recruit additional management or key personnel, our business will suffer.
- We will need to grow our organization, and we may experience difficulties in managing our growth and expanding our operations, which could adversely affect our business.
- Misconduct or other improper actions, including noncompliance with regulatory standards and requirements, by our employees, independent contractors, consultants, commercial partners and vendors exposes us to potential noncompliance with regulatory standards and requirements.
- If our information technology systems or data, or those of third parties with whom we work, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions, litigation, fines and penalties, disruptions of our business operations, reputational harm, loss of revenue or profits and other adverse consequences.
- Risks Related to Our Intellectual Property
- Our commercial success depends on our ability to obtain and maintain sufficient intellectual property protection for VDPHL01 and our other current and any future product candidates and other 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.
- We may not be able to protect our intellectual property rights throughout the world.
- Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
- Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated as a result of noncompliance with these requirements.
- Patent terms may be inadequate to protect our competitive position on products or product candidates for an adequate amount of time.
- Patent rights relating to inventions described and claimed in our pending patent applications may not issue and patents based on our patent applications may be challenged and rendered invalid and/or unenforceable.
- Issued patents covering our product candidates, or the method of use of our product candidates, could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
- 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 VDPHL01 or any of our other current and any future product candidates.
- If we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing VDPHL01 or any of our other current and any future product candidates.
- We may be involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.
- VDPHL01, or any of our other current or future product candidates, may face competition sooner than expected, and our patents may be challenged.
- We may become subject to claims challenging the inventorship or ownership of our or our licensors’ patents and other intellectual property.
- If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
- If we fail to comply with our obligations under our intellectual property licenses with third parties, we could lose license rights that are important to our business.
- We may not be successful in obtaining or maintaining necessary rights to third party patents for our product candidates through acquisitions and in-licenses.
- Certain intellectual property which we have in-licensed may have been discovered through government funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for U.S. industry. Compliance with such regulations may limit our exclusive rights, and limit our ability to contract with non-U.S. manufacturers.
- Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
- Risks Related to Government Regulation
- The regulatory approval process is highly uncertain, and we may be unable to obtain, or may be delayed in obtaining, U.S. regulatory approval and, as a result, unable to commercialize our product candidates or any future product candidates. Even if we believe our current, or planned clinical trials are successful, regulatory authorities may not agree that they provide adequate data on safety or efficacy.
- Even if we receive regulatory approval for any of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal. We may also be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
- Disruptions at the FDA, SEC or comparable foreign regulatory authorities caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel necessary for the review, approval and commercialization of new products in a timely manner or otherwise prevent those authorities from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- If we fail to comply with broad and complex healthcare and other laws, we could face substantial penalties and our business, operations, and financial condition could be adversely affected.
- Legislative, regulatory, and executive healthcare and other reform initiatives aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.
- We are or may become subject to stringent and evolving U.S. and foreign laws, regulations, rules, contractual obligations, industry standards and policies related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse business consequences.
- We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations as well as U.S. and certain foreign export controls, trade sanctions, and import laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
- Risks Related to Our Dependence on Third Parties
- We have relied and expect to continue to rely on third parties to conduct our preclinical studies and clinical trials. If those third parties do not perform as contractually required, fail to satisfy legal or regulatory requirements, miss deadlines or terminate the relationship, our development programs could be delayed, more costly or unsuccessful, and we may never be able to seek or obtain regulatory approval for or commercialize our product candidates.
- If our third-party manufacturer of VDPHL01 is unable to increase the scale of its production or we are not able to qualify additional manufacturers, then commercialization may be delayed or interrupted.
- We depend on third-party suppliers for materials used in the manufacture of our product candidates, and the loss of these third-party suppliers or their inability to supply us with adequate materials could harm our business.
- The operations of our supplier for minoxidil API for VDPHL01 are located outside of the United States and are subject to additional risks that are beyond our control and that could harm our business, financial condition, results of operations and prospects.
- Risks associated with the in-licensing or acquisition of product candidates could cause substantial delays in the preclinical and clinical development of our product candidates.
- We may seek to enter into collaborations, licenses and other similar arrangements for VDPHL01 or any of our other current or future product candidates and may not be successful in doing so, and even if we are, we may relinquish valuable rights and may not realize the benefits of such relationships.
- Our reliance on third parties requires us to share our trade secrets, know-how and other proprietary information, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
- Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
- Risks Related to Ownership of Our Common Stock
- An active and liquid trading market for our common stock may not be sustained.
- The market price of our common stock may be volatile, which could result in substantial losses for investors.
- Our quarterly and annual operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts or any guidance we may publicly provide, each of which may cause our stock price to fluctuate or decline.
- A significant portion of our total outstanding shares are, as of the date of filing this Annual Report on Form 10-K, restricted from immediate resale but may be sold into the market upon expiration of the lock-up agreement entered into in connection with our IPO, which could cause the market price of our common stock to decline significantly, even if our business is doing well.
- Insiders have substantial influence over us, which could limit your ability to affect the outcome of key transactions, including a change of control.
- Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
- We are an “emerging growth company” and a “smaller reporting company,” and the reduced disclosure requirements applicable to emerging growth and smaller reporting companies may make our common stock less attractive to investors.
- Provisions in our restated certificate of incorporation, our amended and restated bylaws and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management.
- Our restated certificate of incorporation designates specific courts as the sole and exclusive forum for certain claims or causes of action that may be brought by our stockholders, which could discourage lawsuits against us and our directors and officers.
- If securities or industry analysts do not publish research or reports about our business, or if they publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
Legal proceedings
From time to time, we may become involved in litigation or other legal proceedings. We are not a party to any litigation or legal proceedings that, in the opinion of our management, are probable to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources, negative publicity and reputational harm and other factors.
The opening of Item 3, Legal Proceedings.3
Sources
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- 11SEC EDGARDavid Matthew Friedman, Board member
- 12SEC EDGARJane M. Grant-Kels, Board member
- 13SEC EDGARKatarina Pance, Board member
- 14SEC EDGARPatrick G. Enright, Board member
- 15SEC EDGARVlad Coric, Board member
- 16SEC EDGARAaron Cowen, Board member
- 17SEC EDGARMichael Greco V., General counsel
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- 28SEC EDGARBylaws or fiscal year changed
- 29NasdaqNasdaq calendar
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