ADGM on Nasdaq
Adagio Medical Holdings, Inc.
American surgical and medical instruments and apparatus company1
In its 2026 annual report the company says: “We are a medical device company focused on developing and commercializing products for the treatment of cardiac arrhythmias with our novel, proprietary, catheter-based Ultra-Low Temperature Ablation technology, formerly known as Ultra-Low Temperature Cryoablation technology. Our initial focus is on the treatment of ventricular tachycardia.”3 It is headquartered in Laguna Hills, California.1 Its shares trade on Nasdaq under the symbol ADGM.1
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Last updated Oct 21, 2026.
Overview
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- TickerADGM on Nasdaq1
- IndustrySurgical & Medical Instruments & Apparatus1
- HeadquartersLaguna Hills, California1
- Incorporated inDE2
- Business address26051 Merit Circle, Suite 102, Laguna Hills, Ca 926532
- Filer category, Emerging growth company2
- Legal formCorporation
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We are a medical device company focused on developing and commercializing products for the treatment of cardiac arrhythmias with our novel, proprietary, catheter-based Ultra-Low Temperature Ablation (“ULTA”) technology, formerly known as Ultra-Low Temperature Cryoablation (“ULTC”) technology. Our initial focus is on the treatment of ventricular tachycardia (“VT”). VT is a rapid, abnormal heart rhythm, or arrhythmia, that originates in the heart’s lower chambers, or ventricles, potentially leading to impaired blood flow and, if sustained, VT can be fatal. In the United States, VT-associated sudden cardiac death (“SCD”) accounts for approximately 300,000 deaths each year. Radio Frequency (“RF”) ablation catheters currently used to treat VT were primarily designed and approved for the treatment of atrial fibrillation (“AF”) and are therefore not designed to optimally treat the specifics of …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
Financial statements
Every line of the income statement as filed: the last 1 fiscal year, latest first.4
| Period ending | 2025-12-31 |
|---|---|
| Revenue | $0 |
| Cost of revenue | $684.0K |
| Research and development | $10.6M |
| Selling, general, and administrative | $10.6M |
| Impairment - Goodwill | $0 |
| Total cost of revenue and operating expenses | $21.9M |
| Loss from operations | -$21.9M |
| Interest expense | -$2.9M |
| Interest income | $477.0K |
| Other (expense) income, net | $195.0K |
| Total other (loss) income, net | -$3.2M |
| Net loss | -$25.1M |
| Foreign currency translation adjustment | -$100.0K |
| Comprehensive loss | -$25.2M |
| Basic net loss per share (in dollars per share) | -$1.51 |
| Diluted net loss per share (in dollars per share) | -$1.51 |
| Weighted-average shares outstanding - Basic (in shares) | 16.6M shares |
| Weighted-average shares outstanding - Diluted (in shares) | 16.6M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 4 fiscal years (annual) or 4 quarters (quarterly), latest first.4
| Period ending | 2025-12-31 | 2024-12-31 | 2024-07-31 | 2023-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $17.1M | $20.6M | ||
| Accounts receivable, net | $35.0K | |||
| Inventory, net | $1.7M | $2.6M | ||
| Prepaid expenses | $989.0K | $1.9M | ||
| Other current assets | $316.0K | $222.0K | ||
| Total current assets | $20.1M | $25.3M | ||
| Property and equipment, net | $1.5M | $2.0M | ||
| Right-of-use assets, net | $697.0K | $188.0K | ||
| Intangible assets, net | $7.0M | $7.0M | ||
| Goodwill, net | $14.0M | $14.0M | ||
| Other assets | $3.0K | $14.0K | ||
| Total assets | $43.3M | $48.4M | ||
| Accounts payable | $1.1M | $2.8M | ||
| Accrued liabilities | $7.0M | $3.7M | ||
| Operating lease liabilities, current | $155.0K | $143.0K | ||
| Other accrued liabilities | $1.1M | |||
| Total current liabilities | $8.2M | $7.8M | ||
| Operating lease liabilities, long-term | $563.0K | $46.0K | ||
| Convertible notes payable, net | $21.0M | $16.1M | ||
| Warrant liabilities | $132.0K | $152.0K | ||
| Deferred tax liabilities, net | $883.0K | $883.0K | ||
| Other long-term liabilities | $3.6M | |||
| Total liabilities | $30.9M | $28.5M | ||
| Common stock, $0.0001 par value; 210,000,000 shares authorized at December 31, 2025 and December 31, 2024; 22,210,459 and 15,198,232 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | $2.0K | $2.0K | ||
| Additional paid-in capital | $108.1M | $90.5M | ||
| Accumulated other comprehensive (loss) income | -$99.0K | $1.0K | ||
| Accumulated deficit | -$95.6M | -$70.6M | ||
| Total stockholders' equity | $12.4M | $19.9M | $73.0M | -$132.0M |
| Total liabilities and stockholders' equity | $43.3M | $48.4M | ||
| Common stock, par value (in dollars per share) | $0.00 | $0.00 | $0.00 | |
| Common stock, shares authorized | 210.0M shares | 210.0M shares | 6.6M shares | |
| Common stock, shares issued | 22.2M shares | 15.2M shares | 786.5K shares | |
| Common stock, shares outstanding | 22.2M shares | 15.2M shares | 779.9K shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2024-07-31 | 2023-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $17.1M | $20.6M | ||
| Accounts receivable, net | $35.0K | |||
| Inventory, net | $1.7M | $2.6M | ||
| Prepaid expenses | $989.0K | $1.9M | ||
| Other current assets | $316.0K | $222.0K | ||
| Total current assets | $20.1M | $25.3M | ||
| Property and equipment, net | $1.5M | $2.0M | ||
| Right-of-use assets, net | $697.0K | $188.0K | ||
| Intangible assets, net | $7.0M | $7.0M | ||
| Goodwill, net | $14.0M | $14.0M | ||
| Other assets | $3.0K | $14.0K | ||
| Total assets | $43.3M | $48.4M | ||
| Accounts payable | $1.1M | $2.8M | ||
| Accrued liabilities | $7.0M | $3.7M | ||
| Operating lease liabilities, current | $155.0K | $143.0K | ||
| Other accrued liabilities | $1.1M | |||
| Total current liabilities | $8.2M | $7.8M | ||
| Operating lease liabilities, long-term | $563.0K | $46.0K | ||
| Convertible notes payable, net | $21.0M | $16.1M | ||
| Warrant liabilities | $132.0K | $152.0K | ||
| Deferred tax liabilities, net | $883.0K | $883.0K | ||
| Other long-term liabilities | $3.6M | |||
| Total liabilities | $30.9M | $28.5M | ||
| Common stock, $0.0001 par value; 210,000,000 shares authorized at December 31, 2025 and December 31, 2024; 22,210,459 and 15,198,232 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | $2.0K | $2.0K | ||
| Additional paid-in capital | $108.1M | $90.5M | ||
| Accumulated other comprehensive (loss) income | -$99.0K | $1.0K | ||
| Accumulated deficit | -$95.6M | -$70.6M | ||
| Total stockholders' equity | $12.4M | $19.9M | $73.0M | -$132.0M |
| Total liabilities and stockholders' equity | $43.3M | $48.4M | ||
| Common stock, par value (in dollars per share) | $0.00 | $0.00 | $0.00 | |
| Common stock, shares authorized | 210.0M shares | 210.0M shares | 6.6M shares | |
| Common stock, shares issued | 22.2M shares | 15.2M shares | 786.5K shares | |
| Common stock, shares outstanding | 22.2M shares | 15.2M shares | 779.9K 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 1 fiscal year, latest first.4
| Period ending | 2025-12-31 |
|---|---|
| Net loss | -$25.1M |
| Depreciation and amortization | $970.0K |
| Stock-based compensation | $1.5M |
| Impairment - Goodwill | $0 |
| Change in fair value of convertible notes payable | $980.0K |
| Change in fair value of warrant liabilities | -$20.0K |
| Accounts receivable, net | $38.0K |
| Inventory, net | $931.0K |
| Prepaid expenses and other current assets | $867.0K |
| Accounts payable | -$1.8M |
| Accrued liabilities | $3.3M |
| Other accrued liabilities | $2.9M |
| Operating lease liabilities | $20.0K |
| Other long-term liabilities | -$3.6M |
| Net cash used in operating activities | -$19.0M |
| Purchases of property and equipment | -$374.0K |
| Net cash used in investing activities | -$374.0K |
| Proceeds from the issuance of common shares, pre-funded warrants and warrants, net of $2,865 issuance costs | $16.1M |
| Net cash provided by financing activities | $16.1M |
| Effect of foreign currency translation on cash and cash equivalents | -$227.0K |
| Net change in cash and cash equivalents | -$3.5M |
| Issuance of common shares, pre-funded warrants and warrants issuance costs | $2.9M |
No quarter-by-quarter statement was filed.
Corporate structure
Adagio Medical Holdings, 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 Adagio Medical Holdings, Inc.
- ADAR1 Capital Management, LLC Filed SCHEDULE 13G/A on Adagio Medical Holdings, Inc., latest Aug 14, 2026 (2 filings since Feb 17, 2026)
- Sio Capital Management, LLC Filed SCHEDULE 13G/A on Adagio Medical Holdings, Inc., latest Jul 28, 2026 (2 filings since Feb 11, 2026)
- PERCEPTIVE ADVISORS LLC Filed SCHEDULE 13G/A on Adagio Medical Holdings, Inc., latest May 15, 2026 (4 filings since Nov 13, 2024)
- Adage Capital Management, L.P. Filed SCHEDULE 13G/A on Adagio Medical Holdings, Inc., latest May 13, 2026 (3 filings since Aug 12, 2025)
- Alyeska Investment Group, L.P. Filed SCHEDULE 13G on Adagio Medical Holdings, Inc., latest Feb 17, 2026
- RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on Adagio Medical Holdings, Inc., latest Aug 26, 2025 (5 filings since Aug 12, 2024)
- Adagio Medical Holdings, Inc. Laguna Hills, California
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Adagio Medical 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
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $4.2M4 Dec 31, 2025 | $4.7M4 Dec 31, 2024 | −10.8% |
| Accumulated depreciation | $2.6M4 Dec 31, 2025 | $2.7M4 Dec 31, 2024 | −3.0% |
| Property and equipment, net | $1.5M4 Dec 31, 2025 | $2.0M4 Dec 31, 2024 | −21.7% |
| Operating-lease assets (leased space) | $697.0K4 Dec 31, 2025 | $188.0K4 Dec 31, 2024 | +270.7% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $17.1M4 Dec 31, 2025 | $20.6M4 Dec 31, 2024 | −16.9% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Goodwill | $14.0M4 Dec 31, 2025 | $14.0M4 Dec 31, 2024 | 0% |
| Intangible assets, net (excluding goodwill) | $7.0M4 Dec 31, 2025 | $7.0M4 Dec 31, 2024 | 0% |
| Indefinite-lived intangibles (excluding goodwill) | $7.0M4 Dec 31, 2024 | ||
| Finite-lived intangibles, gross | $4.1M4 Dec 31, 2024 | ||
| Accumulated amortization | $353.0K4 Dec 31, 2024 |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $1.7M4 Dec 31, 2025 | $2.6M4 Dec 31, 2024 | −34.8% |
| Raw materials | $1.4M4 Dec 31, 2025 | $1.7M4 Dec 31, 2024 | −15.4% |
| Work in process | $163.0K4 Dec 31, 2025 | $388.0K4 Dec 31, 2024 | −58.0% |
| Finished goods | $86.0K4 Dec 31, 2025 | $495.0K4 Dec 31, 2024 | −82.6% |
Properties, in its own words
Our corporate headquarters and manufacturing, storage and distribution centers for our catheters and consoles are located at Laguna Hills, California. We lease approximately 12,000 square feet, which includes clean room space, under an operating lease that expires in January 2030.
We do not own any real property and believe that our current facilities are sufficient to support our operations and growth plans and that, additional space, if needed, will be available on commercially reasonably terms.
Item 2 of the 10-K filed Mar 27, 2026.3
Leadership
Who has led Adagio Medical Holdings, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chair
Chief financial officer
Chief operating officer
- Chief executive officerOlav Bergheim Aug 1, 2024 to Aug 2, 20248
- Chief executive officerTodd Usen Dec 20, 2024 to now9
- ChairOlav Bergheim Aug 1, 2024 to Aug 1, 20248
- Chief financial officerDan George Apr 28, 2025 to Sep 30, 202510
- Chief financial officerDeborah Kaster Sep 30, 2025 to now11
- Chief financial officerJohn T. Dahldorf Aug 1, 2024 to Aug 1, 202412
- Chief operating officerHakon Bergheim Aug 1, 2024 to Aug 2, 202413
Board members and other officers (10)
- Board memberJoseph Edelman Feb 14, 2025 to now14
- Board memberSean Salmon Dec 11, 2025 to now15
- Board memberJames L. Cox Aug 1, 2024 to now16
- Board memberKeyvan Mirsaeedi-Farahani Aug 1, 2024 to now17
- Board memberOrly Mishan Aug 1, 2024 to now18
- Board memberSandra Gardiner Aug 1, 2024 to now19
- Board memberShahram Moaddeb Aug 1, 2024 to Aug 1, 202420
- Board memberTimothy P. Moran Aug 1, 2024 to now21
- Board memberOlav Bergheim Aug 2, 2024 to Aug 2, 202422
- Board memberTodd Usen Dec 20, 2024 to now9
Former names
- Aja Holdco, Inc.Feb 14, 2024 to Aug 1, 20242
Timeline
- Oct 1, 20268-K Unregistered sale of shares23
- Sep 23, 20268-K Exit or restructuring costs; Other events24
- Aug 14, 20268-K Listing notice or transfer25
- Aug 13, 20268-K Regulation FD disclosure26
- Aug 11, 20268-K Results of operations27
- Jun 16, 20268-K Shareholder vote28
- Jun 12, 20268-K Listing notice or transfer29
- May 21, 20268-K Other events30
- May 12, 20268-K Results of operations31
- Apr 27, 20268-K Other events32
- Apr 20, 20268-K Director nominations33
- Apr 8, 20268-K Other events34
- Dec 20, 2024New chief executive Todd Usen becomes CEO9
- Aug 1, 2024New chief executive Olav Bergheim becomes CEO8
Calendar
Coming up
- Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.66) a share, on Nov 12, 2025.35
When it reported results
- Aug 11, 2026Reported quarterly or annual results27
- May 12, 2026Reported quarterly or annual results31
- Mar 27, 2026Reported quarterly or annual results36
- Nov 12, 2025Reported quarterly or annual results37
- Aug 13, 2025Reported quarterly or annual results38
- May 15, 2025Reported quarterly or annual results39
- Apr 2, 2025Reported quarterly or annual results40
- Nov 14, 2024Reported quarterly or annual results41
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
232 filings to the SEC since October 2021: 4 annual reports, 7 quarterly reports, 39 major events, 39 insider forms, 17 large holders, 1 private raises, 125 other. The latest 20:
- Oct 13, 20264 EDGAR
- Oct 13, 2026DEF 14A EDGAR
- Oct 1, 2026PRE 14A EDGAR
- Oct 1, 20268-K EDGAR
- Sep 23, 20268-K EDGAR
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Aug 14, 20268-K EDGAR
- Aug 13, 20268-K EDGAR
- Aug 12, 20264 EDGAR
- Aug 12, 20264 EDGAR
- Aug 12, 20264 EDGAR
- Aug 12, 20264 EDGAR
- Aug 12, 20264 EDGAR
- Aug 12, 20264 EDGAR
- Aug 11, 20268-K EDGAR
- Aug 11, 202610-Q EDGAR
- Jul 28, 2026SCHEDULE 13G/A EDGAR
- Jul 13, 202610-K/A EDGAR
- Jun 16, 20268-K EDGAR
- Jun 12, 20268-K EDGAR
The 232 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
2 open-market trades by officers, directors and large owners since October 2021: 2 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Dec 16, 2025 | Kaster DeborahChief Financial Officer | Buy | 15,000 | $1.20 | $18.0K | Form 4 |
| Dec 12, 2025 | Usen ToddChief Executive Officer | Buy | 207,315 | $1.09 | $226.0K | 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.
- ADAR1 Capital Management, LLCSCHEDULE 13G/A, 2 filings Feb 17, 2026 to Aug 14, 202642
- Sio Capital Management, LLCSCHEDULE 13G/A, 2 filings Feb 11, 2026 to Jul 28, 202643
- PERCEPTIVE ADVISORS LLCSCHEDULE 13G/A, 4 filings Nov 13, 2024 to May 15, 202644
- Adage Capital Management, L.P.SCHEDULE 13G/A, 3 filings Aug 12, 2025 to May 13, 202645
- Alyeska Investment Group, L.P.SCHEDULE 13G, 1 filing Feb 17, 202646
- RA CAPITAL MANAGEMENT, L.P.SCHEDULE 13G/A, 5 filings Aug 12, 2024 to Aug 26, 202547
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) $19.0M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2025 | $19.0M | $19.0M |
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.
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.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Perceptive Advisors LLC | 9,876,586 | $6.4M | 0.1% | +10 |
| Adage Capital Partners Gp, L.l.c. | 1,258,501 | $820.0K | 0.0% | No change |
| ADAR1 Capital Management, LLC | 1,205,447 | $785.5K | 0.0% | No change |
| Alyeska Investment Group, L.P. | 1,159,615 | $755.6K | 0.0% | No change |
| Sio Capital Management, LLC | 698,989 | $455.5K | 0.1% | −589,472 |
| Silverarc Capital Management, LLC | 224,360 | $146.2K | 0.0% | −27,612 |
| Shaolin Capital Management LLC | 171,170 | $111.5K | 0.0% | No change |
| Vanguard Capital Management LLC | 108,954 | $71.0K | 0.0% | +69,346 |
| Affinity Asset Advisors, LLC | 80,000 | $52.1K | 0.0% | No change |
| Geode Capital Management, LLC | 79,115 | $51.5K | 0.0% | −46,126 |
| Vanguard Fiduciary Trust Co | 53,782 | $35.1K | 0.0% | No change |
| Northern Trust Corp | 30,875 | $20.1K | 0.0% | +9,277 |
| Toronto Dominion Bank | 25,000 | $16.3K | 0.0% | No change |
| Opaleye Management Inc. | 18,444 | $13.4K | 0.0% | No change |
| XTX Topco Ltd | 18,153 | $11.8K | 0.0% | −5,197 |
| Citadel Advisors LLC | 16,155 | $10.5K | 0.0% | New |
| Citigroup Inc | 13,255 | $8.6K | 0.0% | +13,254 |
| Bank Of America Corp /de/ | 11,531 | $7.5K | 0.0% | −1,326 |
| Tower Research Capital LLC (TRC) | 6,454 | $4.2K | 0.0% | +4,252 |
| UBS Group AG | 2,268 | $1.5K | 0.0% | New |
| Crewe Advisors LLC | 500 | $326 | 0.0% | No change |
| Morgan Stanley | 137 | $89 | 0.0% | No change |
| Barclays PLC | 23 | $15 | 0.0% | New |
| Hrt Financial LP | 13,705 | $8 | 0.0% | New |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Adagio Medical 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 EDGARAdagio Medical Holdings, Inc.1
- CIK0002006986
- Employer ID (EIN)99-11514663
- 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)3841 Surgical & Medical Instruments & Apparatus1
- SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
- Business address26051 Merit Circle, Suite 102, Laguna Hills, CA 926531
- Phone(949) 348-11881
- Shares outstanding22,210,459 as of Aug 10, 20267
- Public float$7.0M as of Jun 30, 20253
- AuditorWithumSmith+Brown, PC, Whippany, New Jersey PCAOB ID 100; it also attests to the company’s internal control over financial reporting3
- On EDGAR sinceFeb 14, 20241
- Filings232 in all: 424B3 (54), 8-K (37), 4 (24), 3 (15), SCHEDULE 13G/A (11), 425 (10), CORRESP (10), EFFECT (10)1
All 31 form types
POS AM (8), UPLOAD (8), 10-Q (7), S-1 (4), SCHEDULE 13G (4), DEF 14A (3), S-4/A (3), S-8 (3), 10-K (2), 10-K/A (2), 8-K/A (2), ARS (2), S-1/A (2), SC 13G (2), 8-A12B (1), CERT (1), D (1), DEFA14A (1), DRS (1), PRE 14A (1), S-3 (1), S-4 (1), S-8 POS (1)
- Latest filingsAnnual report (10-K) Mar 27, 2026
Quarterly report (10-Q) Aug 11, 2026
Proxy statement (DEF 14A) Oct 13, 2026
Latest 8-K (8-K) Oct 1, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001per share | ADGM | The Nasdaq Stock Market LLC |
From the cover page of the 10-K filed Mar 27, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Adagio Medical Holdings, Inc. names in Item 1A of its 10-K filed Mar 27, 2026: 72 risks under these headings, as written.3
- Risks Related to Our Business
- We are a medical device company that has incurred net losses in every period to date and expect to continue to incur significant losses as we develop our business, and our financial conditions raise substantial doubt about our ability to continue as a going concern.
- We have a limited operating history and no history of commercializing products, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability.
- We may need to raise additional capital to fund our development and commercialization plans.
- Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
- Changes in our business strategy or restructuring of our businesses may increase our costs or otherwise affect the profitability of our businesses or the value of our assets.
- Our growth and revenue prospects partially depend on our ability to accelerate the commercialization of our products and to capitalize on market opportunities.
- Our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
- There is no assurance that we will be able to execute on our business model, including achieving market acceptance of our products.
- The size of the markets for our products may be smaller than estimated, limiting our ability to successfully sell our products.
- If we or the third parties with whom we work experience disruption in our information technology systems, data, or security incidents, our business could be adversely affected, including our ability to operate, the loss of confidential and proprietary information, increased remediation costs, and reputational damage.
- We may be unable to manage our anticipated growth effectively.
The other 61 risks
- We may acquire other companies or technologies, or form strategic partnerships with other companies, which could divert our management’s attention, increase our capital requirements, and otherwise disrupt our operations, subject us to other risks and harm our operating results.
- If we are unable to recruit and retain key executives and scientists, we may be unable to achieve our goals.
- Consolidation in the medical device industry could have an adverse effect on our revenue and results of operations.
- Unfavorable U.S. or global economic conditions as a result of a pandemic, political instability, natural disasters, or otherwise, could adversely affect our ability to raise capital and our business, financial condition and results of operations.
- If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our results of operation could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of common stock.
- If our facilities become unavailable or inoperable, our research and development program and commercialization launch plan could be adversely affected, which could materially and adversely impact our business, financial condition and results of operations.
- We use hazardous chemicals and biological materials in our business. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly.
- International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
- Our corporate prioritization initiative may not achieve our intended outcome and may result in significant adverse consequences.
- Risks Related to our Products
- If our clinical trials are unsuccessful or significantly delayed, or if we do not complete our clinical trials, our business may be harmed.
- We have limited data and experience regarding the safety and efficacy of our products. Results of earlier trials may not be predictive of future clinical trial results, and planned trials may not establish an adequate safety or efficacy profile for such products and other planned or future products, which would affect market acceptance of these products.
- We may not be successful in the commercialization of our products, if approved, if we fail to establish relationships and successfully collaborate with leading life science companies and research institutions or if we are unable to establish effective distribution channels and sales and marketing functions.
- Our products may not be successful if there is inadequate physician training, practice and patient selection.
- The life sciences industry is highly competitive. Even if our products are commercialized and achieve broad scientific and market acceptance, if we fail to improve them or introduce compelling new products, our revenue and our prospects could be harmed.
- If we are unable to establish manufacturing capacity by ourselves or with third-party partners in a timely and cost-effective manner, commercialization of our products would be delayed, which would result in lost revenue and harm our business.
- We are dependent on limited third-party suppliers and manufacturers for some of the components and materials used in our products, and so long as we remain dependent on them, the loss of any of these suppliers and manufacturers, or any difficulties encountered by these suppliers and manufacturers in the production of our products, could harm our business.
- Our products could have unknown defects or errors, which may give rise to claims against us and adversely affect market adoption of our products.
- A breakthrough device designation by the FDA for vCLASTM may not lead to a faster development, regulatory review or approval process, and it may not increase the likelihood that vCLASTM will receive premarket approval (“PMA”) approval from the FDA.
- Risks Related to Our Intellectual Property
- If we are unable to obtain and maintain sufficient intellectual property protection for our products and technology, or if the scope of the intellectual property protection obtained is not sufficiently broad, competitors could develop and commercialize products similar or identical to our products, and our ability to successfully commercialize our products may be impaired.
- The U.S. law relating to the patentability of certain inventions in the life sciences technology industry is uncertain and rapidly changing, which may adversely impact our existing patents or our ability to obtain patents in the future.
- We may not be able to protect our intellectual property rights throughout the world, which could harm our business prospects.
- We may become involved in lawsuits to defend against third-party claims of infringement, misappropriation or other violations of intellectual property or to protect or enforce our intellectual property, any of which could be expensive, time consuming and unsuccessful, and may prevent or delay our development and commercialization efforts.
- Issued patents covering our products could be found invalid or unenforceable if challenged, and could materially impact our business.
- If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected, and our business could be harmed.
- We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property, which could have a material adverse effect on our business.
- We may not be able to protect and enforce our trademarks and trade names or build name recognition in our markets of interest thereby harming our competitive position, which could have a material adverse effect on our business.
- Patent terms may be inadequate to protect our competitive position of our products for an adequate amount of time and may adversely affect our business.
- Obtaining and maintaining our patent protection depends on compliance with various required procedures, document submissions, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements, which could have a material adverse effect on
- our business.
- We may be subject to claims that our employees, consultants, independent contractors or any third parties that have access to our confidential information or trade secrets have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed trade secrets of their former employers, which could have a material adverse effect on our business.
- If we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the futured and thus materially harm our business.
- Our use of open-source software and failure to comply with the terms of the underlying open-source software licenses could impose limitations on our ability to commercialize our products and provide third parties access to our proprietary software, which could have a material adverse effect on our business.
- Intellectual property rights do not necessarily address all potential threats, and such risk could have a material adverse effect on our business.
- Risks Related to Regulatory and Legal Compliance Matters
- We expect to incur substantial expenses in our pursuit of regulatory clearances and approvals for our products in the United States and can provide no assurances that we will obtain the necessary approvals from the FDA to market our products in the United States.
- We may be subject to enforcement action if we engage in improper or off-label marketing or promotion of our products, including significant legal liability, fines, penalties, and injunctions, which could materially and adversely affect our business, financial condition, and results of operations.
- Disruptions at the FDA, the SEC and other government agencies and regulatory authorities caused by funding shortages or global health concerns 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.
- Adverse findings in post-marketing vigilance or regulatory audits could subject us to suspension or withdrawal of our certificates of conformity, mandatory product recalls and significant legal liability, which could materially and adversely affect our business, financial condition, and results of operations.
- We may be subject to enforcement action if we engage in marketing of our products pursuant to improper regulatory classifications in the EU, including suspension or withdrawal of our certificates of conformity, mandatory product recalls and significant legal liability, fines, penalties, and injunctions, which could materially and adversely affect our business, financial condition and results of operations.
- We and the third parties with whom we work are currently subject to, and may in the future become subject to evolving, U.S. federal and state laws, regulations, contractual obligations, industry standards, and other obligations related to data privacy and security. Our (or the third parties with whom we work) actual or perceived failure to comply with such obligations could harm our business. Ensuring compliance with such laws could also impair our efforts to maintain and expand our future customer base and thereby decrease our revenue.
- 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.
- We are or will be subject to anti-corruption and anti-bribery and anti-money laundering and similar laws, and non-compliance with such laws can subject us to administrative, civil and criminal fines and penalties, collateral consequences, remedial measures and legal expenses, all of which could adversely affect our reputation, business, financial condition and results of operations.
- Our employees, independent contractors, consultants, commercial partners, distributors and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- Recently enacted and future legislation may increase the difficulty and cost for us to commercialize our products and obtain marketing approval of our product candidates and may affect the prices we may obtain.
- Risks Related to Litigation and Regulation
- We are subject to extensive laws and regulations of the United States and foreign regulatory agencies that could impose substantial costs, legal prohibitions and restrictions, or unfavorable changes upon our operations, and any failure to comply with these laws and regulations, including as they evolve, could delay or entirely prevent the commercialization of our products or result in litigation and substantially harm our business and results of operations.
- We are subject to risks relating to disputes and other legal proceedings, product liability lawsuits, that may be time consuming and costly.
- We are subject to laws and regulations governing export and import controls, sanctions and embargoes. We could face liability and other serious consequences for violations which can harm our business.
- Risks Related to Financing Transactions
- There are risks associated with our Convertible Securities Notes that could adversely affect our business and financial condition.
- We are subject to risks relating to increased interest rates and any adverse developments in the credit markets.
- Risks Related to Tax
- Our ability to use net operating loss (“NOL”) carryforwards and other tax attributes may be limited as a result of the Business Combination or other ownership changes.
- A new 1% U.S. federal excise tax could be imposed on us in connection with redemptions by us of our stock.
- Unanticipated tax laws or any changes in tax rates or in the application of the existing tax laws to us may adversely impact our results of operations.
- Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits.
- Risks Related to Ownership of Our Securities
- The Perceptive PIPE Investor has control over key decision making as a result of its control of a majority of the voting power of our outstanding common stock.
- We may use our financial resources in ways with which you do not agree and in ways that may not yield a favorable return.
- We are an “emerging growth company” and “smaller reporting company” within the meaning of the Securities Act and if we take advantage of certain exemptions from disclosure requirements available to emerging growth companies, it could make our securities less attractive to investors and may make it more difficult to compare our performance to the performance of other public companies.
- Our stock price may be volatile and may decline regardless of our operating performance.
- We may be unable to maintain the listing of our securities on Nasdaq in the future.
- An active trading market for our common stock may not be sustained.
- Sales of a substantial number of shares of our common stock in the public market could cause the market price of our common stock to drop significantly, even if our business is doing well.
- We may issue additional shares of common stock or other equity securities without your approval, which would dilute your ownership interests and may depress the market price of the common stock.
- If securities or industry analysts either do not publish research about us or publish inaccurate or unfavorable research about us, our business or our market, or if they adversely change their recommendations regarding our common stock, the trading price or trading volume of our common stock could decline.
Legal proceedings
From time to time, we may become involved in various claims and legal proceedings. Regardless of outcome, litigation and other legal and administrative proceedings can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. We are currently not a party to any legal proceedings, the outcome of which, if determined adversely to us, would individually or in the aggregate have a material adverse effect on our business, financial condition, and results of operations.
The opening of Item 3, Legal Proceedings.3
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 9SEC EDGARTodd Usen, Chief executive officer
- 10SEC EDGARDan George, Chief financial officer
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- 14SEC EDGARJoseph Edelman, Board member
- 15SEC EDGARSean Salmon, Board member
- 16SEC EDGARJames L. Cox, Board member
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- 18SEC EDGAROrly Mishan, Board member
- 19SEC EDGARSandra Gardiner, Board member
- 20SEC EDGARShahram Moaddeb, Board member
- 21SEC EDGARTimothy P. Moran, Board member
- 22SEC EDGAROlav Bergheim, Board member
- 23SEC EDGARUnregistered sale of shares
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- 25SEC EDGARListing notice or transfer
- 26SEC EDGARRegulation FD disclosure
- 27SEC EDGARResults of operations
- 28SEC EDGARShareholder vote
- 29SEC EDGARListing notice or transfer
- 30SEC EDGAROther events
- 31SEC EDGARResults of operations
- 32SEC EDGAROther events
- 33SEC EDGARDirector nominations
- 34SEC EDGAROther events
- 35NasdaqNasdaq calendar
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