MTVA on Nasdaq
MetaVia Inc.
In its 2026 annual report the company says: “We are a clinical-stage biotechnology company focused primarily on developing novel pharmaceuticals to treat cardiometabolic diseases. We have two programs focused primarily on the treatment of metabolic dysfunction-associated steatohepatitis and obesity.”3 It is headquartered in Cambridge, Massachusetts.1 Its shares trade on Nasdaq under the symbol MTVA.1
Price unavailable
Last updated Oct 21, 2026.
Overview
- TickerMTVA on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersCambridge, Massachusetts1
- Incorporated inDE2
- Business address545 Concord Avenue, Suite 210, Cambridge, Ma 021382
- Filer categoryNon-accelerated filer, Smaller reporting company2
- Legal formCorporation
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We are a clinical-stage biotechnology company focused primarily on developing novel pharmaceuticals to treat cardiometabolic diseases. We have two programs focused primarily on the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and obesity.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.9
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development | $6.8M | $21.6M |
| General and administrative | $6.9M | $7.3M |
| Total operating expenses | $13.7M | $28.8M |
| Loss from operations | -$13.7M | -$28.8M |
| Gain from change in fair value of warrant liabilities | $225.0K | $297.0K |
| Interest income, net | $510.0K | $920.0K |
| Total other income | $735.0K | $1.2M |
| Loss before income taxes | -$13.0M | -$27.6M |
| Provision for income taxes | $0 | $0 |
| Net loss | -$13.0M | -$27.6M |
| Loss per share of common stock, basic (in dollars per share) | -$7.35 | -$39.13 |
| Loss per share of common stock, diluted (in dollars per share) | -$7.35 | -$39.13 |
| Weighted average shares of common stock, basic (in shares) | 1.8M shares | 705.2K shares |
| Weighted average shares of common stock, diluted (in shares) | 1.8M shares | 705.2K shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.9
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $10.3M | $16.0M | |
| Prepaid expenses and other current assets | $597.0K | $55.0K | |
| Total current assets | $10.9M | $16.1M | |
| Property and equipment, net | $17.0K | $34.0K | |
| Right-of-use asset | $210.0K | $133.0K | |
| Other assets | $21.0K | $21.0K | |
| Total assets | $11.1M | $16.3M | |
| Accounts payable | $1.1M | $3.9M | |
| Clinical trial accrued liabilities | $79.0K | $1.7M | |
| Accrued expenses and other current liabilities | $993.0K | $785.0K | |
| Warrant liabilities | $136.0K | $361.0K | $658.0K |
| Related party payable | $3.3M | $1.5M | |
| Lease liability, short-term | $68.0K | $78.0K | |
| Total current liabilities | $5.6M | $8.3M | |
| Lease liability, long-term | $142.0K | $58.0K | |
| Total liabilities | $5.8M | $8.3M | |
| Common stock, $0.001 par value per share, 100,000,000 shares authorized as of December 31, 2025 and 2024; 2,308,294 and 785,194 shares issued and outstanding as of December 31, 2025 and 2024, respectively | $2.0K | $1.0K | |
| Additional paid-in capital | $154.2M | $143.8M | |
| Accumulated deficit | -$148.8M | -$135.9M | |
| Total stockholders' equity | $5.3M | $7.9M | $16.7M |
| Total liabilities and stockholders' equity | $11.1M | $16.3M | |
| Preferred stock, par value (in dollars per share) | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 10.0M shares | 10.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value (in dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized | 100.0M shares | 100.0M shares | |
| Common stock, shares issued | 2.3M shares | 785.2K shares | |
| Common stock, shares outstanding | 2.3M shares | 785.2K shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $10.3M | $16.0M | |
| Prepaid expenses and other current assets | $597.0K | $55.0K | |
| Total current assets | $10.9M | $16.1M | |
| Property and equipment, net | $17.0K | $34.0K | |
| Right-of-use asset | $210.0K | $133.0K | |
| Other assets | $21.0K | $21.0K | |
| Total assets | $11.1M | $16.3M | |
| Accounts payable | $1.1M | $3.9M | |
| Clinical trial accrued liabilities | $79.0K | $1.7M | |
| Accrued expenses and other current liabilities | $993.0K | $785.0K | |
| Warrant liabilities | $136.0K | $361.0K | $658.0K |
| Related party payable | $3.3M | $1.5M | |
| Lease liability, short-term | $68.0K | $78.0K | |
| Total current liabilities | $5.6M | $8.3M | |
| Lease liability, long-term | $142.0K | $58.0K | |
| Total liabilities | $5.8M | $8.3M | |
| Common stock, $0.001 par value per share, 100,000,000 shares authorized as of December 31, 2025 and 2024; 2,308,294 and 785,194 shares issued and outstanding as of December 31, 2025 and 2024, respectively | $2.0K | $1.0K | |
| Additional paid-in capital | $154.2M | $143.8M | |
| Accumulated deficit | -$148.8M | -$135.9M | |
| Total stockholders' equity | $5.3M | $7.9M | $16.7M |
| Total liabilities and stockholders' equity | $11.1M | $16.3M | |
| Preferred stock, par value (in dollars per share) | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 10.0M shares | 10.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value (in dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized | 100.0M shares | 100.0M shares | |
| Common stock, shares issued | 2.3M shares | 785.2K shares | |
| Common stock, shares outstanding | 2.3M shares | 785.2K 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.9
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$13.0M | -$27.6M |
| Stock-based compensation | $411.0K | $538.0K |
| Non-cash lease (credit) charge | -$3.0K | $4.0K |
| Depreciation | $19.0K | $20.0K |
| Gain from change in fair value of warrant liabilities | -$225.0K | -$297.0K |
| Prepaid expenses and other assets | -$542.0K | $20.0K |
| Accounts payable | -$2.8M | $3.1M |
| Accrued and other liabilities | $431.0K | -$461.0K |
| Net cash used in operating activities | -$15.7M | -$24.7M |
| Purchases of property and equipment | -$2.0K | -$8.0K |
| Net cash used in investing activities | -$2.0K | -$8.0K |
| Proceeds from the issuance of common stock and warrants under the securities purchase agreements from a private placement offering | $10.0M | $20.0M |
| Proceeds from exercise of warrants | $6.0K | $1.0K |
| Payment of employee withholding taxes related to shares withheld from issuance for vested restricted stock units | -$12.0K | -$48.0K |
| Net cash provided by financing activities | $10.0M | $18.3M |
| Net decrease in cash and cash equivalents | -$5.7M | -$6.4M |
| Fair value of warrants issued to placement agent | $309.0K | |
| Right-of-use assets obtained in exchange for operating lease liabilities | $152.0K |
No quarter-by-quarter statement was filed.
Corporate structure
MetaVia 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 MetaVia Inc.
- Alyeska Investment Group, L.P. Filed SCHEDULE 13G on MetaVia Inc., latest May 15, 2026
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on MetaVia Inc., latest Aug 14, 2025 (4 filings since Nov 14, 2024)
- DONG-A ST CO., LTD Filed SCHEDULE 13D/A on MetaVia Inc., latest May 20, 2025 (6 filings since Sep 16, 2022)
- Strategic Risk, LLC. Filed SC 13G on MetaVia Inc., latest Mar 28, 2023
- Altium Capital Management LLC Filed SC 13G/A on MetaVia Inc., latest Feb 14, 2023 (2 filings since Nov 17, 2022)
- JK BioPharma Solutions, Inc Filed SC 13D/A on MetaVia Inc., latest Sep 23, 2022 (2 filings since Nov 10, 2021)
- E&Investment, Inc. Filed SC 13D/A on MetaVia Inc., latest Aug 5, 2022
- MetaVia Inc. Cambridge, Massachusetts
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What MetaVia 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 | $90.0K9 Dec 31, 2025 | $88.0K9 Dec 31, 2024 | +2.3% |
| Accumulated depreciation | $73.0K9 Dec 31, 2025 | $54.0K9 Dec 31, 2024 | +35.2% |
| Property and equipment, net | $17.0K9 Dec 31, 2025 | $34.0K9 Dec 31, 2024 | −50.0% |
| Operating-lease assets (leased space) | $210.0K9 Dec 31, 2025 | $133.0K9 Dec 31, 2024 | +57.9% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $10.3M9 Dec 31, 2025 | $16.0M9 Dec 31, 2024 | −35.8% |
Properties, in its own words
We currently lease 2,441 square feet of office space in Cambridge, Massachusetts, as our corporate headquarters. The initial lease term is for three years with an option, which was exercised in November 2025, to renew for an additional two-year term. The lease commenced in September 2023 and expires in August 2028.
We believe that our leased properties are adequate for our purposes and to pursue our strategy.
Item 2 of the 10-K filed Mar 26, 2026.3
Leadership
Who has led MetaVia Inc., and when. Pick a name to see everywhere that person has worked.
Chief financial officer
Chief operating officer
- Chief executive officerJoseph Hooker Jan 18, 2023 to Jan 18, 202312
- Chief executive officerBen Gil Price Nov 4, 2021 to Nov 4, 202113
- Chief executive officerSteven R. Ph.d. Gullans May 31, 2017 to Jul 26, 201914
- Chief executive officerMina Sooch Aug 4, 2016 to Nov 29, 201615
- ChairCharles Bisgaier Phd. Aug 4, 2016 to Jul 26, 201916
- PresidentJoseph Hooker Jan 18, 2023 to Jan 18, 202312
- PresidentBen Gil Price Nov 4, 2021 to Nov 4, 202113
- PresidentSteven R. Ph.d. Gullans May 31, 2017 to Jul 26, 201914
- PresidentMina Sooch Aug 4, 2016 to Nov 29, 201615
- Chief financial officerMarshall H. Woodworth Oct 30, 2023 to now17
- Chief financial officerJeffrey S. Mathiesen Aug 4, 2016 to Jan 30, 201818
- Chief operating officerAkash Bakshi Jan 5, 2021 to Jan 5, 202119
Board members and other officers (24)
- Chief Medical OfficerMark Versavel Dec 30, 2019 to Jan 2, 202020
- VP, Clinical OperationsNicola Shannon Dec 30, 2019 to Dec 30, 201921
- VP of PreClinical R&D & Manf.Carmen Daniela Oniciu Aug 4, 2016 to Aug 12, 201622
- Chief Commercial OfficerSeth Reno Aug 4, 2016 to Jul 26, 201923
- Chief Medical OfficerLee Scott Golden Oct 6, 2016 to Jan 30, 201824
- Board memberMark A. Glickman May 12, 2023 to now25
- Board memberJames Patrick Tursi Nov 2, 2023 to now26
- Board memberD. Gordon Strickland Feb 2, 2022 to now27
- Board memberAkash Bakshi Jan 5, 2021 to Jan 5, 202119
- Board memberAndrew I. Koven Jul 19, 2021 to now28
- Board memberJeong Gu Kang Jan 2, 2020 to Jun 10, 202229
- Board memberJeong Gyun Oh Jan 2, 2020 to Jan 15, 202030
- Board memberNa Yeon Kim Jan 2, 2020 to Jul 28, 202331
- Board memberDouglas J. Swirsky Sep 3, 2020 to Sep 3, 202032
- Board memberJason L. Groves Dec 30, 2019 to now33
- Board memberMichael Salsbury Dec 30, 2019 to now34
- Board memberTae Heum Jeong Dec 30, 2019 to Jan 15, 202035
- Board memberAndy Sassine Aug 4, 2016 to Jul 26, 201936
- Board memberKenneth W. Kousky Aug 4, 2016 to Jul 26, 201937
- Board memberMina Sooch Aug 4, 2016 to Nov 29, 201615
- Board memberP. Kent Hawryluk Aug 4, 2016 to Jan 30, 201838
- Board memberPedro Lichtinger Aug 4, 2016 to Jul 26, 201939
- Board memberSteven R. Ph.d. Gullans Aug 4, 2016 to Jan 15, 202040
- General counselDavid Lowenschuss Aug 4, 2016 to Aug 12, 201641
Named in SEC Form D filings
People the company listed in its private-offering notices.
Former names
Timeline
- Oct 13, 20268-K Regulation FD disclosure; Other events44
- Sep 9, 20268-K Regulation FD disclosure; Other events45
- Aug 6, 20268-K Results of operations; Regulation FD disclosure46
- Jul 9, 20268-K Regulation FD disclosure; Other events47
- Jul 2, 20268-K Other events48
- Jun 8, 20268-K Regulation FD disclosure; Other events49
- Jun 8, 20268-K Executive or director change; Shareholder vote50
- May 27, 20268-K Regulation FD disclosure51
- May 18, 20268-K Regulation FD disclosure52
- May 14, 20268-K Results of operations; Regulation FD disclosure53
- May 11, 20268-K Regulation FD disclosure54
- Apr 10, 20268-K Regulation FD disclosure55
- Jan 18, 2023New chief executive Joseph Hooker becomes CEO12
- Nov 4, 2021New chief executive Ben Gil Price becomes CEO13
- May 31, 2017New chief executive Steven R. Ph.d. Gullans becomes CEO14
- Aug 4, 2016New chief executive Mina Sooch becomes CEO15
Calendar
Coming up
- Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($1.54) a share, on Nov 6, 2025.56
When it reported results
- Aug 6, 2026Reported quarterly or annual results46
- May 14, 2026Reported quarterly or annual results53
- Mar 26, 2026Reported quarterly or annual results57
- Jan 5, 2026Reported quarterly or annual results58
- Nov 6, 2025Reported quarterly or annual results59
- Aug 7, 2025Reported quarterly or annual results60
- May 14, 2025Reported quarterly or annual results61
- Mar 20, 2025Reported quarterly or annual results62
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
291 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 115 major events, 60 insider forms, 17 large holders, 3 private raises, 76 other. The latest 20:
- Oct 13, 20264 OWNERSHIP DOCUMENT EDGAR
- Oct 13, 20263 OWNERSHIP DOCUMENT EDGAR
- Oct 13, 20268-K EDGAR
- Sep 9, 20268-K EDGAR
- Aug 6, 202610-Q EDGAR
- Aug 6, 20268-K EDGAR
- Jul 9, 20268-K EDGAR
- Jul 2, 20268-K EDGAR
- Jul 2, 2026424B5 EDGAR
- Jun 8, 20264 OWNERSHIP DOCUMENT EDGAR
- Jun 8, 20264 OWNERSHIP DOCUMENT EDGAR
- Jun 8, 20264 OWNERSHIP DOCUMENT EDGAR
- Jun 8, 20264 OWNERSHIP DOCUMENT EDGAR
- Jun 8, 20264 OWNERSHIP DOCUMENT EDGAR
- Jun 8, 20264 OWNERSHIP DOCUMENT EDGAR
- Jun 8, 2026S-8 EDGAR
- Jun 8, 20268-K EDGAR
- Jun 8, 20268-K EDGAR
- May 27, 20268-K EDGAR
- May 18, 20268-K EDGAR
The 291 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
5 open-market trades by officers, directors and large owners since October 2021: 4 buys and 1 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Jun 4, 2025 | Woodworth Marshall HChief Financial Officer | Buy | 14,200 | $0.70 | $9.9K | Form 4 |
| May 8, 2025 | DONG-A ST CO., LTD10% owner | Buy | 4,647,887 | $0.71 | $3.3M | Form 4 |
| Sep 12, 2024 | DONG-A ST CO., LTD10% owner | Sale | 407 | $3.75 | $1.5K | Form 4 |
| Jun 23, 2024 | DONG-A ST CO., LTD10% owner | Buy | 2,544,530 | $3.93 | $10.0M | Form 4 |
| Jun 23, 2024 | DONG-A ST CO., LTD10% owner | Buy | 2,544,530 | $3.13 | $8.0M | 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.
- Alyeska Investment Group, L.P.SCHEDULE 13G, 1 filing May 15, 202663
- ARMISTICE CAPITAL, LLCSCHEDULE 13G/A, 4 filings Nov 14, 2024 to Aug 14, 202564
- DONG-A ST CO., LTDSCHEDULE 13D/A, 6 filings Sep 16, 2022 to May 20, 202565
- Strategic Risk, LLC.SC 13G, 1 filing Mar 28, 202366
- Altium Capital Management LLCSC 13G/A, 2 filings Nov 17, 2022 to Feb 14, 202367
- JK BioPharma Solutions, IncSC 13D/A, 2 filings Nov 10, 2021 to Sep 23, 202268
- E&Investment, Inc.SC 13D/A, 1 filing Aug 5, 202269
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 | Hyung Heon KimPresident and Chief Executive Officer | 50 | $479.7K | $756.3K70 |
| 2025 | Marshall H. WoodworthChief Financial Officer | 68 | $393.3K | $563.0K70 |
| 2024 | Marshall H. WoodworthChief Financial Officer | 68 | $316.7K | $774.7K70 |
| 2024 | Hyung Heon KimPresident and Chief Executive Officer | 50 | $460.1K | $716.4K70 |
Money raised
Private offerings the company reported to the SEC on Form D.
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 |
|---|---|---|---|---|
| Jane Street Group, LLC | 123,583 | $176.7K | 0.0% | +112,680 |
| Citadel Advisors LLC | 61,206 | $87.5K | 0.0% | New |
| Geode Capital Management, LLC | 21,314 | $30.5K | 0.0% | −12,321 |
| UBS Group AG | 12,948 | $18.5K | 0.0% | +12,947 |
| Scientech Research LLC | 12,014 | $17.2K | 0.0% | New |
| Aries Wealth Management | 10,000 | $14.3K | 0.0% | No change |
| Vanguard Capital Management LLC | 8,919 | $12.8K | 0.0% | +6,697 |
| Vanguard Fiduciary Trust Co | 6,940 | $9.9K | 0.0% | No change |
| Tower Research Capital LLC (TRC) | 2,223 | $3.2K | 0.0% | −379 |
| SBI Securities Co., Ltd. | 270 | $386 | 0.0% | +65 |
| Virtu Financial LLC | 29,933 | $43 | 0.0% | New |
| Morgan Stanley | 10 | $14 | 0.0% | New |
| BlackRock, Inc. | 7 | $10 | 0.0% | −472 |
| Caitong International Asset Management Co., Ltd | 3 | $4 | 0.0% | No change |
| Brown Brothers Harriman & Co | 2 | $3 | 0.0% | No change |
| Danske Bank A/s | 2 | $3 | 0.0% | No change |
| International Assets Investment Management, LLC | 2 | $3 | 0.0% | New |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How MetaVia Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARMetaVia Inc.1
- CIK0001638287
- Employer ID (EIN)47-23899843
- Filer statusNon-accelerated filer not 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 address545 Concord Avenue, Suite 210, Cambridge, MA 021381
- Phone(857) 702-96001
- Shares outstanding6,588,101 as of Aug 3, 202611
- Public float$3.0M as of Jun 30, 20253
- AuditorBDO USA, P.C., Boston Massachusetts PCAOB ID 243; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceApr 8, 20151
- Filings631 in all: 8-K (182), 4 (116), 3 (35), CORRESP (32), 10-Q (31), UPLOAD (21), 424B3 (16), EFFECT (16)1
All 48 form types
SC 13D/A (14), SC 13G (14), DEF 14A (12), 425 (11), S-8 (11), 10-K (10), D (9), SC 13G/A (9), 424B5 (7), PRE 14A (7), S-3 (7), 8-K/A (6), S-1 (5), S-1/A (5), SC 13D (5), ARS (4), D/A (4), 4/A (3), 424B4 (3), FWP (3), POS AM (3), S-4/A (3), 10-K/A (2), 3/A (2), CT ORDER (2), DRS (2), DRSLTR (2), PRER14A (2), SCHEDULE 13G (2), SCHEDULE 13G/A (2), SEC STAFF LETTER (2), 8-A12B (1), CERTNAS (1), DEFA14A (1), DRS/A (1), NT 10-K (1), NT 10-Q (1), S-1MEF (1), S-4 (1), SCHEDULE 13D/A (1)
- Latest filingsAnnual report (10-K) Mar 26, 2026
Quarterly report (10-Q) Aug 6, 2026
Proxy statement (DEF 14A) Apr 27, 2026
Latest 8-K (8-K) Oct 13, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common stock, $0.001 par value | MTVA | Nasdaq |
From the cover page of the 10-K filed Mar 26, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks MetaVia Inc. names in Item 1A of its 10-K filed Mar 26, 2026: 68 risks under these headings, as written.3
- Risks related to our financial position and need for capital
- We have incurred net losses since inception, and we anticipate that we will continue to incur net losses for the foreseeable future. We require additional capital to accomplish our business plan and the failure to obtain necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our operations.
- As we do not generate any revenue, we are dependent on working capital to fund our business plan, and raising additional capital may cause dilution to existing stockholders, restrict our operations or require us to relinquish rights to our technologies.
- Future sales, or the perception of future sales, by us or our securityholders could cause the market price of our common stock to decline.
- Adverse global economic conditions could have a material adverse effect on our business, results of operations and financial condition and liquidity.
- Changes in and uncertainty surrounding U.S. trade policy could have a material adverse impact on our business, financial condition and results of operations.
- Conditions in the banking system and financial markets, including the failure of banks and financial institutions, could have an adverse effect on our operations and financial results.
- Risks related to our operations and to the development, marketing, commercialization and regulation of our product candidates
- We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- Public opinion and scrutiny of treatments for obesity, overweight patients, MASH and MASH patients may impact public perception of our Company, DA-1726, vanoglipel (DA-1241), or may adversely affect our ability to conduct our business and our business plans.
- We may be required to make significant payments under the 2022 License Agreement.
- Even if we obtain favorable clinical results, we may not be able to obtain regulatory approval for, or successfully commercialize vanoglipel (DA-1241) and DA-1726.
The other 57 risks
- Preliminary, interim and topline data from our clinical trials that we announce or publish from time to time 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.
- Results of earlier clinical trials may not be predictive of the results of later-stage clinical trials.
- Product candidates may cause undesirable side effects that could delay or prevent their marketing approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any, including marketing withdrawal.
- Our efforts to discover drug candidates beyond our current drug candidates may not succeed, and any drug candidates we recommend for clinical development may not actually begin clinical trials.
- Delays in our clinical trials may lead to a delay in the submission of marketing approval applications and jeopardize our ability to potentially receive approvals and generate revenues from the sale of our products.
- We may develop vanoglipel (DA-1241) and DA-1726, and potentially future product candidates, in combination with other therapies, which exposes us to additional risks.
- Any collaboration arrangement that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our current and potential future drug candidates.
- Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control, including difficulties in identifying patients with MASH or obesity and significant competition for recruiting such patients in clinical trials.
- We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
- Our commercial success depends upon attaining significant market acceptance of our product candidates, if approved, among hospitals, physicians, patients and healthcare payors.
- Even if we are able to commercialize a future pharmaceutical drug candidate, the profitability of such product candidate will likely depend in significant part on third-party reimbursement practices, which, if unfavorable, would harm our business.
- We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
- Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop.
- If we or our third-party manufacturers 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 an adverse effect on the success of our business.
- We rely and will continue to rely on collaborative partners regarding the development of our research programs and product candidates.
- If, in the future, we are unable to establish sales and marketing capabilities or to selectively enter into agreements with third parties to sell and market our product candidates, we may not be successful in commercializing our product candidates if and when they are approved.
- Any product candidate for which we obtain marketing approval could be subject to marketing restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products.
- We or any potential collaborator may never receive regulatory approval to market our product candidates outside of the U.S.
- We may seek to avail ourselves of mechanisms to expedite and/or reduce the cost for development or approval of any of our product candidates or product candidates we may pursue in the future, such as Fast Track designation or orphan drug designation, but such mechanisms may not actually lead to a faster or less expensive development or regulatory review or approval process.
- Current and future legislation may increase the difficulty and cost of obtaining marketing approval and commercialization of our product candidates and affect the prices we may obtain.
- Governments outside the U.S. tend to impose strict price controls, which may adversely affect our revenues, if any.
- Our relationships with healthcare providers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings, among other penalties and 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. 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.
- Our ability to use our net operating losses (“NOLs”) to offset future taxable income may be subject to certain limitations.
- Tax matters, including the changes in corporate tax rates, disagreements with taxing authorities and imposition of new taxes could impact the results of our operations and financial condition.
- Inadequate funding of the FDA 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.
- Federal legislation and actions by state and local governments may permit reimportation of drugs from foreign countries into the U.S., including foreign countries where the drugs are sold at lower prices than in the U.S., which could adversely affect our operating results.
- Risks related to dependence on third parties
- We have relied and will rely on CROs to conduct our preclinical studies and clinical trials. If these CROs do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
- We rely on third parties to manufacture our product candidates and preclinical and clinical drug supplies.
- We may engage in future acquisitions, mergers, in-licenses and out-licenses of technology that could disrupt our business, cause dilution to the organization’s stockholders and harm our financial condition and operating results.
- We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
- Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
- Risks related to intellectual property
- If we are unable to obtain and maintain sufficient intellectual property rights, our competitive position could be harmed.
- We may not be able to protect or practice our intellectual property rights throughout the world.
- We may become involved in lawsuits to protect or enforce our intellectual property rights, which could be expensive, time-consuming and unsuccessful.
- Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
- Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
- We may be subject to damages resulting from claims that our employees or we have wrongfully used or disclosed alleged trade secrets of their former employers.
- Our trade secrets are difficult to protect and if we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- Our ability to obtain and maintain our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
- Risks related to operations, employee matters and managing growth
- We currently have a small number of employees and consultants, and our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel.
- We may need to increase the size of our organization, and we may experience difficulties in managing this growth.
- We intend to market our product candidates outside of the U.S., and if we do, we will be subject to the risks of doing business outside of the U.S.
- The pharmaceutical industry is highly competitive and is subject to rapid and significant technological change, which could render our technologies and products obsolete or uncompetitive.
- Risks related to our common stock
- The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for holders of our common stock.
- Our two largest stockholders may use their significant interest to take actions not supported by our other stockholders.
- Provisions in our corporate charter documents and under Delaware law may make an acquisition of MetaVia, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
- Nasdaq has proposed enhanced listing standards, which could adversely affect our ability to maintain our Nasdaq listing and access to capital markets.
- We are a “smaller reporting company” and we cannot be certain if the reduced reporting requirements applicable to such companies could make our common stock less attractive to investors.
- General risk factors
- Our business and operations may suffer in the event of system failures or other unplanned events.
- We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology or loss of data, including any cyber security incidents, may compromise sensitive information related to our business, prevent us from accessing critical information or expose us to liability which could harm our ability to operate our business effectively and adversely affect our business and reputation.
- An active trading market for our common stock may not be maintained.
- If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our business, the price of our stock could decline.
- We incur increased costs as a result of operating as a public company and our management is required to devote substantial time to compliance initiatives.
- We do not anticipate declaring or paying, in the foreseeable future, any cash dividends and, consequently, the ability of our stockholders to achieve a return on their investment will depend on appreciation in the price of our common stock.
- Our bylaws designate the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Legal proceedings
From time to time, we may be involved in various claims and legal proceedings arising out of our ordinary course of business. We are not currently a party to any claims or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business and consolidated financial statements. Regardless of 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
The numbers on this page point here. Each one links to the record it came from.
- 1SEC EDGARMetaVia Inc. filings on SEC EDGAR
- 2SEC EDGARMetaVia Inc. filings on SEC EDGAR
- 3
- 4SEC EDGARMetaVia Inc. 10-K for fiscal 2019
- 5SEC EDGARMetaVia Inc. 10-K for fiscal 2020
- 6SEC EDGARMetaVia Inc. 10-K for fiscal 2021
- 7SEC EDGARMetaVia Inc. 10-K for fiscal 2022
- 8SEC EDGARMetaVia Inc. 10-K for fiscal 2023
- 9SEC EDGARMetaVia Inc. 10-K for fiscal 2024
- 10SEC EDGARMetaVia Inc. 10-Q for fiscal 2026
- 11SEC EDGARMetaVia Inc. 10-Q for fiscal 2026
- 12
- 13
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- 15SEC EDGARMina Sooch, Chief executive officer
- 16SEC EDGARCharles Bisgaier Phd., Chair
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- 20SEC EDGARMark Versavel, Chief Medical Officer
- 21
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- 23SEC EDGARSeth Reno, Chief Commercial Officer
- 24
- 25SEC EDGARMark A. Glickman, Board member
- 26SEC EDGARJames Patrick Tursi, Board member
- 27SEC EDGARD. Gordon Strickland, Board member
- 28SEC EDGARAndrew I. Koven, Board member
- 29SEC EDGARJeong Gu Kang, Board member
- 30SEC EDGARJeong Gyun Oh, Board member
- 31SEC EDGARNa Yeon Kim, Board member
- 32SEC EDGARDouglas J. Swirsky, Board member
- 33SEC EDGARJason L. Groves, Board member
- 34SEC EDGARMichael Salsbury, Board member
- 35SEC EDGARTae Heum Jeong, Board member
- 36SEC EDGARAndy Sassine, Board member
- 37SEC EDGARKenneth W. Kousky, Board member
- 38SEC EDGARP. Kent Hawryluk, Board member
- 39SEC EDGARPedro Lichtinger, Board member
- 40
- 41SEC EDGARDavid Lowenschuss, General counsel
- 42
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- 44
- 45
- 46
- 47
- 48SEC EDGAROther events
- 49
- 50
- 51SEC EDGARRegulation FD disclosure
- 52SEC EDGARRegulation FD disclosure
- 53
- 54SEC EDGARRegulation FD disclosure
- 55SEC EDGARRegulation FD disclosure
- 56NasdaqNasdaq calendar
- 57
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- 59
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