KRSA on Nasdaq
Korsana Biosciences, Inc.
American pharmaceutical preparations company based in Waltham1
In its 2026 annual report the company says: “We focus on building a pipeline of innovative therapeutics to address serious neuropsychiatric disorders with significant unmet medical need.”3 Its shares trade on Nasdaq under the symbol KRSA.1
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Last updated Oct 21, 2026.
Overview
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- TickerKRSA on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersWaltham, Massachusetts1
- Incorporated inMA2
- Business address203 Crescent Street, Bldgs. #3/3A/4, Suite 503, Waltham, Ma 024532
- Filer categoryNon-accelerated filer, Smaller reporting company2
- Legal formCorporation
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We focus on building a pipeline of innovative therapeutics to address serious neuropsychiatric disorders with significant unmet medical need. Our current strategic focus is centered on the development of a novel therapeutic approach for neuropsychiatric conditions, with the lead indication being treatment-resistant depression (“TRD”), which we believe represents a substantial clinical and commercial opportunity.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
What sells
Revenue by product, business segment and region, as the company reports it to the SEC.
Products and services
License Agreement brought in 48% of the revenue Korsana Biosciences, Inc. broke down this way in fiscal 2025.
Products and services by year
| Products and services | 2023 | 2024 | 2025 |
|---|---|---|---|
| License Agreement | $0 | $1.8M | $1.0M |
| Purchase agreement | $0 | $800.0K | |
| Option Agreement | $250.0K | $274.0K |
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Research and development46¢$959.0K
- Other costs54¢$1.1M
Out of $2.1M in revenue.4 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.4
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Total revenues | $2.1M | $2.0M |
| Research and development | $959.0K | $286.0K |
| General and administrative | $6.1M | $5.3M |
| Total cost and expenses | $7.0M | $5.6M |
| Loss from operations | -$5.0M | -$3.6M |
| Interest income | $128.0K | $208.0K |
| Gain from settlement of account payable | $0 | $363.0K |
| Total other income, net | $1.4M | $571.0K |
| Gain from insurance recovery | $1.3M | $0 |
| Net loss per share - Basic | -$1.11 | -$1.21 |
| Net loss per share - Diluted | -$1.11 | -$1.21 |
| Basic shares | 3.2M shares | 2.5M shares |
| Diluted shares | 3.2M shares | 2.5M shares |
| Net loss | -$3.5M | -$3.1M |
| Foreign currency translation adjustment loss | $0 | -$6.0K |
| Comprehensive loss | -$3.5M | -$3.1M |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 2 fiscal years (annual) or 2 quarters (quarterly), latest first.4
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Cash and cash equivalents | $3.2M | $3.2M |
| Accounts receivable | $1.0M | $556.0K |
| Prepaid expenses | $384.0K | $421.0K |
| Other current assets | $11.0K | $16.0K |
| Total current assets | $4.6M | $4.2M |
| Other investment | $5.3M | $5.3M |
| Total assets | $10.0M | $9.6M |
| Accounts payable | $508.0K | $390.0K |
| Accrued research and development costs | $198.0K | $52.0K |
| Accrued expenses and other current liabilities | $194.0K | $283.0K |
| Total current liabilities | $900.0K | $725.0K |
| Commitments and contingencies (Note 6) | $0 | $0 |
| Preferred stock, no par value, 100,000,000 shares authorized and 351,037 shares of Series A convertible preferred stock issued and outstanding at December 31, 2025 and 2024 | $0 | $0 |
| Common stock, no par value, 400,000,000 shares authorized at December 31, 2025 and 2024; 3,925,314 and 2,710,096 shares issued at December 31, 2025 and 2024, respectively; 3,821,236 and 2,545,922 shares outstanding at December 31, 2025 and 2024, respectively | $0 | $0 |
| Paid-in capital | $280.1M | $276.3M |
| Accumulated deficit | -$271.0M | -$267.5M |
| Total stockholders' equity | $9.1M | $8.8M |
| Total liabilities and stockholders' equity | $10.0M | $9.6M |
| Preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
| Preferred stock, shares authorized | 100.0M shares | 100.0M shares |
| Common stock, par value (in dollars per share) | $0.00 | $0.00 |
| Common stock, shares authorized | 400.0M shares | 400.0M shares |
| Common stock, shares issued | 3.9M shares | 2.7M shares |
| Common stock, shares outstanding | 3.8M shares | 2.5M shares |
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Cash and cash equivalents | $3.2M | $3.2M |
| Accounts receivable | $1.0M | $556.0K |
| Prepaid expenses | $384.0K | $421.0K |
| Other current assets | $11.0K | $16.0K |
| Total current assets | $4.6M | $4.2M |
| Other investment | $5.3M | $5.3M |
| Total assets | $10.0M | $9.6M |
| Accounts payable | $508.0K | $390.0K |
| Accrued research and development costs | $198.0K | $52.0K |
| Accrued expenses and other current liabilities | $194.0K | $283.0K |
| Total current liabilities | $900.0K | $725.0K |
| Commitments and contingencies (Note 6) | $0 | $0 |
| Preferred stock, no par value, 100,000,000 shares authorized and 351,037 shares of Series A convertible preferred stock issued and outstanding at December 31, 2025 and 2024 | $0 | $0 |
| Common stock, no par value, 400,000,000 shares authorized at December 31, 2025 and 2024; 3,925,314 and 2,710,096 shares issued at December 31, 2025 and 2024, respectively; 3,821,236 and 2,545,922 shares outstanding at December 31, 2025 and 2024, respectively | $0 | $0 |
| Paid-in capital | $280.1M | $276.3M |
| Accumulated deficit | -$271.0M | -$267.5M |
| Total stockholders' equity | $9.1M | $8.8M |
| Total liabilities and stockholders' equity | $10.0M | $9.6M |
| Preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
| Preferred stock, shares authorized | 100.0M shares | 100.0M shares |
| Common stock, par value (in dollars per share) | $0.00 | $0.00 |
| Common stock, shares authorized | 400.0M shares | 400.0M shares |
| Common stock, shares issued | 3.9M shares | 2.7M shares |
| Common stock, shares outstanding | 3.8M shares | 2.5M 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 | -$3.5M | -$3.1M |
| Gain from settlement of account payable | $0 | -$363.0K |
| Share-based compensation expense | $441.0K | $625.0K |
| Accounts receivable | -$444.0K | -$556.0K |
| Prepaid expenses | $37.0K | $21.0K |
| Other current assets | $5.0K | -$5.0K |
| Accounts payable | $118.0K | -$445.0K |
| Accrued research and development costs | $146.0K | -$38.0K |
| Accrued expenses and other current liabilities | -$89.0K | -$515.0K |
| Net cash used in operating activities | -$3.3M | -$4.3M |
| Proceeds from ATM | $2.1M | $0 |
| Proceeds from private placement | $1.4M | $0 |
| Issuance costs paid for private placement | -$130.0K | $0 |
| Net cash provided by financing activities | $3.3M | $0 |
| Effect of exchange rate changes on cash and cash equivalents | $0 | -$6.0K |
| Net increase (decrease) in cash and cash equivalents | $8.0K | -$4.3M |
No quarter-by-quarter statement was filed.
Corporate structure
Korsana Biosciences, 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 Korsana Biosciences, Inc.
- J. WOOD CAPITAL ADVISORS LLC Filed SCHEDULE 13G/A on Korsana Biosciences, Inc., latest Oct 15, 2026 (2 filings since Oct 17, 2025)
- FMR LLC Filed SCHEDULE 13G/A on Korsana Biosciences, Inc., latest Oct 7, 2026 (6 filings since Feb 9, 2022)
- GENERAL ATLANTIC, L.P. Filed SCHEDULE 13G on Korsana Biosciences, Inc., latest Sep 18, 2026
- Wellington Biomedical Innovation Master Investors (Cayman) II L.P. Filed SCHEDULE 13G on Korsana Biosciences, Inc., latest Sep 16, 2026
- Venrock Healthcare Capital Partners III, L.P. Filed SCHEDULE 13D on Korsana Biosciences, Inc., latest Sep 15, 2026
- Fairmount Funds Management LLC Filed SCHEDULE 13D on Korsana Biosciences, Inc., latest Sep 11, 2026
- ADAR1 Capital Management, LLC Filed SCHEDULE 13G on Korsana Biosciences, Inc., latest Aug 14, 2026
- BALYASNY ASSET MANAGEMENT L.P. Filed SCHEDULE 13G on Korsana Biosciences, Inc., latest Aug 14, 2026
- Peter M. Hecht Filed SCHEDULE 13D/A on Korsana Biosciences, Inc., latest Jul 20, 2026 (7 filings since Nov 21, 2022)
- TYNDALL CAPITAL PARTNERS L P Filed SCHEDULE 13G/A on Korsana Biosciences, Inc., latest Aug 14, 2025 (4 filings since Sep 5, 2023)
- American Endowment Foundation Filed SCHEDULE 13G/A on Korsana Biosciences, Inc., latest Feb 12, 2025
- MFN Partners Management, LP Filed SCHEDULE 13G/A on Korsana Biosciences, Inc., latest Feb 12, 2025
- Korsana Biosciences, Inc. Waltham, Massachusetts
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Korsana Biosciences, 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 | $126.0K8 Dec 31, 2024 | $126.0K8 Dec 31, 2023 | 0% |
| Accumulated depreciation | $126.0K8 Dec 31, 2024 | $126.0K8 Dec 31, 2023 | 0% |
| Property and equipment, net | $08 Dec 31, 2024 | $08 Dec 31, 2023 |
Investments
Properties, in its own words
In April 2021 we completed our exit from our prior laboratory and office facilities in Cambridge Massachusetts and moved to an operating model under which we outsource our research and development laboratory work, and we are currently leasing office space on an “as-needed” basis.
Item 2 of the 10-K filed Mar 30, 2026.3
Leadership
Who has led Korsana Biosciences, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerPeter M. Hecht Apr 3, 2019 to May 22, 202313
- PresidentRegina Margaret Graul Dec 4, 2023 to Jan 26, 202414
- PresidentWilliam Huyett Mar 14, 2019 to Mar 14, 201915
- PresidentMark G. Currie Apr 3, 2019 to Dec 30, 202016
- Chief financial officerMark J. Vignola Sep 10, 2026 to now17
- Chief financial officerRhonda M. Chicko Mar 11, 2024 to Sep 10, 202618
- Chief financial officerAnjeza Gjino Jan 11, 2021 to Jan 24, 202219
- Chief financial officerWilliam Huyett Apr 3, 2019 to Nov 10, 202020
- Chief operating officerCheryl Gault Jan 11, 2021 to Jan 24, 202221
Board members and other officers (27)
- OfficerJonathan Violin Sep 10, 2026 to now22
- Chief Medical OfficerMatthew James Leoni Sep 10, 2026 to now23
- OfficerRegina Margaret Graul Aug 7, 2024 to now24
- SECRETARY AND TREASURERGina Consylman Mar 14, 2019 to Mar 14, 201925
- Chief Innovation OfficerAndreas Busch May 1, 2019 to Jan 24, 202226
- Board memberAndrew Gottesdiener Sep 10, 2026 to now27
- Board memberHeidi Henson Sep 10, 2026 to now28
- Board memberJonathan Violin Sep 10, 2026 to now22
- Board memberMichelle Patricia Pernice Sep 10, 2026 to now29
- Board memberNimish P. Shah Sep 10, 2026 to now30
- Board memberPeter Evan Harwin Sep 10, 2026 to now31
- Board memberTomas Kiselak Sep 10, 2026 to now31
- Board memberRegina Margaret Graul Aug 7, 2024 to now24
- Board memberDina Katabi Dec 11, 2023 to Dec 11, 202332
- Board memberSteven Hyman Jul 26, 2022 to Dec 4, 202333
- Board memberErrol B. Desouza May 19, 2021 to Dec 4, 202334
- Board memberGina Consylman Mar 14, 2019 to Mar 14, 201925
- Board memberWilliam Huyett Mar 14, 2019 to Mar 14, 201915
- Board memberMarsha Fanucci Mar 15, 2019 to Jun 16, 202235
- Board memberAmy W. Schulman Apr 3, 2019 to Jun 18, 202036
- Board memberGeorge Conrades Apr 3, 2019 to Jun 16, 202237
- Board memberKevin Churchwell Apr 3, 2019 to Jun 28, 202138
- Board memberMichael Mendelsohn Apr 3, 2019 to Jun 16, 202239
- Board memberOle Isacson Apr 3, 2019 to Jun 16, 202240
- Board memberPeter M. Hecht Apr 3, 2019 to now13
- Board memberStephanie Lovell Apr 3, 2019 to Jun 16, 202241
- Board memberTerrance McGuire Apr 3, 2019 to Dec 4, 202342
Named in SEC Form D filings
People the company listed in its private-offering notices.
- DirectorErrol M. De Souza named May 25, 202343
Former names
- Cyclerion Therapeutics, Inc.Oct 9, 2018 to Aug 27, 20262
Timeline
- Sep 11, 20268-K Entered a material agreement; Completed an acquisition or sale; Results of operations44
- Aug 27, 20268-K Shareholder vote; Other events45
- Aug 25, 20268-K Other events46
- Apr 1, 20268-K Entered a material agreement; Change in control; Executive or director change47
- Feb 17, 20268-K Regulation FD disclosure48
- Jan 6, 20268-K Entered a material agreement; Regulation FD disclosure49
- Dec 1, 20258-K Other events50
- Sep 23, 20258-K Entered a material agreement; Regulation FD disclosure51
- Jun 18, 20258-K Shareholder vote52
- May 7, 20258-K Entered a material agreement53
- Mar 25, 20258-K Entered a material agreement; Unregistered sale of shares54
- Dec 17, 20248-K Entered a material agreement; Regulation FD disclosure55
- Apr 3, 2019New chief executive Peter M. Hecht becomes CEO13
Calendar
Coming up
- Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($2.10) a share, on Nov 12, 2025.56
When it reported results
- Sep 11, 2026Reported quarterly or annual results44
- May 12, 2023Reported quarterly or annual results57
- Mar 22, 2023Reported quarterly or annual results58
- Aug 9, 2022Reported quarterly or annual results59
- May 4, 2022Reported quarterly or annual results60
- Feb 24, 2022Reported quarterly or annual results61
- Nov 9, 2021Reported 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
195 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 42 major events, 50 insider forms, 36 large holders, 1 private raises, 44 other. The latest 20:
- Oct 15, 2026SCHEDULE 13G/A EDGAR
- Oct 15, 2026DEF 14A EDGAR
- Oct 7, 2026SCHEDULE 13G/A EDGAR
- Oct 5, 2026PRE 14A EDGAR
- Sep 23, 2026144 EDGAR
- Sep 22, 2026144 EDGAR
- Sep 18, 2026144 EDGAR
- Sep 18, 2026SCHEDULE 13G EDGAR
- Sep 16, 2026SCHEDULE 13G EDGAR
- Sep 15, 2026SCHEDULE 13D EDGAR
- Sep 11, 2026SCHEDULE 13D EDGAR
- Sep 11, 20268-K EDGAR
- Sep 10, 20264 EDGAR
- Sep 10, 20264 EDGAR
- Sep 10, 20264 EDGAR
- Sep 10, 20264 EDGAR
- Sep 10, 20263 EDGAR
- Sep 10, 20263 EDGAR
- Sep 10, 20263 EDGAR
- Sep 10, 20263 EDGAR
The 195 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: 0 buys and 2 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Nov 21, 2024 | Greenspan David Gerald10% owner | Sale | 357,880 | $1.55 | $554.7K | Form 4 |
| Aug 9, 2023 | MCGUIRE TERRANCEDirector | Sale | 8 | $3.40 | $27 | 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.
- J. WOOD CAPITAL ADVISORS LLCSCHEDULE 13G/A, 2 filings Oct 17, 2025 to Oct 15, 202663
- FMR LLCSCHEDULE 13G/A, 6 filings Feb 9, 2022 to Oct 7, 202664
- GENERAL ATLANTIC, L.P.SCHEDULE 13G, 1 filing Sep 18, 202665
- Wellington Biomedical Innovation Master Investors (Cayman) II L.P.SCHEDULE 13G, 1 filing Sep 16, 202666
- Venrock Healthcare Capital Partners III, L.P.SCHEDULE 13D, 1 filing Sep 15, 202667
- Fairmount Funds Management LLCSCHEDULE 13D, 1 filing Sep 11, 202668
- ADAR1 Capital Management, LLCSCHEDULE 13G, 1 filing Aug 14, 202669
- BALYASNY ASSET MANAGEMENT L.P.SCHEDULE 13G, 1 filing Aug 14, 202670
- Peter M. HechtSCHEDULE 13D/A, 7 filings Nov 21, 2022 to Jul 20, 202671
- TYNDALL CAPITAL PARTNERS L PSCHEDULE 13G/A, 4 filings Sep 5, 2023 to Aug 14, 202572
- American Endowment FoundationSCHEDULE 13G/A, 1 filing Feb 12, 202573
- MFN Partners Management, LPSCHEDULE 13G/A, 1 filing Feb 12, 202574
- Slate Path Capital LPSCHEDULE 13G/A, 5 filings Feb 11, 2022 to Dec 6, 202475
- Artal International S.C.A.SC 13G/A, 3 filings Feb 11, 2022 to Jul 12, 202476
- MFN Partners, LPSC 13G/A, 1 filing Feb 9, 202277
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) $5.0M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2023 | $5.0M | $5.0M |
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.
SEC filer profile
How Korsana Biosciences, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARKorsana Biosciences, Inc.1
- CIK0001755237
- Employer ID (EIN)83-18953703
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
- Incorporated inMassachusetts3
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address203 Crescent Street, Bldgs. #3/3A/4, Suite 503, Waltham, MA 024531
- Phone(781) 516-23251
- Shares outstanding4,681,351 as of Aug 4, 202611
- Public float$5.7M as of Jun 30, 20253
- AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceOct 9, 20181
- Filings388 in all: 4 (95), 8-K (69), 3 (32), 10-Q (23), SC 13G/A (16), UPLOAD (13), SC 13G (11), CORRESP (9)1
All 45 form types
SCHEDULE 13G/A (8), 10-K (7), 425 (7), DEF 14A (7), DEFA14A (7), EFFECT (7), 4/A (6), SC 13D/A (6), SCHEDULE 13G (6), S-3 (5), S-8 (5), D (4), 10-K/A (3), 144 (3), DRSLTR (3), S-4/A (3), 10-12B/A (2), 10-Q/A (2), 424B3 (2), 424B4 (2), 424B5 (2), DRS (2), DRS/A (2), PRE 14A (2), S-3/A (2), SC 13D (2), SCHEDULE 13D (2), SCHEDULE 13D/A (2), 10-12B (1), 3/A (1), 8-K/A (1), CERT (1), DEFM14A (1), PREM14A (1), S-1 (1), S-4 (1), SEC STAFF ACTION (1)
- Latest filingsAnnual report (10-K) Mar 30, 2026
Quarterly report (10-Q) Aug 4, 2026
Proxy statement (DEF 14A) Oct 15, 2026
Latest 8-K (8-K) Sep 11, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, no par value | CYCN | Nasdaq |
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 Korsana Biosciences, Inc. names in Item 1A of its 10-K filed Mar 30, 2026: 57 risks under these headings, as written.3
- Risks Related to our Financial Position and Capital Needs
- Risks Related to Development and Clinical Testing of Our Products and Product Candidates
- Risks Related to Reliance on Licensees, Tisento and Third Parties
- Risks Related to Intellectual Property
- Risks Related to the Future Commercialization of our Potential Future Product Candidates
- Risks Related to the holders of Our Common Stock
- Risks Related to Our Financial Position and Capital Needs
- As we are a biopharmaceutical company with a limited operating history and no products approved for commercial sale, valuing our business and predicting our prospects are challenging.
- Our business has incurred significant losses and we anticipate that we will continue to incur significant losses for the foreseeable future. We have never generated revenue from product sales and may never be profitable.
- There is substantial doubt about our ability to continue as a going concern. We will need to raise additional funding in the near term, which may not be available on acceptable terms, if at all to continue as a going concern and advance our product candidates. Failure to obtain capital when needed may force us to delay, limit or terminate our product development efforts or operations altogether. Raising additional capital would dilute our existing shareholders, restrict our operations or cause us to relinquish valuable rights.
- Our approach to the discovery and development of product candidates for the treatment of serious diseases may never lead to marketable products.
- Research and development of biopharmaceutical products is inherently risky. We may encounter substantial delays in our activities, including our planned clinical studies, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities in the development of products to treat patients with serious diseases.
The other 52 risks
- In the event of difficulties in enrolling participants in any clinical studies conducted on our product candidates, those clinical trials could be delayed or prevented from proceeding.
- The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. If we, Tisento, Akebia and any other future licensees, as applicable, are ultimately unable to obtain regulatory approval for the product candidates, we will be unable to generate product revenue and our business will be substantially harmed.
- Our product candidates may cause side effects or adverse events that are presented in the product labeling approved by regulatory authorities. Some may result in label restrictions.
- Changes in regulatory requirements, FDA guidance or unanticipated events during nonclinical studies and clinical studies of our product candidates, which may result in changes to nonclinical or clinical study protocols or additional nonclinical or clinical study requirements, which could result in increased costs and could delay development timelines.
- Obtaining and maintaining regulatory approval of product candidates in one jurisdiction does not mean that there will be success in obtaining regulatory approval of our product candidates in other jurisdictions.
- Data/market exclusivity may be more limited than we expect based upon the competitive landscape and other factors outside of our control that may occur during development or after approval.
- Risks Related to Reliance on Licensees, Tisento and Other Third Parties
- We may not succeed in our pursuit of capital, capabilities, and transactions for the development and commercialization of our future clinical stage assets, which would affect our financial condition.
- Akebia may not be successful in developing any therapies through the praliciguat out-license and we may not realize any future revenue from the out-license.
- Tisento may not be successful in developing any therapies and we may not realize any future value from the Tisento common stock we received under the Asset Purchase Agreement with Tisento.
- We lack operational control over Tisento.
- Any collaboration or license arrangements that we enter into in the future may not be successful, which could impede our ability to develop and commercialize our product candidates.
- We expect in the future to rely on third parties to conduct any nonclinical or clinical studies for any existing or potential future product candidates. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, necessary regulatory approvals for or commercialization of any potential future product candidates may not be obtainable and our business could be substantially harmed.
- Except as out-licensed, we must rely completely on third-party suppliers to manufacture any nonclinical and clinical drug supplies for our product candidates, and we intend to rely on third parties to produce commercial supplies of any product candidates that are approved.
- Our anticipated reliance on third parties requires us to share our confidential information, including trade secrets and know-how, which increases the possibility that our confidential information will be misappropriated or disclosed.
- Risks Related to Our Intellectual Property Rights
- If we or our licensors, licensees or Tisento are unable to adequately protect proprietary technologies, or obtain and maintain issued patents that are sufficient to protect their respective product candidates, others could compete against us, our licensees and Tisento more directly, which would have a material adverse impact on our business, prospects, financial condition and results of operations.
- We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing our product candidates, if approved.
- We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property we own or license from third parties.
- Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies and patent protection could be reduced or eliminated for non-compliance with these requirements.
- We and our licensees and Tisento may not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
- If we, or our licensees, do not obtain additional protection under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act, and similar foreign legislation by extending the patent terms and obtaining data exclusivity for our product candidates, our business, prospects, financial condition and results of operations may be materially harmed.
- Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
- We may be subject to damages resulting from claims that we or our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers.
- Risks Related to the Future Commercialization of Our Current or Potential Future Product Candidates
- The incidence and prevalence for target patient populations of our current and any potential future product candidates we may acquire have not been established with precision. If the market opportunities for our current and potential future product candidates are smaller than we estimate, or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability may be harmed.
- If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any product candidates, if approved, we may not be successful in commercializing those product candidates if and when they are approved.
- Even if we obtain regulatory approval for our product candidates, our product candidates may not achieve broad market acceptance by patients, physicians, healthcare payors or others in the medical community, which would limit the revenue that we generate from their sales.
- Reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our product candidates profitably. Price controls may be imposed in certain markets, which may harm our future profitability.
- If we fail to comply with healthcare and other regulations, we could face substantial penalties and our business, prospects, financial condition and results of operations could be harmed.
- We face significant competition in an environment of rapid technological and scientific change, and our competitors may achieve regulatory approval before us or develop therapies that are safer, more advanced or more effective than ours, which may harm our ability, or a licensee's ability, to successfully market or commercialize any product candidates we may develop and ultimately harm our financial condition.
- The impact of healthcare reform and other governmental and private payor initiatives, as well as the Inflation Reduction Act of 2022, may harm our business.
- Our future growth may depend, in part, on our, or a licensee's, ability to commercialize any current and potential future product candidates outside the United States, where we would be subject to additional regulatory burdens and other risks and uncertainties.
- Our ability to generate meaningful revenues in jurisdictions outside of the United States may be limited due to the strict price controls and reimbursement limitations imposed by governments outside of the United States.
- If any of our product candidates obtain regulatory approval, additional competitors could enter the market with generic versions of such drugs, which may result in a material decline in sales of affected products.
- Risks Related to Our Business Operations
- Our prospects for success depend on our ability to retain Regina Graul, our President and Chief Executive Officer and in the future to attract, retain and motivate qualified personnel.
- We face potential product liability exposure, and, if claims are brought against us, we may incur substantial liability.
- If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which could result in sanctions or other penalties that would harm our business.
- Unfavorable global economic and political conditions could harm our business, prospects, financial condition and results of operations.
- If our information technology systems or data, or those of CRO and other third parties upon which we rely, are or were compromised, we could experience adverse impacts resulting from such compromise, including, but not limited to, regulatory investigations or actions; litigation; fines and penalties; interruptions to our commercial operations, clinical trials or other operations; harm to our reputation; loss of revenue or profits; loss of sales and other adverse consequences.
- Our employee or future employees may engage in misconduct or other improper activities, including violating applicable regulatory standards and requirements or engaging in insider trading, which could significantly harm our business.
- If we or any contract manufacturers and suppliers we engage fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
- We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act, or the FCPA, and other worldwide anti-bribery laws.
- Risks Related to Ownership of Our Common Stock
- We could be delisted from Nasdaq, which would seriously harm the liquidity of our stock and ability to raise capital.
- The market price of our common stock may fluctuate widely and you could lose all or part of your investment in our common stock as a result.
- The market price for our common stock is particularly volatile.
- We run the risk of inadvertently being deemed an investment company required to register under the Investment Company Act of 1940.
- Uncertainties in the interpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate.
- Our ability to use net operating loss carryforwards and certain other tax attributes to offset future taxable income and taxes may be subject to limitations.
- We maintain our cash at financial institutions, often in balances that exceed federally insured limits.
- If securities or industry analysts fail to initiate or maintain coverage of our stock, publish a negative report or change their recommendations regarding our stock adversely, our stock price and trading volume could decline.
- We do not expect to pay any cash dividends for the foreseeable future.
- We have anti-takeover provisions in our articles of organization and bylaws and are subject to provisions of Massachusetts law that may frustrate any attempt to remove or replace our current board of directors or to effect a change of control or other business combination involving our company.
- Our articles of organization designate the state and federal courts located within the Commonwealth of Massachusetts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our shareholders, which could discourage lawsuits against us and our directors and officers.
Legal proceedings
We are not a party to any material legal proceedings at this time. From time to time, we may be subject to various legal proceedings and claims, which may have a material adverse effect on our financial position or 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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- 14SEC EDGARRegina Margaret Graul, President
- 15SEC EDGARWilliam Huyett, President
- 16SEC EDGARMark G. Currie, President
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- 22SEC EDGARJonathan Violin, Officer
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- 24SEC EDGARRegina Margaret Graul, Officer
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- 27SEC EDGARAndrew Gottesdiener, Board member
- 28SEC EDGARHeidi Henson, Board member
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- 30SEC EDGARNimish P. Shah, Board member
- 31SEC EDGARPeter Evan Harwin, Board member
- 32SEC EDGARDina Katabi, Board member
- 33SEC EDGARSteven Hyman, Board member
- 34SEC EDGARErrol B. Desouza, Board member
- 35SEC EDGARMarsha Fanucci, Board member
- 36SEC EDGARAmy W. Schulman, Board member
- 37SEC EDGARGeorge Conrades, Board member
- 38SEC EDGARKevin Churchwell, Board member
- 39SEC EDGARMichael Mendelsohn, Board member
- 40SEC EDGAROle Isacson, Board member
- 41SEC EDGARStephanie Lovell, Board member
- 42SEC EDGARTerrance McGuire, Board member
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- 45SEC EDGARShareholder vote; Other events
- 46SEC EDGAROther events
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- 48SEC EDGARRegulation FD disclosure
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- 50SEC EDGAROther events
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- 52SEC EDGARShareholder vote
- 53SEC EDGAREntered a material agreement
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- 56NasdaqNasdaq calendar
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