Private company
Regulus Therapeutics Inc.
Regulus Therapeutics Inc. is an American pharmaceutical preparations company based in San Diego.1
Last updated Oct 21, 2026.
Overview
- IndustryPharmaceutical Preparations1
- HeadquartersSan Diego, California1
- Incorporated inDE2
- Business address4224 Campus Point Court, Suite 210, San Diego, Ca 921212
- Filer categoryNon-accelerated filer, Smaller reporting company2
- Legal formCorporation
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The Regulus Therapeutics logo is a trademark of Regulus Therapeutics Inc. We use “Regulus Therapeutics” as a trademark in the United States and other countries. We have registered this trademark in the United States, the European Union ("EU") and Switzerland. All other product and company names are trademarks of their respective companies.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 2021
Financial statements
| Fiscal year | 2018 | 2019 | 2020 | 2021 |
|---|---|---|---|---|
| Revenue | $72.0K7 | $6.8M8 | $10.0M4 | $04 |
| Research and development | $34.0M7 | $12.3M8 | $15.3M4 | $17.8M6 |
| Operating expenses | $27.8M6 | |||
| Operating income | -$46.8M7 | -$16.8M8 | -$14.2M4 | -$27.8M6 |
| Interest | $2.3M7 | $2.1M8 | $1.8M4 | $855.0K6 |
| Income before tax | -$27.8M6 | |||
| Income tax | $62.0K7 | $1.0K8 | $04 | $1.0K6 |
| Net income | -$48.7M7 | -$18.6M8 | -$15.7M4 | -$27.8M6 |
| Earnings per share | -$0.454 | $3.246 | ||
| Earnings per share (diluted) | -$0.454 | $3.246 | ||
| Shares (weighted, basic) | 8.6M shares6 | |||
| Shares (weighted, diluted) | 8.6M shares6 |
| Fiscal year | 2018 | 2019 | 2020 | 2021 |
|---|---|---|---|---|
| Cash | $13.9M7 | $34.1M8 | $31.1M4 | $60.4M6 |
| Current assets | $19.3M7 | $40.4M8 | $36.7M4 | $65.2M6 |
| Property, plant and equipment | $281.0K6 | |||
| Intangible assets | $83.0K6 | |||
| Total assets | $27.9M7 | $42.1M8 | $37.6M4 | $68.5M6 |
| Accounts payable | $285.0K6 | |||
| Short-term debt | $06 | |||
| Current liabilities | $26.6M7 | $21.6M8 | $11.6M4 | $5.2M6 |
| Long-term debt | $04 | $4.7M6 | ||
| Total liabilities | $33.8M7 | $22.1M8 | $11.6M4 | $13.5M6 |
| Retained earnings | -$454.9M6 | |||
| Shareholders’ equity | -$5.9M8 | $20.0M4 | $26.0M6 | $55.0M5 |
| Shares outstanding | 8.8M shares7 | 21.0M shares8 | 67.4M shares4 | 14.6M shares6 |
Corporate structure
Regulus Therapeutics 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 Regulus Therapeutics Inc.
- Deep Track Capital, LP Filed SCHEDULE 13G/A on Regulus Therapeutics Inc., latest Aug 14, 2025 (2 filings since Mar 22, 2024)
- Point72 Asset Management, L.P. Filed SCHEDULE 13G/A on Regulus Therapeutics Inc., latest Aug 14, 2025 (3 filings since Feb 14, 2022)
- Vivo Opportunity Fund Holdings, L.P. Filed SCHEDULE 13G/A on Regulus Therapeutics Inc., latest May 15, 2025 (2 filings since Mar 20, 2024)
- BIOTECHNOLOGY VALUE FUND L P Filed SC 13G/A on Regulus Therapeutics Inc., latest Nov 14, 2024 (2 filings since Feb 14, 2022)
- DAFNA Capital Management LLC Filed SC 13G/A on Regulus Therapeutics Inc., latest Nov 14, 2024 (2 filings since Feb 14, 2024)
- RA CAPITAL MANAGEMENT, L.P. Filed SC 13G/A on Regulus Therapeutics Inc., latest Nov 14, 2024 (2 filings since Mar 25, 2024)
- VANGUARD GROUP INC Filed SC 13G/A on Regulus Therapeutics Inc., latest Nov 12, 2024 (2 filings since Nov 4, 2024)
- BlackRock Filed SC 13G on Regulus Therapeutics Inc., latest Nov 8, 2024 (2 filings since Oct 24, 2024)
- Octagon Capital Advisors LP Filed SC 13G on Regulus Therapeutics Inc., latest Oct 11, 2024
- FMR LLC Filed SC 13G/A on Regulus Therapeutics Inc., latest Apr 10, 2024 (3 filings since Oct 11, 2022)
- Growth Equity Opportunities V, LLC Filed SC 13D/A on Regulus Therapeutics Inc., latest Mar 18, 2024 (3 filings since Dec 9, 2021)
- VICTORY CAPITAL MANAGEMENT INC Filed SC 13G/A on Regulus Therapeutics Inc., latest Feb 6, 2024 (4 filings since Jan 4, 2022)
- Regulus Therapeutics Inc. San Diego, California
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Regulus Therapeutics 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 | $5.5M12 Dec 31, 2024 | $5.3M12 Dec 31, 2023 | +4.0% |
| Accumulated depreciation | $4.6M12 Dec 31, 2024 | $4.2M12 Dec 31, 2023 | +8.0% |
| Property and equipment, net | $937.0K12 Dec 31, 2024 | $1.1M12 Dec 31, 2023 | −11.7% |
| Operating-lease assets (leased space) | $874.0K12 Dec 31, 2024 | $1.5M12 Dec 31, 2023 | −40.8% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $38.5M12 Dec 31, 2024 | $23.8M12 Dec 31, 2023 | +62.1% |
| Marketable securities, current | $37.2M12 Dec 31, 2024 | $012 Dec 31, 2023 | |
| Debt securities available for sale | $37.2M12 Dec 31, 2024 | $14.9M5 Dec 31, 2023 | +149.5% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Intangible assets, net (excluding goodwill) | $25.0K12 Dec 31, 2024 | $33.0K12 Dec 31, 2023 | −24.2% |
Properties, in its own words
On February 11, 2021, we entered into a lease agreement (the "Campus Point Lease") with ARE-SD Region No. 58 LLC ("Campus Point Landlord"), for the lease of approximately 13,438 square feet of rentable area located at 4224 Campus Point Court, Suite 210, San Diego, California 92121 (the "Campus Point Premises"). The commencement date of the Campus Point Lease was April 15, 2021. We are using the Campus Point Premises as our principal executive offices and as a laboratory for research and development, manufacturing and other related uses. The term of the Campus Point Lease (“Campus Point Initial Term”) is 60 months, ending April 30, 2026.
We believe that our existing facilities are adequate for our current and future needs.
Item 2 of the 10-K filed Mar 13, 2025.3
Leadership
Who has led Regulus Therapeutics Inc., and when. Pick a name to see everywhere that person has worked.
President
Chief financial officer
Chief operating officer
- Chief executive officerJoseph P. Hagan May 8, 2017 to now13
- Chief executive officerPaul C. Grint Jun 26, 2015 to Feb 23, 201714
- Chief executive officerKleanthis G. Xanthopoulos Oct 4, 2012 to Apr 21, 201515
- PresidentPreston Klassen Jun 12, 2023 to now16
- PresidentJoseph P. Hagan May 8, 2017 to Aug 14, 202313
- PresidentPaul C. Grint Jun 26, 2015 to Feb 23, 201714
- PresidentKleanthis G. Xanthopoulos Oct 4, 2012 to Apr 21, 201515
- Chief financial officerCrispina Calsada Sep 3, 2019 to now17
- Chief financial officerDaniel R. Chevallard May 10, 2017 to Jul 2, 201918
- Chief operating officerJoseph P. Hagan Jan 6, 2016 to Feb 23, 201719
- Chief operating officerGarry E. Menzel Oct 4, 2012 to Dec 13, 201220
Board members and other officers (26)
- Chief Scientific OfficerDenis Drygin Aug 4, 2020 to Mar 1, 202221
- Chief Medical OfficerMark Albert Deeg Jun 14, 2017 to May 21, 201822
- OfficerDavid Leslie Szekeres Mar 13, 2014 to Dec 4, 201423
- Chief Medical OfficerPaul C. Grint Jun 18, 2014 to Dec 4, 201424
- Board memberPreston Klassen Aug 14, 2023 to now25
- Board memberAlice Shih-Hou Huang Jan 27, 2021 to now26
- Board memberJason Raleigh Nunn Jun 11, 2019 to now27
- Board memberSimos Simeonidis Jun 11, 2019 to Jun 10, 202228
- Board memberKathryn J. Collier Apr 17, 2018 to now29
- Board memberJoseph P. Hagan May 8, 2017 to now13
- Board memberPascale Witz Jun 2, 2017 to now30
- Board memberHugh Rosen Jun 3, 2016 to now31
- Board memberPaul C. Grint Jun 26, 2015 to Feb 23, 201714
- Board memberMark G. Foletta Jan 31, 2013 to Dec 6, 201732
- Board memberWilliam H. Rastetter Apr 1, 2013 to now33
- Board memberB. Lynne Parshall Oct 4, 2012 to Nov 5, 201434
- Board memberBarry E. Greene Oct 4, 2012 to Nov 7, 201235
- Board memberBruce L. A. Carter Oct 4, 2012 to Jun 26, 201536
- Board memberDavid Baltimore Oct 4, 2012 to now37
- Board memberJohn Maraganore Oct 4, 2012 to Oct 11, 201238
- Board memberKleanthis G. Xanthopoulos Oct 4, 2012 to Apr 21, 201515
- Board memberStanley T. Crooke Oct 4, 2012 to Nov 7, 201239
- Board memberStelios Papadopoulos Oct 4, 2012 to now40
- Board memberDouglas E. Williams Nov 8, 2012 to Jun 3, 201641
- General counselChristopher Ray Aker Jan 2, 2019 to now42
- General counselDavid Leslie Szekeres Oct 22, 2014 to Oct 22, 201443
Named in SEC Form D filings
People the company listed in its private-offering notices.
- DirectorJake R. Nunn named Dec 6, 202144
Timeline
- Jun 25, 20258-K Completed an acquisition or sale; Listing notice or transfer; Change to shareholders' rights45
- May 8, 20258-K Results of operations46
- Apr 30, 20258-K Entered a material agreement; Executive or director change; Other events47
- Mar 27, 20258-K Regulation FD disclosure; Other events48
- Mar 13, 20258-K Results of operations49
- Mar 4, 20258-K Entered a material agreement50
- Nov 7, 20248-K Results of operations51
- Oct 24, 20248-K Entered a material agreement52
- Aug 8, 20248-K Results of operations53
- Jun 24, 20248-K Other events54
- May 17, 20248-K Executive or director change; Shareholder vote55
- May 9, 20248-K Results of operations56
- May 8, 2017New chief executive Joseph P. Hagan becomes CEO13
- Jun 26, 2015New chief executive Paul C. Grint becomes CEO14
- Oct 4, 2012New chief executive Kleanthis G. Xanthopoulos becomes CEO15
Calendar
When it reported results
- May 8, 2025Reported quarterly or annual results46
- Mar 13, 2025Reported quarterly or annual results49
- Nov 7, 2024Reported quarterly or annual results51
- Aug 8, 2024Reported quarterly or annual results53
- May 9, 2024Reported quarterly or annual results56
- Mar 21, 2024Reported quarterly or annual results57
- Mar 14, 2024Reported quarterly or annual results58
- Nov 9, 2023Reported quarterly or annual results59
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
281 filings to the SEC since October 2021: 5 annual reports, 11 quarterly reports, 37 major events, 110 insider forms, 34 large holders, 1 private raises, 83 other. The latest 20:
- Aug 14, 2025SCHEDULE 13G/A EDGAR
- Aug 14, 2025SCHEDULE 13G/A EDGAR
- Jul 7, 202515-12G EDGAR
- Jul 1, 2025EFFECT EDGAR
- Jul 1, 2025EFFECT EDGAR
- Jul 1, 2025EFFECT EDGAR
- Jul 1, 2025EFFECT EDGAR
- Jul 1, 2025EFFECT EDGAR
- Jul 1, 2025EFFECT EDGAR
- Jul 1, 2025EFFECT EDGAR
- Jul 1, 2025EFFECT EDGAR
- Jun 27, 20254 EDGAR
- Jun 27, 20254 EDGAR
- Jun 27, 20254 EDGAR
- Jun 27, 20254 EDGAR
- Jun 27, 20254 EDGAR
- Jun 27, 20254 EDGAR
- Jun 27, 20254 EDGAR
- Jun 27, 20254 EDGAR
- Jun 27, 20254 EDGAR
The 281 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
17 open-market trades by officers, directors and large owners since October 2021: 7 buys and 10 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Jun 3, 2025 | Klassen PrestonPresident & Head of R & D | Buy | 12,000 | $7.99 | $95.9K | Form 4 |
| Jan 30, 2025 | Hagan Joseph PChief Executive Officer | Buy | 50,000 | $1.09 | $54.5K | Form 4 |
| Jan 30, 2025 | BALTIMORE DAVIDDirector | Buy | 19,610 | $1.06 | $20.8K | Form 4 |
| Jan 14, 2025 | Hagan Joseph PChief Executive Officer | Sale | 11,764 | $1.26 | $14.8K | Form 4 |
| Jan 14, 2025 | Aker Christopher RaySr. VP & General Counsel | Sale | 5,088 | $1.26 | $6.4K | Form 4 |
| Jan 14, 2025 | CALSADA CRISPINAChief Financial Officer | Sale | 5,088 | $1.26 | $6.4K | Form 4 |
| Jan 13, 2025 | Hagan Joseph PChief Executive Officer | Sale | 115,290 | $1.26 | $145.3K | Form 4 |
| Jan 13, 2025 | Aker Christopher RaySr. VP & General Counsel | Sale | 38,547 | $1.26 | $48.6K | Form 4 |
| Jan 13, 2025 | CALSADA CRISPINAChief Financial Officer | Sale | 38,716 | $1.26 | $48.8K | Form 4 |
| Jan 13, 2025 | Klassen PrestonPresident & Head of R & D | Sale | 31,445 | $1.26 | $39.6K | Form 4 |
| Jul 25, 2024 | Collier Kathryn JDirector | Buy | 4,000 | $1.82 | $7.3K | Form 4 |
| Jan 18, 2024 | CALSADA CRISPINAChief Financial Officer | Sale | 5,468 | $1.19 | $6.5K | Form 4 |
| Jan 18, 2024 | Aker Christopher RaySr. VP & General Counsel | Sale | 5,468 | $1.19 | $6.5K | Form 4 |
| Jan 18, 2024 | Hagan Joseph PChief Executive Officer | Sale | 14,580 | $1.19 | $17.4K | Form 4 |
| Mar 1, 2022 | Drygin DenisChief Scientific Officer | Buy | 76,686 | $0.23 | $17.6K | Form 4 |
| Feb 4, 2022 | Drygin DenisChief Scientific Officer | Buy | 23,314 | $0.23 | $5.4K | Form 4 |
| Jan 26, 2022 | Hagan Joseph PChief Executive Officer | Buy | 100,000 | $0.22 | $22.0K | 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.
- Deep Track Capital, LPSCHEDULE 13G/A, 2 filings Mar 22, 2024 to Aug 14, 202560
- Point72 Asset Management, L.P.SCHEDULE 13G/A, 3 filings Feb 14, 2022 to Aug 14, 202561
- Vivo Opportunity Fund Holdings, L.P.SCHEDULE 13G/A, 2 filings Mar 20, 2024 to May 15, 202562
- BIOTECHNOLOGY VALUE FUND L PSC 13G/A, 2 filings Feb 14, 2022 to Nov 14, 202463
- DAFNA Capital Management LLCSC 13G/A, 2 filings Feb 14, 2024 to Nov 14, 202464
- RA CAPITAL MANAGEMENT, L.P.SC 13G/A, 2 filings Mar 25, 2024 to Nov 14, 202465
- VANGUARD GROUP INCSC 13G/A, 2 filings Nov 4, 2024 to Nov 12, 202466
- BlackRockSC 13G, 2 filings Oct 24, 2024 to Nov 8, 202467
- Octagon Capital Advisors LPSC 13G, 1 filing Oct 11, 202468
- FMR LLCSC 13G/A, 3 filings Oct 11, 2022 to Apr 10, 202469
- Growth Equity Opportunities V, LLCSC 13D/A, 3 filings Dec 9, 2021 to Mar 18, 202470
- VICTORY CAPITAL MANAGEMENT INCSC 13G/A, 4 filings Jan 4, 2022 to Feb 6, 202471
- Federated HermesSC 13G/A, 4 filings May 16, 2022 to Jan 18, 202472
- Altium Capital Management LLCSC 13G/A, 1 filing Feb 14, 202273
- EcoR1 Capital, LLCSC 13G/A, 1 filing Feb 14, 202274
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) $34.6M
- PPP loans $661.9K
Figures by year
| Year | Private raises (Form D) | PPP loans | Total |
|---|---|---|---|
| 2021 | $34.6M | – | $34.6M |
| 2020 | – | $661.9K | $661.9K |
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.
- Nov 30, 2021Raised $34.6 million in a private offering of equity44 Form D: 16 investors so far Form D
PPP loans
Paycheck Protection Program loans of $150,000 and up, approved April 2020 to July 2021, from the SBA75. Matched to this company by name and state.
- Apr 13, 2020$661.9K PPP loan (first draw) from Silicon Valley Bridge Bank NA75To REGULUS THERAPEUTICS INC, San Diego CA; $669.1K forgiven May 21, 2021
SEC filer profile
How Regulus Therapeutics Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARRegulus Therapeutics Inc.1
- CIK0001505512
- Employer ID (EIN)26-47383793
- 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 address4224 Campus Point Court, Suite 210, San Diego, CA 921211
- Phone858-202-63001
- Shares outstanding69,234,089 as of May 2, 202511
- Public float$114.9M as of Jun 28, 20243
- AuditorErnst & Young LLP, San Diego, California PCAOB ID 42; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceNov 15, 20101
- Filings1,009 in all: 4 (436), 8-K (145), SC 13G/A (56), 3 (50), 10-Q (38), SC 13G (27), EFFECT (21), CT ORDER (20)1
All 49 form types
S-8 (20), S-8 POS (20), 10-K (13), 4/A (13), CORRESP (13), DEF 14A (13), DEFA14A (12), POS AM (12), UPLOAD (12), 424B5 (9), D (9), S-3 (9), SC 13D/A (7), PRE 14A (5), S-1/A (4), S-1 (3), SC 13D (3), SC 14D9/A (3), SC TO-I/A (3), SC TO-T/A (3), SC14D9C (3), SCHEDULE 13G/A (3), 10-K/A (2), 424B4 (2), 8-K/A (2), ARS (2), SC TO-C (2), 10-Q/A (1), 144 (1), 15-12G (1), 25-NSE (1), 424B3 (1), 8-A12B (1), CERTNAS (1), POSASR (1), S-3/A (1), S-3ASR (1), SC 14D9 (1), SC TO-I (1), SC TO-T (1), SCHEDULE 13G (1)
- Latest filingsAnnual report (10-K) Mar 13, 2025
Quarterly report (10-Q) May 8, 2025
Proxy statement (DEF 14A) Apr 19, 2024
Latest 8-K (8-K) Jun 25, 2025
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.001 per share | RGLS | The Nasdaq Stock Market LLC |
From the cover page of the 10-K filed Mar 13, 2025 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Regulus Therapeutics Inc. names in Item 1A of its 10-K filed Mar 13, 2025: 57 risks under these headings, as written.3
- You should consider carefully the following risk factors, together with all of the other information included in this Annual Report. Each of these risk factors, either alone or taken together, could adversely affect our business, operating results and financial condition, as well as adversely affect the value of an investment in our common stock. There may be additional risks that we do not presently know of or that we currently believe are immaterial which could also impair our business and financial position.
- RISKS RELATED TO THE DISCOVERY AND DEVELOPMENT OF PRODUCT CANDIDATES
- The approach we are taking to discover and develop drugs is novel and may never lead to marketable products.
- We may not be successful in our efforts to identify or discover potential product candidates.
- Preclinical and clinical studies of our product candidates may not be successful. If we are unable to generate successful results from our preclinical and clinical studies of our product candidates, or experience significant delays in doing so, our business may be materially harmed.
- If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
- Any of our product candidates may cause adverse effects ("AEs") or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance.
- Interim, topline and preliminary data from our clinical trials and preclinical studies 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.
- Even if we complete the necessary preclinical studies and clinical trials, we cannot predict whether or when we will obtain regulatory approval to commercialize a product candidate and we cannot, therefore, predict the timing of any revenue from a future product.
- We may attempt to secure approval from the FDA through the use of the accelerated approval pathway. If we are unable to obtain such approval, we may be required to conduct additional clinical trials beyond those that we currently contemplate, which could increase the expense of obtaining, and delay the receipt of, necessary regulatory approvals. Even if we receive accelerated approval from the FDA, if our confirmatory trials do not verify clinical benefit, or if we do not comply with rigorous post-marketing requirements, the FDA may seek to withdraw any accelerated approval we have obtained.
- We may fail to obtain orphan drug designations from the FDA for our product candidates, and even if we obtain such designations, we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
- Even if we obtain regulatory approval for a product candidate, we will still face extensive regulatory requirements and our products may face future development and regulatory difficulties.
The other 46 risks
- We may not be successful in obtaining or maintaining necessary rights to microRNA targets, drug compounds and processes for our development pipeline through acquisitions and in-licenses.
- We may use our financial and human resources to pursue a particular research program, product candidate or clinical development strategy and fail to capitalize on programs, product candidates or clinical development strategies that may be more profitable or for which there is a greater likelihood of success.
- If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
- RISKS RELATED TO OUR FINANCIAL CONDITION AND NEED FOR ADDITIONAL CAPITAL
- We will need to raise additional capital to develop our product candidates and implement our operating plans, and if we are unable to do so when needed, we will not be able to complete the development and commercialization of our product candidates.
- We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future.
- We have never generated any revenue from product sales and may never be profitable.
- RISKS RELATED TO OUR RELIANCE ON THIRD PARTIES
- We may depend upon collaborations for the development and eventual commercialization of certain microRNA product candidates. If these collaborations are unsuccessful or are terminated, we may be unable to commercialize certain product candidates and we may be unable to generate revenues from our development programs.
- We rely on third parties to conduct some aspects of our compound formulation, research and preclinical studies, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such formulation, research or testing.
- We rely on third-party manufacturers to produce our preclinical and clinical product candidates, and we intend to rely on third parties to produce future clinical supplies of product candidates that we advance into clinical trials and commercial supplies of any approved product candidates.
- We rely on limited sources of supply for the drug substance of product candidates and any disruption in the chain of supply may cause a delay in developing and commercializing these product candidates.
- Manufacturing issues may arise that could increase product and regulatory approval costs or delay commercialization.
- We rely on third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
- RISKS RELATED TO OUR INTELLECTUAL PROPERTY
- If we are unable to obtain or protect intellectual property rights related to our future products and product candidates, we may not be able to compete effectively in our markets.
- Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
- If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
- We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
- RISKS RELATED TO COMMERCIALIZATION OF PRODUCT CANDIDATES
- We face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.
- The commercial success of our product candidates will depend upon the acceptance of these product candidates by the medical community, including physicians, patients and healthcare payors.
- If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate any revenues.
- If we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.
- Coverage and adequate reimbursement may not be available for our product candidates, which could make it difficult for us to sell products profitably.
- RISKS RELATED TO OUR BUSINESS OPERATIONS AND INDUSTRY
- Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
- We may need to expand our organization and may experience difficulties in managing this growth, which could disrupt our operations.
- Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
- We may undertake internal restructuring activities that could result in disruptions to our business or otherwise materially harm our results of operations or financial condition.
- Recent and future healthcare legislation may further impact our business operations.
- We face potential product liability, and, if successful claims are brought against us, we may incur substantial liability and costs.
- We and the third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations, rules, contractual obligations, policies 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 lead to regulatory investigations or actions, litigation (including class actions), fines and penalties, disruptions of our business operations, reputational harm, loss of revenue or profits, and other adverse business consequences.
- Cybersecurity risks and the failure to maintain the security, confidentiality, integrity, and availability of our information technology systems or data, those maintained on our behalf, or those of third parties with whom we work, could result in material adverse impact to our business, including without limitation regulatory investigations or actions, a material interruption to our operations, including clinical trials, damage to our reputation and/or subject us to costs, fines and penalties or lawsuits.
- Changes in funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.
- Our business and operations might be disrupted or adversely affected by catastrophic events.
- Our business could be adversely affected by the effects of health pandemics or epidemics in regions where we or third parties with whom we work have significant manufacturing facilities, concentrations of clinical trial sites or other business operations, or materially affect our operations globally, including at our headquarters in San Diego and at our clinical trial sites, as well as the business or operations of our manufacturers, CROs or other third parties with whom we conduct business.
- Our business could be negatively impacted by environmental, social and corporate governance ("ESG") matters or our reporting of such matters.
- RISKS RELATED TO OUR COMMON STOCK
- The market price of our common stock may be highly volatile.
- We may be unable to comply with the applicable continued listing requirements of The Nasdaq Capital Market.
- The requirements of being a publicly traded company may strain our resources and divert management’s attention.
- Changes or modifications in financial accounting standards, including those related to revenue recognition, may harm our results of operations.
- Sales of a substantial number of shares of our common stock in the public market by our existing stockholders could cause our stock price to fall.
- Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
- We may be the subject of putative securities class action litigation in the future.
- Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.
- Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
- We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
- Provisions in our amended and restated certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders or remove our current management.
- GENERAL RISK FACTORS
- Unstable market, economic and geopolitical conditions may have serious adverse consequences on our business, financial condition and stock price.
Legal proceedings
We currently are not a party to, and none of our property is the subject of, any material legal proceedings within the meaning of Item 103 of Regulation S-K promulgated under the Securities Act of 1933, as amended.
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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- 16SEC EDGARPreston Klassen, President
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- 23SEC EDGARDavid Leslie Szekeres, Officer
- 24SEC EDGARPaul C. Grint, Chief Medical Officer
- 25SEC EDGARPreston Klassen, Board member
- 26SEC EDGARAlice Shih-Hou Huang, Board member
- 27SEC EDGARJason Raleigh Nunn, Board member
- 28SEC EDGARSimos Simeonidis, Board member
- 29SEC EDGARKathryn J. Collier, Board member
- 30SEC EDGARPascale Witz, Board member
- 31SEC EDGARHugh Rosen, Board member
- 32SEC EDGARMark G. Foletta, Board member
- 33SEC EDGARWilliam H. Rastetter, Board member
- 34SEC EDGARB. Lynne Parshall, Board member
- 35SEC EDGARBarry E. Greene, Board member
- 36SEC EDGARBruce L. A. Carter, Board member
- 37SEC EDGARDavid Baltimore, Board member
- 38SEC EDGARJohn Maraganore, Board member
- 39SEC EDGARStanley T. Crooke, Board member
- 40SEC EDGARStelios Papadopoulos, Board member
- 41SEC EDGARDouglas E. Williams, Board member
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- 46SEC EDGARResults of operations
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- 49SEC EDGARResults of operations
- 50SEC EDGAREntered a material agreement
- 51SEC EDGARResults of operations
- 52SEC EDGAREntered a material agreement
- 53SEC EDGARResults of operations
- 54SEC EDGAROther events
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- 56SEC EDGARResults of operations
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