Private company
Day One Biopharmaceuticals, Inc.
In its 2026 annual report the company says: “Day One Biopharmaceuticals, Inc., or the Company or Day One, is a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases. Our “search & development” strategy enables us to find, acquire, and develop potential best- or first-in-class programs with the goal of introducing new medicines that will make a real difference in the treatment of children and adults.”4 It is headquartered in Brisbane, California.1
Last updated Oct 20, 2026.
Overview
- IndustryPharmaceutical Preparations1
- HeadquartersBrisbane, California1
- Incorporated inDE2
- Business address1800 Sierra Point Parkway, Suite 200, Brisbane, Ca 940052
- Filer categoryLarge accelerated filer2
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Day One Biopharmaceuticals, Inc., or the Company or Day One, is a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases.4 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
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Research and development94¢$148.1M
- Other costs5¢$8.1M
- Income tax1¢$2.0M
Out of $158.2M in revenue.56 The company lost money this year.
Financial statements
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Revenue | $07 | $05 | $131.2M5 | $158.2M5 | |||
| Research and development | $13.9M8 | $9.1M9 | $43.6M10 | $85.6M7 | $130.5M5 | $227.7M5 | $148.1M5 |
| Operating expenses | $72.7M10 | $146.9M7 | $206.1M5 | $348.4M5 | $285.9M5 | ||
| Operating income | -$14.9M8 | -$13.8M9 | -$72.7M10 | -$146.9M7 | -$206.1M5 | -$217.3M5 | -$127.8M5 |
| Income tax | $07 | $05 | $7.1M5 | -$2.0M5 | |||
| Net income | -$12.6M8 | -$40.5M9 | -$72.8B6 | -$142.2B6 | -$188.9B6 | -$95.5B6 | -$107.3B6 |
| Earnings per share | -$7.339 | -$4.6210 | -$2.177 | -$2.375 | -$1.025 | -$1.045 | |
| Earnings per share (diluted) | -$7.339 | -$4.6210 | -$2.177 | -$2.375 | -$1.025 | -$1.045 | |
| Shares (weighted, basic) | 37.0M shares10 | 65.5M shares7 | 79.8M shares5 | 93.2M shares5 | 103.2M shares5 | ||
| Shares (weighted, diluted) | 37.0M shares10 | 65.5M shares7 | 79.8M shares5 | 93.2M shares5 | 103.2M shares5 |
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Cash | $27.3M8 | $43.7M8 | $284.3M9 | $85.3M10 | $230.8M7 | $125.0M5 | $197.1M5 |
| Inventory | $07 | $3.3M5 | $6.3M5 | ||||
| Current assets | $45.1M8 | $289.4M9 | $347.9M10 | $375.3M7 | $562.3M5 | $485.1M5 | |
| Property, plant and equipment | $57.0K9 | $20.0K10 | $208.0K7 | $2.3M5 | $2.1M5 | ||
| Intangible assets | $07 | $15.6M5 | $18.0M5 | ||||
| Total assets | $45.7M8 | $289.8M9 | $349.1M10 | $376.0M7 | $582.8M5 | $507.8M5 | |
| Accounts payable | $1.7M9 | $260.0K10 | $2.6M7 | $3.3M5 | $3.7M5 | ||
| Current liabilities | $2.0M8 | $8.7M9 | $16.6M10 | $29.5M7 | $73.5M5 | $60.5M5 | |
| Total liabilities | $2.2M8 | $8.7M9 | $17.0M10 | $29.5M7 | $80.0M5 | $66.7M5 | |
| Retained earnings | -$127.5M9 | -$269.7M10 | -$458.6M7 | -$554.1M5 | -$661.4M5 | ||
| Shareholders’ equity | -$10.7M9 | -$54.2M10 | $281.1M7 | $332.0M5 | $346.5M5 | $502.8M5 | $441.2M5 |
| Shares outstanding | 62.0M shares9 | 73.5M shares10 | 87.2M shares7 | 101.1M shares5 | 103.0M shares5 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Cash from operations | -$4.5M8 | -$13.5M9 | -$48.5M10 | -$109.9M7 | -$146.9M5 | -$78.1M5 | -$103.8M5 |
| Depreciation and amortization | $20.0K10 | $63.0K7 | $36.0K5 | $92.0K5 | $366.0K5 | ||
| Stock-based compensation | $13.3M10 | $27.2M7 | $39.3M5 | $48.3M5 | $44.4M5 | ||
| Capital spending | $08 | $92.0K9 | $010 | $26.0K7 | $224.0K5 | $2.2M5 | $320.0K5 |
| Free cash flow | -$4.5M | -$13.6M | -$48.5M | -$109.9M | -$147.1M | -$80.3M | -$104.1M |
| Cash from investing | -$8.0M10 | -$255.1M7 | $128.4M5 | -$231.0M5 | $174.6M5 | ||
| Cash from financing | $297.1M10 | $165.9M7 | $164.0M5 | $203.3M5 | $1.2M5 |
Compare Day One Biopharmaceuticals, Inc. with another company
Corporate structure
Day One Biopharmaceuticals, Inc. sits at the top of its group. 3 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Day One Biopharmaceuticals, Inc.
- Vestal Point Capital, LP Filed SCHEDULE 13G/A on Day One Biopharmaceuticals, Inc., latest May 15, 2026 (2 filings since Feb 17, 2026)
- Atlas Venture Fund XI, L.P. Filed SCHEDULE 13G/A on Day One Biopharmaceuticals, Inc., latest May 14, 2026 (5 filings since Feb 11, 2022)
- AI Day1 LLC Filed SCHEDULE 13D/A on Day One Biopharmaceuticals, Inc., latest Apr 27, 2026 (6 filings since Jun 21, 2022)
- FMR LLC Filed SCHEDULE 13G/A on Day One Biopharmaceuticals, Inc., latest Apr 7, 2026 (11 filings since Sep 12, 2022)
- VANGUARD GROUP INC Filed SCHEDULE 13G/A on Day One Biopharmaceuticals, Inc., latest Mar 26, 2026 (2 filings since Feb 13, 2024)
- GLAZER CAPITAL, LLC Filed SCHEDULE 13G on Day One Biopharmaceuticals, Inc., latest Mar 19, 2026
- RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on Day One Biopharmaceuticals, Inc., latest Aug 14, 2025 (4 filings since Feb 14, 2023)
- Canaan XI L.P. Filed SC 13D/A on Day One Biopharmaceuticals, Inc., latest Nov 2, 2022 (5 filings since Dec 22, 2021)
- Takeda Pharmaceutical Company Filed SC 13G on Day One Biopharmaceuticals, Inc., latest Jan 14, 2022
- Day One Biopharmaceuticals, Inc. Brisbane, California
- Mersana Securities Corp. Subsidiary · Massachusetts, United States
- Mersana Therapeutics, Inc. Subsidiary · Delaware, United States
Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Day One Biopharmaceuticals, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, net | $2.1M5 Dec 31, 2025 | $2.3M5 Dec 31, 2024 | −6.5% |
| Operating-lease assets (leased space) | $2.3M5 Dec 31, 2025 | $2.4M5 Dec 31, 2024 | −3.3% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $197.1M5 Dec 31, 2025 | $125.0M5 Dec 31, 2024 | +57.7% |
| Marketable securities, current | $244.0M5 Dec 31, 2025 | $406.8M5 Dec 31, 2024 | −40.0% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Indefinite-lived intangibles (excluding goodwill) | $18.0M5 Dec 31, 2025 | $15.6M5 Dec 31, 2024 | +15.3% |
| Finite-lived intangibles, gross | $22.6M5 Dec 31, 2025 | $17.1M5 Dec 31, 2024 | +32.2% |
| Accumulated amortization | $4.6M5 Dec 31, 2025 | $1.5M5 Dec 31, 2024 | +211.6% |
| Finite-lived intangibles, net | $18.0M5 Dec 31, 2025 | $15.6M5 Dec 31, 2024 | +15.3% |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $6.3M5 Dec 31, 2025 | $3.3M5 Dec 31, 2024 | +90.5% |
| Raw materials | $05 Dec 31, 2025 | $05 Dec 31, 2024 | |
| Work in process | $4.3M5 Dec 31, 2025 | $2.4M5 Dec 31, 2024 | +77.0% |
| Finished goods | $2.0M5 Dec 31, 2025 | $873.0K5 Dec 31, 2024 | +128.3% |
Properties, in its own words
Our principal executive office is located in Brisbane, California, where we lease approximately 19,000 square feet of office space. The lease expires in January 2032. There is no option to extend the lease term nor is there an option to terminate the lease prior to its expiration. We believe these facilities are sufficient to meet our ongoing needs and that, if we require additional space, we will be able to obtain additional facilities on commercially reasonable terms.
Item 2 of the 10-K filed Feb 24, 2026.4
Leadership
Who has led Day One Biopharmaceuticals, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerJeremy Bender May 26, 2021 to now13
- Chief financial officerCharles N. York Ii. May 26, 2021 to now14
- Chief operating officerCharles N. York Ii. May 26, 2021 to now14
Board members and other officers (16)
- Chief Commercial OfficerLauren Merendino Feb 28, 2025 to now15
- Head of Research and Dev.Michael Vasconcelles Jun 18, 2025 to now16
- Gen Counsel & SecretaryAdam Dubow Aug 19, 2025 to now17
- Chief Medical OfficerSamuel C. Blackman May 26, 2021 to now18
- Board memberHabib J. Dable Jan 19, 2024 to now19
- Board memberWilliam Grossman Jan 19, 2024 to now20
- Board memberGarry A. Nicholson Sep 14, 2022 to now21
- Board memberDaniel J. Becker May 26, 2021 to Jun 26, 202322
- Board memberJeremy Bender May 26, 2021 to now13
- Board memberJohn A. Josey May 26, 2021 to now23
- Board memberMichael Gladstone May 26, 2021 to May 28, 202424
- Board memberNatalie C. Holles May 26, 2021 to now25
- Board memberSaira Ramasastry May 26, 2021 to now26
- Board memberJulie Papanek Jun 2, 2021 to Mar 3, 202327
- Board memberJ. Scott Garland Aug 18, 2021 to now28
- General counselAdam Dubow Nov 16, 2023 to now29
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Former names
- Day One Biopharmaceuticals Holding Co LLCFeb 16, 2021 to May 26, 20212
Timeline
- Apr 23, 20268-K Ended a material agreement; Completed an acquisition or sale; Listing notice or transfer30
- Mar 9, 20268-K Financial statements and exhibits31
- Mar 6, 20268-K Entered a material agreement; Other events32
- Mar 2, 20268-K Regulation FD disclosure33
- Feb 24, 20268-K Results of operations; Regulation FD disclosure34
- Jan 12, 20268-K Results of operations; Regulation FD disclosure35
- Jan 6, 20268-K Entered a material agreement; Completed an acquisition or sale; Regulation FD disclosure36
- Nov 24, 20258-K Regulation FD disclosure; Other events37
- Nov 13, 20258-K Entered a material agreement; Regulation FD disclosure38
- Nov 4, 20258-K Results of operations; Regulation FD disclosure39
- Oct 10, 20258-K Executive or director change40
- Aug 5, 20258-K Results of operations; Regulation FD disclosure41
- May 26, 2021New chief executive Jeremy Bender becomes CEO13
Calendar
When it reported results
- Feb 24, 2026Reported quarterly or annual results34
- Jan 12, 2026Reported quarterly or annual results35
- Nov 4, 2025Reported quarterly or annual results39
- Aug 5, 2025Reported quarterly or annual results41
- May 6, 2025Reported quarterly or annual results42
- Feb 25, 2025Reported quarterly or annual results43
- Jan 13, 2025Reported quarterly or annual results44
- Oct 30, 2024Reported quarterly or annual results45
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
436 filings to the SEC since October 2021: 7 annual reports, 13 quarterly reports, 62 major events, 229 insider forms, 37 large holders, 88 other. The latest 20:
- May 15, 2026SCHEDULE 13G/A EDGAR
- May 14, 2026SCHEDULE 13G/A EDGAR
- May 4, 202615-12G EDGAR
- Apr 27, 2026SCHEDULE 13D/A EDGAR
- Apr 27, 20264 EDGAR
- Apr 23, 20264 EDGAR
- Apr 23, 20264 EDGAR
- Apr 23, 20264 EDGAR
- Apr 23, 20264 EDGAR
- Apr 23, 20264 EDGAR
- Apr 23, 20264 EDGAR
- Apr 23, 20264 EDGAR
- Apr 23, 20264 EDGAR
- Apr 23, 20264 EDGAR
- Apr 23, 20264 EDGAR
- Apr 23, 20264 EDGAR
- Apr 23, 20264 EDGAR
- Apr 23, 2026S-8 POS EDGAR
- Apr 23, 2026S-8 POS EDGAR
- Apr 23, 2026S-8 POS EDGAR
The 436 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
161 open-market trades by officers, directors and large owners since October 2021: 10 buys and 151 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Feb 17, 2026 | Bender JeremyCHIEF EXECUTIVE OFFICER | Sale | 15,459 | $11.60 | $179.3K | Form 4 |
| Feb 17, 2026 | Merendino LaurenChief Commercial Officer | Sale | 5,814 | $11.60 | $67.4K | Form 4 |
| Feb 17, 2026 | Dubow AdamGen Counsel & Secretary | Sale | 6,395 | $11.60 | $74.2K | Form 4 |
| Feb 17, 2026 | VASCONCELLES MICHAELHead of Research and Dev. | Sale | 2,728 | $11.60 | $31.6K | Form 4 |
| Feb 17, 2026 | York Charles N IICOO and CFO | Sale | 6,065 | $11.60 | $70.4K | Form 4 |
| Nov 17, 2025 | Bender JeremyCHIEF EXECUTIVE OFFICER | Sale | 15,894 | $8.91 | $141.6K | Form 4 |
| Nov 17, 2025 | Merendino LaurenChief Commercial Officer | Sale | 3,726 | $8.91 | $33.2K | Form 4 |
| Nov 17, 2025 | Dubow AdamGen Counsel & Secretary | Sale | 4,319 | $8.91 | $38.5K | Form 4 |
| Nov 17, 2025 | York Charles N IICOO and CFO | Sale | 4,062 | $8.91 | $36.2K | Form 4 |
| Aug 18, 2025 | York Charles N IICOO and CFO | Sale | 4,106 | $6.77 | $27.8K | Form 4 |
| Aug 18, 2025 | Dubow AdamGen Counsel & Secretary | Sale | 4,365 | $6.77 | $29.6K | Form 4 |
| Aug 18, 2025 | Bender JeremyCHIEF EXECUTIVE OFFICER | Sale | 16,058 | $6.77 | $108.7K | Form 4 |
| Aug 18, 2025 | Merendino LaurenChief Commercial Officer | Sale | 3,766 | $6.77 | $25.5K | Form 4 |
| May 16, 2025 | Merendino LaurenChief Commercial Officer | Sale | 3,927 | $6.26 | $24.6K | Form 4 |
| May 16, 2025 | Dubow AdamGen Counsel & Secretary | Sale | 4,552 | $6.26 | $28.5K | Form 4 |
| May 16, 2025 | York Charles N IICOO and CFO | Sale | 4,282 | $6.26 | $26.8K | Form 4 |
| May 16, 2025 | Bender JeremyCHIEF EXECUTIVE OFFICER | Sale | 13,964 | $6.26 | $87.4K | Form 4 |
| Feb 18, 2025 | York Charles N IICOO and CFO | Sale | 4,370 | $11.96 | $52.3K | Form 4 |
| Feb 18, 2025 | Dubow AdamGen Counsel & Secretary | Sale | 4,646 | $11.96 | $55.6K | Form 4 |
| Feb 18, 2025 | Bender JeremyCHIEF EXECUTIVE OFFICER | Sale | 12,048 | $11.96 | $144.1K | Form 4 |
All 161 trades can be filtered by person here when JavaScript is on.
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.
- Vestal Point Capital, LPSCHEDULE 13G/A, 2 filings Feb 17, 2026 to May 15, 202646
- Atlas Venture Fund XI, L.P.SCHEDULE 13G/A, 5 filings Feb 11, 2022 to May 14, 202647
- AI Day1 LLCSCHEDULE 13D/A, 6 filings Jun 21, 2022 to Apr 27, 202648
- FMR LLCSCHEDULE 13G/A, 11 filings Sep 12, 2022 to Apr 7, 202649
- VANGUARD GROUP INCSCHEDULE 13G/A, 2 filings Feb 13, 2024 to Mar 26, 202650
- GLAZER CAPITAL, LLCSCHEDULE 13G, 1 filing Mar 19, 202651
- RA CAPITAL MANAGEMENT, L.P.SCHEDULE 13G/A, 4 filings Feb 14, 2023 to Aug 14, 202552
- Canaan XI L.P.SC 13D/A, 5 filings Dec 22, 2021 to Nov 2, 202253
- Takeda Pharmaceutical CompanySC 13G, 1 filing Jan 14, 202254
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 |
|---|---|---|---|---|
| 2024 | Jeremy BenderChief Executive Officer and President | $680.0K | $6.6M55 | |
| 2024 | Charles N. York IIChief Operating Officer and Chief Financial Officer | 48 | $541.0K | $3.9M55 |
| 2024 | Samuel BlackmanCo-Founder and Head of Research and Development | $527.0K | $3.6M55 | |
| 2024 | Adam DubowGeneral Counsel, Chief Compliance Officer and Secretary | 58 | $455.0K | $2.4M55 |
| 2023 | Jeremy BenderChief Executive Officer and President | $647.0K | $6.9M55 | |
| 2023 | Charles N. York IIChief Operating Officer and Chief Financial Officer | 48 | $515.0K | $3.5M55 |
| 2023 | Adam DubowGeneral Counsel, Chief Compliance Officer and Secretary | 58 | $425.0K | $2.8M55 |
| 2023 | Samuel BlackmanCo-Founder and Head of Research and Development | $500.0K | $2.5M55 | |
| 2022 | Jeremy BenderChief Executive Officer and President | $610.0K | $5.1M55 | |
| 2022 | Charles N. York IIChief Operating Officer and Chief Financial Officer | 48 | $495.0K | $2.3M55 |
| 2022 | Samuel BlackmanCo-Founder and Head of Research and Development | $470.0K | $2.1M55 |
SEC filer profile
How Day One Biopharmaceuticals, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARDay One Biopharmaceuticals, Inc.1
- CIK0001845337
- Employer ID (EIN)83-24152154
- Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address1800 Sierra Point Parkway, Suite 200, Brisbane, CA 940051
- Phone650 484-08991
- Shares outstanding103,334,169 as of Apr 15, 20266
- Public float$567.0M as of Jun 30, 20254
- AuditorPricewaterhouseCoopers LLP, Los Angeles, California PCAOB ID 238; it also attests to the company’s internal control over financial reporting4
- On EDGAR sinceFeb 16, 20211
- Filings493 in all: 4 (227), 8-K (63), 144 (39), 3 (20), 10-Q (14), SCHEDULE 13G/A (11), SC 13G/A (10), SC 13D/A (9)1
All 46 form types
SC 13G (7), SC TO-C (7), S-8 (6), S-8 POS (6), SC TO-T/A (6), 10-K (5), CORRESP (5), 424B5 (4), DEF 14A (4), DEFA14A (4), ARS (3), SC 14D9/A (3), SCHEDULE 13G (3), UPLOAD (3), 10-K/A (2), 5 (2), EFFECT (2), POSASR (2), S-1/A (2), S-3ASR (2), SC 13D (2), SC TO-T (2), SCHEDULE 13D/A (2), SEC STAFF LETTER (2), 15-12G (1), 25-NSE (1), 4/A (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), D (1), DRS (1), PRE 14A (1), S-1 (1), S-3 (1), SC 14D9 (1), SC14D9C (1)
- Latest filingsAnnual report (10-K) Feb 24, 2026
Quarterly report (10-Q) Nov 4, 2025
Proxy statement (DEF 14A) Apr 11, 2025
Latest 8-K (8-K) Apr 23, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001 per share | DAWN | Nasdaq Global Select Market |
From the cover page of the 10-K filed Feb 24, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Day One Biopharmaceuticals, Inc. names in Item 1A of its 10-K filed Feb 24, 2026: 74 risks under these headings, as written.4
- Risks Related to Our Financial Position
- We are a commercial-stage biopharmaceutical company with a limited operating history in the initial stages of the commercialization our product OJEMDA, which may make it difficult for investors to evaluate our current business and likelihood of success and viability.
- We have incurred significant net losses since our inception. We expect to incur continued losses for the foreseeable future and may never achieve or maintain profitability.
- Our near-term revenues are highly dependent on the successful commercialization of OJEMDA, which received marketing approval in April 2024 from the FDA for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. To the extent that OJEMDA is not commercially successful, our business, financial condition and results of operations would be materially and adversely affected and the price of our common stock would decline.
- Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating to the development and commercialization of OJEMDA, Emi-Le, DAY301 and our future product candidates.
- We may require additional capital to finance our operations and achieve our goals. If we are unable to raise capital when needed or on terms acceptable to us, we may be forced to delay, reduce or eliminate our research or product development programs, any future commercialization efforts or other operations.
- Risks Related to Development and Commercialization of OJEMDA and our Product Candidates
- Clinical trials are very expensive, time-consuming and difficult to design and implement, and involve uncertain outcomes. Furthermore, results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies or clinical trials. OJEMDA and our product candidates may not have favorable results in later clinical trials, if any, and not all of our product candidates will receive marketing authorization. If we fail to demonstrate the safety and effectiveness of our product candidates, our reputation may be harmed and our business will suffer.
- OJEMDA has only been studied in a limited number of patients. Following commercial launch, OJEMDA is now available to a much larger number of patients, and we do not know whether the results of OJEMDA’s use in such larger number of patients will be consistent with the results from our clinical studies.
- We may rely on data from investigator-initiated studies, as we did for the Phase 1 clinical trial, and we do not control the trial operations or reporting of the results of such trials.
- Our clinical trials may be suspended, delayed or fail to adequately demonstrate the safety and effectiveness of OJEMDA and our product candidates, which would prevent or delay development, marketing authorization and commercialization.
- We cannot predict the outcome of our clinical trials, nor can we guarantee that the data we generate from our clinical trials will be acceptable to regulatory authorities so as to support marketing authorization.
The other 64 risks
- If we experience delays or difficulties in enrolling patients in our ongoing or planned clinical trials, we may be delayed in or prevented from obtaining necessary marketing authorization for any or all of our product candidates.
- Preliminary, interim, initial 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.
- We face substantial competition which may result in others discovering, developing or commercializing products before or more successfully than we do.
- Safety risks or other side effects associated with OJEMDA, Emi-Le, DAY301 or any future products and product candidates we may develop could delay or preclude approval, cause us to suspend or discontinue clinical trials or abandon further development, limit the use of an approved product or result in significant negative consequences following marketing authorization, if any.
- We may expend our limited resources to pursue a particular product or 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.
- The market opportunities for any products and product candidates we develop, if approved, may be limited to certain smaller patient subsets and may be smaller than we estimate them to be.
- Our clinical development activities are primarily focused on the development of targeted therapeutics for patients with genomically-defined cancers, which is a rapidly evolving area of science, and the approach we are taking to search and develop drugs is novel and may never lead to additional approved or marketable products.
- OJEMDA and our product candidates, Emi-Le and DAY301, may not achieve adequate market acceptance among physicians, healthcare professionals, patients or their families, healthcare payors and others in the medical community necessary for commercial success.
- Any products and product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as price restrictions.
- Our business entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage such inability could have an adverse effect on our business and financial condition.
- Risks Related to Government Regulation
- The development and commercialization of pharmaceutical products are subject to extensive regulation, and we may not obtain marketing authorizations for Emi-Le and DAY301 or any future product candidates, on a timely basis or at all.
- If we seek to utilize any of the FDA’s expedited programs, the FDA may not find our product candidates to be eligible for these programs and, if granted, these programs may not lead to faster development, regulatory review or approval of our product candidates.
- The accelerated approval pathway may be unavailable or, if available, may not lead to faster development, regulatory review or marketing authorization, and the use of the accelerated approval pathway does not necessarily increase the likelihood that our product candidates will receive marketing authorization.
- We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates.
- We must comply with certain legal requirements and FDA policies, and may seek incentives under certain laws, relating to the development of drugs for pediatric patients, including the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.
- We may seek a rare pediatric disease designation for one or more of our product candidates under the FDA’s Rare Pediatric Disease Priority Review Voucher Program. Even if we were to obtain marketing authorization for a product with a rare pediatric disease designation, the Rare Pediatric Disease Priority Review Voucher Program may no longer be in effect at the time of such approval or we might not be able to capture the value of the Rare Pediatric Disease Priority Review Voucher Program.
- If we or a business partner are unable to successfully develop, validate, obtain marketing authorization for and commercialize any companion diagnostic tests that are deemed necessary for the use of any of our product candidates, or experience significant delays in doing so, we may not be able to obtain marketing authorization for, or realize the full commercial potential of, one or more of our product candidates.
- For each product and product candidate for which marketing authorization is granted, including OJEMDA, the terms of approvals, ongoing regulation of our products or other post-approval restrictions may limit how we manufacture and market our products and compliance with such requirements may involve substantial resources, which could materially impair our ability to generate revenue in line with our expectations.
- Any product for which we obtain marketing authorization, including OJEMDA, will be subject to ongoing enforcement of post-marketing requirements by regulatory agencies, and we could be subject to substantial penalties, including withdrawal of our product from the market, if we fail to comply with all regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.
- Our failure to obtain marketing authorization in foreign jurisdictions would prevent OJEMDA and our product candidates from being marketed in those jurisdictions, and any approval we are granted for our product candidates in the United States would not assure approval of product candidates in foreign jurisdictions.
- Our current and future relationships with customers and third-party payors may be subject to applicable anti-kickback, fraud and abuse, transparency, health privacy and other healthcare laws and regulations, which could expose us to significant penalties, including criminal, civil and administrative penalties, contractual damages, reputational harm and diminished profits and future earnings.
- Existing, recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing authorization of and commercialize our product candidates and decrease the prices we may obtain.
- Governments outside of the United States tend to impose strict price controls, which may adversely affect our future revenues.
- Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain product candidates and products outside of the United States and require us to develop and implement costly compliance programs.
- Disruptions at the FDA may slow the time necessary for new products to be reviewed and/or approved, which would adversely affect our business. There is substantial uncertainty regarding new initiatives and how these might impact the FDA, its implementation of laws, regulations, policies and guidance and its personnel. Similar initiatives may also be directed toward other government agencies. These initiatives could prevent, limit or delay development and regulatory approval of our product candidates, which would adversely affect our business.
- 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 harm our business.
- We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations. We can face serious consequences for violations.
- We have limited experience as a commercial company and the sales, marketing, and distribution of OJEMDA or any future approved products may be unsuccessful or less successful than anticipated.
- Risks Related to Our Reliance on Third Parties
- We rely, and intend to continue to rely, on third parties to conduct our clinical trials and perform some of our research and potential preclinical studies. If these third parties do not satisfactorily carry out their contractual duties, fail to comply with applicable regulatory requirements or do not meet expected deadlines, our development programs may be delayed or subject to increased costs or we may be unable to obtain marketing authorization, each of which may have an adverse effect on our business, financial condition, results of operations and prospects.
- The manufacture of pharmaceutical products, including OJEMDA and our product candidates, DAY301 and Emi-Le, is complex. Our third-party manufacturers may encounter difficulties in production, which could delay or entirely halt their ability to supply our product candidates for clinical trials or, if approved, for commercial sale.
- We rely on a limited number of suppliers for raw materials and any disruptions arising from our sole suppliers could result in delays in our clinical trials or otherwise adversely affect our business and results of operations.
- Our existing License Agreement with Ipsen is important to our business. If Ipsen fails to fulfill its contract obligations, or if any of the Ipsen License Agreement is terminated, our ability to commercialize OJEMDA in territories outside the United States may be delayed or prevented and we may never receive milestone payments or future royalties under the License Agreement.
- We may enter into collaborations with third parties for the development and commercialization of our product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of our product candidates.
- The loss of any large customer, or any cancellation or delay of a significant purchase by a large customer, could reduce our net sales and harm our operating results.
- Risks Related to Employee Matters and Our Operations
- Our future success depends on our ability to retain our executive officers and key employees and to attract, retain and motivate qualified personnel and manage our human capital.
- We will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth.
- Our employees, clinical trial investigators, CROs, CMOs, consultants, vendors and any future commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
- If our security measures are compromised, or our information technology systems or those of our CROs, CMOs, vendors, contractors, consultants or other third-party partners fail or suffer security breaches, cyber-attacks, loss or leakage of data or other disruptions, it could result in a material disruption of our development programs, compromise sensitive information related to our business and other personal information or prevent us from accessing critical information, potentially exposing us to liability, harming our reputation, or otherwise adversely affecting our business.
- We are subject to stringent and changing laws, regulations, standards, and contractual obligations related to privacy, data protection and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions (which could include civil or criminal penalties), fines, sanctions, private litigation and/or adverse publicity and could negatively affect our operating results and business.
- Investors’ expectations of our performance relating to environmental, social and governance factors may impose additional costs and expose us to new risks.
- We or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
- Changes in tax laws or regulations that are applied adversely to us 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 have engaged, and will continue to engage, in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
- Risks Related to Our Intellectual Property
- If we are unable to obtain and maintain patent protection or other necessary rights for our products and technology, or if the scope of the patent protection obtained is not sufficiently broad or our rights under our patents (owned, co-owned or licensed) is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our products and technology may be adversely affected.
- If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical products or product candidates would be adversely affected.
- Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
- Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
- Some of our current product candidates and research programs are licensed from third parties. If these license agreements are terminated or interpreted to narrow our rights, our ability to advance OJEMDA and our current product candidates or develop new product candidates based on these technologies will be materially adversely affected.
- If we breach our license agreements, it could have a material adverse effect on our commercialization efforts for OJEMDA and our product candidates.
- In the future, we may need to obtain additional licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms, and which may cause us to operate our business in a more costly or otherwise adverse manner that was not anticipated.
- We may be involved in lawsuits to protect or enforce our own patents or our licensors’ patents, which could be expensive, time consuming and unsuccessful. Further, our own issued patents or our licensors’ patents could be found invalid or unenforceable if challenged in court.
- Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline.
- Derivation proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to cease using the related technology or to attempt to license rights from the prevailing party.
- Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
- Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and/or those of our licensors and the enforcement or defense of our issued patents and/or those of our licensors.
- Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect OJEMDA and our product candidates.
- We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
- Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
- If we do not obtain patent term extension for OJEMDA and product candidates, our business may be materially harmed.
- We may not be able to protect our intellectual property rights throughout the world.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
Legal proceedings
The Company, from time to time, may be party to litigation arising in the ordinary course of business. The Company is not subject to any material legal proceedings, and to the best of its knowledge, no material legal proceedings are currently pending or threatened.
The opening of Item 3, Legal Proceedings.4
Sources
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- 17SEC EDGARAdam Dubow, Gen Counsel & Secretary
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- 19SEC EDGARHabib J. Dable, Board member
- 20SEC EDGARWilliam Grossman, Board member
- 21SEC EDGARGarry A. Nicholson, Board member
- 22SEC EDGARDaniel J. Becker, Board member
- 23SEC EDGARJohn A. Josey, Board member
- 24SEC EDGARMichael Gladstone, Board member
- 25SEC EDGARNatalie C. Holles, Board member
- 26SEC EDGARSaira Ramasastry, Board member
- 27SEC EDGARJulie Papanek, Board member
- 28SEC EDGARJ. Scott Garland, Board member
- 29SEC EDGARAdam Dubow, General counsel
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- 31SEC EDGARFinancial statements and exhibits
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- 33SEC EDGARRegulation FD disclosure
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