APVO on Nasdaq
Aptevo Therapeutics Inc.
American pharmaceutical preparations company based in Wilmington2
In its 2026 annual report the company says: “We are a clinical-stage, research and development biotechnology company focused on developing novel immunotherapy candidates for the treatment of different forms of cancer. We have developed two versatile and enabling platform technologies for rational design of precision immune modulatory drugs and have two clinical candidates and six preclinical candidates currently in development.”5 Its shares trade on Nasdaq under the symbol APVO.2
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Last updated Oct 21, 2026.
Overview
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- TickerAPVO on Nasdaq2
- IndustryPharmaceutical Preparations2
- HeadquartersWilmington, United States2
- Incorporated inDE3
- Business address2401 4Th Ave., Suite 1050, Seattle, Wa 981213
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI529900UTQOXOZBMZFN242
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressc/o The Corporation Trust Company, Corporation Trust Center 1209 Orange St, 19801 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 58336862
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We are a clinical-stage, research and development biotechnology company focused on developing novel immunotherapy candidates for the treatment of different forms of cancer. We have developed two versatile and enabling platform technologies for rational design of precision immune modulatory drugs and have two clinical candidates and six preclinical candidates currently in development. Clinical candidate mipletamig is a CD123xCD3 T cell engager currently being clinically evaluated in the RAINIER trail, part one of a Phase 1b/2 program initiated in August 2024 for the treatment of frontline acute myelogenous leukemia (AML) in combination with standard of care venetoclax + azacitidine. Clinical candidate ALG.APV-527 targets 4-1BB (co-stimulatory receptor) and 5T4 (tumor antigen). The compound is designed to reactivate antigen-primed T cells to specifically kill tumor cells and is currently b…5 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 2022
Where the money goes
Where each dollar of revenue went, fiscal 2022
- Research and development69¢$17.9M
- Profit31¢$8.0M
Out of $3.1M in revenue.6
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.14
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development | -$14.5M | -$14.4M |
| General and administrative | -$11.8M | -$10.2M |
| Loss from operations | -$26.3M | -$24.6M |
| Other income, net | $345.0K | $472.0K |
| Net loss | -$26.0M | -$24.1M |
| Dividend attributable to down round feature of warrants | -$1.6M | |
| Net loss attributable to common stockholders | -$27.5M | -$24.1M |
| Basic net loss per share | -$87.27 | -$31,460.23 |
| Diluted net loss per share | -$87.27 | -$31,460.23 |
| Basic shares used in calculation | 315.5K shares | 767 shares |
| Diluted shares used in calculation | 315.5K shares | 767 shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.14
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $21.6M | $8.7M | |
| Prepaid expenses and other current assets | $1.5M | $1.9M | |
| Total current assets | $23.1M | $10.7M | |
| Property and equipment, net | $303.0K | $543.0K | |
| Operating lease right-of-use asset | $3.8M | $4.4M | |
| Total assets | $27.2M | $15.6M | |
| Accounts payable | $877.0K | $1.2M | |
| Accrued expenses and other current liabilities | $4.3M | $4.2M | |
| Operating lease liability, current portion | $866.0K | $768.0K | |
| Total current liabilities | $6.0M | $6.2M | |
| Operating lease liability, net of current portion | $3.8M | $4.6M | |
| Total liabilities | $9.8M | $10.8M | |
| Common stock: $0.001 par value; 500,000,000 shares authorized; 997,830 and 4,051 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | $114.0K | $84.0K | |
| Additional paid-in capital | $292.4M | $252.2M | |
| Accumulated deficit | -$275.1M | -$247.6M | |
| Total stockholders' equity | $17.4M | $4.8M | $12.2M |
| Total liabilities and stockholders' equity | $27.2M | $15.6M | |
| Preferred stock, par value | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 15.0M shares | 15.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 500.0M shares | 500.0M shares | |
| Common stock, shares issued | 997.8K shares | 4.1K shares | |
| Common stock, shares outstanding | 997.8K shares | 4.1K shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $21.6M | $8.7M | |
| Prepaid expenses and other current assets | $1.5M | $1.9M | |
| Total current assets | $23.1M | $10.7M | |
| Property and equipment, net | $303.0K | $543.0K | |
| Operating lease right-of-use asset | $3.8M | $4.4M | |
| Total assets | $27.2M | $15.6M | |
| Accounts payable | $877.0K | $1.2M | |
| Accrued expenses and other current liabilities | $4.3M | $4.2M | |
| Operating lease liability, current portion | $866.0K | $768.0K | |
| Total current liabilities | $6.0M | $6.2M | |
| Operating lease liability, net of current portion | $3.8M | $4.6M | |
| Total liabilities | $9.8M | $10.8M | |
| Common stock: $0.001 par value; 500,000,000 shares authorized; 997,830 and 4,051 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | $114.0K | $84.0K | |
| Additional paid-in capital | $292.4M | $252.2M | |
| Accumulated deficit | -$275.1M | -$247.6M | |
| Total stockholders' equity | $17.4M | $4.8M | $12.2M |
| Total liabilities and stockholders' equity | $27.2M | $15.6M | |
| Preferred stock, par value | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 15.0M shares | 15.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 500.0M shares | 500.0M shares | |
| Common stock, shares issued | 997.8K shares | 4.1K shares | |
| Common stock, shares outstanding | 997.8K shares | 4.1K 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.14
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$26.0M | -$24.1M |
| Stock-based compensation | $96.0K | $1.1M |
| Non-cash lease expense | $1.1M | $1.1M |
| Depreciation and amortization | $240.0K | $352.0K |
| Prepaid expenses and other current assets | $483.0K | $217.0K |
| Accounts payable, accrued compensation, accrued expenses and other current liabilities, and short-term operating lease | -$157.0K | -$1.0M |
| Operating lease liability | -$1.4M | -$1.4M |
| Net cash used in operating activities | -$25.6M | -$23.8M |
| Net cash from investing activities | $0 | $0 |
| Value of equity awards withheld for tax liability | $0 | -$1.0K |
| Proceeds from exercise of common warrants, net of issuance costs | $557.0K | $5.6M |
| Proceeds from issuance of common stock, pre-funded warrants exercise, and common warrants exercise, net of issuance costs | $37.9M | $10.0M |
| Payments in lieu of fractional shares | -$3.0K | |
| Net cash provided by financing activities | $38.5M | $15.6M |
| Increase (decrease) in cash and cash equivalents | $12.9M | -$8.2M |
| Warrant modification - incremental value | $586.0K | $472.0K |
| Dividend attributable to down round feature of warrants | $1.6M | |
| Fair value of December 2024 inducement transaction common warrants | $7.3M |
No quarter-by-quarter statement was filed.
Corporate structure
Aptevo Therapeutics Inc. sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Aptevo Therapeutics Inc.
- CVI Investments, Inc. Filed SCHEDULE 13G/A on Aptevo Therapeutics Inc., latest Aug 14, 2026 (4 filings since Apr 10, 2025)
- NIOWAVE, INC. Filed SCHEDULE 13G on Aptevo Therapeutics Inc., latest Jun 22, 2026
- Point72 Asset Management, L.P. Filed SCHEDULE 13G/A on Aptevo Therapeutics Inc., latest Feb 17, 2026 (2 filings since Sep 17, 2025)
- Bank of America Filed SCHEDULE 13G/A on Aptevo Therapeutics Inc., latest Nov 7, 2025 (2 filings since Oct 6, 2025)
- L1 Capital Global Opportunities Master Fund, Ltd. Filed SCHEDULE 13G/A on Aptevo Therapeutics Inc., latest Aug 14, 2025 (6 filings since Apr 7, 2025)
- Ayrton Capital LLC Filed SCHEDULE 13G on Aptevo Therapeutics Inc., latest Aug 13, 2025
- YA II PN, Ltd. Filed SCHEDULE 13G on Aptevo Therapeutics Inc., latest Jul 8, 2025
- BIGGER CAPITAL FUND L P Filed SCHEDULE 13G on Aptevo Therapeutics Inc., latest Jun 25, 2025 (2 filings since Apr 8, 2025)
- INTRACOASTAL CAPITAL, LLC Filed SCHEDULE 13G on Aptevo Therapeutics Inc., latest Jun 25, 2025 (3 filings since Apr 9, 2025)
- Hudson Bay Capital Management LP Filed SCHEDULE 13G/A on Aptevo Therapeutics Inc., latest Feb 10, 2025 (3 filings since Nov 8, 2024)
- ARMISTICE CAPITAL, LLC Filed SC 13G/A on Aptevo Therapeutics Inc., latest Nov 14, 2024 (2 filings since Feb 14, 2024)
- RTW INVESTMENTS, LP Filed SC 13G/A on Aptevo Therapeutics Inc., latest Feb 14, 2023
- Aptevo Therapeutics Inc. Wilmington, Delaware, United States
- Aptevo Research and Development LLC Subsidiary · Delaware, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); 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 Aptevo 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 | $14.4M14 Dec 31, 2025 | $14.5M14 Dec 31, 2024 | −0.3% |
| Accumulated depreciation | $14.1M14 Dec 31, 2025 | $13.9M14 Dec 31, 2024 | +1.4% |
| Property and equipment, net | $303.0K14 Dec 31, 2025 | $543.0K14 Dec 31, 2024 | −44.2% |
| Operating-lease assets (leased space) | $3.8M14 Dec 31, 2025 | $4.4M14 Dec 31, 2024 | −13.2% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $21.6M14 Dec 31, 2025 | $8.7M14 Dec 31, 2024 | +148.1% |
Properties, in its own words
We lease our headquarters office and laboratory space in Seattle, Washington. The Seattle facility is approximately 48,000 square feet and the lease for the Seattle facility expires in April 2030.
Item 2 of the 10-K filed Mar 26, 2026.5
Leadership
Who has led Aptevo Therapeutics Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerJeffrey G. Lamothe Aug 10, 2026 to now15
- Chief executive officerMarvin L. White Aug 2, 2016 to Aug 10, 202616
- ChairMarvin L. White Aug 10, 2026 to now17
- PresidentJeffrey G. Lamothe Aug 10, 2026 to now15
- PresidentMarvin L. White Aug 2, 2016 to Aug 10, 202616
- Chief financial officerDaphne L. Taylor Mar 7, 2023 to now18
- Chief financial officerJeffrey G. Lamothe Aug 2, 2016 to Jan 30, 202319
- Chief operating officerJeffrey G. Lamothe Mar 7, 2023 to now20
Board members and other officers (18)
- SVP, CSOMary Jo Janatpour May 28, 2026 to now21
- SVP, CMODirk Huebner Jul 9, 2025 to now22
- OfficerSoyoung Kwon Jun 2, 2021 to now23
- SVP, Commercial OperationsMichael Adelman Aug 10, 2018 to Mar 19, 202024
- SVP, GC and Corporate AffairsShawnte Mitchell Aug 10, 2018 to Mar 19, 202025
- Senior VP, OperationsRandy Joe Maddux Sep 2, 2016 to Jul 29, 202026
- OfficerJane A. Gross Sep 12, 2016 to Feb 17, 202127
- Board memberJeffrey G. Lamothe Aug 10, 2026 to now15
- Board memberAnatolio B. Cruz Iii. Jul 15, 2016 to Jul 15, 201628
- Board memberEric M. Burt Jul 15, 2016 to Jul 15, 201629
- Board memberMichael Darling Jul 15, 2016 to Jul 15, 201630
- Board memberZsolt Harsanyi Jul 15, 2016 to now31
- Board memberBarbara Lopez Kunz Aug 2, 2016 to now32
- Board memberDaniel Abdun-Nabi Aug 2, 2016 to now33
- Board memberFuad El-Hibri Aug 2, 2016 to Dec 7, 202134
- Board memberGrady Grant Iii. Aug 2, 2016 to now35
- Board memberJohn Niederhuber Aug 2, 2016 to now36
- Board memberMarvin L. White Aug 2, 2016 to now16
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
- Aptevo Research and Development LLC Delaware4
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Timeline
- Oct 14, 20268-K Other events37
- Sep 24, 20268-K Other events38
- Sep 23, 20268-K Shareholder vote39
- Sep 3, 20268-K Other events40
- Aug 21, 20268-K Shareholder vote41
- Aug 14, 20268-K Results of operations42
- Aug 13, 20268-K Entered a material agreement; Unregistered sale of shares; Other events43
- Aug 10, 2026New chief executive Jeffrey G. Lamothe becomes CEO15
- Jul 27, 20268-K Other events44
- Jun 30, 20268-K Entered a material agreement; Regulation FD disclosure45
- May 27, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure46
- May 13, 20268-K Results of operations47
- May 6, 20268-K Other events48
- Aug 2, 2016New chief executive Marvin L. White becomes CEO16
Calendar
Coming up
- Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($40.11) a share, on Nov 6, 2025.49
When it reported results
- Aug 14, 2026Reported quarterly or annual results42
- May 13, 2026Reported quarterly or annual results47
- Mar 26, 2026Reported quarterly or annual results50
- Nov 6, 2025Reported quarterly or annual results51
- Aug 11, 2025Reported quarterly or annual results52
- May 15, 2025Reported quarterly or annual results53
- Apr 28, 2025Reported quarterly or annual results54
- Feb 14, 2025Reported quarterly or annual results55
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
387 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 99 major events, 108 insider forms, 31 large holders, 2 private raises, 127 other. The latest 20:
- Oct 14, 20268-K EDGAR
- Sep 25, 2026S-8 EDGAR
- Sep 24, 20268-K EDGAR
- Sep 23, 20268-K EDGAR
- Sep 3, 2026424B4 EDGAR
- Sep 3, 20268-K EDGAR
- Sep 2, 2026EFFECT EDGAR
- Aug 31, 2026CORRESP EDGAR
- Aug 31, 2026DEF 14A EDGAR
- Aug 27, 2026UPLOAD EDGAR
- Aug 26, 2026D EDGAR
- Aug 21, 2026PRE 14A EDGAR
- Aug 21, 2026S-1 EDGAR
- Aug 21, 20268-K EDGAR
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Aug 14, 202610-Q EDGAR
- Aug 14, 20268-K EDGAR
- Aug 13, 20268-K EDGAR
- Aug 10, 20264 EDGAR
- Aug 10, 20264 EDGAR
The 387 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
5 open-market trades by officers, directors and large owners since October 2021: 1 buys and 4 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Nov 10, 2025 | Grant Grady IIIDirector | Buy | 13,513 | $1.49 | $20.1K | Form 4 |
| Nov 23, 2021 | TANG CAPITAL PARTNERS LP | Sale | 921,336 | $11.25 | $10.4M | Form 4 |
| Nov 22, 2021 | TANG CAPITAL PARTNERS LP | Sale | 255,331 | $7.04 | $1.8M | Form 4 |
| Nov 19, 2021 | TANG CAPITAL PARTNERS LP | Sale | 213,800 | $7.59 | $1.6M | Form 4 |
| Nov 18, 2021 | TANG CAPITAL PARTNERS LP | Sale | 369,533 | $8.34 | $3.1M | 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.
- CVI Investments, Inc.SCHEDULE 13G/A, 4 filings Apr 10, 2025 to Aug 14, 202656
- NIOWAVE, INC.SCHEDULE 13G, 1 filing Jun 22, 202657
- Point72 Asset Management, L.P.SCHEDULE 13G/A, 2 filings Sep 17, 2025 to Feb 17, 202658
- Bank of AmericaSCHEDULE 13G/A, 2 filings Oct 6, 2025 to Nov 7, 202559
- L1 Capital Global Opportunities Master Fund, Ltd.SCHEDULE 13G/A, 6 filings Apr 7, 2025 to Aug 14, 202560
- Ayrton Capital LLCSCHEDULE 13G, 1 filing Aug 13, 202561
- YA II PN, Ltd.SCHEDULE 13G, 1 filing Jul 8, 202562
- BIGGER CAPITAL FUND L PSCHEDULE 13G, 2 filings Apr 8, 2025 to Jun 25, 202563
- INTRACOASTAL CAPITAL, LLCSCHEDULE 13G, 3 filings Apr 9, 2025 to Jun 25, 202564
- Hudson Bay Capital Management LPSCHEDULE 13G/A, 3 filings Nov 8, 2024 to Feb 10, 202565
- ARMISTICE CAPITAL, LLCSC 13G/A, 2 filings Feb 14, 2024 to Nov 14, 202466
- RTW INVESTMENTS, LPSC 13G/A, 1 filing Feb 14, 202367
- RENAISSANCE TECHNOLOGIES LLCSC 13G/A, 1 filing Feb 10, 202268
- TANG CAPITAL PARTNERS LPSC 13D/A, 2 filings Nov 22, 2021 to Nov 26, 202169
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) $5.6M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2026 | $3.5M | $3.5M |
| 2025 | $2.1M | $2.1M |
Private raises
Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Vanguard Capital Management LLC | 12,713 | $56.4K | 0.0% | No change |
| Geode Capital Management, LLC | 10,821 | $48.0K | 0.0% | −2,516 |
| Vanguard Fiduciary Trust Co | 4,142 | $18.4K | 0.0% | No change |
| UBS Group AG | 730 | $3.2K | 0.0% | −2,715 |
| Osaic Holdings, Inc. | 360 | $1.6K | 0.0% | No change |
| SBI Securities Co., Ltd. | 109 | $484 | 0.0% | No change |
| Barclays PLC | 31 | $138 | 0.0% | New |
| Gsa Capital Partners Llp | 21,539 | $96 | 0.0% | +1,901 |
| Danske Bank A/s | 1 | $4 | 0.0% | No change |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Aptevo 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 EDGARAptevo Therapeutics Inc.1
- CIK0001671584
- Employer ID (EIN)81-15670565
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
- Incorporated inDelaware5
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address2401 4Th Ave., Suite 1050, Seattle, WA 981211
- Phone206-838-05001
- Shares outstanding1,801,970 as of Aug 14, 202613
- Public float$9.8M as of Jun 30, 20255
- AuditorBaker Tilly US, LLP, Seattle, WA PCAOB ID 23; no auditor attestation of internal control over financial reporting5
- On EDGAR sinceApr 15, 20161
- Filings735 in all: 4 (233), 8-K (164), CORRESP (37), 10-Q (31), 3 (26), UPLOAD (22), SC 13G/A (20), EFFECT (17)1
All 45 form types
DEF 14A (16), SCHEDULE 13G (14), SC 13G (13), 424B4 (12), S-1 (11), 10-K (10), 424B5 (10), SCHEDULE 13G/A (10), DEFA14A (9), PRE 14A (9), S-1/A (9), S-3 (8), S-8 (7), 4/A (6), SC 13D/A (5), 10-12B/A (4), ARS (4), DEFR14A (3), 10-K/A (2), CT ORDER (2), D (2), RW (2), SC 13D (2), SC TO-I/A (2), 10-12B (1), 10-Q/A (1), 424B3 (1), 8-A12B (1), 8-K/A (1), CERTNAS (1), DEFC14A (1), DFAN14A (1), DRS (1), PREC14A (1), S-1MEF (1), S-3/A (1), SC TO-I (1)
- Latest filingsAnnual report (10-K) Mar 26, 2026
Quarterly report (10-Q) Aug 14, 2026
Proxy statement (DEF 14A) Aug 31, 2026
Latest 8-K (8-K) Oct 14, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.001 par value per share | APVO | The Nasdaq Stock Market LLC |
From the cover page of the 10-K filed Mar 26, 2026 (Section 12(b) of the Exchange Act).5
Risk factors and legal proceedings
The risks Aptevo Therapeutics Inc. names in Item 1A of its 10-K filed Mar 26, 2026: 58 risks under these headings, as written.5
- RISKS RELATED TO OUR BUSINESS
- Financial Risks
- We have a history of losses and may not be profitable in the future.
- Our management and board of directors have concluded that a substantial doubt is deemed to exist concerning our ability to continue as a going concern.
- We will require additional capital and may be unable to raise capital when needed or on acceptable terms.
- Our business is affected by macroeconomic conditions, including fluctuating inflation rates, interest rates, market volatility, economic uncertainty, and supply chain constraints as well as political events such as a U.S. federal government shutdown and evolving healthcare policies.
- Actions of activist stockholders against us have been and could be disruptive and costly and may cause uncertainty about the strategic direction of our business.
- Our future income will depend, in part, on the ability of Medexus to successfully further develop, market and commercialize IXINITY, resulting in milestone payments to the Company by Medexus.
- Our operating results are unpredictable and may fluctuate.
- We face product liability exposure, which could cause us to incur substantial liabilities and negatively affect our business, financial condition, and results of operations.
- Our success is dependent on our continued ability to attract, motivate and retain key personnel, and any failure to attract or retain key personnel may negatively affect our business.
- We completed a Section 382 study and have concluded that we experienced an "ownership change" as defined in Section 382 of the U.S. Internal Revenue Code of 1986, as amended (the Code), and thus the tax benefits of our pre-"ownership change" net operating loss carryforwards and certain other tax attributes will be subject to an annual limitation under Sections 382 and 383 of the Code.
The other 48 risks
- Our ability to use net operating losses to offset future taxable income may be subject to limitations.
- Tax changes may affect the deductibility of our research and development expenditures.
- Our investments are subject to market and credit risks that could diminish their value and these risks could be greater during periods of extreme volatility or disruption in the financial and credit markets, which could adversely impact our business, financial condition, results of operations, liquidity and cash flows.
- Product Development Risks
- The results of our current and planned preclinical studies and clinical trials may not satisfy the requirements of the FDA or non-U.S. regulatory authorities. Results from early preclinical studies and clinical trials may not be predictive of results from later-stage or other trials and interim or top line data may be subject to change or qualification based on the complete analysis of data.
- We may not be able to file investigational new drugs (INDs), or IND amendments to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.
- If we experience delays or difficulties in the commencement, site initiation, enrollment of patients or completion of our clinical trials, the time to reach critical trial data and receipt of any necessary regulatory approvals could be delayed.
- Serious adverse events, undesirable side effects or other unexpected properties of our product candidates may be identified that could delay, prevent, or cause the withdrawal of regulatory approval, limit the commercial potential, or result in significant negative consequences following marketing approval.
- We depend on third parties to conduct our clinical and non-clinical trials. If these third parties do not effectively carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
- Manufacture of our product candidates, especially in large quantities, is complex and time consuming. The loss of any of our third-party manufacturers, or delays or problems in the manufacture of our product candidates, could result in product shortages and/or delays in clinical development.
- Changes in product candidate manufacturing or formulation may result in additional costs or delay.
- Failure of our third-party manufacturers to successfully manufacture material that conforms to our specifications and the FDA’s or foreign regulatory authorities’ strict regulatory requirements, may prevent regulatory approval of those manufacturing facilities.
- Certain of our product candidates have received orphan drug designation from the FDA. However, there is no guarantee that we will be able to maintain this designation, receive this designation for any of our other product candidates, or receive or maintain any corresponding benefits, including periods of exclusivity.
- We may seek Breakthrough Therapy designation by the FDA for a product candidate that we develop, and we may be unsuccessful. If we are successful, the designation may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.
- We may seek designation for our ADAPTIR and ADAPTIR-FLEX platform technologies as a designated platform technology, but we might not receive such designation, and even if we do, such designation may not lead to a faster development, regulatory review or approval process.
- We have in the past and may in the future conduct clinical trials for our product candidates outside the United States, and the FDA or non-U.S. regulatory authorities may not accept data from such trials in the development or approval of our product candidates in those jurisdictions.
- Commercialization Risks
- Our ability to grow revenues and execute on our long-term strategy depends heavily on our ability to discover, develop, and obtain marketing approval for our product candidates.
- We may not be successful in our efforts to use and further develop our ADAPTIR or ADAPTIR-FLEX platforms.
- We face and will continue to face substantial competition and our failure to effectively compete may prevent us from achieving significant market penetration for our product candidates, if approved.
- Any of our product candidates, if approved, may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business.
- Legislative or healthcare reform measures may have a material adverse effect on our business and results of operations.
- Regulatory and Compliance Risks
- Our long-term success depends, in part, upon our ability to develop, receive regulatory approval for and commercialize our product candidates.
- Generally, no product can receive FDA approval, marketing authorization from the European Commission or the competent authorities of the EU Member States, or approval from comparable regulatory agencies in foreign countries unless data generated in human clinical trials demonstrates both safety and efficacy for each target indication in accordance with such authority’s standards.
- Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, evolving healthcare policies, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- Our product candidates are and will continue to be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. We may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
- If we fail to comply with foreign, federal, state, and local healthcare laws, including fraud and abuse and health information privacy and security laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected.
- Our employees, independent contractors, consultants, commercial partners, principal investigators, or CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
- Our operations, including our use of hazardous materials, chemicals, bacteria, and viruses, require us to comply with regulatory requirements and expose us to significant potential liabilities.
- Our failure to comply with data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
- If we experience a significant disruption in our information technology systems or breaches of data security, including due to a cybersecurity incident, our business could be adversely affected.
- Intellectual Property Risks
- If we are unable to protect our intellectual proprietary rights, our business could be harmed.
- If approved, our products regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.
- Third parties may choose to file patent infringement claims against us.
- Our Aptevo trademarks may be opposed which could have a material and adverse effect on our business.
- We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
- Failure to comply with our obligations in our intellectual property licenses with third parties, could result in loss of license rights or other damages.
- If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and product candidates could be adversely affected.
- Risks Related to Collaborations and Other Transactions
- We may not be successful in establishing and maintaining collaborations and entering into other transactions that leverage our capabilities in pursuit of developing and commercializing our product candidates and any such collaborations and transactions, if any, could result in financial results that differ from market expectations.
- Risks Related to Our Common Stock and General Risks
- Our stock price is and may continue to be volatile.
- We have in the past and may in the future be subject to short selling strategies that may drive down the market price of our common stock.
- In the event that coverage under our directors’ and officers’ liability insurance is reduced or terminated as a result of an ownership change or otherwise, our indemnification obligations and limitations of our directors’ and officers’ liability insurance may have a material adverse effect on our financial condition, results of operations and cash flows.
- If we do not maintain effective internal controls, we may not be able to accurately report our financial results and our business could be harmed.
- The public announcement of data from clinical trials or news of any developments related to our product pipeline may cause significant volatility in our stock price.
- Our common stock may be at risk for delisting from the Nasdaq Capital Market in the future if we do not maintain compliance with Nasdaq’s continued listing requirements. Delisting could adversely affect the liquidity of our common stock and the market price of our common stock could decrease.
- Your percentage of ownership in Aptevo may be diluted in the future.
- Provisions under Delaware law and in our restated certificate of incorporation, amended and restated by-laws and rights agreement may discourage acquisition proposals, delay a change in control or prevent transactions that stockholders may consider favorable.
- Our by-laws include a forum selection clause, which may impact your ability to bring actions against us.
- We may be subject to periodic litigation, which could result in losses or unexpected expenditure of time and resources.
- A significant portion of our shares may be sold into the market at any time which could depress our stock price.
Legal proceedings
We may from time to time be named as a party to legal claims, actions and complaints, including matters involving employment claims, our intellectual property or other third-party claims. Our management believes that there are currently no claims or actions pending against us, the ultimate disposition of which could have a material adverse effect on our results of operations, financial condition, or cash flows.
The opening of Item 3, Legal Proceedings.5
Sources
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- 17SEC EDGARMarvin L. White, Chair
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- 21SEC EDGARMary Jo Janatpour, SVP, CSO
- 22SEC EDGARDirk Huebner, SVP, CMO
- 23SEC EDGARSoyoung Kwon, Officer
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- 27SEC EDGARJane A. Gross, Officer
- 28SEC EDGARAnatolio B. Cruz Iii., Board member
- 29SEC EDGAREric M. Burt, Board member
- 30SEC EDGARMichael Darling, Board member
- 31SEC EDGARZsolt Harsanyi, Board member
- 32SEC EDGARBarbara Lopez Kunz, Board member
- 33SEC EDGARDaniel Abdun-Nabi, Board member
- 34SEC EDGARFuad El-Hibri, Board member
- 35SEC EDGARGrady Grant Iii., Board member
- 36SEC EDGARJohn Niederhuber, Board member
- 37SEC EDGAROther events
- 38SEC EDGAROther events
- 39SEC EDGARShareholder vote
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- 41SEC EDGARShareholder vote
- 42SEC EDGARResults of operations
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- 47SEC EDGARResults of operations
- 48SEC EDGAROther events
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