Private company
HOOKIPA Pharma Inc.
In its 2025 annual report the company says: “We are a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on our proprietary arenavirus platform that is designed to target and amplify T cell and immune responses to fight diseases. Our replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies.”5 It is headquartered in New York, New York.1
Last updated Oct 21, 2026.
Overview
- IndustryPharmaceutical Preparations1
- HeadquartersNew York, New York1
- Incorporated inDE4
- Business address350 Fifth Avenue, 72Nd Floor, Suite 7240, New York, Ny 101184
- Filer categoryNon-accelerated filer, Smaller reporting company4
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We are a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on our proprietary arenavirus platform that is designed to target and amplify T cell and immune responses to fight diseases. Our replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies. We believe that our technologies can meaningfully leverage the human immune system therapeutic purposes by inducing CD8+ T cell response levels previously not achieved by other immune therapy approaches.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 2024
Where the money goes
Where each dollar of revenue went, fiscal 2024
- Research and development100¢$68.5M
- Income tax0¢$106.0K
Out of $43.9M in revenue.23 The company lost money this year.
Financial statements
| Fiscal year | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|---|
| Revenue | $7.6M6 | $11.9M7 | $19.6M8 | $18.4M9 | $14.2M2 | $20.1M2 | $43.9M2 | |
| Research and development | $9.8M10 | $22.0M6 | $46.3M7 | $54.8M8 | $82.9M9 | $68.6M2 | $86.4M2 | $68.5M2 |
| Operating expenses | $100.1M9 | $87.4M2 | $117.8M2 | $95.4M2 | ||||
| Operating income | -$14.2M10 | -$21.2M6 | -$51.1M7 | -$53.3M8 | -$81.7M9 | -$73.2M2 | -$97.7M2 | -$51.5M2 |
| Interest | $606.0K10 | $778.0K6 | $877.0K7 | $786.0K8 | $898.0K9 | $687.0K9 | $317.0K9 | |
| Income before tax | -$75.7M9 | -$64.7M2 | -$81.2M2 | -$43.6M2 | ||||
| Income tax | $4.0K10 | $24.0K6 | $07 | $08 | $1.0K9 | $230.0K2 | $368.0K2 | -$106.0K2 |
| Net income | -$12.7M10 | -$16.2M6 | -$43.0M7 | -$44.1M8 | -$75.7M9 | -$64.9M2 | -$81.6M2 | -$43.5M3 |
| Earnings per share | -$2.417 | -$1.698 | -$2.309 | -$9.912 | -$8.632 | -$3.472 | ||
| Earnings per share (diluted) | -$2.417 | -$1.698 | -$2.309 | -$9.912 | -$8.632 | -$3.472 | ||
| Shares (weighted, basic) | 32.8M shares9 | 6.6M shares2 | 9.5M shares2 | 12.5M shares2 | ||||
| Shares (weighted, diluted) | 32.8M shares9 | 6.6M shares2 | 9.5M shares2 | 12.5M shares2 |
| Fiscal year | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|---|
| Cash | $61.4M6 | $48.6M10 | $113.2M6 | $142.7M7 | $65.9M8 | $112.5M9 | $117.1M2 | $39.7M2 |
| Receivables | $6.9M8 | $6.5M9 | $511.0K2 | $290.0K2 | ||||
| Current assets | $62.3M10 | $128.0M6 | $171.5M7 | $102.1M8 | $147.2M9 | $147.1M2 | $80.7M2 | |
| Property, plant and equipment | $16.4M8 | $18.0M9 | $7.7M2 | $179.0K2 | ||||
| Total assets | $68.3M10 | $143.7M6 | $187.8M7 | $126.0M8 | $170.5M9 | $161.3M2 | $82.5M2 | |
| Accounts payable | $8.8M8 | $5.5M9 | $12.5M2 | $8.7M2 | ||||
| Current liabilities | $14.7M10 | $14.8M6 | $21.1M7 | $27.7M8 | $35.6M9 | $42.0M2 | $24.7M2 | |
| Long-term debt | $7.3M10 | $6.6M6 | $6.1M7 | $2.9M8 | $1.2M9 | |||
| Long-term liabilities | $8.8M8 | $32.3M9 | $29.5M2 | $6.7M2 | ||||
| Total liabilities | $23.9M10 | $25.8M6 | $31.7M7 | $36.5M8 | $67.9M9 | $71.5M2 | $31.3M2 | |
| Retained earnings | -$222.8M8 | -$287.7M9 | -$369.3M2 | -$412.8M2 | ||||
| Shareholders’ equity | -$42.7M6 | -$60.4M7 | $117.9M8 | $156.1M9 | $89.6M2 | $102.5M2 | $89.9M2 | $51.2M2 |
| Fiscal year | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|---|
| Cash from operations | -$11.9M10 | -$15.0M6 | -$41.7M7 | -$39.3M8 | -$66.0M9 | -$20.0M2 | -$57.5M2 | -$77.0M2 |
| Depreciation and amortization | $4.6M9 | $3.6M2 | $3.6M2 | $2.8M2 | ||||
| Stock-based compensation | $7.6M9 | $5.0M2 | $2.3M2 | $2.0M2 | ||||
| Capital spending | $1.3M10 | $2.1M6 | $2.0M7 | $2.4M8 | $12.6M9 | $5.0M2 | $4.2M2 | $194.0K2 |
| Free cash flow | -$13.2M | -$17.1M | -$43.7M | -$41.7M | -$78.6M | -$25.0M | -$61.7M | -$77.2M |
| Cash from investing | -$12.6M9 | -$5.0M2 | -$4.2M2 | -$194.0K2 | ||||
| Cash from financing | -$235.0K9 | $72.3M2 | $65.7M2 | -$1.3M2 |
Corporate structure
HOOKIPA Pharma 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 HOOKIPA Pharma Inc.
- EcoR1 Capital, LLC Filed SCHEDULE 13G/A on HOOKIPA Pharma Inc., latest Feb 14, 2025 (6 filings since Apr 8, 2022)
- SOFINNOVA CAPITAL VI FCPR Filed SCHEDULE 13D/A on HOOKIPA Pharma Inc., latest Feb 14, 2025 (2 filings since Feb 13, 2023)
- Invus Global Management, LLC Filed SC 13G/A on HOOKIPA Pharma Inc., latest Aug 2, 2024
- Artal International S.C.A. Filed SC 13G on HOOKIPA Pharma Inc., latest Jul 8, 2024
- BAKER BROS. ADVISORS LP Filed SC 13D on HOOKIPA Pharma Inc., latest Jun 14, 2024 (3 filings since Feb 14, 2023)
- Redmile Group, LLC Filed SC 13G/A on HOOKIPA Pharma Inc., latest Feb 14, 2024 (3 filings since Feb 14, 2022)
- Gilead Sciences Filed SC 13G/A on HOOKIPA Pharma Inc., latest Dec 22, 2023 (3 filings since Feb 17, 2022)
- FMR LLC Filed SC 13G/A on HOOKIPA Pharma Inc., latest Sep 11, 2023 (4 filings since Feb 9, 2022)
- Knoll Capital Management, LLC Filed SC 13G on HOOKIPA Pharma Inc., latest Jun 20, 2023
- Deep Track Capital, LP Filed SC 13G/A on HOOKIPA Pharma Inc., latest Feb 14, 2023 (2 filings since Mar 4, 2022)
- Forbion Capital Fund II Cooperatief U.A. Filed SC 13G/A on HOOKIPA Pharma Inc., latest Feb 11, 2022
- HOOKIPA Pharma Inc. New York, New York
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What HOOKIPA Pharma 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 | $6.1M2 Dec 31, 2024 | $17.6M2 Dec 31, 2023 | −65.5% |
| Accumulated depreciation | $5.9M2 Dec 31, 2024 | $9.8M2 Dec 31, 2023 | −40.1% |
| Property and equipment, net | $179.0K2 Dec 31, 2024 | $7.7M2 Dec 31, 2023 | −97.7% |
| Operating-lease assets (leased space) | $885.0K2 Dec 31, 2024 | $5.5M2 Dec 31, 2023 | −83.8% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $39.7M2 Dec 31, 2024 | $117.1M2 Dec 31, 2023 | −66.1% |
Properties, in its own words
Our principal executive offices are located in New York, New York, pursuant to a lease that expires in August 2026. Our European research and preclinical development operations are located in Vienna, Austria, where we lease and occupy approximately 30,681 square feet of office and laboratory space. Our first Austrian facility is leased pursuant to two operating leases, comprised of (i) a lease of unlimited duration for approximately 15,239 square feet of office and laboratory space which will be terminated effective March 31, 2025 and (ii) a lease initially set to expire in September 2028 and with no option to extend for approximately 2,367 square feet of storage space which will be terminated effective June 30, 2025. In 2019, we entered into a lease for a second facility located in Vienna, Austria that was initially set to expire in February 2029, where we occupy approximately 15,440 square feet of office and laboratory space, which will be terminated effective February 28, 2025. In May 2021 we purchased a parcel of land in the north of Vienna and have received building permission to build a GMP manufacturing plant of approximately 48,440 square feet.
In January 2024 our Board decided to implement a Restructuring Plan, which included the discontinuation of the GMP manufacturing project and the divestment of all associated assets, including the parcel of land. Strategic considerations preceding the adoption of the Restructuring Plan resulted in the impairment of the full carrying value of the GMP manufacturing facility project in the year ended December 31, 2023 and the land is currently held for sale. We are currently evaluating the required space needed to meet our future need following our strategic refocus. We believe if we require new or additional space, we will be able to obtain additional facilities on commercially reasonable terms.
Item 2 of the 10-K filed Feb 28, 2025.5
Leadership
Who has led HOOKIPA Pharma Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerMalte Peters Jul 24, 2024 to now14
- Chief executive officerJorn Aldag Apr 17, 2019 to Jul 24, 202415
- Chief financial officerMary Theresa Coelho Jul 24, 2024 to now16
- Chief financial officerReinhard Kandera Apr 17, 2019 to Jul 24, 202417
- Chief operating officerChristine D. Baker Jul 1, 2022 to Apr 18, 202318
Board members and other officers (20)
- Chief Development OfficerMark Winderlich Apr 11, 2024 to now19
- Chief Medical OfficerKatia Schlienger Apr 18, 2023 to Apr 18, 202320
- Chief Business OfficerChristine D. Baker Mar 22, 2021 to Apr 20, 202221
- Sr. VP, Technical DevelopmentAnders Lilja Apr 17, 2019 to Jan 27, 202022
- Chief Scientific OfficerDavid Pinschewer Apr 17, 2019 to Apr 24, 201923
- Chief Medical OfficerIgor Matushansky Apr 17, 2019 to Jul 1, 202224
- Sr. VP, ResearchKlaus Orlinger Apr 17, 2019 to now25
- Chief Technology OfficerRoman Necina Nov 19, 2019 to now26
- Board memberSean A. Cassidy Jul 24, 2024 to now27
- Board memberMary Theresa Coelho Apr 4, 2023 to now28
- Board memberMalte Peters Apr 18, 2023 to now29
- Board memberJean-Charles Soria Oct 23, 2020 to Jun 4, 202130
- Board memberChristoph Lengauer Apr 17, 2019 to Jun 4, 202131
- Board memberDavid Ross Kaufman Apr 17, 2019 to now32
- Board memberDeventer Sander Van Apr 17, 2019 to Oct 23, 202033
- Board memberGraziano Seghezzi Apr 17, 2019 to Jun 14, 202134
- Board memberJorn Aldag Apr 17, 2019 to now15
- Board memberJulie O'Neill Apr 17, 2019 to now35
- Board memberMichael Aaron Kelly Apr 17, 2019 to Jul 1, 202236
- Board memberReinhard Kandera Apr 17, 2019 to now17
Timeline
- Jul 29, 20258-K Shareholder vote37
- Jul 18, 20258-K Listing notice or transfer; Other events38
- May 22, 20258-K Entered a material agreement; Ended a material agreement; Executive or director change39
- Feb 20, 20258-K Other events40
- Jan 29, 20258-K Regulation FD disclosure41
- Jan 10, 20258-K Other events42
- Jan 7, 20258-K Other events43
- Jan 2, 20258-K Other events44
- Nov 20, 20248-K Other events45
- Nov 14, 20248-K Results of operations46
- Aug 30, 20248-K Executive or director change; Regulation FD disclosure47
- Aug 8, 20248-K Results of operations48
- Jul 24, 2024New chief executive Malte Peters becomes CEO14
- Apr 17, 2019New chief executive Jorn Aldag becomes CEO15
Calendar
When it reported results
- Nov 14, 2024Reported quarterly or annual results46
- Aug 8, 2024Reported quarterly or annual results48
- May 9, 2024Reported quarterly or annual results49
- Mar 22, 2024Reported quarterly or annual results50
- Jan 29, 2024Reported quarterly or annual results51
- Nov 9, 2023Reported quarterly or annual results52
- Aug 10, 2023Reported quarterly or annual results53
- May 11, 2023Reported quarterly or annual results54
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
219 filings to the SEC since October 2021: 6 annual reports, 11 quarterly reports, 55 major events, 67 insider forms, 27 large holders, 53 other. The latest 20:
- Oct 9, 20254 EDGAR
- Aug 27, 2025144/A EDGAR
- Aug 27, 2025144 EDGAR
- Aug 8, 202515-12G EDGAR
- Jul 29, 2025EFFECT EDGAR
- Jul 29, 2025EFFECT EDGAR
- Jul 29, 202525 EDGAR
- Jul 29, 2025S-8 POS EDGAR
- Jul 29, 2025S-8 POS EDGAR
- Jul 29, 2025S-8 POS EDGAR
- Jul 29, 2025S-8 POS EDGAR
- Jul 29, 2025POS AM EDGAR
- Jul 29, 2025POS AM EDGAR
- Jul 29, 20258-K EDGAR
- Jul 23, 20254 EDGAR
- Jul 23, 20254 EDGAR
- Jul 18, 20258-K EDGAR
- Jul 7, 2025UPLOAD EDGAR
- Jul 3, 2025DEFM14A EDGAR
- Jun 30, 2025CORRESP EDGAR
The 219 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
11 open-market trades by officers, directors and large owners since October 2021: 7 buys and 4 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Aug 19, 2025 | Peters MalteChief Executive Officer | Sale | 25,172 | $0.82 | $20.6K | Form 4 |
| Jul 22, 2025 | Peters MalteChief Executive Officer | Sale | 29,176 | $0.92 | $26.8K | Form 4 |
| Jul 22, 2025 | Coelho Mary TheresaEVP and CFO | Sale | 13,609 | $0.92 | $12.5K | Form 4 |
| Aug 21, 2023 | Kandera ReinhardChief Financial Officer | Buy | 7,000 | $0.73 | $5.1K | Form 4 |
| Aug 16, 2023 | Kandera ReinhardChief Financial Officer | Buy | 8,000 | $0.71 | $5.7K | Form 4 |
| Jul 11, 2023 | Aldag JornChief Executive Officer | Buy | 5,000 | $0.83 | $4.2K | Form 4 |
| Jul 7, 2023 | Aldag JornChief Executive Officer | Buy | 5,000 | $0.81 | $4.0K | Form 4 |
| Jul 5, 2023 | Aldag JornChief Executive Officer | Buy | 5,000 | $0.89 | $4.5K | Form 4 |
| Jul 3, 2023 | Aldag JornChief Executive Officer | Buy | 5,000 | $0.89 | $4.5K | Form 4 |
| Jun 30, 2023 | Kandera ReinhardChief Financial Officer | Buy | 12,000 | $0.88 | $10.6K | Form 4 |
| Dec 21, 2021 | Matushansky IgorChief Medical Officer | Sale | 14,949 | $2.49 | $37.2K | 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.
- EcoR1 Capital, LLCSCHEDULE 13G/A, 6 filings Apr 8, 2022 to Feb 14, 202555
- SOFINNOVA CAPITAL VI FCPRSCHEDULE 13D/A, 2 filings Feb 13, 2023 to Feb 14, 202556
- Invus Global Management, LLCSC 13G/A, 1 filing Aug 2, 202457
- Artal International S.C.A.SC 13G, 1 filing Jul 8, 202458
- BAKER BROS. ADVISORS LPSC 13D, 3 filings Feb 14, 2023 to Jun 14, 202459
- Redmile Group, LLCSC 13G/A, 3 filings Feb 14, 2022 to Feb 14, 202460
- Gilead SciencesSC 13G/A, 3 filings Feb 17, 2022 to Dec 22, 202361
- FMR LLCSC 13G/A, 4 filings Feb 9, 2022 to Sep 11, 202362
- Knoll Capital Management, LLCSC 13G, 1 filing Jun 20, 202363
- Deep Track Capital, LPSC 13G/A, 2 filings Mar 4, 2022 to Feb 14, 202364
- Forbion Capital Fund II Cooperatief U.A.SC 13G/A, 1 filing Feb 11, 202265
SEC filer profile
How HOOKIPA Pharma Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARHOOKIPA Pharma Inc.1
- CIK0001760542
- Employer ID (EIN)81-53956875
- 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 address350 Fifth Avenue, 72Nd Floor, Suite 7240, New York, NY 101181
- Phone01143189063601
- Shares outstanding9,659,522 Common Stock Other Than Class shares; 2,399,517 Common Class A shares as of Feb 24, 20255
- Public float$57.0M as of Jun 30, 20245
- AuditorPwC Wirtschaftsprüfung GmbH, Vienna, Austria PCAOB ID 1259; no auditor attestation of internal control over financial reporting5
- On EDGAR sinceDec 14, 20181
- Filings395 in all: 4 (139), 8-K (73), 3 (28), SC 13G/A (24), 10-Q (19), SC 13G (12), DEFA14A (9), CORRESP (7)1
All 47 form types
EFFECT (7), UPLOAD (7), 10-K (6), 424B5 (6), DEF 14A (5), S-3 (4), S-8 (4), S-8 POS (4), SC 13D/A (4), 10-K/A (2), 4/A (2), ARS (2), DRS/A (2), POS AM (2), PRE 14A (2), SC 13D (2), 144 (1), 144/A (1), 15-12G (1), 25 (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), CT ORDER (1), D (1), DEFM14A (1), DEL AM (1), DRS (1), DRSLTR (1), FWP (1), PREM14A (1), PRER14A (1), S-1 (1), S-1/A (1), SC TO-I (1), SC TO-I/A (1), SCHEDULE 13D/A (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Feb 28, 2025
Quarterly report (10-Q) May 15, 2025
Proxy statement (DEF 14A) Apr 26, 2024
Latest 8-K (8-K) Jul 29, 2025
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.0001 Par Value per Share | HOOK | Nasdaq |
From the cover page of the 10-K filed Feb 28, 2025 (Section 12(b) of the Exchange Act).5
Risk factors and legal proceedings
The risks HOOKIPA Pharma Inc. names in Item 1A of its 10-K filed Feb 28, 2025: 73 risks under these headings, as written.5
- Risks Related to Our Financial Position and Capital Needs
- We are a clinical-stage biopharmaceutical company with no approved products and a limited operating history. We have incurred significant losses since inception. We expect to incur losses for at least the next several years and may never achieve or maintain profitability.
- There is substantial doubt regarding our ability to continue as a going concern. We will need to raise substantial additional funding, which may not be available on acceptable terms, if at all, to be able to continue as a going concern and advance any our product candidates. Failure to obtain capital when needed may force us to delay, limit or terminate our product development efforts or other operations. Raising additional capital may dilute our existing shareholders, restrict our operations or cause us to relinquish valuable rights.
- We will require substantial additional financing and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
- Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish proprietary rights.
- If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders if we issue equity securities, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
- We have obtained funding from an agency of the Austrian government that contains certain covenants that may restrict our operations.
- Risks Related to Our Business and Industry
- If we are unable to advance our current or future product candidates into and through clinical trials, obtain marketing approval and ultimately commercialize any product candidates we develop, or experience significant delays in doing so, our business will be materially harmed.
- The regulatory approval processes of the FDA, the EMA and the European Commission and other comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
- Our clinical trials may fail to demonstrate adequately the safety and efficacy of any of our product candidates, which would prevent or delay regulatory approval and commercialization.
- Our preclinical programs may experience delays or our product candidates may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these product candidates on a timely basis or at all, which would have an adverse effect on our business.
The other 63 risks
- Interim, top line and preliminary 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 regulatory audit and verification procedures that could result in material changes in the final data.
- Results of earlier studies and trials of our product candidates may not be predictive of future trial results.
- Our replicating technology is early in clinical development and could therefore prove to be unsafe.
- Our product candidates are based on a novel approach to the treatment of cancer, which makes it difficult to predict the time and cost of product candidate development.
- Since the number of patients that we plan to dose in some of our planned clinical trials is small, the results from such clinical trials, once completed, may be less reliable than results achieved in larger clinical trials, which may hinder our efforts to obtain regulatory approval for our product candidates.
- Our product candidates may cause serious adverse events, undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, require expansion of the trial size, limit their commercial potential or result in significant negative consequences.
- If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
- We have limited experience as a company conducting clinical trials.
- The market opportunities for our oncology product candidates may be limited to those patients who are ineligible for or have failed prior treatments.
- If the market opportunities for our product candidates are smaller than we believe they are, even assuming approval of a drug candidate, our business may suffer.
- Even if we, or any future collaborators, are able to commercialize any product candidate that we, or they, develop, the product may become subject to unfavorable pricing laws, regulations or third-party payor coverage and reimbursement policies, any of which could harm our business.
- We cannot predict whether we will receive reimbursement from third-party payors for any product we may successfully commercialize in the future. Any reimbursement we may receive might not be adequate for use to generate significant revenue and we may not become profitable.
- We are developing, and in the future may develop, other product candidates, in combination with other therapies, which exposes us to additional risks.
- Negative developments in the field of immuno-oncology and virus-based therapies could damage public perception of any of our product candidates and negatively affect our business.
- We may not be successful in our efforts to identify and successfully commercialize additional product candidates.
- We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
- A variety of risks associated with operating our business internationally could materially adversely affect our business.
- Natural disasters, geopolitical unrest, war, terrorism, public health issues or other catastrophic events could disrupt the supply, delivery or demand of products and reduce our ability to access capital, which could negatively affect our operations and performance.
- Our business may be adversely affected by a pandemic, epidemic or outbreak of an infectious disease, such as the recent coronavirus pandemic or other emerging global health threats on business and operations.
- We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if approved, we may not be able to generate product revenue.
- Insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.
- Exchange rate fluctuations may materially affect our results of operations and financial conditions.
- Risks Related to Our Reliance on Third Parties
- We may seek to establish additional collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
- We rely and will continue to rely on third parties to conduct our clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.
- We rely and expect to continue to rely on third parties to manufacture our clinical product supplies, and we may rely on third parties for at least a portion of the manufacturing process of our product candidates, if approved. Our business could be harmed if those third parties fail to provide us with sufficient quantities of clinical product supplies or product candidates or fail to do so at acceptable quality levels or prices.
- If our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.
- Risks Related to Government Regulation
- Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
- The impact of recent healthcare reform legislation and other changes in the healthcare industry and in healthcare spending on us is currently unknown, and may adversely affect our business model.
- The FDA or comparable foreign regulatory authorities could require the clearance, CE marking or approval of a companion diagnostic device as a condition of approval for our product candidates. Failure to successfully validate, develop and obtain regulatory clearance or approval for companion diagnostics on a timely basis or at all could harm our drug development strategy.
- We may pursue breakthrough therapy designation from the FDA for our product candidates but such designation may not lead to a faster development or regulatory review or approval process, and it would not increase the likelihood that our product candidates will receive marketing approval.
- We may seek Fast Track Designation by the FDA for a product candidate that we develop, and we may be unsuccessful. If we are successful, the designation may not actually lead to a faster development or regulatory review or approval process.
- We may seek Orphan Drug Designation for product candidates we develop, and we may be unsuccessful or may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity.
- Our business operations and current and future relationships with investigators, health care professionals, consultants, third-party payors and customers will be subject, directly or indirectly, to federal, state and foreign healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
- Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
- European data collection and processing is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information.
- Our business activities may be subject to the Foreign Corrupt Practices Act and similar anti-bribery and anti-corruption laws.
- Our ability to utilize our foreign net operating loss carryforwards may be limited by GILTI taxation introduced through the tax reform.
- Changes to section 174 capitalization rules through the tax reform may impact our ability to immediately deduct research and development expenses, leading to higher taxable income and effective income tax payments even before reaching profitability
- Risks Related to Our Intellectual Property
- Our rights to develop and commercialize our product candidates are subject, in part, to the terms and conditions of licenses granted to us by others, and, if we fail to comply with our obligations under these arrangements or resolve related disputes, we could lose such intellectual property rights or owe damages to the licensor of such intellectual property.
- If our efforts to protect the proprietary nature of the intellectual property related to our technologies are not adequate, we may not be able to compete effectively in our market.
- Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts.
- We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
- 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.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.
- Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
- We have less robust intellectual property rights in certain foreign jurisdictions and may not be able to protect our intellectual property rights throughout the world.
- We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
- We may be subject to claims that our employees, consultants or contractors have wrongfully used or disclosed confidential information of third parties.
- Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.
- Risks Related to Employee Matters, Managing Our Growth and Other Risks
- The contractual obligations of Daniel Pinschewer to the University of Basel may present conflicts of interest.
- We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
- Our strategic refocus and the associated workforce reduction announced in January 2024 and additional workforce reductions implemented in September 2024 and November 2024 may not result in anticipated cost savings, could result in total costs and expenses that are greater than expected and could disrupt our business.
- We may need to grow or contract our organization, and we may experience difficulties in managing this growth or contraction, which could disrupt our operations.
- We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
- Risks Related to Ownership of Our Common Stock
- An active trading market for our common stock may not be sustainable, and you may not be able to resell your shares of our common stock at or above the purchase price.
- The price of our stock may be volatile.
- Our principal stockholders and management own a significant percentage of our stock and exert significant influence over matters subject to stockholder approval.
- Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.
- We expect to continue to incur significant increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives.
- We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
Legal proceedings
We are not currently a party to any material legal proceedings. From time to time, we may become involved in other litigation or legal proceedings relating to claims arising from the ordinary course of business.
The opening of Item 3, Legal Proceedings.5
Sources
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- 15SEC EDGARJorn Aldag, Chief executive officer
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- 25SEC EDGARKlaus Orlinger, Sr. VP, Research
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- 27SEC EDGARSean A. Cassidy, Board member
- 28SEC EDGARMary Theresa Coelho, Board member
- 29SEC EDGARMalte Peters, Board member
- 30SEC EDGARJean-Charles Soria, Board member
- 31SEC EDGARChristoph Lengauer, Board member
- 32SEC EDGARDavid Ross Kaufman, Board member
- 33SEC EDGARDeventer Sander Van, Board member
- 34SEC EDGARGraziano Seghezzi, Board member
- 35SEC EDGARJulie O'Neill, Board member
- 36SEC EDGARMichael Aaron Kelly, Board member
- 37SEC EDGARShareholder vote
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- 41SEC EDGARRegulation FD disclosure
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- 46SEC EDGARResults of operations
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- 48SEC EDGARResults of operations
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