SLS on Nasdaq

Galena Biopharma

Logo: Galena Biopharma, Non-free logo, via Wikipedia5

American pharmaceutical company

Galena Biopharma, Inc. (originally RXi Pharmaceuticals) was a publicly traded pharmaceutical company based in San Ramon, California. The company was founded in Worcester, Massachusetts. In 2011, it moved to Oregon, and in 2015 moved to San Ramon, California.3 Its shares trade on Nasdaq under the symbol SLS.1 Wikipedia text CC BY-SA 4.0

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Last updated Oct 21, 2026.

Overview

2006Founded1

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  • TickerSLS on Nasdaq1
  • Industrypharmaceutical industry1
  • HeadquartersPortland1
  • Websitegalenabiopharma.com
  • Legal formDelaware corporation1
  • Incorporated inDE6
  • Business address7 Times Square, Suite 2503, New York, Ny 100366
  • Filer categoryNon-accelerated filer, Smaller reporting company6
  • LEI549300VZIH50VYURLQ984
  • StatusActive4
  • LEI statusLapsed (not renewed)4
  • Registered addressC/O Paracorp Incorporated, 19934 Camden, United States4

Galena Biopharma, Inc. (originally RXi Pharmaceuticals) was a publicly traded pharmaceutical company based in San Ramon, California. The company was founded in Worcester, Massachusetts. In 2011, it moved to Oregon, and in 2015 moved to San Ramon, California. Mark Schwartz was the company's president and chief executive officer. As of December 29, 2017, the company was acquired by Sellas Life Sciences Group Ltd. through a reverse merger transaction. Galena Biopharma was renamed to Sellas Life Sciences Group, Inc. (Nasdaq: SLS).3

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2023

-100.0%Revenue growth, 20239

Financial statements

Revenue1011129$0 in 2023
0$2.0M$4.0M$6.0M$8.0M2019: $0$020192020: $1.9M$1.9M20202021: $7.6M$7.6M2021+300%2022: $1.0M$1.0M2022−87%2023: $0$02023
Operating income101112913-$37.9M in 2023+89% since 2019
-$60.0M-$40.0M-$20.0M02019: -$20.0M-$20.0M20192020: -$17.0M-$17.0M2020−15%2021: -$25.3M-$25.3M2021+49%2022: -$42.0M-$42.0M2022+66%2023: -$37.9M-$37.9M2023−10%
Net income101112913-$37.3M in 2023+94% since 2019
-$60.0M-$40.0M-$20.0M02019: -$19.3M-$19.3M20192020: -$16.8M-$16.8M2020−13%2021: -$20.7M-$20.7M2021+24%2022: -$41.3M-$41.3M2022+100%2023: -$37.3M-$37.3M2023−10%

Every line of the income statement as filed: the last 2 fiscal years, latest first.16

Period ending2025-12-312024-12-31
Research and development$16.0M$19.1M
General and administrative$12.3M$12.4M
Total operating expenses$28.3M$31.5M
Loss from operations-$28.3M-$31.5M
Interest income$1.4M$632.0K
Total non-operating income$1.4M$632.0K
Net loss-$26.9M-$30.9M
Net loss per common share, basic (in dollars per share)-$0.25-$0.50
Net loss per common share, diluted (in dollars per share)-$0.25-$0.50
Weighted-average common shares outstanding, basic (in shares)109.1M shares61.2M shares
Weighted-average common shares outstanding, diluted (in shares)109.1M shares61.2M shares

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Corporate structure

Galena Biopharma sits at the top of its group. 4 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Galena Biopharma

  • Galena Biopharma Camden, Delaware, United States
    • Sellas Life Sciences Group Ltd. Subsidiary · Bermuda
    • Sellas Life Sciences Limited Subsidiary · Ireland
    • SLSG Limited 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 Galena Biopharma 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

ItemLatestA year beforeChange
Operating-lease assets (leased space)$963.0K16 Dec 31, 2025$925.0K16 Dec 31, 2024+4.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$71.8M16 Dec 31, 2025$13.9M16 Dec 31, 2024+417.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$1.9M16 Dec 31, 2025$1.9M16 Dec 31, 20240%

Properties, in its own words

We lease our headquarters in New York, New York. The lease covers approximately 8,455 square feet of office space and expires in September 2027. We believe that our facility is adequate for our current needs.

Item 2 of the 10-K filed Mar 19, 2026.18

The story

In November 2006, Argonaut Pharmaceuticals, Inc. changed the name to RXi Pharmaceuticals Corporation. RXi was a subsidiary of CytRx Corp., which provided $15 million in financing in April 2007. RXi was founded in part by Nobel Prize winner Craig Mello. In September 2007, RXi signed a licensing deal with TriLink Biotechnologies, a competitor in the RNA interference (RNAi) field, in which RXi would pay TriLink to use three of TriLink's technologies.

In March 2011, the company announced the planned acquisition of Arizona-based Apthera, Inc. for $7 million. The acquisition included the breast cancer drug NeuVax. In June 2011, NeuVax was approved by the United States Food and Drug Administration to start a stage three clinical trial.

In September 2011, the company separated its cancer therapies division. It was renamed Galena Biopharma Inc and moved to Lake Oswego, Oregon. RXi became a subsidiary of Galena and retained RNAi technologies. RXi Pharmaceuticals remained in Massachusetts as a publicly traded company. In January 2014, Galena bought Mills Pharmaceuticals. In April 2014, the company headquarters moved to Portland.

In November 2011, the company partnered with Genentech to combine drugs from each company for a cancer treatment. Galena is currently studying the combination of NeuVax and Herceptin in phase II trials.

Leadership

In March 2011, president and CEO Noah Beerman were replaced by Mark Ahn, and in August 2014, Ahn resigned and was replaced by Mark Schwartz. On January 31, 2017, Galena announced the resignation of Mark Schwartz effective that day, and reported in the same press release that it would be exploring strategic alternatives to maximize shareholder value going forward.

Stock

RXi went public in March 2008. CytRx retained 49% ownership of RXi's stock and gave shares of RXi to existing shareholders. Trading began on the Nasdaq market on March 12, 2008, under the ticker symbol of RXII. Fidelity Investments invested $8.5 million in the company in May 2008, followed by a $25 million private-equity investment by Yorkville in February 2009. In 2010, RXi received a National Institutes of Health grant of $600,000. By August 2010, the company had 30 employees. In April 2011, RXi raised about $12 million from a stock offering and received $580,000 in grants from the National Institutes of Health. The company reported a loss of $11.5 million loss for 2011.

In November 2012, an anonymous internet report caused Galena stock to decline. The company filed a lawsuit claiming the report was false and attempted to manipulate the stock. In 2014, Galena's involvement in a fraudulent stock promotion scheme was exposed. On February 1, 2014, analyst Matt Gravitt published an article that revealed Galena had paid MissionIR, DreamTeam brand, to promote Galena's stock. Galena's stock fell 20% following this revelation that received a heated response, and was one of the three most read articles in Seeking Alpha's history. Over the next few weeks, more revelations came out and the company admitted their stock promotion relationship and insider selling. Galena then disclosed that the SEC was investigating their relationship with The DreamTeam Group. By March 2014, five lawsuits were filed against Galena and several of its officers alleging that the company used misleading articles to boost stock prices. Motley Fool, discussing the 23% stock price drop during March 2015, noted there was stock dilution from the offering and also that Abstral's sales were below Galena's estimates from late 2013. Discussing the Motley Fool article, Portland Business Journal also noted the ongoing insider-trading lawsuits as a factor in the stock price. A few days later, Zacks Investment Research said Galena could be a "great candidate" to beat its earnings. In response, Galena's CEO said there were many positive aspects to the company, and that the lawsuits weren't a worry as they should get covered under Directors and officers liability insurance. The company moved to San Ramon, California, in the Bay Area in 2015.

Stock promotion scandal

The revelation that Galena was engaging in fraudulent stock promotion without adequate disclosure led to the investigation of other biotech companies who engaged in similar activities. Richard Pearson, an investor who went undercover to investigate the stock promotion firms, wrote an exposé on DreamTeam and its ties to articles about Galena, CytRx, and other companies on media websites. In April 2017, the Securities and Exchange Commission announced enforcement actions against 27 individuals and entities behind various alleged stock promotion schemes. Fraud charges were filed against three public companies, seven stock promotion or communications firms, and two company CEOs; also on this hit list are six individuals and nine writers.

Read the full text

Merger with Sellas Life Sciences

In 2017, Galena Biopharma Inc. announced a merger "with privately-held oncology company Sellas Life Sciences Group Ltd. in an all-stock transaction." The combined company was Sellas Life Science Group. The newly merged companies focused on the development of novel treatments for cancer.

From Wikipedia’s article on Galena Biopharma, shared under CC BY-SA 4.0.7

Leadership

Who has led Galena Biopharma, and when. Pick a name to see everywhere that person has worked.

Board members and other officers (38)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorAngelos M. Stergiou named Mar 29, 202464
  • DirectorRobert Van Nostrand named Mar 29, 202464

Products and brands

Galena acquired the experimental breast cancer drug NeuVax in 2011 and are currently in phase II trials to combine the drug with Genentech's Herceptin.

In 2013, Galena began selling its first developed drug, an analgesic for cancer pain named Abstral Sublingual.

Anagrelide controlled-released (GALE-401) was approved by the FDA for phase III clinical trials for the treatment of essential thrombocytosis in December 2016.

GALE-301 and GALE-302 are immunotherapies in phase I and II trials for ovarian and breast cancers.

From Wikipedia’s article on Galena Biopharma, shared under CC BY-SA 4.0.7

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • SLSG Limited LLC Delaware8
  • Sellas Life Sciences Group Ltd. Bermuda8
  • Sellas Life Sciences Limited Ireland8

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • GALENA BIOPHARMA, INC.Sep 26, 2011 to Dec 15, 20176
  • RXI PHARMACEUTICALS CORPFeb 7, 2007 to Sep 21, 20116

Timeline

  1. Aug 11, 20268-K Results of operations65
  2. Jul 27, 20268-K Results of operations; Other events66
  3. Jun 25, 20268-K Executive or director change67
  4. Jun 18, 20268-K Shareholder vote68
  5. Jun 2, 20268-K Other events69
  6. May 12, 20268-K Results of operations70
  7. Mar 19, 20268-K Results of operations71
  8. Mar 11, 20268-K Other events72
  9. Jan 8, 20268-K Results of operations; Other events73
  10. Nov 12, 20258-K Results of operations74
  11. Oct 27, 20258-K Entered a material agreement; Other events75
  12. Oct 3, 20258-K Entered a material agreement76
  13. Dec 29, 2017New chief executive Andelos M. Stergiou becomes CEO19
  14. Apr 20, 2011New chief executive Mark J. Ahn becomes CEO20
  15. Nov 9, 2009New chief executive Noah D. Beerman becomes CEO21
  16. Feb 14, 2008New chief executive Tod Woolf becomes CEO22
  17. 2006Founded Founded1

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/202677

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results65
  2. Jul 27, 2026Reported quarterly or annual results66
  3. May 12, 2026Reported quarterly or annual results70
  4. Mar 19, 2026Reported quarterly or annual results71
  5. Jan 8, 2026Reported quarterly or annual results73
  6. Nov 12, 2025Reported quarterly or annual results74
  7. Aug 12, 2025Reported quarterly or annual results78
  8. May 13, 2025Reported quarterly or annual results79

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

215 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 67 major events, 69 insider forms, 13 large holders, 1 private raises, 45 other. The latest 20:

  1. Aug 11, 20268-K EDGAR
  2. Aug 11, 202610-Q EDGAR
  3. Aug 7, 2026SCHEDULE 13G EDGAR
  4. Jul 31, 2026SCHEDULE 13G EDGAR
  5. Jul 27, 20268-K EDGAR
  6. Jun 25, 20268-K EDGAR
  7. Jun 18, 20268-K EDGAR
  8. Jun 18, 20264 OWNERSHIP DOCUMENT EDGAR
  9. Jun 16, 2026S-8 EDGAR
  10. Jun 2, 20268-K EDGAR
  11. May 12, 20268-K EDGAR
  12. May 12, 202610-Q EDGAR
  13. Apr 24, 2026SCHEDULE 13G/A EDGAR
  14. Apr 23, 2026ARS EDGAR
  15. Apr 23, 2026DEFA14A EDGAR
  16. Apr 23, 2026DEF 14A FORM- DEF 14A EDGAR
  17. Mar 27, 2026SCHEDULE 13G/A EDGAR
  18. Mar 20, 2026S-3ASR EDGAR
  19. Mar 19, 20268-K EDGAR
  20. Mar 19, 202610-K EDGAR

The 215 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

10 open-market trades by officers, directors and large owners since October 2021: 4 buys and 6 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Nov 19, 2025Kalin Katherine BachDirectorBuy63,400$1.59$100.8KForm 4
Jun 12, 2025VAN NOSTRAND ROBERT LDirectorBuy10,000$1.48$14.8KForm 4
May 30, 2025Wasman JaneDirectorBuy20,000$1.69$33.8KForm 4
May 22, 2025Kalin Katherine BachDirectorBuy20,000$1.80$36.0KForm 4
Dec 5, 2022Stergiou Angelos M.President and CEOSale6,494$2.61$16.9KForm 4
Dec 5, 2022Burns John ThomasCFOSale1,159$2.59$3.0KForm 4
Dec 5, 2022WOOD BARBARA AEVP, Gen. Counsel, Corp. Sec.Sale2,153$2.59$5.6KForm 4
Dec 2, 2021Stergiou Angelos M.President and CEOSale2,120$6.25$13.2KForm 4
Dec 2, 2021WOOD BARBARA AEVP, Gen. Counsel, Corp. Sec.Sale847$6.25$5.3KForm 4
Dec 2, 2021Burns John ThomasCFOSale231$6.27$1.4KForm 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.

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.

YearExecutiveAgeSalaryTotal pay
2025Angelos M. Stergiou, M.D., Sc.D. h.c.President and Chief Executive Officer50$676.0K$1.9M86
2025Dragan Cicic, M. D.Senior Vice President, Chief Development Officer62$451.2K$991.8K86
2025John T. BurnsSenior Vice President, Chief Financial Officer41$429.6K$959.7K86
2024Angelos M. Stergiou, M.D., Sc.D. h.c.President and Chief Executive Officer50$650.0K$1.2M86
2024Dragan Cicic, M. D.Senior Vice President, Chief Development Officer62$427.7K$713.5K86
2024John T. BurnsSenior Vice President, Chief Financial Officer41$401.5K$680.8K86

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Mar 15, 2024Raised $18.4 million in a private offering of securities Form D: 4 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.15,070,302$222.4M0.0%+2,871,892
State Street Corp12,996,558$191.8M0.0%+4,600,202
Vanguard Capital Management LLC8,226,105$121.4M0.0%+700,176
Geode Capital Management, LLC4,884,175$72.1M0.0%+971,569
Anson Funds Management LP4,500,000$66.4M6.1%New
Vanguard Portfolio Management LLC2,161,099$31.9M0.0%+698,293
Susquehanna International Group, Llp2,050,597$30.3M0.0%+1,653,541
Jones Financial Companies Lllp2,304,561$28.6M0.0%+629,484
Northern Trust Corp1,619,928$23.9M0.0%+343,944
Vanguard Fiduciary Trust Co1,335,166$19.7M0.0%+132,327
UBS Group AG1,252,757$18.5M0.0%+507,338
Morgan Stanley1,236,261$18.2M0.0%−100,032
Dagco, Inc.1,232,433$18.2M3.4%+203,653
Bnp Paribas Financial Markets1,072,022$15.8M0.0%+1,025,006
Bank Of America Corp /de/787,949$11.6M0.0%+146,266
Wellington Management Group Llp597,309$8.8M0.0%+252,531
Goldman Sachs Group Inc585,035$8.6M0.0%+29,122
Charles Schwab Investment Management Inc565,008$8.3M0.0%+84,404
Bank of New York Mellon Corp530,025$7.8M0.0%+51,659
Jane Street Group, LLC508,429$7.5M0.0%New
Nuveen, LLC418,729$6.2M0.0%−252,245
Invesco Ltd.375,342$5.5M0.0%−322,738
Swiss National Bank360,400$5.3M0.0%New
XTX Topco Ltd359,090$5.3M0.1%New
Wells Fargo & Company/mn328,819$4.9M0.0%+103,112

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Galena Biopharma is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARSELLAS Life Sciences Group, Inc.2
  • CIK0001390478
  • Employer ID (EIN)20-809951218
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company18
  • Incorporated inDelaware18
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address7 Times Square, Suite 2503, New York, NY 100362
  • Phone64620052782
  • Shares outstanding201,945,709 as of Aug 10, 202615
  • Public float$219.1M as of Jun 30, 202518
  • AuditorBaker Tilly US, LLP, San Jose, California PCAOB ID 23; no auditor attestation of internal control over financial reporting18
  • On EDGAR sinceFeb 7, 20072
  • Filings1,272 in all: 4 (378), 8-K (297), 10-Q (56), 3 (47), CORRESP (46), 424B5 (36), UPLOAD (34), 424B3 (31)2
    All 54 form types

    EFFECT (30), SC 13G/A (30), DEFA14A (26), S-3 (24), DEF 14A (23), SC 13G (21), 10-K (19), S-8 (17), 8-K/A (14), 425 (13), CT ORDER (12), 4/A (10), PRE 14A (10), S-1/A (9), S-3/A (8), ARS (7), 10-K/A (6), SCHEDULE 13G (6), D (5), POS EX (5), S-1 (5), SCHEDULE 13G/A (5), FWP (4), 424B2 (3), NT 10-K (3), S-4/A (3), SC 13D/A (3), 10-Q/A (2), 424B4 (2), POS AM (2), REGDEX (2), RW (2), S-3MEF (2), SC 13D (2), 5 (1), 8-A12B (1), 8-A12B/A (1), CERTNAS (1), DEFR14A (1), DEL AM (1), NO ACT (1), NT 10-Q (1), PRER14A (1), S-1MEF (1), S-3ASR (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Mar 19, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Apr 23, 2026
    Latest 8-K (8-K) Aug 11, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 Par Value per shareSLSThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 19, 2026 (Section 12(b) of the Exchange Act).18

Risk factors and legal proceedings

The risks Galena Biopharma names in Item 1A of its 10-K filed Mar 19, 2026: 72 risks under these headings, as written.18

  • Risks Related to Our Financial Position and Capital Needs
  • We have incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing losses for the foreseeable future.
  • We currently have no source of revenues from product sales. We may never generate such revenues or achieve profitability.
  • We will need additional financing to fund our operations and complete the development and, if approved, the commercialization of our product candidates. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our product candidates on unfavorable terms to us.
  • Risks Related to the Development and Regulatory Approval of Our Product Candidates
  • Clinical-stage biopharmaceutical companies with product candidates in clinical development face a wide range of challenging activities which may entail substantial risk.
  • Our lead product candidate, GPS, represents a new therapeutic approach that presents significant challenges.
  • The limited number of patients who have the diseases for which our product candidates are being studied, has made it more difficult to enroll patients in our clinical trials, which could delay or prevent the start of clinical trials for our product candidates.
  • The results of preclinical studies or earlier clinical trials are not necessarily predictive of future results. Our existing product candidates in clinical trials, and any other product candidates that may advance into clinical trials, may not have favorable results in later clinical trials or receive regulatory approval.
  • Interim, topline 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 audit and verification procedures that could result in material changes in the final data.
  • We are developing and may continue to develop our programs in combination with other therapies, which exposes us to additional risks.
The other 62 risks
  • Clinical drug development involves a lengthy and expensive process with an uncertain outcome.
  • Risks associated with operating in foreign countries could materially adversely affect our product development.
  • Global, market and economic conditions may negatively impact our business, financial condition and share price.
  • Our partnerships in China subject us to risks and uncertainties relating to the laws and regulations of China and the changes in relations between the United States and China.
  • Climate change or legal, regulatory or market measures to address climate change may negatively affect our business, results of operations, cash flows and prospects.
  • Our current and future product candidates, the methods used to deliver them or their dosage levels may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following any regulatory approval.
  • Our product development program may not uncover all possible adverse events that patients who take our product candidates may experience. The number of subjects exposed to product candidates and the average exposure time in the clinical development program may be inadequate to detect rare adverse events or chance findings that may only be detected once the product is administered to more patients and for greater periods of time.
  • Our future success is dependent on the regulatory approval of our product candidates.
  • Our current and future product candidates could fail to receive regulatory approval from the FDA or comparable foreign regulatory authorities.
  • We currently have orphan designation for GPS and SLS009 for certain indications, which might not provide the intended benefit thereof.
  • We currently have Fast Track designation for GPS and SLS009 and may seek Fast Track designation for additional product candidates, or indications, which might not be received or provide the intended benefits thereof.
  • Failure to obtain regulatory approval in international jurisdictions would prevent our product candidates from being marketed abroad.
  • Even if our current and future product candidates receive regulatory approval, they may still face future development and regulatory difficulties.
  • Risks Related to Our Manufacturing
  • We have limited to no manufacturing or distribution capability and must rely upon third parties for such.
  • We are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our product candidates.
  • In our GPS clinical trials, GM-CSF and Montanide are also administered in addition to GPS and their availability is dependent upon third-party manufacturers, which may or may not reliably provide GM-CSF or Montanide, thus jeopardizing the completion of the trials.
  • If any of the clinical manufacturing facilities of CMOs we rely on for clinical supply are damaged or destroyed or production at such facilities is otherwise interrupted, our business and prospects would be negatively affected.
  • Risks Related to Our Dependence on Third Parties and Our License Agreements
  • We rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, or if we lose any of our CROs or other key third-party vendors, we may not be able to obtain regulatory approval for or commercialize our current or future product candidates on a timely basis, if at all.
  • If any of our relationships with our third-party CROs, third-party vendors or contractors terminate, we may not be able to enter into arrangements with alternative CROs, third-party vendors or contractors on a timely basis, on commercially reasonable terms or at all.
  • We have in-licensed a significant portion of our intellectual property from MSK. If we breach our license agreement with MSK, we could lose the ability to continue the development and potential commercialization of GPS.
  • We rely on a license agreement with GenFleet for the development of SLS009, and if this license is breached or otherwise terminated, we could lose the ability to continue the development and potential commercialization of SLS009.
  • We may not realize the benefits of our strategic alliances that we may form in the future.
  • Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental, health and safety laws and regulations, which can be expensive and restrict how we do business.
  • We may not be able to establish or maintain the third-party relationships that are necessary to develop or potentially commercialize some or all of our product candidates, including our relationship with 3D Medicines.
  • Risks Related to Our Intellectual Property
  • We may not be able to obtain and enforce patent rights or other intellectual property rights that cover our product candidates and that are of sufficient breadth to prevent third parties from competing against us.
  • Our pending and future patent applications, and any collaboration or commercialization partner’s pending and future patent applications, may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products.
  • Changes in the patent laws, regulations, or interpretations thereof in the United States or abroad may diminish the value of our intellectual property.
  • While we intend to take actions reasonably necessary to enforce our patent rights, we may not be able to detect infringement of our own or in-licensed patents, which may be especially difficult for methods of manufacturing or formulation products.
  • SLS009 may face generic competition sooner than expected before the expiration of our composition of matter patent protection.
  • If the FDA, EMA or other foreign regulatory authorities approve generic or biosimilar versions of any of our product candidates that receive marketing approval, or such authorities do not grant our products appropriate periods of exclusivity before approving generic or biosimilar versions of those products, the sales of our products, if approved, could be adversely affected.
  • If we are sued for infringing the intellectual property rights of third parties, such litigation could be costly and time-consuming and could prevent or delay our development and commercialization efforts.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful and have a material adverse effect on the success of our business and on our stock price.
  • Although we have taken steps to protect our trade secrets and unpatented know-how by entering into confidentiality agreements with third parties and proprietary information and invention agreements with our employees and certain consultants and advisors, third parties may still obtain this information or we may be unable to protect our rights.
  • If we are unable to protect the confidentiality of our trade secrets and other proprietary information, the value of our technology could be materially adversely affected, and our business could be harmed.
  • Some intellectual property that we have in-licensed, if created as a result of government funded programs, may be subject to certain federal regulations.
  • Risks Related to Competition and Commercialization of Our Current and Future Product Candidates
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • If we obtain marketing approval, our commercial success depends on establishing or implementing our own sales, marketing, access and reimbursement, and distribution capabilities or entering into licensing or collaboration agreements for these purposes, and the timing of these.
  • Our commercial success depends upon attaining significant market acceptance of our current and future product candidates, if approved, among health care providers, third-party payors and operators of major cancer clinics.
  • Even if we are able to commercialize our current or future product candidates, the products may become subject to unfavorable pricing regulations, third-party reimbursement practices or health care reform initiatives, which could harm our business.
  • Health care policy changes may have a material adverse effect on our business and results of operations.
  • Price controls may be imposed in foreign markets, which may adversely affect our future profitability.
  • Risks Related to Health Care Compliance Regulations
  • Our relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other health care laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings. If we or they are unable to comply with these provisions, we may become subject to civil and criminal investigations and proceedings that could have a material adverse effect on our business, financial condition and prospects.
  • We may be subject to, or may in the future become subject to, U.S. federal and state, and international laws and regulations imposing obligations on how we collect, use, disclose, store and process personal information. Our actual or perceived failure to comply with such evolving privacy and data protection laws could adversely affect our business, results of operations, and financial condition.
  • Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
  • Risks Related to our Business Operations
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reports, which would harm our business, the trading price of our common stock and our ability to raise additional capital in the future.
  • We enter into various contracts in the normal course of our business in which we may be required to indemnify the other party to the contract under certain specific scenarios. In the event we have to perform under these indemnification provisions, it could have a material adverse effect on our business, financial condition and results of operations.
  • Significant disruptions of information technology systems, computer system failures or cybersecurity incidents could adversely affect our business.
  • Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data.
  • A pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, could materially and adversely affect our business.
  • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and its financial condition and results of operations.
  • We will need to grow the size of our organization in the future, and we may experience difficulties in managing this growth.
  • The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain qualified board members.
  • Our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel.
  • Legislation or other changes in U.S. tax law could adversely affect our business and financial condition.
  • Our ability to use net operating losses to offset future taxable income may be subject to limitations.
  • Risks Related to Ownership of Our Common Stock
  • We will likely need to secure additional capital which may cause dilution to you and our existing stockholders, provide subsequent investors with rights and preference that are senior to yours, restrict our operations or require us to relinquish rights to our product candidates on unfavorable terms to us.
  • The market price and trading volume of shares of our common stock may be volatile.
  • Inadequate funding for the FDA, the SEC and other domestic and foreign government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Future sales of substantial amounts of our common stock, or the possibility that such sales could occur, could adversely affect the market price of our common stock.

Legal proceedings

In December 2020, we entered into 3D Medicines Agreement. In November 2022, we announced that we had agreed with 3D Medicines for 3D Medicines to participate in the REGAL study through the inclusion of approximately 20 patients from mainland China.

In accordance with the terms of the 3D Medicines Agreement and the Side Letter, we had expected that 3D Medicines would begin enrolling patients in mainland China in the REGAL study in the second half of 2023 and subsequently make two development milestone payments totaling $13.0 million. Patients were enrolled in the REGAL study in Taiwan, which is part of the 3DMed Territory, prior to the second half of 2023.

On December 20, 2023, we commenced a binding arbitration proceeding against 3D Medicines, administered by the Hong Kong International Arbitration Centre and governed by New York State law as per the 3D Medicines Agreement. The arbitration proceeding involves, among other things, the trigger and payment of the relevant

milestone payments due to us as well as 3D Medicines’ failure to use commercially reasonable best efforts to develop GPS in the 3DMed Territory, and particularly in mainland China.

The opening of Item 3, Legal Proceedings.18

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