SEELAS Life Sciences (SLS) - 2024 Q4 - Annual Report

Special Note Regarding Forward-Looking Statements This section highlights forward-looking statements in the Annual Report, subject to risks that could cause actual results to differ materially - The report includes forward-looking statements regarding development programs, business strategy, financial performance, and future events[9] - Statements are subject to known and unknown risks, uncertainties, and assumptions that could cause actual results to differ materially from projections[10] - Key risk areas include future financial and business performance, ability to develop/commercialize products, clinical trial results, intellectual property, capital requirements, and regulatory changes[10] Summary of Principal Risk Factors This section summarizes the company's principal risks, including financial, development, regulatory, and market challenges - The company has incurred substantial losses since inception and anticipates continued losses, with no current product revenues[15] - Additional financing is required to fund operations and complete product development; inability to raise capital could force delays or elimination of programs[15] - Clinical drug development is lengthy, expensive, and uncertain, with product candidates potentially failing to receive regulatory approval or causing undesirable side effects[15] - Significant risks include reliance on third parties for manufacturing and clinical trials, intellectual property protection, market acceptance, reimbursement, and competition[15][16] PART I Item 1. Business This section details the company's business, focusing on its late-stage cancer therapeutics, strategy, and operations Overview This overview introduces SELLAS Life Sciences, its lead cancer therapeutics GPS and SLS009, and their clinical status - SELLAS is a late-stage clinical biopharmaceutical company focused on novel cancer therapeutics[18] - Lead product candidate is Galinpepimut-S (GPS), a peptide immunotherapy targeting the WT1 antigen[18][19] - Second product candidate is SLS009 (tambiciclib), a highly selective small molecule CDK9 inhibitor[18] - GPS is in an ongoing Phase 3 REGAL study for AML in maintenance setting (CR2); enrollment completed in March 2024, interim analysis in January 2025 recommended continuation[20] - SLS009 completed Phase 1 in mid-2023 with positive safety/efficacy in r/r AML and refractory lymphoma, establishing RP2D[26] - SLS009 Phase 2a trial in r/r AML (in combination with aza/ven) commenced in Q2 2023, showing positive initial topline data and identifying ASXL1 mutation as a potential predictive biomarker[27][28][29] SLS009 Phase 2a Trial Efficacy Data (December 2024 Follow-up) | Dose Level | Evaluable Patients | ORR | AML MRC ORR | mOS | AML MRC mOS | | :--- | :--- | :--- | :--- | :--- | :--- | | 45 mg QW | 10 | 10% | 17% | 5.1 months | 5.8 months | | 60 mg BIW | 9 | 33% | 33% | 3.9 months | 3.9 months | | 30 mg BIW | 9 | 46% | 60% | 7.7 months + | 8.3 months + | | Overall | 28 | 31% | 40% | 5.1 months + | 5.7 months + | - GPS has Orphan Drug Designations and Fast Track designations from FDA for AML, MPM, and MM, plus Rare Pediatric Disease designation for pediatric AML[22][23] - SLS009 has Orphan Drug Designations and Fast Track designations from FDA for AML and PTCL, plus Rare Pediatric Disease designation for pediatric ALL and AML[35] Our Strategy The company's strategy focuses on developing multiple oncology candidates for global marketing, particularly for AML - Overall goal is to develop multiple oncology product candidates for global marketing authorization[37] - Primary focus is on developing better treatments for AML, leveraging hematology/oncology expertise[37] - Aims to build a single streamlined commercial infrastructure for current product candidates[37] Products/Pipeline The pipeline centers on GPS, a WT1 immunotherapy, and SLS009, a CDK9 inhibitor, both in advanced clinical development Galinpepimut-S (GPS): Innovative WT1 Targeting Immunotherapy GPS is a WT1-targeting immunotherapy in Phase 3 for AML, designed to activate immune response against WT1-overexpressing cancers - GPS is a WT1-targeting peptide-based cancer immunotherapeutic, developed as monotherapy and in combination, for cancers overexpressing the WT1 protein[38] - WT1 is a top-priority cancer antigen, overexpressed in 20+ cancer types including AML, MM, and MPM[38][39] - GPS uses a multi-peptide product with deliberately mutated (heteroclitic) peptides to elicit strong CD4 and CD8 T-cell immune responses, mitigating immune tolerance[40][41][42] - The Phase 3 REGAL study for GPS monotherapy in AML CR2 patients completed enrollment in March 2024; interim analysis in January 2025 recommended continuation[20][64][65] - Previous Phase 2 AML trials showed GPS improved median OS to 67.6 months (all ages) and 35.3 months (age 60+) from initial diagnosis, significantly exceeding historical data[57][58] - In a Phase 2 trial for AML CR2 patients, GPS administration resulted in a median OS of 21.0 months compared to 5.4 months in the control group (p-value < 0.02)[61][62] - Combination therapy of GPS with pembrolizumab in ovarian cancer showed median OS of 18.4 months (vs. 13.8 months for pembrolizumab alone) and DCR of 50.1% (vs. 37.2% for pembrolizumab alone)[79] - Combination of GPS with nivolumab in MPM patients showed median OS of 17.6 months (combination) vs. historical 4.5-6.2 months (vinorelbine) and 7.0 months (other chemotherapy)[84] SLS009: Highly Selective Next Generation CDK9 Inhibitor SLS009 is a selective CDK9 inhibitor in Phase 2a for r/r AML, showing promising efficacy and biomarker-driven responses - SLS009 is a highly selective small molecule CDK9 inhibitor, in-licensed from GenFleet for worldwide development and commercialization (excluding Greater China)[24][94] - CDK9 inhibition by SLS009 decreases MCL-1 and c-MYC levels, leading to apoptosis and cell cycle arrest in cancer cells, with high selectivity reducing toxicity compared to older inhibitors[95][96] SLS009 Preclinical IC50 (72h) Comparison | Cell lines | SLS009 IC50 (72h) | VIP152 IC50 (72h) | | :--- | :--- | :--- | | AML | 4.8 ~33 nM | 15.9 136 nM | | Lymphoma | 10.677.9 nM | 16.6 ~138 nM | | MM | 33.6 ~151 nM | 51.4 397 nM | | ALL | 13.435.7 nM | 42.3 ~68.6 nM | | CLL | 25 nM | 40.7 nM | - Phase 1 trial completed in mid-2023, establishing recommended Phase 2 doses (RP2D) of 60 mg QW for AML and 100 mg QW for lymphomas[26][109] - Phase 2a trial in r/r AML (SLS009 + aza/ven) identified ASXL1 mutation as a key predictive biomarker, with 100% response rate at optimal dose (30 mg BIW) in patients with this biomarker[121][123] - Preclinical studies in November 2024 identified ASXL1 mutation as a key predictor of SLS009 response in solid cancers, with high efficacy (IC50 < 100 nM) observed in 67% of ASXL1 mutated solid cancer cell lines[132][136] - GenFleet's Phase 2a study of SLS009 + zanubrutinib in r/r DLBCL showed an overall response rate of 67%, more than double the expected ORR of zanubrutinib alone[34][128] Strategic Collaborations and License Agreements The company relies on strategic collaborations and license agreements for GPS and SLS009 development and commercialization - Exclusive license agreement with MSK for WT1 peptide vaccine technology (GPS), requiring milestone payments and tiered royalties[141][143] - Clinical trial collaboration and supply agreement with Merck to evaluate GPS in combination with pembrolizumab for WT1+ advanced cancers, focusing on ovarian cancer[145][146] - Exclusive license agreement with 3D Medicines Inc. for GPS in Greater China, with $10.5 million received in upfront/milestone payments and $191.5 million in potential future milestones[21][147][148][154] - A binding arbitration proceeding commenced in December 2023 against 3D Medicines regarding milestone payments and commercially reasonable efforts to develop GPS in mainland China[21][156] - Exclusive license agreement with GenFleet Therapeutics for SLS009 worldwide (excluding Greater China), involving an initial $10.0 million payment and potential development, regulatory, and sales milestones up to $140.0 million, plus tiered royalties[157][158][159] Manufacturing The company outsources all manufacturing to third-party CMOs, ensuring cGMP compliance and supply chain optimization - The company relies entirely on third-party CMOs for raw materials, active pharmaceutical ingredients, and finished product candidates for clinical trials[164] - Polypeptide Group is the sole CMO for GPS drug substance peptides, and Lyophilization Services of New England, Inc. (PCI Pharma Services) is the sole CMO for GPS drug product[165] - For GPS, CMC objectives are significantly advanced, and positive guidance from the FDA was received in Q3 2023 regarding potency assay, manufacturing processes, and stability data plan[166] - The company is collecting stability data to enable GPS storage at 2-8°C, which would optimize supply chain logistics[166] - For SLS009, GenFleet manufactures and supplies the product for research and development activities outside Greater China, as per a Clinical Supply Agreement[167] Sales and Marketing The company plans to build a focused commercial infrastructure for North America and seek partnerships for global market access - The company has limited to no manufacturing, sales, marketing, or distribution capability and relies on third parties[15] - Plans to potentially build a focused commercial infrastructure in North America and Europe for approved product candidates, particularly for rare diseases like AML[168][169] - Will remain opportunistic in seeking strategic partnerships for commercialization in various markets[168][170] - 3D Medicines Inc. holds exclusive rights for GPS development and commercialization in Greater China, with SELLAS retaining rights outside this region[171] Intellectual Property Commercial success depends on protecting IP through patents and trade secrets, and avoiding third-party infringement - Commercial success depends on obtaining and maintaining proprietary protection for product candidates and avoiding infringement of third-party rights[172] - Patent terms are generally 20 years from the earliest filing date, with potential for extensions (e.g., Hatch-Waxman Act for up to five years) for FDA-approved drugs[173][174] - GPS patent portfolio includes co-owned and MSK-licensed patents/applications covering heptavalent immunotherapy, WT1-targeting peptides, and combination methods with checkpoint inhibitors, with expected expirations ranging from 2026 to 2040[175][177] - SLS009 patent portfolio includes GenFleet-licensed patents/applications covering composition-of-matter and crystal salts, with expected expirations in 2038 and 2040[182] - The company also relies on trade secrets and confidentiality agreements to protect proprietary know-how[445][172] Competition The company faces intense competition in oncology from larger firms, with GPS having no direct AML CR2 competition - The oncology and cancer immunotherapy market is a significant growth area with substantial competition from large pharmaceutical and biotechnology companies[178] - Principal competitors for AML include companies with marketed products (e.g., AbbVie/Genentech, Pfizer, Daiichi-Sankyo, Rigel Pharmaceuticals, Bristol Myers Squibb) and late-stage clinical candidates (e.g., Delta-Fly Pharma, AROG Pharmaceuticals)[180] - GPS currently has no direct competition in AML in the maintenance setting after CR2[181] - SLS009 faces competition from other selective CDK9-targeting therapies in clinical development, such as Vincerx Pharma (enitociclib), Sumitomo Dainippon Pharma (TP-1287), Cothera Bioscience (zotiraciclib), and Prelude Therapeutics (PRT2527)[182][183] - Key competitive factors for product success include efficacy, safety, price, generic competition, clinical treatment guidelines, and reimbursement[185] Employees and Human Capital The company has 15 full-time employees, emphasizing diversity, inclusion, and competitive benefits to attract talent - As of March 1, 2025, the company had 15 full-time employees and utilizes independent consultants[187] - The company is committed to a diverse, inclusive, and safe work environment, with 53% women, 33% racial/ethnic minorities, and 53% with advanced degrees among employees[188] - Competitive benefits, compensation packages, and health/wellness initiatives are used to recruit and retain talented individuals[189] Government Regulation Product development and commercialization are extensively regulated by the FDA and other authorities, impacting all stages - The company's product candidates are subject to extensive regulation by the FDA and other authorities across all stages from research to post-approval marketing[190][191] - The drug approval process involves preclinical testing (GLP), IND application, human clinical trials (GCP) in phases (1, 2, 3, 4), and submission of a BLA (for biologics like GPS) or NDA (for drugs like SLS009)[192][194][196][197][199][206] - Special FDA programs like Fast Track, Priority Review, Breakthrough Therapy, and Accelerated Approval can expedite development and review for serious conditions with unmet medical needs[218][219][220][222] - Orphan Drug Designation (ODD) provides benefits like market exclusivity (7 years in US, 10 years in EU) and fee waivers for drugs treating rare diseases[228][230] - Biologics (like GPS) are subject to the Biologics Price Competition and Innovation Act (BPCIA), granting 12 years of data exclusivity for reference products[245][246] - Post-approval, products are subject to ongoing cGMP compliance, adverse event reporting, and strict promotion/advertising regulations, with potential for withdrawal of approval if standards are not maintained[248][249][250][251] - The company must comply with various healthcare laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA, GDPR) and evolving pricing and reimbursement regulations, including the Inflation Reduction Act (IRA), which can significantly impact profitability[254][255][256][257][259][263][265][269][273] Corporate Information SELLAS Life Sciences Group, Inc. was incorporated in Delaware in 2006, with principal offices in New York, NY - SELLAS Life Sciences Group, Inc. was incorporated in Delaware on April 3, 2006, and adopted its current name in December 2017[302] - Principal executive offices are located at 7 Times Square, Suite 2503, New York, NY 10036[300] - Corporate governance documents are available on the company's website[302] Item 1A. Risk Factors This section details comprehensive risks affecting the company's business, financial condition, and operations Risks Related to Our Financial Position and Capital Needs The company faces substantial losses, negative cash flows, and requires significant additional financing to fund operations - The company has incurred substantial losses since inception and anticipates continued losses, with no product revenues expected for many years[304][305][308] Net Loss and Accumulated Deficit (2023-2024) | Metric | 2024 (Millions) | 2023 (Millions) | | :--- | :--- | :--- | | Net Loss | $(30.9) | $(37.3) | | Accumulated Deficit | $(248.1) | $(217.2) | - Significant additional capital is required to fund operations, complete product development, and commercialization; availability of funds on acceptable terms is uncertain[312][313] - Raising additional capital through equity or convertible debt will dilute existing stockholders and may include senior rights or restrictive covenants[315] - As of December 31, 2024, cash and cash equivalents ($13.9 million) plus January 2025 offering proceeds ($23.1 million net) are insufficient to fund operations for the next 12 months, indicating substantial doubt about going concern[316][622][687] Risks Related to the Development and Regulatory Approval of Our Product Candidates Product development faces risks from new therapeutic approaches, patient enrollment, clinical trial outcomes, and adverse side effects - Success of product candidates depends on successful preclinical/clinical development, regulatory approvals, IP protection, manufacturing, market acceptance, and reimbursement[317][319] - GPS, as a new therapeutic approach, faces challenges in regulatory approval, component sourcing, manufacturing scalability, market acceptance, and reimbursement[320][321] - Patient enrollment for clinical trials, especially for orphan indications like AML CR2, is difficult and can cause significant delays and increased costs[324][328][329] - Preclinical and early clinical trial results are not predictive of later-stage success; later trials may fail to demonstrate adequate efficacy and safety for regulatory approval[332][333] - Interim, topline, and preliminary clinical data are subject to change upon full review and audit, potentially differing materially from final results[334] - Developing products in combination with other therapies exposes the company to risks of intolerance, revocation of approval for combination agents, and supply issues[335][336][337] - Undesirable side effects from product candidates could delay/halt clinical trials, lead to restrictive labels, or result in denial of regulatory approval[359][360] - Operating in foreign countries (e.g., clinical sites in Europe, Asia) exposes the company to differing regulatory requirements, economic/political instability, and currency fluctuations[343][344] Risks Related to Our Manufacturing The company relies entirely on third-party CMOs, facing risks of supply chain disruption, quality control, and single-source dependency - The company has limited to no manufacturing capability and relies entirely on third-party CMOs, creating dependency and potential disruption risks[83][381] - CMOs must comply with cGMP regulations, and any failure could lead to significant interruptions in development and commercialization[382] - Both GPS and SLS009 currently have single-sourced active pharmaceutical ingredients and drug products, posing risks if these sources become unreliable or unavailable[383] - Manufacturing processes are complex and subject to risks such as product loss due to contamination, equipment failure, temperature control issues, and raw material shortages[384][385] - The availability of GM-CSF and Montanide, co-administered with GPS, is dependent on single third-party manufacturers, and any interruption could jeopardize trials and commercialization[387] - Damage or destruction of CMO facilities could lead to inability to replace manufacturing capacity, causing expensive and time-consuming delays[388] Risks Related to Our Dependence on Third Parties and Our License Agreements Heavy reliance on third parties and license agreements poses risks of non-performance, delays, and loss of IP rights - Heavy reliance on third-party CROs, vendors, and contractors for preclinical studies and clinical trials, with limited control over their performance[390][391] - Failure of third parties to comply with GCP or meet deadlines could lead to clinical trial delays, unreliable data, and increased costs[393][394] - Termination of relationships with CROs or other vendors could disrupt development programs and be difficult to replace on favorable terms[396] - Breach of the exclusive license agreement with MSK could lead to loss of development and commercialization rights for GPS[397][398] - Breach or termination of the license agreement with GenFleet could result in loss of development and commercialization rights for SLS009[399] - An ongoing binding arbitration proceeding with 3D Medicines Inc. highlights risks related to milestone payments and development efforts in Greater China[404] - Use of hazardous materials by third-party manufacturers exposes the company to environmental, health, and safety laws and potential liabilities[402][403] Risks Related to Our Intellectual Property Success depends on obtaining and enforcing IP rights, avoiding infringement, and managing costly, uncertain patent litigation - Success depends on obtaining and maintaining patent protection, preserving trade secrets, and preventing third-party infringement[407] - Patent prosecution is expensive, time-consuming, and uncertain; applications may not result in issued patents or effectively prevent competition[407][409] - Changes in patent laws, judicial interpretations, or patent office practices (e.g., patent reform legislation, court decisions, international harmonization) could diminish IP value or narrow protection scope[410][411][412][413][414][415] - Litigation to enforce or defend IP rights is complex, expensive, and may divert management attention, with uncertain outcomes[416][417][432][433][434][438] - SLS009 may face generic competition sooner than expected, and GPS may face biosimilar competition, potentially reducing market exclusivity[418][419][421][423][426] - Protecting trade secrets and unpatented know-how is difficult, with risks of breach, independent discovery, or misappropriation by employees/consultants[443][445][446] - Some in-licensed IP may be subject to U.S. government rights under the Bayh-Dole Act, including non-exclusive licenses and 'march-in rights'[448] Risks Related to Competition and Commercialization of Our Current and Future Product Candidates Intense competition, commercialization challenges, and unfavorable pricing/reimbursement regulations pose significant market risks - The company faces substantial competition from companies with greater resources and more advanced products in the biotechnology and pharmaceutical industries[450][455] - Failure to be 'first to market' or demonstrate compelling advantages in efficacy, convenience, tolerability, and safety could compromise competitive position and market share[450][456] - Commercial success depends on establishing internal sales, marketing, and distribution capabilities or securing favorable licensing/collaboration agreements, requiring significant financial and management resources[457][458] - Market acceptance of approved products is critical and influenced by efficacy, safety, perceived advantages over alternatives, clinical indications, and willingness of physicians/patients to adopt new therapies[459][460] - Unfavorable pricing regulations, third-party reimbursement practices, and healthcare reform initiatives (e.g., IRA, state PDABs) could significantly harm business by limiting coverage, reducing prices, and impacting profitability[463][464][467][468][469][473][477] - Delays in obtaining reimbursement and varying reimbursement rates across countries can adversely affect commercialization and cost recovery[465][466][477] Risks Related to Health Care Compliance Regulations Interactions with healthcare providers are subject to complex anti-kickback, fraud, and data privacy laws, risking severe penalties - Relationships with customers and third-party payors are subject to anti-kickback, fraud and abuse, and other healthcare laws, risking criminal sanctions, civil penalties, and reputational harm[478][479] - Key federal laws include the Anti-Kickback Statute, False Claims Act (FCA), and HIPAA, which prohibit various fraudulent activities and impose privacy/security obligations[480][481] - Non-compliance with healthcare laws can result in significant civil/criminal penalties, exclusion from government programs, and operational restructuring[482] - The company is subject to U.S. federal and state (e.g., CCPA, CPRA) and international (e.g., GDPR, UK GDPR, China's Data Security Law) data privacy and security laws[483][484][490][491][492][497][498] - GDPR and UK GDPR impose strict requirements on processing personal data, including sensitive health data, with potential fines up to €20 million/4% of global turnover or £17.5 million/4% of global turnover, respectively[491][492] - Limitations on cross-border data transfers (e.g., from EU/UK to US) pose significant challenges and risks of operational disruption, fines, and inability to work with partners[493][494] - Employee misconduct or noncompliance with regulatory standards could lead to significant liability and harm to reputation[501][502] Risks Related to our Business Operations Risks include internal control deficiencies, cybersecurity incidents, public health crises, and challenges of organizational growth - Failure to maintain effective internal control over financial reporting could lead to inaccurate financial reports, fraud, and loss of investor confidence[505][506] - Indemnification provisions in contracts could expose the company to substantial liabilities exceeding insurance coverage[508][509] - Significant disruptions of IT systems, computer failures, or cybersecurity incidents (including those involving AI) could lead to data loss, operational interruptions, and financial/reputational harm[510][511][512][513][514][516][518] - Public health crises (e.g., pandemics) and adverse developments in the financial services industry (e.g., bank failures, liquidity problems) could negatively impact business, financial condition, and access to capital[519][520][521][522][523][524][525] - Future organizational growth will require managing additional managerial, operational, and commercial resources, which may be difficult to achieve effectively[526][527][529] - As a public company, the company faces increased legal and financial compliance costs, diversion of management attention, and challenges in attracting/retaining qualified board members and personnel[530][531][533] Risks Related to Ownership of Our Common Stock Common stock ownership risks include dilution from future capital raises, price volatility, and potential delisting from Nasdaq - Future capital raises through debt or equity will likely dilute existing stockholders and may grant subsequent investors senior rights or preferences[538] - The market price and trading volume of common stock are highly volatile, influenced by clinical trial results, regulatory developments, financing announcements, and general market conditions[539][540][541] - Inadequate funding for regulatory agencies (FDA, SEC) could hinder their operations, delaying product reviews/approvals and negatively impacting the business[542][543][545] - Future sales of substantial amounts of common stock (e.g., from warrant/option exercises) or the perception of such sales could adversely affect the market price[546][547][548] - The company may issue additional preferred stock, whose terms could reduce the value of common stock[549] - Anti-takeover provisions in corporate documents and Delaware law could delay or prevent a change of control[551][552][553] - Delisting from the Nasdaq Capital Market due to non-compliance with listing standards (e.g., minimum stock price) could negatively impact stock price, liquidity, and capital access[555][116] - The company has never paid and does not anticipate paying cash dividends on its common stock in the foreseeable future[557][581] Item 1B. Unresolved Staff Comments The company has no unresolved staff comments from the SEC Item 1C. Cybersecurity The company prioritizes cybersecurity through comprehensive risk management, technical safeguards, and employee training Cybersecurity Risk Management and Strategy; Effect of Risk The company manages cybersecurity risks through NIST-aligned processes, technical safeguards, training, and incident response protocols - The company maintains a comprehensive cybersecurity program to identify and assess material risks, comparing processes to NIST standards[561][562] - Key activities include monitoring data protection laws, enforcing confidentiality, employing technical safeguards (firewalls, anti-malware), and providing mandatory employee training and phishing simulations[562][563] - The company leverages the NIST incident handling framework for identification, protection, detection, response, and recovery from cybersecurity incidents[563] - Information security risk insurance is maintained to protect against potential losses from cybersecurity incidents[564] - No material cybersecurity incidents have been experienced in the last three fiscal years[566] Cybersecurity Governance; Management The Board's Audit Committee oversees cybersecurity risk, with management responsible for operational strategy and policy - The Board of Directors and management prioritize cybersecurity as an important element of overall risk management[567] - The Audit Committee provides direct oversight over cybersecurity risk and receives periodic updates from management[568] - Management, led by the CFO and VP, Associate General Counsel and Head of Compliance, is responsible for operational oversight of cybersecurity strategy and policy[569] Item 2. Properties The company leases its New York headquarters, an 8,455 square foot office space, with the current lease expiring in September 2026 - The company leases its headquarters in New York, New York, covering approximately 8,455 square feet of office space[570] - The current lease for the headquarters expires in September 2026[570] - The current facility is deemed adequate for the company's needs[570] Item 3. Legal Proceedings The company commenced arbitration against 3D Medicines Inc. in December 2023 regarding milestone payments and development efforts - The company commenced a binding arbitration proceeding against 3D Medicines Inc. in December 2023[573] - The arbitration, administered by the Hong Kong International Arbitration Centre, concerns milestone payments and 3D Medicines' failure to use commercially reasonable best efforts to develop GPS in Greater China[573][574] - The company believes its claims are meritorious but cannot predict the outcome or timing of any milestone payments or damages[575] Item 4. Mine Safety Disclosures This item is not applicable to the company PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock is listed on Nasdaq, with no cash dividends anticipated, and no unregistered securities or equity repurchases in 2024 Market Information The company's common stock is listed on The Nasdaq Capital Market under the symbol SLS - Common stock is listed on The Nasdaq Capital Market under the symbol SLS[579] Holders As of March 19, 2025, there were approximately 13 holders of record for the company's common stock - As of March 19, 2025, there were approximately 13 holders of record of the company's common stock[580] Dividends The company has never paid cash dividends and does not anticipate doing so, planning to reinvest earnings - The company has never paid cash dividends on its common stock and does not anticipate paying any in the foreseeable future[581] - Future earnings are expected to be retained for business development and growth[581] Recent Sales of Unregistered Securities The company did not sell any unregistered securities during the reporting period that were not previously reported - No sales of unregistered securities were made that were not previously reported in a Quarterly or Current Report[582] Purchases of Equity Securities The company did not purchase any of its equity securities in 2024, and no repurchase plan is authorized - The company did not purchase any of its equity securities during the year ended December 31, 2024[583] - No repurchase plan or program for common stock or other securities has been authorized by the Board of Directors[583] Equity Compensation Plan Information As of December 31, 2024, 2.3 million securities were issuable from options/warrants, with 3.5 million available for future issuance Equity Compensation Plan Information (as of December 31, 2024) | Plan Category | Number of Securities to be Issued upon Exercise of Outstanding Options, Warrants and Rights | Weighted Average Exercise Price of Outstanding Options, Warrants and Rights | Number of Securities Remaining Available for Future Issuance under Equity Compensation Plans (Excluding Securities Reflected in Previous Columns) | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | | | | | 2017 Equity Incentive Plan | 17,220 | $113.00 | — | | 2023 Amended and Restated Equity Incentive Plan | 1,820,150 | $3.15 | 3,413,929 | | Restricted Stock Units | 471,974 | N/A | — | | 2021 Employee Stock Purchase Plan | — | N/A | 79,604 | | Equity compensation plans not approved by security holders | | | | | None | — | — | — | | Total | 2,309,344 | $4.18 | 3,493,533 | Item 6. [Reserved] This item is reserved and contains no information Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's business, financial condition, and results of operations Overview This overview covers SELLAS's late-stage cancer therapeutics GPS and SLS009, their clinical status, and licensing agreements - SELLAS is a late-stage clinical biopharmaceutical company developing novel cancer therapeutics, including GPS and SLS009[588] - GPS is in an ongoing Phase 3 REGAL study for AML CR2; enrollment completed in March 2024, and interim analysis in January 2025 recommended continuation[590] - SLS009 completed Phase 1 in mid-2023 and is in a Phase 2a trial for r/r AML, showing positive initial topline data and identifying ASXL1 mutation as a potential predictive biomarker[597][598][599][600] - GPS has received Orphan Drug and Fast Track designations for AML, MPM, and MM, plus Rare Pediatric Disease designation for pediatric AML[594] - SLS009 has received Orphan Drug and Fast Track designations for AML and PTCL, plus Rare Pediatric Disease designation for pediatric ALL and AML[603] - The company has received $10.5 million in upfront and milestone payments from 3D Medicines for GPS in Greater China, with $191.5 million in potential future milestones, but is currently in arbitration over certain payments[591][593] - GenFleet initiated a study of SLS009 in combination with zanubrutinib in r/r DLBCL in China, reporting positive data in February 2025 with a 67% overall response rate[601] Components of Results of Operations Operating results are driven by R&D, G&A expenses, and non-operating income, with R&D costs expected to increase - Research and development (R&D) expenses are expensed as incurred and include costs for clinical trials, manufacturing, scientific services, employee-related expenses, license payments, and regulatory activities[604] - R&D expenses are expected to increase due to ongoing and new clinical trials, and expanded regulatory activities[605][606] - General and administrative (G&A) expenses cover personnel, legal, finance, and public company costs, and are expected to increase with commercialization preparations[608][609] - Non-operating income primarily consists of interest income from cash and cash equivalents[610] Results of Operations for the Years Ended December 31, 2024 and 2023 Net loss improved to $30.9 million in 2024 from $37.3 million in 2023, driven by reduced operating expenses Consolidated Results of Operations (Amounts in thousands) | Metric | Year ended December 31, 2024 | Year ended December 31, 2023 | Change | | :--- | :--- | :--- | :--- | | Research and development | $19,096 | $24,007 | $(4,911) | | General and administrative | $12,417 | $13,862 | $(1,445) | | Total operating expenses | $31,513 | $37,869 | $(6,356) | | Loss from operations | $(31,513) | $(37,869) | $6,356 | | Non-operating income | $632 | $529 | $103 | | Net loss | $(30,881) | $(37,340) | $6,459 | - Research and development expenses decreased by $4.9 million, primarily due to reduced clinical and regulatory consultant costs ($2.2 million) and manufacturing costs ($1.5 million) following the completion of REGAL study enrollment[612][613] - General and administrative expenses decreased by $1.5 million, mainly from lower employee-related expenses (including stock-based compensation) and outside services, partially offset by a one-time severance charge and increased legal fees[614] - Non-operating income increased by $0.1 million, driven by higher interest income from cash and cash equivalents[615] Liquidity and Capital Resources The company has historically incurred losses, requires additional financing, and faces going concern uncertainty despite recent capital raises Sources of Liquidity Primary liquidity sources include equity offerings and licensing revenues, with significant net proceeds from recent offerings - On January 29, 2025, the company consummated a registered direct offering, generating approximately $23.1 million in net proceeds[617][690] - On August 1, 2024, a registered direct offering generated approximately $19.5 million in net proceeds[618][691] - On March 19, 2024, a registered direct offering generated approximately $18.5 million in net proceeds[619][692] - On January 8, 2024, a public offering generated approximately $8.2 million in net proceeds[620][693] - Received $10.5 million in upfront and milestone payments from the 3D Medicines Agreement, with $191.5 million in potential future milestones remaining[621][694] Funding Requirements Insufficient funds for the next 12 months raise substantial doubt about going concern, necessitating additional financing Financial Position (as of December 31, 2024) | Metric | Amount (Millions) | | :--- | :--- | | Accumulated Deficit | $(248.1) | | Cash and Cash Equivalents | $13.9 | | Restricted Cash and Cash Equivalents | $0.1 | | Current Liabilities | $9.5 | - Cash and cash equivalents, even with subsequent financing, are insufficient to fund current planned operations for the next 12 months, raising substantial doubt about the company's ability to continue as a going concern[623][687] - The company anticipates incurring additional losses and requires substantial additional financing to develop product candidates[624][625] - Management is evaluating strategies including public/private equity/debt placements and revenue-generating partnerships, but there are no current commitments for additional funds[625][626][697] Components of Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents Total cash, cash equivalents, and restricted cash increased to $13.9 million in 2024, with $0.1 million restricted for credit cards Cash, Cash Equivalents, and Restricted Cash (Amounts in thousands) | Component | December 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $13,886 | $2,530 | | Restricted cash and cash equivalents | $100 | $100 | | Total | $13,986 | $2,630 | - Restricted cash of $0.1 million is maintained as collateral for corporate credit cards[627][146] Cash Flows Operating cash use increased in 2024, while financing activities provided significant cash from equity offerings Cash Flows Summary (Amounts in thousands) | Activity | Year ended December 31, 2024 | Year ended December 31, 2023 | | :--- | :--- | :--- | | Operating activities | $(35,402) | $(31,410) | | Investing activities | $— | $(5,500) | | Financing activities | $46,758 | $22,315 | | Net increase (decrease) in cash, cash equivalents, restricted cash, and restricted cash equivalents | $11,356 | $(14,595) | - Net cash used in operating activities increased to $35.4 million in 2024, primarily due to net loss and changes in operating assets/liabilities[630] - No cash was used in investing activities in 2024, compared to $5.5 million in 2023 for license payments (GenFleet Agreement)[632] - Net cash provided by financing activities was $46.8 million in 2024, mainly from net proceeds of equity offerings and warrant exercises[633] Contractual Obligations and Other Commitments Primary contractual obligation is an office lease; contingent milestone and royalty payments are not included due to uncertainty - The company has a contractual commitment of $1.1 million for its office lease in New York, New York, expiring in September 2026[636] Future Minimum Lease Payments (as of December 31, 2024, in thousands) | Year | Total minimum lease payments | | :--- | :--- | | 2025 | $635 | | 2026 | $477 | | Total future minimum lease payments | $1,112 | | Less: imputed interest | $(111) | | Operating lease liabilities | $1,001 | - Contingent milestone and royalty payments under in-licensing agreements are not included in contractual obligations due to their uncertain nature, but could be material upon achievement of development and commercial success[637][638] - The company enters into cancellable contracts for clinical trials, manufacturing, and other services, with termination payments generally limited to services provided or incurred expenses[639] Critical Accounting Policies and Estimates Critical accounting policies involve significant estimates for revenue, milestones, R&D, and stock-based compensation, impacting financial statements - Critical accounting policies involve significant estimates and judgments, including revenue recognition, milestone payments, goodwill, accrued R&D expenses, and stock-based compensation[641][642] - Revenue is recognized when customers obtain control of promised goods/services, with milestone payments included in transaction price if probable of achievement and no significant revenue reversal is expected[643][644] - Goodwill is tested annually for impairment using the simplified test, comparing carrying value to fair value[647][648] - Accrued R&D expenses are estimated based on services received and efforts expended, with adjustments made if actual timing or effort varies[649] - Stock-based compensation for options is estimated using the Black-Scholes model, requiring assumptions for volatility, expected term, and dividend yield; RSUs are expensed based on grant date fair value over vesting period[650][651][652] - Recent accounting pronouncements (ASU 2023-07, ASU 2023-09, ASU 2024-03) are being evaluated for their impact on financial statements and disclosures[740][741][742] Item 7A. Quantitative and Qualitative Disclosures about Market Risk The company is exposed to interest rate and foreign currency risks, but does not use hedging instruments for capital preservation - The primary objective of investment activities is capital preservation; hedging contracts are not utilized[655] - Exposed to interest rate risk on cash and cash equivalents, managed by investing primarily in money market mutual funds[656] - Exposed to foreign currency exchange rate fluctuations for payments to international vendors and license partners; these risks are not hedged and could adversely affect operating results and stock price[657] Item 8. Financial Statements and Supplementary Data This section presents audited consolidated financial statements, including balance sheets, statements of operations, and cash flows, with notes Report of Independent Registered Public Accounting Firm The independent auditor issued an unqualified opinion but highlighted substantial doubt about the company's going concern ability - Moss Adams LLP issued an unqualified opinion on the consolidated financial statements for 2024 and 2023, stating they present fairly in all material respects[664] - The report includes an Emphasis of Matter paragraph indicating substantial doubt about the company's ability to continue as a going concern due to recurring losses and a net capital deficiency[665] - The company is not required to have, nor was the auditor engaged to perform, an audit of its internal control over financial reporting[667] Consolidated Balance Sheets Total assets increased to $19.4 million in 2024, liabilities decreased, and stockholders' equity shifted to positive $9.5 million Consolidated Balance Sheet Highlights (Amounts in thousands) | Metric | December 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Total assets | $19,432 | $6,219 | | Current assets | $16,327 | $3,172 | | Cash and cash equivalents | $13,886 | $2,530 | | Total liabilities | $9,967 | $14,195 | | Total current liabilities | $9,510 | $13,735 | | Stockholders' equity (deficit) | $9,465 | $(7,976) | | Accumulated deficit | $(248,125) | $(217,244) | - Total assets increased significantly from $6.2 million in 2023 to $19.4 million in 2024, primarily driven by an increase in cash and cash equivalents[671] - Total liabilities decreased from $14.2 million in 2023 to $10.0 million in 2024, mainly due to reductions in accounts payable and accrued expenses[671] - Stockholders' equity improved from a deficit of $8.0 million in 2023 to a positive $9.5 million in 2024, despite an increase in accumulated deficit[671] Consolidated Statements of Operations Net loss improved to $30.9 million in 2024 from $37.3 million in 2023, driven by reduced operating expenses Consolidated Statements of Operations (Amounts in thousands) | Metric | Year Ended December 31, 2024 | Year Ended December 31, 2023 | | :--- | :--- | :--- | | Research and development | $19,096 | $24,007 | | General and administrative | $12,417 | $13,862 | | Total operating expenses | $31,513 | $37,869 | | Loss from operations | $(31,513) | $(37,869) | | Non-operating income | $632 | $529 | | Net loss | $(30,881) | $(37,340) | | Net loss per common share, basic and diluted | $(0.50) | $(1.34) | | Weighted-average common shares outstanding, basic and diluted | 61,202,412 | 27,777,111 | - Net loss decreased from $37.3 million in 2023 to $30.9 million in 2024[674] - Total operating expenses decreased by $6.4 million, driven by reductions in both R&D and G&A expenses[674] - Net loss per common share improved from $(1.34) in 2023 to $(0.50) in 2024, despite a significant increase in weighted-average common shares outstanding[674] Consolidated Statements of Stockholders' Equity (Deficit) Stockholders' equity shifted from a $7.9 million deficit in 2023 to a $9.5 million positive in 2024 due to capital raises Consolidated Statements of Stockholders' Equity (Deficit) Highlights (Amounts in thousands, except share amounts) | Metric | Balance at January 1, 2023 | Balance at December 31, 2023 | Balance at December 31, 2024 | | :--- | :--- | :--- | :--- | | Common Stock Shares | 21,005,405 | 32,132,890 | 73,977,459 | | Common Stock Amount | $2 | $3 | $7 | | Additional Paid-in Capital | $184,753 | $209,265 | $257,583 | | Accumulated Deficit | $(179,904) | $(217,244) | $(248,125) | | Total Stockholders' (Deficit) Equity | $4,851 | $(7,976) | $9,465 | - Total stockholders' equity shifted from a deficit of $7.9 million at December 31, 2023, to a positive $9.5 million at December 31, 2024[677] - Issuance of common stock, warrants, and pre-funded warrants, net of issuance costs, contributed $46.2 million to additional paid-in capital in 2024[677] - Accumulated deficit increased from $217.2 million in 2023 to $248.1 million in 2024 due to net losses[677] Consolidated Statements of Cash Flows Operating cash use increased, investing activities were minimal, and financing activities provided significant cash from equity offerings Consolidated Statements of Cash Flows (Amounts in thousands) | Activity | Year ended December 31, 2024 | Year ended December 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(35,402) | $(31,410) | | Net cash used in investing activities | $— | $(5,500) | | Net cash provided by financing activities | $46,758 | $22,315 | | Net increase (decrease) in cash, cash equivalents, restricted cash, and restricted cash equivalents | $11,356 | $(14,595) | | Cash, cash equivalents, restricted cash, and restricted cash equivalents at end of year | $13,986 | $2,630 | - Net cash used in operating activities increased by $4.0 million in 2024, primarily driven by the net loss and changes in operating assets and liabilities[680][630] - Investing activities shifted from using $5.5 million in 2023 (for in-process R&D acquisition) to no cash used in 2024[680][632] - Net cash provided by financing activities more than doubled to $46.8 million in 2024, mainly from proceeds of equity offerings[680][633] - Total cash, cash equivalents, and restricted cash increased by $11.4 million in 2024, reaching $14.0 million at year-end[680] Notes to Consolidated Financial Statements Notes detail organization, liquidity, accounting policies, collaboration agreements, balance sheet items, legal proceedings, and tax information - The company is a late-stage clinical biopharmaceutical company focused on cancer therapeutics, with GPS and SLS009 as lead product candidates[683] - Substantial doubt exists about the company's ability to continue as a going concern due to recurring losses and insufficient cash to fund operations for the next 12 months[685][687][695] - Key accounting policies include revenue recognition under ASC 606, evaluation of milestone payments, annual goodwill impairment testing, and expensing R&D costs as incurred[643][644][647][721][724][726] - Stock-based compensation is measured at grant-date fair value using the Black-Scholes model for options and closing stock price for RSUs, recognized over the vesting period[650][728][729] - The company has in-license agreements with GenFleet (for SLS009) and MSK (for GPS), involving upfront fees, milestone payments, and royalties[746][747][749][750][751] - An arbitration proceeding is ongoing with 3D Medicines regarding milestone payments and development efforts for GPS in Greater China[757] - As of December 31, 2024, the company had federal and state net operating loss carryforwards of approximately $65.6 million and $4.2 million, respectively, subject to limitations[796][797] Warrants to Acquire Shares of Common Stock (as of December 31, 2024, in thousands, except per share data) | Warrant Issuance | Outstanding, December 31, 2024 | Exercise Price Per Share | Expiration | | :--- | :--- | :--- | :--- | | August 2024 Registered Direct Offering | 15,849 | $1.2000 | August 2029 | | March 2024 Registered Direct Offering | 13,029 | $1.4100 | September 2029 | | January 2024 Offering | 11,467 | $0.7500 | January 2029 | | November 2023 Registered Direct | 3,652 | $0.7500 | January 2029 | | February 2023 Offering | 6,994 | $0.7500 | February 2028 | | April 2022 Offering | 766 | $5.4000 | April 2027 | | April 2022 Offering Modified Warrants | 3,864 | $0.7500 | January 2029 | | Pre-Funded Warrants | — | $0.0001 | n/a | | Other | 334 | $3.8827 | July 2025 - August 2025 | | Total | 55,955 | | | Item 9. Change in and Disagreements with Accountants on Accounting and Financial Disclosure T