UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K þ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission file number: 001-37798 Cartesian Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 26-1622110 (State or other jurisdi ...

Exhibit 99.1 Cartesian Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update Topline data from Phase 2b study of Descartes-08, the Company's potential first-in-class mRNA CAR- T cell therapy, in myasthenia gravis (MG) remains on track for mid-2024 On track to initiate Phase 2 study of Descartes-08 in systemic lupus erythematosus (SLE) in 1H24 as well as Phase 2 basket studies in additional autoimmune indications in 2H24 Following recent IND clearance, planning underway for first ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37798 Cartesian Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 26-1622110 (State ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37798 Selecta Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 26-1622110 (State or othe ...

Selecta Biosciences, Inc. (SELB) Q1 2023 Earnings Conference Call May 4, 2023 8:30 AM ET Company Participants Blaine Davis - CFO Carsten Brunn - CEO, President & Director Peter Traber - Chief Medical Officer Conference Call Participants Joseph Schwartz - SVB Securities Kristen Kluska - Cantor Fitzgerald John Newman - Canaccord Genuity Dipesh Patel - H.C. Wainwright & Co. Uy Ear - Mizuho Securities Gil Blum - Needham & Company Operator Good morning, and thank you for joining the Selecta Biosciences First Qua ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-37798 Selecta Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 26-1622110 (I.R.S. Employe ...

Selecta Biosciences, Inc. (SELB) Q4 2022 Earnings Conference Call March 2, 2023 8:30 AM ET Company Participants Blaine Davis - Chief Financial Officer Carsten Brunn - President, Chief Executive Officer & Director Peter Traber - Chief Medical Officer Conference Call Participants Joseph Schwartz - SVB Securities Kristen Kluska - Cantor Fitzgerald John Newman - Canaccord Genuity Yun Zhong - BTIG Gil Blum - Needham & Company Tiffany Marchell - William Blair Boobalan Pachaiyappan - H.C. Wainwright Uy Ear - Mizuh ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission file number: 001-37798 Selecta Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 26-1622110 (State or other jurisdicti ...

Selecta Biosciences, Inc. (SELB) Q3 2022 Earnings Conference Call November 3, 2022 8:30 AM ET Company Participants Carsten Brunn - President and Chief Executive Officer Kevin Tan - Chief Financial Officer Peter Traber - Chief Medical Officer Takashi Kishimoto - Chief Scientific Officer Conference Call Participants Elizabeth Scott - SVB Securities Rick Miller - Cantor Fitzgerald Yun Zhong - BTIG John Newman - Canaccord Tiffany Marchell - William Blair Boobalan Pachaiyappan - H.C. Wainwright Uy Ear - Mizuho O ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the unaudited consolidated financial statements and related notes, along with management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited consolidated financial statements of Selecta Biosciences, Inc. and its subsidiaries for the period ended September 30, 2022, including the balance sheets, statements of operations and comprehensive income (loss), statements of changes in stockholders' equity, and statements of cash flows, along with detailed notes explaining significant accounting policies, financial instruments, revenue arrangements, and other financial disclosures [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's assets, liabilities, and stockholders' equity at specific points in time Consolidated Balance Sheets (Amounts in thousands) | Metric | Sep 30, 2022 | Dec 31, 2021 | | :-------------------------------- | :----------- | :----------- | | **Assets** | | | | Cash and cash equivalents | $112,843 | $114,057 | | Marketable securities | $33,599 | $13,998 | | Total current assets | $159,677 | $144,443 | | Total assets | $178,265 | $159,883 | | **Liabilities** | | | | Deferred revenue (current) | $3,820 | $53,883 | | Total current liabilities | $23,728 | $72,251 | | Warrant liabilities | $33,473 | $25,423 | | Total liabilities | $93,358 | $137,362 | | **Stockholders' Equity** | | | | Total stockholders' equity | $84,907 | $22,521 | | Accumulated deficit | $(400,830) | $(430,316) | | Total liabilities and stockholders' equity | $178,265 | $159,883 | [Consolidated Statements of Operations and Comprehensive Income (Loss)](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) This section details the company's revenues, expenses, and net income or loss over specific reporting periods Consolidated Statements of Operations and Comprehensive Income (Loss) (Amounts in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :------------------------------------ | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Collaboration and license revenue | $20,710 | $24,427 | $93,982 | $55,140 | | Research and development expenses | $16,539 | $20,951 | $53,410 | $48,418 | | General and administrative expenses | $5,770 | $5,445 | $17,538 | $15,397 | | Total operating expenses | $22,309 | $26,396 | $70,948 | $63,815 | | Operating income (loss) | $(1,599) | $(1,969) | $23,034 | $(8,675) | | Change in fair value of warrant liabilities | $(6,539) | $592 | $7,329 | $(11,335) | | Income (loss) before income taxes | $(8,214) | $(2,066) | $29,165 | $(22,098) | | Income tax (expense) benefit | $321 | $(15,828) | $321 | $(15,828) | | Net income (loss) | $(7,893) | $(17,894) | $29,486 | $(37,926) | | Basic net income (loss) per share | $(0.05) | $(0.16) | $0.21 | $(0.34) | | Diluted net income (loss) per share | $(0.05) | $(0.16) | $0.15 | $(0.34) | [Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=6&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficit)) This section outlines changes in the company's equity, reflecting net income, stock issuances, and other transactions Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Amounts in thousands, except share data) | Metric | Balance at Dec 31, 2021 | Balance at Sep 30, 2022 | | :------------------------------------ | :---------------------- | :---------------------- | | Common stock (shares) | 123,622,965 | 153,028,822 | | Common stock (amount) | $12 | $15 | | Additional paid-in capital | $457,391 | $490,252 | | Accumulated deficit | $(430,316) | $(400,830) | | Total stockholders' equity | $22,521 | $84,907 | Key Changes (Nine Months Ended Sep 30, 2022) * **Net income:** $28,778 (March 31, 2022) + $8,601 (June 30, 2022) - $7,893 (September 30, 2022) = **$29,486** * **Issuance of common stock and common warrants:** **$21,480** * **Stock-based compensation expense:** $2,753 + $2,564 + $2,601 = **$7,918** [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes cash inflows and outflows from operating, investing, and financing activities Consolidated Statements of Cash Flows (Amounts in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :------------------------------------ | :----------------------------- | :----------------------------- | | Net income (loss) | $29,486 | $(37,926) | | Net cash (used in) operating activities | $(19,782) | $(28,922) | | Net cash (used in) investing activities | $(20,491) | $(26,862) | | Net cash provided by financing activities | $39,215 | $31,741 | | Net change in cash, cash equivalents, and restricted cash | $(993) | $(24,040) | | Cash, cash equivalents, and restricted cash at end of period | $114,443 | $116,024 | [Notes to Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the consolidated financial statements [1. Description of the Business](index=9&type=section&id=1.%20Description%20of%20the%20Business) This note describes the company's core business, its ImmTOR platform, and its financial strategy - Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing its ImmTOR platform, which encapsulates rapamycin to induce antigen-specific immune tolerance. The platform aims to restore self-tolerance in autoimmune diseases, amplify biologic efficacy, and mitigate anti-drug antibodies[28](index=28&type=chunk) - The Company has financed operations through public/private equity offerings, debt, research grants, and collaboration/license agreements, with no current product revenue. It expects to incur operating losses for the foreseeable future due to ongoing R&D[32](index=32&type=chunk)[33](index=33&type=chunk) - As of September 30, 2022, cash, cash equivalents, restricted cash, and marketable securities totaled **$148.0 million**, expected to fund operations for at least the next twelve months. However, this is subject to risks and uncertainties, and additional funding may be required sooner[33](index=33&type=chunk) [2. Summary of Significant Accounting Policies](index=10&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements - The Company's significant accounting policies remain consistent with its 2021 Annual Report on Form 10-K, with no material changes except for recent accounting pronouncements[36](index=36&type=chunk) - ASU 2021-04, effective for fiscal years beginning after December 15, 2021, regarding issuer's accounting for certain modifications or exchanges of freestanding equity-classified written call options (warrants), was adopted without impact on financial position or results[37](index=37&type=chunk) - ASU 2020-06 (simplifying accounting for certain financial instruments) and ASU 2016-13 (credit losses) are not yet adopted but are being assessed for potential impact, with ASU 2016-13 not expected to have an impact[38](index=38&type=chunk)[40](index=40&type=chunk) [3. Marketable Securities and Investments](index=11&type=section&id=3.%20Marketable%20Securities%20and%20Investments) This note details the company's holdings in marketable securities and other investments Marketable Securities (Amounts in thousands) | Type | Sep 30, 2022 Fair Value | Dec 31, 2021 Fair Value | | :--------------------------------- | :---------------------- | :---------------------- | | U.S. government agency securities and treasuries | $16,821 | — | | Corporate bonds | $1,945 | $2,006 | | Commercial paper | $14,833 | $11,992 | | **Total** | **$33,599** | **$13,998** | - All marketable securities had maturities of less than 12 months when purchased and are classified as short-term - The Company holds a **$2.0 million** investment in Cyrus Biotechnology, Inc. as of September 30, 2022, and December 31, 2021, with maximum exposure to loss limited to the carrying value of the investment[42](index=42&type=chunk) [4. Net Income (Loss) Per Share](index=11&type=section&id=4.%20Net%20Income%20(Loss)%20Per%20Share) This note provides a breakdown of basic and diluted net income or loss per share calculations Net Income (Loss) Per Share (Amounts in thousands, except share and per-share data) | Metric | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :------------------------------------ | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Net income (loss) | $(7,893) | $(17,894) | $29,486 | $(37,926) | | Basic EPS | $(0.05) | $(0.16) | $0.21 | $(0.34) | | Diluted EPS | $(0.05) | $(0.16) | $0.15 | $(0.34) | | Weighted-average common shares outstanding - basic | 152,849,992 | 115,169,949 | 141,969,449 | 113,161,622 | | Weighted-average common shares used in per share calculations - diluted | 152,849,992 | 115,169,949 | 143,792,060 | 113,161,622 | Potential Dilutive Shares Excluded from Diluted Net Loss Per Share (Anti-dilutive) | Type | Sep 30, 2022 (3 Months) | Sep 30, 2021 (3 Months) | Sep 30, 2022 (9 Months) | Sep 30, 2021 (9 Months) | | :--------------------------------- | :---------------------- | :---------------------- | :---------------------- | :---------------------- | | Options, RSUs and ESPP shares | 16,147,192 | 11,701,844 | 16,960,983 | 11,701,844 | | Warrants to purchase common stock | 31,228,279 | 12,378,016 | 213,339 | 12,378,016 | | **Total** | **47,375,471** | **24,079,860** | **17,174,322** | **24,079,860** | [5. Fair Value Measurements](index=12&type=section&id=5.%20Fair%20Value%20Measurements) This note explains fair value determination for financial instruments, especially warrant liabilities Fair Value Measurements (Amounts in thousands) | Asset/Liability | Sep 30, 2022 Total | Dec 31, 2021 Total | | :--------------------------------- | :----------------- | :----------------- | | Money market funds | $47,448 | $66,563 | | Marketable securities | $33,599 | $13,998 | | **Total Assets at Fair Value** | **$81,047** | **$80,561** | | Warrant liabilities (Level 3) | $33,473 | $25,423 | | **Total Liabilities at Fair Value** | **$33,473** | **$25,423** | - Warrant liabilities are classified as Level 3 due to the use of unobservable inputs (stock price volatility, expected life) in the Black-Scholes valuation model. The fair value of warrant liabilities increased from **$25.4 million** at December 31, 2021, to **$33.5 million** at September 30, 2022, primarily due to new issuances and changes in fair value[52](index=52&type=chunk)[57](index=57&type=chunk) Black-Scholes Valuation Model Assumptions for 2019 Warrants | Assumption | Sep 30, 2022 | Dec 31, 2021 | | :----------------- | :----------- | :----------- | | Risk-free interest rate | 4.22% | 0.97% | | Expected life (years) | 2.23 | 2.98 | | Expected volatility | 83.26% | 96.10% | Black-Scholes Valuation Model Assumptions for 2022 Warrants | Assumption | Sep 30, 2022 | Apr 11, 2022 (At Issuance) | | :----------------- | :----------- | :------------------------- | | Risk-free interest rate | 4.06% | 2.79% | | Expected life (years) | 4.53 | 5.00 | | Expected volatility | 95.66% | 96.00% | [6. Property and Equipment](index=14&type=section&id=6.%20Property%20and%20Equipment) This note provides details on the company's property and equipment, including depreciation Property and Equipment, Net (Amounts in thousands) | Category | Sep 30, 2022 | Dec 31, 2021 | | :--------------------------------- | :----------- | :----------- | | Laboratory equipment | $6,145 | $5,134 | | Computer equipment and software | $699 | $731 | | Leasehold improvements | $57 | $45 | | Furniture and fixtures | $396 | $332 | | Office equipment | $192 | $163 | | Construction in process | $434 | $534 | | **Total property and equipment** | **$7,923** | **$6,939** | | Less accumulated depreciation | $(5,019) | $(4,797) | | **Property and equipment, net** | **$2,904** | **$2,142** | - Depreciation expense was **$0.2 million** and **$0.1 million** for the three months ended September 30, 2022 and 2021, respectively - Depreciation expense was **$0.5 million** and **$0.4 million** for the nine months ended September 30, 2022 and 2021, respectively [7. Accrued Expenses](index=14&type=section&id=7.%20Accrued%20Expenses) This note details the various accrued expenses recognized by the company Accrued Expenses (Amounts in thousands) | Category | Sep 30, 2022 | Dec 31, 2021 | | :--------------------------------- | :----------- | :----------- | | Payroll and employee related expenses | $2,699 | $3,179 | | Accrued patent fees | $460 | $309 | | Accrued external research and development costs | $7,616 | $4,339 | | Accrued professional and consulting services | $687 | $815 | | Accrued interest | $208 | $170 | | Other | $593 | $1,721 | | **Total Accrued expenses** | **$12,263** | **$10,533** | - Other accrued expenses as of December 31, 2021, included a **$0.9 million** estimated liability for litigation settlement [8. Leases](index=15&type=section&id=8.%20Leases) This note provides information on the company's lease agreements, including lease costs and liabilities - On September 1, 2022, the Company amended its lease agreement to expand its corporate headquarters by approximately 7,216 square feet, with a lease term of 5.7 years and rent payments beginning November 2022. This resulted in recording **$3.2 million** in right-of-use assets and operating lease liabilities[60](index=60&type=chunk) Lease Costs (Amounts in thousands) | Lease Cost Type | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :---------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Operating lease cost | $569 | $457 | $1,580 | $1,355 | | Variable lease cost | $205 | $182 | $630 | $652 | | Short-term lease cost | $3 | $2 | $8 | $7 | | **Total lease cost** | **$777** | **$641** | **$2,218** | **$2,014** | Operating Lease Liabilities Maturity as of Sep 30, 2022 (Amounts in thousands) | Year | Amount | | :----------------- | :----- | | 2022 (remainder) | $653 | | 2023 | $2,656 | | 2024 | $2,736 | | 2025 | $2,818 | | 2026 | $2,902 | | Thereafter | $3,936 | | **Total future minimum lease payments** | **$15,701** | | Less imputed interest | $3,643 | | **Total operating lease liabilities** | **$12,058** | [9. Debt](index=16&type=section&id=9.%20Debt) This note provides details on the company's debt obligations, including the 2020 Term Loan - On March 21, 2022, the Company amended its 2020 Term Loan, extending amortization payments to April 1, 2023. A **$0.1 million** fee was added to the debt discount. On September 20, 2022, a third amendment increased the letter of credit by **$0.2 million** to **$1.6 million**[63](index=63&type=chunk) 2020 Term Loan and Unamortized Debt Discount Balances (Amounts in thousands) | Metric | Sep 30, 2022 | | :--------------------------------- | :----------- | | Face value | $25,000 | | Venture debt termination fee | $2,250 | | Less: Debt discount | $(1,156) | | Less: Current portion of loan payable | $(5,879) | | **Loan payable, net of current portion** | **$20,215** | Future Minimum Principal Payments on 2020 Term Loan (Amounts in thousands) | Year Ended | Amount | | :----------------- | :----- | | 2023 | $7,759 | | 2024 | $10,345 | | 2025 | $6,896 | | **Total minimum principal payments** | **$25,000** | [10. Equity](index=16&type=section&id=10.%20Equity) This note details changes in the company's equity, including common stock, warrants, and reserved shares - Stockholders approved an increase in authorized common stock from 200,000,000 to 350,000,000 shares on June 17, 2022[65](index=65&type=chunk) - In April 2022, the Company completed an underwritten offering of 27,428,572 common shares and warrants to purchase up to 20,571,429 shares, generating approximately **$36.9 million** in net proceeds. The 2022 Warrants are classified as liabilities due to potential cash settlement upon acquisition[66](index=66&type=chunk)[67](index=67&type=chunk) Warrant Activity (Nine Months Ended Sep 30, 2022) | Metric | Equity Classified | Liability Classified | Total | Weighted Average Exercise Price | | :--------------------------------- | :---------------- | :------------------- | :------ | :------------------------------ | | Outstanding at Dec 31, 2021 | 292,469 | 10,443,511 | 10,735,980 | $1.62 | | Issuance | — | 20,571,429 | 20,571,429 | $1.55 | | Canceled | (79,130) | — | (79,130) | $17.71 | | **Outstanding at Sep 30, 2022** | **213,339** | **31,014,940** | **31,228,279** | **$1.53** | Reserved Shares for Future Issuance | Category | Sep 30, 2022 | Dec 31, 2021 | | :--------------------------------- | :----------- | :----------- | | Exercise of warrants | 31,228,279 | 10,735,980 | | Shares available for future stock incentive awards | 6,400,527 | 6,039,564 | | Unvested restricted stock units | 1,770,896 | 394,450 | | Outstanding common stock options | 15,172,715 | 11,039,873 | | **Total** | **54,572,417** | **28,209,867** | [11. Stock Incentive Plans](index=17&type=section&id=11.%20Stock%20Incentive%20Plans) This note describes the company's stock incentive plans and related compensation expenses - The Company maintains the 2016 Incentive Award Plan and the 2018 Employment Inducement Incentive Award Plan, with **1,086,951** and **1,675,858** shares available for future issuance, respectively, as of September 30, 2022[76](index=76&type=chunk)[77](index=77&type=chunk) Total Stock-based Compensation Expense (Amounts in thousands) | Category | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development | $954 | $791 | $3,993 | $2,331 | | General and administrative | $1,647 | $1,113 | $4,925 | $3,136 | | **Total stock-based compensation expense** | **$2,601** | **$1,904** | **$8,918** | **$5,467** | - As of September 30, 2022, total unrecognized compensation expense for unvested employee stock options was **$18.4 million**, expected to be recognized over 2.7 years. For restricted stock units, unrecognized compensation expense was **$3.3 million**, also over 2.7 years[80](index=80&type=chunk)[84](index=84&type=chunk) [12. Revenue Arrangements](index=20&type=section&id=12.%20Revenue%20Arrangements) This note details collaboration and license agreements and their impact on revenue recognition - The Company has collaboration and license agreements with Takeda, Sobi, Sarepta, and AskBio. Revenue recognition for these agreements involves upfront payments, milestone payments, and royalties, with variable consideration often constrained until probable of achievement[87](index=87&type=chunk)[91](index=91&type=chunk)[103](index=103&type=chunk)[114](index=114&type=chunk) - For the Sobi License, the Company recognized **$20.7 million** and **$73.6 million** in revenue during the three and nine months ended September 30, 2022, respectively, including **$7.1 million** from prior periods due to a change in transaction price[102](index=102&type=chunk) - For the Sarepta Agreement, the Company received milestone payments of **$2.0 million** for an option extension and **$4.0 million** for preclinical study milestones during the three months ended September 30, 2022. **$10.2 million** in revenue was recognized for the nine months ended September 30, 2022[110](index=110&type=chunk)[111](index=111&type=chunk)[113](index=113&type=chunk) - The Spark License Agreement was mutually terminated on January 18, 2022, resulting in **$9.2 million** of short-term contract liability recognized as revenue during the nine months ended September 30, 2022[123](index=123&type=chunk) Changes in Contract Liabilities (Deferred Revenue) (Amounts in thousands) | Metric | Balance at Beginning of Period | Additions | Deductions | Balance at End of Period | | :--------------------------------- | :----------------------------- | :-------- | :--------- | :--------------------- | | Deferred revenue (Nine Months Ended Sep 30, 2022) | $65,300 | $16,000 | $(72,044) | $9,256 | | **Total contract liabilities** | **$65,300** | **$16,000** | **$(72,044)** | **$9,256** | [13. Related-party Transactions](index=24&type=section&id=13.%20Related-party%20Transactions) This note discloses related-party transactions, including equity purchases and consulting services Related-Party Purchases in April 2022 Offering | Name | Shares of Common Stock Purchased | 2022 Warrants Purchased | Total Aggregate Purchase Price | | :--------------------------------- | :------------------------------- | :---------------------- | :----------------------------- | | TAS Partners, LLC (affiliate of Timothy A. Springer, Ph.D.) | 6,681,600 | 5,011,200 | $9,421,056 | - The Company incurred less than **$0.1 million** and **$0.1 million** for consulting services from founders on its Scientific Advisory Board during the three and nine months ended September 30, 2021, respectively[128](index=128&type=chunk) [14. Collaboration and License Agreements](index=25&type=section&id=14.%20Collaboration%20and%20License%20Agreements) This note provides details on the company's various collaboration and license agreements with partners - The Company has collaboration agreements with Ginkgo Bioworks (First and Second Ginkgo Agreements) to develop IgA proteases and AAV capsids, respectively. Ginkgo is eligible for R&D fees, cash milestones (up to **$85 million** and **$207 million** per product, respectively), stock milestones, and royalties[129](index=129&type=chunk)[130](index=130&type=chunk)[184](index=184&type=chunk)[185](index=185&type=chunk) - In June 2022, the Company paid **$0.5 million** and issued 892,857 common shares (valued at **$1.0 million**) to Ginkgo for achieving a technical development milestone under the First Ginkgo Agreement[131](index=131&type=chunk)[184](index=184&type=chunk) - The Company licensed Xork enzyme technology from Genovis for therapeutic uses, with Genovis eligible for development/sales milestones and low double-digit royalties[132](index=132&type=chunk)[133](index=133&type=chunk)[186](index=186&type=chunk) - A collaboration with Cyrus Biotechnology focuses on protein engineering for an IL-2 protein agonist. The Company made an upfront payment and may pay up to **$1.5 billion** in milestones and royalties. A preclinical milestone was achieved in June 2022[134](index=134&type=chunk)[137](index=137&type=chunk)[187](index=187&type=chunk)[188](index=188&type=chunk) - The AskBio Collaboration Agreement for MMA gene therapy (SEL-302) remains in effect despite AskBio opting out of MMA development. The Company filed an IND for SEL-302, and the clinical hold was removed in March 2022[139](index=139&type=chunk)[140](index=140&type=chunk) - Collaboration expenses under the AskBio Collaboration Agreement were **$0.2 million** and **$0.8 million** for the three and nine months ended September 30, 2022, respectively, reflecting a 50% cost share[146](index=146&type=chunk) [15. Income Taxes](index=28&type=section&id=15.%20Income%20Taxes) This note discusses the company's income tax position, deferred tax assets, and net operating losses - The Company has a full valuation allowance against its net deferred tax assets, indicating that it is more likely than not that these assets will not be realized[152](index=152&type=chunk) - Effective January 1, 2022, IRC Section 174 requires capitalization of R&E expenditures over five years (U.S.) or 15 years (non-U.S.). The Company's analysis projects no income tax due for 2022[153](index=153&type=chunk) - The Company has **$51.1 million** in federal net operating losses and **$1.2 million** in federal tax credits as of December 31, 2021, subject to Section 382 and 383 limitations[153](index=153&type=chunk)[154](index=154&type=chunk) [16. Defined Contribution Plan](index=28&type=section&id=16.%20Defined%20Contribution%20Plan) This note describes the company's 401(k) plan and matching contributions - The Company's 401(k) Plan provides matching contributions that vest ratably over 2 years, while participant contributions vest immediately. Contributions totaled **$0.1 million** and **$0.3 million** for the three and nine months ended September 30, 2022, respectively[156](index=156&type=chunk) [17. Commitments and Contingencies](index=28&type=section&id=17.%20Commitments%20and%20Contingencies) This note outlines the company's commitments and potential contingent liabilities, including litigation - As of September 30, 2022, the Company was not a party to any litigation that could have a material adverse effect on its business or financial position[157](index=157&type=chunk) - A stockholder derivative action filed in August 2020, alleging breach of fiduciary duties related to a private placement, was settled and dismissed with prejudice on August 1, 2022[158](index=158&type=chunk)[159](index=159&type=chunk) - The Company indemnifies its officers, directors, and employees, and has indemnification arrangements under facility leases. No material losses related to these obligations have been experienced to date[160](index=160&type=chunk) [18. Subsequent Events](index=29&type=section&id=18.%20Subsequent%20Events) This note reports significant events occurring after the reporting period but before financial statements issuance - No subsequent events requiring disclosure have occurred through the date of issuance of the consolidated financial statements[162](index=162&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the Company's financial condition and results of operations for the three and nine months ended September 30, 2022, compared to the prior year. It covers business overview, product candidates, collaborations, global event impacts, financial performance, and liquidity, highlighting the Company's focus on its ImmTOR platform and its financial outlook [Overview](index=29&type=section&id=Overview) This section provides a high-level summary of Selecta Biosciences' business, its ImmTOR platform, and strategic focus - Selecta Biosciences is a clinical-stage biopharmaceutical company utilizing its ImmTOR platform, which encapsulates rapamycin, to induce antigen-specific immune tolerance. The platform is designed to enhance biologic therapies, improve gene therapies, and enable novel treatments for autoimmune diseases[164](index=164&type=chunk) - The Company is developing ImmTOR-IL™, a combination of ImmTOR with a Treg-selective IL-2 molecule, which has shown synergistic activity in preclinical studies for inducing and expanding antigen-specific Tregs, potentially offering a 'first-in-class' antigen-specific IL-2 therapy for autoimmune disease[164](index=164&type=chunk) [Our Product Candidates](index=30&type=section&id=Our%20Product%20Candidates) This section details the company's pipeline of product candidates across various therapeutic areas and development phases - The ImmTOR platform's development strategy focuses on three pillars: Biologic therapies (e.g., SEL-212 for chronic refractory gout, IgA nephropathy), Gene therapies (e.g., SEL-302 for MMA, SEL-313 for OTC Deficiency, SEL-018 (Xork) for AAV immunity), and Tolerogenic Therapies for Autoimmune Disease (e.g., proprietary IL-2 receptor agonist, Primary Biliary Cholangitis (PBC))[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk) Summary of Ongoing Discovery, Research, and Development Programs | Program | Phase of Development | Anticipated Next Steps | Commercial Rights | | :--------------------------------- | :------------------- | :--------------------- | :---------------- | | **Biologic Therapies** | | | | | SEL-212 (Chronic Refractory Gout) | Phase 3 clinical trials | Top-line data Q1 2023 | Sobi | | IgA nephropathy | Preclinical | IND enabling studies, 2022 | Selecta | | **Gene Therapies** | | | | | SEL-302 (Methylmalonic acidemia (MMA)) | IND filed / Phase 1 | Study commencement, Q4 2022 | Selecta | | SEL-313 (Ornithine Transcarbamylase (OTC) Deficiency) | IND-enabling | Currently paused | Selecta | | SEL-018 (IgG protease (Xork)) | Preclinical | IND enabling studies, 2022 | Selecta | | Pompe disease | Preclinical | Plans to be announced by collaborator | AskBio | | Duchenne muscular dystrophy (DMD) | Preclinical | Plans to be announced by collaborator | Sarepta | | Limb-girdle muscular dystrophy (LGMD) | Preclinical | Plans to be announced by collaborator | Sarepta | | Two indications for lysosomal storage disorders | Preclinical | Plans to be announced by collaborator | Takeda | | **Tolerogenic Therapies for Autoimmune Disease** | | | | | Proprietary IL-2 receptor agonist | Preclinical | | Selecta | | Primary biliary cholangitis (PBC) | Preclinical | | Selecta | - The SEL-302 program for MMA, previously on clinical hold, received FDA clearance to proceed with its Phase 1/2 clinical trial in March 2022, with study commencement anticipated in Q4 2022[176](index=176&type=chunk) [Licenses and Collaborations](index=32&type=section&id=Licenses%20and%20Collaborations) This section outlines the company's various in-licensing and out-licensing agreements and collaborations - The Company has in-licenses with Ginkgo Bioworks (First and Second Ginkgo Agreements for IgA proteases and AAV capsids), Genovis (Xork enzyme technology), Cyrus Biotechnology (protein engineering for an IL-2 protein agonist), and IGAN Biosciences (IgA proteases, option term extended to 24 months from May 2022)[183](index=183&type=chunk)[185](index=185&type=chunk)[186](index=186&type=chunk)[187](index=187&type=chunk)[189](index=189&type=chunk)[191](index=191&type=chunk) - Out-licenses include agreements with Takeda (ImmTOR for lysosomal storage disorders, up to **$1.124 billion** in milestones), Sobi (SEL-212 for chronic refractory gout, up to **$630 million** in milestones, **$10 million** payment received in July 2022 for DISSOLVE II enrollment completion), and Sarepta (ImmTOR for Duchenne and Limb-Girdle Muscular Dystrophy, **$2 million** for option extension and **$4 million** for preclinical milestones received in August 2022)[192](index=192&type=chunk)[193](index=193&type=chunk)[196](index=196&type=chunk)[197](index=197&type=chunk)[198](index=198&type=chunk) - The AskBio License Agreement grants AskBio exclusive worldwide rights to ImmTOR for Pompe Disease, with potential milestones up to **$237 million** and tiered royalties[199](index=199&type=chunk) [Impact of Global Events](index=34&type=section&id=Impact%20of%20Global%20Events) This section discusses the potential effects of global events, such as the COVID-19 pandemic and geopolitical situations, on the company's operations - The COVID-19 pandemic has not materially impacted clinical programs to date, but future developments could cause delays in trials, supply chain disruptions, and unforeseen costs. The Company is monitoring the situation closely[201](index=201&type=chunk)[202](index=202&type=chunk)[203](index=203&type=chunk)[204](index=204&type=chunk) - In response to the geopolitical situation in Ukraine and Russia, the Company increased DISSOLVE II trial enrollment to 153 subjects to mitigate potential losses from subjects in those regions. Topline results for DISSOLVE II are still expected in Q1 2023[205](index=205&type=chunk) [Financial Operations](index=35&type=section&id=Financial%20Operations) This section provides an overview of the company's financial performance, funding strategies, and accumulated deficit - The Company has incurred significant operating losses since inception, with a net income of **$29.5 million** for the nine months ended September 30, 2022, compared to a net loss of **$37.9 million** for the same period in 2021. The accumulated deficit was **$400.8 million** as of September 30, 2022[207](index=207&type=chunk) - Future cash needs are expected to be financed through equity offerings, debt financings, and license/collaboration agreements, as the Company does not expect to generate product revenue for several years[207](index=207&type=chunk)[210](index=210&type=chunk) - Research and development expenses totaled **$417.4 million** from inception through September 30, 2022, primarily for SEL-212 and platform expansion. These costs are expensed as incurred, with SEL-212 clinical trial costs reimbursed by Sobi[212](index=212&type=chunk)[213](index=213&type=chunk)[214](index=214&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) This section analyzes the company's financial results, including revenue, expenses, and net income/loss, for the reported periods Collaboration and License Revenue (Amounts in thousands) | Period | 2022 | 2021 | Change | % Change | | :--------------------------------- | :----- | :----- | :----- | :------- | | Three Months Ended Sep 30 | $20,710 | $24,427 | $(3,717) | (15)% | | Nine Months Ended Sep 30 | $93,982 | $55,140 | $38,842 | 70% | - The decrease in Q3 revenue was primarily due to the Sobi license. The increase in YTD revenue was driven by Sobi, Sarepta, Spark termination, and Takeda agreements[222](index=222&type=chunk)[234](index=234&type=chunk) Research and Development Expenses (Amounts in thousands) | Period | 2022 | 2021 | Change | % Change | | :--------------------------------- | :----- | :----- | :----- | :------- | | Three Months Ended Sep 30 | $16,539 | $20,951 | $(4,412) | (21)% | | Nine Months Ended Sep 30 | $53,410 | $48,418 | $4,992 | 10% | - Q3 decrease primarily due to lower expenses for SEL-212, preclinical programs, and AskBio collaboration[223](index=223&type=chunk)[224](index=224&type=chunk) - YTD increase primarily due to preclinical programs, contract license/milestone payments, and increased personnel/stock compensation[235](index=235&type=chunk)[236](index=236&type=chunk) General and Administrative Expenses (Amounts in thousands) | Period | 2022 | 2021 | Change | % Change | | :--------------------------------- | :----- | :----- | :----- | :------- | | Three Months Ended Sep 30 | $5,770 | $5,445 | $325 | 6% | | Nine Months Ended Sep 30 | $17,538 | $15,397 | $2,141 | 14% | - Increases in both periods were primarily due to stock compensation and personnel expenses[225](index=225&type=chunk)[237](index=237&type=chunk) Net Income (Loss) (Amounts in thousands) | Period | 2022 | 2021 | | :--------------------------------- | :----- | :----- | | Three Months Ended Sep 30 | $(7,900) | $(17,900) | | Nine Months Ended Sep 30 | $29,500 | $(37,900) | - The nine-month period saw a significant swing from a net loss to net income, largely influenced by the **$7.3 million** income from the change in fair value of warrant liabilities in 2022 versus an **$11.3 million** charge in 2021, and the **$15.8 million** income tax expense in 2021 related to the Sobi license[232](index=232&type=chunk)[245](index=245&type=chunk)[241](index=241&type=chunk)[244](index=244&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to meet its short-term and long-term financial obligations, including funding sources and cash position - Since inception through September 30, 2022, the Company has raised **$716.4 million**, including **$243.3 million** from collaborations and license agreements and **$57.1 million** from at-the-market offerings[247](index=247&type=chunk) - As of September 30, 2022, cash, cash equivalents, restricted cash, and marketable securities totaled **$148.0 million**. This, combined with a **$6.9 million** receivable from Sobi, is expected to fund operations into mid-2024[248](index=248&type=chunk)[259](index=259&type=chunk) - The 2020 Term Loan has an outstanding principal balance of **$25.0 million** as of September 30, 2022, secured by substantially all assets (excluding intellectual property) and subject to customary covenants and events of default[64](index=64&type=chunk)[253](index=253&type=chunk)[255](index=255&type=chunk) - Future funding requirements are dependent on factors such as the number of product candidates, collaboration agreements, manufacturing costs, headcount, R&D progress, regulatory review, commercialization activities, intellectual property costs, and market developments[261](index=261&type=chunk) [Summary of Cash Flows](index=43&type=section&id=Summary%20of%20Cash%20Flows) This section provides a summary and analysis of the company's cash flows from operating, investing, and financing activities Summary of Cash Flows (Amounts in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--------------------------------- | :----------------------------- | :----------------------------- | | Operating activities | $(19,782) | $(28,922) | | Investing activities | $(20,491) | $(26,862) | | Financing activities | $39,215 | $31,741 | | Effect of exchange rate changes on cash | $65 | $3 | | **Net change in cash, cash equivalents, and restricted cash** | **$(993)** | **$(24,040)** | - Cash used in operating activities decreased from **$28.9 million** in 2021 to **$19.8 million** in 2022, primarily due to net income (vs. net loss) adjusted for non-cash items, despite uses of cash for changes in operating assets and liabilities[262](index=262&type=chunk)[263](index=263&type=chunk) - Net cash used in investing activities decreased from **$26.9 million** in 2021 to **$20.5 million** in 2022, mainly driven by purchases and maturities of marketable securities. Net cash provided by financing activities increased from **$31.7 million** in 2021 to **$39.2 million** in 2022, primarily from equity offerings[264](index=264&type=chunk)[265](index=265&type=chunk)[266](index=266&type=chunk) [Recent Accounting Pronouncements](index=44&type=section&id=Recent%20Accounting%20Pronouncements) This section discusses any new accounting standards or pronouncements and their potential impact on the financial statements - No new material accounting pronouncements were adopted or issued during the three and nine months ended September 30, 2022, beyond those discussed in Note 2 to the financial statements[267](index=267&type=chunk) [Off-Balance Sheet Arrangements](index=44&type=section&id=Off-Balance%20Sheet%20Arrangements) This section discloses any off-balance sheet transactions, arrangements, or obligations that could have a material effect on the company's financial condition - As of September 30, 2022, the Company did not have any off-balance sheet arrangements[268](index=268&type=chunk) [Critical Accounting Policies and Use of Estimates](index=44&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) This section highlights the accounting policies that require management's most difficult, subjective, or complex judgments and estimates - There were no material changes to the Company's critical accounting policies or use of estimates during the three and nine months ended September 30, 2022, from those described in its 2021 Annual Report on Form 10-K[269](index=269&type=chunk) [Smaller Reporting Company](index=44&type=section&id=Smaller%20Reporting%20Company) This section clarifies the company's status as a smaller reporting company and the associated disclosure accommodations - The Company qualifies as a 'smaller reporting company' and may take advantage of scaled disclosure requirements. It will retain this status until its public float exceeds **$700 million** or it meets specific revenue and public float thresholds[270](index=270&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the Company's exposure to market risk, primarily interest rate sensitivity, and concludes that an immediate 100 basis point change in interest rates would not materially affect the fair market value of its cash equivalents or short-term marketable securities due to their short-term and low-risk profile - The Company's primary market risk exposure is interest rate sensitivity, affecting its cash, cash equivalents, restricted cash, and marketable securities, which totaled **$148.0 million** as of September 30, 2022[271](index=271&type=chunk) - Due to the short-term and low-risk nature of its money market accounts and marketable securities, and the intent to hold marketable securities to maturity, a 100 basis point change in interest rates is not expected to have a material effect on their fair market value[271](index=271&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms the effectiveness of the Company's disclosure controls and procedures as of September 30, 2022, based on management's evaluation. It also acknowledges the inherent limitations of any internal control system and states that no material changes occurred in internal control over financial reporting during the quarter - Management, with CEO and CFO participation, concluded that the Company's disclosure controls and procedures were effective at the reasonable assurance level as of September 30, 2022[272](index=272&type=chunk) - There were no material changes in the Company's internal control over financial reporting during the three months ended September 30, 2022[274](index=274&type=chunk) - The report acknowledges inherent limitations in any internal control system, meaning even effective systems can only provide reasonable assurance regarding financial statement preparation[273](index=273&type=chunk) [PART II. OTHER INFORMATION](index=46&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, and other required disclosures [Item 1. Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) This section details a stockholder derivative action filed in August 2020, alleging breach of fiduciary duties and corporate waste related to a private placement. The lawsuit was settled and dismissed with prejudice on August 1, 2022 - A stockholder derivative action, Franchi v. Barabe, et al., filed in August 2020, alleging breach of fiduciary duties and corporate waste related to a December 2019 private placement, was settled and dismissed with prejudice on August 1, 2022[276](index=276&type=chunk) [Item 1A. Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) This section refers to previously disclosed risk factors in the Company's Annual Report on Form 10-K for 2021 and Quarterly Report on Form 10-Q for Q2 2022, stating that no material changes have occurred - There have been no material changes to the risk factors previously disclosed in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, and Quarterly Report on Form 10-Q for the quarter ended June 30, 2022[277](index=277&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=46&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section indicates that there were no unregistered sales of equity securities or use of proceeds to report - There were no unregistered sales of equity securities and use of proceeds to report[278](index=278&type=chunk) [Item 3. Defaults Upon Senior Securities](index=46&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities - There were no defaults upon senior securities[279](index=279&type=chunk) [Item 4. Mine Safety Disclosures](index=46&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that there were no mine safety disclosures - There were no mine safety disclosures[280](index=280&type=chunk) [Item 5. Other Information](index=46&type=section&id=Item%205.%20Other%20Information) This section states that there was no other information to report - There was no other information to report[281](index=281&type=chunk) [Item 6. Exhibits](index=47&type=section&id=Item%206.%20Exhibits) This section provides a comprehensive list of exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents, material agreements, certifications, and XBRL-related documents - The exhibit index includes corporate documents (Restated Certificate of Incorporation, Amended and Restated By-laws), material agreements (First Amendment to Lease, Third Amendment to Loan and Security Agreement), certifications (Principal Executive Officer, Principal Financial Officer), and Inline XBRL documents[284](index=284&type=chunk) [Signatures](index=48&type=section&id=Signatures) This section contains the signatures of the Company's President and Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial Officer), certifying the report's submission - The report is signed by Carsten Brunn, Ph.D., President and Chief Executive Officer, and Kevin Tan, Chief Financial Officer, on November 3, 2022[288](index=288&type=chunk)