QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State of incorporation) | (I.R.S. Employer Identification No.) |
Title of each class | Trading symbol(s) | Name of each exchange on which registered | ||||||
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||||||||||||||||
☒ | Smaller reporting company | |||||||||||||||||||
Emerging growth company |
Page | |||||||||||
PART I - FINANCIAL INFORMATION | |||||||||||
Item 1 | |||||||||||
Item 2 | |||||||||||
Item 3 | |||||||||||
Item 4 | |||||||||||
PART II - OTHER INFORMATION | |||||||||||
Item 1 | Legal Proceedings | ||||||||||
Item 1A | Risk Factors | ||||||||||
Item 2 | |||||||||||
Item 3 | |||||||||||
Item 4 | |||||||||||
Item 5 | |||||||||||
Item 6 | |||||||||||
June 30, 2023 | December 31, 2022 | ||||||||||
ASSETS | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Restricted cash and cash equivalents | |||||||||||
Prepaid expenses and other current assets | |||||||||||
Total current assets | |||||||||||
Operating lease right-of-use assets | |||||||||||
Goodwill | |||||||||||
Deposits and other assets | |||||||||||
Total assets | $ | $ | |||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | $ | |||||||||
Accrued expenses and other current liabilities | |||||||||||
Operating lease liabilities | |||||||||||
Acquired in-process research and development payable | |||||||||||
Total current liabilities | |||||||||||
Operating lease liabilities, non-current | |||||||||||
Warrant liability | |||||||||||
Total liabilities | |||||||||||
Commitments and contingencies (Note 7) | |||||||||||
Stockholders’ equity: | |||||||||||
Preferred stock, $ | |||||||||||
Common stock, $ | |||||||||||
Additional paid-in capital | |||||||||||
Accumulated deficit | ( | ( | |||||||||
Total stockholders’ equity | |||||||||||
Total liabilities and stockholders’ equity | $ | $ |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Licensing revenue | $ | $ | $ | $ | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Cost of licensing revenue | |||||||||||||||||||||||
Research and development | |||||||||||||||||||||||
General and administrative | |||||||||||||||||||||||
Acquired in-process research and development | |||||||||||||||||||||||
Total operating expenses | |||||||||||||||||||||||
Operating loss | ( | ( | ( | ( | |||||||||||||||||||
Non-operating income: | |||||||||||||||||||||||
Change in fair value of warrant liability | |||||||||||||||||||||||
Change in fair value of contingent consideration | |||||||||||||||||||||||
Interest income | |||||||||||||||||||||||
Total non-operating income | |||||||||||||||||||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
Per share information: | |||||||||||||||||||||||
Net loss per common share, basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
Weighted-average common shares outstanding, basic and diluted |
Three Months Ended June 30, 2023 | |||||||||||||||||||||||||||||
Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total Stockholders' Equity | ||||||||||||||||||||||||||
Shares | Amount | ||||||||||||||||||||||||||||
Balance at March 31, 2023 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||
Stock-based compensation | — | — | — | ||||||||||||||||||||||||||
Net loss | — | — | — | ( | ( | ||||||||||||||||||||||||
Balance at June 30, 2023 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||
Six Months Ended June 30, 2023 | |||||||||||||||||||||||||||||
Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total Stockholders' Equity | ||||||||||||||||||||||||||
Shares | Amount | ||||||||||||||||||||||||||||
Balance at December 31, 2022 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||
Issuance of common stock and common stock warrants, net of issuance costs | — | ||||||||||||||||||||||||||||
Issuance of common stock, net of issuance costs | |||||||||||||||||||||||||||||
Issuance of common stock under employee stock purchase plan | — | — | |||||||||||||||||||||||||||
Stock-based compensation | — | — | — | ||||||||||||||||||||||||||
Net loss | — | — | — | ( | ( | ||||||||||||||||||||||||
Balance at June 30, 2023 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||
Three Months Ended June 30, 2022 | |||||||||||||||||||||||||||||
Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total Stockholders' Equity | ||||||||||||||||||||||||||
Shares | Amount | ||||||||||||||||||||||||||||
Balance at March 31, 2022 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||
Issuance of common stock and common stock warrants, net of issuance costs | — | — | |||||||||||||||||||||||||||
Issuance of common stock, net of issuance costs | |||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | ||||||||||||||||||||||||||
Net loss | — | — | — | ( | ( | ||||||||||||||||||||||||
Balance at June 30, 2022 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||
Six Months Ended June 30, 2022 | |||||||||||||||||||||||||||||
Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total Stockholders' Equity | ||||||||||||||||||||||||||
Shares | Amount | ||||||||||||||||||||||||||||
Balance at December 31, 2021 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||
Issuance of common stock and common stock warrants, net of issuance costs | — | — | |||||||||||||||||||||||||||
Issuance of common stock, net of issuance costs | |||||||||||||||||||||||||||||
Issuance of common stock under employee stock purchase plan | — | — | |||||||||||||||||||||||||||
Stock-based compensation | — | — | — | ||||||||||||||||||||||||||
Net loss | — | — | — | ( | ( | ||||||||||||||||||||||||
Balance at June 30, 2022 | $ | $ | $ | ( | $ |
For the Six Months Ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
Cash flows from operating activities: | |||||||||||
Net loss | $ | ( | $ | ( | |||||||
Adjustment to reconcile net loss to net cash used in operating activities: | |||||||||||
Acquired in-process research and development expense | |||||||||||
Non-cash stock-based compensation | |||||||||||
Non-cash lease expense | |||||||||||
Change in fair value of common stock warrants | ( | ( | |||||||||
Change in fair value of contingent consideration | ( | ||||||||||
Changes in operating assets and liabilities: | |||||||||||
Prepaid expenses and other assets | ( | ||||||||||
Accounts payable | |||||||||||
Accrued expenses and other current liabilities | ( | ||||||||||
Operating lease liabilities | ( | ( | |||||||||
Net cash used in operating activities | ( | ( | |||||||||
Cash flows from investing activities: | |||||||||||
Cash paid for acquisition of in-process research and development | ( | ( | |||||||||
Net cash used in investing activities | ( | ( | |||||||||
Cash flows from financing activities: | |||||||||||
Proceeds from issuance of common stock and common stock warrants, net of issuance costs | |||||||||||
Proceeds from issuance of common stock, net of issuance costs | |||||||||||
Proceeds from employee stock purchases | |||||||||||
Net cash provided by financing activities | |||||||||||
Net (decrease) increase in cash, cash equivalents, restricted cash, and restricted cash equivalents | ( | ||||||||||
Cash, cash equivalents, restricted cash, and restricted cash equivalents at the beginning of period | |||||||||||
Cash, cash equivalents, restricted cash, and restricted cash equivalents at the end of period | $ | $ | |||||||||
Supplemental disclosure of cash flow information: | |||||||||||
Cash received during the period for interest | $ | $ | |||||||||
Supplemental disclosure of non-cash investing and financing activities: | |||||||||||
Non-cash acquisition of in-process research and development | $ | $ | |||||||||
Increase in operating lease right-of-use assets and current and non-current operating lease liabilities | $ | $ |
Six Months Ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
Common stock warrants | |||||||||||
Stock options | |||||||||||
Restricted stock units ("RSUs") | |||||||||||
Description | June 30, 2023 | Quoted Prices In Active Markets (Level 1) | Significant Other Observable Inputs (Level 2) | Unobservable Inputs (Level 3) | |||||||||||||||||||
Assets: | |||||||||||||||||||||||
Cash equivalents | $ | $ | $ | $ | |||||||||||||||||||
Restricted cash equivalents | |||||||||||||||||||||||
Total assets measured and recorded at fair value | $ | $ | $ | $ | |||||||||||||||||||
Liabilities: | |||||||||||||||||||||||
Warrant liability | $ | $ | $ | $ | |||||||||||||||||||
Total liabilities measured and recorded at fair value | $ | $ | $ | $ |
Description | December 31, 2022 | Quoted Prices In Active Markets (Level 1) | Significant Other Observable Inputs (Level 2) | Unobservable Inputs (Level 3) | |||||||||||||||||||
Assets: | |||||||||||||||||||||||
Cash equivalents | $ | $ | $ | $ | |||||||||||||||||||
Restricted cash equivalents | |||||||||||||||||||||||
Total assets measured and recorded at fair value | $ | $ | $ | $ | |||||||||||||||||||
Liabilities: | |||||||||||||||||||||||
Warrant liability | $ | $ | $ | $ | |||||||||||||||||||
Total liabilities measured and recorded at fair value | $ | $ | $ | $ |
June 30, 2023 | December 31, 2022 | ||||||||||
Insurance | $ | $ | |||||||||
Clinical development | |||||||||||
Professional fees | |||||||||||
Other | |||||||||||
Prepaid expenses and other current assets | $ | $ |
June 30, 2023 | December 31, 2022 | ||||||||||
Clinical trial costs | $ | $ | |||||||||
Compensation and related benefits | |||||||||||
Professional fees | |||||||||||
Other | |||||||||||
Accrued expenses and other current liabilities | $ | $ |
Future minimum lease payments: | ||||||||
2023 (remaining) | $ | |||||||
2024 | ||||||||
Total future minimum lease payments | ||||||||
Less: imputed interest | ( | |||||||
Current and non-current operating lease liabilities | $ |
Warrants outstanding | |||||
Stock options outstanding | |||||
RSUs outstanding | |||||
Shares reserved for future issuance under the Company’s 2019 Equity Incentive Plan | |||||
Shares reserved for future issuance under the 2021 Employee Stock Purchase Plan | |||||
Total common stock reserved for future issuance |
Warrant Issuance | Outstanding, December 31, 2022 | Granted | Outstanding, June 30, 2023 | Exercise Price per Share | Expiration | ||||||||||||||||||||||||
Warrants classified as equity: | |||||||||||||||||||||||||||||
February 2023 Offering | $ | February 2028 | |||||||||||||||||||||||||||
April 2022 Offering | $ | April 2027 | |||||||||||||||||||||||||||
January 2020 Offering | $ | July 2025 | |||||||||||||||||||||||||||
July 2020 PIPE Offering | $ | August 2025 | |||||||||||||||||||||||||||
July 2018 Offering | $ | July 2023 | |||||||||||||||||||||||||||
March 2019 Exercise Agreement | $ | March 2024 | |||||||||||||||||||||||||||
Other | $ | June 2024 | |||||||||||||||||||||||||||
Warrants classified as liability | $ | September 2023 - November 2023 | |||||||||||||||||||||||||||
June 30, 2023 | December 31, 2022 | |||||||||||||
Risk free interest rate | % | % | ||||||||||||
Volatility | % | % | ||||||||||||
Expected term (years) | ||||||||||||||
Expected dividend yield | % | % | ||||||||||||
Strike price | $ | $ |
Warrant liability, December 31, 2022 | $ | ||||
Change in fair value of warrants | ( | ||||
Warrant liability, June 30, 2023 | $ |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Research and development | $ | $ | $ | $ | |||||||||||||||||||
General and administrative | |||||||||||||||||||||||
Total stock-based compensation | $ | $ | $ | $ |
Total Number of Shares (In Thousands) | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term (In Years) | Aggregate Intrinsic Value (In Thousands) | ||||||||||||||||||||
Outstanding at December 31, 2022 | $ | $ | |||||||||||||||||||||
Granted | |||||||||||||||||||||||
Canceled | ( | ||||||||||||||||||||||
Outstanding at June 30, 2023 | $ | $ | |||||||||||||||||||||
Options exercisable at June 30, 2023 | $ | $ |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Risk free interest rate | % | % | % | % | |||||||||||||||||||
Volatility | % | % | % | % | |||||||||||||||||||
Expected lives (years) | |||||||||||||||||||||||
Expected dividend yield | % | % | % | % |
Shares (In Thousands) | Weighted Average Grant Date Fair Value | ||||||||||
Unvested at December 31, 2022 | $ | ||||||||||
Granted | $ | ||||||||||
Canceled | ( | $ | |||||||||
Unvested at June 30, 2023 | $ |
Three Months Ended June 30, | |||||||||||||||||
2023 | 2022 | Change | |||||||||||||||
Licensing revenue | $ | — | $ | — | $ | — | |||||||||||
Operating expenses: | |||||||||||||||||
Cost of licensing revenue | — | — | — | ||||||||||||||
Research and development | 5,923 | 5,529 | 394 | ||||||||||||||
General and administrative | 3,127 | 3,094 | 33 | ||||||||||||||
Total operating expenses | 9,050 | 8,623 | 427 | ||||||||||||||
Operating loss | (9,050) | (8,623) | (427) | ||||||||||||||
Non-operating income | 210 | 209 | 1 | ||||||||||||||
Net loss | $ | (8,840) | $ | (8,414) | $ | (426) |
Six Months Ended June 30, | |||||||||||||||||
2023 | 2022 | Change | |||||||||||||||
Licensing revenue | $ | — | $ | 1,000 | $ | (1,000) | |||||||||||
Operating expenses: | |||||||||||||||||
Cost of licensing revenue | — | 100 | (100) | ||||||||||||||
Research and development | 13,097 | 10,140 | 2,957 | ||||||||||||||
General and administrative | 7,234 | 6,118 | 1,116 | ||||||||||||||
Acquired in-process research and development | — | 10,000 | (10,000) | ||||||||||||||
Total operating expenses | 20,331 | 26,358 | (6,027) | ||||||||||||||
Operating loss | (20,331) | (25,358) | 5,027 | ||||||||||||||
Non-operating income | 394 | 200 | 194 | ||||||||||||||
Net loss | $ | (19,937) | $ | (25,158) | $ | 5,221 |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||||||||||||||||
2023 | 2022 | Change | 2023 | 2022 | Change | |||||||||||||||||||||||||||||||||
Change in fair value of warrant liability | $ | 2 | $ | 48 | $ | (46) | $ | 4 | $ | 37 | $ | (33) | ||||||||||||||||||||||||||
Change in fair value of contingent consideration | — | 115 | (115) | — | 115 | (115) | ||||||||||||||||||||||||||||||||
Interest income | 208 | 46 | 162 | 390 | 48 | 342 | ||||||||||||||||||||||||||||||||
Total non-operating income | $ | 210 | $ | 209 | $ | 1 | $ | 394 | $ | 200 | $ | 194 |
Six Months Ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
Net cash (used in) provided by: | |||||||||||
Operating activities | $ | (19,693) | $ | (12,911) | |||||||
Investing activities | (2,500) | (4,500) | |||||||||
Financing activities | 18,875 | 23,043 | |||||||||
Net (decrease) increase in cash, cash equivalents, restricted cash, and restricted cash equivalents | $ | (3,318) | $ | 5,632 |
Exhibit # | Description | Form | Exhibit | Filing Date | ||||||||||
3.1 | 10-K | 3.1 | April 13, 2018 | |||||||||||
3.2 | 8-K | 3.3 | January 5, 2018 | |||||||||||
10.1 | ||||||||||||||
10.2 | ||||||||||||||
31.1 | ||||||||||||||
31.2 | ||||||||||||||
32.1 | ||||||||||||||
32.2 | ||||||||||||||
101.INS | XBRL Instance Document.* | |||||||||||||
101.SCH | XBRL Taxonomy Extension Schema.* | |||||||||||||
101.CAL | XBRL Taxonomy Extension Calculation Linkbase.* | |||||||||||||
101.DEF | XBRL Taxonomy Extension Definition Linkbase.* | |||||||||||||
101.LAB | XBRL Taxonomy Extension Label Linkbase.* | |||||||||||||
101.PRE | XBRL Taxonomy Extension Presentation Linkbase.* |
* | Indicates management contract or compensatory plans or arrangements. | ||||
** | Filed herewith | ||||
*** | The certifications attached as Exhibit 32.1 and Exhibit 32.2 accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall they be deemed incorporated by reference into any filing of the registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
SELLAS Life Sciences Group, Inc. | |||||||||||
By: | /s/ Angelos M. Stergiou | ||||||||||
Angelos M. Stergiou, MD, ScD h.c. | |||||||||||
President and Chief Executive Officer | |||||||||||
(Principal Executive Officer) | |||||||||||
Date: August 10, 2023 | |||||||||||
By: | /s/ John T. Burns | ||||||||||
John T. Burns, CPA | |||||||||||
Chief Financial Officer | |||||||||||
(Principal Financial and Principal Accounting Officer) | |||||||||||
Date: August 10, 2023 | |||||||||||
SELLAS Life Sciences Group, Inc. | 3D Medicines Inc. | |||||||||||||
By: | /s/ Angelos M. Stergiou | By: | /s/ Shen Xiao | |||||||||||
Name: | Angelos M. Stergiou | Name: | Shen Xiao | |||||||||||
Title: | President & CEO | Title: | Chief Medical Officer | |||||||||||
Date: | May 24, 2023 | Date: | May 16, 2023 | |||||||||||
3D Medicines (Qingdao) Co., Ltd. | ||||||||||||||
By: | /s/ Shen Xiao | |||||||||||||
Name: | Shen Xiao | |||||||||||||
Title: | Chief Scientific Officer | |||||||||||||
Date: | May 16, 2023 | |||||||||||||
/s/ Angelos M. Stergiou | |||||
Angelos M. Stergiou, MD, ScD h.c. | |||||
President and Chief Executive Officer (Principal Executive Officer) |
/s/ John T. Burns | |||||
John T. Burns, CPA | |||||
Chief Financial Officer (Principal Financial and Principal Accounting Officer) |
By: | /s/ Angelos M. Stergiou | ||||||||||
Angelos M. Stergiou, MD, ScD h.c. | |||||||||||
President and Chief Executive Officer (Principal Executive Officer) | |||||||||||
Date: August 10, 2023 |
By: | /s/ John T. Burns | ||||||||||
John T. Burns, CPA | |||||||||||
Chief Financial Officer (Principal Financial and Principal Accounting Officer) | |||||||||||
Date: August 10, 2023 |
5G?X/\ @UW
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 350,000,000 | 350,000,000 |
Common stock, shares issued (in shares) | 28,347,920 | 21,005,405 |
Common stock, shares outstanding (in shares) | 28,347,920 | 21,005,405 |
Series A Preferred Stock | ||
Preferred stock, shares authorized (in shares) | 17,500 | 17,500 |
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Income Statement [Abstract] | ||||
Licensing revenue | $ 0 | $ 0 | $ 0 | $ 1,000,000 |
Operating expenses: | ||||
Cost of licensing revenue | 0 | 0 | 0 | 100,000 |
Research and development | 5,923,000 | 5,529,000 | 13,097,000 | 10,140,000 |
General and administrative | 3,127,000 | 3,094,000 | 7,234,000 | 6,118,000 |
Acquired in-process research and development | 0 | 0 | 0 | 10,000,000 |
Total operating expenses | 9,050,000 | 8,623,000 | 20,331,000 | 26,358,000 |
Operating loss | (9,050,000) | (8,623,000) | (20,331,000) | (25,358,000) |
Non-operating income: | ||||
Change in fair value of warrant liability | 2,000 | 48,000 | 4,000 | 37,000 |
Change in fair value of contingent consideration | 0 | 115,000 | 0 | 115,000 |
Interest income | 208,000 | 46,000 | 390,000 | 48,000 |
Total non-operating income | 210,000 | 209,000 | 394,000 | 200,000 |
Net loss | $ (8,840,000) | $ (8,414,000) | $ (19,937,000) | $ (25,158,000) |
Per share information: | ||||
Net loss per common share, basic (in dollars per share) | $ (0.31) | $ (0.41) | $ (0.77) | $ (1.39) |
Net loss per common share, diluted (in dollars per share) | $ (0.31) | $ (0.41) | $ (0.77) | $ (1.39) |
Weighted-average common shares outstanding, basic (in shares) | 28,347,920 | 20,286,624 | 25,961,001 | 18,104,176 |
Weighted-average common shares outstanding, diluted (in shares) | 28,347,920 | 20,286,624 | 25,961,001 | 18,104,176 |
Description of Business |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of Business Overview SELLAS Life Sciences Group, Inc. is a late-stage clinical biopharmaceutical company focused on novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, galinpepimut-S ("GPS"), is a cancer immunotherapeutic agent licensed from Memorial Sloan Kettering Cancer Center ("MSK") and targets the Wilms Tumor 1 ("WT1") protein, which is present in an array of tumor types. GPS has potential as a monotherapy or in combination with other immunotherapeutic agents to address a broad spectrum of hematologic, or blood, cancers and solid tumor indications. SELLAS' second product candidate is SLS009 (formerly GFH009), a small molecule, highly selective cyclin-dependent kinase 9 ("CDK9") inhibitor, which the Company licensed from GenFleet Therapeutics (Shanghai), Inc. ("GenFleet"), for all therapeutic and diagnostic uses in the world outside of mainland China, Hong Kong, Macau and Taiwan ("SLS009 Territory").
|
Liquidity |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Liquidity | Liquidity Since inception, the Company has incurred recurring losses and negative cash flows from operations and, as of June 30, 2023, has an accumulated deficit of $199.8 million. During the six months ended June 30, 2023, the Company incurred a net loss of $19.9 million, and used $19.7 million of cash in operations. The Company expects to continue to generate operating losses and negative cash flows from operations for the next few years and will need additional funding to support its planned operating activities through profitability. The transition to profitability is dependent upon the successful development, approval, and commercialization of the Company's product candidates and the achievement of a level of revenues adequate to support its cost structure. On February 28, 2023, the Company consummated an underwritten public offering (the "February 2023 Offering"), issuing 7,220,217 shares of common stock and accompanying common stock warrants to purchase an aggregate of 7,220,217 shares of common stock. The shares of common stock and accompanying common stock warrants were sold at a combined price of $2.77 per share and accompanying common stock warrant. Each common stock warrant sold with the shares of common stock represents the right to purchase one share of the Company’s common stock at an exercise price of $2.77 per share. The common stock warrants are exercisable immediately and will expire on February 28, 2028, five years from the date of issuance. The net proceeds to the Company from the February 2023 Offering were approximately $18.5 million, after deducting underwriting discounts and commissions, offering expenses, and excluding the exercise of any warrants. On April 16, 2021, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co. (the "Agent"). From time to time during the term of the Sales Agreement, the Company may offer and sell shares of common stock having an aggregate offering price up to a total of $50.0 million in gross proceeds. The Agent will collect a fee equal to 3% of the gross sales price of all shares of common stock sold. Shares of common stock sold under the Sales Agreement are offered and sold pursuant to the Company's registration statement on Form S-3, which was filed with the SEC on April 16, 2021 and declared effective on April 29, 2021. During the six months ended June 30, 2023, the Company sold a total of 76,882 shares of common stock pursuant to the Sales Agreement at an average price of $3.59 per share for aggregate net proceeds of approximately $0.3 million. There remains approximately $39.2 million available for future sales of shares of common stock under the Sales Agreement. Other than the Sales Agreement, the Company currently does not have any commitments to obtain additional funds. In December 2020, the Company, together with its wholly-owned subsidiary, SLSG Limited, LLC, entered into an Exclusive License Agreement (the “3DMed License Agreement”) with 3D Medicines Inc. ("3DMed"), pursuant to which the Company granted 3DMed a sublicensable, royalty-bearing license, under certain intellectual property owned or controlled by the Company, to develop, manufacture and have manufactured, and commercialize GPS and heptavalent GPS product candidates for all therapeutic and other diagnostic uses in mainland China, Hong Kong, Macau and Taiwan ("3DMed Territory"). To date, the Company has received $10.5 million in upfront payments and certain technology transfer and regulatory milestones. The participation of 3DMed in the Company's REGAL Phase 3 clinical trial in China will trigger two development milestone payments totaling $13.0 million to the Company, which the Company expects to receive in the third quarter of 2023. A total of $191.5 million in potential future development, regulatory, and sales milestones, not including future royalties, remains under the 3DMed License Agreement as of June 30, 2023, which milestones are all variable in nature and not under the Company's control. As of June 30, 2023, the Company had cash and cash equivalents of approximately $13.8 million and restricted cash and cash equivalents of $0.1 million. In accordance with Accounting Standards Codification ("ASC") 205-40, Presentation of Financial Statements - Going Concern, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the consolidated financial statements are issued. The Company expects its cash and cash equivalents will not be sufficient to fund its current planned operations for at least the next twelve months from the date of issuance of these consolidated financial statements. The $13.0 million of development milestone payments to the Company triggered by 3DMed's participation in the REGAL study are variable in nature and not under the Company's control, and therefore are not included in the Company's going concern assumption. The Company will require substantial additional financing to commercially develop any current or future product candidates. If the Company is unable to obtain additional funding on a timely basis, it will be required to scale back its plans and place certain activities on hold. Other than the Sales Agreement, the Company currently does not have any commitments to obtain additional funds. The Company's management continues to evaluate different strategies to obtain the required funding for future operations. These strategies may include utilizing the Sales Agreement, public and private placements of equity and/or debt securities, payments from potential strategic research and development collaborations, and licensing and/or marketing arrangements with pharmaceutical companies. Additionally, the Company may continue to pursue discussions with global and regional pharmaceutical companies for licensing and/or co-development rights to its product candidates. The Company has prepared its consolidated financial statements assuming that it will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
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Basis of Presentation and Significant Accounting Policies |
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Basis of Presentation and Significant Accounting Policies | Basis of Presentation and Significant Accounting Policies The Company's complete summary of significant accounting policies can be found in "Item 8. Financial Statements and Supplementary Data - Note 3. Basis of Presentation and Significant Accounting Policies" in the audited annual consolidated financial statements included in the 2022 Annual Report. The significant accounting policies summarized and included in the 2022 Annual Report have not materially changed, except as set forth below. Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the ASC and Accounting Standards Updates ("ASUs") of the Financial Accounting Standards Board ("FASB"). Principles of Consolidation The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated upon consolidation. Unless the context otherwise indicates, reference in these notes to the "Company" refer to SELLAS Life Sciences Group, Inc., and its wholly owned subsidiaries, SELLAS Life Sciences Group, Ltd., a privately held Bermuda exempted company, SLSG Limited, LLC, Sellas Life Sciences Limited, and Apthera, Inc. The functional currency of the Company's non-U.S. operations is the U.S. dollar. Unaudited Interim Results These consolidated financial statements and accompanying notes should be read in conjunction with the Company's annual consolidated financial statements and the notes thereto included in the 2022 Annual Report. The accompanying consolidated financial statements as of June 30, 2023 and for the three and six months ended June 30, 2023 and 2022, are unaudited, but include all adjustments, consisting of normal recurring entries, that management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2022 have been derived from the audited financial statements as of that date. Reclassification Certain prior year amounts have been reclassified to conform to current year presentation. These reclassifications had no effect on the Company's loss from operations, net loss, and net loss per share. Net Loss Per Share Net loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as warrants, stock options and unvested restricted stock that would result in the issuance of incremental shares of common stock. In computing the basic and diluted net loss per share, the weighted average number of shares remains the same for both calculations due to the fact that, when a net loss exists, dilutive shares are not included in the calculation as the impact is anti-dilutive. The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive (in thousands):
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Fair Value Measurements |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements | Fair Value Measurements The following tables present information about the Company's assets and liabilities measured at fair value on a recurring basis in the consolidated balance sheets (in thousands):
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Acquired In-Process Research and Development |
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Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Acquired In-Process Research and Development | Acquired In-Process Research and Development Exclusive License Agreement with GenFleet Therapeutics (Shanghai) Inc. On March 31, 2022, the Company entered into an exclusive license agreement with GenFleet pursuant to which GenFleet granted to the Company a sublicensable royalty-bearing license under certain of its intellectual property, to develop, manufacture, and commercialize SLS009 for the treatment, diagnosis or prevention of disease in humans and animals in the SLS009 Territory. In consideration for the exclusive license, the Company agreed to pay to GenFleet (i) an upfront and technology transfer fee of $10.0 million, $7.0 million of which was paid as of June 30, 2023 and the remaining $3.0 million of which is expected to be paid during the third quarter of 2023, (ii) development and regulatory milestone payments for up to three indications totaling up to $48.0 million in the aggregate, and (iii) sales milestone payments totaling up to $92.0 million in the aggregate upon the achievement of certain net sales thresholds in a given calendar year. The Company has also agreed to pay GenFleet single-digit tiered royalties based upon a percentage of annual net sales, with the royalty rate escalating based on the level of annual net sales of SLS009 in the SLS009 Territory ranging from the low to high single digits. During the six months ended June 30, 2022, the Company expensed $10.0 million related to the acquired technology as in-process research and development based on the assessment that the technology has no alternative future use, $7.0 million of which has been paid as of June 30, 2023, and the Company has recorded an acquired in-process research and development payable as of June 30, 2023 for the remaining $3.0 million which is expected to be paid during the third quarter of 2023.
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Balance Sheet Accounts |
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance Sheet Accounts | Balance Sheet Accounts Prepaid expenses and other current assets consist of the following (in thousands):
Accrued expenses and other current liabilities consist of the following (in thousands):
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Commitments and Contingencies |
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Commitments and Contingencies Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies | Commitments and Contingencies Leases The Company has a non-cancelable operating lease for certain executive, administrative, and general business office space for its headquarters in New York, New York, which began on June 5, 2020, was amended in February 2022 to add additional space, and has a term through December 31, 2024. The Company assessed the lease amendment for the additional space and determined it should be accounted for as a separate contract. The weighted average discount rate of the Company's operating leases under FASB Topic ASC 842, Leases ("ASC 842") is approximately 13.95%. As of June 30, 2023, the leases have a remaining term of 1.5 years. Rent expense related to the Company's operating leases was approximately $0.1 million for each of the three months ended June 30, 2023 and 2022 and $0.2 million for each of the six months ended June 30, 2023 and 2022. The Company made cash payments related to its operating leases of approximately $0.1 million for each of the three months ended June 30, 2023 and 2022 and $0.3 million and $0.2 million for the six months ended June 30, 2023 and 2022, respectively. Future minimum lease payments are as follows as of June 30, 2023 (in thousands):
Legal Proceedings From time to time, the Company is subject to various pending or threatened legal actions and proceedings, including those that arise in the ordinary course of its business, which may include employment matters, breach of contract disputes and stockholder litigation. Such actions and proceedings are subject to many uncertainties and to outcomes that are not predictable with assurance and that may not be known for extended periods of time. The Company records a liability in its consolidated financial statements for costs related to claims, including future legal costs, settlements and judgments, when the Company has assessed that a loss is probable and an amount can be reasonably estimated. If the reasonable estimate of a probable loss is a range, the Company records the most probable estimate of the loss or the minimum amount when no amount within the range is a better estimate than any other amount. The Company discloses a contingent liability even if the liability is not probable or the amount is not estimable, or both, if there is a reasonable possibility that a material loss may have been incurred. As of June 30, 2023, there was no pending or threatened litigation.
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Stockholders' Equity |
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity | Stockholders’ Equity Preferred Stock The Company has authorized up to 5,000,000 shares of preferred stock, $0.0001 par value per share, for issuance. There were no preferred shares outstanding as of June 30, 2023 and December 31, 2022. Common Stock The Company has authorized up to 350,000,000 shares of common stock, $0.0001 par value per share, for issuance. As of June 30, 2023, the Company has shares of common stock reserved for future issuance as follows (in thousands):
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Warrants to Acquire Shares of Common Stock |
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Warrants and Rights Note Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Warrants to Acquire Shares of Common Stock | Warrants to Acquire Shares of Common Stock Warrants Outstanding The following is a summary of the activity of the Company's warrants to acquire shares of common stock for the six months ended June 30, 2023 (in thousands):
Warrants to acquire shares of common stock primarily consist of equity-classified warrants. In addition, warrants to acquire shares of common stock that may require the Company to settle in cash are liability-classified warrants. Warrants Classified as Equity The warrants to acquire shares of common stock issued during the February 2023 Offering were recorded as equity upon issuance. During its evaluation of equity classification of these warrants, the Company considered the conditions as prescribed within ASC 815-40, Derivatives and Hedging, Contracts in an Entity’s own Equity (“ASC 815-40”). The conditions within ASC 815-40 are not subject to a probability assessment. The warrants to acquire shares of common stock do not fall under the liability criteria within ASC 480, Distinguishing Liabilities from Equity, as they are not puttable and do not represent an instrument that has a redeemable underlying security. The warrants do meet the definition of a derivative instrument under ASC 815 but are eligible for the scope exception as they are indexed to the Company’s own stock and would be classified in permanent equity if freestanding. On February 28, 2023, in connection with closing of the February 2023 Offering, the Company entered into amendments to an aggregate of 3,438,851 warrants, which had been previously issued by the Company in an underwritten public offering that closed on April 5, 2022 (the "April 2022 Offering"), to reduce the exercise price of such warrants from $5.40 to $3.62, the average closing price of the Company’s common stock, as reported on the Nasdaq Capital Market, for the five trading days immediately preceding the pricing of the February 2023 Offering. The Company accounted for the amendment as a cost to issue equity with the incremental fair value of approximately $0.3 million recognized as an offset to the proceeds received. However, there was no net impact to the consolidated statements of stockholders' equity because the warrants are equity classified. Warrants Classified as Liabilities Liability-classified warrants consist of warrants to acquire common stock issued in connection with certain previous equity financings. These warrants may be settled in cash and were determined not to be indexed to the Company’s common stock. The estimated fair value of outstanding warrants accounted for as liabilities is determined at each balance sheet date. Any decrease or increase in the estimated fair value of the warrant liability since the most recent balance sheet date is recorded in the consolidated statement of operations as change in fair value of warrant liability. The fair value of the warrants is estimated using a Black-Scholes pricing model with the following inputs:
The expected volatility assumptions are based on the Company's implied volatility in combination with the implied volatilities of similar publicly traded entities. The expected life assumption is based on the remaining contractual terms of the warrants. The risk-free rate is based on the zero-coupon rates in effect at the time of valuation. The dividend yield used in the pricing model is zero, because the Company has no present intention to pay cash dividends. The changes in fair value of the warrant liability for the six months ended June 30, 2023 were as follows (in thousands):
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Licensing Revenue |
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Jun. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Licensing Revenue | Licensing Revenue Exclusive License Agreement with 3D Medicines Inc. In December 2020, the Company, together with its wholly-owned subsidiary, SLSG Limited, LLC, entered into an Exclusive License Agreement (the “3DMed License Agreement”) with 3D Medicines Inc. ("3DMed"), pursuant to which the Company granted 3DMed a sublicensable royalty-bearing license under certain intellectual property owned or controlled by the Company, to develop, manufacture and have manufactured, and commercialize GPS and heptavalent GPS (referred to as GPS Plus) product candidates ("GPS Licensed Products") for all therapeutic and other diagnostic uses in mainland China, Hong Kong, Macau and Taiwan ("3DMed Territory"). The license is exclusive, except with respect to certain know-how that has been non-exclusively licensed to the Company and is sublicensed to 3DMed on a non-exclusive basis. The Company has retained development, manufacturing and commercialization rights with respect to the GPS Licensed Products in the rest of the world. In partial consideration for the rights granted by the Company, 3DMed agreed to pay the Company (i) a one-time upfront cash payment of $7.5 million, and (ii) milestone payments totaling up to $194.5 million in the aggregate upon the achievement of certain technology transfer, development and regulatory milestones, as well as sales milestones based on certain net sales thresholds of GPS Licensed Products in the 3DMed Territory in a given calendar year. 3DMed also agreed to pay tiered royalties based upon a percentage of annual net sales of GPS Licensed Products in the 3DMed Territory ranging from the high single digits to the low double digits. Revenue Recognition The Company determined the initial transaction price of the single performance obligation to be $9.5 million, which included the $7.5 million upfront fee as well as $2.0 million in development milestones that were assessed as probable of being achieved at the inception of the 3DMed License Agreement and therefore were not constrained. As of December 31, 2021, the full $9.5 million initial transaction price was fully recognized as licensing revenue. The Company determined that the remaining $192.5 million in certain future development, regulatory, and sales milestones is variable consideration subject to constraint at inception. At the end of each reporting period, the Company reevaluates the probability of achievement of the future development, regulatory, and sales milestones subject to constraint and, if necessary, will adjust its estimate of the overall transaction price. Any such adjustments will be recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. On March 31, 2022, the Company announced that an IND application filed by 3DMed, pursuant to its 3DMed License Agreement for GPS, for a small Phase 1 clinical trial investigating safety of GPS in China was approved by China's National Medical Products Administration ("NMPA"). The IND approval by the NMPA triggered a $1.0 million milestone payment to the Company which was recognized as licensing revenue in the first quarter of 2022. An additional $191.5 million in potential future development, regulatory, and sales milestones, not including future royalties, remains under the 3DMed License Agreement as of June 30, 2023, which milestones are variable in nature and not under the Company's control. For the sales-based royalties, the Company will recognize revenue when the related sales occur. To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements. There was no licensing revenue recognized during each of the three months ended June 30, 2023 and 2022. There was no licensing revenue recognized during the six months ended June 30, 2023, and $1.0 million licensing revenue recognized during the six months ended June 30, 2022 related to the IND approval by the NMPA. There was no cost of licensing revenue recognized during each of the three months ended June 30, 2023 and 2022. There was no cost of licensing revenue recognized during the six months ended June 30, 2023, and $0.1 million in cost of licensing revenue for the six months ended June 30, 2022 for sublicensing fees incurred in connection with the 3DMed License Agreement.
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Stock-Based Compensation |
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Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation | Stock-Based Compensation 2017 Equity Incentive Plan On December 29, 2017, the 2017 Equity Incentive Plan was approved by the stockholders of the Company, which currently allows for issuance of up to approximately 22,000 shares of common stock underlying stock options granted prior to September 10, 2019. The 2017 Equity Incentive Plan was terminated upon the approval of the 2019 Incentive Plan subject to outstanding stock options granted under the 2017 Equity Incentive Plan that remain exercisable through maturity for the Company's employees and directors. 2023 Amended and Restated Equity Incentive Plan On September 10, 2019, the 2019 Equity Incentive Plan ("2019 Equity Plan") was approved by the stockholders of the Company, which currently allows for issuance of up to approximately 6,036,000 shares of common stock in connection with the grant of stock-based awards, including stock options, restricted stock, restricted stock units, stock appreciation rights and other types of awards as deemed appropriate. The number of shares reserved for issuance under the 2019 Equity Plan automatically increased on January 1 of each year, for a period of four years, which commenced on January 1, 2020 and ended on (and including) January 1, 2023, by an amount equal to the lesser of (i) 5% of the total number of shares of common stock outstanding at the end of the prior fiscal year; and (ii) an amount determined by the board of directors or authorized committee. On June 20, 2023, an amendment to the 2019 Equity Plan was approved by the stockholders of the Company, which amended and restated the 2019 Equity Plan (as amended and restated, the "2023 Amended and Restated Equity Incentive Plan") to increase the number of shares of common stock authorized for issuance under the 2019 Equity Plan by 3,000,000 shares. As of June 30, 2023, approximately 3,883,000 shares of common stock were reserved for future grants under the 2023 Amended and Restated Equity Incentive Plan. The following table summarizes the components of stock-based compensation expense in the consolidated statements of operations for the three and six months ended June 30, 2023 and 2022, respectively (in thousands):
Options to Purchase Shares of Common Stock The following table summarizes stock option activity of the Company for the six months ended June 30, 2023:
The aggregate intrinsic values of outstanding and exercisable stock options at June 30, 2023 were calculated based on the closing price of the Company’s common stock as reported on the Nasdaq Capital Market on June 30, 2023 of $1.57 per share. The aggregate intrinsic value equals the positive difference between the closing fair market value of the Company’s common stock and the exercise price of the underlying stock options. The Company uses the Black-Scholes option-pricing model to determine the fair value of all its stock options granted. The weighted average assumptions used during the three and six months ended June 30, 2023 and 2022, respectively, were as follows:
The weighted-average grant date fair value of options granted during the three months ended June 30, 2023 and 2022 was $1.45 and $2.13, respectively. The weighted-average grant date fair value of options granted during the six months ended June 30, 2023 and 2022 was $2.88 and $4.76, respectively. The Company’s expected common stock price volatility assumption is based upon the Company's own implied volatility in combination with the implied volatility of a basket of comparable companies. The expected life assumptions for employee grants were based upon the simplified method, which averages the contractual term of the Company’s options of ten years with the average vesting term of four years for an average of approximately six years. The expected life assumptions for non-employees were based upon the contractual term of the option. The dividend yield assumption is zero because the Company has never paid cash dividends and presently has no intention to do so. The risk-free interest rate used for each grant was also based upon prevailing short-term interest rates. The Company accounts for forfeitures as they occur. As of June 30, 2023, there was $3.8 million of unrecognized compensation cost related to outstanding stock options that is expected to be recognized as a component of the Company’s operating expenses over a weighted-average period of 2.72 years. Time-vested RSUs and RSUs with Performance Conditions The following table summarizes RSU activity of the Company for the six months ended June 30, 2023:
As of June 30, 2023, there was $1.2 million of unrecognized compensation cost related to outstanding RSUs that is expected to be recognized as a component of the Company's operating expenses over a weighted-average period of 2.98 years. No RSUs vested during the six months ended June 30, 2023. 2021 Employee Stock Purchase Plan On April 22, 2021, the Board of Directors adopted the 2021 Employee Stock Purchase Plan ("2021 ESPP") which was approved by the Company's stockholders on June 8, 2021 and authorized the issuance of up to 300,000 shares of common stock pursuant to the 2021 ESPP. The 2021 ESPP allows employees to contribute up to 20% of their cash earnings, subject to a maximum of $25,000 per year under Internal Revenue Service rules, to be used to purchase shares of the Company’s common stock on semi-annual purchase dates. The 2021 ESPP allows eligible employees to purchase shares of common stock at a price per share equal to 85% of the lower of the fair market value of the common stock at the beginning or end of each six-month offering period during the term of the 2021 ESPP. During the six months ended June 30, 2023, 45,416 shares of common stock were purchased by employees under the 2021 ESPP for proceeds of approximately $53,000. There are currently 229,495 shares of common stock reserved for issuance under the 2021 ESPP as of June 30, 2023.
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Subsequent Events |
6 Months Ended |
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Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent EventsThe Company evaluated all events or transactions that occurred after June 30, 2023 up through the date these consolidated financial statements were issued. Other than as disclosed elsewhere in the notes to the consolidated financial statements, the Company did not have any material subsequent events. |
Basis of Presentation and Significant Accounting Policies (Policies) |
6 Months Ended |
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Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the ASC and Accounting Standards Updates ("ASUs") of the Financial Accounting Standards Board ("FASB"). |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated upon consolidation. Unless the context otherwise indicates, reference in these notes to the "Company" refer to SELLAS Life Sciences Group, Inc., and its wholly owned subsidiaries, SELLAS Life Sciences Group, Ltd., a privately held Bermuda exempted company, SLSG Limited, LLC, Sellas Life Sciences Limited, and Apthera, Inc. |
Reclassification | Reclassification Certain prior year amounts have been reclassified to conform to current year presentation. These reclassifications had no effect on the Company's loss from operations, net loss, and net loss per share.
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Net Loss Per Share | Net Loss Per Share Net loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as warrants, stock options and unvested restricted stock that would result in the issuance of incremental shares of common stock. In computing the basic and diluted net loss per share, the weighted average number of shares remains the same for both calculations due to the fact that, when a net loss exists, dilutive shares are not included in the calculation as the impact is anti-dilutive.
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Basis of Presentation and Significant Accounting Policies (Tables) |
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive (in thousands):
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Fair Value Measurements (Tables) |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Assets and Liabilities Measured at Fair Value | The following tables present information about the Company's assets and liabilities measured at fair value on a recurring basis in the consolidated balance sheets (in thousands):
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Balance Sheet Accounts (Tables) |
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following (in thousands):
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Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following (in thousands):
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Commitments and Contingencies (Tables) |
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Commitments and Contingencies Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Future Minimum Lease Payments | Future minimum lease payments are as follows as of June 30, 2023 (in thousands):
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Stockholders' Equity (Tables) |
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||
Schedule of Common Stock Reserved for Future Issuance | As of June 30, 2023, the Company has shares of common stock reserved for future issuance as follows (in thousands):
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Warrants to Acquire Shares of Common Stock (Tables) |
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Warrants and Rights Note Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Warrant Activity | The following is a summary of the activity of the Company's warrants to acquire shares of common stock for the six months ended June 30, 2023 (in thousands):
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Schedule of Fair Value of Warrants is Estimated Using Black-Scholes Option Pricing Model | The fair value of the warrants is estimated using a Black-Scholes pricing model with the following inputs:
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Schedule of Changes in Fair Value of Warrant Liability | The changes in fair value of the warrant liability for the six months ended June 30, 2023 were as follows (in thousands):
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Stock-Based Compensation (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Allocated Stock-based Compensation Expense | The following table summarizes the components of stock-based compensation expense in the consolidated statements of operations for the three and six months ended June 30, 2023 and 2022, respectively (in thousands):
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Schedule of Stock Option Activity | The following table summarizes stock option activity of the Company for the six months ended June 30, 2023:
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Schedule of Assumptions for Option Grants Issued | The Company uses the Black-Scholes option-pricing model to determine the fair value of all its stock options granted. The weighted average assumptions used during the three and six months ended June 30, 2023 and 2022, respectively, were as follows:
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Schedule of RSU Activity | The following table summarizes RSU activity of the Company for the six months ended June 30, 2023:
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Basis of Presentation and Significant Accounting Policies - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares shares in Thousands |
6 Months Ended | |
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Jun. 30, 2023 |
Jun. 30, 2022 |
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Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 14,459 | 6,457 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 12,361 | 5,148 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 1,665 | 1,012 |
Restricted stock units ("RSUs") | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 433 | 297 |
Balance Sheet Accounts - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Insurance | $ 1,123 | $ 219 |
Clinical development | 375 | 184 |
Professional fees | 176 | 82 |
Other | 0 | 46 |
Prepaid expenses and other current assets | $ 1,674 | $ 531 |
Balance Sheet Accounts - Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Clinical trial costs | $ 4,839 | $ 4,509 |
Compensation and related benefits | 1,111 | 1,439 |
Professional fees | 208 | 338 |
Other | 82 | 0 |
Accrued expenses and other current liabilities | $ 6,240 | $ 6,286 |
Commitments and Contingencies - Narrative (Details) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease, discount rate (as a percent) | 13.95% | 13.95% | ||
Operating lease, remaining term | 1 year 6 months | |||
Rent expense | $ 0.1 | $ 0.1 | $ 0.2 | $ 0.2 |
Cash payments related to operating lease | $ 0.1 | $ 0.1 | $ 0.3 | $ 0.2 |
Commitments and Contingencies - Schedule of Future Minimum Lease Payments (Details) $ in Thousands |
Jun. 30, 2023
USD ($)
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Commitments and Contingencies Disclosure [Abstract] | |
2023 (remaining) | $ 261 |
2024 | 533 |
Total future minimum lease payments | 794 |
Less: imputed interest | (45) |
Current and non-current operating lease liabilities | $ 749 |
Stockholders' Equity - Narrative (Details) - $ / shares |
Jun. 30, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
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Equity [Abstract] | |||
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 | |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | |
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 |
Common stock, shares authorized (in shares) | 350,000,000 | 350,000,000 | |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Stockholders' Equity - Schedule of Common Stock Reserved for Future Issuance (Details) - shares shares in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
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Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Warrants outstanding (in shares) | 12,361 | 5,141 |
Stock options outstanding (in shares) | 1,665 | 1,040 |
Total common stock reserved for future issuance (in shares) | 18,571 | |
2019 Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares reserved for future issuance (in shares) | 3,883 | |
2021 ESPP | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares reserved for future issuance (in shares) | 229 | |
Restricted stock units ("RSUs") | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
RSUs outstanding (in shares) | 433 | 255 |
Warrants to Acquire Shares of Common Stock - Schedule of Fair Value of Warrants is Estimated Using Black-Scholes Option Pricing Model (Details) |
Jun. 30, 2023 |
Dec. 31, 2022 |
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Risk free interest rate | ||
Class of Warrant or Right [Line Items] | ||
Warrants, measurement input | 0.0544 | 0.0475 |
Volatility | ||
Class of Warrant or Right [Line Items] | ||
Warrants, measurement input | 0.6503 | 1.2060 |
Expected term (years) | ||
Class of Warrant or Right [Line Items] | ||
Warrants, measurement input | 0.25 | 0.75 |
Expected dividend yield | ||
Class of Warrant or Right [Line Items] | ||
Warrants, measurement input | 0 | 0 |
Strike price | ||
Class of Warrant or Right [Line Items] | ||
Warrants, measurement input | 7.50 | 7.50 |
Warrants to Acquire Shares of Common Stock - Narrative (Details) $ / shares in Units, $ in Millions |
Jun. 30, 2023 |
Feb. 28, 2023
USD ($)
$ / shares
shares
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Feb. 27, 2023
$ / shares
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Dec. 31, 2022 |
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Coupon rate | ||||
Class of Warrant or Right [Line Items] | ||||
Expected dividend yield | 0 | |||
Expected dividend yield | ||||
Class of Warrant or Right [Line Items] | ||||
Expected dividend yield | 0 | 0 | ||
Underwriting Agreement | ||||
Class of Warrant or Right [Line Items] | ||||
Common stock to be called by warrants (in shares) | shares | 7,220,217 | |||
Exercise price (in dollars per share) | $ / shares | $ 2.77 | |||
April 2022 Offering | Underwriting Agreement | ||||
Class of Warrant or Right [Line Items] | ||||
Common stock to be called by warrants (in shares) | shares | 3,438,851 | |||
Exercise price (in dollars per share) | $ / shares | $ 3.62 | $ 5.40 | ||
Warrants not settleable in cash, fair value disclosure | $ | $ 0.3 |
Warrants to Acquire Shares of Common Stock - Schedule of Changes in Fair Value of Warrant Liability (Details) $ in Thousands |
6 Months Ended |
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Jun. 30, 2023
USD ($)
| |
Class of Warrant or Right, Fair Value [Roll Forward] | |
Warrant liability, December 31, 2022 | $ 4 |
Change in fair value of warrants | (4) |
Warrant liability, June 30, 2023 | $ 0 |
Licensing Revenue (Details) - USD ($) |
1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 |
Dec. 31, 2020 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2021 |
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Revenue from Contract with Customer [Abstract] | ||||||||
Upfront cash payment received | $ 7,500,000 | |||||||
Future milestone payments received | 194,500,000 | |||||||
Performance obligation, amount | 9,500,000 | |||||||
Milestones probable of being achieved | $ 2,000,000 | |||||||
Deferred revenue recognized license | $ 9,500,000 | |||||||
Potential milestone payments to be received | $ 191,500,000 | $ 192,500,000 | ||||||
Milestone payment received | $ 1,000,000 | 13,000,000 | ||||||
Licensing revenue | $ 0 | $ 0 | 0 | $ 1,000,000 | ||||
Cost of licensing revenue | $ 0 | $ 0 | $ 0 | $ 100,000 |
Stock-Based Compensation - Schedule of Allocated Stock-based Compensation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated share based compensation expense | $ 514 | $ 450 | $ 1,054 | $ 825 |
Research and development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated share based compensation expense | 92 | 70 | 188 | 125 |
General and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated share based compensation expense | $ 422 | $ 380 | $ 866 | $ 700 |
Stock-Based Compensation - Schedule of Assumptions for Option Grants Issued (Details) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Share-Based Payment Arrangement [Abstract] | ||||
Risk free interest rate | 3.69% | 2.87% | 3.78% | 1.80% |
Volatility | 129.55% | 144.75% | 127.77% | 130.60% |
Expected lives (years) | 6 years 3 months | 6 years 3 months | 6 years 2 months 12 days | 6 years 2 months 15 days |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Stock-Based Compensation - Schedule of RSU Activity (Details) - $ / shares shares in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Weighted Average Grant Date Fair Value | ||||
Granted (in dollars per share) | $ 1.45 | $ 2.13 | $ 2.88 | $ 4.76 |
Restricted stock units ("RSUs") | ||||
Shares | ||||
Beginning balance (in shares) | 255 | |||
Granted (in shares) | 195 | |||
Canceled (in shares) | (17) | |||
Ending balance (in shares) | 433 | 433 | ||
Weighted Average Grant Date Fair Value | ||||
Beginning balance (in dollars per share) | $ 3.25 | |||
Granted (in dollars per share) | 3.34 | |||
Canceled (in dollars per share) | 3.76 | |||
Ending balance (in dollars per share) | $ 3.27 | $ 3.27 |
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