Item 1. Financial Statements
Item 1. Financial Statements (unaudited)
PRIME MEDICINE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
September 30, December 31,
(In thousands, except share and per share data) 2022 2021
Assets
Current assets:
Cash and cash equivalents $ 47,947 $ 185,420
Short-term investments 89,175 68,238
Related party short-term investment 9,543 15,962
Prepaid expenses and other current assets 2,180 959
Total current assets 148,845 270,579
Property and equipment, net 14,967 4,932
Operating lease right-of-use lease assets 32,344 10,746
Restricted cash 13,496 13,125
Other assets 5,613 2,474
Total assets $ 215,265 $ 301,856
Liabilities, Redeemable Convertible and Convertible Preferred Stock and Stockholders’ Deficit
Current liabilities:
Accounts payable $ 4,111 $ 1,435
Accrued expenses and other current liabilities 6,530 37,192
Related party forward contract liability — 12,020
Operating lease liability 11,577 7,336
Total current liabilities 22,218 57,983
Operating lease liability, net of current 19,862 3,070
Non current deferred tax liability 481 1,243
Total liabilities 42,561 62,296
Commitments and contingencies (Note 11)
Series A redeemable convertible preferred stock, $ 0.00001 par value; 115,761,842 shares authorized, issued and outstanding at September 30, 2022; liquidation preference of $ 131,927 at September 30, 2022; 115,761,842 shares authorized, issued and outstanding at December 31, 2021; liquidation preference of $ 125,000 at December 31, 2021
196,157 196,157
Series B convertible preferred stock, $ 0.00001 par value; 45,658,957 shares authorized, issued and outstanding at September 30, 2022; liquidation preference of $ 222,766 at September 30, 2022; 45,658,957 shares authorized, issued and outstanding at December 31, 2021; liquidation preference of $ 210,814 at December 31, 2021
199,643 199,643
Stockholders’ deficit:
Common stock, $ 0.00001 par value; 293,258,790 , and 293,258,790 shares authorized at September 30, 2022 and December 31, 2021, respectively; and 33,559,912 , and 32,413,860 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively
— —
Additional paid-in capital 31,272 15,163
Accumulated other comprehensive loss ( 454 ) ( 27 )
Accumulated deficit ( 253,914 ) ( 171,376 )
Total stockholders’ deficit ( 223,096 ) ( 156,240 )
Total liabilities, redeemable convertible and convertible preferred stock and stockholders’ deficit $ 215,265 $ 301,856
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
PRIME MEDICINE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
Three Months Ended
September 30, Nine Months Ended
September 30,
(In thousands, except share and per share data) 2022 2021 2022 2021
Operating expenses:
Research and development $ 25,047 $ 7,400 $ 57,664 $ 17,661
General and administrative 6,608 3,027 20,194 6,737
Total operating expenses 31,655 10,427 77,858 24,398
Loss from operations ( 31,655 ) ( 10,427 ) ( 77,858 ) ( 24,398 )
Other income (expense):
Change in fair value of preferred stock tranche right liability — — — ( 74,319 )
Change in fair value of anti-dilution obligation — — — ( 6,681 )
Change in fair value of related party short-term investment 1,789 ( 8,354 ) ( 6,419 ) 1,075
Other income (expense), net (1)
728 ( 1 ) 977 —
Total other expense, net 2,517 ( 8,355 ) ( 5,442 ) ( 79,925 )
Net loss before income taxes ( 29,138 ) ( 18,782 ) ( 83,300 ) ( 104,323 )
Provision for (benefit from) income taxes 212 ( 2,370 ) ( 762 ) ( 1,867 )
Net loss ( 29,350 ) ( 16,412 ) ( 82,538 ) ( 102,456 )
Accretion of preferred stock to redemption value — — — ( 1,468 )
Cumulative dividend on preferred stock ( 6,362 ) ( 6,363 ) ( 18,879 ) ( 10,922 )
Net loss attributable to common stockholders $ ( 35,712 ) $ ( 22,775 ) $ ( 101,417 ) $ ( 114,846 )
Net loss per share attributable to common stockholders, basic and diluted $ ( 1.61 ) $ ( 1.52 ) $ ( 4.91 ) $ ( 9.74 )
Weighted-average common shares outstanding, basic and diluted 22,226,301 14,965,186 20,665,225 11,795,738
Comprehensive loss:
Net loss $ ( 29,350 ) $ ( 16,412 ) $ ( 82,538 ) $ ( 102,456 )
Change in unrealized (losses) gains on investments, net of tax ( 304 ) 25 ( 427 ) ( 9 )
Total other comprehensive loss ( 304 ) 25 ( 427 ) ( 9 )
Comprehensive loss $ ( 29,654 ) $ ( 16,387 ) $ ( 82,965 ) $ ( 102,465 )
__________________
(1) Includes no related party amounts for the three months ended September 30, 2022 and 2021, and zero and $( 429 ) for the nine months ended September 30, 2022 and 2021, respectively (see Note 13).
The accompanying notes are an integral part of these condensed consolidated financial statements.
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PRIME MEDICINE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE AND CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
(Unaudited)
Redeemable Convertible Preferred Stock Convertible Preferred Stock Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Losses Accumulated Deficit Total Stockholders' Deficit
(In thousands, except share amounts) Shares Amount Shares Amount Shares Amount
Balances at December 31, 2021
115,761,842 $ 196,157 45,658,957 $ 199,643 32,413,860 $ — $ 15,163 $ ( 27 ) $ ( 171,376 ) $ ( 156,240 )
Reclassification of related party forward contract — — — — 1,101,525 — 12,020 — — 12,020
Repurchase of unvested restricted common stock — — — — — — — — — —
Stock-based compensation expense — — — — — — 1,123 — — 1,123
Net loss — — — — — — — — ( 23,840 ) ( 23,840 )
Change in unrealized gain on investments, net of tax — — — — — — — ( 5 ) — ( 5 )
Balances at March 31, 2022 115,761,842 $ 196,157 45,658,957 $ 199,643 33,515,385 $ — $ 28,306 $ ( 32 ) $ ( 195,216 ) $ ( 166,942 )
Reclassification of related party forward contract — — — — — — — — — —
Repurchase of unvested restricted common stock — — — — ( 3,116 ) — — — — —
Stock-based compensation expense — — — — — — 1,345 — — 1,345
Net loss — — — — — — — — ( 29,348 ) ( 29,348 )
Change in unrealized gain on investments, net of tax — — — — — — — ( 118 ) — ( 118 )
Balance at June 30, 2022 115,761,842 $ 196,157 45,658,957 $ 199,643 33,512,269 $ — $ 29,651 $ ( 150 ) $ ( 224,564 ) $ ( 195,063 )
Issuance of common stock upon exercise of stock options — — — — 55,687 — 204 — — 204
Reclassification of related party forward contract — — — — — — — — — —
Repurchase of unvested restricted common stock — — — — ( 8,044 ) — — — — —
Stock-based compensation expense — — — — — — 1,417 — — 1,417
Net loss — — — — — — — — ( 29,350 ) ( 29,350 )
Change in unrealized gain on investments, net of tax — — — — — — — ( 304 ) — ( 304 )
Balances at September 30, 2022
115,761,842 $ 196,157 45,658,957 $ 199,643 33,559,912 $ — $ 31,272 $ ( 454 ) $ ( 253,914 ) $ ( 223,096 )
The accompanying notes are an integral part of these condensed consolidated financial statements.
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PRIME MEDICINE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE AND CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
(Unaudited)
Redeemable Convertible Preferred Stock Convertible Preferred Stock Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Losses Accumulated Deficit Total Stockholders' Equity (Deficit)
(In thousands, except share amounts) Shares Amount Shares Amount Shares Amount
Balances at December 31, 2020
45,000,000 $ 31,136 — $ — 28,489,599 $ — $ 8,347 $ — $ ( 6,009 ) $ 2,338
Accretion of redeemable convertible preferred stock to redemption value — 1,194 — — — — ( 1,194 ) — — ( 1,194 )
Issuance of common stock and settlement of the anti-dilution obligation — — — — 1,443,638 — — — — —
Stock-based compensation expense — — — — — — 206 — — 206
Net loss — — — — — — — — ( 86,660 ) ( 86,660 )
Balances at March 31, 2021 45,000,000 $ 32,330 — $ — 29,933,237 $ — $ 7,358 $ — $ ( 92,669 ) $ ( 85,310 )
Issuance of Series A redeemable convertible preferred stock, including the settlement of the third and fourth tranche right liability, net of issuance costs of $ 41
70,761,842 71,719 — — — — ( 998 ) — — ( 998 )
Reclassification of preferred stock tranche liability upon settlement — 91,834 — — — — — — — —
Accretion of redeemable convertible preferred stock to redemption value — 274 — — — — ( 274 ) — — ( 274 )
Issuance of Series B convertible preferred stock, net of issuance costs of $ 80
— — 45,658,957 199,643 — — — — — —
Issuance of common stock and settlement of the anti-dilution obligation — — — — 2,498,850 — 7,536 — — 7,536
Stock-based compensation expense — — — — — — 94 — — 94
Net loss — — — — — — — — 616 616
Change in unrealized gain on investments, net of tax — — — — — — — ( 34 ) — ( 34 )
Balances at June 30, 2021 115,761,842 $ 196,157 45,658,957 $ 199,643 32,432,087 $ — $ 13,716 $ ( 34 ) $ ( 92,053 ) $ ( 78,370 )
Repurchase of unvested restricted common stock — — — — ( 18,227 ) — — — — —
Stock-based compensation expense — — — — — — 339 — — 339
Net loss — — — — — — — — ( 16,412 ) ( 16,412 )
Change in unrealized gain on investments, net of tax — — — — — — — 25 — 25
Balances at September 30, 2021
115,761,842 $ 196,157 45,658,957 $ 199,643 32,413,860 $ — $ 14,055 $ ( 9 ) $ ( 108,465 ) $ ( 94,418 )
The accompanying notes are an integral part of these condensed consolidated financial statements.
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PRIME MEDICINE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine Months Ended
September 30,
(In thousands) 2022 2021
Cash flows from operating activities:
Net loss $ ( 82,538 ) $ ( 102,456 )
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization expense 1,354 339
Amortization of premiums and discount on short-term investments 100 —
Stock-based compensation expense 3,885 639
Non cash lease expense 6,992 2,910
Deferred income taxes ( 762 ) ( 1,867 )
Loss on disposal of property and equipment 8 —
Change in fair value of preferred stock tranche right liability — 74,319
Change in fair value of anti-dilution obligation — 6,681
Change in fair value of related party short-term investment 6,419 ( 1,075 )
Changes in operating assets and liabilities:
Prepaid expenses and other current assets ( 1,080 ) ( 642 )
Accounts payable 2,027 1,105
Accrued expenses and other current liabilities ( 29,961 ) 1,896
Lease liabilities ( 7,558 ) ( 2,744 )
Net cash used in operating activities ( 101,114 ) ( 20,895 )
Cash flows from investing activities:
Purchases of property and equipment ( 11,281 ) ( 3,768 )
Purchase of short-term investments ( 89,464 ) ( 81,841 )
Matured short-term investments 68,000 —
Payments of security deposits ( 664 ) ( 171 )
Net cash used in investing activities ( 33,409 ) ( 85,780 )
Cash flows from financing activities:
Proceeds from the issuance of convertible preferred stock series A, net of issuance costs paid — 70,721
Proceeds from the issuance of convertible preferred stock series B, net of issuance costs paid — 199,643
Payments of deferred offering costs ( 2,642 ) —
Net proceeds from stock option exercises 63 —
Net cash (used in) provided by financing activities ( 2,579 ) 270,364
Net (decrease) increase in cash, cash equivalents and restricted cash ( 137,102 ) 163,689
Cash and cash equivalents at beginning of period 198,545 36,975
Cash and cash equivalents at end of period $ 61,443 $ 200,664
Supplemental cash flow information:
Right-of-use assets obtained in exchange for new operating lease liabilities $ 28,590 $ 10,103
Supplemental disclosure of non-cash investing and financing activities:
Settlement of Series A preferred stock tranche obligation $ — $ 91,834
Issuance of Series A preferred stock at a price below fair value $ — $ 998
Settlement of anti-dilution obligation $ — $ 7,536
Settlement of related party forward contract $ 12,020 $ —
Deferred offering costs included in accounts payable and accrued expenses at period end $ 239 $ —
Purchases of property and equipment included in accounts payable and accrued expenses at period end $ 870 $ —
Accretion of preferred stock to redemption value $ — $ 1,468
Unrealized loss on short-term investments $ 454 $ 9
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents $ 47,947 $ 200,664
Restricted cash 13,496 —
Total cash, cash equivalents and restricted cash shown in the statement of cash flows $ 61,443 $ 200,664
The accompanying notes are an integral part of these condensed consolidated financial statements.
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PRIME MEDICINE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Nature of the Business and Basis of Presentation
Prime Medicine, Inc., together with its consolidated subsidiary (the “Company”) is a biotechnology company committed to deliver genetic therapies to address diseases by deploying gene editing technology, Prime Editing. The company is deploying Prime Editing technology, a versatile, precise, efficient and broad gene editing technology, which is designed to make only the right edit at the right position within a gene. With the theoretical potential to repair approximately 90 percent of known disease-causing genetic mutations across many organs and cell types, medicines based on Prime Editing, if approved, could offer a one-time curative genetic therapeutic option to a broad set of patients. The Company was incorporated in the State of Delaware in September 2019.
Reverse Stock Split
On October 12, 2022, in connection with the Company’s initial public offering (“IPO”), the Company effected a 1-for-3.10880 reverse stock split of its issued and outstanding shares of common stock and a proportional adjustment to the existing conversion ratios of each series of the Company’s preferred stock (see Note 6). Accordingly, all share and per share amounts for all periods presented in the accompanying condensed consolidated financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect this stock split and adjustment of the preferred stock conversion ratios.
Liquidity and capital resources
Since its inception, the Company has devoted substantially all of our resources to building our Prime editing platform and advancing development of our portfolio of programs, establishing and protecting our intellectual property, conducting research and development activities, organizing and staffing our company, business planning, raising capital and providing general and administrative support for these operations. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not limited to, technical risks associated with the successful research, development and manufacturing of product candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Current and future programs will require significant research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
In October 2022, the Company completed its IPO of its common stock. In connection with its IPO, the Company issued and sold 11,721,456 shares of its common stock, including 1,427,338 shares pursuant to the exercise of the underwriters’ option to purchase additional shares, at a price to the public of $ 17.00 per share. As a result of the IPO, the Company received $ 180.3 million in net proceeds, after deducting underwriting discounts, commissions and offering costs of $ 19.0 million. In connection with the IPO, all outstanding shares of redeemable convertible preferred stock converted into 51,923,758 shares of the Company’s common stock.
The Company is subject to risks and uncertainties common to early stage companies in the biotechnology industry, including, but not limited to, completing preclinical studies and clinical trials, obtaining regulatory approval for product candidates, market acceptance of products, development by competitors of new technological innovations, dependence on key personnel, the ability to attract and retain qualified employees, reliance on third-party organizations, protection of proprietary technology, compliance with government regulations, the impact of the COVID-19 pandemic, and the ability to raise additional capital to fund operations. The Company’s product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure, and extensive compliance-reporting capabilities. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
Since its inception, the Company has incurred substantial losses and as of September 30, 2022, the Company had an accumulated deficit of $ 253.9 million. The Company expects to generate operating losses and negative
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PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
operating cash flows for the foreseeable future. The Company expects that its cash, cash equivalents, and short term investments as of September 30, 2022 of $ 146.7 million will be sufficient to fund its operations for at least the next twelve months from the date of issuance of these financial statements. The Company will need additional financing to support its continuing operations and pursue its growth strategy. Until such time as the Company can generate significant revenue from product sales, if ever, it expects to finance its operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. The Company may be unable to raise additional funds or enter into such other agreements when needed on favorable terms or at all. The inability to raise capital as and when needed would have a negative impact on the Company’s financial condition and its ability to pursue its business strategy. The Company will need to generate significant revenue to achieve profitability, and it may never do so.
Basis of Presentation
The accompanying condensed consolidated financial statements reflect the operations of the Company and its wholly-owned subsidiary. Intercompany balances and transactions have been eliminated in consolidation. The accompanying condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).
The accompanying condensed consolidated financial statements of Prime Medicine, Inc. are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2022 and the results of its operations for the three and nine months ended September 30, 2022 and 2021, and its cash flows for the nine months ended September 30, 2022 and 2021. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2022 and 2021 are also unaudited. The results for the nine months ended September 30, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022, any other interim periods, or any future year or period. The condensed consolidated balance sheet data as of December 31, 2021 was derived from our audited financial statements, but does not include all disclosures required by U.S. generally accepted accounting principles, or U.S. GAAP. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2021, and notes thereto, which are included in the Company’s final prospectus for its IPO filed pursuant to Rule 424(b)(4) under the Securities Act with the Securities and Exchange Commission (the “SEC”) on October 21, 2022.
Impact of the COVID-19 Pandemic
The Company is subject to a number of risks associated with the COVID-19 global pandemic, including potential delays associated with the Company’s ongoing preclinical studies and anticipated clinical trials. COVID-19 may have an adverse impact on the Company’s operations, supply chains and distribution systems or those of its third-party vendors and collaborators, and increase expenses, including as a result of impacts associated with preventive and precautionary measures that are being taken, such as restrictions on travel and border crossings, quarantine policies and social distancing. The Company and its third-party vendors and collaborators may experience disruptions in supply of items that are essential for its research and development activities. The Company cannot predict the scope and severity of any economic recovery after the COVID-19 pandemic abates, including following any additional “waves” or other intensifying of the pandemic will have on its financial condition, operations, and business plans.
2. Summary of Significant Accounting Policies
The Company's significant accounting policies are disclosed in Note 2, "Summary of significant accounting policies," in the audited consolidated financial statements for the year ended December 31, 2021, and notes thereto, included in the Company’s final prospectus for its IPO filed pursuant to Rule 424(b)(4) under the Securities Act with
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PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
the SEC on October 21, 2022. Since the date of those financial statements, there have been no material changes to its significant accounting policies.
Use of Estimates
The preparation of the Company’s condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected within these condensed consolidated financial statements include, but are not limited to, revenue recognition, the valuation of the Company’s common stock and stock-based awards, the valuation of preferred stock tranche right liability, the valuation of the anti-dilution obligation and the valuation of the related party forward contract liability. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates, as there are changes in circumstances, facts and experience. Actual results may differ materially from those estimates or assumptions.
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less at the time of initial purchase to be cash equivalents . As of September 30, 2022 and December 31, 2021, the amount of cash equivalents included in cash and cash equivalents totaled $ 28.8 million and $ 49.5 million, respectively.
Restricted Cash
Restricted cash consisted of letters of credit totaling $ 13.5 million and $ 13.1 million as of September 30, 2022 and December 31, 2021, respectively, that are required to be maintained in connection with the Company’s lease arrangements. Both letters of credit are in the name of the Company’s landlords and are required to fulfill lease requirements in the event the Company should default on its lease obligations. As of both September 30, 2022 and December 31, 2021, the Company classified its restricted cash as non-current on the consolidated balance sheets based on the release dates of the restrictions.
Recently Issued Accounting Pronouncements Not Yet Adopted
In August 2020, the FASB issued ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40). This standard eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, the new guidance modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted earnings per share (“EPS”) computation. Additionally, the amended guidance requires the application of the if-converted method for calculating diluted EPS and the treasury stock method will no longer be available. For public business entities, it is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years using the fully retrospective or modified retrospective method. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company is currently evaluating the potential impact that ASU 2020-06 will have on its condensed consolidated financial statements and related disclosures but does not currently expect that the adoption of ASU 2020-06 will have a material impact.
Other accounting standards that have been issued by the Financial Accounting Standards Board or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on our financial statements upon adoption .
13
PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
3. Fair Value Measurements
We record cash equivalents, short-term investments, preferred stock tranche right liability, anti-dilution obligation and the related party forward contract liability at fair value. ASC 820, Fair Value Measurements and Disclosures , establishes a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our own assumptions (unobservable inputs). The carrying values of the Company’s accounts payable and accrued expenses approximate their fair values due to the short-term nature of these liabilities. The hierarchy consists of three levels:
Level 1 — Quoted prices in active markets for identical assets or liabilities.
Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
Level 3 — Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis and indicate the level within the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value (in thousands):
Fair Value Measurements at September 30, 2022:
Level 1 Level 2 Level 3 Total
Assets:
Cash equivalents:
Money market funds $ — $ 28,819 $ — $ 28,819
Short-term investment:
U.S. Treasury bills and government securities — 89,175 — 89,175
Related party short-term investment:
Beam equity securities 9,543 — — 9,543
$ 9,543 $ 117,994 $ — $ 127,537
Fair Value Measurements at December 31, 2021
Level 1 Level 2 Level 3 Total
Assets:
Cash equivalents:
Money market funds $ — $ 49,450 $ — $ 49,450
Short-term investment:
U.S. Treasury bills and government securities — 68,238 — 68,238
Related party short-term investment:
Beam equity securities 15,962 — — 15,962
$ 15,962 $ 117,688 $ — $ 133,650
Liabilities:
Related party forward contract liability — — 12,020 12,020
$ — $ — $ 12,020 $ 12,020
The Company classifies its U.S. Treasury as short-term based on each instrument’s underlying contractual maturity date. The fair value of the Company’s U.S. Treasury securities and money market funds are classified as Level 2 because they are valued using observable inputs to quoted market prices, benchmark yields, reported trades,
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PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
broker/dealer quotes or alternative pricing sources with reasonable levels of price transparency and U.S. Treasury securities.
The underlying securities held in the money market funds held by the Company are all government backed securities.
Short-term investments consisted of the following (in thousands):
Fair Value Measurements at September 30, 2022
Amortized Cost Unrealized Gains Unrealized Losses Fair Value
Short-term investments:
U.S. Treasury bills and government securities $ 89,629 $ ( 454 ) $ 89,175
Related party short-term investment:
Beam equity securities 5,486 4,057 — 9,543
$ 95,115 $ 4,057 $ ( 454 ) $ 98,718
December 31, 2021
Amortized Cost Unrealized Gains Unrealized Losses Fair Value
Short-term investments:
U.S. Treasury bills and government securities $ 68,265 $ — $ ( 27 ) $ 68,238
Related party short-term investment:
Beam equity securities $ 5,486 $ 10,476 $ — $ 15,962
$ 73,751 $ 10,476 $ ( 27 ) $ 84,200
The contractual maturities of the Company’s short-term investments in available-for-sale debt securities held were as follows:
September 30,
2022 December 31,
2021
Due within one year $ 89,175 $ 68,238
$ 89,175 $ 68,238
Valuation of Preferred Stock Tranche Right Liability
The preferred stock tranche right liability in the table above is composed of the fair value of rights to purchase Series A Preferred Stock (see Note 6). The fair value of the preferred stock tranche right liability was determined based on significant inputs not observable in the market, which represented a Level 3 measurement within the fair value hierarchy. The fair value of the preferred stock tranche right liability was determined using a Black-Scholes option pricing model, which considered as inputs the estimated fair value of the preferred stocks as of each valuation date, the risk-free interest rate, volatility and estimated time to each tranche closing.
The most significant assumption in the Black-Scholes option pricing model impacting the fair value of the preferred stock tranche right liability is the fair value of the Company’s convertible preferred stock as of each measurement date. The Company determines the fair value per share of the underlying convertible preferred stock by taking into consideration the most recent sales of its convertible preferred stock, results obtained from third-party valuations and additional factors the Company deems relevant. In November 2020, the second tranche of the Series A Preferred Stock closed. The fair value of each Series A Preferred Stock was $ 0.73 per share upon the closing of the second tranche. As of December 31, 2020, the fair value of Series A Preferred Stock was $ 0.76 per share. In April 2021, the third and fourth tranches of the Series A Preferred Stock closed. Upon satisfaction of certain conditions and the closing date of the third and fourth tranches, the associated Series A preferred stock tranche right
15
PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
liability was settled. The fair value of Series A Preferred Stock was $ 2.31 per share upon the closing of the third and fourth tranches. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining estimated time to each tranche closing. The volatility is based on the historical volatility of publicly traded peer companies. Changes in the estimated fair value of the Company’s convertible preferred stock can have a significant impact on the fair value of the preferred stock tranche right liability.
The preferred stock tranche right liability was initially recorded at fair value upon the date of issuance of the preferred stock tranche right and is subsequently remeasured to fair value at each reporting date, and immediately prior to the closing dates of Series A preferred stock tranches. Changes in the fair value of the preferred stock tranche right liability are recognized as a component of other income (expense), net in the consolidated statement of operations and comprehensive loss. Changes in the fair value of the preferred stock tranche right liability were recognized until the preferred stock tranche right liability was settled in full upon the satisfaction of certain conditions in April 2021.
The following table provides a roll-forward of the aggregate fair value of the Company’s preferred stock tranche right liability, for which fair value is determined using Level 3 inputs (in thousands):
Preferred Stock Tranche Right
Balance as of December 31, 2020 $ 17,515
Change in fair value of Series A preferred stock tranche right liability 74,319
Reclassification of Series A preferred stock tranche right liability upon settlement ( 91,834 )
Balance as of December 31, 2021 $ —
Valuation of Anti-dilution Obligation
The fair value of the anti-dilution obligation recognized in connection with the anti-dilution provisions set forth in the Company's license agreement with Broad Institute (see Note 11) was determined based on significant inputs not observable in the market, which represented a Level 3 measurement within the fair value hierarchy.
The fair value of the anti-dilution obligation was estimated using a probability-weighted scenario which considered as inputs the probability of occurrence of events that would trigger the issuance of shares, including (i) the closing of Series A Preferred Stock, (ii) the Company’s initial public offering, and (iii) no future sale of equity securities. The weighted-average fair value of all scenarios was calculated utilizing the fair value per share of the underlying common stock. Changes in the estimated fair value of common stock and the probability of achieving different financing scenarios can have a significant impact on the fair value of the anti-dilution obligation. The most significant assumption impacting the fair value of the anti-dilution obligation was the fair value of the Company’s common stock as of each measurement date. The Company determined the fair value per share of the underlying common stock by taking into consideration the most recent sales of its convertible preferred stock, results obtained from third-party valuations and additional factors the Company deems relevant. The per share fair value of the Company’s common stock was $ 0.35 as of December 31, 2020. Immediately prior to the settlement of the anti-dilution obligation, the fair value of the Company’s common stock was $ 3.02 per share.
The anti-dilution obligation was initially recorded at fair value upon entering into the license agreement with Broad Institute and was subsequently remeasured to fair value at each reporting date. Changes in fair value of the anti-dilution obligation were recognized as a component of other income (expense), net in the consolidated statements of operations and comprehensive loss. Changes in the fair value of the anti-dilution obligation were recognized until achievement of $ 100.0 million in cumulative equity financing is raised by the Company, which was achieved in connection with the fourth Series A Preferred Stock closing, resulting in the issuance of 2,498,850 shares of common stock to Broad Institute with a fair value of $ 7.5 million.
16
PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
The following table provides a roll-forward of the aggregate fair value of the Company’s anti-dilution obligation, for which fair value was determined using Level 3 inputs (in thousands):
Anti-dilution Obligation
Balance as of December 31, 2020 $ 855
Change in fair value of anti-dilution obligation 6,681
Reclassification of anti-dilution obligation upon settlement ( 7,536 )
Balance as of December 31, 2021 $ —
Valuation of the Related Party Forward Contract Liability
The Company measured its related party forward contract liability, which was established in connection with its obligation to issue shares of its common stock to Myeloid Therapeutics, Inc. (“Myeloid”) under a stock subscription agreement (see Note 11), at fair value based on significant inputs not observable in the market, which represented a Level 3 measurement within the fair value hierarchy. The initial fair value of the related party forward contract liability was determined based on the number of shares to be issued by the Company and the then per share fair value of the Company’s common stock, which was determined based, in part, on a third-party valuation that utilized methodologies and assumptions consistent with the Company’s most recent common stock valuations, including on a minority, nonmarketable interest basis.
Changes in the fair value of the related party forward contract liability will be recognized as other income (expense), net in the consolidated statements of operations through the settlement date. There was no change in the fair value of the Co mpany’s common stock from the initial date of the related party forward contract liability and December 31, 2021 and the settlement which occurred in January 2022. Upon settlement, the fair value of the related party forward contract liability was reclassified to equity upon issuance of the common stock to Myeloid.
A reconciliation of the related party forward contract liability measured and recorded at fair value on a recurring basis is as follows (in thousands):
Forward Contract
Balance as of December 31, 2021 $ 12,020
Reclassification of related party forward contract liability upon settlement ( 12,020 )
Balance as of September 30, 2022 $ —
4. Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
September 30, December 31,
2022 2021
Laboratory equipment $ 16,227 $ 5,274
Leasehold improvement 475 125
Furniture and Fixture 215 144
Computer hardware and software 11 —
Total property and equipment 16,928 5,543
Less: Accumulated depreciation and amortization ( 1,961 ) ( 611 )
Property and equipment, net $ 14,967 $ 4,932
Depreciation and amortization expense of property and equipment for the three and nine months ended September 30, 2022 was $ 0.6 million and $ 1.4 million, respectively. Depreciation and amortization expense of
17
PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
property and equipment for the three and nine months ended September 30, 2021 was $ 0.2 million and $ 0.3 million, respectively.
5. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
September 30, December 31,
2022 2021
Accrued Myeloid license fee – related party
$ — $ 30,000
Accrued employee compensation and benefits 4,111 2,364
Accrued professional fees 1,070 3,830
Lab-related supplies and services 1,167 719
Other 182 279
Total $ 6,530 $ 37,192
6. Convertible Preferred Stock
The Company has issued Series A Preferred Stock and Series B convertible preferred stock (the “Series B Preferred Stock” and, together with the Series A Preferred Stock, the “Preferred Stock”).
The Series A preferred stock and Series B preferred stock, described in more detail below, converted into 37,236,772 shares and 14,686,986 shares of common stock, respectively, in October 2022 as part of the Company’s IPO.
In September 2019, the Company completed its first closing of its Series A Preferred Stock and issued and sold 10,000,001 shares of Series A Preferred Stock at a price of $ 1.00 per share for gross proceeds of $ 10.0 million (the “2019 Preferred Stock Financing”). The Company incurred issuance costs of $ 20,000 in connection with this transaction.
The purchase agreement for the Series A Preferred Stock obligated the investors of the 2019 Preferred Stock Financing to purchase an additional 104,999,997 Series A Preferred Stock at a price of $ 1.00 per share in the subsequent closings upon certain conditions (“Series A Subsequent Closings”). The investors’ obligation to purchase shares in the subsequent closing terminated upon occurrence of a Deemed Liquidation Event (as defined below), the Company’s initial public offering, or bankruptcy by the Company. If an investor did not participate in the subsequent closing when obligated to do so, then any existing Series A Preferred Stock held by that investor would be converted into common shares of the Company on a ten-for-one basis.
The Company concluded that these obligations of investors to participate in the subsequent closing of Series A Preferred Stock met the definition of a freestanding financial instrument that was required to be recorded as a liability at fair value as (i) the instruments are legally detachable and separately exercisable from the Series A Preferred Stock and (ii) the rights will require the Company to transfer assets upon future closings of the Series A Preferred Stock. Upon the first closing of the Series A Preferred Stock in September 2019, the Company recorded a preferred stock tranche right liability of $ 6.3 million and a corresponding reduction to the carrying value of the Series A Preferred Stock (see Note 3).
In November 2020, the Company completed the second closing of its Series A Preferred Stock, in which the Company issued and sold 34,999,999 shares of Series A Preferred Stock, at a price of $ 1.00 per share, for gross proceeds of $ 35.0 million and incurred $ 46,000 of issuance costs. As the fair value of the Series A Preferred Stock was $ 0.73 at the time of the second closing, the Company recorded a capital contribution of $ 9.5 million for the difference between the fair value per share and the $ 1.00 per share paid by the holders of the Series A Preferred Stock participating in the second closing, which included members of the Company’s board of directors.
In April 2021, the Company completed the third and fourth closings of its Series A Preferred Stock, in which the Company issued and sold an aggregate of 70,761,842 shares of Series A Preferred Stock, at a price of $ 1.00 per
18
PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
share, for gross proceeds of $ 70.8 million and incurred $ 41,000 of issuance costs. As a result of this issuance, the Series A preferred stock tranche right liability with a then fair value of $ 91.8 million, based on a fair value of $ 2.31 per share of Series A Preferred Stock immediately prior to the closings, was settled in full and reclassified as an increase to the carrying value of Series A Preferred Stock.
In April 2021, the Company issued and sold 45,658,957 shares of Series B Preferred Stock, at a price of $ 4.3803 per share, for gross proceeds of $ 200.0 million and incurred $ 0.4 million of issuance costs.
Upon issuance of each series of Preferred Stock, the Company assessed the embedded conversion and liquidation features of the securities and determined that such features did not require the Company to separately account for these features. The Company also concluded that no beneficial conversion feature existed on the issuance date of each series of Preferred Stock.
On October 12, 2022, in connection with the Company’s IPO, the Company effected a 1-for-3.10880 reverse stock split of its issued and outstanding shares of common stock and a proportional adjustment to the existing conversion ratios of each series of the Company’s preferred stock. Accordingly, all share and per share amounts for all periods presented in the accompanying condensed consolidated financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect this stock split and adjustment of the preferred stock conversion ratios.
As of each balance sheet date, the Preferred Stock consisted of the following (in thousands, except share amounts):
September 30, 2022
Preferred Stock Authorized Preferred Stock Issued and Outstanding Carrying Value Liquidation Preference Conversion price per share Common Stock Issuable Upon Conversion
Series A Preferred Stock 115,761,842 115,761,842 $ 196,157 $ 131,927 $ 3.10880 37,236,772
Series B Preferred Stock 45,658,957 45,658,957 199,643 $ 222,766 $ 13.6175 14,686,986
161,420,799 161,420,799 $ 395,800 $ 354,693 51,923,758
December 31, 2021
Preferred Stock Authorized Preferred Stock Issued and Outstanding Carrying Value Liquidation Preference Conversion price per share Common Stock Issuable Upon Conversion
Series A Preferred Stock 115,761,842 115,761,842 $ 196,157 $ 125,000 $ 3.10880 37,236,776
Series B Preferred Stock 45,658,957 45,658,957 $ 199,643 $ 210,814 $ 13.6175 14,686,988
161,420,799 161,420,799 $ 395,800 $ 335,814 51,923,764
The holders of the Preferred Stock have the following rights and preferences:
Voting
The holders of the Preferred Stock are entitled to vote, together with the holders of common stock, as a single class, on all matters submitted to the shareholders for a vote and are entitled to the number of votes equal to the number of common stock into which the Preferred Stock could convert on the record date for determination of shareholders entitled to vote. A majority vote of the holders of Preferred Stock is required to, among others, liquidate or dissolve the Company, amend the certificate of incorporation or bylaws, reclassify common stock or establish another class of capital stock, create shares that would rank senior to or authorize additional shares of Preferred Stock, declare a dividend or make a distribution, or change the authorized number of directors constituting the board of directors.
19
PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
In addition, the holders of shares of Series A Preferred Stock, voting exclusively and as a separate class, are entitled to elect three directors of the Company. The holders of shares of common stock and any other class or series of voting stock (including the Series B Preferred Stock), exclusively and voting together as a single class, are entitled to elect the balance of the total number of directors of the Company.
Conversion
Each Preferred Stock is convertible into voting common stock, at any time, at the option of the holder, and without the payment of additional consideration, at the applicable conversion ratio then in effect. In addition, each share of Preferred Stock will be automatically converted into shares of common stock at the then-effective applicable conversion ratio upon either (i) the closing of a firm-commitment underwritten public offering of its common stock resulting in at least $ 50.0 million of gross proceeds, net of underwriting discount and commissions, to the Company, or (ii) the date specified by vote or written consent of the holders of a majority in voting power of the outstanding shares of Preferred Stock, voting as a single class.
The conversion ratio of each class of Preferred Stock is determined by dividing the Original Issue Price of each class of Preferred Stock by the Conversion Price of each class. As of September 30, 2022 and December 31, 2021, the Conversion Price was $ 3.10880 per share for Series A Preferred Stock and $ 13.6175 per share for Series B Preferred Stock, each subject to appropriate adjustment in the event of any share dividend, share split, combination or other similar recapitalization with respect to the Preferred Stock.
Upon the closing of the IPO in October 2022, 161,420,799 shares of outstanding convertible preferred stock were automatically converted into 51,923,758 shares of common stock, after the effect of the one-for-3.10880 reverse stock split, with the related carrying value of $ 395.8 million reclassified to common stock and additional paid-in capital.
There shall be no adjustment in the conversion price of the Series A Preferred Stock as the result of the issuance or deemed issuance of additional shares of Company’s common stock if the Company receives written notice from the holders of at least 65 percent of the then outstanding shares of Series A Preferred Stock agreeing that no such adjustment shall be made as the result of the issuance or deemed issuance of additional shares of the Company’s common stock. There shall be no adjustment in the conversion price of the Series B Preferred Stock as the result of the issuance or deemed issuance of additional shares of the Company’s common stock if the Company receives written notice from the holders of at least a majority of the then outstanding shares of Series B Preferred Stock agreeing that no such adjustment shall be made as the result of the issuance or deemed issuance of such additional shares of the Company’s common stock.
In the event that any holder of shares of Series A Preferred Stock is required to participate in a Series A Subsequent Closing pursuant to the purchase agreement does not purchase the aggregate number of subsequent closing shares, then each share of Series A Preferred Stock held by such holder shall automatically be converted into shares of common stock at a ratio of one share of common stock for every ten shares of Series A Preferred Stock held immediately prior to the consummation of such Series A Subsequent Closing.
Dividends
The holders of the Series A Preferred Stock are entitled to receive cumulative dividends at a rate of $ 0.25 per share per annum of the Original Issue Price when, as and if declared by the board of directors (the “Series A Preferred Dividend”). The holders of the series B Preferred Stock are entitled to receive cumulative dividends at a rate of $ 1.09 per share per annum of the Original Issue Price when, as and if declared by the board of directors (the “Series B Preferred Dividend”, and together with Series A Preferred Dividend, the “Preferred Dividend”).
The Company may not declare, pay or set aside any dividends on common shares of the Company unless the holders of Preferred Stock then outstanding first receive, or simultaneously receive, the Preferred Dividend on each outstanding Preferred Stock and a dividend on each outstanding Preferred Stock in an amount at least equal to the greater of (i) the amount of the aggregate Preferred Dividend then accrued on such share of Preferred Stock and not previously paid and (ii) (a) in the case of a dividend on common stock or any class or series that is convertible into common stock, that dividend per share of Preferred Stock as would equal to the product of (1) the dividend payable
20
PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
on each share of such class or series determined, as if all shares of such class or series had been converted into common stock and (2) the number of shares of common stock issuable upon conversion of a share of such series of Preferred Stock, in each case calculated on the record date for determination of the holders entitle to receive such dividend or the dividend payable on each share of such class or series determined, if applicable, as if all shares of such class or series had been converted into common shares or (b) in the case of a dividend on any class or series that is not convertible into common stock, at a rate per share of Preferred Stock determined by (1) dividing the amount of dividend payable on each share of such class or series of capital stock by the original issuance price of such class or series of capital stock and (2) multiplying such faction by an amount equal to the Original Issue Price for such series of Preferred Stock. If the Company declares, pays, or sets aside, on the same date, a dividend on shares of more than one class or series of shares in the capital of the Company (other than the Preferred Stock), the dividend payable to the holders of Preferred Stock shall be calculated based upon the dividend on the class or series of shares in the capital of the Company that would result in the highest dividend on the Preferred Stock. Through September 30, 2022 and December 31, 2021 no cash dividends have been declared or paid.
Liquidation
In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, or upon the occurrence of a Deemed Liquidation Event (as defined below), the holders of shares of Preferred Stock then outstanding are entitled, on a pari passu basis, to be paid out of the assets or funds of the Company available for distribution to stockholders before any payment is made to the holders of common stock. The holders of Preferred Stock are entitled to an amount per share equal to (i) in the case of Series A Preferred Stock, the Original Issue Price plus any accruing dividends accrued but unpaid thereon, whether or not declared, together with any other dividends declared but unpaid thereon, and (ii) in the case of Series B Preferred Stock, the greater of (a) the applicable Original Issue Price plus any accruing dividends accrued but unpaid thereon, whether or not declared, together with any other dividends declared, or not declared, but unpaid thereon (the "Series B Preference Amount") or (b) the amount that would have been payable had all shares of each series of Preferred Stock been converted into common stock immediately prior to such liquidation, dissolution, winding up or Deemed Liquidation Event (as defined below). After the payment in full of the Series A Preferred Stock preference amount and if applicable, the Series B Preference Amount, the remaining assets of the Company available for distribution to stockholders shall be distributed among the holders of Series A Preferred Stock and common stock on a pro rata basis provided that such distribution includes holders of Series B Preferred Stock if such distribution is greater than the Series B Preference Amount.
Unless at least the holders of a majority in voting power of the outstanding shares of Preferred Stock, elect otherwise, a Deemed Liquidation Event shall include a merger, consolidation, or share exchange (other than one in which stockholders of the Company own a majority by voting power of the outstanding shares of the surviving or acquiring corporation) or a sale, lease, transfer, exclusive license or other disposition of all or substantially all of the assets of the Company.
Redemption
As of December 31, 2020, at the written election of at least 65 percent of the holders of the outstanding shares of Series A Preferred Stock, voting together as a single class and on an as-converted to common stock basis, the shares of Series A Preferred Stock outstanding were redeemable, at any time on or after the fifth anniversary of issuance, in three equal annual installments commencing 60 days after receipt of the required vote. Shares of Series A Preferred Stock were redeemable in an amount equal to the Original Issue Price per share plus any accruing dividends accrued but unpaid thereon, whether or not declared.
In April 2021, in connection with the Series B Preferred Stock closing, the Company adopted an amended and restated certificate of incorporation, which removed the redemptions rights of the holders of Series A Preferred Stock. As a result of this amendment, Series A Preferred Stock was no longer redeemable at the option of the holders. The Company determined that the changes to the rights underlying the Series A Preferred Stock was not substantive and did not materially modify the rights and preferences of the holders of Series A Preferred Stock.
21
PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Prior to the amendment, the Company recognized changes in the redemption values of its Series A Preferred Stock over the period from the date of issuance to the earliest redemption date and adjusted the carrying value of the instrument to equal the redemption value at the redemption date. During the period from September 19, 2019 (inception) to December 31, 2019, the years ended December 31, 2020 and 2021, the Company recorded adjustments to increase the carrying values of the Series A Preferred Stock by an aggregate of $ 0.3 million, $ 1.6 million, and $ 1.5 million, respectively, which resulted in an increase in redeemable convertible preferred stock by those amounts, offset by charges against additional paid-in-capital, if any, and then in the absence of additional paid-in capital the accretion is charged to the accumulated deficit.
The Company’s articles of the corporation, as amended and restated, does not provide redemption rights to the holders of Series B Preferred Stock.
7. Common Stock
The voting, dividend and liquidation rights of the holders of the Company’s common stock are subject to and qualified by the rights, powers and preferences of the holders of the Preferred Stock set forth above. Each share of common stock entitles the holder to one vote, together with the holders of the Preferred Stock, on all matters submitted to the stockholders for a vote. The holders of common stock are entitled to receive dividends, if any, as declared by the Company’s board of directors, subject to the preferential dividend rights of Preferred Stock.
As of September 30, 2022 the Company had reserved 57,287,852 shares, respectively, of common stock for the potential conversion of shares of Preferred Stock into common stock, the exercise of outstanding stock options for common stock, and the issuance of common stock options and restricted stock awards remaining available for grant under the 2019 Equity Incentive Plan.
8. Stock-Based Compensation
2019 Equity Incentive Plan
The Company’s 2019 Stock Option and Grant Plan (the “2019 Plan”) provides for the Company to grant incentive stock options (“ISO”), non-qualified stock options, unrestricted stock awards, restricted stock awards (“RSA”) and other stock-based awards (collectively, the “Awards”) to the officers, employees, consultants and other key persons of the Company. The 2019 Plan is administered by the board of directors, or at the discretion of the board of directors, by a committee of the board of directors. The exercise prices, vesting and other restrictions are determined at the discretion of the board of directors, or its committee if so delegated.
The total number of shares of common stock issuable under the 2019 Plan was 6,171,635 . In April 2021, the Company’s board of directors further increased the number of shares of common stock reserved for issuance under the plan from 6,171,635 shares to 11,561,815 shares. As of September 30, 2022 there were 1,392,540 shares remaining available for future grants under the 2019 Plan. Shares of unused common stock underlying any Awards that are forfeited, canceled or reacquired by the Company prior to vesting will again be available for the grant of awards under the 2019 Plan.
The exercise price for stock options granted may not be less than the fair market value of the Company’s common stock on the date of grant, as determined by the board of directors, or at least 110 percent of the fair market value of the Company’s common stock on the date of grant in the case of an ISO granted to an employee who owns stock representing more than 10 percent of the voting power of all classes of stock (“10% Owner”) as determined by the board of directors as of the date of grant. The Company’s board of directors determines the fair market value of the Company’s common stock, taking into consideration its most recently available valuation of common stock performed by third parties as well as additional factors which may have changed since the date of the most recent contemporaneous valuation through the date of grant. Unless otherwise provided, at the time of grant, the options granted pursuant to the 2019 Plan expire ten years from the date of grant, or five years from the date of grant in the case of an ISO that is granted to a 10 % Owner. Awards typically vest over four years , with the first 25 percent vesting on the first anniversary of the vesting commencement date and the remainder vesting in 36 equal monthly installments thereafter, contingent on the recipient’s continued employment, service or relationship with the Company.
22
PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
In October 2022, the Company completed its IPO, and in connection with the closing the Board determined that no further awards would be granted under the 2019 Plan.
2022 Stock Option and Incentive Plan
On February 9, 2022, the Company’s board of directors adopted, and on October 10, 2022 its stockholders approved, the 2022 Stock Option and Incentive Plan (the “2022 Plan”), which became effective immediately preceding the date on which the registration statement for the Company’s IPO is declared effective by the SEC. The 2022 Plan allows the Company to make equity-based and cash-based incentive awards to its officers, employees, directors, and consultants. The 2022 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock awards, restricted stock units and other stock-based awards. The number of shares initially reserved for issuance under the 2022 Plan is 8,041,688 shares, which includes the number of shares remaining available for grant under the 2019 Plan, as of the effective date, for the issuance of awards under the 2022 Plan. In addition, the number of shares reserved and available for issuance under the 2022 Plan will automatically increase on January 1, 2023 and each January 1 thereafter, by five percent of the outstanding number of shares of common stock on the immediately preceding December 31 or such lesser number of shares as determined by the compensation committee.
The shares of common stock underlying any awards under the 2022 Plan and the 2019 Plan that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance of stock, expire, or are otherwise terminated (other than by exercise) will be added back to the shares of common stock available for issuance under the 2022 Plan.
As of September 30, 2022, no options were issued and outstanding under the 2022 Plan.
2022 Employee Stock Purchase Plan
On February 9, 2022, the Company’s board of directors adopted, and on October 10, 2022 its stockholders approved, the 2022 Employee Stock Purchase Plan (the “2022 ESPP”), which became effective immediately preceding the date on which the registration statement for the Company’s IPO is declared effective by the SEC. A total of 971,350 shares of common stock were initially reserved for issuance under this plan. The number of shares of common stock that may be issued under the 2022 ESPP shall cumulatively increase beginning on January 1, 2023 and each January 1 thereafter through January 1, 2032, by the least of (i) 971,350 shares of common stock, (ii) one percent of the outstanding number of shares of common stock on the immediately preceding December 31, or (iii) such number of shares of common stock as determined by the administrator of the 2022 ESPP.
No shares of the Company’s common stock were issued and no stock-based compensation expense was recognized during the three and nine months ended September 30, 2022 related to the 2022 ESPP.
Stock Options
The following table summarizes the Company’s stock option activity since December 31, 2021:
Number of Shares Weighted-Average Exercise Price
Balance at December 31, 2021 3,002,803 $ 3.96
Granted 1,160,074 8.40
Exercised ( 55,687 ) 3.67
Forfeited ( 135,633 ) 4.66
Balance at September 30, 2022 3,971,557 $ 5.24
Options vested and exercisable at September 30, 2022 536,064 $ 3.71
Options vested and expected to vest at September 30, 2022 3,971,557 $ 5.24
23
PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
As of September 30, 2022, there was $ 16.1 million of total unrecognized compensation cost related to time-based unvested stock options the Company expects to recognize such amount over a remaining weighted-average period of 3.2 years.
Performance-Based Stock Options
During the year ended December 31, 2021, the Company granted performance-based stock options to purchase 241,248 shares of common stock. The performance-based options commence vesting upon the achievement of (i) IND acceptance, (ii) consummation of the Company’s IPO and (iii) a research milestone to be mutually agreed upon and vest over three equal installments. On February 9, 2022, the Company’s board of directors established and approved the third performance-based vesting milestone, which requires the building of a chemistry facility, initiation of pegRNA piloting operations, and production of a GLP toxicology lot suitable for in vivo non-human primate studies, for stock options to purchase 80,416 shares of common stock granted on October 27, 2021 to the Company’s CTO. The first two performance-based vesting conditions for stock options to purchase 160,833 shares of common stock granted were established by the board of directors on October 27, 2021. The grant date of these awards for accounting purposes is the date on which the performance conditions of the award were established by the board of directors and all terms of the award were known by the recipient. As a result, the grant-date fair value of each such award for accounting purposes was determined on October 27, 2021 and such awards are reflected in the Company’s total stock options outstanding as of December 31, 2021. The performance-based vesting condition for stock options to purchase 80,416 shares of common stock granted on October 27, 2021 which was not established by the Company’s board of directors until February 9, 2022 and therefore a grant date for accounting purposes had not been established for those stock options as of December 31, 2021 although such stock options are included in the Company’s total stock options outstanding as of December 31, 2021. The accounting grant date was established on February 9, 2022 and as such are outstanding stock options for accounting purposes as of September 30, 2022.
In June 2022, the Company granted three performance-based stock options to purchase a total of 32,166 shares of common stock. The performance-based options commence vesting upon the achievement of (i) IND acceptance, (ii) consummation of the Company’s IPO and (iii) first regulatory designation granted to Prime Medicine and vest over three equal installments. The grant date of these awards for accounting purposes is the date on which the performance conditions of the award are established by the board of directors and all terms of the award are known by the recipient. As a result, the grant-date fair value for accounting purposes for the first performance-based stock options to purchase 10,722 shares of common stock was determined on June 3, 2022, when the performance-based vesting conditions were established by the board of directors and the terms of the awards were communicated to the recipients. The second and third performance-based vesting conditions for stock options to purchase the remaining 21,444 shares of common stock was not established by the Company’s board of directors until August 4, 2022 and therefore a grant date for accounting purposes had not been established for those stock options as of September 30, 2022 although such stock options are included in the Company’s total stock options outstanding for legal purposes as of September 30, 2022.
In August 2022, the Company granted 90,066 shares of performance-based options, at an exercise price of $ 7.96 per share. This includes two grants, and 57,900 of the performance-based options vest in three equal installments upon the achievement of (i) IND acceptance, (ii) consummation of the Company’s IPO and (iii) business development deals which generate $ 100.0 million or more in upfront and near-term unrestricted cash. The remaining 32,166 of the performance-based options vest in three equal installments upon the achievement of (i) IND acceptance, (ii) consummation of the Company’s IPO and (iii) maximize the senior leadership team effectiveness by accomplishment of four criteria through year end 2023. The grant date of these awards for accounting purposes is the date on which the performance conditions of the award are established by the board of directors and all terms of the award are known by the recipient. As a result, the grant-date fair value for accounting purposes was determined on August 4, 2022, when the performance-based vesting conditions were established by the board of directors and the terms of the awards were communicated to the recipients. The aggregate grant-date fair value is $ 0.5 million.
Through September 30, 2022, the Company concluded that the achievement of all of the performance conditions for such awards was not probable or consummated.
24
PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
As of September 30, 2022 and December 31, 2021, there was $ 2.6 million and $ 1.4 million respectively, of total unrecognized compensation cost related to performance-based stock options.
Restricted Common Stock Awards
The Company awards restricted common stock to employees and non-employees under its 2019 Plan. The fair value of each share of restricted common stock is based on the market price of the Company's common stock on the date of grant.
For a period of up to six months from a grantee’s termination, the Company has the right and option to repurchase unvested restricted common stock at the lower of (i) the original purchase price per share ($ 0.00004 ) or (ii) the fair market value per share as of the date of the Company elects to exercise its repurchase right. In August 2021, the Company repurchased 18,227 unvested shares of the restricted common stock at a price of $ 0.00004 per share, the original sale price, and the repurchased common shares were restored to the amount of unissued, authorized shares of common stock as of December 31, 2021. In May 2022, the Company repurchased 3,116 unvested shares of the restricted common stock at a price of $ 0.00004 per share, the original sale price, and the repurchased common shares were restored to the amount of unissued, authorized shares of common stock as of September 30, 2022.
Shares of restricted common stock granted to employees and directors are not deemed, for accounting purposes, to be outstanding until those shares have vested.
Each award type is discussed below.
Time-Based Restricted Common Stocks
The majority of the restricted common stock have time-based vesting conditions and vest over a four-year period, subject to the employee’s continued employment with, or service to, the Company on such vesting date. Compensation expense is recognized on a straight-line basis over the vesting period.
Time-Based Restricted Common Stock
In September 2019, a co-founder of the Company was granted a total of 20,835,277 shares of restricted common stock, of which 3,472,545 shares are performance-based restricted common stock as described below. The remaining 17,362,732 shares are subject to service conditions. In February 2020, another co-founder of the Company was granted 694,679 shares of restricted common stock that are subject to service conditions. These awards vest over a four-year period and provide for accelerated vesting of a portion of the unvested awards, as determined in the award agreement, upon the initial or subsequent closings of the Series A Preferred Stock. Upon the grant date, the Company determined the initial and subsequent closings of the Series A Preferred Stock were probable to occur and recognized the compensation expense over the expected service period.
The following table summarizes the Company’s time-based restricted common stock activity since December 31, 2021:
Number of Shares Weighted-Average Grant-Date Fair Value
Unvested restricted common stock at December 31, 2021 10,801,361 $ 0.10
Issued — —
Vested ( 4,385,478 ) 0.09
Repurchased ( 11,160 ) 0.35
Unvested restricted common stock at September 30, 2022 6,404,723 $ 0.04
The aggregate fair value of restricted common stock that vested during the nine months ended September 30, 2022 was $ 0.4 million.
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PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
As of September 30, 2022, there was $ 0.4 million of total unrecognized compensation cost related to unvested ti me-based restricted common stock which the Company expects to recognize over a weighted-average period of 1.3 years.
Performance-Based Restricted Common Stock
The Company has also granted performance‑based restricted common stock to certain executive officers and key persons of the Company with terms that allow the grantees to vest in a specific number of shares based upon the achievement of performance‑based milestones. The Company granted 3,472,545 shares of performance-based restricted common stock to a co-founder of the Company in 2019, which will vest upon on the dosing of first patient in a Phase II or later-stage clinical trial or FDA approval of compound. The Company granted 694,679 and 385,998 shares of performance-based restricted common stock to certain executive officers in the years ended December 31, 2020 and 2021, respectively. These awards vest in three equal installments upon the achievements of (i) proof of concept in lead indication (which was achieved in May 2022), (ii) IND acceptance and (iii) consummation of the Company’s IPO.
Share‑based compensation expense associated with the performance-based restricted common stock is recognized if the performance condition is considered probable of achievement using the Company’s best estimates of the time to vesting for the achievement of the performance‑based milestones. Each reporting period, the Company updates its assessment of the probability that the performance-based milestones will be achieved. As of December 31, 2020 and 2021, the Company has concluded it was not probable that these performance conditions related to performance-based restricted common stock would be achieved, and as a result no compensation expense related to the performance-based restricted common stock has been recorded. As of September 30, 2022, the Company has concluded that the proof of concept in a lead indication was achieved in May 2022, but it was not probable that the remaining performance conditions related to performance-based restricted common stock would be achieved. As a result, compensation expense of $ 0.1 million was recorded for the milestone achieved, and no compensation expense related to the remaining performance-based restricted common stock has been recorded. The fair value of the restricted common stock was based on the fair market value of the Company’s common stock on the date of grant.
The following table summarizes the Company’s performance-based restricted common stock activity since December 31, 2021:
Number of Shares Weighted-Average Grant-Date Fair Value
Unvested restricted common stock at December 31, 2021 4,553,223 $ 0.10
Issued — —
Vested ( 360,226 ) 0.19
Repurchased — —
Unvested restricted common stock at September 30, 2022 4,192,997 $ 0.10
As of September 30, 2022, there was $ 0.3 million of total unrecognized compensation cost related to unvested performance-based restricted common stock.
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PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Stock-Based Compensation
The following table below summarizes the classification of the Company’s stock-based compensation expense related to stock options and restricted common stock awards in the consolidated statements of operations and comprehensive loss (in thousands):
Three Months Ended
September 30, Nine Months Ended
September 30,
2022 2021 2022 2021
General and administrative $ 467 $ 130 $ 1,288 $ 172
Research and development 950 209 $ 2,597 $ 467
$ 1,417 $ 339 $ 3,885 $ 639
9. Leases
Our building leases are comprised of office and laboratory space under non-cancelable operating leases. These lease agreements have remaining lease terms of five years and contain various clauses for renewal at our option. The renewal options were not included in the calculation of the operating lease assets and the operating lease liabilities as the renewal options are not reasonably certain of being exercised. The lease agreements do not contain residual value guarantees.
Summary of lease costs
The following table contains a summary of the lease costs and other information pertaining to the Company’s operating leases for the three and nine months ended September 30, 2022 and 2021.
In connection with the Arsenal Street Sublease, the Company recorded operating sublease income of $ 0.1 million and $ 0.2 million, respectively for the three and nine months ended September 30, 2022 in other income (expense), net in the condensed consolidated statements of operations. The Company was not relieved of its primary obligation under the operating lease as a result of the sublease.
Future annual lease payments under non-cancelable operating leases as of September 30, 2022 w ere as follows (in thousands):
Remaining 2022 $ 2,415
2023 12,610
2024 13,035
2025 3,510
2026 1,683
2027 567
Total future minimum lease payments 33,820
Less: imputed interest ( 2,381 )
$ 31,439
The lease for office and laboratory space at 60 First Street, Cambridge , Massachusetts has not yet commenced and the expected date for which the Company obtains control of the space is currently uncertain but not expected to occur until the first half of 2023. The Company currently expects rent to commence 11 months after taking possession of the space, with occupancy expected to begin in 2024, for which the Company will pay approximately $ 208.7 million over the ten-year lease term. As the lease has not commenced as of September 30, 2022, the operating lease liabilities on the consolidated balance sheet through September 30, 2022 and the table above excludes any amounts related to this lease.
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PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
10. License and Collaboration Agreements
The Company's significant license agreements are disclosed in Note 10, "License and Collaboration Agreements," in the audited consolidated financial statements for the year ended December 31, 2021, and notes thereto, included in the Company’s final prospectus for its IPO filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on October 21, 2022. Since the date of those financial statements, there have been no changes to its license agreements, except as noted below.
Broad Pledge
The Company accounts for this Pledge as research and development expenses as it has access to certain data generated as a result of the Pledge. For the year ended December 31, 2021, the Company recognized $ 5.0 million of research and development expense in connection with the Pledge. For both the three and nine months ended September 30, 2022 and 2021, the Company recognized $ 1.3 million and $ 3.8 million, respectively, of research and development expense in connection with the Pledge.
11. Commitments and Contingencies
Leases
The Company’s commitments under its operating leases are described in Note 9. Additionally, as part of the lease agreement the Company entered into in May 2022 for 480 Arsenal Street, the Company signed a participation rights agreement for up to $ 2.0 million, which allows the landlord or an affiliate or designee of the landlord to participate in any future issuance of equity at the same terms and pricing as other investors. Since the right to participate is on the same terms and pricing afforded to other investors, the participation right is deemed to be at fair value with no separate accounting required. With the completion of our IPO in October 2022, this agreement terminated.
License and Collaboration Agreements
The Company entered into various license and collaboration agreements under which it is obligated to make fixed and contingent payments (see Note 10).
401(k) Plan
The Company maintains a defined-contribution plan under Section 401(k) of the Internal Revenue Code of 1986 (the “401(k) Plan”). The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-t ax basis. Matching contributions to the 401(k) Plan may be made at the discretion of management. The Company is not required to make any matching contributions to the 401(k) Plan. In July 2022, the Company announced a new company match for the 401(k) retirement plan beginning on July 1, 2022. For the three and nine months ended September 30, 2022, the Company has contributed $ 0.1 million. As of September 30, 2022, $ 0.3 million is included within accrued expenses.
Indemnification Agreements
In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with all board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any indemnification arrangements that could have a material effect on its financial position, results of operations or cash flows, and it has not accrued any liabilities related to such obligations in its condensed consolidated financial statements as of September 30, 2022 and December 31, 2021.
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PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Legal Proceedings
From time to time, the Company may become involved in legal proceedings or other litigation relating to claims arising in the ordinary course of business. The Company accrues a liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reasonably estimated. Significant judgment is required to determine both probability and estimated exposure amount. Legal fees and other costs associated with such proceedings are expensed as incurred. As of September 30, 2022 and December 31, 2021, the Company was not a party to any material legal proceedings or claims.
12. Net Loss per Share
Basic and diluted net loss per common share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts):
Three Months Ended
September 30, Nine Months Ended
September 30,
2022 2021 2022 2021
Numerator:
Net loss $ ( 29,350 ) $ ( 16,412 ) $ ( 82,538 ) $ ( 102,456 )
Accretion of preferred stock to redemption value — — — ( 1,468 )
Cumulative dividend on preferred stock ( 6,362 ) ( 6,363 ) ( 18,879 ) ( 10,922 )
Net loss attributable to common stockholders $ ( 35,712 ) $ ( 22,775 ) $ ( 101,417 ) $ ( 114,846 )
Denominator:
Weighted-average common shares outstanding, basic and diluted 22,226,301 14,965,186 20,665,225 11,795,738
Net loss per share attributable to common stockholders, basic and diluted $ ( 1.61 ) $ ( 1.52 ) $ ( 4.91 ) $ ( 9.74 )
Diluted net loss per share available to common shareholders was computed by giving effect to all potentially dilutive common stock equivalents outstanding for the period. For purposes of this calculation, preferred stock, unvested restricted stock and stock options to purchase common stock were considered common stock equivalents but had been excluded from the calculation of diluted net loss per share available to common shareholders as their effect was anti-dilutive. In periods in which the Company reports a net loss available to common shareholders, diluted net loss per share available to common shareholders is the same as basic net loss per share available to common shareholders, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.
The following common stock equivalents were excluded from the calculation of diluted net loss per share applicable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:
As of September 30, 2022
2022 2021
Convertible preferred stock (as converted to common stock) 51,923,758 51,923,764
Stock Options to purchase common stock 3,971,557 1,311,101
Unvested restricted common stock 10,597,726 16,750,912
66,493,041 69,985,777
13. Related Party Transactions
Founder Consulting Services
For both the three and nine months ended September 30, 2022 and 2021, the Company made payments of $ 37,500 and $ 0.1 million, respectively, to one of the Co-founder shareholders for scientific consulting and other expenses. As of September 30, 2022 and December 31, 2021 , there were no amounts included within accounts payable.
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PRIME MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Beam Therapeutics
The Company and Beam Therapeutics, (“Beam”), are parties to the Beam Collaboration Agreement and the Beam Mutual Subscription Agreement and have a common founder and one common board member (see Note 10). For the year ended December 31, 2021 , the Company made payments of $ 0.1 million to Beam for general and administrative service s pursuant to an agreement to receive certain interim management and startup services (see Note 10). The agreement ended on March 31, 2021 and for the nine months ended September 30, 2021, the Company made payments of $ 0.1 million for such services.
Newpath Partners
In connection with the Series A and B Preferred Stock closings (see Note 6), the Company issued and sold 9,999,999 and 5,250,781 shares of Series A and B Preferred Stock, respectively, to Newpath Partners L.P. (“Newpath”), which is an affiliate to one of the Company’s board members, for an aggregate purchase price of $ 10.0 million and $ 23.0 million, respectively.
Myeloid Therapeutics
In December 2021, the Company and Myeloid entered into the Myeloid Collaboration Agreement and Myeloid Subscription Agreement (see Note 10). The Company and Myeloid have one common board member, who is also an affiliate of Newpath, one of the Company’s holders of Series A and B Preferred Stock.
14. Subsequent Events
In October 2022, the Company completed its IPO of its common stock. In connection with its IPO, the Company issued and sold 11,721,456 shares of its common stock, including 1,427,338 shares pursuant to the exercise of the underwriters’ option to purchase additional shares, at a price to the public of $ 17.00 per share. As a result of the IPO, the Company received $ 180.3 million in net proceeds, after deducting underwriting discounts, commissions and offering costs of $ 19.0 million.
Upon the closing of the IPO, 161,420,799 shares of outstanding convertible preferred stock were automatically converted into 51,923,758 shares of common stock, after the effect of the one-for-3.10880 reverse stock split, with the related carrying value of $ 395.8 million reclassified to common stock and additional paid-in capital. Additionally, the performance vesting condition for 360,225 restricted stock units and 121,160 stock options issued under the 2019 Plan was deemed satisfied upon the effective date of the Company's registration statement on Form S-1 filed with the SEC in connection with the IPO. The related compensation expense for these awards was approximately $ 1.0 million.
On February 9, 2022, the Company’s board of directors approved the third amended and restated certificate of incorporation, which was filed upon the closing of the IPO, on October 24, 2022, and which, among other things, increases the number of shares of common stock authorized for issuance from 293,258,790 to 775,000,000 shares of common stock.
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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes thereto included elsewhere in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis and set forth elsewhere in this Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the “Risk Factors” section of this Quarterly Report on Form 10-Q. Our historical results are not necessarily indicative of the results that may be expected for any period in the future.
Overview
We are a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies to address the widest spectrum of diseases by deploying our Prime Editing technology, which we believe is a versatile, precise, efficient and broad gene editing technology.
Genetic mutations implicated in disease are diverse and can range from errors of a single base, known as point mutations, to errors that extend beyond a single base, such as insertions, deletions, duplications, or combinations thereof. Other mutations can affect regulatory sequences that control the function of genes and can affect the function of larger biochemical and genetic pathways. Furthermore, natural genetic variations, revealed by population-level genomic studies, are known to protect against or to increase risk of disease. To maximize the impact of these genetic insights, we believe the ability to alter the human genome at the foundational level may confer the greatest therapeutic impact on human disease.
Since our inception in September 2019, we have devoted substantially all of our efforts on organizing and staffing our company, business planning, raising capital, research and development activities, developing our Prime Editing platform, building our intellectual property portfolio and providing general and administrative support for these operations. Through September 30, 2022, we had received gross proceeds of $315.8 million from sales of preferred stock. In October 2022, we completed our IPO and as a result, we received $180.3 million in net proceeds. To date, we have financed our operations primarily with our initial public offering of common stock, or IPO, and proceeds from sales of preferred stock.
We have incurred significant operating losses since inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of any product candidates we may develop. We generated net losses of $29.7 million, and $16.4 million for the three months ended September 30, 2022 and 2021, respectively and $82.5 million, and $102.5 million for the nine months ended September 30, 2022 and 2021, respectively. As of September 30, 2022, we had an accumulated deficit of $253.9 million. We expect to continue to incur significant expenses for at least the next several years if and as we:
• continue our current research programs and preclinical development of any product candidates we identify;
• seek to identify additional research programs and product candidates;
• initiate preclinical studies and clinical trials for any product candidates we may identify;
• experience any delays or interruptions due to the ongoing COVID-19 pandemic, including delays in preclinical testing and clinical trials or interruptions in the supply chain for any future product candidates;
• further develop our in-licensed and company-owned gene editing platform, which we call our Prime Editing platform;
• maintain, expand, enforce, defend and protect our intellectual property portfolio and provide reimbursement of third-party expenses related to our patent portfolio;
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• seek marketing approvals for any product candidates for which we successfully complete clinical trials;
• develop, maintain and enhance a sustainable, scalable, reproducible and transferable manufacturing process for the product candidates we may develop;
• ultimately establish a sales, marketing and distribution infrastructure to commercialize any therapies for which we may obtain marketing approval;
• hire additional research and development personnel;
• hire clinical and commercial personnel;
• add operational, financial and management information systems and personnel, including personnel to support our product development;
• acquire or in-license product candidates, intellectual property and technologies;
• establish and maintain collaborations;
• should we decide to do so, build and maintain a commercial-scale current Good Manufacturing Practices, or cGMP, manufacturing facility; and
• operate as a public company.
We will not generate revenue from product sales unless and until we successfully initiate and complete clinical development and obtain regulatory approval for any product candidates. If we obtain regulatory approval for any of our product candidates and do not enter into a commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, manufacturing, marketing, and distribution. Further, following the completion of our IPO, we have incurred and expect to continue to incur costs associated with operating as a public company, including increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs as well as investor and public relations expenses associated with being a public company.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of private and public equity offerings, debt financings, or other capital sources, which may include additional collaborations with other companies, marketing, distribution or licensing arrangements with third parties, or other strategic transactions. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, reduce or eliminate the development and commercialization of any product candidates that we may identify or delay our pursuit of potential in-licenses or acquisitions.
Because of the numerous risks and uncertainties associated with product development, we are unable to accurately predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
In October 2022, we completed our IPO. In connection with our IPO, we issued and sold 11,721,456 shares of our common stock, including 1,427,338 shares pursuant to the exercise of the underwriters’ option to purchase additional shares, at a price to the public of $17.00 per share. As a result of the IPO, we received $180.3 million in net proceeds, after deducting underwriting discounts, commissions and offering costs of $19.0 million. Based on our current operating plan, we believe that our existing cash and cash equivalents and short-term investments will be sufficient to fund our operating expenses and capital expenditure requirements into 2025.
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Impact of COVID-19 on Our Operations
We are subject to a number of risks associated with the COVID-19 global pandemic, including potential delays associated with our ongoing preclinical studies and anticipated clinical trials. COVID-19 may have an adverse impact on our operations, supply chains and distribution systems or those of our third-party vendors and collaborators, and increase expenses, including as a result of impacts associated with preventive and precautionary measures that are being taken, such as restrictions on travel and border crossings, quarantine policies and social distancing. We and our third-party vendors and collaborators may experience disruptions in supply of items that are essential for our research and development activities. We cannot predict the scope and severity of any economic recovery after the COVID-19 pandemic abates, including following any additional “waves” or other intensifying of the pandemic will have on our financial condition, operations and business plans.
License Agreements
Pledge to Broad Institute and Harvard
In February 2021, we committed to donate $5.0 million to Broad Institute and Harvard annually for 14 years, commencing in 2021, or the Pledge. The Pledge is intended to be used for research and development related to new genome editing technologies, for example Prime Editing, improve on existing genome-editing technologies, identify delivery mechanisms for these technologies and apply these technologies to the understanding and treatment of rare genetic diseases. We can terminate the Pledge at our discretion, subject to providing one year of funding from the date of termination. In August 2022, we amended and restated the Pledge to clarify that the funds may be used by the laboratory of David Liu, who is a member of Broad Institute and a faculty member at Harvard.
During the nine months ended September 30, 2022, there were no other material changes to our license agreements described under Management’s Discussion and Analysis Overview which are included in the Company’s final prospectus for its IPO filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on October 21, 2022.
Components of Our Results of Operations
Operating Expenses
Research and Development Expenses
Research and development expenses consist primarily of costs incurred in connection with the development and research of our immediate target indications and our differentiation target indications. These expenses include:
• the cost allocated to acquire in-process research and development, or IPR&D, with no alternative future use associated with asset acquisitions or transactions to license intellectual property, such as our Myeloid Agreement and Broad License Agreement;
• expenses incurred in connection with our Pledge to Broad Institute;
• personnel-related expenses, including salaries, bonuses, benefits and stock-based compensation for employees engaged in manufacturing, research and development functions;
• expenses incurred in connection with continuing our current research programs and preclinical development of any product candidates we may identify, including under agreements with third parties, such as consultants and contractors;
• the cost of developing and validating our manufacturing process for use in our preclinical studies and future clinical trials;
• laboratory supplies and research materials; and
• facilities, depreciation and other expenses related to research and development activities, which include direct or allocated expenses for rent and maintenance of facilities, and utilities.
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Upfront and milestone payments made are accrued for and expensed when the achievement of the milestone is probable up to the point of regulatory approval. Milestone payments made upon regulatory approval will be capitalized and amortized over the remaining useful life of the related product.
We expense all research and development costs in the periods in which they are incurred. Most of our research and development expenses have been related to early stage development activities. We have not reported program costs because we have not historically tracked or recorded our research and development expenses on a program-by-program basis, as we do not currently have any product candidates. In the future, external research and development costs for any individual product candidate will be tracked commencing upon product candidate nomination. We do not allocate employee costs, costs associated with our discovery efforts, laboratory supplies, and facilities expenses, including depreciation or other indirect costs, to specific product development programs because these costs are deployed across multiple programs and our platform and, as such, are not separately classified.
We expect our research and development expenses to increase substantially for the foreseeable future as we continue to invest in research and development activities related to developing any future product candidates, including investments in manufacturing, as we advance any product candidates we may identify and begin to conduct clinical trials. The success of product candidates we may identify and develop will depend on many factors, including the following:
• timely and successful completion of preclinical studies, including toxicology studies, biodistribution studies and minimally efficacious dose studies in animals, where applicable;
• effective INDs or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for any product candidates we may develop;
• successful enrollment and completion of clinical trials, including under the FDA’s current Good Clinical Practices, or GCPs, current Good Laboratory Practices, or GLPs, and any additional regulatory requirements from foreign regulatory authorities;
• positive results from our future clinical trials that support a finding of safety and effectiveness and an acceptable risk-benefit profile in the intended populations;
• receipt of marketing approvals from applicable regulatory authorities;
• establishment of arrangements through our own facilities or with third-party manufacturers for clinical supply and, where applicable, commercial manufacturing capabilities;
• establishment, maintenance, defense and enforcement of patent, trademark, trade secret and other intellectual property protection or regulatory exclusivity for any product candidates we may develop; and
• maintenance of a continued acceptable safety, tolerability and efficacy profile of any product candidates we may develop following approval.
Any changes in the outcome of any of these variables with respect to the development of product candidates that we may identify could mean a significant change in the costs and timing associated with the development of such candidates. For example, if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect, or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time to complete clinical development of that therapeutic candidate. We may never obtain regulatory approval for any of our candidates, and, even if we do, drug commercialization takes several years and millions of dollars in development costs.
Following consummation of our IPO, certain bonuses became payable, and certain performance-based restricted stock awards and options to purchase common stock vested and the related compensation expense was approximately $0.8 million related to research and development expenses.
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General and Administrative Expenses
General and administrative expenses consist primarily of salaries and personnel-related costs, including stock-based compensation, for our personnel in executive, legal, finance and accounting, human resources and other administrative functions. General and administrative expenses also include legal fees relating to patents and corporate matters; professional fees paid for accounting, auditing, consulting and tax service; insurance costs; office and information technology costs; and facilities, depreciation and other general and administrative expenses, which include direct or allocated expenses for rent and maintenance of facilities and utilities.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support development of product candidates and our continued research activities. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs as well as investor and public relations expenses associated with being a public company. We also expect to incur additional intellectual property-related expenses as we file patent applications to protect innovations arising from our research and development activities.
Following consummation of our IPO, certain performance-based restricted stock awards vested and the related compensation expense was approximately $0.2 million related to general and administrative expenses.
Other Income (Expense)
Change in Fair Value of Preferred Stock Tranche Liability
Our Series A preferred stock purchase agreement obligated the Series A investors to participate in subsequent offerings of Series A preferred stock upon satisfaction of certain conditions, or the preferred stock tranche right. The preferred stock tranche right was classified as a liability and initially recorded at fair value upon the issuance date of the right. The liability was subsequently remeasured to fair value at each reporting date and immediately prior to being settled, and changes in fair value of the preferred stock tranche right liability were recognized as a component of other income (expense), net in our consolidated statements of operations and comprehensive loss. In 2020, we closed the second tranche Series A preferred stock financing and in April 2021, we closed the third and fourth tranche Series A preferred stock financings, resulting in full settlement of the preferred stock tranche right, upon both of which we issued additional shares of Series A preferred stock. Immediately prior to the issuance of such shares, the preferred stock tranche right liability was remeasured to fair value with the change in fair value recognized as a component of other income (expense), net.
As a result of the preferred stock tranche right settlement in April 2021, we will no longer recognize changes in the fair value of the preferred stock tranche liability in our consolidated statements of operations and comprehensive loss.
Change in Fair Value of Anti-Dilution Obligation
In connection with the Broad License Agreement, we entered into the Broad Subscription Agreement, in which we granted Broad Institute 623,529 shares of common stock, which represented a 5.0 percent of our then outstanding capital stock on a fully-diluted basis. The Broad Subscription Agreement obligated us to issue additional shares of common stock to Broad Institute without additional consideration to maintain Broad Institute’s ownership of us at 5.0 percent on a fully-diluted basis, if at any time prior to the achievement of an equity financing up to $100.0 million, we issue additional securities that would cause Broad Institute shares of common stock to be less than 5.0 percent of our outstanding capital stock on a fully-diluted basis, which we refer to collectively as the Anti-Dilution Obligation. We classified the Anti-Dilution Obligation as a liability on our consolidated balance sheet that we remeasured to fair value at each reporting date, and we recognized changes in the fair value of the liability associated with the Anti-Dilution Obligation as a component of other income (expense) in our consolidated statement of operations and comprehensive loss.
As a result of the achievement of $100.0 million in equity financing upon the fourth Series A preferred stock closing, we fully settled the Anti-Dilution Obligation and will no longer recognize changes in the fair value of the Anti-Dilution Obligation in our consolidated statements of operations and comprehensive loss.
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Change in Fair Value of Related Party Short-Term Investment
In connection with the Beam Collaboration Agreement, Beam issued 200,307 shares of Beam common stock to us on October 6, 2020. Our related party short-term investment is recorded at fair value based upon quoted market prices at each reporting date. Unrealized and realized gains and losses on this investment subsequent to its initial recognition are recognized as a component of other income (expense) in the consolidated statements of operations and comprehensive loss.
Other Income (Expense), Net
Other income (expense), net consists of the change in the fair value of the shares we were entitled to receive from our related party Beam from the first anniversary of the Beam Collaboration Agreement through the date we received the shares from Beam, October 6, 2020. In connection with the Beam Collaboration Agreement, Beam granted 200,307 shares of Beam common stock to us. We were entitled to receive the shares of Beam upon the first anniversary of the Beam Collaboration Agreement in September 2020. We received the shares of Beam on October 6, 2020. The change in the fair value of the shares from September through our receipt on October 6, 2020 is included as other income (expense), net in the consolidated statements of operations and comprehensive loss. As the shares were received on October 6, 2020, we no longer recognize changes in the fair value of the Beam shares we were entitled to receive.
Income Taxes
For the three and nine months ended September 30, 2022 we recorded an income tax provision of $0.2 million and benefit of $0.8 million, respectively. For the three and nine months ended September 30, 2021, we recorded income tax benefits of $2.4 million and $1.9 million, respectively. These are a result of changes associated with the unrealized gains on investments. We recorded a full valuation allowance of our net deferred tax assets as of December 31, 2021 and September 30, 2022, respectively, as we believed it was more likely than not we would not be able to utilize our deferred tax assets prior to their expiration.
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Results of Operations
Comparison of the three months ended September 30, 2022 and 2021
The following table summarizes our results of operations for the three months ended September 30, 2022 and 2021:
Three Months Ended September 30,
2022 2021 Change
(in thousands)
Operating expenses:
Research and development $ 25,047 $ 7,400 $ 17,647
General and administrative 6,608 3,027 3,581
Total operating expenses 31,655 10,427 21,228
Loss from operations (31,655) (10,427) (21,228)
Other income (expense):
Change in fair value of related party short-term investment 1,789 (8,354) 10,143
Other income (expense), net (1)
728 (1) 729
Total other expense, net 2,517 (8,355) 10,872
Net loss before income taxes (29,138) (18,782) (10,356)
Provision for (benefit from) income taxes 212 (2,370) 2,582
Net loss $ (29,350) $ (16,412) $ (12,938)
(1) Includes no related party amounts for the three months ended September 30, 2022 and 2021, (see Note 13).
Operating Expenses
Research and Development Expenses
Three Months Ended September 30,
2022 2021 Change
(in thousands)
License, intellectual property fees and other $ 1,945 $ 1,279 $ 666
Personnel related (including stock-based compensation) 8,348 2,701 5,647
Lab supplies 9,390 1,706 7,684
Professional and consultant fees 543 122 421
Facility related and other 4,821 1,592 3,229
Total research and development expenses $ 25,047 $ 7,400 $ 17,647
Research and development expenses were $25.0 million for the three months ended September 30, 2022, compared to $7.4 million for the three months ended September 30, 2021. The increase of $17.6 million was primarily due an increase of $7.7 million in lab supplies expense due to continued discovery efforts and expansion of our research and development activities, an increase of $5.6 million in personnel-related expense driven by increased new hires in research and development, and an increase of $3.2 million facility related expense primarily due to the expansion of our office and laboratory space through new facilities being leased.
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General and Administrative Expenses
Three Months Ended September 30,
2022 2021 Change
(in thousands)
Personnel related (including stock-based compensation) $ 3,255 $ 1,132 $ 2,123
Professional and consultant fees 2,518 1,397 1,121
Facility related and other 835 498 337
Total general and administrative expenses $ 6,608 $ 3,027 $ 3,581
General and administrative expenses were $6.6 million for the three months ended September 30, 2022, compared to $3.0 million for the three months ended September 30, 2021. The increase of $3.6 million was primarily due to an increase of $2.1 million in professional and consultant fees as we operate as a public company, an increase of $1.1 million of personnel-related expense primarily due to compensation related costs related to increased new hires to expand upon our administrative staff functions and an increase of $0.3 million of facility related expenses primarily due to newly signed office leases to support our expanded general and administrative staff.
Other Income (Expense)
Three Months Ended September 30,
2022 2021 Change
(in thousands)
Change in fair value of related party short-term investment $ 1,789 $ (8,354) $ 10,143
Other income (expense), net 728 (1) 729
Total other expense, net $ 2,517 $ (8,355) $ 10,872
Change in Fair Value of Related Party Short-Term Investment
The change in fair value of related party short-term investment increased by $10.1 million from the three months ended September 30, 2022 compared to the three months ended September 30, 2021. The decrease was primarily due to a $39.37 decrease in the stock price of the Beam stock from September 30, 2021 to September 30, 2022 as compared to the $20.25 increase in the per share value of Beam common stock used to determine the fair value of related party short-term investments from October 6, 2020, the date on which we received the Beam shares, to September 30, 2022.
Other Income (Expense), Net
The change in other income (expense), is due to interest income of $0.5 million, gain on marketable securities of $0.1 million and sublease income of $0.1 million.
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Comparison of the Nine Months ended September 30, 2022 and 2021
The following table summarizes our results of operations for the nine months ended September 30, 2022 and 2021:
Nine Months Ended
September 30,
2022 2021 Change
(in thousands)
Operating expenses:
Research and development $ 57,664 $ 17,661 $ 40,003
General and administrative 20,194 6,737 13,457
Total operating expenses 77,858 24,398 53,460
Loss from operations (77,858) (24,398) (53,460)
Other income (expense):
Change in fair value of preferred stock tranche right liability — (74,319) 74,319
Change in fair value of anti-dilution obligation — (6,681) 6,681
Change in fair value of related party short-term investment (6,419) 1,075 (7,494)
Other income (expense), net (1)
977 — 977
Total other expense, net (5,442) (79,925) 74,483
Net loss before income taxes (83,300) (104,323) 21,023
Provision for (benefit) from income taxes (762) (1,867) 1,105
Net loss $ (82,538) $ (102,456) $ 19,918
(1) Includes related party amounts of zero and $(429) for the nine months ended September 30, 2022 and 2021, respectively (see Note 13).
Operating Expenses
Research and Development Expenses
Nine Months Ended
September 30,
2022 2021 Change
(in thousands)
License, intellectual property fees and other $ 4,575 $ 4,005 $ 570
Personnel related (including stock-based compensation) 21,383 5,907 15,476
Lab supplies and services 19,321 3,619 15,702
Professional and consultant fees 1,263 275 988
Facility related and other 11,122 3,855 7,267
Total research and development expenses $ 57,664 $ 17,661 $ 40,003
Research and development expenses were $57.7 million for the nine months ended September 30, 2022, compared to $17.7 million for the nine months ended September 30, 2021. The increase of $40.0 million was primarily due to an increase of $15.7 million in lab supplies and services expense due to continued discovery efforts and expansion of our research and development activities, an increase of $15.5 million in personnel-related expense driven by increased new hires in research and development, an increase of $7.3 million facility related expense primarily due to the expansion of our office and laboratory space through new facilities being leased, and an increase of $1.0 million in professional and consultant fees as we operate as a public company.
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General and Administrative Expenses
Nine Months Ended
September 30,
2022 2021 Change
(in thousands)
Personnel related (including stock-based compensation) $ 8,711 $ 2,329 $ 6,382
Professional and consultant fees 8,219 3,425 4,794
Facility related and other 3,264 983 2,281
Total general and administrative expenses $ 20,194 $ 6,737 $ 13,457
General and administrative expenses were $20.2 million for the nine months ended September 30, 2022, compared to $6.7 million for the nine months ended September 30, 2021. The increase of $13.5 million was primarily due to an increase of $6.4 million of personnel-related expense primarily due to compensation related costs related to increased new hires to support our expanding operations, $4.8 million in professional and consultant fees as we operate as a public company, and an increase of $2.3 million of facility and IT related expenses primarily due to newly signed office leases to support our expanded general and administrative staff.
Other Income (Expense)
Nine Months Ended
September 30,
2022 2021 Change
(in thousands)
Change in fair value of preferred stock tranche right liability $ — $ (74,319) $ 74,319
Change in fair value of anti-dilution obligation — (6,681) 6,681
Change in fair value of related party short-term investment (6,419) 1,075 (7,494)
Other income (expense), net 977 — 977
Total other expense, net $ (5,442) $ (79,925) $ 74,483
Change in Fair Value of Preferred Stock Tranche Right Liability
The change in fair value of the preferred stock tranche right liability increased by $74.3 million from the nine months ended September 30, 2022 compared to the nine months ended September 30, 2021. The increase was primarily due to the preferred stock tranche right being settled in full upon the satisfaction of certain conditions in April 2021.
Change in Fair Value of Anti-Dilution Obligation
The change in fair value of the Anti-Dilution Obligation increased by $6.7 million from the nine months ended September 30, 2022 compared to the nine months ended September 30, 2021. The decrease was primarily due to the settlement date in connection with the fourth Series A preferred stock closing in 2021, with no corresponding change in the nine months ended September 30, 2022.
Change in Fair Value of Related Party Short-Term Investment
The change in fair value of related party short-term investment decreased by $7.5 million from the nine months ended September 30, 2022 compared to the nine months ended September 30, 2021. The decrease was due to a $32.05 decrease in the stock price from December 31, 2021 to September 30, 2022, as compared to the $5.37 increase in the stock price of the Beam stock from December 31, 2020 to September 30, 2021.
Other Income (Expense), Net
The change in other income (expense), is due to interest income of $0.9 million, sublease income of $0.2 million, partially offset by loss on marketable securities of $0.1 million.
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Income Taxes
We recorded an income tax benefit of $0.8 million for the nine months ended September 30, 2022 and an income tax benefit of $1.9 million for the nine months ended September 30, 2021.
Liquidity and Capital Resources
Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we commence the clinical development of our programs and continue our platform development and early-stage research activities. We have not yet commercialized any products and we do not expect to generate revenue from sales of products for several years, if at all. To date, we have funded our operations primarily with proceeds from our IPO and the sale of our convertible preferred stock. Through September 30, 2022, we had received gross proceeds of $315.8 million from sales of our preferred stock. As of September 30, 2022, we had cash and cash equivalents and short-term investments of $146.7 million, excluding our restricted cash, or $160.2 million, including restricted cash.
Cash Flows
The following table summarizes our sources and uses of cash for each of the periods presented:
Nine Months Ended
September 30,
2022 2021
Net cash used in operating activities $ (101,114) $ (20,895)
Net cash used in investing activities (33,409) (85,780)
Net cash (used in) provided by financing activities (2,579) 270,364
Net (decrease) increase in cash, cash equivalents and restricted cash $ (137,102) $ 163,689
Operating Activities
During the nine months ended September 30, 2022, operating activities used $101.1 million of cash, resulting primarily from our net loss of $82.5 million, non-cash rent expense of $7.0 million, change in the fair value of related party short-term investment of $6.4 million, stock-based compensation expense of $3.9 million, depreciation and amortization expense of $1.4 million, and a change in deferred income taxes of $0.8 million. Net cash provided by changes in our operating assets and liabilities for the nine months ended September 30, 2022 was $36.6 million which primarily consisted of a decrease in accrued expenses and other current liabilities of $30.0 million and an increase in accounts payable of $2.0 million, partially offset by a decrease in lease liabilities of $7.6 million and an increase in prepaid expenses and other current assets of $1.1 million. The decrease in accrued expenses and other current liabilities was primarily due to a $30.0 million payment that we made to Myeloid in January 2022 in connection with the Myeloid Agreement.
During the nine months ended September 30, 2021, operating activities used $20.9 million of cash, resulting primarily from our net loss of $102.5 million and a change in deferred income taxes of $1.9 million, partially offset by a change in the fair value of preferred stock tranche right liability of $74.3 million, a change in the fair value of anti-dilution obligation of $6.7 million, a change in the fair value of related party short-term investment of $1.1 million, non-cash rent expense of $2.9 million, stock-based compensation expense of $0.6 million, depreciation and amortization expense of $0.3 million. Net cash used by changes in our operating assets and liabilities for the nine months ended September 30, 2021 was $0.4 million which primarily consisted of an increase in accrued expenses and other current liabilities of $1.9 million and an increase in accounts payable of $1.1 million, partially offset by an increase in lease liabilities of $2.7 million.
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Investing Activities
During the nine months ended September 30, 2022, net cash used in investing activities was $33.4 million, primarily consisting of purchases of short-term investments of $89.5 million, purchases of property and equipment of $11.3 million, and payments of security deposits of $0.7 million, partially offset by maturities of short-term investments of $68.0 million. The purchases of equipment were primarily related to laboratory equipment purchases, which increased as we expanded our discovery and preclinical activities.
During the nine months ended September 30, 2021, net cash used in investing activities was $85.8 million, primarily consisting of purchases of short-term investments of $81.8 million, purchases of property and equipment of $3.8 million, and payments of security deposits of $0.2 million. The purchases of equipment were primarily related to laboratory equipment purchases, which increased as we expanded our discovery and preclinical activities.
Financing Activities
During the nine months ended September 30, 2022, net cash used in financing activities was $2.6 million, primarily consisting of $2.6 million in payments of deferred offering costs.
During the nine months ended September 30, 2021, net cash provided by financing activities was $270.4 million, consisting of net cash proceeds received of $270.4 million from our issuance of Series A and B preferred stock in April 2021.
Funding Requirements
To date, we have not generated any revenue from product sales. We do not expect to generate revenue from product sales unless and until we successfully complete preclinical and clinical development of, receive regulatory approval for, and commercialize a product candidate and we do not know when, or if at all, that will occur. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and studies and initiate clinical trials. In addition, if we obtain regulatory approval for any product candidates, we expect to incur significant expenses related to product sales, marketing, and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. Further, we have incurred, and expect to continue to incur, costs associated with operating as a public company. The timing and amount of our operating expenditures will depend largely on the factors set out above. For more information, see “Risk Factors—Risks Related To Our Financial Position and Need for Additional Capital.”
We believe our existing cash and cash equivalents and short-term investments, including the net proceeds received in connection with our IPO, will be sufficient to fund our operating expenses and capital expenditure requirements into 2025. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. We expect that we will require additional funding to: continue our current research development activities; identify product candidates; initiate preclinical testing and clinical trials for our future product candidates we identify; develop, maintain, expand and protect our intellectual property portfolio; further develop our Prime Editing platform; and hire additional research, clinical and scientific personnel. If we receive regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize ourselves.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of private and public equity offerings, debt financings, additional collaborations, strategic alliances, and marketing, distribution or licensing arrangements with third parties. To the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interest may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specified actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, strategic alliances or marketing, or distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, any future revenue streams, research programs or product candidates or grant licenses on terms
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that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Contractual Obligations and Other Commitments
Leases
As of September 30, 2022, we have future remaining operating lease payments of $33.8 million relating to leases we have recognized on our consolidated balance sheet, of which an aggregate $2.4 million is payable before December 31, 2022. In addition, we have one lease that has been entered into but has not yet commenced, as of September 30, 2022, for which we expect to pay approximately $208.7 million over the 10 year lease term. Refer to Note 9 – Leases to our condensed consolidated financial statements for more information on our lease obligations.
License and Collaboration Agreements
During the nine months ended September 30, 2022, there were no material changes to our license and collaboration agreements described under Management’s Discussion and Analysis of Contractual Obligations and Other Commitments which are included in the Company’s final prospectus for its IPO filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on October 21, 2022.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses incurred during the reporting periods. We base our estimates on historical experience, known trends and events, and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities recorded revenues and expenses that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Actual results may differ from these estimates.
During the nine months ended September 30, 2022, there were no material changes to our critical accounting policies and significant judgements described under Management’s Discussion and Analysis of Critical Accounting Policies and Significant Judgments and Estimates which are included in the Company’s final prospectus for its IPO filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on October 21, 2022.
Recently Issued and Adopted Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our condensed consolidated financial statements.
Emerging Growth Company Status
The Jumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company. As a result of this election, our condensed consolidated financial statements may not be comparable to other public companies that comply with new or revised accounting pronouncements as of public company effective dates. We may choose to
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early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.