PepGen Inc
For the period ended Jun 30, 2024. Filed Aug 8, 2024.
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Jun 30, 2024 · Filed Aug 8, 2024
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Notes to Condensed Consolidated Financial Statements (Unaudited)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
- Nature of Business and Basis of Presentation
PepGen Inc., hereinafter referred to as PepGen or the Company, is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurologic diseases. The Company's principal offices are located in Boston, Massachusetts.
The Company was initially formed as PepGen Limited on January 25, 2018, in the United Kingdom, or the U.K. On November 9, 2020, PepGen Limited completed a corporate reorganization, or the Reorganization. As part of the Reorganization, PepGen Limited formed PepGen, a Delaware corporation with nominal assets and liabilities, for the purpose of consummating the Reorganization. In connection with the Reorganization, the existing stockholders of PepGen Limited exchanged each of its classes of shares of PepGen Limited for the same number and class of common stock of PepGen on a one-to-one basis. The newly issued stock of PepGen had substantially identical rights to the exchanged shares of PepGen Limited. As a result of the exchange, PepGen became the sole stockholder of PepGen Limited. Upon the completion of the Reorganization on November 23, 2020, the historical financial statements of PepGen Limited became the historical financial statements of PepGen as the Reorganization was deemed to be between entities under common control.
Liquidity and Capital Resources
Since inception, the Company has not generated any revenue from product sales or other sources and has incurred significant operating losses and negative cash flows from operations. The Company’s primary uses of cash and cash equivalents to date have been to fund research and development activities, business planning, establishing and maintaining the Company’s intellectual property portfolio, hiring personnel, leasing premises and associated capital expenditures, raising capital, and providing general and administrative support for these operations. As of June 30, 2024, the Company had an accumulated deficit of $227.8 million. To date, the Company has funded operations primarily through private placements of convertible preferred stock, the sale of shares of common stock in its initial public offering, or IPO, the sale of shares of common stock under its At-the-Market Equity Offering Sales Agreement, or Sales Agreement, with Stifel, Nicolaus & Company, Incorporated, or Stifel, and through the sale of shares of common stock in a follow-on offering, referred to as the Follow-on Offering. As of June 30, 2024, the Company had cash, cash equivalents, and marketable securities of $161.3 million. The Company believes that its cash, cash equivalents, and marketable securities as of June 30, 2024, will be sufficient to fund its currently planned operations for at least the next 12 months from the issuance of these unaudited condensed consolidated financial statements.
The Company filed a shelf registration statement on Form S-3 with the United States Securities and Exchange Commission, or SEC, which covers the offering, issuance and sale of an amount up to $300.0 million in the aggregate of shares of common stock, preferred stock, debt securities, warrants, and/or units or any combination thereof, which was declared effective on June 16, 2023. On August 8, 2023, the Company filed a prospectus supplement and entered into the Sales Agreement with Stifel, as sales agent, which provides for the issuance and sale by the Company of up to $100.0 million of shares of common stock from time to time in “at-the-market” offerings. The sales agent is entitled to receive a commission of up to 3.0% of gross proceeds from sales under the Sales Agreement. On February 5, 2024, the Company sold 1,000,000 shares of common stock at a price of $10.00 per share under the Sales Agreement, resulting in net proceeds of $9.9 million. On February 9, 2024, the Company sold 7,530,000 shares of common stock in the Follow-on Offering, pursuant to an underwriting agreement with Leerink Partners LLC dated as of February 6, 2024, at a price of $10.635 per share resulting in net proceeds of $76.4 million after deducting underwriting fees and offering costs of $3.7 million. Net proceeds from sales under the Sales Agreement and Follow-on Offering, after deducting underwriters' fees and costs, were $86.3 million. On June 28, 2024, the Company filed a second shelf registration statement on Form S-3 with the SEC, which covers the offering, issuance and sale of an amount up to $250.0 million in the aggregate of shares of common stock, preferred stock, debt securities, warrants, and/or units or any combination thereof, which was declared effective on July 8, 2024.
As the Company continues to pursue its business plan to successfully develop and obtain regulatory approval for the Company’s product candidates, it expects to finance its operations through the sale of equity, debt financings or other capital resources, which could include income from collaborations, strategic partnerships or marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. However, there can be no assurance that any additional financing or strategic transactions will be available to the Company on acceptable terms, if at all. If events or circumstances occur such that the Company does not obtain additional funding, it may need to delay, reduce or eliminate its product development or future commercialization efforts, which could have a material adverse effect on the Company’s business, results of operations or financial condition.
Basis of Presentation and Consolidation
The accompanying condensed consolidated financial statements are unaudited and have been prepared in conformity with generally accepted accounting principles in the United States of America, or GAAP. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification and Accounting Standards Update of the Financial Accounting Standards Board. The condensed consolidated financial statements have been prepared on the same basis as the audited annual financial statements. Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. These condensed consolidated financial statements, in the opinion of management, reflect all normal recurring adjustments necessary for a fair presentation of the Company’s financial position as of June 30, 2024, and results of operations for the interim periods ended June 30, 2024 and June 30, 2023.
The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full year. These condensed consolidated financial statements should be read in conjunction with the audited financial statements as of and for the years ended December 31, 2023 and 2022, and the notes thereto, included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 6, 2024, or Form 10-K, as amended by the Form 10-K/A filed on March 29, 2024.
- Summary of Significant Accounting Policies
The Company’s significant accounting policies are disclosed in the audited financial statements for the year ended December 31, 2023 included in the Form 10-K. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies.
Concentration of Credit Risk
Financial instruments, which potentially subject the Company to concentrations of credit risk, consist of cash and money market accounts. As of June 30, 2024, the Company’s cash and money market accounts were held by three financial institutions in the United States, or U.S., and one financial institution in the United Kingdom, or U.K. At times, the Company’s deposits held in the U.S. and U.K. may exceed the respective insured limits of the Federal Depository Insurance Corporation and Financial Services Compensation Scheme.
Deferred Offering Costs
The Company capitalizes within other long-term assets certain legal, accounting, and other third-party fees that are directly related to the Company’s shelf registration statements and in-process equity financings, until such financings are consummated. After consummation of the equity financing, these costs are recorded as a reduction of the proceeds received from the offering. Should a planned equity financing be abandoned, terminated, or significantly delayed, the deferred offering costs are written off to operating expenses. As of June 30, 2024, deferred offering costs of $0.4 million were recorded within other assets on the condensed consolidated balance sheets related to the Company’s shelf registration statement on Form S-3 filed with the SEC on June 2, 2023, the Prospectus Supplement filed on August 8, 2023, and the Company’s shelf registration statement on Form S-3 filed with the SEC on June 28, 2024.
Income Taxes
Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts or existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using the enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period of enactment. The Company records a valuation allowance to reduce deferred tax assets to an amount for which realization is more likely than not.
The Company recognizes the tax benefit from an uncertain tax position if it is more likely than not that the tax position will be sustained upon examination by the tax authorities, based on the merits of the position. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. To date, there have beenno interest or penalties charged in relation to the unrecognized tax benefits.
Restricted Cash
The Company classifies all cash whose use is limited by contractual provisions as restricted cash. Restricted cash arises from the requirement for the Company to maintain cash of $1.5 millionas collateral under a lease agreement. As of June 30, 2024 and
December 31, 2023, the Company had $1.5 million of restricted cash classified inother assets on the unaudited condensed consolidated balance sheets.
- Fair Value Measurements
The following tables present information about the Company’s financial assets that have been measured at fair value as of June 30, 2024 and December 31, 2023, and indicate the fair value of the hierarchy of the valuation inputs utilized to determine such fair value. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair value determined by Level 2 inputs utilize observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted market prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities. Fair values determined by Level 3 inputs are unobservable data points for the asset or liability, and include situations where there is little, if any, market activity for the asset or liability. The following tables set forth marketable securities as of June 30, 2024 and December 31, 2023 (in thousands):
| Amortized Cost | Unrealized Gains | Unrealized Losses | Total | |
|---|---|---|---|---|
| U.S. Treasury notes | 95,278 | — | (57) | 95,221 |
| Total | $95,278 | $— | $(57) | $95,221 |
| Amortized Cost | Unrealized Gains | Unrealized Losses | Total | |
|---|---|---|---|---|
| U.S. Treasury notes | 29,622 | 11 | — | 29,633 |
| Total | $29,622 | $11 | $— | $29,633 |
The following tables set forth the fair value of the Company’s financial assets measured at fair value on a recurring basis and indicate the level within the fair value hierarchy utilized to determine such values as of June 30, 2024 and December 31, 2023 (in thousands):
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| Cash Equivalents: | ||||
| U.S. Treasury-backed money market funds | $63,116 | $63,116 | $— | $— |
| U.S. Treasury notes | — | — | — | — |
| Marketable Securities: | ||||
| U.S. Treasury notes | 95,221 | 95,221 | — | — |
| Total | $158,337 | $158,337 | $— | $— |
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| Cash Equivalents: | ||||
| U.S. Treasury-backed money market funds | $64,397 | $64,397 | $— | $— |
| U.S. Treasury notes | 11,980 | 11,980 | — | — |
| Marketable Securities: | ||||
| U.S. Treasury notes | 29,633 | 29,633 | — | — |
| Total | $106,010 | $106,010 | $— | $— |
Money market funds are highly liquid investments that are valued based on quoted market prices in active markets, which represent a Level 1 measurement within the fair value hierarchy. These money market funds are classified on the balance sheet under cash and cash equivalents.
- Property and Equipment, Net
The cost and accumulated depreciation of property and equipment were as follows (in thousands):
| June 30,2024 | December 31,2023 | |
|---|---|---|
| Lab equipment | $4,898 | $4,821 |
| Computer and office equipment | 1,557 | 1,446 |
| Construction in process | 92 | 69 |
| Total property and equipment | 6,547 | 6,336 |
| Less: accumulated depreciation | (2,311) | (1,572) |
| Total property and equipment, net | $4,236 | $4,764 |
Depreciation expense was $0.4 million and $0.3 million for the three months ended June 30, 2024 and June 30, 2023, respectively. Depreciation expense was $0.7 million and $0.5 million for the six months ended June 30, 2024 and June 30, 2023, respectively.
- Accrued Expenses
Accrued expenses consisted of the following (in thousands):
| June 30,2024 | December 31, 2023 | |
|---|---|---|
| Research and development expenses | $7,426 | $9,521 |
| Employee-related expenses | 2,070 | 2,368 |
| Professional services | 877 | 715 |
| Other | 944 | 918 |
| Total accrued expenses | $11,317 | $13,522 |
- Related Party Transactions
Technology License Agreement with Oxford University Innovation Limited
In March 2018, the Company, Oxford University Innovation Limited, or OUI, and the Medical Research Council of United Kingdom Research and Innovation, or MRC, or collectively, the Licensors, entered into a license of technology agreement, which was subsequently amended in December 2018, further amended and restated in November 2020, and further amended in February 2022, or the License Agreement. The Licensors and affiliates held shares of Series A-1 and Series A-2 preferred stock, Series B preferred stock and Class A common stock. The License Agreement provides the Company with an exclusive world-wide license to licensed data and technology owned by OUI and MRC in respect of cell-penetrating peptides for the treatment of Duchenne muscular dystrophy, spinal muscular atrophy, and other conditions. The License Agreement provides the Company with the rights to grant and authorize sublicenses to make, use, sell, and import products and otherwise exploit the patent rights.
As consideration for the license, the Company made an initial upfront payment in 2018, as well as a Restatement Completion Fee and a License Data Fee (each as defined in the License Agreement) in 2020 totaling $0.1 million.
The Company could be required to make milestone payments to the Licensors upon achievement of certain patent and commercial milestones related to the patents and commercialization of certain of the Company’s product candidates. The aggregate potential milestone payments are $0.1 million. The Company also agreed to pay the Licensors low single digit royalties on net sales of any licensed products that are commercialized by the Company in excess of a threshold amount between £20 million and £30 million ($25.3 million and $37.9 million as of June 30, 2024), subject to certain adjustments. The term of the License Agreement continues until the later of (i) the date on which all the patents and patent applications covered thereunder have been abandoned or allowed to lapse or expired or been rejected or revoked or (ii)20 years from the date of the original license agreement.
Upon completion of the IPO, the Company became obligated to pay OUI an exit fee between 0.5% to 2% of the value determined in an acquisition or initial public offering, not to exceed £5 million ($6.2 million as of the IPO date). The exit fee due to OUI, based on the proceeds of the IPO, was $1.4 million, which was paid during the second quarter of 2022 and included in research and development expense on the condensed consolidated statement of operations.
One member of the Company’s board of directors, Dr. Christopher Ashton, is also employed by Oxford Science Enterprises, or OSE, which is an affiliate of OUI.
As of June 30, 2024, OSE owned 14.6% of the Company’s outstanding common stock. Pursuant to the terms of Dr. Ashton's employment agreement with OSE, he is obligated to transfer any cash compensation from the Company to OSE. Fees paid in cash for Dr. Ashton's service on the Company's board of directors are paid directly to OSE and are included within general and administrative expense on the unaudited consolidated statement of operations. The Company paid $11,875 for the three months ended June 30, 2024 and 2023 and $23,750 for the six months ended June 30, 2024 and 2023 to OSE as compensation for Dr. Ashton's service on the board of directors.
RA Capital Management, L.P.
Entities affiliated with RA Capital Management, L.P., or RA Capital, purchased common stock in the Company’s IPO in May 2022 and the Company’s Follow-on Offering in February 2024. As of June 30, 2024, entities affiliated with RA Capital owned 32.9% of the Company’s outstanding common stock.
Two members of the Company’s board of directors, Dr. Joshua Resnick and Habib Dable, are affiliated with RA Capital. Pursuant to the governing legal documents of RA Capital, Dr. Resnick is obligated to transfer any cash compensation from the Company to RA Capital. Fees paid in cash for Dr. Resnick's service on the Company's board of directors were paid directly to RA Capital and are included within general and administrative expense on the unaudited consolidated statement of operations. The Company paid $10,750 for the three months ended June 30, 2024 and 2023 and $21,500 for the six months ended June 30, 2024 and 2023 to RA Capital for Dr. Resnick’s service on the board of directors.
- Commitments and Contingencies
Legal proceedings
From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. 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.
The Company is not party to any litigation and does not have contingency reserves established for any litigation liabilities.
Other
The Company enters into standard indemnification agreements in the ordinary course of business. Pursuant to the agreements, the Company agrees to indemnify, hold harmless, and to reimburse the indemnified party for losses suffered or incurred by the indemnified party, including in connection with any U.S. patent or any copyright or other intellectual property infringement claim by any third-party with respect to the Company’s products. Further, the Company indemnifies its directors and officers who are, or were, serving at the Company’s request in such capacities. The Company’s maximum exposure under these arrangements is unknown as of June 30, 2024. The Company does not anticipate recognizing any significant losses relating to these arrangements. The term of these indemnification agreements is generally perpetual any time after execution of the agreement. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements may be unlimited. The Company has never incurred costs to defend lawsuits or settle claims related to these indemnification agreements.
- Stockholders’ Equity
Under the Third Amended and Restated Certificate of Incorporation, dated May 10, 2022, as amended on June 20, 2024, as currently in effect, the Company has the authority to issue a total of 500,000,000 shares of common stock (par value of $0.0001 per share) and 10,000,000 shares of undesignated preferred stock (par value of $0.0001 per share). In connection with the IPO, the Company re-designated all shares of Class A common stock as shares of common stock. Each share of common stock has the right toone vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors, subject to the prior rights of holders of all classes of stock outstanding having priority rights as to dividends. No cash dividends were declared by the board of directors during the three or six months ended June 30, 2024 and June 30, 2023.
The Company has reserved shares of common stock for issuance, on an as-converted basis, as follows:
| June 30,2024 | December 31,2023 | |
|---|---|---|
| Stock options issued and outstanding | 5,278,975 | 4,233,203 |
| Unvested restricted stock and performance stock units | 103,740 | — |
| Authorized for future stock awards or option grants | 968,289 | 1,091,187 |
| Authorized for future issuance under employee stock purchase plan | 421,924 | 216,306 |
| Total | 6,772,928 | 5,540,696 |
- Stock-Based Compensation
The Company maintains three equity compensation plans; the 2020 Stock Plan, or the 2020 Plan, the 2022 Stock Option and Incentive Plan, or the 2022 Plan, and the 2022 Employee Stock Purchase Plan, or the ESPP. As of the Company's IPO in May 2022, the Company's board of directors determined that no further awards would be made under the 2020 Plan. The number of shares of common stock that may be issued under the 2022 Plan is subject to increase by the number of shares under any outstanding stock options forfeited and not exercised under the 2020 Plan. Additionally, the number of shares reserved for issuance under the 2022 Plan automatically increases on the first day of each fiscal year in an amount equal to the lower of (1)5% of the shares of common stock outstanding on such date and (2) an amount determined by the Company’s board of directors. The 2022 Plan allows the board of directors to grant incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock awards, restricted stock units, unrestricted stock awards, cash-based awards, and dividend equivalent rights to the Company’s officers, employees, directors and other key persons. As of June 30, 2024,968,289 shares remained available for grant under the 2022 Plan and 421,924 shares remained available for issuance under the ESPP.
Stock Option Activity
Stock option activity under the 2020 Plan and the 2022 Plan, is as follows:
| StockOptions | Weighted-AverageExercisePrice | |
|---|---|---|
| Outstanding as of December 31, 2023 | 4,233,203 | $10.83 |
| Granted | 1,474,417 | $15.68 |
| Exercised | (164,548) | $10.93 |
| Canceled/Forfeited | (264,097) | $12.98 |
| Outstanding as of June 30, 2024 | 5,278,975 | $12.07 |
The weighted-average grant date fair value of options granted during the six months ended June 30, 2024 was $11.24 per share. The Company had 5,278,975 unvested stock options outstanding as of June 30, 2024. As of June 30, 2024, total unrecognized compensation cost related to stock options was $31.3 million. This amount is expected to be recognized over a weighted average period of approximately 2.68 years.
Restricted Stock Units
A restricted stock unit, or RSU, represents the right to receive one share of common stock upon vesting of the RSU. In February 2024, the Company granted employees a one-time RSU award that vests fully on the one-year anniversary of the grant date, provided that the employee remains employed with the Company. Certain employees, including employees who are executive officers of the Company, received a one-time RSU award that vests upon the achievement of certain performance-based clinical development milestones, or PSUs. Such awards cannot vest in less than one year, regardless of when the performance milestone is achieved. The Company’s chief executive officer did not receive any RSU or PSU awards. A summary of the Company’s RSU and PSU activity and related information for the six months ended June 30, 2024 is as follows:
| Time-based RSUs | PSUs | Weighted-AverageGrant Date Fair Value | |
|---|---|---|---|
| Outstanding as of December 31, 2023 | — | — | $— |
| Granted | 77,645 | 28,555 | 10.64 |
| Vested | — | — | — |
| Forfeited | (2,460) | — | 10.64 |
| Issued and unvested as of June 30, 2024 | 75,185 | 28,555 | $10.64 |
The weighted average grant date fair value of the time-based RSUs and the PSUs granted during the six months ended June 30, 2024 was $10.64. As of June 30, 2024, there was $0.5 million of unrecognized compensation costs related to unvested time-based RSUs, which are expected to be recognized over a weighted-average period of 0.6 years, and $0.3 million of unrecognized compensation costs related to unvested PSUs, which are dependent upon achievement of the aforementioned clinical development milestones.
Stock-Based Compensation Expense
Stock-based compensation expense associated with stock options, RSUs, PSUs, and the Company’s ESPP included in the accompanying condensed consolidated statements of operations and comprehensive loss is as follows (in thousands):
| Three Months EndedJune 30, | Six Months EndedJune 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Research and development | $1,269 | $782 | $2,014 | $1,382 |
| General and administrative | 1,593 | 1,055 | 2,870 | 1,803 |
| Total stock-based compensation expense | $2,862 | $1,837 | $4,884 | $3,185 |
- Income Taxes
The Company recorded income tax expense ofnil for the three months ended June 30, 2024 and 2023 and for the six months ended June 30, 2024 and 2023.
On January 1, 2022, or the Transfer Date, the Company’s wholly owned subsidiary, PepGen Limited, transferred all intellectual property, or IP, assets to the parent company, PepGen, in an arm’s length transaction at fair value pursuant to an asset transfer agreement. The fair value of the IP assets is a non-recurring fair value measurement. The Company engaged valuation specialists to calculate the IP value, and the IP value was measured using the historical cost method. The historical cost method estimated the fair value of the IP assets using the historical cost base of the IP assets and the expected market return as of the Transfer Date. The significant assumption inherent in estimating the fair value using the historical cost method was the expected market return. The Company utilized a 40% expected market return, which a third-party investor may expect as a return on their investment, and which is based on studies of venture capital investment returns. The Company calculated the fair value of the IP assets by computing the present value of the historical cost base using the 40% expected market return. The assumptions used in the estimation of the IP assets represent level 3 inputs of the fair value hierarchy.
The transfer of the IP assets resulted in an estimated tax charge during 2022 to His Majesty’s Revenue & Customs, or HMRC, after considering net operating loss carryforwards, of $4.4 million, inclusive of the $0.7 million uncertain tax position. The Company paid amounts owed to HMRC in September 2023.
The Company recognizes the impact of an uncertain income tax position taken on its income tax returns at the amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will be recognized if it has less than a 50% likelihood of being sustained. The tax positions are analyzed at least quarterly, and adjustments are made as events occur that warrant adjustments for those positions. As of June 30, 2024, the Company maintains the liability for the uncertain tax position related to the IP transfer of $0.7 million, which is accounted for in accrued expenses on the condensed consolidated balance sheet.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.