UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For The Transition Period FromTo
Commission file number:
(Exact name of registrant as specified in its charter)
| ||
(State of Other Jurisdiction of incorporation or Organization) | (I.R.S. Employer Identification No.) | |
(Address of principal executive offices) | (Zip code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
| Name Of Each Exchange |
| ||
Title of Each Class | Trading Symbol(s) | On Which Registered | ||
*
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically; every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.0405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ |
| Accelerated filer ☐ |
|
| Smaller reporting company |
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
The aggregate number of outstanding ordinary shares of the registrant, each with par value $0.0001 per share, as of October 31, 2023, was
TABLE OF CONTENTS
2
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (“Quarterly Report”), contains forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “can,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. All statements other than statements of historical facts contained in this Quarterly Report, including without limitation statements regarding:
● | the timing, progress and results of preclinical studies and clinical trials for our product candidates, including our product development plans and strategies; |
● | the impact of data collection omissions at any of our clinical sites; |
● | the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; |
● | the potential benefits and market opportunity for our product candidates and discovery platform; |
● | expectations regarding the size, scope and design of clinical trials; |
● | our plans and strategy with respect to our drug discovery efforts and potential benefits of our discovery platform; |
● | our manufacturing, commercialization, and marketing plans and strategies; |
● | our plans to hire additional personnel and our ability to attract and retain such personnel; |
● | our estimates of the number of patients who suffer from the diseases we are targeting and potential growth in our target markets; |
● | our expectations regarding the approval and use of our product candidates; |
● | our competitive position and the development and impact of competing therapies that are or may become available; |
● | expectations regarding future events under collaboration and licensing agreements, including potential future payments, as well as our plans and strategies for entering into further collaboration and licensing agreements; |
● | our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights; |
● | the rate and degree of market acceptance and clinical utility of product candidates we may develop; |
● | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
● | our future financial performance; |
● | the period over which we estimate our existing cash, cash equivalents and short-term investments will be sufficient to fund our future operating expenses and capital expenditure requirements; |
● | the impact of laws and regulations; and |
● | the ongoing impact of geopolitical and macroeconomic factors. |
The forward-looking statements in this Quarterly Report are only predictions and are based largely on our current expectations and projections about future events and trends that we believe may affect our financial
3
condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of known and unknown risks, uncertainties, and assumptions, including those described under Part I. Item 2 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and Part II. Item 1A. “Risk Factors” elsewhere in this Quarterly Report. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties, and assumptions, the future events and trends discussed in this Quarterly Report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely upon these forward-looking statements as predictions of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, performance, or achievements. The forward-looking statements made in this Quarterly Report relate only to events or information as of the date on which the statements are made in this Quarterly Report. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. We intend the forward-looking statements contained in this Quarterly Report to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
SUMMARY RISK FACTORS
Our business is subject to numerous risks and uncertainties, including those described in Part II. Item 1A. “Risk Factors” in this Quarterly Report. You should carefully consider these risks and uncertainties when investing in our securities. The principal risks and uncertainties affecting our business include the following:
◾ | We have a limited operating history and have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future. |
◾ | We will require substantial additional capital to finance our operations, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate certain of our product development programs, commercialization efforts or other operations. |
◾ | Our approach to the discovery of product candidates based on our technology platform is unproven, and we do not know whether we will be able to develop any products of commercial value. |
◾ | We are early in our development efforts and only have two product candidates, GSBR-1290 and ANPA-0073, in early clinical development. All of our other development programs are in the preclinical or discovery stage. If we are unable to advance our product candidates in clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed. |
◾ | Clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes. The results of prior clinical trials and preclinical studies are not necessarily predictive of future results, and may not be favorable, or receive regulatory approval on a timely basis, if at all. |
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◾ | Any difficulties or delays in the commencement or completion, or termination or suspension, of our planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects. |
◾ | Serious adverse events, undesirable side effects or other unexpected properties of our product candidates may be identified during development or after approval, which could lead to the discontinuation of our clinical development programs, refusal by regulatory authorities to approve our product candidates or, if discovered following marketing approval, revocation of marketing authorizations or limitations on the use of our product candidates, any of which would limit the commercial potential of such product candidate. |
◾ | As an organization, we have never conducted later-stage clinical trials or submitted a New Drug Application (“NDA”), and may be unable to do so for any of our product candidates. |
◾ | The marketing approval processes of the U.S. Food and Drug Administration (“FDA”) and applicable foreign authorities are lengthy, time consuming, expensive and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our product candidates, our business will be substantially harmed. |
◾ | We have conducted, or plan to conduct, our initial clinical studies for GSBR-1290, ANPA-0073, LTSE-2578, and our other product candidates outside of the United States. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business. |
◾ | We rely on third parties for the manufacture of our product candidates for preclinical and clinical development and expect to continue to do so for the foreseeable future. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts. |
◾ | Our current and anticipated future dependence upon others for the manufacture of our product candidates or drugs may adversely affect our future profit margins and our ability to commercialize any product candidates that receive marketing approval on a timely and competitive basis. |
◾ | We rely on third parties to conduct, supervise and monitor our discovery research, preclinical studies and clinical trials. We have experienced delays due to actions of third parties in the past and if in the future third parties do not satisfactorily carry out their contractual duties or fail to meet expected deadlines, our development programs may be delayed or subject to increased costs, each of which may have an adverse effect on our business and prospects. |
◾ | We have entered into, and may in the future enter into, collaboration agreements and strategic alliances to maximize the potential of our structure-based drug discovery platform and product candidates, and we may not realize the anticipated benefits of such collaborations or alliances. We expect to continue to form collaborations in the future with respect to our product candidates, but may be unable to do so or to realize the potential benefits of such transactions, which may cause us to alter or delay our development and commercialization plans. |
◾ | Our existing discovery collaborations with Schrödinger, LLC (“Schrödinger”) are important to our business. If we are unable to maintain these collaborations, or if these collaborations are not successful, our business could be adversely affected. |
◾ | We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than us. |
5
◾ | We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenue. |
◾ | We conduct certain research and development operations through our Australian wholly-owned subsidiaries. If we lose our ability to operate in Australia, or if any of our subsidiaries are unable to receive the research and development tax credit allowed by Australian regulations, or are required to refund any research and development tax credit previously received or reserve for such credit in our financial statements, our business and results of operations could suffer. |
◾ | Changes in the political and economic policies of the Chinese government or in relations between China and the United States may affect our business, financial condition, results of operations and the market price of our American Depositary Shares (“ADSs”). |
◾ | If we are unable to obtain and maintain sufficient intellectual property protection for our platform technologies and product candidates, or if the scope of the intellectual property protection is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be adversely affected. |
◾ | We may rely on one or more in-licenses from third parties. If we lose these rights, our business may be materially adversely affected, and if disputes arise with one or more licensors, we may be subjected to future litigation as well as the potential loss of or limitations on our ability to develop and commercialize products and technologies covered by these license agreements. |
6
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited).
STRUCTURE THERAPEUTICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(UNAUDITED)
SEPTEMBER 30, | DECEMBER 31, | ||||||
| 2023 |
| 2022 |
| |||
Assets | |||||||
Current assets: |
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Cash and cash equivalents | $ | | $ | | |||
Short-term investments |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Operating right-of-use assets |
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Other non-current assets |
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Total assets | $ | | $ | | |||
Liabilities, redeemable convertible preferred shares and shareholders’ equity (deficit) |
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Current liabilities: |
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Accounts payable | $ | | $ | | |||
Accrued expenses and other current liabilities |
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Operating lease liabilities, current portion |
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Total current liabilities |
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Operating lease liabilities, net of current portion | | — | |||||
Other non-current liabilities | | — | |||||
Total liabilities |
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Commitments and contingencies (Note 5) |
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Series A redeemable convertible preferred shares – $ |
| — |
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Series A+ redeemable convertible preferred shares – $ |
| — |
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Series B redeemable convertible preferred stock – $ |
| — |
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Series B‑1 redeemable convertible preferred stock – $ |
| — |
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Shareholders’ equity (deficit): |
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Undesignated shares – $ | |||||||
Non-voting ordinary shares – $ | | — | |||||
Ordinary shares – $ |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
| ( |
| ( | |||
Accumulated deficit |
| ( |
| ( | |||
Total shareholders’ equity (deficit) |
| |
| ( | |||
Total liabilities, redeemable convertible preferred shares and shareholders’ equity (deficit) | $ | | $ | | |||
The accompanying notes are an integral part of these condensed consolidated financial statements.
7
STRUCTURE THERAPEUTICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(UNAUDITED)
THREE MONTHS ENDED | NINE MONTHS ENDED | ||||||||||||
SEPTEMBER 30, | SEPTEMBER 30, | ||||||||||||
| 2023 |
| 2022 |
| 2023 |
| 2022 |
| |||||
Operating expenses: |
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Research and development | $ | | $ | | $ | | $ | | |||||
General and administrative |
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Total operating expenses |
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Loss from operations |
| ( |
| ( |
| ( |
| ( | |||||
Interest and other income (expense), net |
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Loss before provision for income taxes |
| ( |
| ( |
| ( | ( | ||||||
Provision for income taxes |
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Net loss |
| ( |
| ( |
| ( |
| ( | |||||
Less: Accretion of redeemable convertible preferred shares to their redemption value |
| — |
| — |
| — |
| ( | |||||
Net loss attributable to ordinary shareholders | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Net loss per share attributable to ordinary shareholders, basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Weighted-average ordinary shares used in computing net loss per share attributable to ordinary shareholders, basic and diluted |
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Other comprehensive loss: |
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Unrealized gain (loss) on investments, net |
| |
| ( |
| ( |
| ( | |||||
Total other comprehensive loss |
| |
| ( |
| ( |
| ( | |||||
Comprehensive loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
8
STRUCTURE THERAPEUTICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS’ EQUITY (DEFICIT)
(IN THOUSANDS)
(UNAUDITED)
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ACCUMULATED | |||||||||||||||||||||||||||||||||||||||||||
REDEEMABLE CONVERTIBLE PREFERRED SHARES | ORDINARY | NON-VOTING | ADDITIONAL | OTHER | TOTAL | ||||||||||||||||||||||||||||||||||||||
SERIES A | SERIES A+ | SERIES B | SERIES B-1 | SHARES | ORDINARY SHARES | PAID-IN | COMPREHENSIVE | ACCUMULATED | SHAREHOLDERS’ | ||||||||||||||||||||||||||||||||||
| SHARES |
| AMOUNT |
| SHARES |
| AMOUNT |
| SHARES |
| AMOUNT |
| SHARES |
| AMOUNT |
|
| SHARES |
| AMOUNT |
| SHARES |
| AMOUNT |
| CAPITAL |
| INCOME (LOSS) |
| DEFICIT |
| EQUITY (DEFICIT) | |||||||||||
Balance at December 31, 2022 | | $ | | | $ | | | $ | | | $ | | | $ | | — | $ | — | $ | | $ | ( | $ | ( | $ | ( | |||||||||||||||||
Conversion of redeemable convertible preferred shares into ordinary shares upon initial public offering |
| ( |
| ( |
| ( |
| ( |
| ( |
| ( |
| ( |
| ( |
|
| |
| |
| — |
| — |
| |
| — |
| — |
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Issuance of ordinary shares upon initial public offering, net of issuance costs and underwriting discount of $ |
| — |
| — |
| — |
| — |
| — |
| — |
| — |
| — |
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| — |
| — |
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| — |
| — |
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Net exercise of ordinary share warrants |
| — |
| — |
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| — |
| — |
| — |
| — |
| — |
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| — |
| — |
| — |
| — |
| — |
| — | ||||||||||
Issuance of ordinary shares upon exercise of vested share options |
| — |
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| — |
| — |
| — |
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| — |
| — |
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Share-based compensation expense |
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Unrealized gain on investments, net |
| — |
| — |
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| — |
| — |
| — |
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| — |
| — |
| — |
| — |
| — |
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Net loss |
| — |
| — |
| — |
| — |
| — |
| — |
| — |
| — |
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| — |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||||||
Balance at March 31, 2023 |
| — | — |
| — | — |
| — | — |
| — | — |
| | |
| — | — | | | ( |
| | ||||||||||||||||||||
Exchange of ordinary shares to non-voting ordinary shares | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | ( | ( | | | — | — | — | — | ||||||||||||||||||||
Issuance of ordinary shares upon exercise of vested share options | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | | — | — | — | | — | — | | ||||||||||||||||||||
Share-based compensation expense | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | — |
| — | — |
| — |
| |
| — |
| — | | |||||||||||||||
Unrealized loss on investments, net | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | — |
| — | — |
| — |
| — |
| ( |
| — | ( | |||||||||||||||
Net loss | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | — |
| — | — |
| — |
| — |
| — |
| ( | ( | |||||||||||||||
Balance at June 30, 2023 | — | — | — | — | — | — | — | — | | | | | | ( | ( | | |||||||||||||||||||||||||||
Issuance of ordinary shares upon exercise of vested share options | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | | — | — | — | | — | — | | ||||||||||||||||||||
Share-based compensation expense | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | — |
| — | — |
| — |
| |
| — |
| — | | |||||||||||||||
Unrealized gain on investments, net | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | — |
| — | — |
| — |
| — |
| |
| — | | |||||||||||||||
Net loss | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | — |
| — | — |
| — |
| — |
| — |
| ( | ( | |||||||||||||||
Balance at September 30, 2023 | — | $ | — | — | $ | — | — | $ | — | — | $ | — | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | | |||||||||||||||||
9
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ACCUMULATED | ||||||||||||||||||||||||||||||||||||||
REDEEMABLE CONVERTIBLE PREFERRED SHARES | ORDINARY | ADDITIONAL | OTHER | TOTAL | ||||||||||||||||||||||||||||||||||
SERIES A | SERIES A+ | SERIES B | SERIES B-1 | SHARES | PAID-IN | COMPREHENSIVE | ACCUMULATED | SHAREHOLDERS’ | ||||||||||||||||||||||||||||||
| SHARES |
| AMOUNT |
| SHARES |
| AMOUNT |
| SHARES |
| AMOUNT |
| SHARES |
| AMOUNT |
|
| SHARES |
| AMOUNT |
| CAPITAL |
| LOSS |
| DEFICIT |
| DEFICIT | ||||||||||
Balance at December 31, 2021 |
| | $ | |
| | $ | |
| | $ | |
| | $ | |
| | $ | |
| $ | — | $ | — | $ | ( |
| $ | ( | ||||||||
Share-based compensation expense |
| — |
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Unrealized loss on investments, net |
| — |
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| — |
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| — |
| — |
| — |
| — |
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| — |
| ( |
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| ( | ||||||||
Net loss |
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| — |
| — |
| — |
| — |
| — |
|
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| — |
| ( |
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| ( | ||||||||
Balance at March 31, 2022 |
| | |
| | |
| | |
| | |
| | |
| | $ | ( | ( |
| ( | ||||||||||||||||
Issuance of Series B redeemable convertible preferred shares, net of issuance costs of $ | — |
| — |
| — |
| — |
| |
| |
| — |
| — | — |
| — |
| — |
| — |
| — | — | |||||||||||||
Accretion of Series B redeemable convertible preferred shares to their redemption value | — |
| — |
| — |
| — |
| — |
| |
| — |
| — | — |
| — |
| ( |
| — |
| ( | ( | |||||||||||||
Repurchase of restricted stock awards | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | ( | — | ( | — | — | ( | |||||||||||||||||
Issuance of ordinary shares upon exercise of vested share options | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | | — | | — | — | | |||||||||||||||||
Share-based compensation expense | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | — | — | | — | — | | |||||||||||||||||
Unrealized loss on investments, net | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | — | — | — | ( | — | ( | |||||||||||||||||
Net loss | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | — | — | — | — | ( | ( | |||||||||||||||||
Balance at June 30, 2022 | | | | | | | | | | | | ( | ( | ( | ||||||||||||||||||||||||
Issuance of ordinary shares upon exercise of vested share options | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | | — | | — | — | | |||||||||||||||||
Share-based compensation expense | — |
| — |
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| — |
| — |
| — |
| — |
| — | — | — | | — | — | | |||||||||||||||||
Unrealized loss on investments, net | — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | — | — | — | ( | — | ( | |||||||||||||||||
Net loss | — |
| — |
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| — | — | — | — | ( | ( | ||||||||||||||||||
Balance at September 30, 2022 | | $ | | | $ | | | $ | | | $ | | | $ | | $ | |