QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
(Address of principal executive offices) |
(Zip Code) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer |
☒ | Smaller reporting company | ||||
Emerging growth company |
Table of Contents
Page | ||||||
PART I. | 2 | |||||
Item 1. | 2 | |||||
2 | ||||||
3 | ||||||
Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) |
4 | |||||
5 | ||||||
6 | ||||||
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
19 | ||||
Item 3. | 33 | |||||
Item 4. | 33 | |||||
PART II. | 34 | |||||
Item 1. | 34 | |||||
Item 1A. | 35 | |||||
Item 2. | 88 | |||||
Item 3. | 88 | |||||
Item 4. | 88 | |||||
Item 5. | 89 | |||||
Item 6. | 89 | |||||
91 |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains statements that are not historical facts and are considered forward-looking within the meaning of 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”). Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies, our ability to fund our working capital requirements, our financial performance and our ability to effectively manage our anticipated growth, our ability to obtain additional funding for our operations, and other risks and uncertainties, including those listed under the section titled “Risk Factors” in this Quarterly Report regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including, any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward looking statements in this Quarterly Report on Form 10-Q (“Quarterly Report”) may include, for example, statements about:
• | the initiation, timing, progress and results of our current and future preclinical studies and clinical trials and related preparatory work and the period during which the results of the trials will become available, as well as our research and development programs; |
• | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
• | our strategies, prospects, plans, expectations or objectives of management for our future operations; |
• | our progress, scope or timing of the development of our product candidates; |
• | our expectations surrounding the potential safety, efficacy, and regulatory and clinical progress of TX45 and any other product candidates, and our anticipated milestones and timing therefor; |
• | the benefits that may be derived from any of our future products or the commercial or market opportunity with respect to any of our future products; |
• | our ability to identify and develop additional product candidates using our GEODe™ platform; |
• | our ability to protect our intellectual property rights; |
• | our ability to enroll patients in clinical trials, to timely and successfully complete those trials and to receive necessary regulatory approvals; |
• | the expected timing of filings with regulatory authorities for any product candidates that we develop; |
• | our expectations regarding the potential market size and the rate and degree of market acceptance for any current or future product candidates that we develop; and |
• | our ability to receive any milestone or royalty payments under our collaboration and license agreements. |
These forward-looking statements are based on our management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s beliefs and assumptions and are not guarantees of future performance or development. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described under the section titled “Risk Factors” under Part II, Item 1A below, and under similar captions in our periodic reports filed with the SEC from time to time. Moreover, we operate in a very competitive and rapidly changing environment, and 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 forward-looking events and circumstances 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.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this Quarterly Report. While we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information.
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report to conform these statements to new information, actual results or changes in our expectations, except as required by law.
1
June 30, |
December 31, |
|||||||
2024 |
2023 |
|||||||
(unaudited) |
||||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | $ | ||||||
Prepaid expenses and other current assets |
||||||||
|
|
|
|
|||||
Total current assets |
||||||||
Property, equipment and improvements, net |
||||||||
Finance right-of-use |
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Operating right-of-use |
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Deferred offering costs |
||||||||
Restricted cash |
||||||||
Other assets |
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|
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|
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Total assets |
$ | $ | ||||||
|
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|
|||||
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit) |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | $ | ||||||
Accrued expenses and other current liabilities |
||||||||
SAFE liabilities |
||||||||
Operating lease liability - current portion |
||||||||
Finance lease liability - current portion |
||||||||
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|||||
Total current liabilities |
||||||||
Operating lease liability - net of current portion |
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Finance lease liability - net of current portion |
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Total liabilities |
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Commitments and contingencies (Note 7) |
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Convertible preferred stock (Series A-1, A-2, A-3 and A-4), $December 31, 2023; |
||||||||
Stockholders’ Equity (Deficit): |
||||||||
Common stock, $ |
||||||||
Additional paid-in capital |
||||||||
Accumulated other comprehensive loss |
( |
) | ( |
) | ||||
Accumulated deficit |
( |
) | ( |
) | ||||
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|
|||||
Total stockholders’ equity (deficit) |
( |
) | ||||||
|
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|
|
|||||
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) |
$ | $ | ||||||
|
|
|
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
$ | $ | $ | $ | ||||||||||||
General and administrative |
||||||||||||||||
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|
|||||||||
Total operating expenses |
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|
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|
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|
|
|||||||||
Loss from operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Other (expense) income, net: |
||||||||||||||||
Change in fair value of SAFE liabilities |
( |
) | ( |
) | ||||||||||||
Interest income |
||||||||||||||||
Interest expense |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Other expense |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
|
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|
|||||||||
Total other (expense) income, net |
( |
) | ( |
) | ||||||||||||
|
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|
|
|
|
|||||||||
Net loss |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss per share attributable to common stockholders, basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
|
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|
|
|
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|
|||||||||
Weighted-average common shares outstanding, basic and diluted |
||||||||||||||||
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|
|
|||||||||
Other comprehensive loss: |
||||||||||||||||
Foreign currency translation adjustment |
( |
) | ( |
) | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Comprehensive loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
|
|
|
|
|
|
|
|
Convertible Preferred Stock |
Common Stock |
Additional |
Total |
|||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Paid-in Capital |
Accumulated Other Comprehensive Loss |
Accumulated Deficit |
Stockholders’ Equity (Deficit) |
|||||||||||||||||||||||||
Balances as of January 1, 2024 |
$ | $ | — | $ | $ | ( |
) | $ | ( |
) | $ | ( |
) | |||||||||||||||||||
Retroactive application of reverse recapitalization |
( |
) | — | ( |
) | — | — | — | — | — | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Adjusted balance, beginning of period |
— | ( |
) | ( |
) | ( |
) | |||||||||||||||||||||||||
Exercise of stock options |
— | — | — | — | — | |||||||||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Foreign currency translation adjustment |
— | — | — | — | — | ( |
) | — | ( |
) | ||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balances as of March 31, 2024 |
$ | $ | — | $ | $ | ( |
) | $ | ( |
) | $ | ( |
) | |||||||||||||||||||
Conversion of convertible preferred stock into common stock in connection with the M erger |
( |
) |
( |
) |
— | — | — | |||||||||||||||||||||||||
Exercise of stock options |
— | — | — | — | — | |||||||||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Issuance of common stock to related party investors upon redemption of the SAFEs |
— | — | — | — | — | |||||||||||||||||||||||||||
Issuance of common stock under subscription agreement, net of offering costs of $ |
— | — | — | — | ||||||||||||||||||||||||||||
Issuance of common stock upon the M erger |
— | — | — | — | ||||||||||||||||||||||||||||
Transaction costs in connection with the M erger |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
Foreign currency translation adjustment |
— | — | — | — | — | ( |
) | — | ( |
) | ||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balances as of June 30, 2024 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | $ | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible Preferred Stock |
Common Stock |
Additional |
Total |
|||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Paid-in Capital |
Accumulated Other Comprehensive Loss |
Accumulated Deficit |
Stockholders’ Deficit |
|||||||||||||||||||||||||
Balances as of January 1, 2023 |
$ | $ | — | $ | $ | — | $ | ( |
) | $ | ( |
) | ||||||||||||||||||||
Retroactive application of reverse recapitalization |
( |
) | — | ( |
) | — | — | — | — | — | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Adjusted balance, beginning of period |
— | — | ( |
) | ( |
) | ||||||||||||||||||||||||||
Exercise of stock options |
— | — | — | — | — | |||||||||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balances as of March 31, 2023 |
$ | $ | — | $ | $ | — | $ | ( |
) | $ | ( |
) | ||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balances as of June 30, 2023 |
$ | $ | — | $ | $ | — | $ | ( |
) | $ | ( |
) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
||||||||
2024 |
2023 |
|||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation and amortization expense |
||||||||
Stock-based compensation expense |
||||||||
Non-cash lease expense |
||||||||
Change in fair value of SAFE liabilities |
||||||||
Change in operating assets and liabilities: |
|
|
| |||||
Prepaid expenses and other current assets |
( |
) |
( |
) | ||||
Other non-current assets |
( |
) | ||||||
Accounts payable |
( |
) |
||||||
Accrued expenses and other current liabilities |
||||||||
Operating lease liabilities |
( |
) |
( |
) | ||||
|
|
|
|
|||||
Net cash used in operating activities |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Cash flows from investing activities: |
||||||||
Purchase of property, equipment and improvements |
( |
) | ||||||
|
|
|
|
|||||
Net cash used in investing activities |
( |
) | ||||||
|
|
|
|
|||||
Cash flows from financing activities: |
||||||||
Proceeds from the Subscription Agreement , net of offering costs of $ |
||||||||
Cash acquired in connection with the Merger |
||||||||
Payment for Merger transaction costs |
( |
) |
||||||
Proceeds from exercise of common stock options |
||||||||
Repayment of finance lease obligations |
( |
) |
( |
) | ||||
|
|
|
|
|||||
Net cash provided by (used in) financing activities |
( |
) | ||||||
|
|
|
|
|||||
Effect of exchange rate changes on cash and cash equivalents |
( |
) |
||||||
Net increase (decrease) in cash and cash equivalents and restricted cash |
( |
) | ||||||
Cash and cash equivalents and restricted cash as of beginning of period |
||||||||
|
|
|
|
|||||
Cash and cash equivalents and restricted cash as of end of period |
$ | $ | ||||||
|
|
|
|
|||||
Components of cash, cash equivalents and restricted cash: |
||||||||
Cash and cash equivalents |
$ | $ | ||||||
Restricted cash |
||||||||
|
|
|
|
|||||
Total cash, cash equivalents and restricted cash |
$ | $ | ||||||
|
|
|
|
|||||
Supplemental disclosure of non-cash financing activities: |
||||||||
Merger transaction costs included in accounts payable and accrued expenses and other current liabilities |
$ | $ | ||||||
Conversion of SAFEs to Common Stock |
$ | $ |
| |||||
Conversion of Convertible Preferred Stock to Common Stock |
$ | $ |
| |||||
Supplemental disclosure of cash flow information: |
||||||||
Cash paid for interest |
$ | $ |
1. |
DESCRIPTION OF BUSINESS |
2. |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
3. |
MERGER |
Cash and cash equivalents |
$ |
|||
Prepaid expenses and other current assets |
||||
Accounts payable |
( |
) | ||
Accrued expenses and other current liabilities |
( |
) | ||
|
|
|||
Net assets acquired |
$ |
|||
|
|
4. |
FAIR VALUE MEASUREMENTS |
June 30, 2024 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
Assets: |
||||||||||||||||
Cash equivalents: |
||||||||||||||||
Money market funds |
$ | $ | — | $ | — | $ | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
$ | $ | — | $ | — | $ | |||||||||||
|
|
|
|
|
|
|
|
December 31, 2023 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
Assets: |
||||||||||||||||
Cash equivalents: |
||||||||||||||||
Money market funds |
$ | $ | — | $ | — | $ | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Liabilities: |
$ | $ | — | $ | — | $ | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
SAFE liabilities |
$ | — | $ | — | $ | $ | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
$ | — | $ | — | $ | $ | |||||||||||
|
|
|
|
|
|
|
|
SAFE Liabilities |
||||
Balance as of January 1, 2023 |
$ | |||
Initial fair value recognition |
||||
Loss on issuance |
||||
Fair value adjustments |
( |
) | ||
|
|
|||
Balance as of December 31, 2023 |
||||
Fair value adjustments |
||||
Conversion |
( |
) | ||
|
|
|||
Balance as of June 30, 2024 |
$ | |||
|
|
5. |
PROPERTY, EQUIPMENT AND IMPROVEMENTS, NET |
June 30, 2024 |
December 31, 2023 |
|||||||
Laboratory equipment |
$ | $ | ||||||
Furniture and office equipment |
||||||||
Computer equipment |
||||||||
Construction in progress |
— | |||||||
Leasehold improvements |
||||||||
|
|
|
|
|||||
Less: accumulated depreciation |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Property and equipment, net |
$ | $ | ||||||
|
|
|
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
General and administrative |
$ | $ | $ | $ | ||||||||||||
Research and development |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
$ | $ | $ | $ | |||||||||||||
|
|
|
|
|
|
|
|
6. |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES |
June 30, 2024 |
December 31, 2023 |
|||||||
Accrued Tectonic transaction costs |
$ | $ | ||||||
Accrued AVROBIO transaction costs |
||||||||
Employee compensation related costs |
||||||||
A ccrued offering costs related to the Subscription Agreement |
||||||||
Accrued professional fees |
||||||||
Accrued contract research organization fees |
||||||||
Accrued contract development and manufacturing organization fees |
||||||||
Accrued office and laboratory costs |
||||||||
Other current liabilities |
||||||||
|
|
|
|
|||||
$ | $ | |||||||
|
|
|
|
7. |
COMMITMENTS AND CONTINGENCIES |
8. |
LEASES |
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
Finance lease cost |
||||||||||||||||
Amortization of ROU assets |
$ | $ | $ | $ | ||||||||||||
Interest on lease liabilities |
||||||||||||||||
Operating lease cost |
||||||||||||||||
Short-term lease cost |
||||||||||||||||
Variable lease cost |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total lease costs |
$ | $ | $ | $ | ||||||||||||
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
||||||||
2024 |
2023 |
|||||||
Cash paid for amounts included in the measurement of lease liabilities |
||||||||
Finance leases - financing cash flows |
$ | $ | ||||||
Finance leases - operating cash flows |
||||||||
Operating leases - operating cash flows |
||||||||
Weighted-average remaining lease terms (in years) |
||||||||
Finance leases |
||||||||
Operating leases |
||||||||
Weighted-average discount rate |
||||||||
Finance leases |
% | % | ||||||
Operating leases |
% | % |
Year ended December 31, |
Finance Leases |
Operating Leases |
||||||
2024 (remaining) |
$ | $ | ||||||
2025 |
||||||||
2026 |
||||||||
2027 |
— | |||||||
2028 |
— | — | ||||||
Thereafter |
— | — | ||||||
|
|
|
|
|||||
Total lease payments |
||||||||
Less: interest |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total lease liabilities |
$ | $ | ||||||
|
|
|
|
9. |
STOCKHOLDERS’ EQUITY |
1 0 . |
STOCK-BASED COMPENSATION |
Number of Shares |
Weighted- Average Exercise Price |
Weighted-Average Remaining Contractual Term (Years) |
Aggregate Intrinsic Value |
|||||||||||||
Balance as of January 1, 2024 |
$ |
$ |
||||||||||||||
Granted |
||||||||||||||||
Exercised |
( |
) |
$ |
|||||||||||||
Forfeited and expired |
( |
) |
||||||||||||||
Options assumed from AVROBIO upon Merger closing |
||||||||||||||||
Balance as of June 30, 2024 |
$ |
$ |
||||||||||||||
Options vested and exercisable as of June 30, 2024 |
$ |
$ |
||||||||||||||
Options vested and expected to vest as of June 30, 2024 |
$ |
$ |
Six Months Ended June 30, | ||||
2024 |
2023 | |||
Fair value per share of underlying common stock |
$ |
$ | ||
Expected term (in years) |
||||
Expected volatility |
||||
Risk-free interest rate |
||||
Expected dividend yield |
Number of Shares |
||||
Unvested restricted common stock as of January 1, 2024 |
||||
Granted |
— | |||
Early exercise of options |
||||
Vested |
( |
) | ||
Forfeited |
— | |||
Unvested restricted common stock as of June 30, 2024 |
||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
General and administrative |
$ | $ | $ | $ | ||||||||||||
Research and development |
||||||||||||||||
$ | $ | $ | $ | |||||||||||||
1 1 . |
INCOME TAXES |
1 2 . |
NET LOSS PER SHARE |
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
Numerator: |
||||||||||||||||
Net loss attributable to common stockholders |
$ | ( |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||||
Denominator: |
||||||||||||||||
Weighted-average common shares outstanding, basic and diluted |
||||||||||||||||
Net loss per share attributable to common stockholders, basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
Convertible preferred stock (as converted to common stock) |
||||||||||||||||
Stock options to purchase common stock |
||||||||||||||||
Unvested restricted common stock |
||||||||||||||||
13. |
RELATED PARTY TRANSACTIONS |
14. |
EMPLOYEE BENEFIT PLAN |
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
General and administrative |
$ |
$ |
$ |
$ |
||||||||||||
Research and development |
||||||||||||||||
$ |
$ |
$ |
$ |
|||||||||||||
Item 2. 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 unaudited condensed consolidated financial statements and the related notes included elsewhere in this Quarterly Report. In addition to historical information, the following discussion contains forward-looking statements. Our actual results may differ significantly from those projected in the forward-looking statements. Factors that might cause future results to differ materially from those projected in the forward-looking statements include, but are not limited to, those discussed in the sections entitled “Risk Factors” and “Special Note Regarding Forward-Looking Statements” in this Quarterly Report.
Unless otherwise indicated or the context otherwise requires, references in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section to the Company, “we,” “us,” and “our” refer to the business and operations of Tectonic Operating Company, Inc. (previously Tectonic Therapeutic, Inc., referred to as “Legacy Tectonic”) and its consolidated subsidiaries prior to the Merger, and the business and operations of Tectonic Therapeutic, Inc. (previously AVROBIO, Inc., referred to as “AVROBIO”) and its consolidated subsidiaries following the Merger.
Overview
We are a clinical-stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (“GPCRs”). The discovery of biologics that can modulate GPCRs has historically been quite challenging. We have developed a proprietary technology platform called GEODe™, with the aim of addressing these challenges to enable the discovery and development of GPCR-targeted biologic medicines that can modify the course of disease. We focus on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality or extend duration of life.
GPCRs are receptor molecules found on the surface of cells that act as sensors for various extracellular stimuli to enable communication between cells and their environment. These molecules regulate diverse aspects of human biology including blood pressure, glucose metabolism, transmission between neurons and immune surveillance. There are over 800 human genes encoding GPCRs, underscoring the extent to which nature has relied on this molecular system for physiological control. The breadth of effects controlled by GPCRs is best illustrated by the fact that greater than 30% of all approved drugs address targets in this class. The vast majority of these drugs, however, are small molecules, and their targets have been largely confined to a few GPCR subfamilies, many of which have a natural ligand that is also a small molecule. We believe there are many situations where biologics could present advantages over small molecules for this class of targets. For instance, when targeting a single member of a highly related family of GPCRs, the selectivity profile achievable with an antibody may be preferable to that of a small molecule to optimize therapeutic efficacy and safety for the patient. Conversely, when multi-modal action is needed to achieve a desired physiological effect, proteins engineered for bispecific function allow for dual target engagement, unlike small molecules that are generally optimized for action on a single target. We are focused on developing biologics to address GPCRs with the goal of capturing such opportunities.
It has been historically difficult, however, to discover therapeutic proteins and antibodies that bind to and modulate the activity of GPCRs because of the low endogenous level of expression of many GPCRs, complex biochemistry and their inherent instability when removed from their natural environment, the cell membrane. With the goal of unlocking the potential for biologic therapeutics to broaden the clinical utility of GPCRs, we use our proprietary GEODe™ technology platform in an attempt to overcome the known challenges of GPCR-targeted drug discovery.
Our lead asset, TX45, is an Fc-relaxin fusion molecule that activates the RXFP1 receptor, the GPCR target of the hormone, relaxin. Relaxin is an endogenous protein, expressed at low levels in both men and women. In normal human physiology, relaxin is upregulated during pregnancy where it exerts vasodilative effects, reduces systemic and pulmonary vascular resistance and increases cardiac output to accommodate the increased demand for oxygen and nutrients from the developing fetus. Relaxin also exerts anti-fibrotic effects on pelvic ligaments to facilitate delivery of the baby. It has long been hypothesized that these unique dual aspects of relaxin biology may offer therapeutic potential in the treatment of cardiovascular disease.
19
Unfortunately, the development of a viable therapeutic has been challenging, primarily because of relaxin’s very short half-life. We believe TX45’s pharmacological profile, the direct result of applying our protein engineering capabilities, has the potential to overcome the limitations that have impeded previous attempts to develop relaxin as a therapeutic protein. To interrogate the therapeutic potential of relaxin, we have identified: Group 2 Pulmonary Hypertension (“PH”) in the setting of Heart Failure with Preserved Ejection Fraction (“HFpEF”), referred to as Group 2 PH / HFpEF hereafter, as the initial disease setting. We hypothesize that in this setting, treatment with relaxin could improve hemodynamics through effects on pulmonary and systemic vasodilation, cardiac diastolic remodeling and potential remodeling in both the pulmonary vessels and the heart which could translate into a clinically meaningful improvement in exercise capacity in these patients. Clinical trials are planned to confirm this hypothesis. Despite this belief, our business carries substantial risks, including our limited experience in therapeutic discovery and development, and the risk that the platform may never result in the regulatory approval of a product candidate.
Since our inception in 2019, our operations have focused on organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio and conducting preclinical studies and clinical trials. We do not have any product candidates approved for sale and have not generated any revenue from product sales. We have funded our operations primarily with proceeds from sales of Series A-1, A-2, A-3, and A-4 convertible preferred stock (collectively, the “Preferred Stock”), proceeds received from the Merger (as defined below), proceeds from the issuance of common stock, proceeds from issuance of convertible promissory notes, which were all converted to convertible preferred stock in March 2021 and proceeds from issuance of Simple Agreements for Future Equity (“SAFEs”) in October and December 2023. From inception through June 30, 2024, we have received $288.6 million in capital contributions from sales of Preferred Stock, issuance of convertible promissory notes, proceeds from issuance of SAFEs, proceeds from the Merger and proceeds from the issuance of common stock. As of June 30, 2024, we had $185.1 million in cash and cash equivalents. Based on our current operating plan, we believe that our existing cash and cash equivalents should be sufficient to fund our operations for at least the next twelve months following the issuance of our interim condensed consolidated financial statements.
Since inception, we have incurred significant operating losses. Our net losses were $12.7 million and $10.5 million for the three months ended June 30, 2024 and 2023, respectively, and $27.9 million and $24.9 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $118.5 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we:
• | continue our ongoing and planned research and clinical development of our lead product candidate TX45 and our other product candidates; |
• | initiate preclinical studies and clinical trials for any additional product candidates that we may pursue in the future; |
• | seek to discover and develop additional product candidates and further expand our clinical product pipeline; |
• | seek regulatory approvals for any product candidates that successfully complete clinical trials; |
• | continue to scale up external manufacturing capacity with the aim of securing sufficient quantities to meet our capacity requirements for clinical trials and eventual potential commercialization; |
• | establish sales, marketing and distribution infrastructure to commercialize any product candidate for which we may obtain regulatory approval; |
• | develop, maintain, expand and protect our intellectual property portfolio; |
• | acquire or in-licenses other product candidates and technologies; |
• | hire additional clinical, quality control, regulatory and manufacturing personnel; |
• | add discovery, clinical, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts; and |
20
• | incur additional legal, accounting, investor relations and other expenses associated with operating as a public company. |
We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for one or more of our 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 internal commercialization capability to support product sales, marketing and distribution. Further, we will continue to incur additional costs associated with operating as 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 public or private equity offerings, debt financings or other capital sources, which may include 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 our product discovery and development programs or commercialization efforts.
Because of the numerous risks and uncertainties associated with pharmaceutical 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.
Recent Developments
Merger with AVROBIO
On January 30, 2024, Legacy Tectonic entered into the Agreement and Plan of Merger and Reorganization (“Merger Agreement”) with AVROBIO and Alpine Merger Subsidiary, Inc. (“Merger Sub”). Pursuant to the Merger Agreement and the satisfaction of the conditions described in the Merger Agreement, on June 20, 2024, Merger Sub merged with and into Legacy Tectonic, with Legacy Tectonic surviving as a wholly owned subsidiary of AVROBIO (the “Merger”). The Merger Agreement and the transactions contemplated therein were approved by the members of the AVROBIO board of directors and Legacy Tectonic board of directors. Subject to the terms and conditions of the Merger Agreement, at the effective time, (a) each outstanding share of Legacy Tectonic common stock (including shares of Legacy Tectonic common stock issued upon conversion of its preferred stock and the shares issued pursuant to that certain Subscription Agreement dated January 30, 2024, entered into among Legacy Tectonic and the investors party thereto (the “Subscription Agreement”) and conversion of the SAFEs into the right to receive a number of shares of AVROBIO common stock equal to the exchange ratio; and (b) each then outstanding Legacy Tectonic stock option that was outstanding and unexercised immediately prior to the effective time was assumed by AVROBIO, subject to the exchange ratio.
Immediately after the Merger, AVROBIO securityholders as of immediately prior to the Merger owned approximately 24.8% of the outstanding shares of our capital stock on a diluted basis. Immediately after the Merger, Legacy Tectonic securityholders owned approximately 38.5% of the outstanding shares of our capital stock on a diluted basis. Investors participating in the Subscription Agreement and the SAFEs owned approximately 27.1% and 9.6% of the outstanding shares of our capital stock, respectively, on a diluted basis.
Legacy Tectonic stockholders received approximately 10,956,614 shares of AVROBIO common stock in connection with the Merger, including 11,448 shares of AVROBIO common stock subject to vesting terms, based on the number of shares of Legacy Tectonic common stock outstanding immediately prior to the Merger, including Legacy Tectonic restricted stock, the number of shares of Legacy Tectonic common stock issued to investors participating in the Subscription Agreement and SAFEs, and Legacy Tectonic convertible preferred stock outstanding immediately prior to the Merger, which was converted into shares of Legacy Tectonic common stock on a one-for-one basis immediately prior to the closing of the Merger.
21
Tectonic Subscription Agreement
Concurrently with the closing of the Merger, on June 20, 2024, certain investors completed the purchase of shares of Legacy Tectonic common stock pursuant to the Subscription Agreement at a price of approximately $12.40 per share for an aggregate purchase price of approximately $96.6 million. The shares of Legacy Tectonic common stock that were issued pursuant to the Subscription Agreement were converted into 4,163,606 shares of our common stock upon the closing of the Merger based on the exchange ratio, pursuant to the Merger Agreement.
Macroeconomic Considerations
Uncertainty in the global economy presents significant risks to our business. We are subject to continuing risks and uncertainties in connection with the current macroeconomic environment, including rising interest rates, recent bank failures and geopolitical factors, such as tensions involving China and the United States, the war between Russia and Ukraine and the conflict in the Middle East and the responses thereto. While we are closely monitoring the impact of the current macroeconomic conditions on all aspects of our business, including the impacts on our participants in our clinical trials, employees, suppliers, vendors and collaboration partners, the ultimate extent of the impact on our business remains highly uncertain and will depend on future developments and factors that continue to evolve. Most of these developments and factors are outside our control and could exist for an extended period of time. We will continue to evaluate the nature and extent of the potential impacts to our business, results of operations, liquidity and capital resources.
Revenue
We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products in the foreseeable future, if at all. If our development efforts for our product candidates are successful and result in regulatory approval, or in collaboration or license agreements with third parties, we may generate revenue in the future from product sales or payments from collaboration or license agreements that we may enter into with third parties, or any combination thereof. We cannot predict if, when or to what extent we will generate revenue from the commercialization and sale of our product candidates. We may never succeed in obtaining regulatory approval for any of our product candidates.
Operating Expenses
Research and Development
Research and development expenses consist of costs incurred for our research activities, including our discovery efforts and the development of our programs and platform. These expenses include:
• | employee-related expenses, including salaries and bonuses, related benefits and share-based compensation expense, for employees engaged in research and development functions; |
• | expenses incurred in connection with research and the preclinical and clinical development of our programs and our product candidates, including under agreements with third parties; |
• | costs related to manufacturing material for our preclinical studies and clinical trials, including fees paid to contract manufacturing organizations, (“CMOs”); |
• | laboratory supplies, consumables and other research materials; |
• | 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; |
• | costs related to compliance with regulatory requirements; and |
• | payments made under third-party licensing agreements. |
We expense all research and development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on our evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and third-party service providers. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense when the goods have been delivered or the services have been performed, or when it is no longer expected that the goods will be delivered or the services rendered. Upfront payments under license agreements are expensed upon receipt of the license, and annual maintenance fees under license agreements are expensed in the period in which they are incurred. Milestone payments under license or collaboration agreements are accrued, with a corresponding expense being recognized, in the period in which the milestone is determined to be probable of achievement and the related amount is reasonably estimable.
22
Our direct research and development expenses relate to the development of our lead product candidate, TX45, as well as the nonclinical safety pharmacology and toxicology testing of our product candidates. Our external services expenses consist of the external costs and fees paid to consultants and other research laboratories in connection with our preclinical development and clinical development activities.
Costs that are deployed across multiple of our programs, including the HHT program and programs aimed at the discovery and development of potential therapies for fibrotic disease, and our platform technology and are not directly attributable to any single program are not allocated to any single program and, as such, are not separately classified. These costs include multi-program employee costs, cross-program payments made under third-party licensing agreements, costs of laboratory supplies and facilities expenses, including rent, depreciation and other indirect costs, the costs of our discovery efforts and projects are included in unallocated employee-related expenses, laboratory supplies and other expenses.
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments and our ongoing assessments as to each product candidate’s commercial potential. We will need to raise substantial additional capital in the future. Our clinical development costs are expected to increase significantly as we commence clinical trials. Our future expenses may vary significantly each period based on factors such as:
• | expenses incurred to conduct preclinical studies required to advance our product candidates into clinical development; |
• | per patient trial costs, including based on the number of doses that patients received; |
• | the number of patients who enroll in each trial; |
• | the number of trials required for approval; |
• | the number of sites included in the trials; |
• | the countries in which the trials are conducted; |
• | the length of time required to enroll eligible patients; |
• | the drop-out or discontinuation rates of patients; |
• | potential additional safety monitoring requested by regulatory agencies; |
• | the duration of patient participation in the trials and follow-up; |
• | the phase of development of the product candidate; |
• | third-party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; |
• | the ability to manufacture our product candidates; |
• | regulators or institutional review boards requiring that we or our investigators suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks; and |
• | the efficacy and safety profile of our product candidates. |
General and Administrative
General and administrative expenses consist primarily of salaries and personnel-related costs, including share-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, travel expenses, office and information technology costs and facilities, depreciation and other expenses related to general and administrative activities, 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 expect to incur significantly increased accounting, audit, legal, regulatory, compliance, director and officer insurance, and investor and public relations expenses associated with operating as 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.
23
Other (Expense) Income, Net
Loss on Issuance of SAFE Liabilities and Change in Fair Value of SAFE Liabilities
In October and December 2023, Legacy Tectonic issued SAFEs for proceeds of $34.1 million. The SAFEs were recorded as liabilities in the consolidated balance sheet at their fair value on the issuance dates. Until redemption, the SAFEs were measured at a fair value on a recurring basis, with subsequent changes in fair value recorded in other income and expenses on the consolidated statement of operations and comprehensive loss. We recorded a loss of $3.6 million resulting from the remeasurement of the SAFEs to fair value from March 31, 2024 to June 20, 2024.
Immediately prior to the closing of the Merger, the principal balance of the SAFEs was automatically redeemed into 2,752,216 shares of Legacy Tectonic’s common stock at the conversion price of approximately $12.40 per share. At the closing of the Merger, shares of Legacy Tectonic common stock issued pursuant to the redemption of the SAFEs were converted into 1,470,839 shares of our common stock based on the exchange ratio, pursuant to the Merger Agreement.
Interest Income
Interest income primarily consists of interest earned on our invested cash balances, which consist of deposit accounts and a sweep account.
Interest Expense
Interest expense primarily consists of interest expense on finance lease liabilities.
Other Expense
Other expense primarily consists of the difference between transactional currency and functional currency.
Income Taxes
Since our inception, we have not recorded any income tax benefits for the net losses we have incurred or for the research and development tax credits earned in each year by our operations in the United States, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credit carryforwards will not be realized.
Components of Results of Operations
Comparison of the Three Months Ended June 30, 2024 and 2023
The following table summarizes our results of operations for the three months ended June 30, 2024 and 2023:
Three Months Ended June 30, |
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2024 | 2023 | Change | % | |||||||||||||
(in thousands) | ||||||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
$ | 7,074 | $ | 8,766 | $ | (1,692 | ) | (19 | )% | |||||||
General and administrative |
4,347 | 1,865 | 2,482 | 133 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses |
11,421 | 10,631 | 790 | 7 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Loss from operations |
(11,421 | ) | (10,631 | ) | (790 | ) | 7 | |||||||||
|
|
|
|
|
|
|
|
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Other (expense) income, net: |
||||||||||||||||
Change in fair value of the SAFE liabilities |
(1,535 | ) | — | (1,535 | ) | 100 | ||||||||||
Interest income |
318 | 224 | 94 | 42 | ||||||||||||
Interest expense |
(28 | ) | (40 | ) | 12 | (30 | ) | |||||||||
Other expense |
(5 | ) | (8 | ) | 3 | (38 | )% | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Total other (expense) income, net |
(1,250 | ) | 176 | (1,426 | ) | (810 | ) | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss |
$ | (12,671 | ) | $ | (10,455 | ) | $ | (2,216 | ) | 21 | % | |||||
|
|
|
|
|
|
|
|
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Operating Expenses
Research and Development Expenses
Three Months Ended June 30, |
||||||||||||||||
2024 | 2023 | Change | % | |||||||||||||
(in thousands) | ||||||||||||||||
Direct research and development expenses by program: |
||||||||||||||||
TX45 |
$ | 2,460 | $ | 4,381 | (1,921 | ) | (44 | )% | ||||||||
Platform development, early-stage research and unallocated expenses: |
||||||||||||||||
Personnel related (including share-based compensation) |
2,763 | 2,873 | (110 | ) | (4 | ) | ||||||||||
External services |
786 | 188 | 598 | 318 | ||||||||||||
Facility, supplies and other |
1,065 | 1,324 | (259 | ) | (20 | ) | ||||||||||
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