Table of Contents
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
 
 
FORM
10-Q
 
 
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2024
OR
 
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ______________ to ______________
Commission File Number:
001-38537
 
 
TECTONIC THERAPEUTIC, INC.
(Exact Name of Registrant as Specified in its Charter)
 
 
 
Delaware
 
81-0710585
(State or other jurisdiction of
incorporation or organization)
 
(I.R.S. Employer
Identification No.)
490 Arsenal Way, Suite 210
Watertown,
MA
 
02472
(Address of principal executive offices)
 
(Zip Code)
Registrant’s telephone number, including area code: (339)
666-3320
 
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
 
Trading
Symbol(s)
 
Name of each exchange
on which registered
Common Stock, par value $0.0001 per share   TECX   The Nasdaq Stock Market LLC
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. Yes ☒ No ☐
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
(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated
filer, 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  
Non-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 ☐ No 
As of August 9, 2024, the registrant had
 14,734,479
shares of common stock, $0.0001 par value per share, outstanding.
 
 
 


Table of Contents

Table of Contents

 

         Page  
PART I.  

FINANCIAL INFORMATION

     2  
Item 1.  

Financial Statements (Unaudited)

     2  
 

Balance Sheets

     2  
 

Statements of Operations and Comprehensive Loss

     3  
 

Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

     4  
 

Statements of Cash Flows

     5  
 

Notes to Unaudited Interim Financial Statements

     6  
Item 2.  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

     19  
Item 3.  

Quantitative and Qualitative Disclosures About Market Risk

     33  
Item 4.  

Controls and Procedures

     33  
PART II.  

OTHER INFORMATION

     34  
Item 1.  

Legal Proceedings

     34  
Item 1A.  

Risk Factors

     35  
Item 2.  

Unregistered Sales of Equity Securities and Use of Proceeds

     88  
Item 3.  

Defaults Upon Senior Securities

     88  
Item 4.  

Mine Safety Disclosures

     88  
Item 5.  

Other Information

     89  
Item 6.  

Exhibits

     89  
 

Signatures

     91  


Table of Contents

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


Table of Contents
0
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
TECTONIC THERAPEUTIC, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(unaudited)
 
    
June 30,
   
December 31,
 
    
2024
   
2023
 
    
(unaudited)
       
Assets
    
Current assets:
    
Cash and cash equivalents
   $ 185,124     $ 28,769  
Prepaid expenses and other current assets
     2,264       2,115  
  
 
 
   
 
 
 
Total current assets
     187,388       30,884  
Property, equipment and improvements, net
     2,639       3,122  
Finance
right-of-use
assets, net
     1,208       1,437  
Operating
right-of-use
assets
     2,075       2,669  
Deferred offering costs
           669  
Restricted cash
     587       587  
Other assets
     13       31  
  
 
 
   
 
 
 
Total assets
   $ 193,910     $ 39,399  
  
 
 
   
 
 
 
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)
    
Current liabilities:
    
Accounts payable
   $ 4,090     $ 409  
Accrued expenses and other current liabilities
     20,009       8,141  
SAFE liabilities
           30,515  
Operating lease liability - current portion
     1,428       1,348  
Finance lease liability - current portion
     474       475  
  
 
 
   
 
 
 
Total current liabilities
     26,001       40,888  
Operating lease liability - net of current portion
     905       1,644  
Finance lease liability - net of current portion
     637       876  
  
 
 
   
 
 
 
Total liabilities
     27,543       43,408  
  
 
 
   
 
 
 
Commitments and contingencies (Note 7)
Convertible preferred stock (Series
A-1,
A-2,
A-3
and
A-4),
$0.0001 par value; 6,825,483 shares authorized as of 
December 31, 2023; 6,825,483 shares issued and outstanding as of December 31, 2023; aggregate liquidation preference of $87,459 as of December 31, 2023
           80,627  
Stockholders’ Equity (Deficit):
    
Common stock, $0.0001 par value; 150,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 14,734,323 and 2,634,246 shares issued and outstanding as of June 30, 2024 and December 31, 2023
     2        
Additional
paid-in
capital
     284,922       5,979  
Accumulated other comprehensive loss
     (61     (11
Accumulated deficit
     (118,496     (90,604
  
 
 
   
 
 
 
Total stockholders’ equity (deficit)
     166,367       (84,636
  
 
 
   
 
 
 
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)
   $ 193,910     $ 39,399  
  
 
 
   
 
 
 
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
 
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TECTONIC THERAPEUTIC, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(unaudited)
 
    
Three Months Ended June 30,
   
Six Months Ended June 30,
 
    
2024
   
2023
   
2024
   
2023
 
Operating expenses:
        
Research and development
   $ 7,074     $ 8,766     $ 17,892     $ 21,751  
General and administrative
     4,347       1,865       6,497       3,411  
  
 
 
   
 
 
   
 
 
   
 
 
 
Total operating expenses
     11,421       10,631       24,389       25,162  
  
 
 
   
 
 
   
 
 
   
 
 
 
Loss from operations
     (11,421     (10,631     (24,389     (25,162
Other (expense) income, net:
        
Change in fair value of SAFE liabilities
     (1,535           (3,610      
Interest income
     318       224       574       352  
Interest expense
     (28     (40     (59     (82
Other expense
     (5     (8     (408     (8
  
 
 
   
 
 
   
 
 
   
 
 
 
Total other (expense) income, net
     (1,250     176       (3,503     262  
  
 
 
   
 
 
   
 
 
   
 
 
 
Net loss
     (12,671     (10,455     (27,892     (24,900
  
 
 
   
 
 
   
 
 
   
 
 
 
Net loss per share attributable to common stockholders, basic and diluted
   $ (4.34   $ (8.51   $ (12.97   $ (20.60
  
 
 
   
 
 
   
 
 
   
 
 
 
Weighted-average common shares outstanding, basic and diluted
     2,919,872       1,228,778       2,150,160       1,208,447  
  
 
 
   
 
 
   
 
 
   
 
 
 
Other comprehensive loss:
        
Foreign currency translation adjustment
     (8           (50      
  
 
 
   
 
 
   
 
 
   
 
 
 
Comprehensive loss
   $ (12,679   $ (10,455   $ (27,942   $ (24,900
  
 
 
   
 
 
   
 
 
   
 
 
 
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
 
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TECTONIC THERAPEUTIC, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
(DEFICIT)
(In thousands, except share and per share amounts)
(unaudited)
 
 
 
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
     6,825,483     $ 80,627        2,634,246     $ —       $ 5,979     $ (11   $ (90,604   $ (84,636
Retroactive application of reverse
recapitalization
     (3,177,808     —         (1,226,452     —         —        —        —        —   
  
 
 
   
 
 
    
 
 
   
 
 
    
 
 
   
 
 
   
 
 
   
 
 
 
Adjusted balance, beginning of
period
     3,647,675       80,627        1,407,794       —         5,979       (11     (90,604     (84,636
Exercise of stock options
     —        —         1,535       —         4       —        —        4  
Stock-based compensation
expense
     —        —         —        —         321       —        —        321  
Foreign currency translation adjustment
     —        —         —        —         —        (42     —        (42
Net loss
     —        —         —        —         —        —        (15,221     (15,221
  
 
 
   
 
 
    
 
 
   
 
 
    
 
 
   
 
 
   
 
 
   
 
 
 
Balances as of March 31, 2024
     3,647,675     $ 80,627        1,409,329     $ —       $ 6,304     $ (53   $ (105,825   $ (99,574
Conversion of convertible
preferred stock into common
stock in connection with the
M
erger
     (3,647,675
)
    (80,627
)
 
     3,647,675       —         80,627       —        —        80,627  
Exercise of stock options
     —        —         265,165       —         644       —        —        644  
Stock-based compensation
expense
     —        —         —        —         403       —        —        403  
Issuance of common stock to
related party investors upon
redemption of the SAFEs
     —        —         1,470,839       —         34,125       —        —        34,125  
Issuance of common stock under subscription agreement, net of offering costs of $2,000
     —        —         4,163,606       1        94,600       —        —        94,601  
Issuance of common stock upon
the
M
erger
     —        —         3,777,709       1        78,156       —        —        78,157  
Transaction costs in connection
with the
M
erger
     —        —         —        —         (9,937     —        —        (9,937
Foreign currency translation adjustment
     —        —         —        —         —        (8     —        (8
Net loss
     —        —         —        —         —        —        (12,671     (12,671
  
 
 
   
 
 
    
 
 
   
 
 
    
 
 
   
 
 
   
 
 
   
 
 
 
Balances as of June 30, 2024
         $        14,734,323     $ 2      $ 284,922     $ (61   $ (118,496   $ 166,367  
  
 
 
   
 
 
    
 
 
   
 
 
    
 
 
   
 
 
   
 
 
   
 
 
 
 
 
  
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
     6,825,483     $ 80,627        2,525,771     $ —       $ 2,127      $ —       $ (47,781   $ (45,654
Retroactive application of reverse recapitalization
     (3,177,808     —         (1,175,948     —         —         —         —        —   
  
 
 
   
 
 
    
 
 
   
 
 
    
 
 
    
 
 
    
 
 
   
 
 
 
Adjusted balance, beginning of period
     3,647,675       80,627        1,349,823       —         2,127        —         (47,781     (45,654
Exercise of stock options
     —        —         686       —         1        —         —        1  
Stock-based compensation expense
     —        —         —        —         275        —         —        275  
Net loss
     —        —         —        —         —         —         (14,445     (14,445
  
 
 
   
 
 
    
 
 
   
 
 
    
 
 
    
 
 
    
 
 
   
 
 
 
Balances as of March 31, 2023
     3,647,675     $ 80,627        1,350,509     $ —       $ 2,403      $ —       $ (62,226   $ (59,823
Stock-based compensation expense
     —        —         —        —         277        —         —        277  
Net loss
     —        —         —        —         —         —         (10,455     (10,455
  
 
 
   
 
 
    
 
 
   
 
 
    
 
 
    
 
 
    
 
 
   
 
 
 
Balances as of June 30, 2023
     3,647,675     $ 80,627        1,350,509     $ —       $ 2,680      $ —       $ (72,681   $ (70,001
  
 
 
   
 
 
    
 
 
   
 
 
    
 
 
    
 
 
    
 
 
   
 
 
 
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
 
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TECTONIC THERAPEUTIC, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(unaudited)
 
    
June 30,
 
    
2024
   
2023
 
Cash flows from operating activities:
    
Net loss
   $ (27,892   $ (24,900
Adjustments to reconcile net loss to net cash used in operating activities:
    
Depreciation and amortization expense
   713     734  
Stock-based compensation expense
   724     552  
Non-cash
lease expense
   595     549  
Change in fair value of SAFE liabilities
   3,610      
Change in operating assets and liabilities:
          
 
 
 
Prepaid expenses and other current assets
   (252
)
    (479
Other
non-current
assets
   422     (14
Accounts payable
   (70
)
    1,706  
Accrued expenses and other current liabilities
   153     1,645  
Operating lease liabilities
   (658
)
    (336
  
 
 
   
 
 
 
Net cash used in operating activities
     (22,655 )     (20,543
  
 
 
   
 
 
 
Cash flows from investing activities:
    
Purchase of property, equipment and improvements
       (222
  
 
 
   
 
 
 
Net cash used in investing activities
           (222
  
 
 
   
 
 
 
Cash flows from financing activities:
    
Proceeds from
the Subscription Agreement
, net of offering costs of $2,000
     94,600        
Cash acquired in connection with the Merger
     85,230        
Payment for Merger transaction costs
   (1,168
)
     
Proceeds from exercise of common stock options
   648     1  
Repayment of finance lease obligations
   (240
)
    (270
  
 
 
   
 
 
 
Net cash provided by (used in) financing activities
     179,070       (269
  
 
 
   
 
 
 
Effect of exchange rate changes on cash and cash equivalents
   (60
)
     
Net increase (decrease) in cash and cash equivalents and restricted cash
   156,355     (21,034
Cash and cash equivalents and restricted cash as of beginning of period
   29,356     36,553  
  
 
 
   
 
 
 
Cash and cash equivalents and restricted cash as of end of period
   $ 185,711     $ 15,519  
  
 
 
   
 
 
 
Components of cash, cash equivalents and restricted cash:
    
Cash and cash equivalents
   $ 185,124   $ 14,932  
Restricted cash
   587     587  
  
 
 
   
 
 
 
Total cash, cash equivalents and restricted cash
   $ 185,711     $ 15,519  
  
 
 
   
 
 
 
Supplemental disclosure of
non-cash
financing activities:
    
Merger transaction costs included in accounts payable and accrued expenses and other current liabilities
   $ 8,769   $  
Conversion of SAFEs to Common Stock
   $ 34,125    
$
 
Conversion of Convertible Preferred Stock to Common Stock
   $ 80,627    
$

 
Supplemental disclosure of cash flow information:
    
Cash paid for interest
   $ 59   $ 82  
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
 
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Table of Contents
TECTONIC THERAPEUTIC, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
1.
DESCRIPTION OF BUSINESS
Business
Tectonic Therapeutic, Inc. (formerly AVROBIO, Inc.) (the “Company” or “Tectonic”) is 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 Company focuses 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 of life. The Company’s corporate headquarters are in Watertown, Massachusetts.
Reverse Merger and
Pre-Merger
Financing Transaction
On June 20, 2024, the Company completed its previously announced merger transaction in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of January 30, 2024 (the “Merger Agreement”) with AVROBIO, Inc. (“AVROBIO”), pursuant to which Alpine Merger Subsidiary, Inc., a wholly owned subsidiary of AVROBIO, merged with and into the entity formerly known as Tectonic Therapeutic, Inc., now known as Tectonic Operating Company, Inc. (“Legacy Tectonic”), with Legacy Tectonic continuing as a wholly owned subsidiary of the surviving corporation of AVROBIO (the “Merger”). The Merger is being accounted for as a reverse recapitalization in accordance with generally accepted accounting principles in the United States of America (“GAAP”), with AVROBIO treated as the acquired company for financial reporting purposes, and Legacy Tectonic treated as the accounting acquirer.
Upon the closing of the Merger, each outstanding share of
Legacy Tectonic’s
common stock, including outstanding and unvested restricted stock, was converted into the right to receive a number of shares of AVROBIO’s common stock based on an exchange ratio of 0.53 (the “Exchange Ratio”),
as defined in the Merger Agreement, after giving effect to the 1-for-12 reverse stock split of AVROBIO common stock that was effected on June 20, 2024. The exchange ratio was retroactively applied to all outstanding common shares, convertible preferred shares, stock options and restricted stock. 
Each outstanding and unexercised option to purchase shares of Legacy Tectonic’s common stock immediately prior to closing was assumed by AVROBIO and was converted into an option to purchase shares of AVROBIO common stock, with necessary adjustments to the number of shares and exercise price to reflect the Exchange Ratio. All of Legacy Tectonic’s restricted common stock outstanding and unvested immediately prior to the closing that was assumed by AVROBIO in the Merger remains unvested to the same extent and is subject to the same repurchase option, risk of forfeiture or other condition under any applicable restricted stock purchase agreement.
Legacy Tectonic stockholders received approximately
 
10,956,614
shares of AVROBIO common stock in connection with the Merger, including
6,901
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 restricted stock, the number of shares of common stock issued to investors participating in the Subscription Agreements (as defined below) 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.
In connection with the Merger, the Company and its designated rights agent entered into a contingent value rights agreement (the “CVR Agreement”). Pursuant to the CVR Agreement, each holder of AVROBIO common stock immediately prior to the closing received a contractual contingent value right (“CVR”) subject to and in accordance with the terms and conditions of the CVR Agreement, representing the contractual right to receive a pro rata portion of any net proceeds, if any, as a resulting from a disposition of certain AVROBIO intellectual property (including a license of AVROBIO’s pre-closing assets as defined in the CVR Agreement) after the closing and prior to the 
18-month anniversary
of the
c
losing, received within
10-year period
following the
c
losing; provided that no contingent payment will be payable to any holder of the CVRs until such time as the then-outstanding and undistributed proceeds exceeds $0.4 million in the aggregate. As of June 30, 2024, no
 proceeds have been received under the CVR Agreement. As of June 30, 2024 there is no liability recorded in connection with the CVR Agreement.
Concurrently with the closing of the Merger, certain investors of
Legacy Tectonic
completed the purchase of 7,790,889 shares of
Legacy Tectonic
 common stock pursuant to that certain
Subscription Agreement
dated January 30, 2024 (the “Subscription Agreement”) at a purchase price of approximately $12.40 per share for an aggregate purchase price of approximately $96.6 million. Shares of
Legacy Tectonic
 common stock issued pursuant to the Subscription Agreements were converted into 4,163,606 shares of AVROBIO common stock at the closing of the Merger based on the Exchange Ratio, pursuant to the Merger Agreement.
 
6

Risks and Uncertainties
The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing. Product candidates currently under development will require significant additional research and development efforts, including extensive
pre-clinical
and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure, and extensive compliance reporting capabilities.
The Company’s proprietary GEODe
platform is currently in development. There can be no assurance that current and future research and development activities will be successfully completed, that adequate protection for owned intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies.
Liquidity and Going Concern
As of June 30, 2024, the Company had an accumulated deficit of $118.5 million and has incurred losses and negative cash flows from operations since inception, including a net loss of $12.7 million and $27.9 million for the three and six months ended June 30, 2024, respectively. To date, the Company has financed its operations primarily through the issuance of common stock, convertible preferred stock, convertible promissory notes and Simple Agreements for Future Equity (“SAFEs”). The Company has devoted substantially all of its financial resources and efforts to business planning, conducting research and development, recruiting management and technical staff, and raising capital. Management expects that the Company’s operating losses and negative cash flows will continue for the foreseeable future as it continues to develop its product candidates.
As the Company continues to develop its proprietary platform and potential product candidates, it will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. It may never achieve profitability, and unless and until it does, it will continue to need to raise additional capital to fund its operations. Management believes that its current cash on hand, which includes the proceeds related to the Merger and Subscription Agreements, is sufficient to fund the Company’s planned operations for at least one year from the date of issuance of these unaudited condensed consolidated financial statements.
 
2.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
During the six months ended June 30, 2024, there were no significant changes to the Company’s significant accounting policies as described in the Company’s audited consolidated financial statements as of and for the years ended December 31, 2023 and 2022.
Basis of Presentation
The accompanying unaudited interim condensed consolidated financial statements have been prepared in conformity with GAAP and the rules and regulations of the Securities and Exchange Commission (“SEC”). Any reference in these notes to applicable guidance is meant to refer to GAAP, as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of the Company, the accompanying unaudited condensed consolidated financial statements contain all adjustments, consisting of only normal recurring adjustments, necessary for a fair presentation of its financial position and its results of operations, changes in convertible preferred stock and stockholders’ equity (deficit) and cash flows. The information as of December 31, 2023 included in the unaudited interim condensed consolidated balance sheets was derived from audited annual consolidated financial statements but does not contain all of the footnote disclosures from the audited annual consolidated financial statements.
 
7

These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited annual consolidated financial statements as of
and
for the years ended December 31, 2023 and 2022.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting periods. Significant items subject to such estimates and assumptions include the contract research accruals, stock-based compensation expense, the fair value of the Company’s common stock, the income tax valuation allowance, and the fair value determination of the SAFEs. Management’s estimates are based on historical experience and various other assumptions that it believes are reasonable under the circumstances. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates.
Principles of Consolidation
The condensed consolidated financial statements include the accounts of the Company and its subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB, or other standard setting bodies and are adopted by the Company as of the specified effective dates. Unless
otherwise
discussed, the impact of recently issued standards that are not yet effective are not anticipated to have a material impact on the Company’s condensed consolidated financial statements upon adoption.
Recently Issued Accounting Pronouncements Not Yet Adopted
In November 2023, the FASB issued ASU
No. 2023-07,
Segment Reporting
(Topic 280) (“ASU
2023-07”),
which enhances the segment disclosure requirements for public entities on an annual and interim basis. Under ASU
2023-07,
public entities will be required to disclose significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”) and included within each reported measure of segment profit or loss. Additionally, current annual disclosures about a reportable segment’s profit or loss and assets will be required on an interim basis. Entities will also be required to disclose information about the CODM’s title and position at the Company along with an explanation of how the CODM uses the reported measures of segment profit or loss in their assessment of segment performance and deciding whether how to allocate resources. Finally, ASU
2023-07
requires all segment disclosures for public entities that have only a single reportable segment. The amendments in ASU
2023-07
are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, and early adoption is permitted. The Company is currently evaluating the impact of ASU
2023-07
on its condensed consolidated financial
statements.
In December 2023, the FASB issued ASU
No. 2023-09,
Income Taxes
(Topic 740) (“ASU
2023-09”),
which enhances the income tax disclosure requirements for public entities on an annual basis. Under ASU
2023-09,
public entities will be required to disclose in their rate reconciliation, on an annual basis, both percentages and amounts in their reporting currency for certain categories in a tabular format, with accompanying qualitative disclosures. The amendments in ASU
2023-09
are effective for fiscal years beginning after December 15, 2024, and early adoption is permitted. The Company is currently evaluating the impact of ASU
2023-09
on its condensed consolidated financial statements.
 
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Table of Contents
3.
MERGER
As described in Note 1, the Company completed its previously announced Merger with AVROBIO on June 20, 2024. The Merger was accounted for as a reverse recapitalization in accordance with GAAP with Legacy Tectonic as the accounting acquirer of AVROBIO. At the effective time of the Merger, substantially all the assets of AVROBIO consisted of cash and cash equivalents, as well as other nominal
non-operating
assets. Under such reverse recapitalization accounting, the assets and liabilities of AVROBIO were recorded at their fair value in AVROBIO’s financial statements at the effective time of the Merger, which approximated book value due to the short-term nature. No goodwill or intangible assets were recognized. Consequently, the condensed consolidated financial statements of the Company reflect the historical operations of Legacy Tectonic for accounting purposes together with the issuance of shares to the former shareholders of AVROBIO, the legal acquirer, and a recapitalization of the equity of Legacy Tectonic, the accounting acquirer. The exchange ratio was retroactively applied to all outstanding common shares, convertible preferred shares, stock options and restricted stock of Legacy Tectonic.
As part of the recapitalization, Legacy Tectonic obtained the assets and liabilities listed below:

Cash and cash equivalents
  
$
85,230
 
Prepaid expenses and other current assets
  
 
319
 
Accounts payable
  
 
(1,988
Accrued expenses and other current liabilities
  
 
(5,405
)
  
 
 
 
Net assets acquired
  
$
78,156
 
  
 
 
 
The Company incurred transaction costs of $9.9 million, of which $8.2 million was recorded within accrued expenses and other current liabilities on the condensed consolidated balance sheet, $0.6 million was recorded within accounts payable on the condensed consolidated balance sheet and $1.2
 
million was paid in cash as of June 30, 2024. This amount was recorded as a reduction to additional
paid-in
capital in the condensed consolidated statements of convertible preferred stock and stockholders’ equity (deficit) for the three and six months ended June 30, 2024.
With respect to the CVRs issued in connection with the Merger, the Company believes that any receipt of payments resulting from an AVROBIO disposition of AVROBIO’s pre-closing assets described in the CVR Agreement are highly susceptible to factors outside the Company’s influence that are not expected to be resolved within the timeline outlined in the CVR Agreement, if at all. In particular, these amounts are primarily influenced by the actions and judgments of third parties and the buyers of such assets and are based on the buyers of such assets progressing the specific platform and intellectual property and early stage of research and development programs. If the Company were to record a receivable for such contingent payments, it would also record a corresponding liability. As of June 
30, 2024, no
receivables or liabilities were recorded on the condensed consolidated balance sheet relating to such contingent payments.
 
9

Table of Contents
4.
FAIR VALUE MEASUREMENTS
The following tables present information about financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
 
    
June 30, 2024
 
    
Level 1
    
Level 2
    
Level 3
    
Total
 
Assets:
           
Cash equivalents:
           
Money market funds
   $ 100,442      $ —       $ —       $ 100,442  
  
 
 
    
 
 
    
 
 
    
 
 
 
   $ 100,442      $ —       $ —       $ 100,442  
  
 
 
    
 
 
    
 
 
    
 
 
 
 
    
December 31, 2023
 
    
Level 1
    
Level 2
    
Level 3
    
Total
 
Assets:
           
Cash equivalents:
           
Money market funds
   $ 27,278      $ —       $ —       $ 27,278  
  
 
 
    
 
 
    
 
 
    
 
 
 
Liabilities:
   $ 27,278      $ —       $ —       $ 27,278  
  
 
 
    
 
 
    
 
 
    
 
 
 
SAFE liabilities
   $ —       $ —       $ 30,515      $ 30,515  
  
 
 
    
 
 
    
 
 
    
 
 
 
   $ —       $ —       $ 30,515      $ 30,515  
  
 
 
    
 
 
    
 
 
    
 
 
 
As of June 30, 2024 and December 31, 2023, the Company’s cash equivalents, which were invested in money market funds, were valued based on Level 1 inputs.
There were no transfers between the Level 1, Level 2 or Level 3 categories during the six months ended June 30, 2024 and 2023.
SAFE Liabilities
From October through December 2023,
Legacy Tectonic
entered into multiple SAFE agreements with certain existing investors and received $34.1 
million. Prior to redemption, the SAFE liabilities were valued using a probability weighted scenario analysis and discount rates derived by application of the build-up method to reflect the cost of equity. The valuation model required a variety of inputs, including the probability of occurrence of events that would trigger conversion or redemption of the SAFEs, the expected timing of such events, and a discount rate. 
Upon the closing of the Merger, the principal balance of the SAFEs was automatically redeemed for 2,752,216 shares of
Legacy
Tectonic common stock at the conversion price of $12.40
per share immediately prior to the Merger closing. As such the valuation inputs utilized to adjust the SAFE liability to fair value upon the closing of the
Merger
was $
12.40.
At closing, shares of
Legacy
Tectonic common stock issued pursuant to the redemption of
Legacy Tectonic
SAFEs were converted into 
1,470,839 shares of AVROBIO common stock based on the Exchange Ratio, pursuant to the Merger Agreement.
The following table presents activity for the SAFE liabilities that were measured at fair value using significant unobservable Level 3 inputs during the six months ended June 30, 2024 and the year ended December 31, 2023 (in thousands):
 
    
SAFE Liabilities
 
Balance as of January 1, 2023
   $  
Initial fair value recognition
     31,515  
Loss on issuance
     255  
Fair value adjustments
     (1,255
  
 
 
 
Balance as of December 31, 2023
     30,515  
Fair value adjustments
     3,610  
Conversion
     (34,125
  
 
 
 
Balance as of June 30, 2024
   $  
  
 
 
 
 
10

Table of Contents
5.
PROPERTY, EQUIPMENT AND IMPROVEMENTS, NET
Property, equipment and improvements, net is comprised of the following (in thousands):
 
    
June 30,
2024
    
December 31,
2023
 
Laboratory equipment
   $ 4,554      $ 4,510  
Furniture and office equipment
     244        244  
Computer equipment
     198        161  
Construction in progress
     —         38  
Leasehold improvements
     25        25  
  
 
 
    
 
 
 
     5,021        4,978  
Less: accumulated depreciation
     (2,382      (1,856
  
 
 
    
 
 
 
Property and equipment, net
   $ 2,639      $ 3,122  
  
 
 
    
 
 
 
Depreciation expense was $0.3 million and $0.2 million during the three months ended June 30, 2024 and 2023, respectively, and $0.5 million
during each of the six months ended June 30, 2024 and 2023, which was recorded as follows (in thousands):
 
    
Three Months Ended June 30,
    
Six Months Ended June 30,
 
    
2024
    
2023
    
2024
    
2023
 
General and administrative
   $ 5      $ 4      $ 9      $ 8  
Research and development
     259        242        517        468  
  
 
 
    
 
 
    
 
 
    
 
 
 
   $ 264      $ 246      $ 526      $ 476  
  
 
 
    
 
 
    
 
 
    
 
 
 
 
6.
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued expenses and other current liabilities is comprised of the following (in thousands):
 
 
  
June 30,

2024
 
  
December 31,

2023
 
Accrued Tectonic transaction costs
   $ 8,215      $  
Accrued AVROBIO transaction costs
     2,821         
Employee compensation related costs
     2,755        2,840  
A
ccrued offering costs related to the Subscription Agreement
     2,000         
Accrued professional fees
     1,607        1,798  
Accrued contract research organization fees
     985        2,298  
Accrued contract development and manufacturing organization fees
     649        660  
Accrued office and laboratory costs
     91        211  
Other current liabilities
     886        334  
  
 
 
    
 
 
 
   $ 20,009      $ 8,141  
  
 
 
    
 
 
 
 
7.
COMMITMENTS AND CONTINGENCIES
Leases
The Company’s commitments under its operating and finance leases are described in Note 8.
Harvard Agreement
In July 2020, Legacy Tectonic entered into an agreement with the President and Fellows of Harvard College (“Harvard”), for an option fee in the low five digits, whereby Harvard granted Legacy Tectonic an exclusive option to negotiate a worldwide, exclusive, royalty-bearing license under Harvard’s interest in the patent rights covering certain technology that was developed by Harvard. In October 2021, Legacy Tectonic exercised the option and on February 10, 2022, entered into a license agreement (“License Agreement”) with Harvard to conduct research and development activities using certain materials, technology and patent rights owned by Harvard, with the intent to develop, obtain regulatory approval for, and commercialize products. The License Agreement will remain in effect until the expiration of the last valid claim within the patent rights covering a product developed under the License Agreement or the termination of the License Agreement. Management concluded that the acquisition of patents and materials received under the License Agreement represents an asset acquisition of an
in-progress
research and development asset without future alternative use; therefore, any consideration paid was expensed.
 
11

As consideration for the License Agreement,
Legacy Tectonic
agreed to pay Harvard a
non-refundable
license fee, consisting of a cash payment due in three equal annual installments, in total amounting to $170,000 and 227,486 shares of common stock. The installments became due on July 2, 2022 (“First Payment Due Date”) and the first and second anniversaries of the First Payment Due Date. The first payment of $56,666 was paid in July 2022. The common stock issued to Harvard had a fair value of $0.4 million. Both the cash payment and the issuance of shares were expensed to research and development during the year ended December 31, 2022. The second payment of $56,666 was made in July 2023. The remaining installment amount of $56,668 is due in July 2024.
The Company also will be responsible for payment of (1) annual maintenance fees ranging from the low five digits to the low six digits during the term of the License Agreement (through the first commercial sale of a royalty-bearing product); (2) royalty payments as a percentage in the low single digits of the annual net sales that the Company generates from products that utilize the license technology (“Licensed Products”) and royalty payments as a percentage in the low single digits of the annual net sales that the Company generates from
know-how
enabled product licenses
(“Know-How
Enabled Products”) and (3) a percentage between
10-20%
of all
non-royalty
income received by the Company under sublicenses, strategic partnerships and
know-how
enabled product licenses that utilize the license technology. Subsequent to the first commercial sale of a royalty-bearing product, annual maintenance fees will increase to a low six digits for the remainder of the term of the License Agreement. The royalty term from sales of Licensed Products will terminate on a
country-by-country
and
product-by-product
basis on the earlier of (i) the expiration of the patent rights covering the product, expected to be no earlier than May 2041, and (ii) the termination of the License Agreement.
The royalty term from sales of
Know-How
Enabled Products will terminate on the earlier of (i) ten years after the first commercial sale of the first
Know-How
Enabled Product and (ii) twelve years after the first commercial sale of the first Licensed Product. There was $0.1 million due to Harvard as of June 30, 2024. During the three months ended June 30,
 
2024 and 2023,
the Company paid less than $
0.1 million and $0.1 million, respectively, and during the six months ended June 30, 2024 and 2023, the Company paid $0.1 million and $0.2 million, respectively, to Harvard.
Alloy Therapeutics License Agreement
On November 29, 2021,
Legacy Tectonic
executed a license agreement with Alloy Therapeutics, LLC (“ATX”), whereby the Company will use ATX technology for the purpose of preclinical development, clinical development and commercialization of potential product candidates, for an initial period of three years, with an option to extend the term for an additional two years. The Company will pay ATX a
non-refundable
and
non-creditable
annual fee of $0.1 million on each anniversary of the agreement. On November 7, 2022,
Legacy Tectonic
and ATX amended the agreement and extended the period of payment for the first fee due in May 2023. Additionally, the Company will be responsible for annual partnering fees if the Company decides to pursue clinical development of a product candidate using the ATX technology. The partnering fees may be creditable against future milestone development fees paid by the Company. The Company will also be responsible to pay ATX development milestone payments for the movement of certain product candidates through clinical trials, which range from the low six digits to the low seven digits upon completion of each milestone and amount to $4.8 million in total milestone payments under the license agreement. Provided the Company is able to commercialize a product using ATX technology, the Company will be responsible to pay ATX commercial payments in the low seven digits per year during the first six years of commercial sales, amounting to an amount in the high eight digits in total commercial payments under the license agreement.
During the three months ended June 30, 2024 and 2023, the Company paid $
0 and $0.1 million to ATX, respectively, and during the six months ended June 30, 2024 and 2023, the Company paid $0.1 million and $0.1 million to ATX, respectively.
Adimab Agreement
On May 1, 2023, Legacy Tectonic entered into a discovery agreement with Adimab, LLC (“Adimab”), an antibody discovery company, whereby Legacy Tectonic and Adimab are collaborating on human antibody discovery in accordance with an agreed upon research program. Legacy Tectonic paid an upfront technology access fee totaling
$20,000 upon execution of the agreement.
 
12

The Company also will be responsible for payment of (1) quarterly funding equal to 100% of the actual full-time employee (“FTE”) expended by Adimab in the performance of its obligations in accordance with the agreed upon research program at an annual rate of $0.4 million per FTE (subject to annual consumer price index increases) per the agreement, (2) delivery fees equal to $0.1 million upon both Adimab’s initial delivery of sequences or physical materials and completion pursuant to the research program (initial and completion fees payable once per target for a total of up to $0.4 million), (3) a
non-creditable,
non-refundable
fee of $0.5 million upon the exercise of an option to obtain the licenses and assignments for information discovered during the research program, (4) development milestone payments for the movement of certain product candidates thought clinical trials, which range in the low seven digits, and (5) royalty payments based on the annual net sales that the Company generates from products that utilize Adimab technology. The Company has the right to terminate the agreement if certain criteria are met. As of June 30, 2024, the Company recorded $0.1 million of costs associated with the FTEs in accrued expenses and other current liabilities and $0
of discovery delivery fees in accounts payable. 
During the three months ended June 30, 2024 and 2023, the Company paid $0.2 million and less than $0.1 million to Adimab, respectively. During the six months ended June 30, 2024 and 2023, the Company paid $0.3 million and less than $0.1 million to Adimab, respectively.
Indemnification Agreements
In accordance with the Company’s amended and restated certificate of incorporation (“ARCOI”) and certain indemnification agreements, the Company indemnifies certain officers and directors for specified events or occurrences, subject to certain limits, in which the officer or director is or was serving at the Company’s request in such capacity.
The Company enters into certain types of contracts that contingently requires it to indemnify various parties against claims from third parties. These contracts primarily relate to (i) the Company’s bylaws, under which it must indemnify directors and executive officers, and may indemnify other officers and employees, for liabilities arising out of their relationship with the Company, (ii) contracts under which it must indemnify directors and certain officers and consultants for liabilities arising out of their relationship, and (iii) procurement, service or license agreements under which the Company may be required to indemnify vendors, service providers or licensees for certain claims, including claims that may be brought against them arising from the Company’s acts or omissions with respect to the its products, technology, intellectual property or services.
From time to time, the Company may receive indemnification claims under these contracts in the normal course of business. In the event that one or more of these matters were to result in a claim against the Company, an adverse outcome, including a judgment or settlement, may cause a material adverse effect on future business, operating results or financial condition. It is not possible to estimate the maximum amount potentially payable under these contracts since there is no history of prior indemnification claims and the unique facts and circumstances involved in each particular claim will be determinative.
As of June 30, 2024 and December 31, 2023, the Company did not have any liabilities or other commitments related to indemnification claims.
Litigation
In the normal course of operations, the Company may become involved in various legal proceedings. As of June 30, 2024 and December 31, 2023, the Company has not recorded accruals for probable losses related to any existing or pending litigation as the Company’s management has determined that there are no matters where a potential loss is probable and reasonably estimable. The Company does not believe that any existing or pending claims would have a material impact on the Company’s condensed consolidated financial statements.
 
8.
LEASES
Legacy Tectonic
has entered into operating leases for office and laboratory facilities and financing leases for laboratory equipment used in research and development activities. The remaining lease terms for its leases range
from approximately
 two months
to approximately
 3.5
 
years. These 
leases often include options to extend the term of the lease. When it is reasonably certain that the option will be exercised, the impact of the renewal term is included in the lease term for purposes of determining total future lease payments and measuring the ROU asset and lease liability. The Company is not reasonably certain to exercise any available renewal options, which are therefore excluded from the measurement of leases. The Company applies the short-term lease policy election for its real estate and equipment leases, which allows it to exclude from recognition leases with an original term of twelve months or less.
In November 2020,
Legacy Tectonic
executed a facilities lease agreement to occupy 18,768 square feet of office and laboratory space, that was subsequently amended on April 21, 2022. The lease requires the Company to pay fixed base rent, which is included in the measurement of the lease, as well as its proportionate share of the facilities operating expenses which are treated as variable lease costs based on the Company’s election to combine lease and associated
non-lease
components and are excluded from the measurement of the lease. The lease expires on January 31, 2026, and contains a five-year renewal option exercisable by the Company which is not included in the measurement of the lease.
 
13

The following table sets forth information about lease costs for the three and six months ended June 30, 2024 and 2023 (in thousands):
 
    
Three Months Ended June 30,
    
Six Months Ended June 30,
 
    
2024
    
2023
    
2024
    
2023
 
Finance lease cost
           
Amortization of ROU assets
   $ 115      $ 124      $ 230      $ 258  
Interest on lease liabilities
     28        39        59        81  
Operating lease cost
     351        351        702        702  
Short-term lease cost
     185        198        360        348  
Variable lease cost
     198        195        448        401  
  
 
 
    
 
 
    
 
 
    
 
 
 
Total lease costs
   $ 877      $ 907      $ 1,799      $ 1,790  
  
 
 
    
 
 
    
 
 
    
 
 
 
The following table sets forth information about the Company’s leases for the six months ended June 30, 2024 and 2023 (in thousands):
 
    
Six Months Ended June 30,
 
    
2024
   
2023
 
Cash paid for amounts included in the measurement of lease liabilities
    
Finance leases - financing cash flows
   $ 240     $ 270  
Finance leases - operating cash flows
     59       81  
Operating leases - operating cash flows
     765       489  
Weighted-average remaining lease terms (in years)
    
Finance leases
     2.75       3.73  
Operating leases
     1.59       2.59  
Weighted-average discount rate
    
Finance leases
     9.69     9.58
Operating leases
     8.25     8.25
The following table presents the maturity of the Company’s finance and operating lease liabilities for as of ended June 30, 2024 (in thousands):
 
Year ended December 31,
  
Finance Leases
    
Operating Leases
 
2024 (remaining)
   $ 284      $ 769  
2025
     552        1,580  
2026
     363        132  
2027
     44        —   
2028
     —         —   
Thereafter
     —         —   
  
 
 
    
 
 
 
Total lease payments
     1,243        2,481  
Less: interest
     (132      (148
  
 
 
    
 
 
 
Total lease liabilities
   $ 1,111      $ 2,333  
  
 
 
    
 
 
 
 
9.
STOCKHOLDERS’ EQUITY
Convertible Preferred Stock
Prior to the conversion upon the closing of the Merger, Legacy Tectonic issued Series
A-1,
A-2, A-3 and A-4 convertible preferred stock (the “Preferred Stock”).
 
14

Prior to the completion of the Merger, Legacy Tectonic classified the Preferred Stock outside of permanent equity as the shares had redemption features that were not entirely within the control of Legacy Tectonic.
Upon the closing of the Merger, all outstanding shares of the Preferred Stock were converted into 
3,647,675 shares of common stock. No 
shares of the Preferred Stock were outstanding as of June 30, 2024.
Preferred Stock
Subsequent to consummation of the Merger, the Company authorized the issuance of 
10,000,000
 
shares of new undesignated preferred stock, however 
no
 such shares were issued or outstanding as of June 30, 2024.
Common Stock
As of June 30, 2024 and as a result of the Merger, the Company’s ARCOI authorized
the Company
to issue 
150,000,000
 shares of voting common stock of $
0.0001
par value common stock, of which
14,734,323
shares were issued and outstanding
.
 
Holders of voting common stock are entitled to one vote per share
. In addition, holders of voting common stock are entitled to receive dividends, if and when declared by the Company’s Board of Directors. As of June 30, 2024, 
no
 dividends had been declared.
The Company has included in issued and outstanding common stock shares of restricted common stock granted by the Company. As of June 30, 2024, there were 14,734,323
shares of
common
stock
issued and outstanding, of which 11,447
relate to shares of restricted common stock (see Note 10). 
 
1
0
.
STOCK-BASED COMPENSATION
2019 Equity Incentive Plan
The
Legacy Tectonic 2019 Equity Incentive Plan (the “2019 Plan”) provides employees, consultants and advisors and
non-employee
members of the Board of Directors and its affiliates with the opportunity to receive grants of stock options, stock awards and equity awards. Since inception, Legacy Tectonic has only issued stock options.
2024 Equity Incentive Plan
On June 20, 2024, the Company adopted the 2024 Equity Incentive Plan (the “2024 Plan”) which became effective upon completion of the Merger. The 2024 Plan provides for the grant of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other forms of awards to employees, consultants, and
non-employee
directors of the Company. The terms of stock award agreements, including vesting requirements, are determined by the Company’s Board of Directors and are subject to the provisions of the 2024 Plan. The term of each stock option shall be no more than ten years from the date of grant. Following the effectiveness of the 2024 Plan, no further grants will be made under the 2019 Plan; however, any outstanding equity awards granted under the 2019 Plan will continue to be governed by the terms of the 2019 Plan.
The 2024 Plan initially provided for the issuance of up to 1,938,799 shares of common stock (the “Initial Share Reserve”). Subject to any other adjustments as defined in the 2024 Plan, such aggregate number of shares of common stock will automatically increase on January 1st of each year for a period of ten years commencing on January 1, 2025 and ending on (and including) January 1, 2034, in an amount equal to 5% of the total number of shares of common stock issued and outstanding determined as of the day prior to such increase; provided, however that the board of directors may act prior to January 1st of a given year to provide that the increase for such year will be a lesser number of shares of common stock. The aggregate maximum number of shares of common stock that may be issued pursuant to the exercise of incentive stock options is three multiplied by the Initial Share Reserve.
As of June 30, 2024, there were 1,063,999 shares available for issuance under the 2024 Plan.
 
15

2024 Employee Stock Purchase Plan
On June 20, 2024, the Company adopted the 2024 Employee Stock Purchase Plan (the “2024 ESPP”), which became effective upon completion of the Merger. The maximum number of shares of common stock that may be issued under the 2024 ESPP will not exceed 147,343 shares (the “Initial ESPP Share Reserve”), plus the number of shares of common stock that are automatically added on January 1st of each year for a period of up to ten years commencing on January 1, 2025 and ending on (and including) January 1, 2034, in an amount equal to the lesser of (x) 1% of the total number of shares of common stock issued and outstanding determined as of the day prior to such increase and (y) a number of shares equal to three times the Initial ESPP Share Reserve. Notwithstanding the foregoing, the
B
oard of
D
irectors may act prior to the first day of any calendar year to provide that there will be no January 1st increase in the share reserve for such calendar year or that the increase in the share reserve for such calendar year will be a lesser number of shares of common stock than would otherwise occur pursuant to the preceding sentence. No offering periods under the 2024 ESPP had been initiated as of June 30, 2024.
 
The option activity below reflects the reverse stock split and retroactive application of the exchange ratio as discussed in Note 1.
A summary of the stock option activity for the six months ended June 30, 2024 is as follows (in thousands except share and per share amounts):
 
 
  
Number of Shares
 
  
Weighted-
Average Exercise Price
 
  
Weighted-Average

Remaining Contractual
Term (Years)
 
  
Aggregate
Intrinsic Value
 
Balance as of January 1, 2024
  
 
1,002,485
 
  
$
3.11
 
  
 
8.2
 
  
$
2,276
 
Granted
  
 
874,800
 
  
 
16.80
 
  
  
Exercised
  
 
(266,705
  
 
2.44
 
  
  
$
3,743
 
Forfeited and expired
  
 
(31,922
  
 
2.71
 
  
  
Options assumed from AVROBIO upon Merger closing
  
 
365,428
 
  
 
89.92
 
  
  
  
 
 
 
  
  
  
Balance as of June 30, 2024
  
 
1,944,086
 
  
$
25.68
 
  
 
7.5
 
  
$
9,830
 
  
 
 
 
  
  
  
Options vested and exercisable as of June 30, 2024
  
 
683,184
 
  
$
49.36
 
  
 
3.8
 
  
$
4,987
 
Options vested and expected to vest as of June 30, 2024
  
 
1,944,086
 
  
$
25.68
 
  
 
7.5
 
  
$
9,830
 
The weighted-average grant-date fair value of options granted during the six months ended June 30, 2024 and 2023 was $13.95 and $2.51 per share, respectively. The total intrinsic value of options exercised during the three months ended June 30, 2024 and 2023 was $3.7 million and $0, respectively, and was $3.7 million and
 less than
 
$0.1
 million
during the six months ended June 30, 2024 and 2023, respectively. Forfeitures of options are recorded as incurred.
Cash received from option exercises was $0.6 million for the three and six months ended June 30, 2024 and $0 
and less tha
n $0.1 million for the three and six months ended June 30, 2023, respectively
.
The fair values of the options granted in the six months ended June 30, 2023 were estimated based on the Black-Scholes-Merton option pricing model, using the following assumptions:
 
 
  
Six Months Ended June 30,
 
  
2024
 
2023
Fair value per share of underlying common stock
  
$16.80
 
$2.98
Expected term (in years)
  
6.25
 
5.93
Expected volatility
  
104.00%
 
111.05% - 111.21%
Risk-free interest rate
  
4.26%
 
3.65%
Expected dividend yield
  
0%
 
0%
Restricted Common Stock
Since 2019,
Legacy Tectonic
has granted restricted common stock to founders, employees and consultants. The purchase price of the restricted common stock is the estimated fair value on the grant date and the restricted stock is subject to various vesting schedules. Unvested restricted common stock are subject to repurchase rights held by the Company at the original issuance price in the event the restricted common stockholders’ service to the Company is terminated either voluntarily or involuntarily. As of June 30, 2024, there were 11,447 shares of unvested restricted common stock, with a repurchase liability of less than $0.1 million, that is classified in accrued expenses and other current liabilities in the accompanying condensed consolidated balance sheet.
The following table summarizes restricted stock activity:
 
    
Number of Shares
 
Unvested restricted common stock as of January 1, 2024
     18,968  
Granted
     —   
Early exercise of options
     6,859  
Vested
     (14,380
Forfeited
     —   
  
 
 
 
Unvested restricted common stock as of June 30, 2024
     11,447  
  
 
 
 
 
16

The weighted-average grant date fair value of unvested restricted common stock and restricted common stock vested and forfeited for the six months ended June 30, 2024 and 2023 was immaterial.
Stock-Based Compensation Expense
The Company recorded stock-based compensation expense regarding its employees and nonemployees as follows (in thousands):
 
    
Three Months Ended June 30,
    
Six Months Ended June 30,
 
    
2024
    
2023
    
2024
    
2023
 
General and administrative
   $ 228      $ 175      $ 421      $ 349  
Research and development
     175        102        303        203  
  
 
 
    
 
 
    
 
 
    
 
 
 
   $ 403      $ 277      $ 724      $ 552  
  
 
 
    
 
 
    
 
 
    
 
 
 
The Company records compensation expense for options with service based vesting conditions on a straight-line basis over the vesting period. As of June 30, 2024, total compensation cost not yet recognized related to unvested stock options was $
13.8 million, which is expected to be recognized over a weighted-average period of 3.4 years.
 
1
1
.
INCOME TAXES
During the three and six months ended June 30, 2024 and 2023, the Company recorded no income tax provision or benefit.
The Company has evaluated the positive and negative evidence bearing upon its ability to realize its deferred tax assets, which primarily consist of net operating loss carryforwards. The Company has considered its history of cumulative net losses, estimated future taxable income and prudent and feasible tax planning strategies and has concluded that it is more likely than not that the Company will not realize the benefits of its deferred tax assets. As a result, as of June 30, 2024, the Company has maintained a full valuation allowance against its net deferred tax assets.
 
1
2
.
NET LOSS PER SHARE
Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts):
 
    
Three Months Ended June 30,
    
Six Months Ended June 30,
 
    
2024
    
2023
    
2024
    
2023
 
Numerator:
           
Net loss attributable to common stockholders
   $ (12,671)      $ (10,455    $ (27,892    $ (24,900
  
 
 
    
 
 
    
 
 
    
 
 
 
Denominator:
           
Weighted-average common shares outstanding, basic and diluted
     2,919,872        1,228,778        2,150,160        1,208,447  
  
 
 
    
 
 
    
 
 
    
 
 
 
Net loss per share attributable to common stockholders, basic and diluted
   $ (4.34    $ (8.51    $ (12.97    $ (20.60
  
 
 
    
 
 
    
 
 
    
 
 
 
The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. For the three and six months ended June 30, 2024 and 2023, the Company excluded the following potential common shares from the computation of diluted net loss per share attributable to common stockholders for the period because including them would have had an anti-dilutive effect:
 
    
Three Months Ended June 30,
    
Six Months Ended June 30,
 
    
2024
    
2023
    
2024
    
2023
 
Convertible preferred stock (as converted to common stock)
            3,647,675               3,647,675  
Stock options to purchase common stock
     1,944,086        852,667        1,944,086        852,667  
Unvested restricted common stock
     11,447        36,504        11,447        36,504  
  
 
 
    
 
 
    
 
 
    
 
 
 
     1,955,533        4,536,846        1,955,533        4,536,846  
  
 
 
    
 
 
    
 
 
    
 
 
 
 
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13.
RELATED PARTY TRANSACTIONS
Scientific Advisory Board Member
One of the Company’s
co-founders
and former director is a member of the Company’s Scientific Advisory Board (“SAB”) and meets the criteria of a related party. The Company paid the SAB member fees in the amount of less
than $0.1 million during the three months ended June 30, 2024 and 2023, respectively, and less than $
0.1
 
million during the six months ended June 30, 2024 and 2023 for advisory services provided. There was less than $0.1 million and $0 due to this related party as of June 30, 2024 and December 31, 2023. 
 

License Agreement
Harvard meets the criteria of a related party resulting from the Company’s
co-founders’
employment as professors in the Harvard Department of Molecular Pharmacology. Additionally, both
co-founders
were members of the Board during the six months ended June 30, 2024 and one
co-founder
is a major shareholder in the Company. Core intellectual property utilized by the Company is licensed from Harvard in exchange for license fees, future milestones and royalties, and equity in the Company in the form of common stock.
For the six months ended June 30, 2024 and 2023, the Company paid Harvard $0.1 
million and $0.2 million in cash considerations, respectively (see Note 7). Accounts payable to Harvard amounted to less than $
0.1 million and $0.1 
million as of June 30, 2024 and December 31, 2023, respectively. 
SAFE Agreements
From October through December 2023,
Legacy Tectonic
entered into multiple SAFE agreements with certain existing investors and received $34.1 
million representing the purchase amount. All investors were considered related parties of the Company. The SAFE agreements had no maturity date, bore no interest, and were redeemable by
Legacy Tectonic
upon the occurrence of a triggering event, including the Merger which qualified as a public listing transaction under the SAFE agreements. 
As discussed in Note 4, the SAFEs were redeemed for shares of Legacy Tectonic common stock in connection with the closing of the Merger.
 
14.
EMPLOYEE BENEFIT PLAN
The Company has a 401(k) retirement plan (the “Plan”) that covers eligible U.S. employees. Eligible employees may elect to contribute up to the maximum limits, as set by the Internal Revenue Service, of their eligible compensation. The Company’s funding policy is to contribute 3% (“Nonelective Contribution”) of employees’ eligible pay to the Plan. Highly compensated employees (as defined by the Plan) are not eligible to receive the Nonelective Contribution. The Company’s contributions were $0.1 million during each of the three and six months ended June 30, 2024 and 2023 and were recorded as follows:
 
 
  
Three Months Ended June 30,
 
  
Six Months Ended June 30,
 
 
  
2024
 
  
2023
 
  
2024
 
  
2023
 
General and administrative
  
$
10
 
  
$
5
 
  
$
16
 
  
$
12
 
Research and development
  
 
70
 
  
 
47
 
  
 
114
 
  
 
116
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
$
80
 
  
$
52
 
  
$
130
 
  
$
128
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
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Table of Contents

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.

 

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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

 

 

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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.

 

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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.

 

 

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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.

 

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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,
               
     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  
  

 

 

    

 

 

    

 

 

    

 

 

 

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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Table of Contents

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