Item 1.01. Entry into a Material Definitive Agreement.

Business Combination Agreement

On October 12, 2022, Good Works II Acquisition Corp., a Delaware corporation ("Good Works"), entered into a Business Combination Agreement (the "BCA"), by and among Good Works, Direct Biologics, Inc., a Delaware corporation ("Company Topco"), DB Merger Sub, Inc., a Delaware corporation ("Company Merger Sub"), DB DRE LLC, a Delaware limited liability company ("DRE LLC"), and Direct Biologics, LLC, a Wyoming limited liability company ( "Direct Biologics"). Upon consummation of the transactions contemplated by the BCA (the "Business Combination"), Company Topco would become the Nasdaq-listed parent company of both Good Works and Direct Biologics. The BCA supersedes the non-binding letter of intent between Good Works and Direct Biologics announced via press release on September 27, 2022.





The Business Combination

The BCA provides, among other things, that on the terms and subject to the conditions set forth therein, (i) Company Merger Sub will merge with and into Good Works, with Good Works surviving the merger and becoming a wholly-owned subsidiary of Company Topco (the "Topco Merger"), (ii) DRE LLC will merge with and into Direct Biologics, with Direct Biologics surviving the merger (the "Rollover Merger", and together with the Topco Merger, the "Mergers"). Following the closing of the Mergers, the combined company will be organized in an "Up-C" structure, and Company Topco's only direct assets will consist of equity in Good Works and Direct Biologics. The date on which the closing of the Mergers (the "Closing") actually occurs is hereinafter referred to as the "Closing Date."

Immediately following the Mergers, certain members of Direct Biologics will contribute a portion of their equity in Direct Biologics to Company Topco in exchange for equity in Company Topco (the "Topco Contribution"), with Direct Biologics continuing as a partially-owned subsidiary of Company Topco. Following the Topco Contribution, Good Works will contribute to Direct Biologics all funds remaining in its trust account following its stockholder vote to approve the Business Combination, less any amounts used to pay transaction expenses associated with the Business Combination.

Business Combination Consideration

The aggregate consideration available to be received by the members of Direct Biologics is based on an enterprise value of $1,025,000,000 and consists of (i) shares of Company Topco common stock and Direct Biologics Up-C units based on a pre-money enterprise value of $625 million with equity consideration valued at $10.00 per share, (ii) shares of Company Topco common stock and Direct Biologics Up-C units currently valued at $50 million that are subject to forfeiture if Direct Biologics does not achieve a primary efficacy endpoint of 60-day all-cause mortality in its Phase 3 EXTINGuish trial by December 31, 2023, and (iii) shares of Company Topco common stock and Direct Biologics Up-C units currently valued at $350 million that are subject to forfeiture if Direct Biologics does not obtain either Biologics License Application approval or Emergency Use Authorization from the FDA for its ExoFlo product (or a derivative product for any applicable indication) by December 31, 2024.

The BCA and the Business Combination have been approved by the boards of directors of each of Good Works, and Company Topco and the board of managers of Direct Biologics. The Business Combination is expected to close in the first half of 2023, subject to customary closing conditions, including the satisfaction of the minimum Available Cash conditions, the receipt of certain governmental approvals and the required approval by Good Works' stockholders and Direct Biologics' unit holders.





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Representations, Warranties and Covenants

The BCA contains customary representations and warranties for transactions of this type by the parties thereto as well as customary pre-closing covenants of the parties, including the obligation of Good Works, Direct Biologics and their respective subsidiaries to conduct their respective businesses in the ordinary course and to refrain from taking certain specified actions without the other party's consent. The representations, warranties, agreements and covenants of the parties set forth in the BCA will terminate at Closing, except for those covenants and agreements that, by their terms, contemplate performance after Closing. Each of the parties to the BCA has agreed to use its reasonable best efforts to take or cause to be taken all actions and things necessary to consummate and expeditiously implement the Mergers.





Governance

Current members of management of Direct Biologics will continue to serve in their respective roles and capacities following the Business Combination.

The Board of Directors of Company Topco upon completion of the Transaction will be compliant with NASDAQ's independence and diversity rules and will consist of at least such number of independent directors as is necessary to comply with stock exchange and other regulatory requirements. One initial director shall be designated by Good Works, and the remaining initial directors shall be designated by Direct Biologics.

Conditions to Each Party's Obligations

Under the BCA, the obligations of the parties to consummate the Business Combination are subject to a number of conditions to Closing, including the following without limitation: (i) the requisite approval by Good Works stockholders and the members of Direct Biologics; (ii) the absence of specified adverse laws, injunctions or orders; (iii) the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act . . .

Item 5.03. Amendments to Articles of Incorporation or Bylaws.

The information included in Item 5.07 of this Current Report on Form 8-K is incorporated by reference in this Item 5.03 to the extent required herein.

Item 5.07. Submission of Matters to a Vote of Security Holders.

On October 11, 2022, Good Works held a special meeting of stockholders (the "Meeting"), at which the its stockholder of record voted on the proposals set forth below, each of which is described in detail in the proxy statement filed with the Securities and Exchange Commission (the "SEC") on September 9, 2022, which was first mailed by Good Works to its stockholders on or about September 12, 2022.

As of August 26, 2022, the record date for the Meeting, there were 29,400,000 shares of Good Works common stock, par value $0.0001 per share(the "Good Works Common Stock"), issued and outstanding and entitled to vote at the Meeting. A total of 25,295,453 shares of the Good Works Common Stock, representing approximately 86.0% of the issued and outstanding shares of the Good Works Common Stock, were present in person by virtual attendance or represented by proxy at the Meeting, constituting a quorum for the Meeting. The final voting results for each proposal submitted to the stockholders of record of Good Works at the Special Meeting are included below.

Each of the proposals described below was approved by Good Works' stockholders of record. In connection with the Extension Proposal, 20,525,530 shares of Good Works Common Stock were redeemed (the "Redemption"), with 8,874,470 shares of Good Works Common Stock remaining outstanding after the Redemption. Our public stockholders will continue to have the opportunity to redeem all or a portion of their public shares upon the completion of our initial business combination at a per-share price, payable in cash, equal to the aggregate amount on deposit in the trust account as of two business days prior to the consummation of our initial business combination, including interest (which interest shall be net of taxes payable) divided by the number of then outstanding public shares, subject to the limitations described herein.





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Following the Redemption, approximately $24.85 million remains on deposit in our trust account.

If we are unable to complete an initial business combination on or before April 14, 2023 (unless the stockholders approve a further amendment to Good Works' amended and restated certificate of incorporation to extend the date by which Good Works has to consummate a business combination), we will: (i) cease all operations except for the purpose of winding up, (ii) as promptly as reasonably possible but not more than ten business days thereafter, redeem the public shares, at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the trust account, including interest (which interest shall be net of taxes payable, and less up to $100,000 of interest to pay dissolution expenses) divided by the number of then outstanding public shares, which redemption will completely extinguish public stockholders' rights as stockholders (including the right to receive further liquidation distributions, if any), subject to applicable law, and (iii) as promptly as reasonably possible following such redemption, subject to the approval of our remaining stockholders and our board of directors, dissolve and liquidate, subject in each case to our obligations under Delaware law to provide for claims of creditors and the requirements of other applicable law.

Set forth below are the final voting results for the proposals:





Proposal 1:

To amend the Good Works' amended and restated certificate of incorporation to extend from October 14, 2022 to April 14, 2023 (the "Extended Date"), the date by which Good Works must consummate a business combination or, if it fails to do so, cease its operations and redeem or repurchase 100% of the shares of Good Works' common stock issued in Good Works' initial public offering, is set forth in Annex A to the Proxy Statement, was as follows:





    For           Against       Abstentions
  24,231,694       963,759         100,000




Proposal 2:

To approve the adjournment of the Meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies in the event that there are insufficient votes for, or otherwise in connection with, the approval of Proposals 1, was as follows:





    For           Against       Abstentions
  24,230,599       964,854         100,000

A copy of the Good Works' amendment to its amended and restated certificate of incorporation is filed with this Current Report on Form 8-K as Exhibit 3.1 and is incorporated herein by reference, and the foregoing description of such amendment is qualified in its entirety by reference thereto.

Item 7.01. Regulation FD Disclosure.

On October 13, 2022, Good Works and Direct Biologics issued a joint press release announcing their entry into the BCA. The full text of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.

Furnished as Exhibit 99.2 hereto and incorporated into this Item 7.01 by reference is the investor presentation that Good Works and Direct Biologics have prepared for use in connection with the announcement of the Business Combination.

The information in this Item 7.01 of this Form 8-K, including Exhibits 99.1 and 99.2, is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933 or the Exchange Act, except as otherwise stated in such filing.





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Important Information and Where to Find It

In connection with the proposed Business Combination, Company Topco intends to file a registration statement on Form S-4 (the "Registration Statement") with the SEC, which will include a proxy statement/prospectus, and certain other related documents, to be used at a meeting of Good Works stockholders to approve the proposed Business Combination. Investors and security holders of Good Works are urged to read the proxy statement/prospectus, any amendments thereto and other relevant documents that will be filed with the SEC carefully and in their entirety when they become available because they will contain important information about Direct Biologics, Good Works and the proposed business combination. The definitive proxy statement/prospectus will be mailed to stockholders of Good Works as of a record date to be established for voting on the proposed Business Combination. Good Works' stockholders and other interested persons are advised to read, once available, the preliminary proxy statement / prospectus and any amendments thereto and, once available, the definitive proxy statement / prospectus, in connection with Good Works' solicitation of proxies for its special meeting of shareholders to be held to approve, among other things, the proposed Business Combination, because these documents will contain important information about Good Works, Direct Biologics and the proposed Business Combination. Investors and security holders will also be able to obtain copies of the Registration Statement and other documents containing important information about the business combination and the parties to the Business Combination once such documents are filed with the SEC, without charge, at the SEC's web site at www.sec.gov, or by directing a request to: Good Works, Cary Grossman, cgrossman@shorelinecapitaladvisors.com, 713-204-3873.

Participants in the Solicitation

Good Works, Direct Biologics, and certain of their respective directors and executive officers may be deemed participants in the solicitation of proxies from Good Works' shareholders with respect to the potential transaction. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of Good Works' stockholders in connection with the proposed Business Combination will be set forth in Good Works' proxy statement / prospectus when it is filed with the SEC. A list of the names of those directors and executive officers and a description of their interests in Good Works is contained in Good Works' final prospectus relating to its initial public offering dated July 9, 2021, which was filed with the SEC and is available free of charge at the SEC's web site at www.sec.gov. Additional information regarding the interests of such participants will be contained in the proxy statement/prospectus for the potential transaction when available. Direct Biologics and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from Good Works' shareholders in connection with the potential transaction. A list of the names of such directors and executive officers and information regarding their interests in the potential transaction will be included in the proxy statement/prospectus for the potential transaction when available.





Forward-Looking Statements

Some of the statements in this Current Report on Form 8-K are forward-looking statements within the meaning of the federal securities laws with respect to the proposed business combination between Good Works and Direct Biologics, including statements regarding the benefits of the proposed business combination, the anticipated timing of the proposed business combination, the products being developed by Direct Biologics and the markets in which Direct Biologics intends to operate, business strategies, debt levels, industry environment, potential growth opportunities, and the effects of regulations. These forward-looking statements generally are identified by the words "believe," "project," "expect," "anticipate," "estimate," "intend," "strategy," "future," "forecast," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," "positions," "enables" and similar expressions (including the negative versions of such words or expressions).





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Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including but not limited to: (i) the risk that the proposed business combination may not be completed in a timely manner or at all, which may adversely affect the price of Good Works' securities; (ii) the risk that the proposed business combination may not be completed by Good Works' initial business combination deadline and the potential failure to obtain an extension of the initial business combination deadline; (iii) the failure to satisfy the conditions to the consummation of the proposed business combination, including the approval of the proposed business combination by the Good Works stockholders, the satisfaction of the minimum cash amount of at least $75 million net cash following completion of a private placement by Direct Biologics and redemptions by Good Works' public stockholders, and the receipt of certain governmental and regulatory approvals; (iv) the effect of the announcement or pendency of the proposed business combination on Direct Biologics' business relationships, performance and business generally; (v) risks that the proposed business combination disrupts current plans of Direct Biologics; (vi) the outcome of any legal proceedings that may be instituted against Good Works, or related to the BCA or the proposed business combination; (vii) the ability of Company Topco to list its securities on NASDAQ; (viii) the price of Good Works' securities and the future price of Company Topco's securities, including volatility resulting from changes in the competitive and highly regulated industries in which Direct Biologics plans to operate, variations in performance across competitors, changes in laws and regulations affecting Direct Biologics' business and changes in the combined companies' capital structure; (ix) the ability to implement business plans, forecasts and other expectations after the completion of the proposed business combination, and identify and realize . . .

Item 9.01. Financial Statements and Exhibits.





(d) Exhibits



No.      Description

2.1†       Business Combination Agreement, dated as of October 12, 2022, by and
         among Good Works II Acquisition Corp., Direct Biologics, Inc., DB Merger
         Sub, Inc., DB DRE LLC, and Direct Biologics, LLC
3.1        Amendment to Amended and Restated Certificate of Incorporation of Good
         Works II Acquisition Corp., dated October 11, 2022
10.1       Form of Transaction Support Agreement
10.2       Form of Registration Rights Agreement
10.3       Amended and Restated Business Combination Marketing Agreement, dated
         October 12, 2022
99.1       Press Release dated October 13, 2022
99.2       Investor Presentation
104      Cover Page Interactive Data File (embedded within the Inline XBRL
         document)

† Certain of the exhibits and schedules to this exhibit have been omitted in


    accordance with Regulation S-K Item 601(b)(2). The Registrant agrees to
    furnish supplementally a copy of all omitted exhibits and schedules to the
    SEC upon its request.




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