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    SEC Form S-8 filed by Savara Inc.

    7/26/24 4:09:33 PM ET
    $SVRA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $SVRA alert in real time by email
    S-8 1 d852389ds8.htm S-8 S-8

    As filed with the Securities and Exchange Commission on July 26, 2024

    Registration No. 333-  

     

     

     

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    Washington, D.C. 20549

     

     

    FORM S-8

    REGISTRATION STATEMENT

    UNDER

    THE SECURITIES ACT OF 1933

     

     

    SAVARA INC.

    (Exact name of Registrant as specified in its charter)

     

     

     

    Delaware   84-1318182
    (State or other jurisdiction of
    incorporation or organization)
      (I.R.S. Employer
    Identification Number)

     

    1717 Langhorne Newtown Rd.

    Suite 300

    Langhorne, PA

      19047
    (Address of principal executive offices)   (Zip code)

    SAVARA INC. 2024 OMNIBUS INCENTIVE PLAN

    (Full title of the plan)

    Matthew Pauls

    Chief Executive Officer

    Savara Inc.

    1717 Langhorne Newtown Rd.

    Suite 300

    Langhorne, PA 19047

    (Name and address of agent for service)

    (512) 614-1848

    (Telephone number, including area code, of agent for service)

     

     

    Copies to: 

    Shawn Turner, Esq.

    Holland & Knight LLP

    1801 California Street, Suite 5000

    Denver, CO 80202

    (303) 974-6660

     

     

    Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

     

    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 7(a)(2)(B) of the Securities Act ☐

     

     

     


    EXPLANATORY NOTE

    The Board of Directors of Savara Inc. (the “Registrant”) approved the 2024 Omnibus Incentive Plan (the “2024 Plan”) on March 21, 2024, and the 2024 Plan was approved by the Company’s stockholders on June 6, 2024. The 2024 Plan was effective on June 7, 2024, the day immediately following its approval by the Company’s stockholders (the “Effective Date”). This registration statement on Form S-8 (“Registration Statement”) is being filed to register the offer of up to 12,815,139 shares of common stock, par value $0.01 per share (“Common Stock”) to be issued pursuant to the 2024 Plan. The number of shares of Common Stock being registered is equal to (i) the 11,700,000 shares of Common Stock approved by the Company’s stockholders on the Effective Date, plus (ii) 1,115,139 shares of Common Stock remaining available for issuance under the Amended and Restated 2015 Omnibus Incentive Plan (the “2015 Plan”) and that were not subject to outstanding awards under the 2015 Plan as of the Effective Date.

    PART I

    INFORMATION REQUIRED IN THE SECTION 10(a) PROSPECTUS

    Item 1. Plan Information

    The documents containing the information specified in this Item 1 will be sent or given to participants as specified by Rule 428(b)(1) under the Securities Act of 1933, as amended (the “Securities Act”). In accordance with the rules and regulations of the U.S. Securities and Exchange Commission (the “Commission”) and the instructions to Form S-8, such documents are not being filed with the Commission either as part of this Registration Statement or as prospectuses or prospectus supplements pursuant to Rule 424 under the Securities Act.

    Item 2. Registration Information and Employee Plan Annual Information

    The documents containing the information specified in this Item 2 will be sent or given to participants as specified by Rule 428(b)(1) under the Securities Act. In accordance with the rules and regulations of the Commission and the instructions to Form S-8, such documents are not being filed with the Commission either as part of this Registration Statement or as prospectuses or prospectus supplements pursuant to Rule 424 under the Securities Act. Such documents, together with the documents incorporated by reference herein pursuant to Item 3 of Part II of this Registration Statement, constitute a prospectus that meets the requirements of Section 10(a) of the Securities Act, and are available, without charge, upon written or oral request to: Savara Inc., Attn: Chief Financial & Administrative Officer, 1717 Newtown Langhorne Rd., Suite 300, Langhorne, PA 19047, Tel: (512) 614-1848.

    PART II

    INFORMATION REQUIRED IN THE REGISTRATION STATEMENT

    Item 3. Incorporation of Documents by Reference

    The Registrant hereby incorporates by reference into this Registration Statement the following documents previously filed with the Commission (other than information in a Current Report on Form 8-K that is furnished and not filed pursuant to Form 8-K and, except as may be noted in any such Current Report on Form 8-K, exhibits filed on such form that are related to such information):

    (i) The Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Commission on March  7, 2024, including the information specifically incorporated by reference therein from the Registrant’s Definitive Proxy Statement on Schedule14A, pursuant to Section 13 of the Securities Exchange Act of 1934, as amended (the “1934 Act”);

     

    2


    (ii) The Registrant’s Quarterly Report on Form 10-Q for the period ended March 31, 2024, filed with the Commission on May 9, 2024;

    (iii) The Registrant’s Current Reports on Form 8-K filed with the Commission pursuant to Section 13 of the 1934 Act on January 25, 2024, February 16, 2024, April 12, 2024, June 7, 2024, June 10, 2024, June 26, 2024, and June 28, 2024; and

    (iv) The description of the Registrant’s Common Stock included in the Registrant’s Registration Statement on Form 8-A filed on April 27, 2017 (File No. 001-32157-17789572), including any amendment or report updating such description.

    All documents filed by the Registrant pursuant to Section 13(a), 13(c), 14 or 15(d) of the 1934 Act after the date of this Registration Statement and prior to the filing of a post-effective amendment which indicates that all securities offered hereby have been sold or which deregisters all securities then remaining unsold shall be deemed to be incorporated by reference into this Registration Statement and to be a part hereof from the date of filing of such documents; provided, however, that documents or information deemed to have been furnished and not filed in accordance with the rules of the Commission shall not be deemed incorporated by reference into this Registration Statement. Any statement contained in a document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded for purposes of this Registration Statement to the extent that a statement contained herein or in any subsequently filed document which also is deemed to be incorporated by reference herein modifies or supersedes such statement. Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this Registration Statement.

    Item 4. Description of Securities

    Not applicable.

    Item 5. Interests of Named Experts and Counsel

    Not applicable.

    Item 6. Indemnification of Directors and Officers

    Section 145 of the Delaware General Corporation Law authorizes a corporation to indemnify its directors and officers against liabilities arising out of actions, suits and proceedings to which they are made or threatened to be made a party by reason of the fact of their prior or current service to the corporation as a director or officer, in accordance with the provisions of Section 145, which are sufficiently broad to permit indemnification under certain circumstances for liabilities arising under the Securities Act. The indemnity may cover expenses (including attorneys’ fees) judgments, fines and amounts paid in settlement actually and reasonably incurred by the director or officer in connection with any such action, suit or proceeding. Section 145 permits corporations to pay expenses (including attorneys’ fees) incurred by directors and officers in advance of the final disposition of such action, suit or proceeding. In addition, Section 145 provides that a corporation has the power to purchase and maintain insurance on behalf of its directors and officers against any liability asserted against them and incurred by them in their capacity as a director or officer, or arising out of their status as such, whether or not the corporation would have the power to indemnify the director or officer against such liability under Section 145.

     

    3


    The Registrant’s amended and restated certificate of incorporation (the “Certificate of Incorporation”), provides that, to the fullest extent permitted by the Delaware General Corporation Law, (1) no director or officer shall be personally liable to the Registrant or its stockholders for monetary damages for breach of fiduciary duty as a director, and (2) the Registrant shall indemnify any director or officer made a party to an action or proceeding, whether criminal, civil, administrative or investigative, by reason of the fact of such person’s current or prior service as a director or officer of the Registrant, any predecessor of the Registrant or any other enterprise per the Registrant’s or any predecessor to the Registrant’s request.

    The Registrant’s amended and restated bylaws, as amended (the “Bylaws”), provide that (a) the Registrant shall indemnify its directors and officers to the maximum extent and in the manner permitted by the Delaware General Corporation Law against expenses (including attorneys’ fees), judgments, fines, ERISA excise taxes, settlements and other amounts actually and reasonably incurred in connection with any proceeding, whether civil, criminal, administrative or investigative, arising by reason of the fact that such person is or was an agent of the corporation, subject to certain limited exceptions, (b) the Registrant shall advance expenses incurred by any director or officer prior to the final disposition of any proceeding to which the director or officer was or is or is threatened to be made a party promptly following a request therefore, subject to certain limited exceptions, and (c) the rights conferred in the Bylaws are not exclusive.

    The Registrant has entered into indemnification agreements with each of its directors and executive officers to give such directors and officers additional contractual assurances regarding the scope of the indemnification set forth in the Certificate of Incorporation and the Bylaws and to provide additional procedural protections. These agreements, among other things, provide that the Registrant will indemnify its directors and executive officers for expenses (including attorneys’ fees), judgments, fines, penalties and amounts paid in settlement (including all interest, assessments and other charges paid or payable in connection therewith) actually and reasonably incurred by a director or executive officer in connection with any action or proceeding to which such person was, is or is threatened to be made a party, a witness or other participant by reason of such person’s services as a director or executive officer of the Registrant, any of the Registrant’s subsidiaries or any other company or enterprise to which the person provides services at the Registrant’s request, and any federal, state, local or foreign taxes imposed on the director or executive officer as a result of the actual or deemed receipt of any payments under the indemnification agreements.

    In addition, the indemnification agreements provide that, upon the written request of a director or executive officer, the Registrant shall advance expenses (including attorneys’ fees) to the director or officer. The Registrant intends to enter into indemnification agreements with any new directors and executive officers in the future.

    The Registrant has also obtained insurance policies covering its directors and officers with respect to certain liabilities, including liabilities arising under the Securities Act.

    Item 7. Exemption from Registration Claimed

    Not applicable.

     

    4


    Item 8. Exhibits

     

    Exhibit
    Number
      

    Documents

     4.1    Savara Inc. 2024 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K/A filed on June 10, 2024)
     5.1    Opinion of Holland & Knight LLP
    23.1    Consent of RSM US LLP, Independent Registered Public Accounting Firm
    23.2    Consent of Holland & Knight LLP is contained in Exhibit 5.1 to this Registration Statement
    24.1    Power of Attorney is contained on the signature page
    107    Filing fee table

    Item 9. Undertakings.

    (a) The undersigned Registrant hereby undertakes:

    (1) To file, during any period in which offers or sales are being made, a post-effective amendment to this Registration Statement:

    (i) To include any prospectus required by Section 10(a)(3) of the Securities Act;

    (ii) To reflect in the prospectus any facts or events arising after the effective date of the Registration Statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the Registration Statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Filing Fee Tables” in the effective Registration Statement.

    (iii) To include any material information with respect to the plan of distribution not previously disclosed in the Registration Statement or any material change to such information in the Registration Statement.

    Provided, however, that Paragraphs (a)(1)(i) and (a)(1)(ii) do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the 1934 Act (15 U.S.C. 78m or 78o(d)) that are incorporated by reference in this Registration Statement.

    (2) That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new Registration Statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

    (3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

     

    5


    (b) The undersigned Registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of the Registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the 1934 Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the 1934 Act) that is incorporated by reference in this Registration Statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

    (c) Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

     

    6


    SIGNATURES

    Pursuant to the requirements of the Securities Act of 1933, as amended, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-8 and has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Langhorne, State of Pennsylvania, on July 26, 2024.

     

    SAVARA INC.
    By:   /s/ Matthew Pauls
      Matthew Pauls
    Title: Chief Executive Officer

    POWER OF ATTORNEY

    KNOW ALL PERSONS BY THESE PRESENT, that each person whose signature appears below constitutes and appoints Matthew Pauls and David Lowrance, and each of them, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) to this Registration Statement on Form S-8, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them, or their or his substitutes, may lawfully do or cause to be done by virtue thereof.

    Pursuant to the requirements of the Securities Act of 1933, this Registration Statement has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated:

     

    Signature

      

    Title

     

    Date

    /s/ Matthew Pauls

    Matthew Pauls

      

    Chief Executive Officer and Director

    (Principal Executive Officer)

      July 26, 2024

    /s/ Dave Lowrance

    Dave Lowrance

      

    Chief Financial Officer

    (Principal Financial and Accounting Officer)

      July 26, 2024

    /s/ Nevan Elam

    Nevan Elam

       Director   July 26, 2024

    /s/ Rick Hawkins

    Rick Hawkins

       Director   July 26, 2024

    /s/ Joseph McCracken

    Joseph McCracken

       Director   July 26, 2024


    /s/ David Ramsay

    David Ramsay

       Director   July 26, 2024

    /s/ An Van Es-Johansson

    An Van Es-Johansson

       Director   July 26, 2024
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    Savara Announces Molgramostim Nebulizer Solution (Molgramostim) Achieved Statistical Significance for Primary Endpoint and Multiple Secondary Endpoints in IMPALA-2, a Pivotal Phase 3 Clinical Trial in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

    Statistically Significant Improvement in Percent Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Versus Placebo at Week 24 (Primary Endpoint) and Week 48 (Secondary Endpoint) Statistically Significant Improvement in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 24 (Secondary Endpoint) 97% of Patients Completed Double-Blind Treatment Through Week 48 with No Trial Drug Related Adverse Events Leading to Discontinuation 100% of Patients Completing the 48-Week Double-Blind Period Elected to Participate in the 96-Week Open-Label Period Company Plans to Complete BLA Submission in 1H 2025 Company to Host Webcast Conference Call Today, Ju

    6/26/24 6:30:00 AM ET
    $SVRA
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Savara to Host Investor Call to Discuss Top Line Results From Pivotal Phase 3 IMPALA-2 Trial of Molgramostim Nebulizer Solution (Molgramostim) in Patients With Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

    Conference Call to Take Place Tomorrow, Wednesday, June 26, 2024, at 8:00am ET Savara Inc. (NASDAQ:SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that it will host a conference call and webcast tomorrow, Wednesday, June 26, 2024, at 8:00am ET to discuss top line results from the pivotal, Phase 3 IMPALA-2 clinical trial assessing the efficacy and safety of molgramostim, an inhaled form of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with aPAP. The Company plans to issue a press release sharing the top line results at approximately 6:30am ET tomorrow, prior to the start of the c

    6/25/24 8:05:00 PM ET
    $SVRA
    Biotechnology: Pharmaceutical Preparations
    Health Care