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    Amendment: SEC Form 10-K/A filed by Savara Inc.

    4/25/25 4:03:07 PM ET
    $SVRA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $SVRA alert in real time by email
    10-K/A
    true0001160308FY00011603082025-03-2700011603082024-01-012024-12-3100011603082024-06-30xbrli:sharesiso4217:USD

     

    mt

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    Washington, D.C. 20549

     

    FORM 10-K/A

    Amendment No. 1

    (Mark One)

    ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

    For the fiscal year ended December 31, 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 001-32157

    img199040218_0.jpg

    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 No.)

    1717 Langhorne Newtown Road, Suite 300 Langhorne, Pennsylvania

    19047

    (Address of principal executive offices)

    (Zip Code)

    Registrant’s telephone number, including area code: (512) 614-1848

    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 $0.001 per share

     

    SVRA

     

    The Nasdaq Global Select Market

     

    Securities registered pursuant to Section 12(g) of the Act: None

    Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

    Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒

    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 has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

    If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

    Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

    Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

    The aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant, based on the closing price of the shares of common stock on The Nasdaq Global Select Market on June 30, 2024, (the last business day of the registrant’s most recently completed second fiscal quarter), was $544,458,670.

    The number of shares of Registrant’s Common Stock outstanding as of March 27, 2025 was 172,633,140.

    Portions of the Registrant’s Definitive Proxy Statement relating to the Annual Meeting of Shareholders, scheduled to be held on June 5, 2025, are incorporated by reference into Part III of this Report.

     

     

     


     

    EXPLANATORY NOTE

     

    Savara Inc. (the “Company") is filing this Amendment No. 1 on Form 10-K/A (this “Amendment”) to amend the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “Original Filing”), which was originally filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 27, 2025 (the “Original Filing Date”). The sole purpose of this Amendment is to supplement the Exhibits contained in Item 15(a) of Part IV of the Original Filing to include Exhibit 19.1, the Company’s Insider Trading and Disclosure Policy, which was inadvertently omitted in the Original Filing.

     

    This Amendment is an exhibit-only filing. Except as described above, no changes have been made to the Original Filing and this Amendment does not modify, amend, or update in any way any of the financial or other information contained in the Original Filing. This Amendment does not reflect events that may have occurred subsequent to the Original Filing Date. Accordingly, this Amendment should be read in conjunction with the Original Filing and the Company’s other filings with the SEC.

     

    Pursuant to Rule 12b-15 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), currently dated certifications are filed herewith as exhibits to this Amendment pursuant to Rule 13a-14(a) or 15d-14(a) of the Exchange Act under Item 15(a) of Part IV hereof. Because no financial statements have been included in this Amendment and this Amendment does not contain any disclosure with respect to Items 307 and 308 of Regulation S-K, paragraphs 3, 4, and 5 of the certifications have been omitted. Similarly, because no financial statements have been included in this Amendment, certifications pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 have been omitted.

     

     

     

     


     

    PART IV

    Item 15. Exhibits, Financial Statement Schedules

    Exhibit Index

     

    Exhibit Number

     

    Description

    3.1

     

    Savara Inc. Certificate of Amendment to Amended and Restated Certificate of Incorporation (Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on June 7, 2024).

    3.2

     

    Amended and Restated Bylaws of Savara, Inc., dated March 28, 2023 (Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on March 30, 2023).

    4.1

     

    Form of common stock certificate of the Registrant (Incorporated by reference to Exhibit 4.1 to the Registrant’s Annual Report on Form 10-K filed on March 14, 2018.)

    4.2

     

    Warrant to Purchase Shares of Common Stock of the Registrant issued to Life Science Loans II, LLC on April 28, 2017 (Incorporated by reference to Exhibit 4.3 to the Registrant’s Quarterly Report on Form 10-Q filed on May 9, 2017.)

    4.3

     

    Warrant to Purchase Shares of Common Stock of the Registrant issued to Silicon Valley Bank on April 28, 2017 (Incorporated by reference to Exhibit 4.2 to the Registrant’s Quarterly Report on Form 10-Q filed on May 9, 2017.)

    4.4

     

    Amendment to Warrant to Purchase Shares of Common Stock of the Registrant issued to Life Science Loans II, LLC on June 26, 2017. (Incorporated by reference to Exhibit 4.1 to the Registrant’s Quarterly Report on Form 10-Q filed on August 9, 2017.)

    4.5

     

    Amendment to Warrant to Purchase Shares of Common Stock of the Registrant issued to SVB Financial Group on June 26, 2017. (Incorporated by reference to Exhibit 4.2 to the Registrant’s Quarterly Report on Form 10-Q filed on August 9, 2017.)

    4.6

     

    Warrant to Purchase Shares of Common Stock of the Registrant issued to Life Science Loans II, LLC on June 26, 2017. (Incorporated by reference to Exhibit 4.3 to the Registrant’s Quarterly Report on Form 10-Q filed on August 9, 2017.)

    4.7

     

    Warrant to Purchase Shares of Common Stock of the Registrant issued to Silicon Valley Bank on June 26, 2017. (Incorporated by reference to Exhibit 4.4 to the Registrant’s Quarterly Report on Form 10-Q filed on August 9, 2017.)

    4.8

     

    Form of Pre-Funded Warrant (Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on October 25, 2017.)

    4.9

     

    Warrant to Purchase Shares of Common Stock of the Registrant issued to Life Science Loans II, LLC on December 4, 2018. (Incorporated by reference to Exhibit 4.19 to the Registrant’s Annual Report on Form 10-K filed on March 13, 2019.)

    4.10

     

    Warrant to Purchase Shares of Common Stock of the Registrant issued to Silicon Valley Bank on December 4, 2018. (Incorporated by reference to Exhibit 4.20 to the Registrant’s Annual Report on Form 10-K filed on March 13, 2019.)

    4.11

     

    Form of Common Stock Purchase Warrant (Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on December 20, 2019.)

    4.12

     

    Form of Pre-Funded Common Stock Purchase Warrant (Incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed on December 20, 2019.)

    4.13

     

    Second Amendment to Warrant to Purchase Common Stock dated January 31, 2020, to Warrant to Purchase Common Stock of the Registrant issued to Life Science Loans II, LLC on April 28, 2017 (as amended by that certain Amendment to Warrant to Purchase Common Stock dated as of June 26, 2017) (Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on February 3, 2020.)

    4.14

     

    Second Amendment to Warrant to Purchase Common Stock dated January 31, 2020, to Warrant to Purchase Common Stock of the Registrant issued to Silicon Valley Bank on April 28, 2017 (as amended by that certain Amendment to Warrant to Purchase Common Stock dated as of June 26, 2017) (Incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed on February 3, 2020.)

    4.15

     

    Amendment to Warrant to Purchase Common Stock of the Registrant dated January 31, 2020, to Warrant to Purchase Common Stock of the Registrant issued to Life Science Loans II, LLC on June 26, 2017 (Incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K filed on February 3, 2020.)

    4.16

     

    Amendment to Warrant to Purchase Common Stock of the Registrant dated January 31, 2020, to Warrant to Purchase Common Stock of the Registrant issued to Silicon Valley Bank on June 26, 2017 (Incorporated by reference to Exhibit 4.4 to the Registrant’s Current Report on Form 8-K filed on February 3, 2020.)

     


     

    4.17

     

    Amendment to Warrant to Purchase Common Stock of the Registrant dated January 31, 2020, to Warrant to Purchase Common Stock of the Registrant issued to Life Science Loans II, LLC on December 4, 2018 (Incorporated by reference to Exhibit 4.5 to the Registrant’s Current Report on Form 8-K filed on February 3, 2020.)

    4.18

     

    Amendment to Warrant to Purchase Common Stock of the Registrant dated January 31, 2020, to Warrant to Purchase Common Stock of the Registrant issued to Silicon Valley Bank on December 4, 2018 (Incorporated by reference to Exhibit 4.6 to the Registrant’s Current Report on Form 8-K filed on February 3, 2020.)

    4.19

     

    Description of Registered Securities (Incorporated by reference to Exhibit 4.25 to the Registrant’s Annual Report on Form 10-K filed on March 12, 2020.)

    4.20

     

    Form of Pre-Funded Warrant (Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on March 11, 2021.)

    4.21

     

    Form of Pre-Funded Warrant (Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on July 13, 2023).

    10.1

     

    Amended and Restated Loan and Security Agreement, dated April 21, 2022, between the Registrant and its subsidiary, Aravas Inc., as borrowers, and Silicon Valley Bank (Incorporated by reference to Exhibit 10.1 to the Registrant's Quarterly Report on Form 10-Q filed on May 11, 2022.)

    10.2

    #

    Savara Inc. Amended and Restated 2015 Omnibus Incentive Plan, as amended (Incorporated by reference to Appendix A of the Registrant’s Proxy Statement filed on April 19, 2022.)

    10.3

    #

    Form of Non-Statutory Stock Option Grant Agreement – Director (for grants to non-employee directors) under the 2015 Omnibus Incentive Plan (Incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on June 16, 2015.)

    10.4

    #

    Form of Incentive Stock Option Grant Agreement – Exempt Employees under the 2015 Omnibus Incentive Plan (Incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed on June 16, 2015.)

    10.5

    #

    Form of Incentive Stock Option Grant Agreement – Non-Exempt Employees under the 2015 Omnibus Incentive Plan (Incorporated by reference to Exhibit 10.4 to the Registrant’s Current Report on Form 8-K filed on June 16, 2015.)

    10.6

    #

    Form of Non-Statutory Stock Option Grant Agreement – General under the 2015 Omnibus Incentive Plan (Incorporated by reference to Exhibit 10.8 to the Registrant’s Annual Report on Form 10-K filed on March 14, 2018.)

    10.7

    #

    Form of Grant of Restricted Stock Units under the 2015 Omnibus Incentive Plan. (Incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q filed on November 8, 2017.)

    10.8

    #

    Aravas Inc. (formerly Savara Inc.) Stock Option Plan (Incorporated by reference to Exhibit 10.53 to the Registrant’s Registration Statement on Form S-4 filed on February 10, 2017.)

    10.9

    #

    Aravas Inc. (formerly Savara Inc.) Form of Incentive Stock Option Agreement (Incorporated by reference to Exhibit 10.54 to the Registrant’s Registration Statement on Form S-4 filed on February 10, 2017.)

    10.10

     

    Savara Inc. 2021 Inducement Equity Incentive Plan (Incorporated by reference to Exhibit 4.1 to the Registrant's Registration Statement on Form S-8 filed on January 20 2023.)

    10.11

     

    Form of Non-Statutory Stock Option Agreement – Under the 2021 Inducement Equity Incentive Plan (Incorporated by reference to Exhibit 10.16 to the Registrant’s Annual Report on Form 10-K filed on March 30, 2022.)

    10.12

     

    Form of Restricted Stock Unit Agreement (Inducement Award) – Under the 2021 Inducement Equity Incentive Plan (Incorporated by reference to Exhibit 10.17 to the Registrant’s Annual Report on Form 10-K filed on March 30, 2022.)

    10.13

    #

    Form of Director and Officer Indemnification Agreement (Incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on October 23, 2006.)

    10.14

    +

    Commercial Supply Agreement dated April 24, 2015 between PARI Pharma GmbH and Serendex Pharmaceuticals A/S (Incorporated by reference to Exhibit 10.62 to the Registrant’s Registration Statement on Form S-4 filed on February 10, 2017.)

    10.15

    +

    Research Collaboration and License Agreement dated November 7, 2014 between PARI Pharma GmbH and Serendex Pharmaceuticals A/S (Incorporated by reference to Exhibit 10.63 to the Registrant’s Registration Statement on Form S-4 filed on February 10, 2017.)

    1016

    +

    Amendment No. 1, effective May 23, 2018, to the Research Collaboration and License Agreement between Savara Inc. (as successor in interest to Serendex Pharmaceuticals A/S) and PARI Pharma GmbH dated November 7, 2014 (Incorporated by reference to Exhibit 10.3 of the Registrant’s Quarterly Report on Form 10-Q filed on August 9, 2018.)

    10.17

     

    Securities Purchase Agreement (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on December 20, 2019.)

     


     

    10.18

     

    Registration Rights Agreement (Incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on December 20, 2019.)

    10.19

    +

    Manufacture and Supply Agreement, dated as of April 26, 2019, between Savara ApS and GEMABIOTECH SAU (Incorporated by reference to Exhibit 10.1 of the Registrant’s Quarterly Report on Form 10-Q filed on May 9, 2019.)

    10.20

    +

    Master Services Agreement by and between Savara Inc. and Parexel International (IRL) Limited, effective January 6, 2021 (Incorporated by reference to Exhibit 10.4 of the Registrant's Quarterly Report on Form 10-Q filed on May 13, 2021.)

    10.21

    +

    Work Order under Master Services Agreement by and between Savara Inc. and Parexel International (IRL) Limited, effective January 6, 2021 (Incorporated by reference to Exhibit 10.5 of the Registrant's Quarterly Report on Form 10-Q filed on May 13, 2021.)

    10.22

     

    Sales Agreement, dated July 6, 2021, between the Registrant and Evercore Group L.L.C. (Incorporated by reference to Exhibit 1.2 of the Registrant’s Registration Statement on Form S-3 filed on July 6, 2021.)

    10.23

     

    Amended and Restated Executive Employment Agreement, dated December 13, 2022, between Savara Inc. and Matthew Pauls (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on December 15, 2022.)

    10.24

     

    Amended and Restated Executive Employment Agreement, dated December 13, 2022, between Savara Inc. and David Lowrance (Incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on December 15, 2022.)

    10.25

    +

    Amendment No. 1 to the Manufacture and Supply Agreement, dated December 7, 2022 entered into by and between Savara ApS and GEMABIOTECH SAU (Incorporated by reference to Exhibit 10.33 to the Registrant’s Annual Report on Form 10-K filed on March 30, 2023.)

    10.26

     

    Executive Employment Agreement, dated November 10, 2022, between Savara Inc. and Raymond D. Pratt, M.D. (Incorporated by reference to Exhibit 10.34 to the Registrant’s Annual Report on Form 10-K filed on March 30, 2023.)

    10.27

     

    Executive Employment Agreement, dated February 13, 2023, between Savara Inc. and Rob Lutz (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on February 13, 2023.)

    10.28

     

    Lease Agreement, dated July 7, 2021, between Savara Inc. and 1717 OSSRE, LLC. (Incorporated by reference to Exhibit 10.1 of the Registrant's Quarterly Report on Form 10-Q filed on May 15, 2023.)

    10.29

     

    First Amendment to Lease Agreement, dated February 28, 2023, between Savara Inc. and 1717 OSSRE, LLC. (Incorporated by reference to Exhibit 10.1 of the Registrant's Quarterly Report on Form 10-Q filed on May 15, 2023.)

    10.30

    +

    Amendment No. 2 to the Manufacture and Supply Agreement, dated December 13, 2023 entered into by and between Savara ApS GEMABIOTECH SAU (Incorporated by reference to Exhibit 10.36 to the Registrant’s Annual Report on Form 10-K filed on March 7, 2024.)

     


     

    10.31

    +

    Master Services Agreement, dated February 13, 2024, by and between Fujifilm Diosynth Biotechnologies UK Limited, Fujifilm Diosynth Biotechnologies Texas, LLC, and Fujifilm Diosynth Biotechnologies U.S.A., Inc. and Savara Inc. (Incorporated by reference to Exhibit 10.1 of the Registrant's Quarterly Report on Form 10-Q filed on May 9, 2024.)

    10.32

     

    Savara Inc. 2021 Inducement Equity Incentive Plan, as amended (Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-8 filed on March 7, 2024).

    10.33

     

    Savara Inc. 2024 Omnibus Incentive Plan (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K/A (Amendment No. 1) filed on June 10, 2024).

    10.34

     

    Savara Inc. 2021 Inducement Equity Incentive Plan, as amended (Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-8 filed on October 1, 2024).

    10.35

    #

    Form of Incentive Stock Option Award Agreement under the 2024 Omnibus Incentive Plan. (Incorporated by reference to Exhibit 10.2 of the Registrant's Quarterly Report on Form 10-Q filed on November 12, 2024.)

    10.36

    #

    Form of Nonqualified Stock Option Award Agreement under the 2024 Omnibus Incentive Plan. (Incorporated by reference to Exhibit 10.3 of the Registrant's Quarterly Report on Form 10-Q filed on November 12, 2024.)

    10.37

    #

    Form of Restricted Stock Unit Award Agreement under the 2024 Omnibus Incentive Plan. (Incorporated by reference to Exhibit 10.4 of the Registrant's Quarterly Report on Form 10-Q filed on November 12, 2024.)

    10.38

     

    Executive Employment Agreement, dated October 15, 2024, between Savara Inc. and Braden Parker.

    10.39

     

    Executive Employment Agreement, dated August 24, 2023, between Savara Inc. and Anne Erickson.

    10.40

     

    Amended and Restated Executive Employment Agreement, dated March 13, 2025, between Savara Inc. and Kathleen McCabe.

    10.41

    +

    Master Services Agreement by and between Savara ApS and Selvita S.A., effective January 17, 2024.

    19.1

    *

    Insider Trading and Disclosure Policy.

    21.1

     

    List of Subsidiaries (Incorporated by reference to Exhibit 21.1 to the Registrant’s Annual Report on Form 10-K filed on March 30, 2023.)

    23.1

     

    Consent of RSM US LLP, Independent Registered Public Accounting Firm

    24.1

     

    Power of Attorney (included on signature page)

    31.1

    *

    Certification of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a)

    31.2

    *

    Certification of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a)

    32.1

    **

    Certification of principal executive officer and principal financial officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

    97

     

    Clawback Policy

    101.INS

     

    Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.

    101.SCH

     

    Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents

    104

     

    Cover Page Interactive Data File (embedded within the Inline XBRL document)

     

    #

    Indicates management contract or compensatory plan

     

    *

    Filed herewith.

     

    +

    Indicates confidential treatment has been granted to certain portions of this exhibit, which portions have been omitted and filed separately with the SEC.

     

    **

    These certifications are being furnished solely to accompany this report pursuant to 18 U.S.C. 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation by reference language in such filing.

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     


     

    Signatures

     

     

    Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

     

    SAVARA INC.

    Date: April 25, 2025 By: /s/ David Lowrance David Lowrance Chief Financial and Administrative Officer

     

     


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      11/10/22 4:05:00 PM ET
      $SVRA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Savara Announces Resignation of Chief Medical Officer

      Savara Inc. (NASDAQ:SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that Badrul Chowdhury, M.D., Ph.D., has resigned from his role as Chief Medical Officer, effective September 9, 2022. "We appreciate Dr. Chowdhury's contributions during his tenure with the company," said Matt Pauls, Chair and CEO, Savara. "His leadership helped progress our molgramostim nebulizer solution (molgramostim) development program through some important milestones and we wish him well in the future." "I am pleased to have been part of the Savara team and wish the company success in the continued development of molgramostim for the treatment of the rare lung

      8/26/22 8:05:00 AM ET
      $SVRA
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $SVRA
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    • Savara Receives Refusal to File (RTF) Letter From the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for MOLBREEVI* to Treat Patients With Autoimmune Pulmonary Alveolar Proteinosis (autoimmune PAP)

      Savara Inc. (NASDAQ:SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced that the Company received an RTF letter from the FDA for the BLA of MOLBREEVI as a therapy to treat patients with autoimmune PAP. Upon preliminary review, the FDA determined that the BLA submitted in March 2025 was not sufficiently complete to permit substantive review and requested additional data related to Chemistry, Manufacturing, and Controls (CMC). The RTF was not the result of safety concerns, and the FDA did not request or recommend additional efficacy studies. Within the next 30 days, the Company intends to request a Type A meeting with the Age

      5/27/25 8:05:00 AM ET
      $SVRA
      Biotechnology: Pharmaceutical Preparations
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    • Savara Announces New Employment Inducement Grant

      Savara Inc. (NASDAQ:SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the grant of inducement awards to five new employees. On May 21, 2025, the Compensation Committee of Savara's Board of Directors granted the inducement awards to five new employees who recently joined the Company. The inducement awards consist of options to purchase an aggregate of 85,000 shares of the Company's common stock and restricted stock units (RSUs) covering an aggregate of 75,000 shares of the Company's common stock. These equity awards were granted under the Savara Inc. 2021 Inducement Equity Incentive Plan pursuant to Rule 5635(c)(4) of the NASDAQ Listing

      5/23/25 4:05:00 PM ET
      $SVRA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Savara Announces Participation in Jefferies Global Healthcare Conference

      Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced members of the management team will host 1x1 meetings and present at the Jefferies Global Healthcare Conference on June 4, 2025, at 9:20am ET/6:20am PT. The live webcast and subsequent replay will be available on the "Events & Presentations" section of the Company's corporate website and will be archived for 90 days. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development

      5/22/25 9:05:00 AM ET
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      Biotechnology: Pharmaceutical Preparations
      Health Care

    $SVRA
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    • Savara downgraded by H.C. Wainwright with a new price target

      H.C. Wainwright downgraded Savara from Buy to Neutral and set a new price target of $2.00

      5/29/25 8:15:44 AM ET
      $SVRA
      Biotechnology: Pharmaceutical Preparations
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    • Wells Fargo initiated coverage on Savara with a new price target

      Wells Fargo initiated coverage of Savara with a rating of Overweight and set a new price target of $8.00

      12/20/24 7:52:08 AM ET
      $SVRA
      Biotechnology: Pharmaceutical Preparations
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    • Savara downgraded by Evercore ISI with a new price target

      Evercore ISI downgraded Savara from Outperform to In-line and set a new price target of $5.00 from $7.00 previously

      11/13/24 8:25:47 AM ET
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      Biotechnology: Pharmaceutical Preparations
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    • Director Hawkins Richard J bought $98,572 worth of shares (48,225 units at $2.04), increasing direct ownership by 72% to 115,466 units (SEC Form 4)

      4 - Savara Inc (0001160308) (Issuer)

      6/23/25 2:39:22 PM ET
      $SVRA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Director Mccracken Joseph S bought $20,825 worth of shares (10,000 units at $2.08), increasing direct ownership by 4% to 260,837 units (SEC Form 4)

      4 - Savara Inc (0001160308) (Issuer)

      6/2/25 7:59:29 AM ET
      $SVRA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Director Ramsay David A bought $416,250 worth of shares (150,000 units at $2.77), increasing direct ownership by 6% to 2,513,642 units (SEC Form 4)

      4 - Savara Inc (0001160308) (Issuer)

      4/1/25 7:00:04 AM ET
      $SVRA
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    • Director Hawkins Richard J bought $98,572 worth of shares (48,225 units at $2.04), increasing direct ownership by 72% to 115,466 units (SEC Form 4)

      4 - Savara Inc (0001160308) (Issuer)

      6/23/25 2:39:22 PM ET
      $SVRA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Director Mccracken Joseph S bought $20,825 worth of shares (10,000 units at $2.08), increasing direct ownership by 4% to 260,837 units (SEC Form 4)

      4 - Savara Inc (0001160308) (Issuer)

      6/2/25 7:59:29 AM ET
      $SVRA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Director Ramsay David A bought $416,250 worth of shares (150,000 units at $2.77), increasing direct ownership by 6% to 2,513,642 units (SEC Form 4)

      4 - Savara Inc (0001160308) (Issuer)

      4/1/25 7:00:04 AM ET
      $SVRA
      Biotechnology: Pharmaceutical Preparations
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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

    $SVRA
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    • SEC Form SC 13G filed by Savara Inc.

      SC 13G - Savara Inc (0001160308) (Subject)

      11/27/24 11:01:58 AM ET
      $SVRA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Amendment: SEC Form SC 13G/A filed by Savara Inc.

      SC 13G/A - Savara Inc (0001160308) (Subject)

      11/14/24 5:48:34 PM ET
      $SVRA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Amendment: SEC Form SC 13G/A filed by Savara Inc.

      SC 13G/A - Savara Inc (0001160308) (Subject)

      11/12/24 10:25:33 AM ET
      $SVRA
      Biotechnology: Pharmaceutical Preparations
      Health Care