What changed in this filing

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Item 9A. Controls and Procedures

2022-03-08 compared with 2021-03-18 · 27 added, 36 removed, 129 unchanged (33% of the section changed)

15 unchanged sentences

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.

Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Our management, with the participation of our principal executive officer and principal financial officer, assessed the effectiveness of our internal control over financial reporting as of December 31, 2021.

2 unchanged sentences

This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting.

For as long as we remain an “emerging growth company” as defined in Section 2(a) of the Securities Act of 1933, or the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012, we intend to take advantage of the exemption permitting us not to comply with the requirement that our independent registered public accounting firm provide an attestation on the effectiveness of our internal control over financial reporting.

For as long as we remain a “ smaller reporting company” as defined by Rule 12b-2 of the Exchange Act and report less than $100 million of annual revenues in our most recent fiscal year , we intend to take advantage of the exemption permitting us not to comply with the requirement that our independent registered public accounting firm provide an attestation on the effectiveness of our internal control over financial reporting.

Changes in Internal Control over Financial Reporting

1 unchanged sentence

OTHER INFORMATION

Entry into Registration Rights Agreement

On March 16, 2021, we entered into a registration rights agreement, or the Registration Rights Agreement, with Baker Brothers Life Sciences, L.P.

and 667, L.P., or the Baker Funds, pursuant to which the Baker Funds are entitled to certain resale registration rights with respect to shares of our common stock held by the Baker Funds, or Registrable Securities.

Under the Registration Rights Agreement, following a request by the Baker Funds, we are obligated to file a resale registration statement on Form S-3, or other appropriate form, covering Registrable Securities.

Under the Registration Rights Agreement, the Baker Funds also have the right to up to two underwritten public offerings or block trades per calendar year, but no more than three underwritten public offerings and eight block trades in total, to effect the sale or distribution of their Registrable Securities, subject to specified exceptions, conditions and limitations.

The Registration Rights Agreement also includes customary indemnification obligations in connection with registrations conducted pursuant to the Registration Rights Agreement.

The rights of the Baker Funds under the Registration Rights Agreement terminate automatically upon the earlier to occur of the following events:

(i) all Registrable Securities covered by the Registration Rights Agreement have been sold pursuant to an effective registration statement;

(ii) all Registrable Securities covered by the Registration Rights Agreement have been sold pursuant to Rule 144, or other similar rule;

(iii) at any time after the Baker Funds are no longer our affiliate, all Registrable Securities covered by the Registration Rights Agreement may be resold by the Baker Funds without limitations as to volume or manner of sale pursuant to Rule 144;

or (iv) ten (10) years after the date of the Registration Rights Agreement.

The foregoing is only a brief description of the terms of the Registration Rights Agreement and the transactions contemplated thereby and is qualified in its entirety by reference to the Agreement that is filed as Exhibit 4.5 hereto.

Appointment of Principal Financial Officer

As previously disclosed, Charles N.

York resigned from his position as Chief Financial Officer and principal financial officer as of February 12, 2021.

On March 16, 2021, the Board of Directors appointed Anthony Quinn, age 59, our current Chief Executive Officer as our principal financial officer, effective immediately.

Quinn has served as a director since March 2016 and has served as our President and Chief Executive Officer since July 2018.

Quinn previously served as our interim Chief Medical Officer between April 2017 and July 2017 and served as our interim Chief Executive Officer between July 2017 and July 2018.

Since October 2015, Dr.

Quinn has worked as a private consultant for IDBioPharm Consulting LLC.

Quinn received a B.MSc in General Pathology and a M.B Ch.B in Medicine from the University of Dundee.

Quinn later earned a Ph.D.

in Cancer Research from the University of Newcastle upon Tyne.

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

42 unchanged sentences

and the Cancer Prevention Research Institute of Texas

Offer Letter, dated June 16, 2014, issued by the Registrant to Mr.

Offer Letter, dated July 18, 2018, by and between the Registrant and Anthony G.

4 unchanged sentences

Severance Agreement dated August 7, 2019 by and between the Registrant and Dr.

Capital on DemandTM Sales Agreement, dated April 16, 2020, by and between Aeglea BioTherapeutics, Inc.

and JonesTrading Institutional Services LLC

License and Supply Agreement, dated March 21, 2021, by and between the Registrant and Immedica Pharma AB

Offer Letter, dated June 14, 2021 issued by the Registrant to Mr.

Jonathan Alspaugh

Severance Agreement dated July 6, 2021 by and between the Registrant and Mr.

Jonathan Alspaugh

Subsidiaries of the Registrant

4 unchanged sentences

Description of Document

Certification of the Principal Executive Officer and Prinicipal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.

Certification of the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C.

Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934

Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934

Certification of the Principal Executive Officer pursuant to 18 U.S.C.

Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Certification of the Principal Financial Officer pursuant to 18 U.S.C.

Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

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

18 unchanged sentences

President, Chief Executive Officer and Director

(Principal Executive Officer and Principal Financial Officer)

(Principal Executive Officer)

POWER OF ATTORNEY

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Anthony G.

Ch.B, Ph.D., jointly and severally, his or her attorneys-in-fact, each with the power of substitution, for him or her in any and all capacities, to sign any amendments to this Report on Form 10-K and to file same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his substitutes, may do or cause to be done by virtue hereof.

and Jonathan Alspaugh, jointly and severally, his attorneys-in-fact, each with the power of substitution, for him in any and all capacities, to sign any amendments to this Report on Form 10-K and to file same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his substitutes, may do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.

3 unchanged sentences

March 8, 2022

(Principal Executive Officer and Principal Financial Officer)

(Principal Executive Officer)

/s/ Jonathan Alspaugh

Chief Financial Officer

March 8, 2022

Jonathan Alspaugh

(Principal Financial Officer)

/s/ Steven Weber

19 unchanged sentences

Alison Lawton

/s/ Sara Brownstein

/s/ Marcio Souza, M.B.A.

March 8, 2022

Sara Brownstein

Marcio Souza, M.B.A.

/s/ Hunter C.

Smith, M.B.A.

March 8, 2022

Smith, M.B.A.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures