Capstone Therapeutics CAPS

Capstone Therapeutics: securities offering (amended)

Form
S-1/A
Filed
Importance
Routine
Document
S-1/A

Not explained yet; the original is on EDGAR.

Securities offering (amended)

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What changed since the last draft

6 changes since the S-1 filed Jun 26, 2015

Compared with the S-1 0001171843-15-003613, filed Jun 26, 2015.

  1. Changed Risk factors and forward looking statements

    We will require substantial additional capital, and/or a development partner, to complete the clinical…

    Adds "These circumstances raise substantial doubt about"; drops "The audit opinion from our independent accounting firm, Moss Adams, LLC, on our December…".

    From the filings

    Before

    We will require substantial additional capital, and/or a development partner, to complete the clinical trials and supporting research and production efforts necessary to obtain FDA or comparable foreign agencies' approval, if any, for our JV's product candidates. Our cash reserves are the primary source of our working capital. The audit opinion from our independent accounting firm, Moss Adams, LLC, on our December 31, 2014 financial statements, included in our Form 10-K filed with the SEC on March 16, 2015 includes a "subject to going concern" qualification.

    Now

    We will require substantial additional capital, and/or a development partner, to complete the clinical trials and supporting research and production efforts necessary to obtain FDA or comparable foreign agencies' approval, if any, for our JV's product candidates. Our cash reserves are the primary source of our working capital. These circumstances raise substantial doubt about the Company's ability to continue as a going concern.
  2. New MD&A

    At May 31, 2015, we had cash and cash equivalents of $1.2 million.

    New paragraph in MD&A.

    From the filings

    Now

    At May 31, 2015, we had cash and cash equivalents of $1.2 million. The JV and Company intend to explore fundraising, partnering or licensing to obtain additional funding to continue development activities of AEM-28 and AEM-28-02. The JV and the Company do not have sufficient funding at this time to continue additional material development activities of AEM-28 and its analogs. These circumstances raise substantial doubt about the Company's ability to continue as a going concern.
  3. Changed Experts

    The consolidated financial statements of Capstone Therapeutics Corp. as of December 31, 2014 and 2013, and…

    Adds "The"; drops "Our".

    From the filings

    Before

    Our consolidated financial statements for the years ended December 31, 2014 and 2013 included in this prospectus were audited by Moss Adams, LLP, an independent registered public accounting firm, as stated in their report appearing with such financial statements (which report expressed a qualified opinion on the financial statements), and are included in reliance upon the report of such firm given upon their authority as experts in accounting and auditing.

    Now

    The consolidated financial statements of Capstone Therapeutics Corp. as of December 31, 2014 and 2013, and for the years then ended, included in this prospectus have been so included in reliance on the report of Moss Adams LLP, an independent registered public accounting firm, as stated in their report appearing with such financial statements (which report includes an explanatory paragraph to an uncertainty with respect to the Company's ability to continue as a going concern) , and given on the authority of said firm as experts in accounting and auditing.
  4. New Where you can find more information

    We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board…

    New paragraph in Where you can find more information.

    From the filings

    Now

    We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
  5. New Where you can find more information

    In our opinion, the consolidated financial statements referred to above present fairly, in all material…

    New paragraph in Where you can find more information.

    From the filings

    Now

    In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of Capstone Therapeutics Corp. as of December 31, 2014 and 2013 and the results of its consolidated operations and its cash flows for each of the two years in the period ended December 31, 2014, in conformity with accounting principles generally accepted in the United States.
  6. New Where you can find more information

    As discussed in Note 1 to the financial statements, the uncertainty with regards to the Company's ability to…

    New paragraph in Where you can find more information.

    From the filings

    Now

    As discussed in Note 1 to the financial statements, the uncertainty with regards to the Company's ability to raise funding to implement the future business strategy of the Company raises substantial doubt about the Company's ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Show the redline

Section by section. Added words and removed words against the earlier filing.

Cover page 1 change

FORM S-1 (AMENDMENT NO. 1)

73 unchanged paragraphs

Prospectus summary 2 changes

3 unchanged paragraphs

Concurrent with the development activities for AEM-28, the JV has performed limited pre-clinical studies that have identified analogs of AEM-28, including one referred to as AEM-28-02, that have the potential of equivalent efficacy, higher human dose toleration and an extended composition of matter patent life. The JV has a development plan to pursue regulatory approval and commercialization of AEM-28, or one or more of its analogs, as treatment in orphan (rare disease) indications, including acute pancreatitis ("AP") and homozygous familial hypercholesterolemia ("HoFH"), and potentially in acute coronary syndrome, peripheral artery disease and metabolic syndrome. HoFH as has been designated by the FDA as an orphan indication. We believe that AP should also qualify for orphan indication designation.

Most of the proceeds of this offering will be made available to our JV to fund the continued development of AEM-28 and its analogs and the remainder will be used to fund our continuing operations. We have not agreed with our JV regarding the manner in which offering proceeds will be made available to the JV. Proceeds from the offering could be made available through loans or equity contributions by us to the JV, or in some combination of debt and equity. If all of the Units offered hereby are sold, we believe that we will have sufficient funds for our JV to complete the preclinical development and possibly Phase 1a and Phase1b/2a clinical trials as well for AEM 28-02, but we cannot predict the total cost of these efforts which depends on, among other things, successful and timely outcomes in our preclinical and clinical studies. In any event, our JV will require substantial additional capital, and/or a development partner, to complete the clinical trials and supporting research and production efforts necessary to obtain FDA or comparable foreign agencies' approval, if any, for our JV's product candidates. We may seek to obtain the necessary additional funding through the issuance of debt and/or equity securities by us or our JV in one or more private or public offerings in the future (which could include bridge financing from certain of our significant existing stockholders), through a strategic partner arrangement or otherwise. In addition, our JV currently is exploring potential sub-licensing of AEM-28 and/or its analogs for development in indications not being actively pursued by the joint venture.

46 unchanged paragraphs

Risk factors and forward looking statements 2 changes

14 unchanged paragraphs

We will require substantial additional capital, and/or a development partner, to complete the clinical trials and supporting research and production efforts necessary to obtain FDA or comparable foreign agencies' approval, if any, for our JV's product candidates. Our cash reserves are the primary source of our working capital. The audit opinion from our independent accounting firm, Moss Adams, LLC, on our December 31, 2014 financial statements, included in our Form 10-K filed with These circumstances raise substantial doubt about the SEC on March 16, 2015 includes a "subject Company's ability to continue as a going concern. qualification.

88 unchanged paragraphs

We intend to use most of the net proceeds we receive from the sale of securities to extend the development of AEM-28 and its analogs, and the remainder for other general corporate purposes, including working capital needs. We have not agreed with our JV regarding the manner in which offering proceeds will be made available to the JV. Proceeds from the offering could be made available through loans or equity contributions by us to the JV, or in some combination of debt and equity. In particular, planned uses by the JV of the net proceeds from the offering, to the extent such proceeds are sufficient, include:

8 unchanged paragraphs

Information with respect to the company 1 change

2 unchanged paragraphs

Concurrent with the development activities for AEM-28, the JV has performed limited pre-clinical studies that have identified analogs of AEM-28, including one referred to as AEM-28-02, that have the potential of equivalent efficacy, higher human dose toleration and an extended composition of matter patent life. The JV has a development plan to pursue regulatory approval and commercialization of AEM-28, or one or more of its analogs, as treatment in orphan (rare disease) indications, including AP and HoFH, and potentially in acute coronary syndrome, peripheral artery disease and metabolic syndrome. HoFH as has been designated by the FDA as an orphan indication. We believe that AP should also qualify for orphan indication designation.

40 unchanged paragraphs

MD&A 2 changes

38 unchanged paragraphs

On August 3, 2012, we entered into our joint venture, LipimetiX Development, Inc, to develop Apo E mimetic peptide molecule AEM-28 and its analogs. As of June 24, 2015, we have contributed $6.0 million and loaned an additional $700,000 to our JV. At May 31, 2015, we had cash and cash equivalents of $1.2 million on a consolidated basis with our JV.

At May 31, 2015, we had cash and cash equivalents of $1.2 million. The JV and Company intend to explore fundraising, partnering or licensing to obtain additional funding to continue development activities of AEM-28 and AEM-28-02. The JV and the Company do not have sufficient funding at this time to continue additional material development activities of AEM-28 and its analogs. These circumstances raise substantial doubt about the Company's ability to continue as a going concern.

4 unchanged paragraphs

Experts 1 change

Our The consolidated financial statements for the years ended of Capstone Therapeutics Corp. as of December 31, 2014 and 2013, and for the years then ended, included in this prospectus were audited by have been so included in reliance on the report of Moss Adams LLP, an independent registered public accounting firm, as stated in their report appearing with such financial statements (which report expressed a qualified opinion on includes an explanatory paragraph to an uncertainty with respect to the financial statements), Company's ability to continue as a going concern) , and are included in reliance upon given on the report authority of such said firm given upon their authority as experts in accounting and auditing.

Where you can find more information 4 changes

8 unchanged paragraphs

Consolidated Statements of Operations for the years ended December 31, 2014 and 2013 Consolidated Statements of Changes in Equity for the period from December 31, 2012 to December 31, 2014 Consolidated Statements of Cash Flows for the years ended December 31, 2014 and 2013 Condensed Consolidated Balance Sheets at March 31, 2015 (unaudited) and December 31, 2014 Condensed Consolidated Statements of Operations for the three months ended March 31, 2015 and 2014 (unaudited) Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2015 and 2014 (unaudited) REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM * * The Board of Directors and Stockholders of Capstone Therapeutics Corp. We have audited the accompanying consolidated balance sheets of Capstone Therapeutics Corp. (the "Company") as of December 31, 2014 and 2013 and the related consolidated statements of operations, changes in equity, and cash flows for each of the two years in the period ended December 31, 2014. These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to be provided by amendment. express an opinion on these consolidated financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of Capstone Therapeutics Corp. as of December 31, 2014 and 2013 and the results of its consolidated operations and its cash flows for each of the two years in the period ended December 31, 2014, in conformity with accounting principles generally accepted in the United States.

As discussed in Note 1 to the financial statements, the uncertainty with regards to the Company's ability to raise funding to implement the future business strategy of the Company raises substantial doubt about the Company's ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

53 unchanged paragraphs

Undertakings 5 changes

12 unchanged paragraphs

Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing this Amendment No. 1 to the Registration Statement on Form S-1 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Tempe, State of Arizona, on June 26, July 2, 2015.

4 unchanged paragraphs

Pursuant to the requirements of the Securities Act of 1933, as amended, this Amendment No. 1 to the Registration Statement on Form S-1 has been signed by the following persons in the capacities and on the date indicated.* Signature Title /s/ John M. Holliman, III Executive Chairman (Principal Executive Officer), John M. Holliman, III Chairman of the Board and Director /s/ Les M. Taeger Senior Vice President and Chief Financial Officer Les M. Taeger (Principal Financial and Accounting Officer) /s/ Eric W. Fangmann Director Eric W. Fangmann.

4 unchanged paragraphs

*Each of the above signatures is affixed as of June 26, July 2, 2015.

5 unchanged paragraphs

Certificate of Conversion of Lipimetix Development, LLC, effective as of June 23, 25, 2015 Exhibit 2.1 to the Company's Registration Statement on Form S-1 filed with the SEC on June 26, 2015 2.2 Plan of Conversion of Lipimetix Development, LLC, effective as of June 23, 25, 2015 Exhibit 2.2 to the Company's Registration Statement on Form S-1 filed with the SEC on June 26, 2015 3.1 Second Amended and Restated Certificate of Incorporation, as amended through June 22, 2015, including the Amended and Restated Certificate of Designation of Series A Preferred Stock, executed June 24, 2014 Exhibit 3.1 to the Company's Registration Statement on Form S-1 filed with the SEC on June 26, 2015 3.2 Bylaws of the Company Exhibit 4.2 to the Company's Registration Statement on Form S-8 filed with the SEC on June 23, 2015 3.3 Certificate of Incorporation of Lipimetix Development, Inc., Bylaws of LipimetiX Development, Inc. Exhibit 3.3 to the Company's Registration Statement on Form S-1 filed with the SEC on June 26, 2015 4.1 Class A Warrant Agreement dated February 24, 2006, between OrthoLogic Corp. and PharmaBio Development Inc. (d/b/a NovaQuest) Exhibit 4.1 to the Company's Current Report on Form 8-K filed with the SEC on March 3, 2006 4.2 Class A Warrant Agreement dated June 30, 2006 by and between OrthoLogic Corp. and PharmaBio Development Inc. Exhibit 4.1 to the Company's Current Report on Form 8-K filed with the SEC on July 6, 2006 4.3 Amended and Restated Class B Warrant Agreement dated February 24, 2006, and amended and restated as of June 30, 2006, between OrthoLogic Corp. and PharmaBio Development Inc. (d/b/a NovaQuest) (asterisks located within exhibit denote information that has been redacted pursuant to a request for confidential treatment filed with the SEC) Exhibit 4.4 to the Company's Amendment No. 1 to Registration Statement on Form 8-A/A filed with the SEC on May 25, 2010.

7 unchanged paragraphs

Exhibit 10.4 to the Company's Quarterly Report on Form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012 10.21 Accounting Services Agreement by and among LipimetiX Development, LLC and Capstone Therapeutics Corp., effective as of August 3, 2012 Exhibit 10.5 to the Company's Quarterly Report on Form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012 10.22 Escrow Agreement by and among Capstone Therapeutics Corp., LipimetiX Development, LLC dated as of August 3, 2012 Exhibit 10.6 to the Company's Quarterly Report on Form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012 10.23 Exclusive License Agreement between the UAB Research Foundation and LipimetiX LLC dated August 26, 2011 Exhibit 10.7 to the Company's Quarterly Report on Form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012 10.24 Second Amendment to Exclusive License Agreement between the UAB Research Foundation and LipimetiX, LLC, last signed on January 26, 2015 Exhibit 10.1 to the Company's Current Report on Form 8-K filed with the SEC on January 30, 3015 10.25 Capstone Therapeutics Corp. Joint Venture Bonus Plan Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the period ended September 30, 2012, filed with the SEC on November 8, 2012 10.26 Accounting Services Agreement Amendment #1, dated August 23, 2013 Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the period ended September 30, 2013, filed with the SEC on November 12, 2013 10.27 Capstone Therapeutics Corp. 2015 Equity Incentive Compensation Plan Exhibit 10.1 to the Company's Current Report on Form 8-K filed with the SEC on June 22, 2015 10.28 Form of Incentive Stock Option Grant Letter for Grants under the 2015 Equity Incentive Plan Exhibit 10.2 to the Company's Current Report on Form 8-K filed with the SEC on June 22, 2015 10.29 Form of Non-Qualified Stock Option Grant Letter for Grants to Directors under the 2015 Equity Incentive Plan Exhibit 10.3 to the Company's Current Report on Form 8-K filed with the SEC on June 22, 2015 10.30 Form of Non-Qualified Stock Option Grant Letter for Grants to Consultants under the 2015 Equity Incentive Plan Exhibit 10.4 to the Company's Current Report on Form 8-K filed with the SEC on June 22, 2015 10.31 Stockholders Agreement, dated as of June 23, 2015, by and among LipimetiX Development, Inc. and the stockholders named therein Exhibit 10.31 to the Company's Registration Statement on Form S-1 filed with the SEC on June 26, 2015 23.1 Consent of Moss Adams LLP (***) 23.2 Consent of Quarles & Brady LLP (***) 24.1 Powers of Attorney (Included on the Signature Page) * Capstone Therapeutics Corp. has entered into separate indemnification agreements with each of its current directors and executive officers that differ only in party names and dates. Pursuant to the instructions accompanying Item 601 of Regulation S-K, Capstone has filed the form of such indemnification agreement.

3 unchanged paragraphs

Unchanged: About this prospectus, Plan of distribution, Competition, Description of property, Legal proceedings, Our common equity and related stockholder matters, Management, Transactions with related persons, Description of our capital stock, Legal matters, Notes to the financial statements, Note 2: INVESTMENTS, Note 3: FURNITURE AND EQUIPMENT, Note 4: INCOME TAXES, Note 6: COMMITMENTS, Note 8: AUTHORIZED PREFERRED STOCK, Note 10: CONTINGENCY – LEGAL PROCEEDINGS, Note A: OVERVIEW OF BUSINESS, Note B: JOINT VENTURE FOR DEVELOPMENT OF APO E MIMETIC PEPTIDE MOLECULE AEM-28 AND ANALOGS, Note C: CONTINGENCY – LEGAL PROCEEDINGS - SUBSEQUENT EVENT, Note D: Australian Refundable Research & Development Credit, Other Expenses of Issuance and Distribution, Indemnification of Directors and Officers, Recent Sale of Unregistered Securities, Exhibits

Compared by code from the two drafts’ text: offering terms first, then sections and risk factors added or removed, numbers that moved, and rewording. No model wrote this list. Not investment advice.

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