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Co-Diagnostics, Inc.
Response Received
1 company response(s)
Medium - date proximity
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Co-Diagnostics, Inc.
Response Received
1 company response(s)
Medium - date proximity
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Co-Diagnostics, Inc.
Response Received
1 company response(s)
High - file number match
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Co-Diagnostics, Inc.
Response Received
1 company response(s)
High - file number match
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Co-Diagnostics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2018-08-29
Co-Diagnostics, Inc.
Filing - SEC Comment Letter to Co-Diagnostics, Inc.
UPLOAD · 2018-08-29
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Company responded
2018-09-05
Co-Diagnostics, Inc.
Filing - Correspondence from Co-Diagnostics, Inc.
CORRESP · 2018-09-05
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Co-Diagnostics, Inc.
Response Received
5 company response(s)
High - file number match
Company responded
2017-05-24
Co-Diagnostics, Inc.
References: May 17, 2017
Filing - Correspondence from Co-Diagnostics, Inc.
CORRESP · 2017-05-24
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SEC wrote to company
2017-06-05
Co-Diagnostics, Inc.
Filing - SEC Comment Letter to Co-Diagnostics, Inc.
UPLOAD · 2017-06-05
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Company responded
2017-06-09
Co-Diagnostics, Inc.
References: June 2, 2017
Filing - Correspondence from Co-Diagnostics, Inc.
CORRESP · 2017-06-09
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Company responded
2017-06-28
Co-Diagnostics, Inc.
Filing - Correspondence from Co-Diagnostics, Inc.
CORRESP · 2017-06-28
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Company responded
2017-07-11
Co-Diagnostics, Inc.
Filing - Correspondence from Co-Diagnostics, Inc.
CORRESP · 2017-07-11
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Company responded
2017-07-12
Co-Diagnostics, Inc.
Filing - Correspondence from Co-Diagnostics, Inc.
CORRESP · 2017-07-12
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Co-Diagnostics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-05-18
Co-Diagnostics, Inc.
Filing - SEC Comment Letter to Co-Diagnostics, Inc.
UPLOAD · 2017-05-18
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Co-Diagnostics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-04-21
Co-Diagnostics, Inc.
Filing - SEC Comment Letter to Co-Diagnostics, Inc.
UPLOAD · 2017-04-21
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Co-Diagnostics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-02-09
Co-Diagnostics, Inc.
Filing - SEC Comment Letter to Co-Diagnostics, Inc.
UPLOAD · 2017-02-09
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-28 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2026-05-28 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | 377-09400 | Read Filing View |
| 2026-05-13 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2026-04-14 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | 377-09237 | Read Filing View |
| 2023-04-04 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2023-03-22 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2020-11-02 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2020-10-29 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2018-09-05 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2018-08-29 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-07-12 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-07-11 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-06-28 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-06-09 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-06-05 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-05-24 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-05-18 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-04-21 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-02-09 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-28 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | 377-09400 | Read Filing View |
| 2026-04-14 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | 377-09237 | Read Filing View |
| 2023-03-22 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2020-10-29 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2018-08-29 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-06-05 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-05-18 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-04-21 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-02-09 | SEC Comment Letter | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-28 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2026-05-13 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2023-04-04 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2020-11-02 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2018-09-05 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-07-12 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-07-11 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-06-28 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-06-09 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
| 2017-05-24 | Company Response | Co-Diagnostics, Inc. | UT | N/A | Read Filing View |
2026-05-28 - CORRESP - Co-Diagnostics, Inc.
CORRESP 1 filename1.htm CO-DIAGNOSTICS, INC. May 28, 2026 VIA EDGAR United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Co-Diagnostics, Inc.-Registration Statement on Form S-3 (File No. 333-296312) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-3 (File No. 333-296312) (as amended, the "Registration Statement") of Co-Diagnostics, Inc. (the "Company"). We respectfully request that the Registration Statement be declared effective as of 5:00 p.m., Eastern Time, on May 29, 2026, or as soon as practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Dorsey & Whitney LLP, by calling Dan Lyman at (801) 933-4028. Very truly yours, CO-DIAGNOSTICS, INC. /s/ Brian Brown Brian Brown Chief Financial Officer
2026-05-28 - UPLOAD - Co-Diagnostics, Inc. File: 377-09400
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 28, 2026 Dwight Egan President and Chief Executive Officer Co-Diagnostics, Inc. 2401 S. Foothill Drive Salt Lake City, Utah 84109 Re: Co-Diagnostics, Inc. Draft Registration Statement on Form S-3 Submitted May 22, 2026 CIK No. 0001692415 Dear Dwight Egan: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement and non-public draft submission on EDGAR at least two business days prior to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Conlon Danberg at 202-551-4466 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Daniel P. Lyman, Esq. </TEXT> </DOCUMENT>
2026-05-13 - CORRESP - Co-Diagnostics, Inc.
CORRESP 1 filename1.htm CO-DIAGNOSTICS, INC. May 13, 2026 VIA EDGAR United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Co-Diagnostics, Inc. - Registration Statement on Form S-3 (File No. 333-295803) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-3 (File No. 333-295803) (the "Registration Statement") of Co-Diagnostics, Inc. (the "Company"). We respectfully request that the Registration Statement be declared effective as of 5:00 p.m., Eastern Time, on May 15, 2026, or as soon as practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Dorsey & Whitney LLP, by calling Dan Lyman at (801) 933-4028. Very truly yours, CO-DIAGNOSTICS, INC. /s/ Brian Brown Brian Brown Chief Financial Officer
2026-04-14 - UPLOAD - Co-Diagnostics, Inc. File: 377-09237
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 14, 2026 Dwight Egan President Co-Diagnostics, Inc. 2401 S. Foothill Drive Salt Lake City, UT 84109 Re: Co-Diagnostics, Inc. Draft Registration Statement on Form S-3 Submitted April 10, 2026 CIK 0001692415 Dear Dwight Egan: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement and non-public draft submission on EDGAR at least two business days prior to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Robert Augustin at 202-551-8483 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: David Marx </TEXT> </DOCUMENT>
2023-04-04 - CORRESP - Co-Diagnostics, Inc.
CORRESP
1
filename1.htm
CO-DIAGNOSTICS,
INC.
April
4, 2023
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporate Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Co-Diagnostics,
Inc.—Registration Statement on Form S-3 (File No. 333-270628)
Ladies
and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration
Statement on Form S-3 (File No. 333-270628) (as amended, the “Registration Statement”) of Co-Diagnostics, Inc. (the “Company”).
We respectfully request that the Registration Statement be declared effective as of 5:00 p.m., Eastern Time, on April 6, 2023, or as
soon as practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with our
counsel, Dorsey & Whitney LLP, by calling David Marx at (801) 933-7363.
Very
truly yours,
CO-DIAGNOSTICS,
INC.
/s/ Brian Brown
Brian
Brown
Chief
Financial Officer
2023-03-22 - UPLOAD - Co-Diagnostics, Inc.
United States securities and exchange commission logo
March 22, 2023
Dwight Egan
President and Chief Executive Officer
Co-Diagnostics, Inc.
2401 S. Foothill Drive
Salt Lake City, Utah 84109
Re:Co-Diagnostics, Inc.
Registration Statement on Form S-3
Filed March 16, 2023
File No. 333-270628
Dear Dwight Egan:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jane Park at 202-551-7439 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: David Marx, Esq.
2020-11-02 - CORRESP - Co-Diagnostics, Inc.
CORRESP
1
filename1.htm
November 2, 2020
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F. Street, N.E.
Washington,
D.C. 20549
Re:
Co-Diagnostics,
Inc. (the “Company”)
Registration
Statement on Form S-3
File
No. 333-249651
Ladies
and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned respectfully requests that the effective
date of the Company’s above-referenced Registration Statement be accelerated so that the same will become effective at 2:00
P.M. (EST) on November 5, 2020, or as soon thereafter as is practicable.
Very
truly yours,
CO-DIAGNOSTICS,
INC.
By:
/s/
Dwight H. Egan
Name:
Dwight
H. Egan
Title:
President,
Chief Executive Officer and Chairman of the Board of Directors
2020-10-29 - UPLOAD - Co-Diagnostics, Inc.
United States securities and exchange commission logo
October 29, 2020
Reed L. Benson
Chief Financial Officer
Co-Diagnostics, Inc.
2401 S. Foothill Drive
Salt Lake City, Utah 84109
Re:Co-Diagnostics, Inc.
Registration Statement on Form S-3
Filed October 23, 2020
File No. 333-249651
Dear Mr. Benson:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Philip Magri, Esq.
2018-09-05 - CORRESP - Co-Diagnostics, Inc.
CORRESP
1
filename1.htm
CO-DIAGNOSTICS,
INC.
2401
S. Foothill Drive
Salt
Lake City, Utah 84109
(801)
438-1036
September
5, 2018
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F. Street, N.E.
Washington,
D.C. 20549
RE:
Co-Diagnostics,
Inc.
Registration
Statement on Form S-3 (File No. 333-226835)
Request
for Acceleration
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, Co-Diagnostics, Inc., a Utah corporation (the “Company”),
hereby respectfully requests that the effective date of its Registration Statement on Form S-3 (File No. 333-226835) (the “Registration
Statement”) be accelerated by the Securities and Exchange Commission so that it will be declared effective at 4:00 p.m.
EST on September 7, 2018, or as soon as possible thereafter. The Company hereby authorizes Peter DiChiara of Carmel, Milazzo &
DiChiara LLP, counsel to the Company, to orally modify or withdraw this request for acceleration.
It
would be appreciated if, as soon as the Registration Statement is declared effective, you would inform Peter DiChiara of Carmel,
Milazzo & DiChiara LLP at pdichiara@cmdllp.com or (212) 658-0458.
Very
truly yours,
CO-DIAGNOSTICS,
INC.
By:
/s/
Dwight Egan
Dwight
Egan
President
and Chief Executive Officer
2018-08-29 - UPLOAD - Co-Diagnostics, Inc.
August 29, 2018
Dwight Egan
Chief Executive Officer, President and Director
Co-Diagnostics, Inc.
2401 S. Foothill Drive
Salt Lake City, Utah 84109
Re:Co-Diagnostics, Inc.
Registration Statement on Fom S-3
Filed August 14, 2018
File No. 333-226835
Dear Mr. Egan:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Thomas Jones at 202-551-3602 with any questions.
Sincerely,
Division of Corporation Finance
Office of Electronics and Machinery
cc: Peter DiChiara, Esq.
2017-07-12 - CORRESP - Co-Diagnostics, Inc.
CORRESP 1 filename1.htm codx_corresp.htmJuly 11, 2017 Securities and Exchange Commission 450 Fifth Street, N.W. Washington, D.C. 20549 Re: Co-Diagnostics, Inc. Registration Statement on Form S-1 File No. 333-217542 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), the undersigned hereby join in the request of Co-Diagnostics, Inc. that the effective date of the above-captioned Registration Statement be accelerated to 5:30 p.m. on July 11, 2017, or as soon thereafter as practicable. In connection with the Preliminary Prospectus distribution for the above-captioned issue, the prospective underwriters have confirmed that they are complying with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. The following information with respect to the distribution of the Preliminary Prospectus dated July 10, 2017 is furnished pursuant to Rule 460 of the Rules and Regulations of the Commission under the Securities Act, in connection with the request for acceleration of the effective date of the Registration Statement. The undersigned have effected approximately the following distribution of copies of the Preliminary Prospectus, July 10, 2017, through the date hereof: Preliminary Prospectus, dated July 10, 2017: 600 copies were distributed to prospective underwriters, institutional investors, dealers and others. [Remainder of page intentionally left blank] 1 Very truly yours, WallachBeth Capital, LLC as Representative of the Several Underwriters By: /s/ Daniel Tapia Daniel Tapia Chief Compliance Officer Network 1 Financial Securities, Inc. as Representative of the Several Underwriters By: /s/ Damon Testaverde Damon Testaverde Managing Director 2
2017-07-11 - CORRESP - Co-Diagnostics, Inc.
CORRESP 1 filename1.htm axdx_corresp.htmCo-Diagnostics, Inc. 8160 S. Highland Drive Salt Lake City, Utah 84124 July 11, 2017 VIA EDGAR TRANSMISSION United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Amanda Ravitz, Assistant Director Re: Co-Diagnostics, Inc. Registration Statement on Form S-1 (Registration No. 333-217542) Ladies and Gentlemen: In accordance with Rules 460 and 461 under the Securities Act of 1933, as amended, we hereby respectfully request acceleration of the effective date of the Registration Statement on Form S-1, as amended (File No. 333-217542) (the “Registration Statement”), of Co-Diagnostics, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 5:30 p.m., Eastern Time, on July 11, 2017, or as soon as practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Carmel, Milazzo & DiChiara LLP, by calling Peter DiChiara at (646) 838-1312. Thank you for your consideration. Very truly yours, Co-Diagnostics, Inc. By: /s/ Dwight H. Egan Dwight H. Egan President and Chief Executive Officer
2017-06-28 - CORRESP - Co-Diagnostics, Inc.
CORRESP 1 filename1.htm codx_corresp.htmCo-Diagnostics, Inc. 8160 S. Highland Drive Salt Lake City, Utah 84124 June 28, 2017 VIA EDGAR TRANSMISSION United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Amanda Ravitz, Assistant Director Re: Co-Diagnostics, Inc. Registration Statement on Form S-1 (Registration No. 333-217542) Ladies and Gentlemen: In accordance with Rules 460 and 461 under the Securities Act of 1933, as amended, we hereby respectfully request acceleration of the effective date of the Registration Statement on Form S-1, as amended (File No. 333-217542) (the “Registration Statement”), of Co-Diagnostics, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:00 p.m., Eastern Time, on June 29, 2017, or as soon as practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Carmel, Milazzo & DiChiara LLP, by calling Peter DiChiara at (646) 838-1312. The Company acknowledges the following: · should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; · the action of the Commission or the staff, acting pursuant to delegated authority in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and · the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Thank you for your consideration. Very truly yours, Co-Diagnostics, Inc. By: /s/ Dwight H. Egan Dwight H. Egan President and Chief Executive
2017-06-09 - CORRESP - Co-Diagnostics, Inc.
CORRESP 1 filename1.htm codx_corresp.htm June 9, 2017 Securities and Exchange Commission Division of Corporate Finance 100 F Street, NE Washington, DC 20549 Attn: Amanda Ravitz Re: Co-Diagnostics, Inc. Amendment No. 1 to Registration Statement on Form S-1 Filed on May 24, 2017 File No. 333-217542 Dear Ms. Ravitz: Please find below responses to certain questions raised by the staff of the Securities and Exchange Commission in its letter dated June 2, 2017 (the “Comment Letter”) relating to the filing made by Co-Diagnostics, Inc. (the “Company”) referenced above. Capitalization, page 34 1. The capitalization table assumes conversion of all of your convertible notes payable upon completion of your offering. If true, disclose that you have agreements requiring conversion for all of the convertible notes. Alternatively, revise to present pro forma conversion only for those notes where you have definitive agreements requiring conversion. The Company amended its disclosure to include in the capitalization table the convertible notes that have agreed to convert. Exhibit 10.13.7, filed with Amendment No. 1 to Registration Statement on Form S-1, was amendment where holders of convertible notes agreed to: “convert all of the Note principal and accrued interest to Company common stock”. Audited Financial Statements for the Years Ended December 31, 2016 and 2015 Report of Independent Registered Public Accounting Firm, page F-2 2. Disclosure in financial statement Note 2 has been updated for events occurring after the date of the audit report. Please have your auditor explain to us why their report should not be dual-dated pursuant to PCAOB AS 3110. The Company’s auditor has dual dated their opinion Securities and Exchange Commission June 9, 2017 Page 2 Unaudited Financial Statements for the Quarter Ended March 31, 2017 Description of Business, page F-25 3. Revise to remove the promotional language from the second and third paragraphs of the disclosure. The description of your business should present a factual discussion of the nature of the company’s operations. Refer to FASB 275-10-50-2. The Company removed the promotional language from the second and third paragraphs of the disclosure Please call me at 212-658-0458 if you have any further questions regarding our responses. Sincerely, /s/ Peter DiChiara Peter DiChiara Cc: Dwight Egan Reed Benson
2017-06-05 - UPLOAD - Co-Diagnostics, Inc.
Mail S top 3030 June 2, 2017 Via E -mail Dwight H. Egan Chief Executive Officer, President and Director Co-Diagnostics, Inc. 4049 S. Highland Drive Salt Lake City, Utah 84124 Re: Co-Diagnostics, Inc. Amendment No. 1 to Re gistration Statement on Form S -1 Filed May 24, 2017 File No. 333-217542 Dear Mr. Egan : We have reviewed your amended registration statement and have the following comments . In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration stateme nt and the information you provide in response to these comments, we may have additional comments. Unless we note otherwise , our references to prior comments are to comments in our [Month day, year] letter . Capitalization, page 34 1. The capitalization table assumes conversion of all of your convertible notes payable upon completion of your offering. If true, disclose that you have agreements requiring conversion for all of the convertible notes. Alternatively, revise to present pro forma conversion only for those notes where you have definitive agreements requiring conversion. Dwight H. Egan Co-Diagnostics , Inc. June 2, 2017 Page 2 Audited Financial Statements for the Years Ended December 31, 2016 and 2015 Report of Independent Registered Public Accounting Firm, page F -2 2. Disclosure in financial statement Note 2 has been updated for events occurring after the date of the audit report. Please have your auditor explain to us why their report should not be dual -dated pursuant to PCAOB AS 3110. Unaudited Financial Statements for the Quarter Ended March 31, 2017 Description of Business, page F -25 3. Revise to remove the promotional language from the second and third paragraphs of the disclosure. The description of your business should present a factual discussion of the nature of the c ompany’s operations. Refer to FASB 275 -10-50-2. You may contact Andri Carpenter at (202) -551-3645 or Gary Todd, Senior Accountant at (202) 551 -3605 if you have questions regarding comments on the financial statements and related matters. Please c ontact me at (202) 551 -3528 with any other questions. Sincerely, /s/ Amanda Ravitz Amanda Ravitz Assistant Director Office of Electronics and Machinery cc: Peter DiChiara, Esq. Carmel, Milazzo & DiChiara LLP
2017-05-24 - CORRESP - Co-Diagnostics, Inc.
CORRESP
1
filename1.htm
axdx_corresp.htm
May 24, 2017
Securities and Exchange Commission
Division of Corporate Finance
100 F Street, NE
Washington, DC 20549
Attn: Amanda Ravitz
Re:
Co-Diagnostics, Inc.
Registration Statement on Form S-1 Filed on April 28, 2017
File No. 333-217542
Dear Ms. Ravitz:
Please find below responses to certain questions raised by the staff of the Securities and Exchange Commission in its letter dated May 17, 2017 (the “Comment Letter”) relating to the filing made by Co-Diagnostics, Inc. (the “Company”) referenced above.
The Company’s responses are numbered to correspond to your comments. For your convenience, each of the comments contained in the Comment Letter has been restated below in its entirety, with the Company’s response set forth immediately beneath such comment.
Prospectus Cover Page
1. Please note that you will need to fill in the number of shares you are offering prior to circulating a preliminary prospectus. In addition, the fixed price for your selling shareholder prospectus will need to be completed.
The Company is working with the underwriters to calculate the anticipated offering price. When determined, the Company will fill in the number of shares to be offered prior to circulating a preliminary prospectus. In addition, the fixed price for the selling shareholder prospectus will be completed.
The Company, page 8
2. Please tell us what you mean when you say that your tests “have been designed and verified in CDI’s laboratory.” What have you verified, by what means and with what data?
As described in the Registration Statement, the Company designed its tests by identifying the optimal locations on the target gene for amplification and paired the location with the optimized primer and probe structure to achieve outputs that meet the design input requirements identified from market research. This is done by following planned and documented processes, procedures and testing. In other words, the data resulting from the tests verify that we succeeded in designing what we intended to at the outset. Verification is a series of testing that concludes that the product is ready to proceed to validation in a clinical evaluation setting using initial production tests to confirm that the product as designed meets the user needs.
Securities and Exchange Commission
May 24, 2017
Page 2
Caribbean, Central and South America, page 9
3. Clarify whether you have products manufactured and ready for sale. Also clarify whether you have commenced any PMA approval steps with FDA.
The U.S. Food and Drug Administration (FDA) has granted permission for us to export many of our products. The FDA's permission to export was granted under Section 801 (e) of the Federal Food, Drug, and Cosmetic Act, as amended (the “FDC Act”). Section 801(e) of the FDA Act covers certain medical devices that have not yet received an approved Premarket Approval in the United States by the FDA, such as our products. We have not commenced any Premarket Approval steps with the FDA.
We do not have products manufactured and ready=for-sale. Products will be manufactured for sale upon receipt of purchase orders from labs and hospitals.
Capitalization, page 34
4. We refer to prior comment 11. Please revise so that the capitalization table is mathematically accurate. Further, please appropriately label total capitalization, which does not appear to be “total liabilities and stockholders’ equity (deficit).”
The Company revised the capitalization table in response to your comments and to reflect March 31, 2017 balances.
Management’s Discussion and Analysis, page 36
5. We note your response to our prior comment 13. We will further review the disclosure once you have disclosed the price range.
The Company will clarify whether the conversion price is the greater or lesser of the two alternatives when a price range is determined.
Summary Compensation Table, page 55
6. Explain why you have not included Brent Satterfield’s compensation in your disclosure.
Brent Satterfield has been added to the Summary Compensation Table.
7. Refer to page 58. With respect to the January 22, 2015 transaction, explain what exemption you relied upon with respect to your issuance to the 30 people referenced.
The issuance of the shares was exempt from the registration requirements of the Securities Act pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act.
Securities and Exchange Commission
May 24, 2017
Page 3
Consolidated Financial Statements, page F-1
Consolidated Balance Sheets, page F-3
8. Please revise so that the line item “Total long-term assets” is mathematically accurate.
The Company revised the line item “Total long-term assets”.
Revenue Recognition, page F-10
9. Refer to prior comment 24. While we acknowledge your revisions, it continues to be unclear how a factual accounting policy is currently determinable absent specific actual customer arrangements. For instance, the policy does not appear to address reagents or the accounting complexities of potential leasing arrangements. We also do not see a description of planned service offerings and it is unclear whether sales of equipment and reagents raise multiple element accounting issues. Please appropriately revise or advise us how the disclosed revenue policy is complete and appropriate.
The Company revised its revenue recognition disclosures.
10. We refer to prior comment 25. You disclose that you have elected to apply accounting standards transition periods applicable to non-public companies. Please revise your disclosure about pending accounting standards to disclose transition guidance consistent with that election.
The Company revised its disclosures. The Company has elected to apply accounting standards for transition periods applicable to non-public companies.
Note 2. Notes Payable, page F-11
11. Please refer to prior comment 26. Please also revise the description of the Pine Valley line of credit to describe the impact of the failure to file an initial registration statement by December 31, 2016.
The Company entered into amendments with certain noteholders and disclosed the terms of the amendments in the footnotes.
Securities and Exchange Commission
May 24, 2017
Page 4
12. As a related matter, revised disclosure in response to prior comment 26 indicates that certain note holders would not be required to convert their notes to common stock because you did not file an initial registration statement by December 31, 2016. However, based on the terms of some of the borrowings as described in the related exhibits, it is not clear that the instruments continue to be convertible after December 31, 2016. For instance, the language of Exhibit 10.13 and related amendments filed as Exhibits 10.13.1 through 10.13.6, which collectively cover several debt instruments, suggests that the conversion feature is no longer applicable. Further, some of the exhibits do not appear to include conversion terms as described in the notes to financial statements. Please revise as necessary to ensure that the notes to financial statements appropriately convey the substance of the underlying note agreements.
The Company entered into amendments with certain noteholders and disclosed the terms of the amendments in the footnotes.
13. Please refer to prior comment 31. Please revise your disclosure to more fully address the second sentence of the prior comment. In that regard, we note that you have debt and warrants that include down-round provisions or that have conversion prices that are linked to instruments with down-round provisions. Conversion options and warrants that include down-round provisions are commonly accounted for as derivative instruments by public companies. Accordingly, please expand your disclosure to describe the potential impact on the accounting for the conversion features and warrants in the event that your initial public offering is successful. Similar considerations may apply to other equity- linked instruments with variable conversion rates or non-standard anti-dilution provisions. Refer to ASC 815-40.
The Company revised its disclosures, including adding a disclosure for “Accounting for Derivatives” in the Significant Accounting Policies.
Please at 212-658-0458 if you have any further questions regarding our responses.
Sincerely,
/s/ Peter DiChiara
Peter DiChiara
Cc: Dwight Egan
Reed Benson
2017-05-18 - UPLOAD - Co-Diagnostics, Inc.
Mail Stop 3030 May 17, 2017 Via E -mail Dwight H. Egan Chief Executive Officer, President and Director Co-Diagnostics, Inc. 4049 S. Highland Drive Salt Lake City, Utah 84124 Re: Co-Diagnostics, Inc. Registration Statement on Form S -1 Filed April 28, 2017 File No. 333 -217542 Dear Mr. Egan : We have reviewed your registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested informati on. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your respon se. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our April 21, 2017 letter. Prospectus Cover Page 1. Please note that you will need to fill in the number of shares you are offering prior to circulating a preliminary prospectus. In addition, the fixed price for your selling shareholder prospect us will need to be completed. The Company, page 8 2. Please tell us what you mean when you say that your tests “have been designed and verified in CDI’s laboratory.” What have you verified, by what means and with what data? Dwight H. Egan Co-Diagnostics, Inc. May 17, 2017 Page 2 Caribbean, Central and South America, page 9 3. Clarify whether you have products manufactured and ready for sale. Also clarify whether you have commenced any PMA approval steps with FDA. Capitalization, page 34 4. We refer to prior comment 11. Please revise so that the capitalization table is mathematically accurate. Further, please appropriately label total capitalization, which does not appear to be “total liabilities and stockholders’ equity (deficit).” Management’s Discussion and Analysis, page 36 5. We note your response to our prior comment 13. We will further review the disclosure once you have disclosed the price range. Summary Compensation Table, page 55 6. Explain why you have not included Brent Satterfield ‘s compensation in your disclosure. 7. Refer to page 58. With respect to the January 22, 2015 transaction, explain what exemption you relied upon with respect to your issuance to the 30 people referenced. Consolidated Financial Statements, page F -1 Consolidated Balance Sheets, page F -3 8. Please revise so that the line item “Total long -term assets” is mathematically accurate. Revenue Recognition, page F -10 9. Refer to prior comment 24. While we acknowledge your revisions, it continues to be unclear how a factual accounting policy is cur rently determinable absent specific actual customer arrangements. For instance, the policy does not appear to address reagents or the accounting complexities of potential leasing arrangements. We also do not see a description of planned service offerings and it is unclear whether sales of equipment and reagents raise multiple element accounting issues. Please appropriately revise or advise us how the disclosed revenue policy is complete and appropriate. 10. We refer to prior comment 25. You disclose that you have elected to apply accounting standards transition periods applicable to non -public companies. Please revise your disclosure about pending accounting standards to disclose transition guidance consist ent with that election. Dwight H. Egan Co-Diagnostics, Inc. May 17, 2017 Page 3 Note 2. Notes Payable, page F -11 11. Please refer to prior comment 26. Please also revise the description of the Pine Valley line of credit to describe the impact of the failure to file an initial registration s tatement by Decemb er 31, 2016. 12. As a related matter, revised disclosure in response to prior comment 26 indicates that certain note holders would not be required to convert their notes to common stock because you did not file an initial registration statement by December 31 , 2016. However, based on the terms of some of the borrowings as described in the related exhibits, it is not clear that the instruments continue to be convertible after December 31, 2016. For instance, the language of Exhibit 10.13 and related amendment s filed as Exhibits 10.13.1 through 10.13.6, which collectively cover several debt instruments, suggests that the conversion feature is no longer applicable . Further, some of the exhibits do not appear to include conversion terms as described in the notes to financial statements. Please revise as necessary to ensure that the notes to financial statements appropriately convey the substance of the underlying note agreements. 13. Please refer to prior comment 31. Please revise your disclosure to more fully a ddress the second sentence of the prior comment. In that regard, we note that you have debt and warrants that include down -round provisions or that have conversion prices that are linked to instruments with down -round provisions. Conversion options and w arrants that include down -round provisions are commonly accounted for as derivative instruments by public companies. Accordingly, please expand your disclosure to describe the potential impact on the accounting for the conversion features and warrants in the event that your initial public offering is successful. Similar considerations may apply to other equity - linked instruments with variable conversion rates or non -standard anti -dilution provisions. Refer to ASC 815 -40. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, com ments, action or absence of action by the staff. Refer to Rules 460 and 461 regarding requests for acceleration . Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Dwight H. Egan Co-Diagnostics, Inc. May 17, 2017 Page 4 You may contact Andri Carpenter at (202) -551-3645 or Gary Todd, Senior Accountant at (202) 551 -3605 if you have questions regarding comments on the financial statements and related matters. Please contact me at (202) 551 -3528 with any other questions. Sincerely, /s/ Amanda Ravitz Amanda Ravitz Assist ant Director Office of Electronics and Machinery cc: Peter DiChiara, Esq. Carmel, Milazzo & DiChiara LLP
2017-04-21 - UPLOAD - Co-Diagnostics, Inc.
Mail Stop 3030 April 21, 2017 Via E -mail Dwight H. Egan President and Chief Executive Officer Co-Diagnostics, Inc. 4049 S. Highland Drive Salt Lake City, Utah 84124 Re: Co-Diagnostics, Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted March 31, 2017 CIK No. 0001692415 Dear Mr. Egan: We have reviewed your amended draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understan d your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to you r facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Unless we note otherwise, our references to prior comments are to com ments in our February 8, 2017 letter. Explanatory Note, page 3 1. We note your response to prior comment 1. If you choose to use 2 separate prospectuses, please continue to revise throughout to ensure that each prospectus clearly and thorough ly highlight s the concurrent offerin g and related impacts. At a minimum, your revisions should address : how the concurrent offerings could impact factors such as price, demand, and liquidity , and Dwight H. Egan Co-Diagnostics, Inc. April 21, 2017 Page 2 the requirement in paragraph 16 of Schedule A and Item 501(b)(3) of Regulation S- K that an issuer include a fixed price or bona fide price range where there is no public market for that issuer’s securities. We note in th is regard that the selling shareholder prospectus must disclose a bona fide price at which the selling shareholders will sell the offered shares until a market develops for your shares and thereafter at prevailing market prices or privately negotiated prices. Prospectus Summary, page 8 2. Please revise further here and throughout to clearly identify what you intend to sell, in what part of the world and to whom. Importantly, your present disclosure focus es heavily on the scientific explanation of a unique al gorit hm underlying your proposed tests, but it is still unclear whether you have developed or will develop the actual test, or just sell the algorith m or a license . For example, under “The Company” you indicate that you intend to “manufacture and market molecular diagnostic tests that are designed … to provide better tests.” It is unclear from this whether you intend to sell a diagnostic test or a product that allows other co mpanies to develop better tests . Also, clarify whether your menu of tests, described as “Current” in the bullet points under “Product Offering” are actually available to purchase. 3. In addition, you indicate that you intend to focus your sales efforts outside of the United States and Europe in the near term, but given your references to FDA , CE mark and CLIA , please ensure that you have highlighted y our expectations in terms of regulatory pathways, including timelines and capital outlays, for any US or Eur opean sales. Any such disclos ure should be clearly identifie d as subject to significant uncertainty. Further , provide more detail around your conclusions regarding FDA reg ulation for lab developed tests, as well as w hether you expect that y our plant in India will be subject to FDA inspection, and why you believe that your “ field validation” will permit faster CE mark approval. 4. Explain what “field validation ” entails and clarify , if true, that it does not relate to any present pending or anticipated FDA submission. Also, clarify that y ou have not taken any steps or made any preparations in furtherance of achieving a CE mark or FDA clearance. 5. We note your response to prior comment 4. Given that you have not yet derived any revenue from sales of your products, please clarify your reference to “maintaining” your profit margin in the first paragraph under the heading “The Company.” 6. Please expand your response to prior comment 5 to disclose what material steps you must complete in order to achieve your timeline of making initial sales in India within six months of the closing of this offering and your anticipated capital needs to complete each step. Dwight H. Egan Co-Diagnostics, Inc. April 21, 2017 Page 3 Recent Developments, page 1 0 7. We note your added disclosure regarding the license agreement and stock purchase agreement with Watermark Group, Inc. and the January 31, 2017 lawsuit filed by P&G Holdings. Please tell us what consideration you have given to added risk factor disclosu re regarding any potential liability you may have for terminating the license agreement, rescinding the stock purchase agreement, and pursuant to the lawsuit filed by P&G Holdings. Please also disclose the material terms of the rescission and cancelation agreement, and file as exhibits the stock purchase agreement, the rescission and cancelation agreement, and the $445,000 Watermark note. The Offering, page 12 8. Revise to make clear that you have not yet applied for or received your Nasdaq listing or ticker symb ol. Risk Factors, page 13 9. Please reconcile your response to prior comment 10 with your disclosure in the last paragraph on pages 8 and 44 indicati ng that you may derive revenue from HMOs. Use of Proceeds, page 31 10. We note your response to prior comment 12. Please reconcile your disclosure here regarding $10 million with the proposed maximum aggregate offering price disclosed in your fee table and ensure that your fee table covers the maximum amount of all securities being registered by both prospectuses. Capitalization, page 32 11. We refer to prior comment 14. Please revise the table to present total capitalization equal to the sum of total debt, including both current and non -current portions, and total stockholders’ deficit. Please also revise to show both historical capitaliza tion as of the most recent balance sheet date presented in the filing and pro forma capitalization adjusted for the proceeds of the offering and any other material changes in capitalization expected to occur in connection with your offering. Management’s Discussion and Analysis , page 34 Executive Overview, page 37 12. We note your response to prior comment 15. Please ensure that your exhibit index includes all exhibits that will be filed with your registration statement. Dwight H. Egan Co-Diagnostics, Inc. April 21, 2017 Page 4 13. In the second paragraph on page 39, please clarify whether the conversion price is the greater or lesser of the two alternatives. Net Loss, page 41 14. It appears from your disclosure that your net loss decreased for the year ended December 31, 2016 as compared to the year ende d December 31, 2015. Accordingly, please revise your disclosure regarding an increase in net loss or advise. Business, page 43 Product Offering, page 45 15. We note your response to prior comment 18; however, you continue to include disclosure here and on page 9 about your current offerings in international markets. Please revise. CDI Reagents and Software, page 45 16. We note your response to prior comment 19. We may have further comments pending our receipt and review of the supplemental materials. Revenue Model, page 46 17. We note your response to prior comment 21. Please disclose the material terms of your agreement with Synbiotics Limited, including the mat erial obligations of the parties, duration of the agreement, and any termination provisions, and file the agreement as an exhibit. 18. Please expand your revisions made in response to prior comment 22 to describe the regulatory process in India and in the dis closed Caribbean nations and the steps you will need to complete to achieve your anticipated regulatory approval timeframe. Please also explain what you mean by “successfully marked” in the last paragraph on page 46. Principal Stockholders, page 56 19. Please advise how you determined not to (1) aggregate the holdings of Dwight and Seth Egan or (2) include the selling security holders in this table. Certain Relationships and Related Party Transactions, page 57 20. We note your response to prior comment 28. Please reconcile your disclosure in the fifth paragraph of this section with your disclosure in the last paragraph on page F -18 regarding the oral modifica tion to the license agreement, and tell us whether you have Dwight H. Egan Co-Diagnostics, Inc. April 21, 2017 Page 5 any written documentation of this oral modification. Please also file as an exhibit the March 1, 2017 amendment to the April 18, 2014 license agreement. 21. Please file as exhibits the revolving loan agreements with the entities associated with your CFO. Description of our Capital Stock, page 58 22. Please respond to that portion of prior comment 29 that asked you to provide the disclosure required by Regulation S -K Item 201(a)(2). Consolidated Financial Statements, page F -1 Note 1. Description of Business, page F -7 23. We note that you entered into an agreement with Synbiotics Limited to construct and jointly own and operate a manufacturing facility in India. Please expand the notes to financial statements to describe the significant terms of the arrangement, including a description of your rights and obligations and the related accounting applied. 24. The first paragraph of the revenue disclosure on page F -10 describes general revenue policies for equipment and services. However, disclosure on page 45 of your filing suggests that your planned products include reagents and software. Please either revis e the disclosure to be specific to your planned product offering or consider whether it is appropriate and useful to disclose a prospective revenue policy at this time. 25. As a related matter, tell us why you should not present disclosure about the pending adoption of ASC 606, Revenue from Contracts with Customers. Note 2. Notes Payable, page F -11 26. The descriptions for some of your notes payable appear to have conversion terms that were contingent on filing a registration statement by December 31, 2016. Since that event did not occur by the specified date, please expand your disclosure to clarify the impact on the terms of the notes. 27. The descriptions for some of your notes payable have conversion terms that reference an anticipated bridge financing. P lease revise to clarify whether you are referring to the December 2016 bridge notes or some other anticipated financing. 28. With respect to the December 2016 Bridge notes payable, please reconcile the disclosure on page F -14 about the conversion terms with disclosure about the conversion terms appearing on pages 39, 65 and 74 of your filing. Please ensure that the notes to financial Dwight H. Egan Co-Diagnostics, Inc. April 21, 2017 Page 6 statements fully describe the conversion terms and potential penalties in the event of non - performance. Refer to ASC 470 -10-50-5. 29. As a related matter, please ensure that the notes to financial statements fully explain all material rights and privileges of the Bridge notes. For instance, based on the underlying agreements, the notes appear to include registration rights, restrict you r ability to restructure other debt and provide for significant penalties in the event of default or other non-performance. Refer to ASC 470 -10-50-5. 30. With respect to the warrants issued with the Bridge notes, the description of the floating exercise pri ce does not appear to be as described in the underlying agreement filed in Exhibit 10.7. Please revise or advise. Further, based on the underlying agreement, it appears that there are circumstances where you could be required to issue additional warrants . Please ensure that the notes to financial statements describe all material terms of the warrants. Refer to ASC 505 -10-50-3. 31. Based on the underlying agreements, the bridge notes and related warrants appear to include a down -round feature for subsequent sales of equity. Please expand the notes to financial statements to describe this feature and to describe the potential impact of the registration and public listing of your shares on the accounting for the conversion feature and warrants. Refer to ASC 815-40. Similar considerations appear applicable to your other convertible debt instruments. Note 3. Stock -based Compensation, page F -16 32. Tell us why you believe it is appropriate to estimate expected volatility based on volatility of one comparable c ompany. Similarly, for warrants, tell us how y ou determined “historical and market -based implied volatility” for your privately held shares. Alternate pages for Selling Stockholder Prospectus 33. We note that th at the notes are convertible at a ra te that depends upon the price in the underwritten portion of this offering. Please confirm, however, that you will complete the volume of shares offered prior to requesting effectiveness. This also applies to the form of primary offering prospectus. Recent Sales of Unregistered Securities, page 72 34. Please provide the Regulation S -K Item 701 disclosure for the November and December convertible promissory notes disclosed on page 58. Dwight H. Egan Co-Diagnostics, Inc. April 21, 2017 Page 7 You may contact Andri Carpenter at (202) 551 -3645 or Gary Todd, Senior Accountant, at (202) 551 -3605 if you have questions regarding comments on the financial statements and related matters. Please contact me at (202) 551 -3528 with any other questions. Sincerely, /s/ Amanda Ravitz Amanda Ravit z Assistant Director Office of Electronics and Machinery cc: Peter DiChiara, Esq. Carmel, Milazzo & DiChiara LLP
2017-02-09 - UPLOAD - Co-Diagnostics, Inc.
Mail Stop 3030 February 8, 2017 Via E -mail Dwight H. Egan President and Chief Executive Officer Co-Diagnostics, Inc. 4049 S. Highland Drive Salt Lake City, Utah 84124 Re: Co-Diagnostics, Inc. Draft Registration Statement on Form S -1 Submitted January 12, 2017 CIK No. 0001692415 Dear Mr. Egan : We have reviewed your draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amende d draft registration statement or filed registration statement, we may have additional comments. Explanatory Note, page 3 1. Please revise both forms of prospectus to include disclosure about the other offering, including attendant risks. Explain how the offering taking place concurrently might affect price, demand , and other factors. Make sure that your beneficial ownership table reflects all shares that may be acquired within 60 days, even if they will be registered for resale in this offering. Also, if true, highlight that significant equity holders/creditors are seeking to sell their shares as part of your initial public offering. Dwight H. Egan Co-Diagnostics, Inc. February 8, 2017 Page 2 Prospectus Cover , page 4 2. In your next amendment, please revise to name the lead underwriters or advise. Please note tha t we may defer further review of the filing until the lead underwriters are named. 3. Please include the dealer prospectus delivery obligation on the outside back cover of the prospectus. See Item 502(b) of Regulation S -K. Prospectus Summary, page 8 4. It appears that you have not derived any revenue from sales of any product and that your licensing revenue, if any, is limited. Please revise your disclosure significantly to accurately reflect the current state of your business, and to identify all statements about what you plan for your business as anticipatory only. Your summary should make clear that you have no or limited revenues. 5. Revise to provide a clear indication of your business plan to achieve revenues. Your discussion should make clear (1) what p roduct, service, license , or other technology you intend to sell, (2) what material steps are needed to achieve sales of your product, service, license , or other technology, including regulatory clearances, and (3) your anticipated capital needs to complete each step. 6. In this regard, please revise jargon to explain what your technology or innovation does. You state that through “mathematics” and “the power of computers” you improve molecular diagnostics, but it is unclear whether you have developed your own diagnostics tools or plan to apply some additional method to existing diagnostic test, or something else. Simply defining PCR, cooperative primers , primer dimers and CLIA, among other terms, does not clarify for a person not in your industry what your proposed product is. 7. Where you disclose qualitative attributes about your product, competing products, or the market in which you compete, please lim it those conclusions to management’s belief or provide support for your conclusions. In this regard, we note your disclosure on pages 8 and 9 regarding the “fast growing” molecular diagnostics market and disclosure stating that your product represents a “ radical new advancement,” a “revolutionary leap forward,” and is a “fraction of the cost of” and “more accurate than” competitive products. We likewise note disclosure on page 43 stating PCR diagnostics is the “gold standard” for the amplification of DNA and on page 44 regarding the “significant advantages” that your products have over competing products. 8. Given your reference to the U.S. in vitro market in the fourth paragraph on page 8, please highlight in your prospectus summary that you have not yet re ceived FDA approval to market your products in the United States. Dwight H. Egan Co-Diagnostics, Inc. February 8, 2017 Page 3 Implications of Being an Emerging Growth Company, page 11 9. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, tha t you , or anyone authorized to do so on your behalf , present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. Risk Factors, page 13 10. If your anticipated products will depe nd upon private insurance or other third party payors, please discuss attendant risk here. We will need to raise additional capital . . . , page 13 11. Given your current cash balance, please clarify your disclosure here indicating your belief that existing capital resources will fund your operations for twelve months. Please also disclose the amount of additional financing necessary to continue operations for twelve months. Use of Proceeds, page 31 12. Given that you have not yet disclosed the number of shar es you plan to offer as part of an over-allotment option or a bona fide estimate of the price range, please tell us how you estimated the $10 million in net proceeds, should the underwriters exercise their over - allotment option. 13. Please disclose the appro ximate amount of proceeds you intend to use for each purpose you have listed. If any material amounts of other funds are necessary to accomplish the specified purposes, please state the amounts and sources of other such funds. See Regulation S -K Item 504 and Instruction 3 to that Item. In this regard, please specifically address any capital needs to achieve necessary regulatory clearances. Capitalization, page 32 14. Please revise the table to present total capitalization equal to the sum of total debt and stockholders’ deficit. Cash and cash equivalents are not a component of capitalization and should not be included in total capitalization. Dwight H. Egan Co-Diagnostics, Inc. February 8, 2017 Page 4 Management’s Discussion and Analysis . . . , page 34 Executive Overview, page 37 15. We note your disclosure regarding various subscription agreements, notes, warrants , and lines of credit. Please file as exhibits all such agreements or instruments required to be filed under Item 601(b)(4) or (10) of Regulation S -K. Quantitative and Qualitative Disclosures about Market Risk, page 43 16. Please reconcile the statement that features of your convertible notes and warrants are deemed to be derivatives and subject to mark -to-market accou nting with the accounting actually applied in the financial statements. Business, page 43 Technological and Financial Advantages, page 44 17. We note your disclosure that your test “significantly outperformed” two competitors in a recent clinical study. Pl ease clarify whether the results of the study are published. Please also provide additional details about the conditions under which this study was conducted and discuss the objective, empirical results that support the conclusion about performance set fo rth in the quoted language above. Current Tests, page 45 18. Please clarify in which portions of the “international market” your products are available, whether you have received regulatory approval to market your products in such countries or regions, and whether you have begun to sell your product s in those markets. Products, page 45 19. Please supplementally provide us with copies of the descriptive article and commentary from The Journal of Molecular Diagnostics . 20. Please clarify what steps are necessary for your LightPRC product to be “market -ready” by 2017. Revenue Model, page 46 21. Since you do not appear to have any contractual arrangements with the “largest India distributor of diagnostics ,” it does not appear appropriate to highlight significant detai ls about the market served by this company, including its customer base, or to anticipated contractual terms with this company. Please revise or advise. Dwight H. Egan Co-Diagnostics, Inc. February 8, 2017 Page 5 22. We note from the first paragraph on page 47 that you expect to expand your revenue base in “Year 2.” Please clarify in what year you expect to first begin generating revenue in India and China and what steps, including regulatory approval, are necessary before you reach revenue generation in those markets. Market Rollout, page 47 23. We note your disclosur e in numbered paragraph 4 on page 48 regarding expanding your CE mark -certified test menu. Please clarify whether any of your products have already received CE Marking. Please also describe the types of U.S. applications involving PCR tests and commercial ization that you do not believe will require FDA approval, as indicated in numbered paragraph 5. Intellectual Property Protections, page 48 24. Please disclose the duration of your U.S. patents. See Regulation S -K Item 101(h)(4)(vii). Executive Compensation, page 52 25. Please file as an exhibit the 2015 Long -term Incentive Plan disclosed on page 53. See Regulation S -K Item 601(b)(10)(iii). Certain Relationships and Related Party Transactions, page 57 26. Please include the names of all related perso ns involved in each of the disclosed transactions. See Regulation S -K Item 404(a)(1). 27. Please provide the required Regulation S -K Item 404 disclosures for (1) the January 2015 stock exchange agreement with Dr. Satterfield, and (2) the May 1, 2015 amended subscription agreement with Co -Diagnostics, Ltd, or advise. 28. Given your payment obligations to Dr. Satterfield pursuant to the minimum monthly royalty provision of the April 18, 2014 license agreement, please clarify why you paid only $125,000 during 2015 and whether there are outstanding amounts due under this agreement. Please also disclose the amounts paid or due under this agreement since 2015. Description of our Capital Stock, page 57 29. Please provide the disclosure required by Regulation S -K Item 2 01(a)(2) and (b)(1). Dwight H. Egan Co-Diagnostics, Inc. February 8, 2017 Page 6 Underwriting, page 60 30. Please clarify whether Network Securities, Inc. is serving as an underwriter for this offering, as indicated in underwriter compensation table. If so, please disclose it as such on the cover page of your prospe ctus. See Regulation S -K Item 501(b)(8). Please also file as an exhibit the underwriting agreement referenced in this section. See Regulation S-K Item 601(b)(1). Audited Financial Statements as of December 31, 2015 and 2014 Note 1 – Description of Business, page F -7 31. Please disclose how you accounted for the acquisition of DNA Logix and clarify the basis in the FASB Codification for your accounting determination. 32. We refer to the last two paragraphs on page F -7. Please revise to remove the promot ional language from these paragraphs and to only present a factual disclosure of the nature of the company’s operations. Refer to FASB 275 -10-50-2. Basis of Presentation, page F -8 33. The audit report describes the financial statements as consolidated while disclosure under Basis of Presentation describes the financial statements as combined. Please revise to resolve the inconsistency between the audit report and disclosure in the notes to financial statements. Note 4 – Related Party Transactions, page F -16 34. Please revise your disclosure to clarify how the acquisition of DNA Logix impacted the license arrangement with that entity, including the payment obligations. In that regard, the parties to the license agreement filed as Exhibit 10.2 appear to be Co -Diagnostics and DNA Logix. Accordingly, it is unclear why the license fee obligations continue subsequent to your acquisition of the licensor. 35. Please also expand to fully describe the payment terms of the DNA Logix license as set forth in the License Fees and Royalties section of the license agreement dated April 14, 2014 and to disclose the life of the arrangement. In this regard, it appears th at the license requires substantial future payments that are not described in the notes to financial statements. Item 17. Undertakings, page 76 36. Please include the undertaking required by Regulation S -K Item 512(f). Dwight H. Egan Co-Diagnostics, Inc. February 8, 2017 Page 7 You may contact Andri Carpenter at (202) 551 -3645 or Gary Todd, Senior Accountant, at (202) 551 -3605 if you have questions regarding comments on the financial statements and related matters. Please contact Laurie Abbott at (202) 551 -8071 or me at (202) 551 -3528 with any other questions . Sincerely, /s/ Amanda Ravitz Amanda Ravitz Assistant Director Office of Electronics and Machinery cc: Peter DiChiara, Esq. Carmel, Milazzo & DiChiara LLP
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