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Quanterix Corp
Response Received
6 company response(s)
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Quanterix Corp
Awaiting Response
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Quanterix Corp
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High
Quanterix Corp
Response Received
1 company response(s)
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Quanterix Corp
Response Received
4 company response(s)
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Quanterix Corp
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Medium
SEC wrote to company
2017-09-15
Quanterix Corp
Summary
Generating summary...
Quanterix Corp
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-08-18
Quanterix Corp
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-11 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2025-06-03 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2025-05-30 | SEC Comment Letter | Quanterix Corp | DE | 333-284932 | Read Filing View |
| 2025-04-11 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2025-04-10 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2025-04-10 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2025-04-09 | SEC Comment Letter | Quanterix Corp | DE | 333-284932 | Read Filing View |
| 2025-03-28 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2025-02-24 | SEC Comment Letter | Quanterix Corp | DE | 333-284932 | Read Filing View |
| 2019-05-08 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2019-03-26 | SEC Comment Letter | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-12-04 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-12-04 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-11-20 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-11-09 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-10-30 | SEC Comment Letter | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-10-06 | SEC Comment Letter | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-09-15 | SEC Comment Letter | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-08-18 | SEC Comment Letter | Quanterix Corp | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-30 | SEC Comment Letter | Quanterix Corp | DE | 333-284932 | Read Filing View |
| 2025-04-09 | SEC Comment Letter | Quanterix Corp | DE | 333-284932 | Read Filing View |
| 2025-02-24 | SEC Comment Letter | Quanterix Corp | DE | 333-284932 | Read Filing View |
| 2019-03-26 | SEC Comment Letter | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-10-30 | SEC Comment Letter | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-10-06 | SEC Comment Letter | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-09-15 | SEC Comment Letter | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-08-18 | SEC Comment Letter | Quanterix Corp | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-11 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2025-06-03 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2025-04-11 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2025-04-10 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2025-04-10 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2025-03-28 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2019-05-08 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-12-04 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-12-04 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-11-20 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
| 2017-11-09 | Company Response | Quanterix Corp | DE | N/A | Read Filing View |
2025-06-11 - CORRESP - Quanterix Corp
CORRESP 1 filename1.htm Quanterix Corporation 900 Middlesex Turnpike Billerica, MA 01821 Via EDGAR June 11 , 2025 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-4628 Attn: Margaret Sawicki and Lauren Nguyen Re: Quanterix Corporation Post-Effective Amendment No. 2 to Registration Statement on Form S-4 Filed June 4, 2025 File No. 333-284932 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Quanterix Corporation hereby respectfully requests that the effective date of the above referenced Registration Statement on Form S-4 be accelerated to 4:00 p.m., Eastern Time, on June 12 , 2025, or as soon as practicable thereafter. Please contact Kerry S. Burke of Covington & Burling LLP at (202) 662-5297 with any questions you may have regarding this request. In addition, please notify Ms. Burke by telephone when this request for acceleration has been granted. Respectfully, Quanterix Corporation By: /s/ Vandana Sriram Name: Vandana Sriram Title: Chief Financial Officer cc: Kerry S. Burke, Covington & Burling LLP Catherine Dargan, Covington & Burling LLP Kyle Rabe, Covington & Burling LLP Laurie A. Churchill, Quanterix Corporation Patrick J. O'Malley, DLA Piper LLP
2025-06-03 - CORRESP - Quanterix Corp
CORRESP
1
filename1.htm
Via EDGAR
June 3,
2025
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Industrial Applications and Services
100 F Street, N.E.
Washington D.C. 20549
Attention: Margaret Sawicki and Lauren Nguyen
Re:
Quanterix Corporation
Post-Effective Amendment No. 1 to Registration Statement on Form S-4
Filed May 21, 2025
File No. 333-284932
Dear Mses. Sawicki and Nguyen:
On behalf of Quanterix Corporation (the "Company"),
we are submitting this letter in response to the comments of the staff of the Division of Corporation Finance (the "Staff")
of the U.S. Securities and Exchange Commission, dated May 30, 2025, with respect to Post-Effective Amendment No. 1 to the Company's
Registration Statement on Form S-4 (the "Registration Statement"). The Company will file Post-Effective Amendment No. 2 to
the Company's Registration Statement on Form S-4 (the "Amended Registration Statement"), which includes changes to reflect
responses to the Staff's comments.
The numbering of the paragraphs below corresponds
to the numbering of the comments in the letter from the Staff. For the Staff's convenience, we have incorporated the text of the
Staff's comments into this response letter in bold text. Unless otherwise indicated, page references in the responses correspond
to the page numbers in the Amended Registration Statement, and page references otherwise correspond to the page numbers in the Registration
Statement. Capitalized terms used in this letter but otherwise not defined herein shall have the meanings set forth in the Amended Registration
Statement.
The responses provided herein are based upon information
provided to Covington & Burling LLP by the Company.
Post-Effective Amendment No. 1 to Registration Statement on Form
S-4, filed May 21, 2025
General
1. We note the following statements on page 9: "The Original Proxy Statement/Prospectus contained certain unaudited prospective
financial information of Quanterix (the "Original Quanterix Projections"). The Original Quanterix Projections are not included
in this proxy statement/prospectus" and "[t]he Original Akoya Projections are not included in this proxy statement/prospectus,
and have been replaced with certain projections for Akoya included in the Akoya Projections." We also note your statement on page
225: "On April 24, 2025, representatives of Akoya, PWP, Quanterix and Goldman Sachs met to discuss certain updated financial projections
of Akoya and Quanterix..." Please revise to disclose why updated Quanterix projections were not disclosed in this post-effective
amendment. Revise to also clarify whether the Original Quanterix Projections differ from the Quanterix Projections included in the Quanterix
Base Case and Quanterix Downside Sensitivity Case calculations, used by PWP, Akoya's financial advisor, in its analysis. We also note
that the Quanterix Base Case and Quanterix Downside Sensitivity Case calculations appear to be based on the Quanterix Projections, and
the calculations based on the Quanterix Base Case and Quanterix Downside Sensitivity Case differ from the calculations based on, and presentation
of, the Quanterix Mgmt. Base Case and Quanterix Mgmt. Upside Case in the Form S-4.
Response:
We acknowledge the Staff's
comment and have revised the Amended Registration Statement on page 227 to include the updated projections of the Company that were discussed
with representatives of Akoya, PWP, Goldman Sachs and the Company.
2. We note that Akoya has partnered with Acrivon Therapeutics, Inc. ("Acrivon") to codevelop, clinically validate, seek
regulatory approval for, and commercialize Acrivon's OncoSignature test. We also note that, in performing its analysis, Akoya's
financial advisor, PWP, used and relied upon certain forecasts, including "[t]he Akoya Mgmt. (40% Acrivon PTS 25% other CDx PTS)
Case." Given the probability of technical success of Acrivon's test appears to be material to Akoya's forecasts, it appears Akoya's
relationship with Acrivon is material to Akoya's business. We also note that your director, Ivana Magovčević-Liebisch, sits
on the board of directors for Acrivon, and, after her appointment to your board on October 2, 2024, was present at certain meetings held
in October of 2024 related to the transaction, but was not a member of the Quanterix Transaction Committee. Please revise to disclose
how Quanterix management considered Ivana Magovčević-Liebisch's role as a board member of both Quanterix and Acrivon in
the context of this transaction. Additionally, please also revise to reinstate the definition of "PTS" and "CDx" that
appeared in the Form S-4 filed April 10, 2025, or otherwise define these terms.
2
Response:
We acknowledge the Staff's comment and have
updated the Amended Registration Statement on page 203 to disclose how the Company's board of directors considered Ivana Magovčević-Liebisch's
role as a director of the Company and of Acrivon. The Company also has included the definitions of "PTS" and "CDx"
on page 229 of the Amended Registration Statement.
*****
Please do not hesitate to call me at (202) 662-6000
if you have any questions or require any additional information.
Sincerely,
Kerry S. Burke
cc:
Laurie Churchill, Senior Vice President and General Counsel, Quanterix Corporation
Catherine Dargan, Covington & Burling LLP
Kyle Rabe, Covington & Burling LLP
3
2025-05-30 - UPLOAD - Quanterix Corp File: 333-284932
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
May 30, 2025
Masoud Toloue
President and Chief Executive Officer
Quanterix Corporation
900 Middlesex Turnpike
Billerica, MA 01821
Re: Quanterix Corporation
Post-Effective Amendment No. 1 to Registration Statement on Form S-4
Filed May 21, 2025
File No. 333-284932
Dear Masoud Toloue:
We have reviewed your post-effective amendment and have the following
comments.
Please respond to this letter by amending your registration statement
and providing
the requested information. If you do not believe a comment applies 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 statement and the
information
you provide in response to this letter, we may have additional comments.
Post-Effective Amendment No. 1 to Registration Statement on Form S-4, Filed May
21, 2025
General
1. We note the following statements on page 9: "The Original Proxy
Statement/Prospectus contained certain unaudited prospective financial
information of
Quanterix (the "Original Quanterix Projections"). The Original Quanterix
Projections
are not included in this proxy statement/prospectus" and "[t]he Original
Akoya
Projections are not included in this proxy statement/prospectus, and
have been
replaced with certain projections for Akoya included in the Akoya
Projections." We
also note your statement on page 225: "On April 24, 2025,
representatives of Akoya,
PWP, Quanterix and Goldman Sachs met to discuss certain updated
financial
projections of Akoya and Quanterix..." Please revise to disclose why
updated
Quanterix projections were not disclosed in this post-effective
amendment. Revise to
also clarify whether the Original Quanterix Projections differ from the
Quanterix
Projections included in the Quanterix Base Case and Quanterix Downside
Sensitivity
May 30, 2025
Page 2
Case calculations, used by PWP, Akoya's financial advisor, in its
analysis. We also
note that the Quanterix Base Case and Quanterix Downside Sensitivity
Case
calculations appear to be based on the Quanterix Projections, and the
calculations
based on the Quanterix Base Case and Quanterix Downside Sensitivity Case
differ
from the calculations based on, and presentation of, the Quanterix Mgmt.
Base Case
and Quanterix Mgmt. Upside Case in the Form S-4.
2. We note that Akoya has partnered with Acrivon Therapeutics, Inc.
("Acrivon") to co-
develop, clinically validate, seek regulatory approval for, and
commercialize
Acrivon s OncoSignature test. We also note that, in performing its
analysis, Akoya's
financial advisor, PWP, used and relied upon certain forecasts,
including "[t]he Akoya
Mgmt. (40% Acrivon PTS 25% other CDx PTS) Case." Given the probability
of
technical success of Acrivon's test appears to be material to Akoya's
forecasts, it
appears Akoya's relationship with Acrivon is material to Akoya's
business. We also
note that your director, Ivana Magovcevic-Liebisch, sits on the board of
directors for
Acrivon, and, after her appointment to your board on October 2, 2024,
was present at
certain meetings held in October of 2024 related to the transaction, but
was not a
member of the Quanterix Transaction Committee. Please revise to disclose
how
Quanterix management considered Ivana Magovcevic-Liebisch's role as a
board
member of both Quanterix and Acrivon in the context of this transaction.
Additionally, please also revise to reinstate the definition of "PTS"
and "CDx" that
appeared in the Form S-4 filed April 10, 2025, or otherwise define these
terms.
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 Margaret Sawicki at 202-551-7153 or Lauren Nguyen at
202-551-3642
with any questions.
Sincerely,
Division of
Corporation Finance
Office of Industrial
Applications and
Services
cc: Kerry Burke, Esq.
</TEXT>
</DOCUMENT>
2025-04-11 - CORRESP - Quanterix Corp
CORRESP 1 filename1.htm Quanterix Corporation 900 Middlesex Turnpike Billerica, MA 01821 Via EDGAR April 11, 2025 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-4628 Attn: Margaret Sawicki Re: Quanterix Corporation Amendment No. 3 to Registration Statement on Form S-4 Filed April 10, 2025 File No. 333-284932 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Quanterix Corporation hereby respectfully requests that the effective date of the above referenced Registration Statement on Form S-4 be accelerated to 4:00 p.m., Eastern Time, on April 14, 2025, or as soon as practicable thereafter. Please contact Kerry S. Burke of Covington & Burling LLP at (202) 662-5297 with any questions you may have regarding this request. In addition, please notify Ms. Burke by telephone when this request for acceleration has been granted. Respectfully, Quanterix Corporation By: /s/ Vandana Sriram Name: Vandana Sriram Title: Chief Financial Officer cc: Kerry S. Burke, Covington & Burling LLP Catherine Dargan, Covington & Burling LLP Kyle Rabe, Covington & Burling LLP Laurie A. Churchill, Quanterix Corporation Patrick J. O'Malley, DLA Piper LLP
2025-04-10 - CORRESP - Quanterix Corp
CORRESP 1 filename1.htm Via EDGAR April 10, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services 100 F Street, N.E. Washington D.C. 20549 Attention: Laura McKenzie, Margaret Sawicki and Lauren Nguyen Re: Quanterix Corporation Amendment No. 2 to Registration Statement on Form S-4 Filed April 4, 2025 File No. 333-284932 Dear Mses. McKenzie, Sawicki and Nguyen: On behalf of Quanterix Corporation (the "Company"), we are submitting this letter in response to the comments of the staff of the Division of Corporation Finance (the "Staff") of the U.S. Securities and Exchange Commission, dated April 9, 2025, with respect to Amendment No. 2 to the Company's Registration Statement on Form S-4 (the "Registration Statement"). The Company will file Amendment No. 3 to the Company's Registration Statement on Form S-4 (the "Amended Registration Statement"), which includes changes to reflect responses to the Staff's comments. The numbering of the paragraphs below corresponds to the numbering of the comments in the letter from the Staff. For the Staff's convenience, we have incorporated the text of the Staff's comments into this response letter in bold text. Unless otherwise indicated, page references in the responses correspond to the page numbers in the Amended Registration Statement, and page references otherwise correspond to the page numbers in the Registration Statement. Capitalized terms used in this letter but otherwise not defined herein shall have the meanings set forth in the Amended Registration Statement. The responses provided herein are based upon information provided to Covington & Burling LLP by the Company. Amendment No. 2 to Registration Statement on Form S-4 filed April 4, 2025 Risk Factors, page 22 1. We note your disclosure on page 26 stating that "two of Quanterix's stockholders have indicated that they currently intend to oppose the Merger" (emphasis added). Given Kent Lake is actively soliciting in opposition to the Share Issuance Proposal and the Adjournment Proposal, please update this risk factor. Response: We acknowledge the Staff's comment an d note that the Company intends to amend the disclosure on page 26 of the Amended Registration Statement as follows: Actions of activist or dissident stockholders could delay or prevent the approval of the Merger and negatively affect Quanterix's and Akoya's business and operations. Recently two of Quanterix's stockholders have indicated that they currently intend to oppose the Merger. In addition, on March 3, 2025, one of these stockholders announced that it had nominated three directors for election to the Quanterix Board at its 2025 annual meeting of stockholders , and on March 31, 2025, the stockholder filed a preliminary proxy statement with the SEC soliciting proxies from the Quanterix stockholders to vote against each of the Quanterix Share Issuance Proposal and the Quanterix Adjournment Proposal . As a result of these actions, Quanterix will incur significant expenses even if it is successful in completing the Merger or is successful in a potential proxy contest. In addition, perceived uncertainties as to the future direction, strategy, or leadership, and the diversion of the attention and resources of the management and Board, of Quanterix and Akoya created by such activism may result in the loss of business opportunities and make it more difficult for each company to complete strategic transactions or attract and retain investors, customers, employees, and other business partners. Such stockholder activism may also cause significant fluctuation in the price of Quanterix Common Stock and Akoya Common Stock based on temporary or speculative market perceptions or other factors that do not necessarily reflect the underlying fundamentals and prospects of such company's business. The outcome or timing of any matters relating to stockholder activism or potential proxy contests or the ultimate impact that such matters may have on the business, liquidity, financial condition, or results of operations of Quanterix and Akoya is uncertain . 2 General 2. To aid stockholder understanding, please consider adding disclosure related to Quanterix's evaluation of the materiality of Akoya's cash burn, debt burden, and going-concern issues. If these issues were not considered or considered but granted little weight, this also may be helpful for stockholders to understand. Please describe how any such evaluation, as well as any plans to mitigate such issues, influenced negotiations or the terms of the Merger. Response: We acknowledge the Staff's comment an d note that the Company intends to amend the disclosure on pages 127 and 135 of the Amended Registration Statement as set forth in Appendix A attached hereto. ***** Please do not hesitate to call me at (202) 662-6000 if you have any questions or require any additional information. Sincerely, /s/ Kerry S. Burke Kerry S. Burke cc: Laurie Churchill, Senior Vice President and General Counsel, Quanterix Corporation Catherine Dargan, Covington & Burling LLP Kyle Rabe, Covington & Burling LLP 3 Appendix A Page 127 On December 17, 2024, Quanterix delivered an updated indication of interest to Akoya (the "December 17 Quanterix Indication of Interest"). In the December 17 Quanterix Indication of Interest, Quanterix reiterated its proposed exchange ratio of 0.2970, implying 28% ownership for Akoya stockholders in a combined company. Based on each company's share price at market close on December 16, 2024, such offer implied an offer price of $3.39 per share of Akoya Common Stock, which represented a premium of 40% to Akoya's stock price. The December 17 Quanterix Indication of Interest clarified that Quanterix was willing to discuss Akoya having the right to appoint two members of a nine-seat board of the combined company (as opposed to the "addition" of two board members as originally indicated in the December 11 Quanterix Indication of Interest). Additionally, the December 17 Quanterix Indication of Interest proposed that Akoya's termination fee would be 3.5% of the implied equity value of Akoya in connection with the proposed transaction and that Quanterix's termination fee would be the same as Akoya's termination fee, plus 1% of the implied equity value of Akoya in the proposed transaction. The December 17 Quanterix Indication of Interest also contemplated a convertible note funding option intended to address the Akoya Board's concerns around funding in the event the proposed transaction failed to close in a timely manner. Under the proposed convertible note funding, Quanterix would provide Akoya with up to $20,000,000 in the form of a subordinated convertible note in two tranches of $10,000,000 each, the first of which would be available at signing of the definitive documentation at Akoya's option, and the second of which would be available during the 30-day period following May 31, 2025, if the proposed transaction had not closed by such date. The convertible notes were further structured such that, if drawn, the exchange ratio offered to Akoya stockholders would be reduced to 0.2810 for the first tranche drawn and 0.2650 for the second tranche drawn. The convertible notes would be convertible at Quanterix's option into shares of Akoya Common Stock at the lower of the implied per share price in the proposed transaction or the average Akoya share price for the 20-day trading period preceding the conversion date. Quanterix's understanding of Akoya's future cash needs and debt covenants, and Akoya's request for a financing backstop, influenced Quanterix's decision to extend bridge financing to Akoya as a component of Quanterix's overall offer, as reflected in the December 17 Quanterix Indication of Interest. On December 17, 2024, the Akoya Strategic Transactions Committee along with representatives of PWP and DLA met to discuss the terms of the December 17 Quanterix Indication of Interest. During the meeting, the Akoya Strategic Transactions Committee discussed Quanterix's proposed convertible note funding structure and determined it did not address Akoya's concerns, would require consents from Akoya's lenders and was unattractive due to the adjustment mechanism to the exchange ratio and conversion features that the Akoya Strategic Transactions Committee perceived as punitive. The Akoya Strategic Transactions Committee instructed representatives of PWP to determine if MidCap as Akoya's agent under Akoya's existing credit facility would be willing to provide Akoya with further covenant relief in the event of a delayed or failed Quanterix stockholder vote in order to provide Akoya with additional time to secure financing to continue to operate on a standalone basis. Page 135 · [. . .] · the belief that the size of the termination fee that might be payable to Akoya pursuant to the Merger Agreement (i) was reasonable in light of the overall terms of the Merger Agreement, (ii) was within the range of termination fees in other transactions of this size and nature and (iii) would not be likely to preclude another party from making a competing proposal. The Quanterix Board also considered Akoya's financial projections, with revenue, EBIT and cash burn expectations adjusted by Quanterix management (see "Summary of the Quanterix Management Adjusted Akoya Projections" below), and took into consideration Akoya's cash burn. The Quanterix Board determined that the Combined Company would be adequately capitalized and have sufficient cash to sustain its operations until cash flow break even. The Quanterix Board weighed these advantages and opportunities against a number of potentially negative factors in its deliberations concerning the Merger Agreement and the Merger, including: [. . .] 2
2025-04-10 - CORRESP - Quanterix Corp
CORRESP 1 filename1.htm Quanterix Corporation 900 Middlesex Turnpike Billerica, MA 01821 Via EDGAR April 10 , 2025 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-4628 Attn: Margaret Sawicki Re: Quanterix Corporation Registration Statement on Form S-4 Filed February 13, 2025 and amended on March 28, 2025 and April 4, 2025 File No. 333-284932 Ladies and Gentlemen: We hereby withdraw our prior acceleration request, dated March 28, 2025, with respect to the above-referenced Registration Statement. We intend to submit an acceleration request at a later time. Respectfully, Quanterix Corporation By: /s/ Vandana Siriram Name: Vandana Sriram Title: Chief Financial Officer cc: Kerry S. Burke, Covington & Burling LLP Catherine Dargan, Covington & Burling LLP Kyle Rabe, Covington & Burling LLP Laurie A. Churchill, Quanterix Corporation Patrick J. O'Malley, DLA Piper LLP
2025-04-09 - UPLOAD - Quanterix Corp File: 333-284932
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 9, 2025 Masoud Toloue, Ph.D. President and Chief Executive Officer Quanterix Corp 900 Middlesex Turnpike Billerica, MA 01821 Re: Quanterix Corp Amendment No. 2 to Registration Statement on Form S-4 Filed April 4, 2025 File No. 333-284932 Dear Masoud Toloue Ph.D.: We have conducted a limited review of your registration statement and have the following comment(s). Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe a comment applies 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 statement and the information you provide in response to this letter, we may have additional comments. Amendment No. 2 to Registration Statement on Form S-4 filed April 4, 2025 Risk Factors, page 22 1. We note your disclosure on page 26 stating that two of Quanterix s stockholders have indicated that they currently intend to oppose the Merger (emphasis added). Given Kent Lake is actively soliciting in opposition to the Share Issuance Proposal and the Adjournment Proposal, please update this risk factor. General 2. To aid stockholder understanding, please consider adding disclosure relating to Quanterix s evaluation of the materiality of Akoya s cash burn, debt burden, and going-concern issues. If these issues were not considered or considered but granted little weight, this also may be helpful for stockholders to understand. Please describe April 9, 2025 Page 2 how any such evaluation, as well as any plans to mitigate such issues, influenced negotiations or the terms of the Merger. 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. 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. Please contact Laura McKenzie at 202-551-4568, Margaret Sawicki at 202-551-7153 or Lauren Nguyen at 202-551-3642 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Kerry Burke, Esq. </TEXT> </DOCUMENT>
2025-03-28 - CORRESP - Quanterix Corp
CORRESP 1 filename1.htm Quanterix Corporation 900 Middlesex Turnpike Billerica, MA 01821 Via EDGAR March 28, 2025 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-4628 Attn: Margaret Sawicki Re: Quanterix Corporation Amendment No. 1 to Registration Statement on Form S-4 Filed March 28, 2025 File No. 333-284932 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Quanterix Corporation hereby respectfully requests that the effective date of the above referenced Registration Statement on Form S-4 be accelerated to 4:00 p.m., Eastern Time, on April 1, 2025, or as soon as practicable thereafter. Please contact Kerry S. Burke of Covington & Burling LLP at (202) 662-5297 with any questions you may have regarding this request. In addition, please notify Ms. Burke by telephone when this request for acceleration has been granted. Respectfully, Quanterix Corporation By: /s/ Vandana Sriram Name: Vandana Sriram Title: Chief Financial Officer cc: Kerry S. Burke, Covington & Burling LLP Catherine Dargan, Covington & Burling LLP Kyle Rabe, Covington & Burling LLP Laurie A. Churchill, Quanterix Corporation Patrick J. O'Malley, DLA Piper LLP
2025-02-24 - UPLOAD - Quanterix Corp File: 333-284932
February 22, 2025
Masoud Toloue, Ph.D.
President and Chief Executive Officer
Quanterix Corp
900 Middlesex Turnpike
Billerica, MA 01821
Re:Quanterix Corp
Registration Statement on Form S-4
Filed February 14, 2025
File No. 333-284932
Dear Masoud Toloue Ph.D.:
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 Margaret Sawicki at 202-551-7153 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Kerry Burke, Esq.
2019-05-08 - CORRESP - Quanterix Corp
CORRESP 1 filename1.htm Quanterix Corporation 113 Hartwell Avenue Lexington, MA 02421 May 8, 2019 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Thomas Jones Re: Quanterix Corporation Registration Statement on Form S-3 Initially Filed March 19, 2019 File No. 333-230399 Acceleration Request Dear Mr. Jones: With respect to the above-referenced Registration Statement on Form S-3 (the “Registration Statement”), and pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of Quanterix Corporation (the “Company”), that the Securities and Exchange Commission accelerate the effective date of the Registration Statement to Friday, May 10, 2019, at 5:30 p.m. Eastern Time, or as soon as practicable thereafter. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please call Megan Gates or John Condon of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 542-6000, with any comments or questions regarding the Registration Statement. Very truly yours, Quanterix Corporation By: /s/ Brian Keane Name: Brian Keane Title: General Counsel and Secretary cc: Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. William T. Whelan, Esq. Megan N. Gates, Esq. John P. Condon, Esq.
2019-03-26 - UPLOAD - Quanterix Corp
March 26, 2019
E. Kevin Hrusovsky
Chairman, President and Chief Executive Officer
Quanterix Corporation
113 Hartwell Avenue
Lexington, MA 02421
Re:Quanterix Corporation
Registration Statement on Form S-3
File No. 333-230399
Filed March 19, 2019
Dear Mr. Hrusovsky:
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: William T. Whelan, Esq.
2017-12-04 - CORRESP - Quanterix Corp
CORRESP 1 filename1.htm Quanterix Corporation 113 Hartwell Avenue Lexington, MA 02421 December 4, 2017 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Amanda Ravitz, Assistant Director Re: Quanterix Corporation Registration Statement on Form S-1 File No. 333-221475 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Quanterix Corporation, a Delaware corporation (the “Registrant”), hereby respectfully requests that the effective date of the above-captioned registration statement on Form S-1 (Registration No. 333-221475) be accelerated so that the registration statement may become effective at 4:05 p.m., Eastern time, on Wednesday, December 6, 2017, or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff. This request for acceleration is subject, however, to your receiving a telephone call prior to such time from our legal counsel, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., confirming this request. The Registrant hereby authorizes each of William Whelan, Megan Gates and John Condon of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, to make such request on its behalf. Please call Megan Gates (617-348-4443) or John Condon (617-348-4453) of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, with any comments or questions regarding this matter. Very truly yours, Quanterix Corporation By: /s/ E. Kevin Hrusovsky Name: E. Kevin Hrusovsky Title: Executive Chairman, President and Chief Executive Officer cc: Securities and Exchange Commission Tim Buchmiller Geoff Kruczek Gary Newberry Kevin Kuhar Quanterix Corporation Joseph Driscoll Ernie Orticerio Brian Keane Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. William T. Whelan Megan N. Gates John P. Condon Ropes & Gray LLP Patrick O’Brien Michael Pilo Ernst & Young LLP Mark M. Rocca
2017-12-04 - CORRESP - Quanterix Corp
CORRESP 1 filename1.htm December 4, 2017 VIA EDGAR AND HAND DELIVERY U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Tim Buchmiller Geoff Kruczek Gary Newberry Kevin Kuhar Amanda Ravitz Re: Quanterix Corporation (the “Company”) Registration Statement on Form S-1 File No. 333-221475 Ladies and Gentleman: In connection with the above-referenced Registration Statement, we wish to advise you that between November 27, 2017 and the date hereof we effected the distribution of approximately 2,650 copies of the Company’s Preliminary Prospectus dated November 27, 2017 to prospective underwriters, institutional investors, prospective dealers, brokers, individuals, rating agencies and others. We will comply and have been informed by the other participating underwriters that they will comply with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. As Representatives of the several underwriters, we hereby join in the request of the Company that the effectiveness of the above-referenced Registration Statement, as amended, be accelerated to 4:05 p.m., Washington, D.C. time, on December 6, 2017, or as soon thereafter as practicable. [Signatures follow.] Very truly yours, J.P. MORGAN SECURITIES LLC, LEERINK PARTNERS LLC COWEN AND COMPANY LLC As Representatives of the several Underwriters J.P. MORGAN SECURITIES LLC By: /s/ David Ke Name: David Ke Title: Vice President LEERINK PARTNERS LLC By: /s/ John I. Fitzgerald, Esq. Name: John I. Fitzgerald, Esq. Title: Managing Director COWEN AND COMPANY LLC By: /s/ Michael Campbell Name: Michael Campbell Title: Managing Director [Signature Page to Request for Acceleration of Effectiveness]
2017-11-20 - CORRESP - Quanterix Corp
CORRESP 1 filename1.htm Megan N. Gates | 617 348 4443 | mngates@mintz.com One Financial Center Boston, MA 02111 617-542-6000 617-542-2241 fax www.mintz.com FOIA CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO 17 C.F.R. § 200.83 BY QUANTERIX CORPORATION November 20, 2017 VIA EDGAR & OVERNIGHT MAIL CONFIDENTIAL Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Tim Buchmiller Re: Quanterix Corporation Registration Statement on Form S-1 (File No. 333-221475) Ladies and Gentlemen: We are submitting this letter on behalf of Quanterix Corporation (the “Company”) to assist the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in its review of the above-referenced registration statement on Form S-1 of the Company (the “Registration Statement”) and the prospectus contained therein. The Company supplementally advises the Staff on a confidential basis that it currently anticipates that in a subsequent pre-effective amendment to the Registration Statement it will disclose an offering with a proposed price range of $[***] to $[***] per share (the “Anticipated Price Range”), after giving effect to an anticipated reverse stock split of 1-for-[***] (the “Reverse Stock Split”). The Anticipated Price Range and the Reverse Stock Split are based on existing conditions in the public capital markets for life sciences companies, the Company’s financial position and prospects (assuming the completion of the offering), the market valuations of comparable publicly traded companies and preliminary discussions with the underwriters regarding potential valuations for the Company. Until such time as the Company revises the Registration Statement through a pre-effective amendment to include the price range and other details of the offering and to commence the road show, the Anticipated Price Range and the Reverse Stock Split remain subject to adjustment based on factors outside the Company’s control, such as changes in market conditions, the Company’s business and prospects and the valuation of comparable publicly traded companies. However, the Company believes that the actual bona fide price range will not be subject to significant change. In addition, the actual price range to be included in such pre-effective Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. BOSTON | LONDON | LOS ANGELES | NEW YORK | SAN DIEGO | SAN FRANCISCO | STAMFORD | WASHINGTON amendment will comply with the Staff’s interpretation regarding the parameters of a bona fide price range. Stock Option Grants from January 1, 2016 through September 30, 2017 After taking into account the Reverse Stock Split, the Company’s pre-effective amendment to the Registration Statement that includes the Anticipated Price Range will reflect the following split-adjusted amounts related to all stock options granted from January 1, 2016 through September 30, 2017: Grant date Number of shares underlying option granted Exercise price per share Estimated fair value per share of common stock at grant date August 31, 2017 (unaudited) [***] $ [***] $ [***] June 2, 2017 (unaudited) [***] $ [***] $ [***] May 25, 2017 (unaudited) [***] $ [***] $ [***] March 31, 2017 (unaudited) [***] $ [***] $ [***] August 25, 2016 [***] $ [***] $ [***] June 24, 2016 [***] $ [***] $ [***] Stock Option Grants and Common Stock Valuations As there has been no public market for our common stock to date, the estimated fair value of our common stock has been determined by our board of directors as of the date of each option grant, with input from management, considering the most recently available third-party valuations of common stock and our board of directors’ assessment of additional objective and subjective factors, including (1) our business, financial condition and results of operations, including related industry trends affecting our operations; (2) our forecasted operating performance and projected future cash flows discounted to present value using our estimated weighted average cost of capital; (3) the illiquid nature of our common stock; (4) liquidation preferences and other rights and privileges of our preferred stock over our common stock; (5) likeliness and estimated timing of the potential option to have our stock become publicly traded; (6) market multiples of our most comparable public peers; (7) recently completed equity financing transactions; and (8) market conditions affecting our industry. We have been receiving third-party valuations on a quarterly basis since September 30, 2015. These third-party valuations have been performed in accordance with the guidelines outlined in the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “Practice Aid”). 2 The Practice Aid prescribes several valuation approaches for estimating the value of an enterprise, such as the market, income and asset-based approaches, and various methodologies for allocating the value of an enterprise across classes and series of capital stock to determine the estimated fair value of common stock at a valuation date. Based on the Company’s stage of development and other relevant factors, the Company valued the common stock using a hybrid approach, with two scenarios considered: (1) an IPO scenario and (2) a “remain-private” scenario (the “Hybrid Approach”). The Hybrid Approach combines allocation methods to better capture a potential scenario/outcome in the near future (i.e. an IPO has become more feasible for an exit). For the IPO scenario, equity value was estimated using a market-based approach, the guideline public company method, whereas for the remain-private scenario equity value was estimated using an income-based approach, the discounted cash flow method. Value was allocated in the remain-private scenario using the option pricing method (“OPM”)(1). Utilizing the Hybrid Approach to estimate the Company’s per share value, the IPO method was weighted as follows as of the dates indicated: Date IPO Weight March 31, 2016 25% June 30, 2016 25% September 30, 2016 25% December 31, 2016 40% March 31, 2017 40% June 30, 2017 55% Beginning in the fourth quarter of 2016, the Company began internal discussions regarding the potential for an IPO. Accordingly, at December 31, 2016, the Company re-assessed the weighting assigned to the scenarios and ascribed a 40% weighting to the IPO scenario. Near the end of the second quarter of 2017 the Company had begun discussions with underwriters regarding a potential IPO, and at June 30, 2017, the Company again re-assessed the weighting and ascribed a 55% weighting to the IPO scenario. This change in weighting drove the increase in value on a post-split basis to $[***] at June 30, 2017. The Registration Statement was confidentially submitted on July 20, 2017. However, market and other business conditions did not suggest that an IPO was imminent. Accordingly, the Company considered the stage of development of the business, the historic uncertainties of the public markets for the life science industry and the fact that the mere submission/filing of a registration statement does not in any way guarantee the successful completion of an offering in determining that these scenario weightings were appropriate. Now that the Anticipated Price Range has been established, the Company considered factors contributing to the differences between grant date estimated fair values and the midpoint of the Anticipated Price Range, including: (1) Under the OPM, shares are valued by creating a series of call options with exercise prices based on the liquidation preferences and conversion terms of each equity class. The estimated fair values of the preferred and common stock are inferred by analyzing these options 3 · The Anticipated Price Range represents a future price for shares of common stock that, if issued in the IPO, will be immediately freely tradable in a public market, whereas the estimated fair value of the common stock as of all of the option grant dates described above represents a contemporaneous estimate of the fair value of shares that were then illiquid, might never become liquid and, even if an IPO were successfully completed, would remain illiquid for the 180-day lockup period following the IPO. This illiquidity accounts for a portion of the difference between the estimated fair values of the common stock through September 30, 2017 and the Anticipated Price Range. · The holders of the Company’s preferred stock currently enjoy substantial economic rights and preferences that are senior to the rights of the holders of its common stock. The Anticipated Price Range assumes the conversion of all of the preferred stock into common stock upon completion of the IPO. The corresponding elimination of these economic rights and preferences results in a higher valuation of the common stock after the IPO than before it. · The successful completion of an IPO would strengthen the Company’s balance sheet, provide access to public equity, provide enhanced operational flexibility and strengthen the Company’s reputation. · The Anticipated Price Range reflects the fact that investors may be willing to purchase shares in the IPO at a per share price that takes into account other factors that were not expressly considered in the Company’s prior valuations as a private company. · The Anticipated Price Range for this offering is based only upon a scenario in which the Company completes this IPO and is not probability weighted, in contrast to the Company’s prior valuations of the Company’s common stock, which considered multiple potential outcomes, some of which resulted in a lower value of the Company’s common stock than the midpoint of the Anticipated Price Range. In connection with the Company’s proposed initial public offering and in consultation with the underwriters, in light of the contributions to the increases in value of the Company’s common shares over the time periods set forth above, the Company reassessed the determination of the fair value of the common shares and has determined that it believes no further adjustment is necessary. The Company respectfully advises the Staff that the post-split shares and exercise prices for stock options granted from January 1, 2016 through September 30, 2017, when compared to the midpoint of the Anticipated Price Range, are supported by the progress in the Company’s business over that time period, as well as by the fact that the initial public offering was in no way a certainty when such options were granted, a fact that was taken into account by the board of directors in reaching its conclusions as to the appropriate valuation of the common stock during these time periods. We hope that the above information will be acceptable to the Staff. Please do not hesitate to call me, Megan Gates, at (617) 542-6000 with any comments or questions regarding the Registration Statement and this letter. We thank you for your time and attention. 4 Sincerely, /s/ Megan N. Gates Megan N. Gates cc: Securities and Exchange Commission Tim Buchmiller Geoff Kruczek Gary Newberry Kevin Kuhar Amanda Ravitz Quanterix Corporation E. Kevin Hrusovsky Joseph Driscoll Ernie Orticerio Brian Keane Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. William T. Whelan John P. Condon Ropes & Gray LLP Patrick O’Brien Michael Pilo 5
2017-11-09 - CORRESP - Quanterix Corp
CORRESP 1 filename1.htm One Financial Center Boston, MA 02111 617-542-6000 617-542-2241 fax www.mintz.com November 9, 2017 VIA EDGAR & OVERNIGHT MAIL Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Office of Electronics and Machinery Re: Quanterix Corporation Draft Registration Statement on Form S-1 Submitted July 21, 2017, as amended on August 17, 2017, August 31, 2017, September 25, 2017 and October 16, 2017 CIK No. 0001503274 (the “Fourth Amended Draft Registration Statement”) Ladies and Gentlemen: We are submitting this letter on behalf of Quanterix Corporation (the “Company”) in response to the comment from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated October 30, 2017 (the “Comment Letter”) from the Division of Corporation Finance, Office of Electronics and Machinery, to E. Kevin Hrusovsky, Executive Chairman, President and Chief Executive Officer of the Company, relating to the above-referenced Fourth Amended Draft Registration Statement. In conjunction with this letter, the Company is making amendments to the Fourth Amended Draft Registration Statement, which will be included in the Company’s initial public filing of its registration statement on Form S-1, dated the date hereof (the “Initial Public Filing”). For convenient reference, we have set forth below the Staff’s comment set forth in the Comment Letter along with our response, which is based on information provided to Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. by representatives of the Company. The Company has responded to the Staff’s comment by making changes to the disclosure in the Fourth Amended Draft Registration Statement, the applicable page numbers for which are noted below. We are providing by overnight delivery to your attention five courtesy copies of this letter and copies of the Initial Public Filing that have been marked to show changes from the Fourth Amended Draft Registration Statement. Note 2. Significant accounting policies Product revenue, page F-9 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. BOSTON | LONDON | LOS ANGELES | NEW YORK | SAN DIEGO | SAN FRANCISCO | STAMFORD | WASHINGTON Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. November 9, 2017 Page 2 Comment 1: We note your responses to comments 5, 6 and 7. Please revise your discussions throughout the filing to clarify what you mean by “implied warranty”, to explain when and how it is provided to customers, and to describe the types of services you provide for the implied warranty and the extended warranty - i.e. semi-annual preventative maintenance, troubleshooting, etc. Response: The Staff’s comment is acknowledged, and the Company has revised the disclosure on pages 63 and F-9 as requested. We hope that the response above and the related revisions reflected in the Initial Public Filing will be acceptable to the Staff. Please do not hesitate to call me, William T. Whelan or John P. Condon of this firm at (617) 542-6000 with any comments or questions regarding the Initial Public Filing and this letter. We thank you for your time and attention. Sincerely, /s/ Megan N. Gates Megan N. Gates cc: Securities and Exchange Commission Tim Buchmiller Geoff Kruczek Gary Newberry Kevin Kuhar Amanda Ravitz Quanterix Corporation E. Kevin Hrusovsky Joseph Driscoll Ernie Orticerio Brian Keane Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. William T. Whelan John P. Condon Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. November 9, 2017 Page 3 Ropes & Gray LLP Patrick O’Brien Michael Pilo
2017-10-30 - UPLOAD - Quanterix Corp
Mail Stop 3030 October 30, 2017 Via E -mail E. Kevin Hrusovsky Executive Chairman, President and Chief Executive Officer Quanterix Corporation 113 Hartwell Avenue Lexington, MA 02421 Re: Quanterix Corporation Amendment No. 4 to Draft Registration Statement on Form S -1 Submitted October 17, 2017 CIK No. 0001503274 Dear Mr. Hrusovsky : 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 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 d o 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 amended draft registr ation statement or filed registration statement, we may have additional comments. Note 2. Significant accounting policies Product revenue, page F -9 1. We note your responses to comments 5, 6 and 7. Please revise your discussions throughout the filing to clarify what you mean by “implied warranty”, to explain when and how it is provided to customers, and to describe the types of services you provide for the implied warranty and the extended warranty - i.e. semi -annual preventative maintenance, troubleshoo ting, etc. You may contact Gary Newberry at (202) 551 -3761 or Kevin Kuhar, Accounting Branch Chief, at (202) 551 -3662 if you have questions regarding comments on the financial statements E. Kevin Hrusovsky Quanterix Corporation October 30, 2017 Page 2 and related matters. Please contact Tim Buchmiller at (202) 551 -3635 or Geoff Kruczek, Special Counsel, at (202) 551 -3641 with any other questions. Sincerely, /s/ Geoff Kruczek for Amanda Ravitz Assistant Director Office of Electronics and Machinery cc: Megan N. Gates, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2017-10-06 - UPLOAD - Quanterix Corp
Mail Stop 3030 October 6 , 2017 Via E -mail E. Kevin Hrusovsky Executive Chairman, President and Chief Executive Officer Quanterix Corporation 113 Hartwell Avenue Lexington, MA 02421 Re: Quanterix Corporation Amendment No. 3 to Draft Registration Statement on Form S -1 Submitted September 25, 2017 CIK No. 0001503274 Dear Mr. Hrusovsky : 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 wi th 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 amended draft registration statement or filed registration statement, we may have additional comments. Overview, page 1 1. We note your revisions in response to prior comment 1. Please revise to clarify whether you intend to expand into the mar kets referenced here, given your disclosure on pages 51 and 107 indicating a lack of certainty regarding such intended expansion by you and your collaborators. If you elect to continue to highlight your aspirations regarding accessing these markets, also discuss the material hurdles that remain, including that you and your collaborators have not received or begun the process for obtaini ng regulatory approvals. 2. We note your revised disclosure in response to prior comment 2 that you have granted bioMérieux an exclusive license to, “among other things,” develop and sell “certain” in vitro diagnostic products and a co -exclusive license for “certain” other in vitro diagnostic products. Please describe the nature of this agreement in concrete, everyday terms E. Kevin Hrusovsky Quanterix Corporation October 6, 2017 Page 2 avoiding the use of phrases like “among other things” and “certain.” Given that you have granted bioMérieux exclusive and co -exclusive licenses for potential diagnostic products, please describe the effect this agreement has on the $30 billion addressable m arket you disclose in your summary. Also revise to disclose the status of bioMérieux’s efforts at developing and securing regulatory approval under this agreement. 3. We note your revised disclosure in response to prior comment 3. Please continue to revise your disclosure so that the first and most prominent disclosure regarding your current market opportunity is the $3 billion per year that you believe is addressable given the current “research use only ” status of your products. License agreement . . ., p age 106 4. Please expand your response to prior comment 9 to clarify what you mean by the qualifier “that would be relevant to future activities under the current agreement between the parties.” Notes to Consolidated Financial Statements Note 2. Signific ant accounting policies Product revenue, page F -9 5. We note your response to comment 10. Please tell us when and how your customer is informed that they are entitled to the various services provided under the implied warranty. 6. We note the four deliverables identified as the additional services provided under the implied warranty ; i.e., preventative maintenance, minor hardware and software upgrades, additional training and troubleshooting. Please explain how you determined that these services ar e one unit of accounting, refer to paragraphs 25 -3 to 25 -6 of ASC 605 -25 as part of your response. 7. Please tell us how you determined the best estimate of selling price for the implied warranty. As part of your response, tell us the time and cost involved to provide the semi -annual maintenance. E. Kevin Hrusovsky Quanterix Corporation October 6, 2017 Page 3 You may contact Gary Newberry at (202) 551 -3761 or Kevin Kuhar, Accounting Branch Chief, at (202) 551 -3662 if you have questions regarding comments on the financial statements and related matters. Please contact T im Buchmiller at (202) 551 -3635 or Geoff Kruczek, Special Counsel, at (202) 551 -3641 with any other questions. Sincerely, /s/ Geoff Kruczek for Amanda Ravitz Assistant Director Office of Electronics and Machinery cc: Megan N. Gates, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2017-09-15 - UPLOAD - Quanterix Corp
Mail Stop 3030 September 15, 2017 Via E -mail E. Kevin Hrusovsky Executive Chairman, President and Chief Executive Officer Quanterix Corporation 113 Hartwell Avenue Lexington, MA 02421 Re: Quanterix Corporation Amendment No. 2 to Draft Registration Statement on Form S -1 Submitted August 31, 2017 CIK No. 0001503274 Dear Mr. Hrusovsky : 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 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 amended draft registra tion statement or filed registration statement, we may have additional comments. Overview, page 1 1. We note your response to prior comment 1. Continue to revise your disclosure to state clearly and prominently on the first page that you currently sell your products for “research use only.” 2. We note your responses to prior comments 2, 3 and 11. Given what appears to be the scope of the bioMérieux agreement and its effect on your ability to enter the diagnostics and precision health markets, and other ma rkets, it continues to appear that such agreement currently has, and will have, a significant impact on your operations and intended operations. Therefore, it also appears you should highlight the nature and effect of this agreement in the summary. Pleas e revise accordingly. E. Kevin Hrusovsky Quanterix Corporation September 15 , 2017 Page 2 3. We note that you have revised your disclosure in response to prior comment 4 to disclose that your products “may be subject to regulation.” We al so note your disclosure on page 27 that if you seek to market your products for clinica l diagnostics or health screening use, you will be required to obtain regulatory clearance or approval. Revise your prospectus summary to provide investors with greater insight into whether your products are subject to regulation, the steps you have taken towards obtaining regulatory approval and the steps that remain. Also highlight how your current regulatory approval and current sales into the research use only market changes your addressable market size of an aggregate of $30 billion per year. We als o note your disclosure on page 113 that “[i]f and when [you] decide to market [y]our products for clinical diagnostic use, [y]our products will be regulated by the FDA as medical devices.” Since it not clear that you have decided to market your products o ther than for research use only at this time, please tell us why you have indicated the size of the clinical diagnostic use and health screening use markets and revise your disclosure as appropriate. Protein analysis, page 5 4. We note your response to prio r comment 5; however, your disclosure, such as here and on pages 80, 86, 87 and 92, continues to discuss the lack of sensitivity of “conventional” detection technologies while noting the greater sensitivity your system provides. Given this, please revise to also compare the number of secreted proteins your system currently addresses. Many of the reagents…, page 19 5. We note your revised disclosure that many of the materials, including certain reagents, and components that are used in your consumable produ cts are purchased from suppliers with a restriction that they be used for research use only. In an appropriate location, disclose if such materials would have to be approved as part of any regulatory process if you intend to enter into the clinical diagno stics or health screening markets. Special note regarding forward -looking statements, page 50 6. We note your response to prior 13 that you have commissioned data from a third -party that you have included in your registration statement. Please file the con sent of that third -party as an exhibit to your registration statement. Use of proceeds, page 51 7. We note your revisions in response to prior comments 14 and 15 . It remains unclear what new life sciences applications, chemistry and instrumentation for you r technology platform and specific products in areas outside of research you intend to develop with the proceeds of this offering . Please revise as appropriate. Also, while we note the disclosure that you do not currently market your products outside of the research use only E. Kevin Hrusovsky Quanterix Corporation September 15 , 2017 Page 3 market, it is unclear from those revisions disclosure what is the status of development, including regulatory status, of those products and the new life sciences applications, chemistry and instrumentation for you technology platform. Please revise. Dilution, page 55 8. As requested by prior comment 16, expand your disclosure to show how the numbers and percentages in the table on page 56 would change assuming the exercise of all outstanding options and warrants. License agreement with bioMérieux SA, page 106 9. While we note your revised disclosure in response to prior comment 26 that the development and regulatory criteria were not satisfied and were removed from the agreement , it continues to be unclear why those criteria were not met. As requested by that comment , please revise to clarify why the development and regulatory criteria were not met . Note 2. Significant accounting policies Product revenue, page F -9 10. We note your response to prior comment 35. Please address the following: Tell us how the historical pattern of providing the additional services began and developed since 2014. Tell us how each of the services you describe under the implied warranty ensure the continued performance of the instrument and how often th ey are typically provided. Explain how you determine when such services are needed – i.e., is this provided through routine scheduled visits, by customer request or some other manner. Explain how the implied warranty services differ from inconsequential or perfunctory performance obligations as described in SAB Topic 13A.3.c. Quantify for us the amount of revenue recognized for the implied warranty in each of the periods presented and deferred as of each balance sheet date. E. Kevin Hrusovsky Quanterix Corporation September 15 , 2017 Page 4 You may contact Gary Newberry a t (202) 551 -3761 or Kevin Kuhar, Accounting Branch Chief, at (202) 551 -3662 if you have questions regarding comments on the financial statements and related matters. Please contact Tim Buchmiller at (202) 551 -3635 or Geoff Kruczek, Special Counsel, at (20 2) 551 -3641 with any other questions. Sincerely, /s/ Geoff Kruczek for Amanda Ravitz Assistant Director Office of Electronics and Machinery cc: Megan N. Gates, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2017-08-18 - UPLOAD - Quanterix Corp
Mail Stop 3030 August 17, 2017 Via E -mail E. Kevin Hrusovsky Executive Chairman, President and Chief Executive Officer Quanterix Corporation 113 Hartwell Avenue Lexington, MA 02421 Re: Quanterix Corporation Draft Registration Statement on Form S -1 Submitted July 21, 2017 CIK No. 0001503274 Dear Mr. Hrusovsky : 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 amended draft registration statement or filed registration statemen t, we may have additional comments. Overview, page 1 1. We note your disclosure on page 22 and page 26 . If true, expand your over view to indicate that you have focused initially on the life sciences research market and that you currently sell all your products for research use only. Clarify if you have received material revenue to date from the diagnostics and precision health screening markets. If you have no revenue from, or regulatory approvals to operate in, those markets, please state so clearly and directly. 2. We note the scope of the exclusive license and a co -exclusive license granted to bioMérieux SA discussed on page 105 and bioMérieux ’s current objective to identify and develop an assay menu supporting the commercial launch of a new, benchtop in-vitro diagnostic instrument using your Simoa technology for use in clinical lab applications, E. Kevin Hrusovsky Quanterix Corporation August 17, 2017 Page 2 food quality control testing and pharmaceutical quality control testing . Please revise to describe how the license terms and bioMérieux’s objective limit you r ability to enter the diagnostics and precision health markets, or any other market you may access . 3. We note your disclosure on page F -41 that you can engage a collaboration partner, subject to certain restrictions, in the field of in vitro diagnostics used in Clinical Lab Applications and that you shall pay bioMérieux a royalty based on a percentage of the royalty you will receive from that partner. Please tell us about the restrictions and the royalty payment and if disclosure of this arrangement shou ld be briefly disclosed in your prospectus summary. 4. Briefly indicate the regulatory status of your products . Revise your disclosure under “Market Overview” on page 2 to reflect how your current regulatory approval and current sales into the research use only market changes your addressable market size in the three bullet points on page 2. Briefly disclose what regulatory approvals you will need to enter into the indicated markets, the steps you or your collaborators, such as bioMérieux, have taken to sec ure such approvals and what steps remain. 5. We understand from your disclosure that your system uses capture antibodies that bind specifically to known proteins. Please clarify in an appropriate location how your system enables researche rs to discover novel protein biomarkers. 6. Given your disclosure that you r system is used for protein detection, please clarify in an appropriate location in your prospectus how researchers “can now better understand how proteins are individually and/or collectively contr ibuting to important biological processes and the health and well -being of individuals ” and also how your detection system enables the understanding of “individual character istics and functioning of proteins.” 7. Since you have chosen to highlight your reven ue growth, please balance this disclosure with your net losses for the periods presented and your accumulated deficit. Also, given your disclosure on page 70, indicate that you sold fewer instruments in 2016 than in 2015 and that your instrument sales wer e flat for the March 31 quarter over quarter periods. 8. The first full paragraph on page 2 indicates your product can directly detect nucleic acids. The third bullet point on page 84 and disclosures on pages 90 and 92 indicate your product does not yet hav e that testing capability. Please reconcile. Protein analysis, page 5 9. Balance your disclosure by indicating how many of the 10,500 secreted proteins your system currently addresses. E. Kevin Hrusovsky Quanterix Corporation August 17, 2017 Page 3 Implications of being an emerging growth company, page 7 10. Supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that 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. We depend on strategic collaborations and licensing arrangements… , page 20 11. We note your disclosure that given the exclusive nature of a portion of the license rights granted to bioMérieux SA your ability to collaborate with others in certain areas will be limited . Expand your risk factor, and other disclosure as appropriate, to clarify how the exclusive license will affect your ability to collabora te with others and indicate the “certain areas” that will be affected by that license. Some of our owned and in -licensed intellectual property . . ., page 32 12. We note that “some” of the intellectual property rights you own and have been licensed “may” be subject to federal regulations. Please revise to clarify the specific intellectual property rights to which you refer, such as the “core Simoa technology” noted on page 33. Please also revise to clarify why you do not know whether those rights are subjec t to the federal regulations to which you refer. Special note regarding forward -looking statements , page 48 13. Tell us whether you commissioned any of the third -party data you cite for use in connection with your registration statement. Use of proceeds, pa ge 50 14. Please revise to clarify the new life sciences applications, chemistry and instrumentation for your technology platform you intend to develop with the proceeds of this offering . Disclose here and in other locations in your prospectus, as appropriate, if you intend to develop applications outside of protein detection , and the status, to date, of your efforts . 15. Disclose with more specificity which in vitro diagnostic markets you intend to address and clarify in an appropriate location in y our prospectus what FDA approval you may seek for your existing or new products to be utilized for diagnostic purposes, as indicated in the third bullet point on page 15. Also revise to clarify the status of product development efforts in “areas outside o f research” and whether you will require funds to complete development in addition to those received through this offering. E. Kevin Hrusovsky Quanterix Corporation August 17, 2017 Page 4 Dilution, page 54 16. Expand the disclosure on page 55 to clarify how the numbers and percentages in the table would change assuming t he exercise of all outstanding options and warrants . Overview, page 58 17. We note the discussion here that you have sold 135 instruments to date and that on pages 68 and 70 you attribute increased consumable sales to the number of instruments sold. The number of installed instruments appears to be a key non -financial performance indicator that would be material to investors. Please revise the filing to quantify th e total number of installed instruments at each period end. Refer to Section I.B of SEC Release 33-8350. Stock -based compensation, page 63 18. Please expand your disclosure on page 65 of the factors considered to determine the best estimate of the fair valu e of your common stock to state, if true, that your projected future cash flows were discounted at an appropriate rate. 19. Please describe to us in greater detail the nature of the comparable public peer companies you selected and the basis for your conclusi on to select those companies. Discuss how you considered factors such as industry, stage of life cycle, size and financial leverage when selecting the comparable companies. Refer to ASC paragraphs 718 -10-55-36 and 37 and Question 6 in SAB Topic 14D.1. Results of operations, page 68 20. Revise your revenue disclosure to quantify the changes in your revenue during the periods presented that are attributable to changes in prices and changes in volume . Include quantification of the comparable amount of instrum ents sold in each period presented . Refer to Item 303(a)(3)(iii) of Regulation S -K. 21. Revise to clarify all material reasons for the changes in your line items and quantify each material reason driving the changes as appropriate . For example, on page 70, you refer to a “lower number of instruments sold” during 2016, but it is unclear why a lower number were sold and what was the extent of the decrease. Preferred stock financings, page 71 22. Please provide an expanded discussion of the significant terms of the preferred stock issued during the periods presented. Refer to Item 303(a)(1) and Instruction 3 to Item 303(a) of Regulation S -K. E. Kevin Hrusovsky Quanterix Corporation August 17, 2017 Page 5 Diagnostics, page 80 23. We note your disclosure that significant interest from third parties has resulted in collaborations with leading diagnostic companies such as bioMérieux SA . If any of the other collaborations have been material, please identify those collaborations. If t he other collaborations have not been material to date, please revise your disclosure as appropriate. Simoa analytic process, page 88 24. Revise to indicate the significance of “paramagnetic” beads. Also indicate what the stars and arrow in your first graph ic indicate and better describe the enzyme substrate you have presented. Assays and consumables, page 102 25. Please clarify if the 80 assays you mention include “homebrew assays.” Also clarify whether you have or retain any intellectual property rights to “homebrew assays.” License agreement with bioMérieux SA , page 105 26. From the disclosure on page F -40, it appears that neither the developmental nor regulatory criteria were met under the original agreement or subsequent amendments. It also appears from your disclosure here that bioMérieux SA has not yet commercially launc hed a product based on your Simoa technology. Please disclose the reasons the development and regulatory criteria were not satisfied under the prior agreements. Competition, page 108 27. We note your reference to Singulex as a competitor. Please tell us if you are referring to the MilliporeSigm a SMCxPRO product and revise your disclosure as appropriate . Also expand your first risk factor on page 25 as appropriate. Intellectual property, page 108 28. You disclose that your patent strategy is multilayered, pro viding coverage of aspects of your core technology. We also note your disclosure regarding the first and second layers of your strategy. Please clarify if the capture antibodies are proprietary or sourced from third parties. Also clarify what you consid er as your “core technology” and what you mean by the “fundamental methods for detecting single molecules independent of specific embodiments” and “specific embodiments of the core technology.” Further explain the effect of your patents on these aspects o f your technology. E. Kevin Hrusovsky Quanterix Corporation August 17, 2017 Page 6 Government regulation, page 111 29. Please revise to clarify how you concluded that the labeling and promotion of your products complies with the guidance you cite, as disclosed in the last sentence of the second paragraph, given the disclosure in this document regarding your current lack of regulatory approvals and the capabilities of your Simoa product. We note, for example, disclosure that your platform “advances precision health for . . . diagnostics” and disclosures on pages 93 -99 regarding key focus areas. Executive officers, page 115 30. Disclose the principal occupation of Mr. Hrusovsky from May 2013 until he became your chief executive officer. For each of your executive officers, disclose the principal business of the employers named as part of their business experience. Certain relationships . . ., page 131 31. If Tufts University is a related party to you due to Tuft’s equity ownership, as disclosed on page F -34, please clarify why Tufts is not included in the table on page 137. Principal stockholders, page 136 32. Disclose all natural persons who exercise the sole or share voting and dispositive powers with respect to the shares held in the name Trinitas Innovation -Q Investment Co., Ltd and bioMerieux, S.A. Underwriting, page 154 33. We note your reference to past relationships with “certain” of the underwriters. Please clarify to which underwriters you are referring and the nature and terms of such relationships. Consolidated statements of cash flows, page F -6 34. Please revise the filing to present the warrant liabilities converted into preferred stock as supplemental cash flow information. Product revenue, page F -9 35. Please tell us why consideration in a multiple element arrangement is allocated to an implied one year se rvice type warranty and why such revenue is recognized over one year as part of service revenue. Describe how you have concluded that this warranty is “implied” and how it relates to the periods covered under the extended warranty contracts that you offer . Discuss whether you have a regular pattern of providing these services E. Kevin Hrusovsky Quanterix Corporation August 17, 2017 Page 7 and what services are generally provided. Refer to ASC 605 -20-25, 605 -25-25 or paragraphs 66 and 67 of 985 -605-25 as appropriate. 36. Tell us your accounting policy for and the nature of any sales returns, discounts and allowances and specify any differences in polices between direct sales and sales to distributors. Refer to SAB Topic 13A as appropriate. Unaudited pro forma information, page F -12 37. Please tell us whether you believe it is probable that the preferred stock will automatically convert into common stock. We note the terms of automatic conversion in Note 7 on page F -28. Refer to Article 11 of Regulation S -X. Fair value of financial instruments, page F -14 38. You disclose on page F -16 that the changes in the fair value of the preferred stock warrant liability are recorded in other expense (income). In Notes 9 and 10 on pages F- 36 and F -37, you disclose certain warrants were issued to non -employees for goods or services. Plea se address the following: Tell us the fair value of warrants issued for goods or services that were outstanding at the beginning and ending balance sheet dates for each period presented, and the related change in fair value for such warrants recognized in income for each period presented. Tell us how you considered paragraphs 4 and 5 of ASC 505 -50-25, SAB Topics 14A and 14F and the definition of non -operating income or expense under Rule 5 -03 of Regulation S -X in classifying the changes in fair value of non -employee share based payment arrangements outside of operating income and not in the same manner as if you had paid cash for the services. Stock -based compensation, page F -20 39. Please disclose your policy for the initial and subsequent measurement of equ ity based instruments issued to non -employees for goods and services. In particular, include the policy for warrants to be issued contingent on future events such as those on page F -37. Recent accounting pro