SEC Company Response from INTELLIGENT BIO SOLUTIONS INC. (INBS) (CIK 0001725430) (INBS) — Jul 3, 2019
INTELLIGENT BIO SOLUTIONS INC. (INBS) (CIK 0001725430)
Date: July 3, 2019 · CIK: 0001725430 · Accession: 0001493152-19-010288
AI Filing Summary & Sentiment
Referenced dates: June 7, 2019
Show Raw Text
CORRESP
1
filename1.htm
Graubard
Miller
The
Chrysler Building
405
Lexington Avenue
New
York, N.Y. 10174-1101
(212)
818-8800
direct
dial number
(212)
818-8602
facsimile
email
address
(212) 818-8881
eschwartz@graubard.com
July
3, 2019
Division
of Corporation Finance
Office
of Electronics and Machinery
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Glucose
Biosensor Systems (Greater China) Holdings, Inc.
Draft
Registration Statement on Form S-1
Filed
May 13, 2019
File
No. 0001725430
Ladies
and Gentlemen:
On
behalf of Glucose Biosensor Systems (Greater China) Holdings, Inc. (the “Company”), we respond as follows to
the Staff’s comment letter, dated June 7, 2019, relating to the above-captioned Draft Registration Statement on Form S-1
(“Registration Statement”). Captions and page references herein correspond to those set forth in amended filing
of the Registration Statement, a copy of which has been marked with the changes from the prior filing of the Registration Statement.
Please
note that for the Staff’s convenience, we have recited each of the Staff’s comments and provided the response to each
comment immediately thereafter.
Draft
Registration Statement on Form S-1 submitted May 13, 2019
Prospectus
Summary, page 1
1.
If
true, please disclose that to date you have not generated any revenues from sales of your intended products and that to date
you have incurred net losses and negative cash flows from operations.
The
Company has not generated any revenues from sales of its intended products and has incurred net losses and negative cash
flows from operations to date. The Company has revised the disclosure as requested on page 3 of the Registration
Statement.
Securities and Exchanage Commission
July 3, 2019
Page 2
2.
Please
balance your disclosure that the SGB produces a signal directly correlated to the amount of glucose present in saliva with
disclosure of whether you have any third-party clinical validation that supports a meaningful correlation between glucose
present in saliva and glucose present in blood. If you do not have clinical evidence of a meaningful correlation at this time,
please disclose in an appropriate location in your prospectus the basis for your belief that the measurement of salivary glucose
is a meaningful proxy for blood glucose levels and include appropriate risk factor disclosure regarding your beliefs.
Numerous
research reports from various institutions have shown a direct relationship exists between blood glucose levels and the concentration
of glucose in saliva. See, for example, Gupta et al., Correlation of salivary glucose level with blood glucose level in diabetes
mellitus, J Oral Maxillofac Pathol. 2017 Sep-Dec; 21(3): 334–339; Hartman et al., Unhealthy Phenotype as Indicated by Salivary
Biomarkers: Glucose, Insulin, VEGF-A, and IL-12p70 in obese Kuwaiti Adolescents, Journal of Obesity Volume 2016, Article ID
6860240; Patel et al., Comparison and correlation of glucose levels in serum and saliva of both diabetic and non- diabetic patients,
Journal of International Oral Health 2015; 7(8):70-76; Tiongco et al., Salivary glucose as a non-invasive biomarker of type 2
diabetes mellitus, J Clin Exp Dent. 2018 Sep 1;10(9):e902-e907; Bhattacharyya et al., Salivary glucose levels and oral candidal
carriage in Type 2 diabetics J Oral Biol Craniofac Res. 2018 Sep-Dec;8(3):158-164; Abd-Elraheem et al., Salivary changes in type
2 diabetic patients, Diabetes Metab Syndr. 2017 Dec;11 Suppl 2:S637-S641; Carramolino-Cuéllar et al., Salivary glucose
as a metabolic control marker in patients with type 2 diabetes, J Biol Regul Homeost Agents. 2017 Apr-Jun;31(2 Suppl 1):181-187;
Yousri et al., A systems view of type 2 diabetes-associated metabolic perturbations in saliva, blood and urine at different timescales
of glycaemic control, Diabetologia, 2015, Volume 58, Issue 8, pp 1855–1867; Jha et al., Estimation of salivary glucose
level and plasma glucose level in subjects with and without diabetes mellitus: a comparative study, NJIRM 2014; Vol. 5(3).May-June;
Mascarenhas et al., Effect of diabetes mellitus type 2 on salivary glucose – a systematic review and meta- analysis of observational
studies, PLoS ONE 9(7): e101706; Kumar et al., Correlation of salivary glucose, blood glucose and oral candida carriage in the
saliva of type 2 diabetics: a case-control study., Contemporary Clinical Dentistry, Jul-Sep 2014, Vol 5, Issue 3; Abiskshyeet
et al., Glucose estimation in the salivary secretion of diabetes mellitus patients, Diabetes, Metabolic Syndrome and Obesity:
Targets and Therapy 2012:5 149– 154. For further readings supporting the claim that blood glucose and salivary glucose levels
are positively correlated, see Andersson et al. Glucose concentration in parotid saliva after glucose/food intake in individuals
with glucose intolerance and diabetes mellitus, Eur J Oral Sci 1998; 106:931; Kortuen et al., Saliva glucose and blood glucose.
AM J Clin Pathol 1944; 14:70; Shela et al., Salivary glucose concentrations in patients with diabetes mellitus – a minimally
invasive technique for monitoring blood glucose levels. Pak J Pharm Sci 2001; 14:33-7; Kannan et al., Salivary glucose levels
and oral candida carriage in type II diabetics. Oral Surg Oral Med Oral Pathol Oral RadioIEndod2010; 109:706-11.
Securities and Exchanage Commission
July 3, 2019
Page 3
Notwithstanding,
a few research papers have found no significant correlation between salivary and blood glucose levels. See Manjrekar PA, Hegde
A, Shrilaxmi, D’souza F, Kaveeshwar V, et al. (2012), Fructosamine in Non-diabetic First Degree Relatives of Type 2 Diabetes
Patients: Risk Assessor. J Clin Diagnostic Res. June, Vol-6(5): 770–77. doi: JCDR/2012/3863:0000; Vasconcelos ACU, Soares
MSM, Almeida PC, Soares TC (2010) Comparative study of the concentration of salivary and blood glucose in type 2 diabetic patients,
J Oral Sci Jun; 52(2):293–8.
Overall,
the Company believes there is abundant clinical evidence in independently reviewed scientific literature that saliva can be utilized
as a non-invasive alternative to blood to monitor glycemic status in diabetic patients.
The
Company has revised the disclosure on pages 2 and 46 of the Registration Statement to clarify the foregoing and include
certain references to the scientific literature. The Company will supplementally provide copies of the above-referenced
scientific literature upon request.
3.
We
note your disclosure that the biosensor technology has been “extensively referenced in scientific literature.”
It is unclear what this disclosure is intended to convey since you also appear to disclose that you have not generated clinical
evidence to support regulatory clearance. If you elect to reference scientific literature please briefly indicate the nature
of the references and provide balanced disclosure, including information regarding any reference with results that may not
support that salivary glucose biosensors provide meaningful information for blood glucose monitoring.
While
the Company has not yet generated the clinical evidence that is specifically required for regulatory approval, the mode of action
of the biosensor, including the direct signal correlation with the amount of glucose, has been reviewed in numerous scientific
journal articles. See Biosensors and Bioelectronics, Volume 7, Issue 3, 1992, Pages 165-185; Int J Biochem Cell Biol. 2005 Apr;37(4):731-50;
J Diabetes Sci Technol. 2011; 5(5): 1068–1076); Applied Physics Letters 106(26), 2015; Applied Physics Letters 105(4):043303,
2014. The Company is not aware of any research indicating that the biosensor technology licensed by the Company does not operate
as described in the Registration Statement.
The
Company has revised the disclosure on page 46 of the Registration Statement to clarify the foregoing and include references
to the scientific literature. The Company has revised the disclosure on page 2 of the Registration Statement to insert a cross-referenced
to the fuller description on page 46. The Company will supplementally provide copies of the above-referenced journal articles
upon request.
Securities and Exchanage Commission
July 3, 2019
Page 4
4.
Given
your disclosure that the Licensor owns all of the intellectual property related to the biosensor technology, including any
improvements made to the technology by you, and all data and any derivations related to the foregoing, briefly disclose how
you intend to conduct business after your license agreement expires and include appropriate risk factor disclosure.
The
Company and the Licensor have entered into an amended and restated license agreement that does not provide for expiration of the
license. Instead, upon expiration of the last of the patents covered by the license, the license will cease to be exclusive and
the royalty fee will be reduced. The Company has revised the disclosure to reflect the foregoing on pages 5 and 61 of the
Registration Statement.
5.
We
note the intended launch of other diagnostics tests. Briefly explain the status of development of those products. Also compare
that status with the status of your SGB product.
The
Company has revised the disclosure as requested on pages 3 and 48 of the Registration Statement.
License
Agreement, page 3
6.
Revise
the second paragraph to clarify whether you, your affiliates, the Licensor or its affiliates currently are capable of manufacturing
your product.
Although
the Company, the Licensor and their respective affiliates are authorized under the License Agreement to manufacture the product,
the Company intends to outsource fabrication to an unrelated third-party. The Company has revised the disclosure on pages
4 and 59 of the Registration Statement to clarify the foregoing.
7.
Please
briefly explain the reason for the geographic scope limitation of the License Agreement. If the Licensor has granted other
licenses with different or overlapping scopes, please also disclose that fact and explain the extent of that scope. Please
also explain the purpose and intended use of the demographic information and personally identifiable information, including
health information, you are required to assemble.
The
Company has revised the disclosure as requested on pages 4, 59 and 60 of the Registration Statement.
Risks
We Face, page 5
8.
Revise
your ninth bullet point to disclose, if true, that the Licensor may choose not to protect the intellectual property and proprietary
rights.
The
Company has revised the disclosure as requested on page 5 of the Registration Statement.
Securities and Exchanage Commission
July 3, 2019
Page 5
Implications
of being an Emerging Growth Company, page 6
9.
Please
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.
The
Company will supplementally provide to the Staff copies of all written communications presented to potential investors in reliance
on Section 5(d) of the Securities Act. No such written communications have been presented to investors to date.
Common
Stock to be Outstanding after this Offering, page 7
10.
Please
tell us how the 1,861,706 outstanding shares of your Series A Convertible Preferred Stock is reconcilable to the information
in your balance sheet as of December 31, 2018 and the information on pages F-15 and F-16.
Of
the 1,964,884 shares of Series A Convertible Preferred Stock outstanding, 742,378 shares were issued after December 31, 2018 (of
which 562,085 shares were issued after March 31, 2019). The reference to 1,222,506 shares outstanding on page F-15 represented
the number of shares outstanding as of December 31, 2018. The reference to 185,800 shares on page F-16 represented shares that
had not been allotted, but for which subscription funds had been received as of December 31, 2018. Page F-15 and F-16 did not
contain disclosure of shares that had not been allotted and for which funds had not been received as of December 31, 2018. The
Company has revised the disclosure on pages 7, 8 and F-15 of the Registration Statement to clarify the foregoing
and to update the disclosure to reflect the inclusion the financial statements for the nine month period ending March 31, 2019.
Our
parent company may exert significant influence..., page 30
11.
If
true, please disclose that your decision not to seek exemption as a “controlled company” could change. If your
decision could change with respect to relying on the exemptions, please include appropriate risk factor disclosure. Please
also revise your disclosure in an appropriate section, such as pages 63-66, to specify the nature of the “controlled
company” exemptions that would be available to you.
The
Company has revised the disclosure as requested on pages 30, 66 and 70 of the Registration Statement.
Use
of Proceeds, page 34
12.
Please
clarify the extent to which the proceeds to be received will enable you to achieve the items specified in the first two bullet
points.
The
Company has revised the disclosure as requested on page 34 of the Registration Statement.
Securities and Exchanage Commission
July 3, 2019
Page 6
Liquidity
and Capital Resources, page 40
13.
We
note the references to financial support from the shareholders of your parent entity in the third paragraph of Note 1 to your
financial statements on page F-8. Please tell us why you have not included disclosure regarding those arrangements in this
section or revise your disclosure as appropriate. In this regard, we also note your disclosure on page 10 that you do not
currently have any arrangements or credit facilities in place as a source of funds. Please ensure that your disclosure is
consistent throughout your prospectus. Please also file as exhibits the letters relating to the financial support those entities
intend to provide.
The
Company has revised the disclosure as requested on pages 10, 40 and 75 of the Registration Statement.
Description
of Business, page 41
14.
We
note your disclosure in the second risk factor on page 13. Please tell us the basis for your statement above figure 5 on page
44 that the pictured technology allows mass volume printing at low cost or revise your disclosure as appropriate. Since you
have not entered the mass production stage, please tell us why it is appropriate to depict this technology in your prospectus
summary.
The
Company based the above-referenced statement on previously published research regarding the cost of manufacture of printed organic
electronic devices, like the Company’s product. See C.J. Mulligan, M. Wilson, G. Bryant, B. Vaughan, X. Zhou, W.J. Belcher,
P.C. Dastoor, Solar Energy Materials & Solar Cells 120 (2014) 9–17. As such, the Company believes the above-referenced
statement is justified. The Company has revised the disclosure on page 44 of the Registration Statement to reference the research.
The Company will supplementally provide copies of the above-referenced journal article upon request.
Because the printing technology
is an established technology, has been independently studied and already has been used to fabricate the product for testing purposes
(as disclosed in “Description of Business—Performance Testing, Current State of Development and