Correspondence 0001731122-24-000408 from RENOVARO INC. (RENB) (CIK 0001527728) (LNAI)
RENOVARO INC. (RENB) (CIK 0001527728)
Date: March 11, 2024 · CIK: 0001527728 · Accession: 0001731122-24-000408
AI Filing Summary & Sentiment
File numbers found in text: 001-38758
Referenced dates: January 30, 2024
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CORRESP
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filename1.htm
March 11, 2024
Mr. Frank Wyman
Ms. Angela Connell
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
Washington, D.C. 20549
Re: Renovaro Biosciences Inc.
Form 10-K for the Fiscal Year Ended June 30, 2023
Filed October 2, 2023
File No. 001-38758
Dear Mr. Wyman and Ms. Connell:
Renovaro Inc., f/k/a Renovaro Biosciences Inc. (“Renovaro”
or the “Company”) submits this letter in response to your letter dated January 30, 2024, relating to the above-referenced
filing by the Company. Set forth below are the comments contained in the Staff’s letter, followed by the Company’s responses.
Capitalized terms not defined herein should be given the meaning provided in the above-referenced filing.
Form 10-K for the Fiscal Year Ended June 30, 2023
Notes to the Consolidated Financial Statements
Note 1 - Summary of Significant Accounting Policies
Impairment of Goodwill and Indefinite Lived Intangible Assets,
page F-11
1. You
disclose that your annual fair value analysis performed on goodwill supported that goodwill
is not impaired as of June 30, 2023. Please provide us with the following information and
consider disclosing this information in future filings:
● The
percentage by which fair value of your reporting unit exceeded its carrying value as of the
date of the most recent quantitative test;
● A
description of the methods and key assumptions used to estimate the fair value of the reporting
unit and how these key assumptions were determined and
● A
description of potential events and/or circumstances that could reasonably be expected to
negatively affect the key assumptions.
Response:
Based on the annual fair value analysis performed on goodwill, the fair
value of the Company’s reporting unit was 11% greater than its carrying value as of June 30, 2023, the date of the most recent quantitative
test.
The Company used a discounted cash flow model and the cost-to-recreate
method to determine the fair value of the reporting unit. Key assumptions in the discounted cash flow model with regards to each of the
Company’s cell and gene therapy product candidates for the treatment or prevention of cancer, HBV, or HIV, other than the RENB-HV01
product candidate, included: (i) the probability of successfully completing clinical trials and obtaining regulatory approval; (ii) the
population and market share; (iii) the timing and the amount of the expected costs to advance development programs through clinical trials
and commercialization; (iv) the pricing of estimated future product sales; and (v) the weighted average cost of capital (“WACC”).
Key assumptions in the cost-to-recreate method that was applied to the valuation of the RENB-HV01 product candidate were (i) direct costs,
(ii) entrepreneurial incentive, and (iii) replacement period.
The key assumptions would be negatively affected by the following potential
events and/or circumstances: the Company is unable to obtain future financing to fund the development and commercialization of the product
candidates; significant setbacks are experienced in development or regulatory approval processes for the product candidates; competitive
products are developed that impact the Company’s ability to capture expected market share; and intellectual property protection
cannot be obtained or maintained for the product candidates.
As
per the SEC Staff request, the information above will be included in future filings.
Fair
Value of Financial Instruments, page F-12
2. We
note that you perform an annual impairment assessment of your indefinite life intangible
assets and that your quantitative assessment as of June 30, 2023, and 2022 indicated that
the carrying value of the IPR&D asset exceeded its fair value. Please revise your future
filings to provide the disclosures required by ASC 820-10-50-2bbb as it relates to this non-recurring
fair value measurement. In particular, please disclose the following:
● The
level of the fair value hierarchy within which the fair value measurement is categorized,
● A
description of the valuation techniques and inputs used in the fair value measurement and
● If
a Level 3 fair value measurement, quantitative information about the significant unobservable
inputs used in the fair value measurement.
Response:
The
Company’s IPR&D asset relates to a license agreement for technology pertaining to the treatment or prevention of HIV. The Company
used a discounted cash flow model and the cost-to-recreate method to determine the fair value of the IPR&D asset. The discounted
cash flow model included the following inputs with regard to each of the Company’s cell and gene therapy product candidates for
the treatment or prevention of HIV other than the RENB-HV01 product candidate: (i) the probability of successfully completing clinical
trials and obtaining regulatory approval; (ii) the population and market share ; (iii) the timing and the amount of the expected costs
to advance development programs through clinical trials and commercialization; (iv) the pricing of estimated future product sales; and
(v) the WACC. Inputs in the cost-to-recreate method that were applied to the valuation of the RENB-HV01 product candidate were direct
costs, computed entrepreneurial incentive, and the replacement period. These inputs, other than the direct costs, are unobservable, and
the fair value measurement of the IPR&D asset is thus categorized at Level 3 within the fair value hierarchy.
The
Company will provide this disclosure as required by ASC 820-10-50-2bbb for this non-recurring fair value measurement in future filings.
3. As
a related matter, please clarify for us your disclosure on page F-15 which states that the
carrying value of the licenses acquired as IPR&D exceeded its fair value “due to
the changes in the projected economic benefits to be realized from these assets.” Cite
the primary reasons for the change in projected economic benefits in your response.
Response:
While
the Company is still committed to all of its current product candidates, the HIV product line has been deprioritized with regards to
development by the Company for business reasons, while pipelines that have been determined to be able to generate returns more quickly,
such as the Oncology product candidate RENB-DC11 have been prioritized. Therefore, a business decision was made to not currently pursue
the development of the product candidate RENB HV-01 (technology that has been sub-licensed to a third party) and to delay the development
and commercialization of the other HIV product candidates. There was also updated information on the cell-gene therapy sector with respect
to new competitive products being developed or introduced into the market and insurance coverage limitations that impacted projected
market share. These changes negatively impacted the timing and amount of the benefits to be realized from this IPR&D asset and its
resultant valuations.
Note
9 - Commitments and Contingencies, page F-27
4. You
have disclosed a number of legal proceedings to which you are a party. To the extent that
you believe that it is reasonably possible that resolution of these proceedings could result
in a material adverse effect on your financial condition,
results of operations, or cash flows, please revise
your future filings to provide the disclosures required by ASC 450- 20-50, including an estimate
of reasonably possible losses in excess of accrued amounts.
Response:
The
Company accounts for litigation and claims losses in accordance with ASC 450, Contingencies. Under ASC 450, loss contingency accruals
are recognized for probable and estimable losses.
In
accordance with ASC 450-20-25-2, the Company reviewed the facts surrounding each legal proceeding and determined that the various pending
litigation claims did not meet either the threshold of probable as defined in ASC 450-20-20 nor were they reasonably estimable, and therefore,
no accruals for loss contingencies were recorded as of the date of the financial statements. The Company evaluated the legal proceedings
and determined that the resolution of these proceedings could result in a material adverse effect on the Company’s financial condition,
results of operations, or cash flows; however, due to the nature of the contingencies, an estimate of the reasonably possible losses
cannot be made. In order to provide the disclosures required by ASC 450-20-50-3 and 50-4, future filings will include a statement that
such an estimate cannot be made.
Please
contact me at 305 918-1980 Ext. 305 or at lpuche@renovarobio.com, if you have any questions.
Sincerely,
Luisa
Puche
Renovaro
Inc.
CFO