U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
☒ QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2024
OR
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________ to ________
Commission file number 001-38758
Renovaro Inc.
(Exact name of registrant as specified in its charter)
Delaware
45-2559340
(State or other jurisdiction of
(I.R.S. Employer
incorporation or organization)
Identification Number)
2080 Century Park East , Suite 906
Los Angeles , CA
90067
(Address of principal executive offices)
(Zip Code)
+1( 305 ) 918-1980
(Registrant’s telephone number, including area
code)
N/A
(Former name, former address and former fiscal year,
if changed since last report)
Securities registered pursuant to Section 12(b) of
the Act:
Title of Each Class
Trading Symbol
Name of Each Exchange on Which Registered
Common Stock, par value $0.0001 per share
RENB
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant (1)
has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has
submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of
this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒
No ☐
Indicate by check mark whether the registrant is a
large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definitions of “large
accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company”
in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☐
Accelerated filer
☐
Non-accelerated filer
☒
Smaller reporting company
☒
Emerging growth company
☐
If an emerging growth company, indicate by check mark
if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a
shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐
No ☒
As of November 11, 2024, the number of shares of the
registrant’s Common Stock outstanding was 158,717,342 .
RENOVARO INC. AND SUBSIDIARIES
- INDEX -
Page
PART I – FINANCIAL INFORMATION:
1
Item 1.
Financial Statements (Unaudited):
1
Condensed Consolidated Balance Sheets as of September 30, 2024 (Unaudited) and June 30, 2024
2
Condensed Consolidated Statements of Operations for the Three Months Ended September 30, 2024, and 2023 (Unaudited)
3
Condensed Consolidated Statements of Comprehensive Loss for the Three Months Ended September 30, 2024, and 2023 (Unaudited)
4
Condensed Consolidated Statements of Stockholders’ Equity for the Three Months Ended September 30, 2024, and 2023 (Unaudited)
5
Condensed Consolidated Statements of Cash Flows for the Three Months Ended September 30, 2024, and 2023 (Unaudited)
6
Notes to the Condensed Consolidated Financial Statements (Unaudited)
7
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
20
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
32
Item 4.
Controls and Procedures
32
PART II – OTHER INFORMATION:
33
Item 1.
Legal Proceedings
33
Item 1A.
Risk Factors
35
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
35
Item 3.
Defaults Upon Senior Securities
35
Item 4.
Mine Safety Disclosures
35
Item 5.
Other Information
35
Item 6.
Exhibits
36
Signatures
37
i
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements.
The accompanying financial statements
have been prepared in accordance with generally accepted accounting principles for interim financial information and in accordance with
the instructions for Form 10-Q. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting
principles for complete financial statements.
In the opinion of management, the
financial statements contain all material adjustments, consisting only of normal recurring adjustments necessary to present fairly the
financial condition, results of operations, and cash flows of the Company for the interim periods presented.
The results for the period ended
September 30, 2024, are not necessarily indicative of the results of operations for the full year. These financial statements and related
footnotes should be read in conjunction with the financial statements and footnotes thereto included in the Company’s Form 10-K
for the fiscal year ended June 30, 2024, filed with the Securities and Exchange Commission on October 10, 2024.
1
RENOVARO INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
September
30,
June
30,
2024
2024
(Unaudited)
ASSETS
CURRENT
ASSETS:
Cash
$ 220,571
$ 220,467
Insurance
receivable
1,242,360
1,108,247
Prepaids
and other assets
485,228
668,929
Total
Current Assets
1,948,159
1,997,643
Property
and equipment, net
452,212
482,121
OTHER
ASSETS:
Definite
life intangible assets, net
28,750
30,043
Goodwill
118,171,345
159,330,161
Deposits
and other assets
81,697
19,849
Operating
lease right-of-use assets
1,150,474
1,269,633
Total
Other Assets
119,432,266
160,649,686
TOTAL
ASSETS
$ 121,832,637
$ 163,129,450
LIABILITIES
CURRENT
LIABILITIES:
Accounts
payable – trade
$ 11,402,223
$ 9,448,683
Accrued
expenses
5,359,454
5,311,324
Other
current liabilities
102,741
295,361
Contingent
consideration liability
3,060,000
12,310,000
Convertible
notes payable
245,000
245,000
Current
portion of operating lease liabilities
504,254
493,553
Notes
payable – related parties, net
2,361,707
2,205,996
Total
Current Liabilities
23,035,379
30,309,917
NON-CURRENT
LIABILITIES:
Operating
lease liabilities, net of current portion
710,260
842,389
Total
Non-Current Liabilities
710,260
842,389
Total
Liabilities
23,745,639
31,152,306
Commitments
and Contingencies (Note 7)
STOCKHOLDERS’
EQUITY:
Preferred
stock, $ 0.0001
par value; 10,000,000
shares authorized; no
shares issued and outstanding
—
—
Common
Stock, par value $ 0.0001 ,
350,000,000
shares authorized, 157,617,368
shares issued and outstanding at September
30, 2024, and 155,027,245
shares issued and outstanding at June 30,
2024
15,763
15,504
Additional
paid-in capital
460,665,481
456,811,911
Accumulated
deficit
( 368,891,461 )
( 324,679,425 )
Accumulated
other comprehensive income (loss)
6,297,215
( 170,846 )
Total
Stockholders’ Equity
98,086,998
131,977,144
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 121,832,637
$ 163,129,450
See accompanying notes to the unaudited condensed consolidated
financial statements.
2
RENOVARO INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
For the Three Months Ended
September 30,
2024
2023
Operating Expenses
General and administrative
$ 5,301,251
$ 8,290,210
Research and development
390,189
566,644
Goodwill impairment
47,614,729
—
Depreciation and amortization
32,385
27,260
Total Operating Expenses
53,338,554
8,884,114
LOSS FROM OPERATIONS
( 53,338,554 )
( 8,884,114 )
Other Income (Expense)
Change in fair value of contingent consideration
9,250,000
—
Loss on extinguishment of debt
—
( 120,018 )
Interest expense
( 250,080 )
( 179,271 )
Interest income and other income (expense)
126,598
8,375
Total Other Income (Expense)
9,126,518
( 290,914 )
NET LOSS
$ ( 44,212,036 )
$ ( 9,175,028 )
BASIC AND DILUTED NET LOSS PER SHARE
$ ( 0.28 )
$ ( 0.14 )
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK OUTSTANDING - BASIC AND DILUTED
156,567,973
64,480,753
See accompanying notes to the unaudited condensed consolidated
financial statements.
3
RENOVARO INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS
(UNAUDITED)
For the Three Months Ended
September 30,
2024
2023
Net Loss
$ ( 44,212,036 )
$ ( 9,175,028 )
Other Comprehensive Income (Loss)
Foreign Currency Translation, net of taxes
6,468,061
( 34,601 )
Comprehensive Loss
$ ( 37,743,975 )
$ ( 9,209,629 )
See accompanying notes to the unaudited condensed consolidated
financial statements.
4
RENOVARO INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
(UNAUDITED)
# of Series A Preferred Shares
Series A Preferred Shares Amount
# of Common Shares
Common Shares Amount
Additional Paid-In Capital
Accumulated Deficit
Accumulated Other Comprehensive Income
Total
July 1, 2023
—
—
63,698,144
6,371
290,554,875
( 244,029,253 )
( 29,882 )
46,502,111
Issuance of preferred stock and warrants in private placement
280,505
28
—
—
1,999,972
—
—
2,000,000
Issuance of preferred stock and warrants for conversion of $2 million note
280,505
28
—
—
1,999,973
—
—
2,000,001
Restricted shares issued for services rendered
—
—
2,000,000
200
4,469,800
—
—
4,470,000
Stock-based compensation
—
—
—
—
983,829
—
—
983,829
Net loss
—
—
—
—
—
( 9,175,028 )
—
( 9,175,028 )
Foreign currency translation adjustment
—
—
—
—
—
—
( 34,601 )
( 34,601 )
September 30, 2023
561,010
$ 56
65,598,144
$ 6,571
$ 300,008,449
$ ( 253,204,281 )
$ ( 64,483 )
$ 46,746,312
July 1, 2024
—
—
155,027,245
15,504
456,811,911
( 324,679,425 )
( 170,846 )
131,977,144
Issuance of common stock under private placement offering
—
—
1,423,456
142
2,096,039
—
—
2,096,181
Restricted shares issued for services rendered
—
—
2,000,000
200
1,399,800
—
—
1,400,000
Forfeited shares of common stock
—
—
( 833,333 )
( 83 )
83
—
—
—
Stock-based compensation
—
—
—
—
357,648
—
—
357,648
Net loss
—
—
—
—
—
( 44,212,036 )
—
( 44,212,036 )
Foreign currency translation adjustment
—
—
—
—
—
—
6,468,061
6,468,061
September 30, 2024
—
$ —
157,617,368
$ 15,763
$ 460,665,481
$ ( 368,891,461 )
$ 6,297,215
$ 98,086,998
See accompanying notes to the unaudited condensed consolidated
financial statements.
5
RENOVARO INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
For the Three Months Ended
September 30,
2024
2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 44,212,036 )
$ ( 9,175,028 )
ADJUSTMENTS TO RECONCILE NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES:
Depreciation and amortization
32,385
27,260
Loss on extinguishment of debt
—
120,018
Changed in value of contingent consideration
( 9,250,000 )
—
Stock-based compensation expense
357,648
983,829
Restricted shares for services rendered
1,400,000
4,470,000
Goodwill impairment
47,614,729
—
Amortization of discount of notes payable
23,718
167,765
Changes in assets and liabilities:
Other receivables
( 195,961 )
—
Prepaid expenses/deposits
183,701
411,352
Accounts payable
1,953,539
124,303
Accrued expenses
46,891
77,055
Other current liabilities
31,325
—
Operating leases, net
( 2,269 )
( 16,239 )
NET CASH USED IN OPERATING ACTIVITIES
( 2,016,328 )
( 2,777,207 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Notes receivable
—
( 1,057,875 )
NET CASH USED IN INVESTING ACTIVITIES
—
( 1,057,875 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of convertible promissory notes
—
750,000
Repayment of finance agreement
( 223,945 )
( 187,183 )
Proceeds from private placement
2,096,181
2,000,000
Proceeds from notes payable
156,947
—
NET CASH PROVIDED BY FINANCING ACTIVITIES
2,029,183
2,562,817
Effect of exchange rates on cash
( 12,751 )
( 78,741 )
NET CHANGE IN CASH
104
( 1,351,006 )
CASH, BEGINNING OF PERIOD
220,467
1,874,480
CASH, END OF PERIOD
$ 220,571
$ 523,474
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
Cash paid during the period for:
Interest
$ —
$ 5,256
SUPPLEMENTAL DISCLOSURES OF NON-CASH FINANCING ACTIVITIES
Conversion of note payable for issuance of preferred stock
$ —
$ 2,000,001
Debt discount related to convertible promissory notes
$ 24,954
$ 39,474
Cancellation of restricted stock awards
$ 83
$ —
See accompanying notes to the unaudited condensed consolidated
financial statements.
6
RENOVARO INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
NOTE 1 — ORGANIZATION AND SUMMARY OF SIGNIFICANT
ACCOUNTING POLICIES
Business
– On February 13, 2024, the Company changed its corporate name from Renovaro
Biosciences Inc. to Renovaro Inc. (“Renovaro”, and together with its subsidiaries, the “Company”, “we”
or “us”). Renovaro Inc. operates through two subsidiaries, Renovaro Biosciences and Renovaro Cube. Renovaro Cube refers to
Renovaro Cube Intl Ltd. (formerly known as GediCube Intl. Ltd.) and its wholly owned subsidiaries GediCube, B.V. and Grace Systems B.V.,
which were acquired on February 13, 2024.
Renovaro Biosciences is a biotechnology
company intending to develop advanced allogeneic cell and gene therapies to promote stronger immune system responses potentially for long-term
or life-long cancer remission in some of the deadliest cancers, and potentially to treat or cure serious infectious diseases such as Human
Immunodeficiency Virus (HIV) infections. Renovaro Cube is an AI-driven healthcare technology company focusing on the earliest possible
detection of cancer and its recurrence. Renovaro Cube has developed a proprietary AI platform that analyzes genetics using Explainable
AI to provide earlier and more accurate cancer diagnosis.
Basis of Presentation –
The Company prepares consolidated financial statements in accordance with accounting
principles generally accepted in the United States of America (“U.S. GAAP”) and follows the rules and regulations of the U.S.
Securities and Exchange Commission (“SEC”). The accompanying financial statements are unaudited. In the opinion of management,
all adjustments (which include only normal recurring adjustments) necessary to present fairly the financial position, results of operations
and cash flows at September 30, 2024, and 2023 and for the periods then ended have been made. Certain information and footnote disclosures
normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. The accompanying unaudited
condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in
the Company’s June 30, 2024 audited financial statements. The results of operations for the period ended September 30, 2024 are
not necessarily indicative of the operating results for the full year.
Consolidation – For
the three months ended September 30, 2024, and 2023, the condensed consolidated financial statements include the accounts and operations
of the Company and its subsidiaries. All material inter-company transactions and accounts have been eliminated in the consolidation.
Accounting Estimates –
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities, the disclosures of contingent assets and liabilities at the
date of the financial statements and the reported amount of revenues and expenses during the reporting period. Actual results could differ
from those estimated. Significant estimates include the fair value of assets acquired in a business acquisition, contingent consideration,
and equity instruments issued for goods or services.
Functional Currency & Foreign
Currency Translation – The functional currency of Renovaro Biosciences Denmark ApS is the Danish Kroner (“DKK”)
and the functional currency of Renovaro Cube is the Euro (“EUR”). The Company’s reporting currency is the U.S. Dollar
for the purpose of these financial statements. The Company’s balance sheet accounts are translated into U.S. dollars at the period-end
exchange rates and all revenue and expenses are translated into U.S. dollars at the average exchange rates prevailing during the periods
ended September 30, 2024, and 2023. Translation gains and losses are deferred and accumulated as a component of other comprehensive income
in stockholders’ equity. Transaction gains and losses that arise from exchange rate fluctuations from transactions denominated in
a currency other than the functional currency are included in the statement of operations as incurred.
Recently Adopted Accounting
Pronouncements – In November 2023, the FASB issued ASU 2023-07, “ Segment Reporting (Topic 280): Improvements to Reportable
Segment Disclosures ,” which requires a public entity to disclose significant segment expenses and other segment items on an
annual and interim basis and to provide in interim periods all disclosures about reportable segment’s profit or loss and assets
that are currently required annually. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods
within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company adopted this ASU on July 1, 2024. The
adoption of this ASU had no impact on the Company's condensed consolidated financial statements.
7
In December
2023, the FASB issued ASU 2023-09, “ Income Taxes (Topic 740): Improvements to Income Tax Disclosures ,” which enhances
the transparency and decision usefulness of income tax disclosures by requiring; (1) consistent categories and greater disaggregation
of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. It also includes certain other amendments
to improve the effectiveness of income tax disclosures. ASU 2023-09 is effective for fiscal years beginning after December 15, 2025, with
early adoption permitted. These amendments are to be applied prospectively, with retrospective application permitted. The Company is currently
evaluating the impact this standard will have on its condensed consolidated financial statements.
The Company
currently believes there are no other issued and not yet effective accounting standards that are materially relevant to our condensed
consolidated financial statements.
NOTE 2 — GOING CONCERN
The Company’s consolidated
financial statements are prepared using the generally accepted accounting principles applicable to a going concern, which contemplates
the realization of assets and liquidation of liabilities in the normal course of business. However, the Company has incurred substantial
recurring losses from continuing operations, has used cash in the Company’s continuing operations, and is dependent on additional
financing to fund operations. The Company incurred a net loss of $ 44,212,036 and $ 9,175,028 for the quarters ended September 30, 2024
and 2023, respectively. As of September 30, 2024, the Company had cash and cash equivalents of $ 220,571 and an accumulated deficit of
$ 368,891,461 and a working capital deficit of $ 21,087,220 . These conditions raise substantial doubt about the Company’s ability
to continue as a going concern for one year after the date the financial statements are issued. The consolidated financial statements
do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities
that might be necessary should the Company be unable to continue in existence.
Management has reduced overhead and administrative costs by streamlining the organization
to focus around the development and validation of its AI-driven cancer diagnostics platform. The Company has tailored its workforce to
focus on these activities. In addition, the Company intends to secure additional required funding through equity or debt financing. However,
there can be no assurance that the Company will be able to obtain any sources of funding. Such additional funding may not be available
or may not be available on reasonable terms, and, in the case of equity financing transactions, could result in significant additional
dilution to our stockholders. If we do not obtain required additional equity or debt funding, our cash resources will be depleted and
we could be required to materially reduce or suspend operations, which would likely have a material adverse effect on our business, stock
price and our relationships with third parties with whom we have business relationships, at least until additional funding is obtained.
If we do not have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that
could result in our stockholders losing some or all of their investment in us.
Funding that we may receive during the fiscal year
2025 is expected to be used to satisfy existing and future obligations and liabilities and working capital needs, to support commercialization
of our products, to conduct the clinical and regulatory work to develop our product candidates, and to begin building working capital
reserves.
NOTE 3 — FAIR VALUE MEASUREMENTS
The Company accounts for fair value
measurements for financial assets and financial liabilities in accordance with FASB ASC Topic 820, “Fair Value Measurements”.
The authoritative guidance among other things, defines fair value, establishes a consistent framework for measuring fair value and expands
disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value
is defined as the exit price, representing the amount that would either be received to sell an asset or be paid to transfer a liability
in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based
on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the guidance
establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
8
●
Level 1. Observable inputs such as quoted prices in active markets for identical assets or liabilities;
●
Level 2. Inputs, other than quoted prices in active markets, that are observable either directly or indirectly; and
●
Level 3. Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.
There were no Level 1, 2 or 3 assets,
nor any Level 1 or 2 liabilities as of September 30, 2024.
Unless otherwise disclosed, the
fair value of the Company’s financial instruments including cash, accounts receivable, prepaid expenses, accounts payable, accrued
expenses, lease obligations and notes payable approximate their recorded values due to their short-term maturities.
Level 3 liabilities held as of September 30, 2024, consisted of a contingent consideration
liability related to the February 13, 2014 acquisition of Renovaro Cube, (the “Acquisition”).
As consideration for the Acquisition, the stockholders of Renovaro Cube received (i) 70,834,183 shares of Common Stock, and (ii) the right
to receive contingent shares pro rata upon the exercise of convertible notes, options, and warrants, which were outstanding at closing.
The contingent consideration liability was recorded at fair value of $20,557,500 at the time of the Acquisition and is subsequently remeasured
to fair value at the end of each reporting period. As of September 30, 2024, there were 7,613,301 contingent shares issuable in connection
with the Acquisition.
The fair value of the contingent consideration liability is estimated using
a Black-Scholes option-pricing model and a Monte-Carlo option pricing model. The key inputs to the model are all contractual or observable
with the exception being volatility, which is computed based on the volatility of the Company’s underlying stock. The key inputs
to valuing the contingent consideration liability as of September 30, 2024, were:
Schedule of contingent consideration liability
Stock Price
$ 0.48
Exercise Price
$ 0.46 - $ 8.23
Volatility
113 % - 134 %
Risk Free Rate
3.52 % - 4.31 %
Expected Dividends
0 %
Expected Term (years)
0.48 – 9.25
The following table sets forth
the Level 3 liability at September 30, 2024, which is recorded on the consolidated balance sheet at fair value on a recurring basis.
As required, this liability is classified based on the lowest level of input that is significant to the fair value measurement:
Schedule of fair value measurement on recurring basis
Fair Value Measurements at
Reporting Date Using
Quoted Prices in
Active Markets for Identical Assets Inputs
Significant Other
Observable Inputs
Significant Other Unobservable Inputs
(Level 1)
(Level 2)
(Level 3)
The roll forward of the contingent consideration liability is as follows:
Balance June 30, 2024
$ 12,310,000
Fair value adjustment
( 9,250,000 )
Contingent Consideration Liability at September 30, 2024
$ 3,060,000
9
NOTE 4 — INTANGIBLE ASSETS AND GOODWILL
On February 13, 2024, the Company
acquired Renovaro Cube as a wholly owned subsidiary pursuant to a stock purchase agreement. As part of the acquisition of Renovaro
Cube, the Company acquired goodwill valued at $ 159,464,039 .
Impairment – During the quarter ended September
30, 2024, the results of the assessment indicated that the carrying value of the RENC reporting unit exceeded its fair value, due to the
changes in the projected economic benefits to be realized from this reporting unit. Management concluded the significant driver for the
change in the economic benefits was due to the Company’s continued inability to raise capital for the further development of the
technologies within this reporting unit. Therefore, an impairment adjustment of $ 47,614,729 was recorded for the period ended September
30, 2024.
At September 30, 2024 and June
30, 2024, definite-life and indefinite-life intangible assets consisted of the following:
Schedule of definite-life and indefinite-life intangible assets
Useful Life
June 30, 2024
Additions
Amortization
Impairment
Translation Adjustment
September 30, 2024
Definite Life Intangible Assets
Patents
20 Years
$ 284,977
$
$
$
$ 11,644
$ 296,621
Less Accumulated Amortization
( 254,934 )
( 2,501 )
( 10,436 )
( 267,871 )
Net Definite-Life Intangible Assets
$ 30,043
$
$ ( 2,501 )
$
$ 1,208
$ 28,750
Goodwill
Goodwill
159,330,161
( 47,614,729 )
6,455,913
118,171,345
Total Goodwill
$ 159,330,161
$
$
$ ( 47,614,729 )
$ 6,455,913
$ 118,171,345
Expected future amortization expense is as follows:
Schedule of expected future amortization expense
Years ended June 30,
2025
$ 7,189
2026
7,187
2027
7,187
2028
7,187
Total
$ 28,750
NOTE 5 — DEBT
Convertible Notes Payable —
The January 2024 Note —
On January 12, 2024, the Company entered into Subscription Agreements with an investor to issue a Convertible Promissory Note for an aggregate
principal amount of $ 125,000 (the “January 2024 Note”). The Company received a total of $ 125,000 in gross proceeds. The
January 2024 Note bears an interest rate of 12 % per annum and shall mature on December 29, 2024 . The Company is required to pay interest
quarterly, in arrears, in cash, on the first day of each quarter of each year following the issue date prior to the maturity of the January
2024 Note. The January 2024 Note is convertible either at the option of the holder or automatically upon maturity into shares of the Company’s
Common Stock at the Note Conversion Price of $ 3.38 .
10
December 2023 Notes —
On December 20, 2023, the Company entered into Subscription Agreements to purchase Convertible Promissory Notes for an aggregate
principal amount of $ 120,000 (the “December 2023 Notes”). The Company received a total of $ 120,000 from the private placement
between December 2023 and January 2024. The December 2023 Notes bear an interest rate of 12 % per annum and shall mature one year
after their respective dates of issuance (the “Maturity Date”). The Company is required to pay interest quarterly, in arrears,
in cash, on the first day of each quarter of each year following the issue date prior to the maturity of the December 2023 Notes. Notwithstanding
the immediately foregoing, at the option of the holder, interest may accrue on the December Notes on a quarterly basis. The December 2023
Notes are convertible into shares of the Company’s Common Stock in whole or in part at any time and from time to time, after the
original issue date and prior to the Maturity Date, at a conversion price of $ 3.38 per share.
The January 2024 Note and December
2023 Notes balance at September 30, 2024 was $ 245,000 .
Notes Payable —
Bridge Loans — On
September 16, 2024, the Company entered into an agreement with RS Bio ApS, a Danish entity controlled by a shareholder (“RS Bio”),
to issue a Promissory Note for the principal amount of $ 100,000 (the “September 2024 Note”). The Company received $ 100,000
in gross proceeds. The note bears an interest rate of 12 % per annum and matures on December 31, 2024 . The note balance at September 30,
2024 was $ 100,000 .
On September 6, 2024, the Renovaro
Cube entered into an agreement with Paseco ApS, a Danish entity controlled by a shareholder (“Paseco ApS”), to issue a Promissory
Note for the principal amount of € 50,000 . The note bears an interest rate of 12 % per annum and matures on December 31, 2024 . The
note balance at September 30, 2024 was approximately $ 57,000 .
On February 5, 2024, the Company
entered into an agreement with RS Bio to issue a 5% Original Issue Discount Secured Promissory Note for the principal amount of $ 105,263
(the “February 2024 Note”). The Company received $ 100,000 in gross proceeds after taking into account the 5 % original issue
discount. The note bears an interest rate of 12 % per annum and matures on December 31, 2024 . The note balance, net of discount at September
30, 2024 was $ 105,263 .
On January 2, 2024, the Company
entered into an agreement with RS Bio to issue a 5% Original Issue Discount Secured Promissory Note for the principal amount of $526,315.
The Company received a total of $500,000 in gross proceeds after taking into account the 5% original issue discount. The note bears
an interest rate of 12% per annum and matures on December 31, 2024. The note balance, net of discount at September 30, 2024 was $526,315.
On November 3, 2023, the Company
entered into an agreement with RS Bio to issue a 5% Original Issue Discount Promissory Note for the principal amount of $ 1,000,000 . The
Company received a total of $ 950,000 in gross proceeds after taking into account the 5 % original issue discount. The discount of
$ 50,000 will be accreted over the life of the note. The note bears an interest rate of 12 % per annum and matures on December 31, 2024.
The note balance, net of discount at September 30, 2024 was $ 750,000 .
Promissory Note — On
March 30, 2020 (the “Issuance Date”), the Company issued a Promissory Note in the principal amount of $ 5,000,000 (the “Promissory
Note”) to Paseco ApS. There have been eight amendments to the Promissory Note since the issuance date, the most recent of which
is dated August 1, 2024. The principal amount of the Promissory Note, as amended, was payable on November 1, 2024 (the “Maturity
Date”). The Promissory Note, as amended, bears interest at a fixed rate of 12 % per annum. The Promissory Note balance, net of discount
at September 30, 2024 is $ 823,182 .
The Company’s obligations
under the Promissory Note, November 2023 Note, January 2024 Note, February 2024 Note and the September 2024 Note are secured by a Security
Agreement. To secure the Company’s obligations under the Promissory Note, the Company entered into a Security Agreement with the
Holder, pursuant to which the Company granted a lien on all assets of the Company (the “Collateral”) for the benefit of Paseco
ApS. Upon an Event of Default (as defined in the notes, respectively) Paseco ApS may, among other things, collect or take possession of
the Collateral, proceed with the foreclosure of the security interest in the Collateral or sell, lease, or dispose of the Collateral.
11
NOTE 6 — STOCKHOLDERS’ EQUITY
Purchase Agreement with Lincoln Park Capital
On June
20, 2023, the Company entered into a purchase agreement (the “2023 Purchase Agreement”) with Lincoln Park Capital Fund, LLC
(“Lincoln Park”), pursuant to which the Company may sell and issue to Lincoln Park, and Lincoln Park is obligated to purchase,
up to $ 20,000,000 of shares of Common Stock over the 36-month term of the 2023 Purchase Agreement. Concurrently with entering into the
2023 Purchase Agreement, the Company also entered into a registration rights agreement with Lincoln Park, pursuant to which it agreed
to provide Lincoln Park with certain registration rights related to the shares issued under the 2023 Purchase Agreement.
In consideration for entering into
the 2023 Purchase Agreement, the Company issued 696,021 shares of Common Stock to Lincoln Park as a commitment fee on June 20, 2023.
During the quarter ended September
30, 2024 and 2023, no shares of Common Stock to Lincoln Park were sold under the Purchase Agreement.
Common Stock Issuances
On June
14, 2024, Renovaro Inc., a Delaware corporation (the “ Company ”) closed a private
placement of 5,315,215 of the Company’s units, each such Unit consisting of (i) one share of the Company’s Common
Stock and (ii) one common stock purchase warrant to purchase one-tenth of a share of Common Stock, with certain investors (the “June
2024 Private Placement”). Related to the June 2024 Private Placement, ranging from July 3, 2024, to September 16, 2024, the
Company sold 1,423,456 Units at a price per Unit equal to $ 1.4726 to a certain investor who paid in cash an aggregate amount of $ 2,096 ,181
in consideration of the Units.
On August 1, 2024, the Company
issued 2,000,000 shares of Common Stock for consulting services valued at $ 1,400,000 .
Stock-based Compensation
The Company recognizes compensation
costs for stock option awards to employees and directors based on their grant-date fair value. The value of each stock option is estimated
on the date of grant using the Black-Scholes option-pricing model. The weighted-average assumptions used to estimate the fair values of
the stock options granted using the Black-Scholes option-pricing model are as follows in the three months ended September 30, 2024:
Schedule of weighted-average assumptions used to estimate the fair values of the stock options granted
Renovaro Inc.
Expected term (in years)
5.5
Volatility
113.12 %
Risk free interest rate
4.22 %
Dividend yield
0 %
On August 23, 2024, Avram Miller,
a former member of the Company’s board of directors (the “Board of Directors”), forfeited 833,333 shares of Common Stock
from the original 1,000,000 shares of Common Stock for advisory services originally granted to him on October 11, 2023. As consideration
for such forfeiture, the Company granted to Mr. Miller, an option to purchase 978,261 shares of Common Stock of the Company with a per-share
exercise price of, $ 0.69 . The Company determined that this transaction represented a modification of the original award. The Company measured
the fair value of the options issued as compared to the fair value of the original issuance and determined that there was no incremental
compensation to recognize as the fair value of the options was less than the fair value of the Common Stock. Therefore, the Company will
recognize the remaining fair value of the original award over the remaining vesting period, which is one year. The Company recognized
stock-based compensation expense of $ 222,306 related to the vesting of the stocks options during the period ended September 30, 2024.
At September 30, 2024, the Company had $ 1,122,537 of unrecognized compensation cost related to the options which vest at August 23, 2025.
12
In total, the Company recognized
stock-based compensation expense related to options of $ 357,648 and $ 983,829 for the three months ended September 30, 2024 and 2023, respectively.
At September 30, 2024, the Company had approximately $ 1,239,528 of unrecognized compensation cost related to non-vested options.
NOTE 7 — COMMITMENTS AND CONTINGENCIES
Commitments
On January 31, 2020, the Company entered into a Statement of Work and License
Agreement (the “HBV License Agreement”) by and among the Company, G Tech Bio, LLC, a California limited liability company
(“G Tech”), and G Health Research Foundation, a not-for-profit entity organized under the laws of California doing business
as Seraph Research Institute (“SRI”) (collectively the “Licensors”), whereby the Company acquired a perpetual,
sublicensable, exclusive license (the “HBV License”) for a treatment under development (the “Treatment”) aimed
to treat Hepatitis B Virus (HBV) infections.
The HBV License Agreement states
that in consideration for the HBV License, the Company shall provide cash funding for research costs and equipment and certain other in-kind
funding related to the Treatment over a 24-month period, and provides for an up-front payment of $ 1.2 million within 7 days of January
31, 2020, along with additional payments upon the occurrence of certain benchmarks in the development of the technology set forth in the
HBV License Agreement, in each case subject to the terms of the HBV License Agreement. Additionally, the HBV License Agreement provides
for cooperation related to the development of intellectual property related to the Treatment and for a 2 % royalty to G Tech on any net
sales that may occur under the HBV License. On February 6, 2020, the Company paid the $ 1.2 million up-front payment. The HBV License Agreement
contains customary representations, warranties, and covenants of the parties with respect to the development of the Treatment and the
HBV License.
The cash funding for research costs
pursuant to the HBV License Agreement consisted of monthly payments amounting to $144,500 that covered scientific staffing resources to
complete the project as well as periodic payments for materials and equipment needed to complete the project. There were no payments made
after January 31, 2022. The Company paid zero under the HBV License Agreement during the quarters ending September 30, 2024, and 2023.
The Company has filed a claim against the Licensors, which includes certain payments it made related to this license (see Contingencies
sub-section below).
On April 18, 2021, the Company
entered into a Statement of Work and License Agreement (the “License Development Agreement”), by and among the Company, G
Tech and SRI (collectively, the “Licensors”), whereby the Company acquired a perpetual sublicensable, exclusive license (the
“Development License”) to research, develop, and commercialize certain formulations which were aimed at preventing and treating
pan-coronavirus or the potential combination of the pan-coronavirus and pan-influenza, including the SARS-coronavirus that causes COVID-19
and pan-influenza (the “Prevention and Treatment”).
The Development License Agreement
was entered into pursuant to the existing Framework Agreement between the parties dated November 15, 2019. The Development License Agreement
states that in consideration for the Development License, the Company shall provide cash funding for research costs and equipment and
certain other in-kind funding related to the Prevention and Treatment over a 24-month period. Additionally, the Development License Agreement
provides for an up-front payment of $ 10,000,000 and a $ 760,000 payment for expenditures to date prior to the effective date related to
research towards the Prevention and Treatment within 60 days of April 18, 2021. The Development License Agreement provides for additional
payments upon the occurrence of certain benchmarks in the development of the technology set forth in the Development License Agreement,
in each case subject to the terms of the Development License Agreement.
The Development License Agreement
provides for (i) cooperation related to the development of intellectual property related to the Prevention and Treatment and (ii) a 3%
royalty to G Tech on any net sales that may occur under the Development License Agreement. The Company is no longer pursuing any product
candidates that relate to this license. The Company has filed a claim against the Licensors to recover all monies it paid related to this
license (see Contingencies below).
13
On August 25, 2021, the Company
entered into an ALC Patent License and Research Funding Agreement in the HIV Field (the “ALC License Agreement”) with Serhat
Gümrükcü and SRI (collectively, the “Licensors”) whereby the Licensors granted the Company an exclusive, worldwide,
perpetual, fully paid-up, royalty-free license, with the right to sublicense, proprietary technology subject to a U.S. patent application,
to make, use, offer to sell, sell or import products for use solely for the prevention, treatment, amelioration of or therapy exclusively
for HIV in humans, and research and development exclusively relating to HIV in humans; provided the Licensors retained the right to conduct
HIV research in the field. Pursuant to the ALC License Agreement, the Company granted a non-exclusive license back to the Licensors, under
any patents or other intellectual property owned or controlled by the Company, to the extent arising from the ALC License, to make, use,
offer to sell, sell or import products for use in the diagnosis, prevention, treatment, amelioration or therapy of any (i) HIV Comorbidities
and (ii) any other diseases or conditions outside the HIV Field. The Company made an initial payment to SRI of $ 600,000 and agreed to
fund future HIV research conducted by the Licensors, as mutually agreed to by the parties. On September 10, 2021, pursuant to the ALC
License Agreement, the Company paid the initial payment of $ 600,000 .
G Tech and SRI are controlled by
Anderson Wittekind, a stockholder of the Company.
Service Agreements – The
Company maintains employment agreements with certain senior staff in the ordinary course of business.
Contingencies
Securities Class Action Litigation. On July 26,
2022 and July 28, 2022, securities class action complaints (the former, the “Chow Action” and the latter, the “Manici
Action”) and together, the “Securities Class Action Litigation”) were filed by purported stockholders of the Company
in the United States District Court for the Central District of California against the Company and certain of the Company’s current
and former officers and directors. The complaints allege, among other things, that the defendants violated Sections 10(b) and 20(a) of
the Securities Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions of
material fact in connection with the Company’s relationship with Serhat Gümrükcü and its commercial prospects. The
complaints seek unspecified damages, interest, fees, and costs. On November 22, 2022, the Manici Action was voluntarily dismissed without
prejudice, but the Chow action remains pending. On October 22, 2023, the Court appointed a lead plaintiff in the Chow Action. The
lead plaintiff filed an amended complaint on December 15, 2023. The Company has filed a motion to dismiss the amended complaint on March
15, 2024. The Court denied the Company’s motion to dismiss on June 28, 2024. A mediation was held on September 17, 2024, after which
the parties signed a stipulation of settlement, dated November 8, 2024. The plaintiff’s deadline to file a motion for preliminary
approval of the settlement is December 9, 2024.
Federal Derivative Litigation . On September 22,
2022, Samuel E. Koenig filed a shareholder derivative action in the United States District Court for the Central District of California.
On January 19, 2023, John Solak filed a substantially similar shareholder derivative action in the United States District Court for the
District of Delaware. Both derivative actions recite similar underlying facts as those alleged in the Securities Class Action Litigation.
The actions, filed on behalf of the Company, name Serhat Gümrükcü and certain of the Company’s former directors as
defendants. The actions also name the Company as a nominal defendant. The actions allege violations of Sections 14(a) and 20(a) of the
Securities Exchange Act of 1934 and also set out claims for breach of fiduciary duty, contribution and indemnification, aiding and abetting,
and gross mismanagement. Plaintiffs do not quantify any alleged injury, but seek damages, disgorgement, restitution, and other costs and
expenses. On January 24, 2023, the United States District Court for the Central District of California stayed the Koenig matter pending
resolution of the defendants’ anticipated motion to dismiss in the Securities Class Action Litigation. On April 4, 2023, the United
States District Court for the District of Delaware stayed the Solak matter pending resolution of the defendants’ anticipated motion
to dismiss in the Securities Class Action Litigation. On June 28, 2024, the United States District Court for the Central District of California
denied defendants’ motion to dismiss the Securities Class Action Litigation. On October 23, 2024, the court in the Koenig matter
stayed the case pending further order of the court. The parties’ deadline to file a joint status report in the Koenig matter
is January 10, 2025. On October 28, 2024, the court in the Solak matter stayed the case for ninety (90) days. The defendants
have not yet responded to either complaint. The Company intends to contest these matters but expresses no opinion as to the likelihood
of favorable outcomes. Management is unable to determine the likelihood of a loss, including a possible range of losses, if any, arising
from this matter as of the reporting date.
14
State Derivative Litigation. On October 20, 2022, Susan
Midler filed a shareholder derivative action in the Superior Court of California, Los Angeles County, reciting similar underlying facts
as those alleged in the Securities Class Action Litigation. The action, filed on behalf of the Company, names Serhat Gümrükcü
and certain of the Company’s current and former directors as defendants. The action also names the Company as a nominal defendant.
The action sets out claims for breaches of fiduciary duty, contribution and indemnification, aiding and abetting, and gross mismanagement.
Plaintiff does not quantify any alleged injury, but seeks damages, disgorgement, restitution, and other costs and expenses. On January
20, 2023, the Court stayed the Midler matter pending resolution of the defendants’ anticipated motion to dismiss in the Securities
Class Action Litigation. On June 28, 2024, the United States District Court for the Central District of California denied defendants’
motion to dismiss the Securities Class Action Litigation. On October 28, 2024, the court in the Midler matter stayed the case for ninety
(90) days. The defendants have not yet responded to the complaint. The Company intends to contest this matter but expresses no opinion
as to the likelihood of a favorable outcome. Management is unable to determine the likelihood of a loss, including a possible range of
losses, if any, arising from this matter as of the reporting date.
On October
21, 2022, the Company filed a Complaint in the Superior Court of the State of California for the County of Los Angeles against Serhat
Gümrükcü, William Anderson Wittekind (“Wittekind”), G Tech, SG & AW Holdings, LLC, and SRI (collectively,
the “Defendants”). The Complaint alleges that the Defendants engaged in a “concerted, deliberate scheme to alter, falsify,
and misrepresent to the Company the results of multiple studies supporting its Hepatitis B and SARS-CoV-2/influenza pipelines.”
Specifically, “Defendants manipulated negative results to reflect positive outcomes from various studies, and even fabricated studies
out of whole cloth.” As a result of the Defendants’ conduct, the Company claims that it “paid approximately $25 million
to Defendants and third-parties that it would not otherwise have paid.” On April 21, 2023, defendants Wittekind, G Tech, SG &
AW Holdings, LLC, and SRI filed a demurrer with respect to some, but not all, of the Company’s claims, as well as a motion to strike.
On September 6, 2023, the court denied in part and granted in part the pending motions. On September 7, 2023, the court entered a case
management order setting the final status conference, trial, and other intervening deadlines.
On December
4, 2023, the Defendants answered the Company’s First Amended Complaint and G Tech and SRI filed a Cross-Complaint. In the Cross-Complaint,
G Tech and SRI seek declaratory and injunctive relief related to certain agreements between G Tech, SRI, and the Company, including, inter
alia , a declaration that the Framework Agreement, effective as of November 15, 2019, the Statement of Work & License Agreement,
effective as of January 31, 2020, and the Statement of Work and License Agreement for Influenza and Coronavirus Indications, effective
as of April 18, 2021, have been terminated and the Company has no rights to any license under such agreements. Trial is currently scheduled
to begin on March 3, 2025. The Company denies these allegations and intends to vigorously defend against the cross claims while pursuing
its claims against the Defendants.
On March 1, 2021, the Company’s
former Chief Financial Officer, Robert Wolfe, and his company, Crossfield, Inc., filed a Complaint in the U.S. District Court for the
District of Vermont against the Company, Renovaro Biosciences Denmark ApS, and certain directors and officers. In the Complaint, Mr. Wolfe
and Crossfield, Inc. asserted claims for abuse of process and malicious prosecution, alleging, inter alia, that the Company lacked probable
cause to file and prosecute an earlier action, and sought millions of dollars of compensatory damages, as well as punitive damages. The
allegations in the Complaint relate to an earlier action filed by the Company and Renovaro Biosciences Denmark ApS in the Vermont Superior
Court, Orange Civil Division. On March 3, 2022, the court partially granted the Company’s motion to dismiss, dismissing the abuse
of process claim against all defendants and all claims against Mark Dybul and Henrik Grønfeldt-Sørensen, the Company’s
former Chief Executive Officer and former member of the Board of Directors, respectively. On November 29, 2022, the Company filed a motion
for summary judgment with respect to the sole remaining claim of malicious prosecution. On August 24, 2023, the court denied the motion
for summary judgment.On November 7, 2024, the Court reset the trial date for May 6, 2025. The Company denies the allegations set forth
in the Complaint and will continue to vigorously defend against the remaining claim.
On June 7, 2023, Weird Science
LLC (“Weird Science”), Wittekind, the William Anderson Wittekind 2020 Annuity Trust, the William Anderson Wittekind 2021 Annuity
Trust, the Dybul 2020 Angel Annuity Trust, and the Ty Mabry 2021 Annuity Trust (collectively, the “Trusts”) (collectively,
“Plaintiffs”) filed a Verified Complaint against the Company in the Court of Chancery of Delaware. In the Verified Complaint,
Plaintiffs alleged that the Company breached the February 16, 2018 Investor Rights Agreement between the Company, Weird Science, and RS
Group ApS (the “Investor Rights Agreement”). According to the Verified Complaint, the Investor Rights Agreement required the
Company to (i) notify all “Holders” of “Registrable Securities” at least 30 days prior to filing a registration
statement and (ii) afford such Holders an opportunity to have their Registrable Securities included in such registration statement. Plaintiffs
alleged that the Company breached these registration rights by failing to provide the required notice in connection with S-3 registration
statements filed by the Company on July 13, 2020 and February 11, 2022. The Company moved to dismiss the Verified Complaint on September
15, 2023.
15
On December
4, 2023, in lieu of opposing the motion to dismiss, Plaintiffs filed a Verified First Amended Complaint (“FAC”). In the FAC,
Plaintiffs assert claims against the Company and others for purported breaches of the Investor Rights Agreement, fraud, tortious interference
with a contract, and several other torts. Plaintiffs seek compensatory, exemplary, and punitive damages, as well as certain declaratory
relief, specific performance, and pre- and post-judgment interest, costs, and attorneys’ fees. The Company filed a motion to dismiss
the FAC on December 18, 2023 and a hearing is scheduled for November 15, 2024. The Company denies Plaintiffs’ allegations and intends
to vigorously defend against the claims.
On August 24, 2023, counsel on
behalf of Weird Science, Wittekind, individually, and Wittekind, as trustee of the Trusts served a demand to inspect the Company’s
books and records (the “Demand”) pursuant to Delaware General Corporation Law, § 220 (“Section 220”). The
Demand seeks the Company’s books and records in connection with various issues identified in the Demand. The Company takes its obligations
under Section 220 seriously and, to the extent that the requests are proper under Section 220, intends to comply with those obligations.
On January 19, 2024, Weird Science
and Wittekind sent the Board of Directors a letter demanding it take corrective actions with respect to twenty-one issues identified therein.
On February 27, 2024, Weird Science and Wittekind sent the Board of Directors a supplemental letter that expanded their demand for corrective
actions to twenty-six issues. In response to these demand letters, the Board of Directors initially formed a Special Committee (“Special
Committee”) of independent directors on February 29, 2024. The Special Committee retained Stradling Yocca Carlson & Rauth LLP
as its counsel to investigate the issues identified in the demand letters. The Special Committee’s investigation is ongoing.
On January 23, 2024, Weird Science
and Wittekind filed a shareholder derivative action in the United States District Court for the Central District of California against
certain officers, directors, and investors of the Company, as well as other defendants, in connection with, inter alia , Weird Science
and Wittekind’s demand for corrective action. Plaintiffs filed an amended complaint on June 21, 2024. The First Amended Verified
Stockholder Derivative Complaint (“Derivative Complaint”) alleges, among other claims, violations of Section 13(d) and 14(a)
and Rules 10b-5(a), 10b-5(c) and 14a-9 of the Exchange Act of 1934. The Derivative Complaint also includes claims of breach of fiduciary
duty, corporate waste, unjust enrichment, and contribution/indemnification. Weird Science and Wittekind seek unspecified compensatory,
exemplary, and punitive damages and certain injunctive relief. The Derivative Complaint names the Company as a nominal defendant. On July
19, 2024, certain of the director defendants, who had agreed to waive service of the summons and Derivative Complaint, filed a motion
to dismiss the Derivative Complaint on a variety of procedural and substantive grounds. A hearing on the motion dismiss was held on October
3, 2024 and the court subsequently took the motion under submission. On October 22, 2024, the plaintiffs filed a notice of certain subsequent
events that they allege relate to their pending motion to dismiss. On October 29, 2024, the court granted the director defendants’
motion to dismiss and dismissed the Derivative Complaint without prejudice, but also without leave to amend.
On June 21, 2024, the Company filed
suit against Weird Science, Wittekind, and certain trusts in connection with the February 16, 2018 merger involving the Company and two
companies closely associated with Gumrukcu. In the complaint, the Company alleges that Gumrukcu and others deliberately and fraudulently
concealed a murder-for-hire scheme from the Company in order to induce the Company to enter into the merger agreement, which resulted
in the defendants receiving shares and compensation. The Company asserts claims for fraudulent concealment, equitable fraud, unjust enrichment,
and civil conspiracy and seeks, inter alia , equitable relief, including, but not limited to, return to the Company any shares received
in connection with the merger, and damages. On October 1, 2024, the defendants moved to dismiss the complaint.
NOTE 8 — RELATED PARTY TRANSACTIONS
As of September 30, 2024, the Company
has accrued $ 283,652 of compensation related expenses for the Company’s former Chief Executive Officer, Mark Dybul, related to budget
constraints.
On August 23, 2024, Avram Miller,
a former member of the Board of Directors, forfeited 833,333 shares of Common Stock from the original 1,000,000 shares of Common Stock
for advisory services originally granted to him on October 11, 2023. As consideration for such forfeiture, the Company granted to Mr.
Miller, an option to purchase 978,261 shares of Common Stock of the Company with a per-share exercise price of, $ 0.69 . The Company determined
that this transaction represented a modification of the original award. The Company measured the fair value of the options issued as compared
to the fair value of the original issuance and determined that there was no incremental compensation to recognize as the fair value of
the options was less than the fair value of the Common Stock. Therefore, the Company will recognize the remaining fair value of the original
award over the remaining vesting period, which is one year. The Company recognized stock-based compensation expense of $ 222,306
related to the vesting of the stocks options during the period ended September 30, 2024. At September 30, 2024, the Company had $ 1,122,537
of unrecognized compensation cost related to the options which vest at August 23, 2025.
16
NOTE 9 — SEGMENT REPORTING
For the period ending September
30, 2024, the Company had two reportable segments. These segments have different strategic and economic goals and are managed separately
because they require different technology and marketing strategies.
Reportable Segment
Description
RENB (United States)
Developing new immunotherapies to combat cancer
RENC (Netherlands)
Developing a predicative artificial intelligence based diagnostic methodology for the use of earlier cancer detection
The Company’s
chief executive officer is the chief operating decision maker and reviews the internal management reports for each segment at least quarterly.
During the quarter ended September 30, 2024, there were no significant inter-company revenues or expenses. The chief operating decision
maker assesses performance for each segment and decides how to allocate resources based on segment operating losses that also is reported
on the consolidated statement of operations. The measure of segment assets is reported on the balance sheet as total consolidated assets.
The accounting policies of each segment are the same as those described in the summary of significant accounting policies.
Schedule of segment operating loss and
asset information
Operating loss
Assets
United States
$ 4,960,737
$ 2,856,326
Netherlands
48,377,817
118,976,311
$ 53,338,554
$ 121,832,637
The chief
operating decision maker uses loss from operations to evaluate the performance of each segment’s assets in deciding how to allocate
available capital between segments. The chief operating decision maker also uses loss from operations in their competitive analysis by
benchmarking the Company’s competitors. The competitive analysis along with the monitoring of budgeted versus actual results are
used in assessing the performance of the segment.
Information
regarding each reportable segment for the quarter ended September 30, 2024, is as follows:
Schedule of information regarding segment reporting
RENB
RENC
Total
General and administrative
$ 4,548,449
$ 752,802
$ 5,301,251
Research and development
381,686
8,503
390,189
Goodwill impairment
—
47,614,729
47,614,729
Depreciation and amortization
30,602
1,783
32,385
Segment operating loss
$ 4,960,737
$ 48,377,817
$ 53,338,554
Geographic information:
RENB and
RENC are managed on a worldwide basis but operate in offices located in the United Stated and the Netherlands, respectively. The geographic
information analyses the Company’s operations and assets based on the country in which each segment operates. In presenting this
geographic information, segment operating results have been based on the geographic location in which the services were provided to the
segment and segment assets were based on the geographic location of the assets.
17
NOTE 10 — ACQUISITION
On September
28, 2023, the Company, entered into a Stock Purchase Agreement (the “ Purchase Agreement ”)
with GEDi Cube Intl Ltd., a private company formed under the laws of England and Wales (“ GEDi
Cube ”) to acquire 100% of the equity interests of GEDi Cube from its equity holders (the “ Sellers ”).
On September 28, 2023, the Board of Directors of the Company, and the board of managers of GEDi Cube unanimously approved the Purchase
Agreement and on January 25, 2024, the shareholders of the Company approved the issuance of the shares of Common Stock pursuant to the
Purchase Agreement. On February 13, 2024 (the “Closing Date”), the Company consummated the acquisition of GEDi Cube and the
other transactions contemplated by the Stock Purchase Agreement (collectively, the “Transaction”). As a result of the Transaction,
GEDi Cube became a wholly-owned subsidiary of the Company.
Pursuant
to the Stock Purchase Agreement, as of the Closing Date, the Company acquired all the issued and outstanding equity interests of GEDi
Cube owned by the Sellers as of the Closing Date (each, a “GEDi Cube Share” and, collectively, the “GEDi Cube Shares”)
in exchange for which each Seller was entitled to receive (i) as of the Closing Date, such Seller’s pro rata percentage of an aggregate
of 70,834,183 shares of common stock, par value $0.0001 per share, of the Company (“Common Stock”), which represents the 67,224,089
shares of Common Stock issued and outstanding as of the Closing Date (minus (a) 1 million shares of Common Stock previously issued to
a consultant assisting with the Transaction and (b) 1 million shares of Common Stock previously issued to Avram Miller, a director of
the Company, pursuant to his Advisory Agreement, dated October 11, 2023, by and between Mr. Miller and the Company) (the “Closing
Consideration”) plus 5,610,100 shares of Common Stock representing the Seller’s Earnout Shares (defined below) resulting from
the automatic conversion of the Company’s Series A Convertible Preferred and, (ii) following the Closing Date, such Seller’s
pro rata percentage of the shares of Common Stock (the “Earnout Shares” and, together with the Closing Consideration, the
“Exchange Consideration”) to be issued to the Sellers upon the exercise or conversion of any of the Company’s derivative
securities (subject to certain exceptions) that are outstanding at the Closing Date (the “Closing Derivative Securities”).
Each Seller’s pro rata percentage of the Exchange Consideration is equal to the ratio of the aggregate number of GEDi Cube Shares
owned by such Seller divided by the aggregate number of GEDi Cube Shares issued and outstanding, in each case, as of the Closing Date.
The
transaction was accounted for in accordance with the provisions of ASC 805-10 - Business Combinations . As a result
of the issuance of the Closing Consideration on the Closing Date and based on the number of shares of Common Stock outstanding as of the
Closing Date, the Sellers held approximately 49% of the issued and outstanding shares of Common Stock immediately following the closing
of the Transaction and the conversion of the Series A Convertible Preferred Stock.
The assets
acquired and liabilities assumed were initially recognized provisionally in the accompanying consolidated balance sheets at their estimated
fair values as of the acquisition date. The fair values as of the acquisition date are based on information that existed as of the acquisition
date. The Company completed its accounting for this acquisition during the period ended June 30, 2024. As a result of the completion of
the Company’s analysis, the amount of provisional in-process research and development was determined to have a value of nil. Accordingly,
the amount of goodwill recognized was increased to include the previously recognized provisional amount of in-process research and development.
There was no impact to the Company’s consolidated statement of operations as a result of this change to the provisional allocation.
The acquisition-date
fair value of the consideration transferred totaled approximately $ 156.6 million, which consisted of the following:
Schedule of acquisition date fair value
Common stock
$ 136,001,631
Contingent consideration
20,557,500
Total consideration transferred
$ 156,559,131
The
fair value of the Company’s common shares issued as consideration was based on the closing price of the Company’s common stock
as of the Acquisition Date. The fair value of the contingent consideration was based on the Sellers’ right to receive additional
shares of common, pro rata, upon the exercise or conversion of warrants, options and convertible notes payables outstanding as of the
Closing Date.
18
The
following table details the provisional fair values of the assets acquired and liabilities assumed at the acquisition date:
Schedule of fair value of assets acquired and liabilities assumed
Cash
$ 65,851
Prepaid & Other Assets
151,544
Fixed Assets
16,243
Operating lease ROU
624,366
Total Assets Acquired:
858,004
Accounts Payable
583,577
Accrued Expenses
722,509
Operating Lease liability
624,367
Notes Payable
1,832,460
Total Liabilities Assumed
3,762,913
Net Assets Acquired
( 2,904,909 )
Goodwill
159,464,040
Total Consideration
$ 156,559,131
The goodwill
recognized is attributable primarily to expected synergies and the assembled workforce of Gedi Cube. None of the goodwill is expected
to be deductible for income tax purposes.
The fair
values of the acquired tangible and intangible assets were determined using variations of the income approach. The income approach valuation
methodology used for the intangible assets acquired makes use of Level 3 inputs.
The amounts
of revenue and loss of Renovaro Cube, included in the Company’s condensed consolidated statements of operations from the three months
ended September 30, 2024 are as follows:
Schedule of consolidated statements of operations
Revenues
$
Net loss
$ ( 48,406,163 )
Consolidated
unaudited pro forma information:
The following consolidated pro
forma information assumes that the acquisition of Renovaro Cube took place on July 1, 2023 for the statement of operations for the three-month
period ended September 30, 2023. These amounts have been estimated after applying the Company’s accounting policies:
Schedule of consolidated proforma information
Revenues
$
Net loss
$ ( 13,146,452 )
The
unaudited pro forma results are presented for informational purposes only and are not necessarily indicative of what the actual results
of operations would have been if the acquisition had occurred at the beginning of the period presented, nor are they indicative of future
results of operations.
NOTE 11 — SUBSEQUENT EVENTS
From October 21, 2024, to November
6, 2024, the Company issued Promissory Notes in the aggregate principal amount of $ 900,000 . The Notes bear an interest rate ranging from
10 % to 12 % per annum and mature from December 31, 2024 , to January 31, 2025 (the “Maturity Date”). The Company is required
to pay principal and interest on the Maturity Date.
On October 17, 2024, the Company
entered into an investor relations consulting agreement with MZHCI, LLC. Pursuant to the agreement, the Company issued 160,000 shares
of Common Stock to MZHCI, LLC valued at $ 118,400 .
On October 14, 2024, the
Company issued 250,000 shares of Common Stock as part of a sign on bonus valued at $ 137,500 to the Chief Executive Officer effective
October 14, 2024, David Weinstein.
On October 14, 2024, the
Company issued 500,000 shares of Common Stock for consulting services valued at $ 275,000 .
Related to the June 2024 Private
Placement, ranging from October 2, 2024, to October 10, 2024, the Company sold 190,140 Units at a price per Unit equal to $1.4726 to
a certain investor who paid in cash an aggregate amount of $280,000 in consideration of the Units.
19
Item 2. Management’s Discussion and Analysis of Financial Condition
and Results of Operations.
Forward-Looking Statement Notice
Certain statements made in this
Quarterly Report on Form 10-Q are “forward-looking statements” (within the meaning of the Private Securities Litigation Reform
Act of 1995) regarding the plans and objectives of management for future operations. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance, or achievements of Renovaro Inc. (“Renovaro,”
and together with its subsidiaries, the “Company”, “we” or “us”) to be materially different from any
future results, performance or achievements expressed or implied by such forward-looking statements. The forward-looking statements included
herein are based on current expectations that involve numerous risks and uncertainties. Our actual future results and trends may differ
materially depending on a variety of factors, including, but not limited to, the risks and uncertainties discussed in Part I, Item 1A,
“Risk Factors” in our Annual Report on Form 10-K as filed with the SEC on October 10, 2024. The Company’s plans and
objectives are based, in part, on assumptions involving the continued expansion of the business. Assumptions relating to the foregoing
involve judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions,
all of which are difficult or impossible to predict accurately and many of which are beyond the control of the Company. Although the Company
believes its assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and,
therefore, there can be no assurance the forward-looking statements included in this Quarterly Report will prove to be accurate. In light
of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should
not be regarded as a representation by the Company or any other person that the objectives and plans of the Company will be achieved.
Our Business
Renovaro
Inc. operates through two subsidiaries, Renovaro Biosciences and Renovaro Cube. Renovaro Cube refers to Renovaro Cube Intl. Ltd. (formerly
known as GediCube Intl. Ltd.) and its wholly owned subsidiaries GediCube, B.V. and Grace Systems B.V., which were acquired on February
13, 2024.
Renovaro Biosciences Overview
Renovaro
Biosciences is a biotechnology company intending, if the necessary funding
is obtained, to develop advanced allogeneic cell and gene therapies to promote stronger immune system responses potentially for long-term
or life-long cancer remission in some of the deadliest cancers, and potentially to treat or cure serious infectious diseases such as Human
Immunodeficiency Virus (HIV) infections. As a result of our acquisition of GEDi Cube Intl Ltd. on February 13, 2024, we have shifted the
Company’s primary focus and resources to the development of the Renovaro Cube technologies.
Therapeutic Technologies
Renovaro Biosciences aims to train the immune system to allow a person to better
fight diseases through allogeneic cell and/or gene therapy. Our vision is for a world with healthy longevity, and free from toxic chemotherapy,
for those with cancer and other serious diseases. Renovaro Biosciences will seek to leverage general principles and advances in the knowledge
of the immune response to engineer cells with enhanced attributes to promote the recognition and elimination of disease cells.
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Allogeneic Cell Therapy
The strategic benefit of the allogeneic
cell therapy technologies is to potentially allow for the manufacture of large, “off-the-shelf” banks of therapeutic cells
that are readily available on demand by healthcare professionals, to potentially decrease the time between diagnosis and treatment.
In certain treatments (e.g., HIV
and cancer), cells taken from healthy donors are engineered to introduce signaling molecules that are designed to enhance the ability
of specific immune cells to recognize diseased cells, and to help recruit other cells that will destroy cancer or virus infected cells.
Gene
Therapy
Renovaro Biosciences may also seek
to explore various approaches for gene therapy design elements to potentially eliminate virus-infected or cancer cells by the modulation
of the patient’s immune system. Upon injecting into the patients, these genetically engineered allogeneic cells have little to no
risk of passing those modifications to the patient since they are terminally differentiated with locked functionality to activate the
host immune system. Gene modified allogeneic cells are expected to be rejected naturally once they activate the patient’s immune
system therefore will have a very short survival time.
Renovaro
Biosciences Focus Areas:
Oncology:
RENB-DC11: Genetically modified
Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Product for Long-term Remission of Solid Tumors; specifically Pancreatic tumors
Allogeneic Cell Therapy Platform
– Completed pre-IND, IND-enabling phase.
Based
on learnings from our internal research, literature reviews of ongoing clinical development for solid tumors, and recent advances in immune
modulation, we have designed an innovative therapeutic vaccination platform that could potentially be used to induce life-long remission
from some of the deadliest solid tumors such as pancreatic, liver, triple negative breast and head & neck cancers.
The platform
may one day enable broad immune enhancements that are combined with cancer specific antigens that could be applicable to a wide range
of solid tumors. This approach allows us to quickly adapt our approach to any patient solid tumor using the same banked allogenic drug
substance.
RENB-DC20: Genetically modified Allogeneic Dendritic
Cell Therapeutic Vaccine as Potential Treatment Product for Long-term Remission of Triple Negative Breast Cancer
Triple Negative Breast Cancer (TNBC)
is a subtype of breast cancer that is negative for estrogens receptor (ER) negative, progesterone receptor (PR) negative and human epidermal
growth factor receptor 2 (HER2). TNBC is characterized by its unique molecular profile, aggressive nature, and distinct metastatic patterns
that lack targeted therapies. TNBC is well known for its aggressive behavior and is characterized by onset at a younger age, high mean
tumor size, and higher-grade tumors.
Based upon our internal research,
literature reviews of ongoing clinical development for solid tumors, and recent advances in immune modulation, we believe we may have
the ability to design an innovative therapeutic vaccination platform that could potentially be used to treat some of the deadliest and
hard-to-treat solid tumors that include triple negative breast cancer.
21
Infectious Diseases:
RENB-HV12: Genetically Modified
Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Treatment Product for Long-term Remission of HIV; A Chronic Infectious Disease
The oncology therapeutic vaccine
technology could potentially be adapted to target infectious disease antigens and be a viable therapeutic approach in difficult to treat
chronic infectious diseases. As described above, the engineered allogenic dendritic cell drug substance is thought to be able to be loaded
with various cancer antigens for specific solid tumors but could or may be loaded with infectious disease antigens to elicit a more robust
immune response to viruses and other difficult to treat infections.
Renovaro Cube Overview
Renovaro Cube is an AI-driven healthcare
technology company focusing on the earliest possible detection of cancer and its recurrence. Renovaro Cube has developed a proprietary
AI platform that analyzes genetics using Explainable AI (as defined below) to provide earlier and more accurate cancer diagnosis. This
platform uses a multi-omics approach to search for individual biomarkers that are present even in asymptomatic patients. This approach
is combined with differential molecular capabilities that are designed to identify, differentiate and pinpoint the exact source. Renovaro
Cube’s process also involves the mining of biomarker panels, which are integrated into a machine learning library referred to as
“RenovaroCube” to further enhance diagnosis.
Renovaro Cube also aims to utilize
its proprietary AI platform in the development of commercial products to support clinical, research and pharmaceutical organizations that
are trying to improve patient care through precision diagnosis, prediction of success of therapy, new drug discovery, treatment protocols
or clinical trials. Specifically, Renovaro Cube is focused on developing products and services aimed at (i) early cancer characterization,
(ii) personalized treatment selection, (iii) prediction and tracking response to therapies, (iv) recurrence detection and efficacy monitoring,
and (v) ultimately, drug discovery.
Renovaro Cube was initially incorporated
as Grace Systems B.V. (“Grace Systems”) in 2013 under the laws of the Netherlands to develop unique data mining algorithms
to enable banking, finance and government entities to extract business insights from data. Grace Systems began applying its algorithms
to biological data in 2018 to uncover cancer-associated patterns. Beginning in 2018, Grace Systems pivoted its platform to focus only
on healthcare. Renovaro Cube has focused on developing its AI technology for early cancer detection.
Renovaro Cube has now focused on
commercialization of its AI technology. Renovaro Cube believes that it has developed a unique approach to the early detection and diagnosis
of cancer and its recurrence and, in time, other rare diseases through the systematic analysis of data using AI technologies, data mining
procedures and algorithms for health technology.
Renovaro Cube’s technology
has been trained on complex heterogeneous cancer data and appears to find patterns associated with cancer in public and private data resources.
With the help of Renovaro Cube’s algorithms, discovered patterns may be translated into biomarkers that can be used in a clinical
setting to target various aspects of cancer diagnosis and treatment.
Renovaro Cube’s Strategy
Renovaro Cube’s product development
focuses on four core areas:
●
Early Detection. Multi-cancer early detection (“MCED”) blood tests are advanced diagnostic
tools that analyze cell-derived molecules present in the bloodstream. These tests specifically look for abnormal genetic, epigenetic or
proteomic patterns of these cell-derived molecules, which can indicate the presence of cancer cells. By examining the molecules shed from
various cells, including cancer cells, MCED tests aim to detect cancer at an early stage. This approach holds promise for improving cancer
detection and potentially saving lives.
22
●
Recurrence of cancer . A recurrence refers to the return of cancer after a period of remission.
A cancer recurrence happens because, in spite of the efforts to kill the cancer, some cells may remain, which grow and eventually cause
symptoms. In rare instances, a patient may develop a new cancer that’s completely unrelated to the originally diagnosed cancer,
which is referred to as a second primary cancer. An early warning system could help to identify a recurrence as early as possible, thereby
helping to accelerate any treatment and diagnosis. The different types of recurrence include:
o
Local recurrence, meaning that the cancer has returned in the same place it first started;
o
Regional recurrence , meaning that the cancer has returned to the lymph nodes near the place
it first started; and
o
Distant recurrence , meaning the cancer has returned in another part of the body.
●
Response to treatment. At Renovaro Cube we aim to develop a new array of diagnostic products that
can accurately identify patients that are going to respond or fail to a certain drug. In highly toxic therapies it will not only increase
survival but will also reduce unnecessary exposure to chemotherapy. Furthermore, the costs for cancer drugs are usually very high. Providing
the right therapy to the right patient will therefore significantly reduce the costs of medicine in cancer.
●
Clinical trials . Clinical trials involve a type of research that studies new tests and treatments
and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including
drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments and preventive
care. Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start.
In response to these four core areas, the key components of Renovaro Cube’s
product development are to build a software and hardware platform that:
●
Uses data science to develop novel insights into the characterization of diseases
such as cancer. Renovaro Cube intends to apply its proprietary technology to biological data from multiple sources to enable the typification
(or classification) of disease entities and sub-entities to provide insights about the nature and behavior of diseases to payers, providers,
pharmaceutical companies and patients.
●
Enables more accurate diagnosis and earlier detection of cancer and other diseases
with the goal of maximizing outcomes and minimizing the costs of treatment. Renovaro Cube intends to develop a system to understand the
smallest fragments of cancer in the blood of the patient. Presently, Renovaro Cube is developing a product to analyze results from liquid
biopsy run through an Oxford Nanopore Sequencer. We expect the Renovaro Cube product will subsequently identify, train and validate explainable
biomarkers, panels and models on different molecular layers. Multiple models will be individually trained for optimal stratification through
the entire health journey, ensuring the right accuracy for a therapeutic decision in every stage. Renovaro Cube will integrate different
modalities and molecular data sources into a differential diagnostic report. Diagnostics and prognosis will be explainable with quality
control reports and biomarker insights for different disciplines ensuring maximum trust and insight in medical decision making.
23
●
Assists in clinical trials with patient cohort selection and response tracking,
to be used by companies like Renovaro Biosciences in their patient cohort selection for their clinical trials, by looking at which patients
are reacting positively, negatively and have no reaction. This data becomes more important through the progression of the different phases
of drug development, as more and more patients are added. Renovaro Cube will provide multi-omic data analysis, looking for specific changes
in the patients that might indicate a change in their molecular make-up. This can then be used for the next phase of a clinical trial
to look for the specific molecular data that has showed a positive reaction in the previous phase. It also provides insights for more
effective response tracking, which Renovaro Cube believes is important to the providers of care as well as the development and evaluation
of new pharmaceuticals and immune therapies in clinical trials. Patient response to treatment can be used to focus the target audience
for drugs in development and in subsequent clinical practice. As Renovaro Cube collects more data, longitudinal about treatment and response,
it will have the ability to train prognostic models to give an insight in disease progression and treatment response, both critical for
enrolling in clinical trials and eventually every treatment. Because Renovaro Cube consists of many independently trained and validated
models, it will have the ability to assist in virtually every therapeutic decision, for different subtypes and groups (stratifications).
The multi-omics and multi-modal pipelines could allow the use of multiple combinations of tissue samples and diagnostic platforms. The
detailed diagnostic reports will allow and support insights for multiple disciplines such as cancer biology, genomics and pathology to
look at underpinning biomarkers, pathways and clinical annotations.
●
Provides insight into patients who have had cancer previously. These insights will
provide for more effective recurrence monitoring, which Renovaro Cube believes is important to the providers of care and patients during
follow-up monitoring of remissions. Renovaro Cube anticipates that payers want to detect and re-treat recurrences at the earliest possible
stage to maximize patients’ outcomes in terms of time and cost and that, similarly, patients with a recurrence are keen to re-engage
with effective treatment at the earliest opportunity. A key aspect of this will be taking blood from the patients, sequencing this blood
and running it through the Renovaro Cube platform which will identify if the patient has any indication of the recurrence of the same
or a new cancer. For recurrence monitoring, Renovaro Cube will focus on a highly sensitive combination of lab and information technology.
Lab protocols, sequence post processing and machine learning will all be designed, trained and validated to get the best signal with the
highest sensitivity to catch early signals of recurrence. This will be done on a regular basis allowing surveillance analysis over time.
●
Includes biomarker panels that will be extended to include as many layers of genetic
information (multi-omics) as possible including mutation, gene expression, methylation status, fragmentomics, nucleosome mapping, collectively
named multi-omics, with the goal to reach the highest accuracy possible, both in terms of sensitivity and specificity of each individual
biomarker panel. This provides a non-invasive alternative for the current complex, expensive and cumbersome procedures.
●
Create value through advancing more sophisticated typification of diseases in
an effort to address some of the pressing problems faced by modern healthcare, including healthcare costs, an aging population and developments
in medical technology that produce a stream of increasingly sophisticated treatments requiring more precise targeting.
One additional key focus of Renovaro
Cube is its multi-modal, data analysis. Multi-modal data encompasses the whole aspect of data from a patient perspective, whether genomics,
imaging, phenotypic or even wearable data, which can be cross analyzed to produce data that could not be previously produced. Renovaro
Cube intends to use multi-modal data to bring new insights to the clinical and research teams trying to understand what to do next with
the patient.
Renovaro Cube’s Technology
and Techniques
Renovaro Cube is dedicated to
the development of early cancer detection blood tests and expects to develop partnerships with third-party laboratories across the United
Kingdom, the Netherlands and the rest of Europe and will also expand to the United States. Renovaro Cube is focused on developing diagnostic
tests and test kits that would analyze samples derived from non-invasive liquid biopsy samples and intends to perform these tests from
Renovaro’s dedicated fully certified service laboratory and engage third-party laboratories to perform these tests for end-users.
24
For this purpose, Renovaro Cube
has developed an AI platform that aims to leverage expertise in both biological and computational sciences and to go beyond traditional
tumor signals by detecting the body’s early warning signs of cancer. Renovaro Cube’s goal is to provide accurate and reliable
tests that can aid in the early diagnosis and treatment of cancer. Renovaro Cube’s AI technology is created to detect a wide range
of biological signs to enhance the accuracy and sensitivity of early cancer detection and, thereby, enable earlier intervention and potentially
improved patient outcomes.
Renovaro Cube’s AI technology
aims to address three critical facets of medical needs within the domain of cancer diagnosis (as illustrated below):
●
type-specific cancer detection;
●
pan-cancer detection; and
●
patient stratification.
Moreover, the versatility of Renovaro
Cube’s AI technology extends to encompass the realm of rare cancers, including cases such as cancer of unknown primary.
Leveraging DNA methylation data,
Renovaro Cube has identified and validated biomarker panels tailored for the detection of a wide range of cancers, including bladder,
breast, colon, prostate, thyroid, head and neck, liver, kidney and lung cancer.
The foundational architecture of
Renovaro Cube’s AI technology is engineered to facilitate comprehensive pan-cancer analysis through its extensive record of informative
biomarkers discovered across a diverse array of cancer types. This comprehensive repository empowers Renovaro Cube’s AI technology
to swiftly cross-reference biomarkers and explore molecular commonalities and distinctions that span multiple tumor categories.
For example, the capabilities of
Renovaro Cube’s AI technology have unearthed biomarkers capable of pinpointing a specific subgroup of thyroid cancer patients characterized
by a distinct genomic alteration, the neurotrophic tyrosine receptor kinase (“NTRK”) gene fusion. Identification of these
NTRK-positive patients provides an actionable therapeutic target.
Uses of Renovaro Cube’s AI Technology
Renovaro Cube has developed its AI platform to support:
●
AI-assisted patient diagnostics;
●
multi-omic data analysis;
●
genome-wide or targeted analysis;
●
pan-cancer analysis;
●
different technology platforms (sequence or array);
●
tracking of each sample;
●
AI-guided biomarker discovery for single or multiple cancer types; and
●
logs of analysis steps and outcomes (data preparation, discovery, validation).
Renovaro Cube’s AI platform
is an enterprise software platform that is distinguished from its competitors’ technology by its core attributes encompassing AI-guided
analysis and meticulous record-keeping of data handling procedures within audit trails, logs, and data discoveries. Renovaro Cube designed
this technology to support and validate every phase of the process, from the initial handling of raw data to the creation of essential
biomarker panels. Renovaro Cube’s AI platform also facilitates the integration of data originating from diverse sources, including
public databases and collaborative partnership data.
25
Illustrated below is the three-phase
workflow behind Renovaro Cube’s AI platform for biomarker discovery using DNA methylation data. This workflow commences with the
identification of pertinent single- and multi-omic data best suited to address the specific inquiries of Renovaro Cube’s clients,
and the subsequent stages involve the meticulous pre-processing and loading of this data into the platform. This process culminates in
the availability of a dashboard offering the client insights into the data’s characteristics, such as data quality, the technology
employed, and associated metadata.
●
Phase I of the workflow behind Renovaro Cube’s AI platform primarily centers on the pivotal process of biomarker discovery. This intricate procedure unfolds through the application of data mining algorithms and statistical methodologies integrated into the AI platform. The paramount objective of Phase I is to reduce the plethora of genomic features displaying variations across samples, which is accomplished by systematically eliminating extraneous or inconsequential features while preserving those features that exhibit the greatest potential for accurately detecting cancer.
●
Phase II of the workflow builds upon the foundation of selected biomarkers by focusing on understanding the dynamic interplay among these chosen biomarkers, culminating in the creation of composite panels. The goal of Phase II is to pinpoint biomarker combinations that not only demonstrate robustness in detecting cancer but also maintain their efficacy across diverse contexts. Renovaro Cube believes that its AI algorithms are adept at uncovering multiple combinations across a spectrum of panels, which is supported by Renovaro Cube’s AI-guided panel mining, a proprietary combinatorial optimization technique used by Renovaro Cube’s AI technology. This approach, coupled with the capacity to explore numerous panels, significantly enhances the likelihood of discovering panels that align with specific metric criteria, such as sensitivity, specificity, precision, and recall and allows for tailoring criteria to align with clients’ unique needs, such as the number of biomarkers included per panel, or the inclusion of biomarkers associated with the expression of specific genes. The performance of the top-tier panels is further fine-tuned through the application of machine learning models. Subsequently, the efficacy of these biomarker panels in detecting cancer is validated through independent data sets.
●
Phase III of the workflow involves Renovaro Cube’s collaboration with its clinical partners to validate the performance of the biomarker panels. Through this collaboration, Renovaro Cube can confirm the utility and accuracy of its biomarker panels in real-world clinical contexts.
AI-Assisted Diagnostics
The process of biomarker discovery
facilitated by Renovaro Cube’s AI technology has yielded a set of data that enables scrutiny of the genomic distinctions and commonalities
inherent in diverse cancer types. This data set can support the diagnosis of cancers when their type or origin remains unidentified.
In addition to this role in biomarker
discovery and the development of diagnostic tests, Renovaro Cube’s AI technology also integrates AI-guided molecular profiling of
patient samples and furnishes diagnostic patient reports. These diagnostic reports reflect the outcomes of molecular profiling, coupled
with interpretations provided by Renovaro Cube’s team, to facilitate the process of cancer diagnostics by a qualified healthcare
provider, who can consider these reports in the context of a patient’s medical history, clinical signs, and symptoms, among other
factors.
Quality Control Process
Renovaro Cube undertakes post-processing
of data generated from sequence and arrays to ensure accurate and meaningful results. These post-processing steps for omic data include:
1.
Quality Control : Quality control is performed to assess the overall data quality and to identify any technical issues or anomalies.
2.
Normalization : arrays can introduce various sources of technical variation, such as batch effects, intensity variations, and probe-specific biases.
26
3.
Quality Filtering : After genotype calling, additional quality filtering may be performed to remove low-quality SNPs based on criteria like call rates, minor allele frequency, Hardy-Weinberg equilibrium p-values, and linkage disequilibrium.
Other post-processing steps may
include genotype calling, population stratification and association analysis. Specific post-processing steps may vary depending on the
type of array used, the study design, and the analytical goals.
Planning for Commercialization
Partnerships in Development
To enhance multi-omic and multi-modal
capacity, and to work to validate those capabilities with human samples including liquid-biopsy-based tests/test kits, Renovaro Cube is
actively pursuing relationships with leading academic cancer centers, pathology and imagery centers in Europe, the USA and the Middle
East. In certain cases, scopes of work are in process. This is a very attractive model for partners to be involved with Renovaro Cube
to perform multi-omics genetic analysis using liquid biopsies.
Resources
Renovaro Cube intends to hire additional
staff to increase the speed and velocity of its organization, including the development of the AI platform and the opportunities to deploy
the AI platform for research perspective and ultimately for clinical practice and into clinical trials.
In addition, Renovaro Cube intends
to build out its infrastructure by leasing space for storage, networking and hosting facilities.
Target Market
Renovaro Cube’s intended
customers will be hospitals, clinics, insurance companies, pharmaceutical companies, biotech companies, research centers, physicians and
individual patients.
Renovaro Cube aims to utilize its
AI technology to commercialize products and test kits for healthcare providers, hospitals, clinics and doctors that will expedite diagnosis
and the selection of appropriate treatment for various types of cancer. Renovaro Cube intends to differentiate its products based on the
following factors:
●
Proprietary and unique panel mining algorithms to create multiple biomarker stratifications per cancer;
●
Explainable AI, offering traceability between the prediction and the exact biomarkers, panels and genes;
●
Differential diagnosis, inclusion and exclusion of cancer types based on facts; and
●
Precision diagnosis, with a high accuracy percentage with machine-learning tuning.
The multi-omic design of Renovaro
Cube’s AI platform enables the use of different molecular layers, such as epigenomics, transcriptomics, and metabolomics, together
with genomics and clinical data.
Panel Mining
The unique panel mining technique
in Renovaro Cube’s technology repeatedly investigates genes to identify relevant biomarkers. The proprietary technique in Renovaro
Cube’s technology not only searches for individual biomarkers, but also integrates validated panels for different cancer types into
the “RenovaroCube” machine learning library. This process enables precision diagnosis, by including one cancer and excluding
others based on statistically, scientifically and clinically validated machine-learning panels.
27
Panel mining is designed to combine
biomarkers into panels in such a way that the final panel meets:
●
performance metric criteria;
●
technical criteria, such as a minimum or maximum number of biomarkers for the selected assay;
●
biological criteria, non-annotated genes inclusion; and
●
stratification criteria.
Explainable AI
The term “Explainable AI”
refers to the ability of an AI system or model to provide human-understandable explanations for its decision-making process or predictions.
This feature aims to bridge the gap between the “black box” nature of many AI algorithms and the need for transparency, interpretability,
and accountability in AI applications.
In traditional machine learning
approaches, such as deep neural networks, the internal workings of the model can be complex and difficult to interpret. This lack of interpretability
poses challenges in critical domains where decisions have significant implications, such as healthcare.
Renovaro Cube believes that Explainable
AI is crucial for ensuring transparency, fairness, and accountability in AI systems. Renovaro Cube’s AI platform includes Explainable
AI by design. All data points, calculations and results are traceable, and all calculations are verifiable and reproducible with the same
result.
Disease prognosis is one of the
diagnostic capabilities of the Explainable AI feature of Renovaro Cube’s technology. Disease prognosis gives more insight for a
specific patient that empowers healthcare providers, patients, and their families to make well-informed decisions about treatment, care,
and future planning, thereby enhancing patient-centered care, optimizing resource utilization, and contributing to improved patient outcomes
and quality of life.
Differential Diagnosis
Renovaro Cube’s AI platform
offers differential diagnosis by design due to its approach with a multitude of models for different diseases and the ability to include
and exclude diseases.
Diseases like cancer are very homogenous,
meaning that markers like TP53 or BRCA are expressed with multiple cancers. To address this homogeneity, differential diagnosis distinguishes
between two or more conditions or diseases that share similar signs, symptoms or characteristics. The goal of differential diagnosis is
to consider and evaluate all possible diagnoses for the patient’s symptoms to determine the most likely cause. Differential diagnosis
therefore aims to identify the underlying condition accurately and guide appropriate treatment and management strategies.
Corporate History
We were incorporated under the
laws of the State of Delaware on January 18, 2011, under the name Putnam Hills Corp. and in 2014 we merged with and changed our name to
DanDrit Biotech USA, Inc. In 2018, we acquired Enochian Biopharma and changed our name to Enochian BioSciences Inc. In August 2023, the
Company changed its corporate name to Renovaro Biosciences Inc. On February 13, 2024, the Company changed its corporate name to Renovaro
Inc. On February 13, 2024, Renovaro Inc. acquired Renovaro Cube Intl Ltd and its subsidiaries, in which Renovaro Cube became a wholly-owned
subsidiary of Renovaro Inc.
28
Going Concern and Management’s Plans
The Company’s consolidated financial statements are prepared using the
generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and liquidation of
liabilities in the normal course of business. However, the Company has incurred substantial recurring losses from continuing operations,
has used cash in the Company’s continuing operations, and is dependent on additional financing to fund operations. The Company incurred
a net loss of $44,212,036 and $9,175,028 for the quarters ended September 30, 2024 and 2023, respectively. As of September 30, 2024, the
Company had cash and cash equivalents of $220,571 and an accumulated deficit of $368,891,461 and a working capital deficit of $21,087,220.
These conditions raise substantial doubt about the Company’s ability to continue as a going concern for one year after the date
the financial statements are issued. The consolidated financial statements do not include any adjustments relating to the recoverability
and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to
continue in existence.
Management has reduced overhead and administrative costs by streamlining the organization
to focus around the development and validation of its AI-driven cancer diagnostics platform. The Company has tailored its workforce to
focus on these activities. In addition, the Company intends to secure additional required funding through equity or debt financing. However,
there can be no assurance that the Company will be able to obtain any sources of funding. Such additional funding may not be available
or may not be available on reasonable terms, and, in the case of equity financing transactions, could result in significant additional
dilution to our stockholders. If we do not obtain required additional equity or debt funding, our cash resources will be depleted and
we could be required to materially reduce or suspend operations, which would likely have a material adverse effect on our business, stock
price and our relationships with third parties with whom we have business relationships, at least until additional funding is obtained.
If we do not have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that
could result in our stockholders losing some or all of their investment in us.
Funding that we may receive during
the fiscal year 2025 is expected to be used to satisfy existing and future obligations and liabilities and working capital needs, to support
commercialization of our products, to conduct the clinical and regulatory work to develop our product candidates, and to begin building
working capital reserves.
Results of Operations for the three months ended September 30, 2024
and 2023
The following table sets forth
our revenues, expenses and net loss for the three months ended September 30, 2024 and 2023. The financial information below is derived
from our unaudited condensed consolidated financial statements.
For the Three Months Ended
September 30,
Increase/(Decrease)
2024
2023
$
%
Operating Expenses
General and administrative
$ 5,301,251
$ 8,290,210
$ (2,988,959 )
(36 )%
Research and development
390,189
566,644
(176,455 )
(31 )%
Goodwill impairment
47,614,729
47,614,729
100 %
Depreciation and amortization
32,385
27,260
5,125
19 %
Total Operating Expenses
53,338,554
8,884,114
44,454,440
500 %
LOSS FROM OPERATIONS
(53,338,554 )
(8,884,114 )
(44,454,440 )
500 %
Other Income (Expenses)
Change in fair value of contingent consideration
9,250,000
9,250,000
100 %
Loss on extinguishment of debt
(120,018 )
(120,018 )
(100 )%
Interest expense
(250,080 )
(179,271 )
(70,809 )
39 %
Interest income and other income (expense)
126,598
8,375
118,223
1,412 %
Total Other Income (Expense)
9,126,518
(290,914 )
9,417,432
(3,237 )%
NET LOSS
$ (44,212,036 )
$ (9,175,028 )
$ (35,037,008 )
382 %
29
Revenues
We are a pre-revenue, pre-clinical
biotechnology and artificial intelligence driven healthcare technology company. We have never generated revenues and have incurred losses
since inception. We do not anticipate earning any revenues until our therapies or products are approved for marketing and sale.
Expenses
Our operating expenses for the three months ended September 30, 2024 and 2023,
were $53,338,554 and $8,884,114, respectively, representing an increase of $44,454,440, or approximately 500%. The increase in operating
expenses primarily relates to goodwill impairment of $47,614,729 offset by the decrease in general and administrative expenses of
$2,988,959 and the decrease in research and development expenses of $176,455.
General
and administrative expenses for the three months ended September 30, 2024, and 2023, were $5,301,251 and $8,290,210, respectively, representing
a decrease of $2,988,959 or approximately 36%. The variance is related to a decrease in non-cash consulting fees of $3,070,000 partially
offset by an increase in compensation and related expenses of $377,142 and legal expenses of $261,903.
Research and development expenses
for the three months ended September 30, 2024, and 2023, were $390,189 and $566,644, respectively, representing a decrease of $176,455
or approximately 31%. The variance is primarily driven by a decrease of $262,065 in collaborating partner expenses with CDMO and
CROs related to discontinued product candidates.
The
Company recorded
other income of $9,126,518 for the three months ended September 30, 2024, compared to other expense of $290,914 for the three months ended
September 30, 2023, representing a change in other income (expense) of $9,417,432 or 3,237%. The variance is primarily due to the change
in fair value of contingent consideration of $9,250,000 in the current period.
Net Loss
Net loss for the three months ended September 30, 2024, and 2023, was $44,212,036
and $9,175,028, respectively, representing an increase in net loss of $35,037,008 or approximately 382%. The increase in net loss was
primarily due to an increase in goodwill impairment of $47,614,729, partially offset by the change in fair value of contingent consideration
of $9,250,000.
Liquidity and Capital Resources
We have historically satisfied
our capital and liquidity requirements through funding from stockholders, the sale of our Common Stock and warrants, and debt financing.
We have never generated any sales revenue to support our operations, and we expect this to continue until our therapies or products are
approved for marketing in the United States and/or Europe. Even if we are successful in having our therapies or products approved for
sale in the United States and/or Europe, we cannot guarantee that a market for the therapies or products will develop. We may never be
profitable.
As noted above under the heading
“Going Concern and Management’s Plans,” through September 30, 2024, we have incurred substantial losses. We will need
additional funds both in the next twelve months and beyond for (a) research and development, (b) increases in personnel, (c) the purchase
of equipment, and investment in the development and validation of our technology. The availability of any required additional funding
cannot be assured. In addition, an adverse outcome in legal or regulatory proceedings in which we are currently involved or in the future
may be involved could adversely affect our liquidity and financial position. We may raise such funds from time to time through public
or private sales of our equity or debt securities. Such financing may not be available on acceptable terms, or at all, and our failure
to raise capital when needed could materially adversely affect our growth plans and our financial condition and results of operations.
As of September 30, 2024, the Company had $220,571 in cash and working capital
of $(21,087,220) as compared to $220,467 in cash and working capital of $(28,312,274) as of June 30, 2024, a decrease of zero and 26%,
respectively.
30
Assets
Total assets at September 30, 2024, were $121,832,637 compared to $163,129,450
as of June 30, 2024. The decrease in assets is primarily due to goodwill impairment of $47,614,729 in the current period.
Liabilities
Total liabilities at September 30, 2024, were $23,745,639 compared to $31,152,306
as of June 30, 2024. The decrease in total liabilities was primarily related to the decrease of $9,250,000 in contingent consideration
liability, partially offset by an increase of $1,953,540 in accounts payable.
The following is a summary of the
Company’s cash flows (used in) or provided by operating, investing, and financing activities:
Three Months
Ended
September 30,
2024
Three Months
Ended
September 30,
2023
Net Cash Used in Operating Activities
$ (2,016,328 )
$ (2,777,207 )
Net Cash Used in Investing Activities
—
(1,057,875 )
Net Cash Provided by Financing Activities
2,029,183
2,562,817
Effect of exchange rates on cash
(12,751 )
(78,741 )
Change in Cash and Cash Equivalents
$ 104
$ (1,351,006 )
Cash Flows
Cash used in operating activities for the three months ended September 30, 2024,
and 2023 was ($2,016,328) and ($2,777,207), respectively, representing a decrease of $760,879. The decrease is primarily related to the
changes in our operating assets and liabilities.
Cash used in investing activities
for the three months ended September 30, 2024, and 2023 was zero and ($1,057,875), respectively. Cash used in investing activities during
the prior period primarily related to the issuance of notes receivable prior to the acquisition of Renovaro Cube totaling $1,057,875.
Cash provided by financing activities
for the three months ended September 30, 2024, was $2,029,183 as compared to cash provided by financing activities of $2,562,817 during
the three months ended September 30, 2023. During the three months ended September 30, 2024, the Company received net proceeds of $156,947
from issuance of notes payable and $2,096,181 from private placements that were partially offset by $223,945 in repayment of a finance
agreement.
Off-Balance Sheet Arrangements
The Company does not have any off-balance
sheet arrangements that have or are reasonably likely to have a current or future effect on the Company’s financial condition, changes
in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material
to investors.
Significant Accounting Policies and Critical Accounting
Estimates
The methods, estimates, and judgments
that we use in applying our accounting policies have a significant impact on the results that we report in our financial statements. Some
of our accounting policies require us to make difficult and subjective judgments, often as a result of the need to make estimates regarding
matters that are inherently uncertain.
31
For a summary of our accounting
policies, see Note 1 to the unaudited condensed consolidated financial statements.
Item 3. Quantitative and Qualitative Disclosures
About Market Risk.
As a “smaller reporting company”
as defined by Rule 12b-2 of the Securities Exchange Act of 1934, the Company is not required to provide the information required by this
Item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our Chief Executive Officer and
Chief Financial Officer (the “Certifying Officers”) are responsible for establishing and maintaining disclosure controls and
procedures for the Company. The Certifying Officers have designed such disclosure controls and procedures to ensure that material information
is made known to them, particularly during the period in which this Report was prepared.
The Certifying Officers are responsible
for establishing and maintaining adequate internal control over financial reporting for the Company and used the “Internal Control
over Financial Reporting Integrated Framework” issued by the Committee of Sponsoring Organizations (“COSO”) to conduct
an extensive review of the Company’s “disclosure controls and procedures” (as defined in the Exchange Act, Rules 13a-15(e)
and 15-d-15(e)) as of the end of each of the periods covered by this Report (the “Evaluation Date”). Based upon that evaluation,
the Certifying Officers concluded that, as of September 30, 2024, our disclosure controls and procedures were not effective in ensuring
that the information we were required to disclose in reports that we file or submit under the Securities and Exchange Act of 1934, as
amended, is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms. The deficiency is attributed
to the Company not having adequate resources to address complex accounting matters. This control deficiency will be monitored, and attention
will be given to this matter as we grow.
The Certifying Officers based their
conclusion on the fact that the Company has identified a material weakness in controls over financial reporting, detailed above. We expect
to be deficient in our disclosure controls and procedures until sufficient capital is available to hire the appropriate internal accounting
staff.
Changes in Internal Controls
There have been no changes in our
internal controls over financial reporting during the three months ended September 30, 2024, that have materially affected or are reasonably
likely to materially affect our internal controls.
32
PART II — OTHER INFORMATION
Item 1. Legal Proceedings.
Securities Class Action Litigation. On July 26,
2022 and July 28, 2022, securities class action complaints (the former, the “Chow Action” and the latter, the “Manici
Action”) and together, the “Securities Class Action Litigation”) were filed by purported stockholders of the Company
in the United States District Court for the Central District of California against the Company and certain of the Company’s current
and former officers and directors. The complaints allege, among other things, that the defendants violated Sections 10(b) and 20(a) of
the Securities Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions of
material fact in connection with the Company’s relationship with Serhat Gümrükcü and its commercial prospects. The
complaints seek unspecified damages, interest, fees, and costs. On November 22, 2022, the Manici Action was voluntarily dismissed without
prejudice, but the Chow action remains pending. On October 22, 2023, the Court appointed a lead plaintiff in the Chow Action. The
lead plaintiff filed an amended complaint on December 15, 2023. The Company has filed a motion to dismiss the amended complaint on March
15, 2024. The Court denied the Company’s motion to dismiss on June 28, 2024. A mediation was held on September 17, 2024, after which
the parties signed a stipulation of settlement, dated November 8, 2024. The plaintiff’s deadline to file a motion for preliminary
approval of the settlement is December 9, 2024.
Federal Derivative Litigation . On September 22,
2022, Samuel E. Koenig filed a shareholder derivative action in the United States District Court for the Central District of California.
On January 19, 2023, John Solak filed a substantially similar shareholder derivative action in the United States District Court for the
District of Delaware. Both derivative actions recite similar underlying facts as those alleged in the Securities Class Action Litigation.
The actions, filed on behalf of the Company, name Serhat Gümrükcü and certain of the Company’s former directors as
defendants. The actions also name the Company as a nominal defendant. The actions allege violations of Sections 14(a) and 20(a) of the
Securities Exchange Act of 1934 and also set out claims for breach of fiduciary duty, contribution and indemnification, aiding and abetting,
and gross mismanagement. Plaintiffs do not quantify any alleged injury, but seek damages, disgorgement, restitution, and other costs and
expenses. On January 24, 2023, the United States District Court for the Central District of California stayed the Koenig matter pending
resolution of the defendants’ anticipated motion to dismiss in the Securities Class Action Litigation. On April 4, 2023, the United
States District Court for the District of Delaware stayed the Solak matter pending resolution of the defendants’ anticipated motion
to dismiss in the Securities Class Action Litigation. On June 28, 2024, the United States District Court for the Central District of California
denied defendants’ motion to dismiss the Securities Class Action Litigation. On October 23, 2024, the court in the Koenig matter
stayed the case pending further order of the court. The parties’ deadline to file a joint status report in the Koenig matter
is January 10, 2025. On October 28, 2024, the court in the Solak matter stayed the case for ninety (90) days. The defendants
have not yet responded to either complaint. The Company intends to contest these matters but expresses no opinion as to the likelihood
of favorable outcomes. Management is unable to determine the likelihood of a loss, including a possible range of losses, if any, arising
from this matter as of the reporting date.
State Derivative Litigation. On October 20,
2022, Susan Midler filed a shareholder derivative action in the Superior Court of California, Los Angeles County, reciting similar underlying
facts as those alleged in the Securities Class Action Litigation. The action, filed on behalf of the Company, names Serhat Gümrükcü
and certain of the Company’s current and former directors as defendants. The action also names the Company as a nominal defendant.
The action sets out claims for breaches of fiduciary duty, contribution and indemnification, aiding and abetting, and gross mismanagement.
Plaintiff does not quantify any alleged injury, but seeks damages, disgorgement, restitution, and other costs and expenses. On January
20, 2023, the Court stayed the Midler matter pending resolution of the defendants’ anticipated motion to dismiss in the Securities
Class Action Litigation. On June 28, 2024, the United States District Court for the Central District of California denied defendants’
motion to dismiss the Securities Class Action Litigation. On October 28, 2024, the court in the Midler matter stayed the case for ninety
(90) days. The defendants have not yet responded to the complaint. The Company intends to contest this matter but expresses no opinion
as to the likelihood of a favorable outcome. Management is unable to determine the likelihood of a loss, including a possible range of
losses, if any, arising from this matter as of the reporting date.
33
On October
21, 2022, the Company filed a Complaint in the Superior Court of the State of California for the County of Los Angeles against Serhat
Gümrükcü, William Anderson Wittekind (“Wittekind”), G Tech Bio, SG & AW Holdings, LLC, and SRI (collectively,
the “Defendants”). The Complaint alleges that the Defendants engaged in a “concerted, deliberate scheme to alter, falsify,
and misrepresent to the Company the results of multiple studies supporting its Hepatitis B and SARS-CoV-2/influenza pipelines.”
Specifically, “Defendants manipulated negative results to reflect positive outcomes from various studies, and even fabricated studies
out of whole cloth.” As a result of the Defendants’ conduct, the Company claims that it “paid approximately $25 million
to Defendants and third-parties that it would not otherwise have paid.” On April 21, 2023, defendants Wittekind, G Tech, SG &
AW Holdings, LLC, and SRI filed a demurrer with respect to some, but not all, of the Company’s claims, as well as a motion to strike.
On September 6, 2023, the court denied in part and granted in part the pending motions. On September 7, 2023, the court entered a case
management order setting the final status conference, trial, and other intervening deadlines.
On December
4, 2023, the Defendants answered the Company’s First Amended Complaint and G Tech and SRI filed a Cross-Complaint. In the Cross-Complaint,
G Tech and SRI seek declaratory and injunctive relief related to certain agreements between G Tech, SRI, and the Company, including, inter
alia , a declaration that the Framework Agreement, effective as of November 15, 2019, the Statement of Work & License Agreement,
effective as of January 31, 2020, and the Statement of Work and License Agreement for Influenza and Coronavirus Indications, effective
as of April 18, 2021, have been terminated and the Company has no rights to any license under such agreements. Trial is currently scheduled
to begin on March 3, 2025. The Company denies these allegations and intends to vigorously defend against the cross claims while pursuing
its claims against the Defendants.
On March 1, 2021, the Company’s
former Chief Financial Officer, Robert Wolfe and his company, Crossfield, Inc., filed a Complaint in the U.S. District Court for the District
of Vermont against the Company, Renovaro Biosciences Denmark ApS, and certain directors and officers. In the Complaint, Mr. Wolfe and
Crossfield, Inc. asserted claims for abuse of process and malicious prosecution, alleging, inter alia, that the Company lacked probable
cause to file and prosecute an earlier action, and sought millions of dollars of compensatory damages, as well as punitive damages. The
allegations in the Complaint relate to an earlier action filed by the Company and Renovaro Biosciences Denmark ApS in the Vermont Superior
Court, Orange Civil Division. On March 3, 2022, the court partially granted the Company’s motion to dismiss, dismissing the abuse
of process claim against all defendants and all claims against Mark Dybul and Henrik Grønfeldt-Sørensen, the Company’s
former Chief Executive Officer and former member of the Board of Directors, respectively. On November 29, 2022, the Company filed a motion
for summary judgment with respect to the sole remaining claim of malicious prosecution. On August 24, 2023, the court denied the motion
for summary judgment. On November 7, 2024, the Court reset the trial date for May 6, 2025. The Company denies the allegations set forth
in the Complaint and will continue to vigorously defend against the remaining claim.
On June 7, 2023, Weird Science
LLC (“Weird Science”), Wittekind, the William Anderson Wittekind 2020 Annuity Trust, the William Anderson Wittekind 2021 Annuity
Trust, the Dybul 2020 Angel Annuity Trust, and the Ty Mabry 2021 Annuity Trust (collectively, the “Trusts”) (collectively,
“Plaintiffs”) filed a Verified Complaint against the Company in the Court of Chancery of Delaware. In the Verified Complaint,
Plaintiffs alleged that the Company breached the February 16, 2018 Investor Rights Agreement between the Company, Weird Science, and RS
Group ApS (the “Investor Rights Agreement”). According to the Verified Complaint, the Investor Rights Agreement required the
Company to (i) notify all “Holders” of “Registrable Securities” at least 30 days prior to filing a registration
statement and (ii) afford such Holders an opportunity to have their Registrable Securities included in such registration statement. Plaintiffs
alleged that the Company breached these registration rights by failing to provide the required notice in connection with S-3 registration
statements filed by the Company on July 13, 2020 and February 11, 2022. The Company moved to dismiss the Verified Complaint on September
15, 2023.
On December
4, 2023, in lieu of opposing the motion to dismiss, Plaintiffs filed a Verified First Amended Complaint (“FAC”). In the FAC,
Plaintiffs assert claims against the Company and others for purported breaches of the Investor Rights Agreement, fraud, tortious interference
with a contract, and several other torts. Plaintiffs seek compensatory, exemplary, and punitive damages, as well as certain declaratory
relief, specific performance, and pre- and post-judgment interest, costs, and attorneys’ fees. The Company filed a motion to dismiss
the FAC on December 18, 2023 and a hearing is scheduled for November 15, 2024. The Company denies Plaintiffs’ allegations and intends
to vigorously defend against the claims.
34
On August 24, 2023, counsel on
behalf of Weird Science, Wittekind, individually, and Wittekind, as trustee of the Trusts served a demand to inspect the Company’s
books and records (the “Demand”) pursuant to Delaware General Corporation Law, § 220 (“Section 220”). The
Demand seeks the Company’s books and records in connection with various issues identified in the Demand. The Company takes its obligations
under Section 220 seriously and, to the extent that the requests are proper under Section 220, intends to comply with those obligations.
On January 19, 2024, Weird Science
and Wittekind sent the Board of Directors a letter demanding it take corrective actions with respect to twenty-one issues identified therein.
On February 27, 2024, Weird Science and Wittekind sent the Board of Directors a supplemental letter that expanded their demand for corrective
actions to twenty-six issues. In response to these demand letters, the Board of Directors initially formed a Special Committee (“Special
Committee”) of independent directors on February 29, 2024. The Special Committee retained Stradling Yocca Carlson & Rauth LLP
as its counsel to investigate the issues identified in the demand letters. The Special Committee’s investigation is ongoing.
On January 23, 2024, Weird Science
and Wittekind filed a shareholder derivative action in the United States District Court for the Central District of California against
certain officers, directors, and investors of the Company, as well as other defendants, in connection with, inter alia , Weird Science
and Wittekind’s demand for corrective action. Plaintiffs filed an amended complaint on June 21, 2024. The First Amended Verified
Stockholder Derivative Complaint (“Derivative Complaint”) alleges, among other claims, violations of Section 13(d) and 14(a)
and Rules 10b-5(a), 10b-5(c) and 14a-9 of the Exchange Act of 1934. The Derivative Complaint also includes claims of breach of fiduciary
duty, corporate waste, unjust enrichment, and contribution/indemnification. Weird Science and Wittekind seek unspecified compensatory,
exemplary, and punitive damages and certain injunctive relief. The Derivative Complaint names the Company as a nominal defendant. On July
19, 2024, certain of the director defendants, who had agreed to waive service of the summons and Derivative Complaint, filed a motion
to dismiss the Derivative Complaint on a variety of procedural and substantive grounds. A hearing on the motion dismiss was held on October
3, 2024 and the court subsequently took the motion under submission. On October 22, 2024, the plaintiffs filed a notice of certain subsequent
events that they allege relate to their pending motion to dismiss. On October 29, 2024, the court granted the director defendants’
motion to dismiss and dismissed the Derivative Complaint without prejudice, but also without leave to amend.
On June 21, 2024, the Company filed
suit against Weird Science, Wittekind, and certain trusts in connection with the February 16, 2018 merger involving the Company and two
companies closely associated with Gumrukcu. In the complaint, the Company alleges that Gumrukcu and others deliberately and fraudulently
concealed a murder-for-hire scheme from the Company in order to induce the Company to enter into the merger agreement, which resulted
in the defendants receiving shares and compensation. The Company asserts claims for fraudulent concealment, equitable fraud, unjust enrichment,
and civil conspiracy and seeks, inter alia , equitable relief, including, but not limited to, return to the Company any shares received
in connection with the merger, and damages. On October 1, 2024, the defendants moved to dismiss the complaint.
Item 1A. Risk Factors.
As a “smaller
reporting company” as defined by Rule 12b-2 of the Securities Exchange Act of 1934, the Company is not required to provide the
information required by this Item.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Insider Trading Plans
During the quarter ended September 30, 2024, no director
or Section 16 officer adopted , modified, or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading
arrangement” (in each case, as defined in Item 408(a) of Regulation S-K).
35
Item 6. Exhibits.
Exhibits required by Item 601 of Regulation S-K:
Exhibit No.
Description
2.1
Second Amendment to Stock Purchase Agreement, dated February 13, 2024, by and among Renovaro Inc., GEDi Cube Intl Ltd., the sellers party thereto and Yalla Yalla Ltd. (incorporated by reference to Exhibit 2.1 to the Company’s Form 8-K filed with the SEC on February 14, 2024)
3.1
Certificate of Incorporation, as amended (incorporated by reference to Exhibit 3.1 to the Company’s Form 10-Q filed with the SEC on February 14, 2024)
3.2
Amended and Restated Bylaws (incorporated herein by reference to Exhibit 3.1 to Form 8-K filed with the SEC on May 24, 2024)
4.1
Registration Rights Agreement (incorporated by reference to Exhibit 4.1 to the Company’s Form 8-K filed with the SEC on February 14, 2024)
4.2
Form of Warrant (incorporated herein by reference to Exhibit 4.1 to the Company’s Form 8-K filed with the SEC on June 21, 2024)
10.1
Form of Subscription Agreement (incorporated herein by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on June 21, 2024)
10.2**
Employment Agreement by and between David Weinstein and Renovaro Inc., dated as of October 14, 2024.
31.1**
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934
31.2**
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934
32.1***
Certification of Principal Executive Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350
32.2***
Certification of Chief Financial Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350
101.INS
XBRL Instance Document
101.SCH
XBRL Taxonomy Extension Schema
101.CAL
XBRL Taxonomy Extension Calculation Linkbase
101.DEF
XBRL Taxonomy Extension Definition Linkbase
101.LAB
XBRL Taxonomy Extension Label Linkbase
101.PRE
XBRL Taxonomy Extension Presentation Linkbase
**
Filed herewith.
***
Furnished herewith.
36
SIGNATURES
Pursuant to the requirements of
Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
Date: November 14, 2024
RENOVARO INC.
By:
/s/ David Weinstein
David Weinstein
Chief Executive Officer
(Principal Executive Officer)
By:
/s/ Simon Tarsh
Simon Tarsh
Interim Chief Financial Officer
(Principal Financial and Accounting Officer)
37
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.