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United States securities and exchange commission logo
June 3, 2021
Thomas Zindrick, J.D.
President and Chief Executive Officer
Genelux Corporation
3030 Bunker Hill Street, Suite 300
San Diego, CA 92109
Re: Genelux Corporation
Draft Registration
Statement on Form S-1
Submitted May 7,
2021
CIK No. 0001231457
Dear Mr. Zindrick:
We have reviewed your draft registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so
we may better
understand your disclosure.
Please respond to this letter by providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. If you do not believe our comments apply to your facts and
circumstances or do not
believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Draft Registration Statement on Form S-1 Submitted May 7, 2021
Prospectus Summary
Overview, page 1
1. We note your disclosure
here and elsewhere implying safety and efficacy of your product
candidates, although
none of your candidates have received regulatory approval to
date. As determinations
of safety and efficacy are solely within the authority of the U.S.
Food and Drug
Administration (FDA) and comparable regulatory bodies, please revise
your disclosure
throughout the prospectus to remove all claims of safety and efficacy.
Note that we will not
object to a discussion of objective data resulting from your trials
without safety and
efficacy conclusions.
Thomas Zindrick, J.D.
Genelux Corporation
June 3, 2021
Page 2
2. Please revise the arrows in the pipeline table on pages 2 and 98 to
accurately reflect where
each product candidate currently stands in development and eliminate
any implications of
completed phases or steps that have not yet occurred. Please also
clarify your rights and
responsibilities under the joint venture agreement with respect to
your pancreatic cancer
program.
3. Please revise your discussion of V2ACT Immunotherapy and the pipeline
table on page 2
to clearly disclose that no clinical trial is currently scheduled to
be initiated, consistent
with your disclosure on page 16. Please also include similar
disclosure in the Business
section.
4. We note your plan to submit an amendment to your IND application in
the second
quarter of 2021 and obtain FDA authorization to initiate a
registrational Phase 3 trial of
Olvi-Vec in PRROC in the second half of 2021. Please provide balancing
disclosure that
you must demonstrate comparability of product manufactured under your
updated process
to the product used in the Phase 2 trial, as you state on page 18,
disclose why you plan to
submit an amendment to your IND, and clarify whether you have
discussed with the FDA
the potential of your Phase 3 clinical trial to serve as a
registrational trial.
5. We note that you identify certain entities as investors in your
company; however, they do
not appear to be among your principal stockholders as disclosed on
page 177. If material,
please expand your disclosure to describe the nature of each named
entity's investment in
you and explain to us why including this information is appropriate.
Please also explain in
your response your plans to update investors about any changes these
entities make with
respect to their investments in the company.
Implications of Being an Emerging Growth Company and Smaller Reporting Company,
page 4
6. Please supplementally provide us with copies of all written
communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to
do so on your behalf,
present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
not they retain copies of the communications.
Risk Factors, page 10
7. Please include a risk factor discussing the material risks related to
your default on notes
payable and convertible notes payable in the aggregate amount of $1.8
million.
Public health crises such as pandemics, including the COVID-19 pandemic...,
page 62
8. We note your disclosure about potential disruptions due to the COVID-19
pandemic. To
FirstName LastNameThomas Zindrick, J.D.
the extent you have experienced delays in clinical trials, difficulties
enrolling new
Comapany NameGenelux
participants, Corporation
participants terminating their participation, or any other
disruptions, please
revise the discussion
June 3, 2021 Page 2 to describe the events and their potential
impact.
FirstName LastName
Thomas Zindrick, J.D.
FirstName LastNameThomas Zindrick, J.D.
Genelux Corporation
Comapany
June 3, 2021NameGenelux Corporation
June 3,
Page 3 2021 Page 3
FirstName LastName
Use of Proceeds, page 80
9. Please revise the discussion to separately identify the amounts you
intend to allocate to
each of your product candidate's indications and identify the stage of
development you
expect to achieve with the proceeds of the offering for each. To the
extent you expect to
begin particular stage of development but do not expect to complete
it, please indicate that
you will need to raise additional funding to complete that stage of
development.
10. We note your plan to pay outstanding accounts payable and accrued
liabilities with the
offering proceeds. Please revise here to more specifically discuss any
debts you plan to
extinguish. Refer to Instruction 4 to Item 504 of Regulation S-K.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation, page 95
11. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the initial public offering and the estimated offering price.
This information will help
facilitate our review of your accounting for equity issuances. Please
discuss with the staff
how to submit your response.
Business, page 97
12. We note your disclosure that you formed V2ACT Therapeutics, LLC, a
joint venture with
TVAX Biomedical Inc., in January 2019. Please expand your disclosure
to discuss your
accounting policy for the joint venture, and if material, provide the
disclosures required by
the applicable authoritative accounting guidance.
Business
Overview, page 97
13. Please provide a brief summary of the RECIST rules and criteria
referenced throughout
the Business section.
Clinical Development of Olvi-Vec, page 104
14. We note your disclosure on page 21 that you previously conducted five
Phase 1 clinical
studies and one Expanded Access Program in different indications,
using different routes
of administration, and different dosing regimens. For the clinical
trials discussed in this
section, please disclose the indication, endpoints, dates of the
trials; the number of
patients, duration of treatment, dosage information, any serious
adverse events that were
experienced, including the number of patients experiencing SAEs, and
whether the trial
achieved its primary endpoint. Please also disclose why you are no
longer
continuing development in the previous indications.
Thomas Zindrick, J.D.
Genelux Corporation
June 3, 2021
Page 4
V2ACT Therapeutics, LLC, page 124
15. Please expand your disclosure to describe the material rights and
obligations of each party
to the joint venture agreement, including a discussion of how the
profits, losses, votes and
expenses of the joint venture are allocated between the parties.
Financial Statements
Balance Sheets, page F-3
16. We note that you are in default of convertible notes payable to
shareholders in the amount
of $1,755 at December 31, 2020. Please expand your disclosure in the
section of
Liquidity and Capital Resources in your Management's Discussion and
Analysis of
Financial Condition and Results of Operations to discuss the nature of
the loan violations
and your remediation plan. Refer to Section 501.03.a of the Financial
Reporting
Codification for additional guidance.
You may contact Tracie Mariner at 202-551-3744 or Vanessa Robertson at
202-551-3649
if you have questions regarding comments on the financial statements and
related
matters. Please contact Jeffrey Gabor at 202-551-2544 or Laura Crotty at
202-551-7614 with
any other questions.
Sincerely,
FirstName LastNameThomas Zindrick, J.D.
Division of
Corporation Finance
Comapany NameGenelux Corporation
Office of Life
Sciences
June 3, 2021 Page 4
cc: Amy Hallman Rice, Esq.
FirstName LastName