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United States securities and exchange commission logo
November 3, 2020
Jay Short, Ph.D.
Chairman and Chief Executive Officer
BioAtla, Inc.
11085 Torreyana Road
San Diego, CA 92121
Re: BioAtla, Inc.
Draft Registration
on Form S-1
Submitted on
October 6, 2020
CIK No. 0001826892
Dear Dr. Short:
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
Overview, page 1
1. We note statements
throughout the prospectus that imply efficacy, such as "[y]our
approach affords the
necessary targeting and potency required for cancer cell
destruction," the
"tumor-selective activity markedly improves both safety and efficacy of
antibodies against a
wide range of targets by widening the therapeutic window, or the
possibility for a more
effective therapy," that your "CAB technology is validated," that
"TmPS, . . . appears to
correlate with achievement of clinical response," that you "have
developed CAB
antibodies with specificity for tumors, while avoiding binding to the same
antigen target
expressed on many normal tissues," and that you have "invented, developed
and refined this
technology so that you can effectively and selectively activate proteins
Jay Short, Ph.D.
FirstName LastNameJay Short, Ph.D.
BioAtla, Inc.
Comapany 3,
November NameBioAtla,
2020 Inc.
November
Page 2 3, 2020 Page 2
FirstName LastName
and antibodies in the tumor microenvironment." Please revise your
disclosure throughout
your prospectus to revise these and similar statements to eliminate
conclusions or
predictions that your product candidates are effective as
determinations of efficacy are
solely within the authority of the FDA. You may provide a summary of
the data that you
used to draw these conclusions, and such discussion is more
appropriate in the Business
section where full and proper context can be provided.
2. Additionally, we note your disclosure that you you have observed "an
improved
therapeutic window relative to non-CAB products." Please refrain from
making such
comparisons unless you have conducted head to head trials.
3. We note your disclosure that you have initiated potentially
registration-enabling Phase 2
trials for your two latest stage ADC product candidates
BA3011(targeting AXL) and
BA3021 (targeting ROR2) in multiple cancer indications. Please provide
balancing
disclosure that the the FDA has not opined on whether the Phase 2
clinical trials will in
fact be sufficient to support regulatory approval, as you state on
page 17, and that there
can be no assurance that that the FDA will agree that such data will
be sufficient to
support approval. Please also provide similar disclosure in your
summary risk factor
section.
4. We note your disclosure on page 25 that you have developed a
quantitative biomarker
assay called the Tumor membrane Percent Score, which measures
expression levels of
AXL and ROR2 on the tumor membrane and cytoplasm. Please provide a
brief
explanation of the TmPS with respect to AXL and ROR2 and your use of
such predictive
biomarkers in connection with your Phase 2 trials.
Our Pipeline, page 3
5. We note that you have included in your pipeline table your bispecific
antibody programs,
which appear to be pre-clinical. Given their materiality, please
expand your disclosure on
pages 142-143 to provide a more fulsome discussion of these programs.
Alternatively,
remove tany programs that are not currently material from your
pipeline table..
Additionally, we note your disclosure that you have advanced two CAB
bispecific
antibody product candidates into investigational new drug, or IND,
enabling studies in the
second half of 2020. However, based on your pipeline table it appears
that all four
programs are in IND enabling studies. Please revise the arrows to
appropriately reflect
whether the programs are in discovery or the IND enabling studies
phase.
6. We note your completed clinical trials relate to some, but not all of
the stated indications.
Please explain your basis for depicting the development status with
respect to indications
that have not been subject to clinical trials. For example, you
include Ovarian Cancer in
the indication column, however, it does not appear that you have
initiated Phase 2 trials
for BA3011 or BA3021 for the treatment of Ovarian Cancer.
Our Strengths, page 5
Jay Short, Ph.D.
FirstName LastNameJay Short, Ph.D.
BioAtla, Inc.
Comapany 3,
November NameBioAtla,
2020 Inc.
November
Page 3 3, 2020 Page 3
FirstName LastName
7. We note your statement that your CAB technology is "validated by
robust clinical Phase
I data from our two leading clinical programs." Additionally, your
disclosures beginning
on page 111 indicate you a correlation between a proprietary biomarker
and antitumor
activity and antitumor responses resulting from treatment. Generally,
the purpose Phase I
trials are to measure collect data related to safety and dosing. To
the extent the trials you
have conducted to date were designed to measure and collect data about
efficacy, please
expand the description of the trials appearing in your business
section to quantify the
number of participants, describe the trails endpoints, and summarize
all the results from
the trials, including the p values. Alternatively, if the Phase I
trials were not designed to
measure and collect information about efficacy relative to trial
endpoints, the statements
about efficacy appear anecdotal and not appropriate to include in your
filing.
Risks associated with our business, page 6
8. We note your disclosure on page 25 that if the AXL and ROR2 TmPS
scores prove to be a
useful method for patient selection, you expect to incorporate the
specific diagnostic test
into your registrational studies and partner with the appropriate
diagnostic provider to
codevelop a companion diagnostic. Please add a bullet point explaining
that if use of any
of your product candidates, such as BA3011 and BA3021, depends on a
companion
diagnostic test then the FDA generally will require approval or
clearance of that
companion diagnostic, at the same time that the FDA approves your
product candidates,
as you state on page 25.
Implications of being an emerging growth company . . ., page 8
9. Please 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
Risks related to our common stock and this offering
We are an emerging growth company and , page 70
10. We note that you elected to take advantage of the extended transition
period for
complying with new or revised accounting standards under Section
102(b)(1) of the JOBS
Act. Please expand your risk factor to also state that, as a result of
this election, your
financial statements may not be comparable to companies that comply
with public
company effective dates.
Market, industry and other data, page 77
11. We note your statement that industry publications and third-party
research, surveys and
studies generally indicate that their information has been obtained
from sources believed
Jay Short, Ph.D.
FirstName LastNameJay Short, Ph.D.
BioAtla, Inc.
Comapany 3,
November NameBioAtla,
2020 Inc.
November
Page 4 3, 2020 Page 4
FirstName LastName
to be reliable, although they do not guarantee the accuracy or
completeness of such
information and that no independent source has verified such
assumptions. These
statements appear to imply a disclaimer of responsibility for this
information in the
registration statement. Please either delete this statement or
specifically state that you are
liable for the information related to the market and industry data.
LLC Conversion, page 81
12. We note that on July 10, 2020, the Company completed a corporate
reorganization. Please
revise this section to clearly identify the Company's current
organizational structure.
Include a diagram showing the Company and its subsidiaries and
indicate the respective
capital structure (e.g. outstanding preferred stock and debt). We also
note that on page F-
9, the Company has certain entities that it considers to be variable
interest entities. Please
also include such entities.
Capitalization, page 82
13. We noted that you have issued warrants in connection with certain
advisory services the
fair value of which will be vest upon the completion of your public
offering. Please tell us
why this compensation is not reflected as a pro-forma adjustment to
your accumulated
deficit in the capitalization table.
Unaudited Pro Forma Condensed Consolidated Financial Information, page 89
14. Following the Division, it appears that you have succeeded to the
remaining business
of BioAtla, LLC that was not transferred to BA Holdings or Inversagen,
LLC and that you
had no prior operations before succession. In this regard, please tell
us why audited
financial statements and related disclosures of BioAtla, LLC as your
predecessor through
the acquisition date are not required under Article 8 of Regulation
S-X through the date of
acquisition along with pro forma financial information giving effect
to the "Division"
under Article 11 of Regulation S-X.
Management s Discussion and Analysis
Research and Development Expense, page 100
15. Please disclose for each period presented the amount of research and
development
expense incurred for each of your lead product candidates . To the
extent that you do not
track expenses by product candidate, please disclose that fact and
explain why you do not
maintain and evaluate research and development costs by project.
CAB leverages the low pH found in the tumor microenvironment, page 118
16. Please expand your disclosure on page 118 to explain how to interpret
the color key
located to the right of the tumor heat map graphic. Please also
explain how to interpret the
the bullet point list of percentages to the right of the graphic.
BA3011 Phase 1 clinical trial, page 129
Jay Short, Ph.D.
FirstName LastNameJay Short, Ph.D.
BioAtla, Inc.
Comapany 3,
November NameBioAtla,
2020 Inc.
November
Page 5 3, 2020 Page 5
FirstName LastName
17. We note your disclosure that based upon the overall safety and
response rates, the
recommended Phase 2 dose is 1.8 mg/kg delivered every two weeks.
Please provide a
description of how the phase 1 trial was conducted, including the
total number of patients
enrolled, number of patients dosed in each cohort, the doses
administered within the
range, and the number of patients with each type of solid tumor (e.g.
sarcoma, pancreatic,
NSCLC). Please provide similar disclosure on page 135 with respect to
the BA 3021
Phase 1 trial.
Safety, page 134
18. Please revise to define on-target toxicity has been identified to date
in patients that
received BA 3011 during the Phase 1 trial. Please provide similar
disclosure on page
139 with respect to the BA3021 Phase 1 trial.
19. We note that you include cross-trial comparisons regarding toxicities
observed for other
non-CAB ADCs. Please disclose why you believe this comparison is
appropriate. If you
provide disclosure regarding results from other trials, expand your
disclosure to provide
the other information regarding these trials that would help an
investor make a meaningful
comparison (e.g, number of patients, dosage, types cancers associated
with the patients
enrolled, etc.)
20. We note that you disclose the treatment related SAE's observed at the
anticipated Phase 2
does level. Please describe all all SAE's observed in the Phase 1
trial for BA3011 and
provide similar disclosure on page 139 with respect to the BA3021
Phase 1 trial.
Clinical development plans, page 135
21. Please expand your discussion of the graphical illustration on page
135 to more clearly
explain the Company's clinical development plan for BA 3011. Please
provide similar
disclosure for the graphical illustration on page 140 with respect to
the Company's clinical
development plan for BA3021.
Global Co-Development and Collaboration Agreement with BeiGene, Ltd., page 146
22. Please revise your summary of the Global Co-Development and
Collaboration Agreement
with BeiGene, Ltd. to disclose the term of the agreement and the
royalty term as well as a
summary of the termination provisions under the agreement.
23. We note that the Company has also entered into license agreements with
Himalaya
Therapeutics SEZC, Inversagen, LLC, and F1 Oncology Inc. Please
include a summary of
the material terms associated with each of these agreements. .
Intellectual Property, page 147
24. We note your disclosure that as of September 1, 2020, you have 474
patents and patent
applications with 254 issued, 7 allowed applications and 213 pending
applications. Please
Jay Short, Ph.D.
BioAtla, Inc.
November 3, 2020
Page 6
expand your disclosure to include the specific technologies to which
such patents relate,
the type of patent protection, the patent expiration dates and the
applicable jurisdictions.
25. We note your disclosure on page F-9 that the Company's VIE, HTKY,
holds intellectual
property related to certain CAB Antibodies and is seeking a funding
partner to further
develop this intellectual property. Please revise to clarify whether
any patents or other
intellectual property are held by entities other than the Company.
Principal Stockholders, page 195
26. Please revise to identify the natural persons with voting and/or
dispositive control of the
shares held by Pfizer Ventures (US) LLP, Soleus Private Equity Fund I,
L.P., HBM
Healthcare Investments (Cayman) Ltd. in footnotes 2, 3, and 4 to the
principal stockholder
table.
Notes to Consolidated Financial Statements
1. Organization and Summary of Significant Accounting Policies
Organization, page F-7
27. Please expand your discussion of BioAtla, LLC's (the Predecessor)
business prior to the
"Division" and whether there are any continuing operations.
Variable Interest Entities, page F-8
28. Please clearly identify all of the entities you consider to be a
Variable Interest Entity and
provide the disclosures requiredby ASC 810-10-50, as applicable. For
example, you have
identified Inversagen and F1 Oncology to be a variable interest
entity.
Exhibits
29. Please file the promissory note evidencing the Company's PPP loan as
an exhibit to the
registration statement, pursuant to Item 601(b)(10) of Regulation S-K.
Alternatively,
please explain to us why such disclosure is not appropriate.
You may contact Nudrat Salik at 202-551-3692 or Sasha Parikh at 202-3627
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Deanna Virginio at 202-551-4530 or Suzanne Hayes at 202-551-3675 with any other
questions.
FirstName LastNameJay Short, Ph.D. Sincerely,
Comapany NameBioAtla, Inc.
Division of
Corporation Finance
November 3, 2020 Page 6 Office of Life
Sciences
FirstName LastName