SEC Comment Letter for KALA BIO, Inc. (KALA) (CIK 0001479419) (KALA) — Apr 26, 2017
KALA BIO, Inc. (KALA) (CIK 0001479419)
Date: April 26, 2017 · CIK: 0001479419 · Accession: 0000000000-17-014456
AI Filing Summary & Sentiment
Reasoning
Letter
Mail Stop 4546 April 26, 2017 Mark Iwicki Chief Executive Officer Kala Pharmaceuticals, Inc. 100 Beaver Street, Suite 201 Waltham, MA 02453
Re: Kala Pharmaceuticals, Inc. Amendment No. 3 to Draft Registration Statement on Form S-1 Submitted March 30, 2017 CIK No. 0001479419
Dear Mr. Iwicki :
We have reviewed your amended 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 circum stances 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.
Prospectus Summary Overview, page 1
1. At their first use, please describe the meaning of strabismus, viteoretinal and prostaglandins.
Our Product Candidates, page 2
2. Please revise your pipeline chart on page to clearly illustra te that you are continuing to conduct phase 3 trials related to post -operative inflammation and pain following surgery and the temporary relief of the signs and symptoms of dry eye disease. It is not visually clear from the horizontal bar that you are con tinuing to conduct phase 3 trials.
Mark Iwicki Kala Pharmaceuticals, Inc. April 26, 2017 Page 2
3. We refer to your statement on page 2 that KPI -121 1.0% has a “favorable safety and tolerability” profile, your similar statement for KP -121 0.25% on page 3, and similar disclosures elsewhere. While we will not object to a statement that your drug candidate was well tolerated, a safety determination is solely within the FDA’s authority. Please remove the statement that the study results displayed a favorable safety profile or trials demonstrated or established safety.
4. Please limit the summary discussion of your results to whether the candidate met the primary end points, the description of the primary endpoints and disclosure of any serious adverse effects. Your discussion of p values is more appropriate for the Business discussion, where you should also discuss the meaning of these values and how they relate to the FDA’s evidentiary standards of efficacy.
5. We refer to your statement on page 3 that if approved, KPI -121 0.25% could be the first product providing “temporary relief” for the signs and symptoms of dry eye disease. However, we also note that you state that the prescription product Xiidra treats the signs and symptoms of dry eye disease. Please further explain why your product differs from Xiidra, and also that Xiidra is dosed only twice a day.
Risks Associated with Our Business, page 4
6. Please expand your disclosure in the penultimate bullet in this section to also discuss that you are aware of a third party European patent that may limit your ability to devel op and commercialize KPI -121 0.25% for the treatment of dry eye disease in Europe without a license.
Business Our Product Candidates, page 83
7. We refer to your disclosures on pages 83 and 84 regarding a clinician survey of 73 ophthalmologists and optometr ists, and a survey of 30 patients with dry eye disease commissioned by you. Please clarify whether the surveys were conducted by a third party for use in the registration statement. If they were conducted by a third party, identify the party and file a c onsent pursuant to Rule 436 of the Securities Act. In addition, please provide additional details regarding the surveys so that an investor may understand their significance, including what information regarding the product candidates were provided to tho se surveyed, and how the surveyed clinicians and patients were selected. Please also provide balancing disclosure regarding the limited number of those surveyed, and delete references to these surveys from your Summary.
Mark Iwicki Kala Pharmaceuticals, Inc. April 26, 2017 Page 3
You may contact Mark Brunhofer at (202) 551 -3638 or James Rosenberg at (202) 551 - 3679 if you have questions regarding comments on the financial statements and related matters. Please contact Dorrie Yale at 202 -551-8776 or me at 202 -551-3675 with any other questions.
Sincerely,
/s/ Mary Beth Breslin for
Show Raw Text
Mail Stop 4546
April 26, 2017
Mark Iwicki
Chief Executive Officer
Kala Pharmaceuticals, Inc.
100 Beaver Street, Suite 201
Waltham, MA 02453
Re: Kala Pharmaceuticals, Inc.
Amendment No. 3 to Draft Registration Statement on Form S-1
Submitted March 30, 2017
CIK No. 0001479419
Dear Mr. Iwicki :
We have reviewed your amended 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 circum stances 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.
Prospectus Summary
Overview, page 1
1. At their first use, please describe the meaning of strabismus, viteoretinal and
prostaglandins.
Our Product Candidates, page 2
2. Please revise your pipeline chart on page to clearly illustra te that you are continuing to
conduct phase 3 trials related to post -operative inflammation and pain following surgery
and the temporary relief of the signs and symptoms of dry eye disease. It is not visually
clear from the horizontal bar that you are con tinuing to conduct phase 3 trials.
Mark Iwicki
Kala Pharmaceuticals, Inc.
April 26, 2017
Page 2
3. We refer to your statement on page 2 that KPI -121 1.0% has a “favorable safety and
tolerability” profile, your similar statement for KP -121 0.25% on page 3, and similar
disclosures elsewhere. While we will not object to a statement that your drug candidate
was well tolerated, a safety determination is solely within the FDA’s authority. Please
remove the statement that the study results displayed a favorable safety profile or trials
demonstrated or established safety.
4. Please limit the summary discussion of your results to whether the candidate met the
primary end points, the description of the primary endpoints and disclosure of any serious
adverse effects. Your discussion of p values is more appropriate for the Business
discussion, where you should also discuss the meaning of these values and how they
relate to the FDA’s evidentiary standards of efficacy.
5. We refer to your statement on page 3 that if approved, KPI -121 0.25% could be the first
product providing “temporary relief” for the signs and symptoms of dry eye disease.
However, we also note that you state that the prescription product Xiidra treats the signs
and symptoms of dry eye disease. Please further explain why your product differs from
Xiidra, and also that Xiidra is dosed only twice a day.
Risks Associated with Our Business, page 4
6. Please expand your disclosure in the penultimate bullet in this section to also discuss that
you are aware of a third party European patent that may limit your ability to devel op and
commercialize KPI -121 0.25% for the treatment of dry eye disease in Europe without a
license.
Business
Our Product Candidates, page 83
7. We refer to your disclosures on pages 83 and 84 regarding a clinician survey of 73
ophthalmologists and optometr ists, and a survey of 30 patients with dry eye disease
commissioned by you. Please clarify whether the surveys were conducted by a third
party for use in the registration statement. If they were conducted by a third party,
identify the party and file a c onsent pursuant to Rule 436 of the Securities Act. In
addition, please provide additional details regarding the surveys so that an investor may
understand their significance, including what information regarding the product
candidates were provided to tho se surveyed, and how the surveyed clinicians and patients
were selected. Please also provide balancing disclosure regarding the limited number of
those surveyed, and delete references to these surveys from your Summary.
Mark Iwicki
Kala Pharmaceuticals, Inc.
April 26, 2017
Page 3
You may contact Mark Brunhofer at (202) 551 -3638 or James Rosenberg at (202) 551 -
3679 if you have questions regarding comments on the financial statements and related matters.
Please contact Dorrie Yale at 202 -551-8776 or me at 202 -551-3675 with any other questions.
Sincerely,
/s/ Mary Beth Breslin for
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Lia Der Marderosian, Esq.
Wilmer Cutler Pickering Hale and Dorr LLP