SEC Comment Letter 0000000000-23-006513 to Apogee Therapeutics, Inc. (APGE) (CIK 0001974640) (APGE)
Apogee Therapeutics, Inc. (APGE) (CIK 0001974640)
Date: June 16, 2023 · CIK: 0001974640 · Accession: 0000000000-23-006513
AI Filing Summary & Sentiment
Letter
United States securities and exchange commission logo June 16, 2023 Michael Henderson, M.D. Chief Executive Officer Apogee Therapeutics, LLC 221 Crescent St., Building 17, Suite 102b Waltham, MA 02453 Re:Apogee Therapeutics, LLC Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted June 5, 2023 CIK No. 0001974640 Dear Michael Henderson: 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 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. DRS/A Prospectus Summary, page 1 1.Stating, implying or predicting that your product candidates are safe, effective or will be approved is not appropriate. Only the FDA or equivalent foreign government entity have the authority to determine that a product candidate is safe and/or effective. Please delete your statements that APG777 and APG808 have "the potential for significantly improved dosing over standard of care," as they inappropriately assume the product candidates are effective.
FirstName LastNameMichael Henderson, M.D. Comapany NameApogee Therapeutics, LLC June 16, 2023 Page 2 FirstName LastName Michael Henderson, M.D. Apogee Therapeutics, LLC June 16, 2023 Page 2
2.We note your response to comment 5 and continue to object to the predicted timing of your Phase 2 trials in instances when your Phase 1 trials have not yet begun. These predictions make assumptions about the INDs related to your Phase 1and 2 trials, the results of your Phase 1 trials, enrollment in your Phase 1 trials and potential delays, or lack of delays in clinical trials. Given the assumptions inherent in these predictions, we continue to object to the predicted timing of your Phase 2 trials. Please revise your disclosure and pipeline table accordingly. Our Pipeline , page 3 3.Please revise your pipeline table to use the column heading "preclinical," rather than "IND-Enabling." Preclinical is a term the FDA uses in discussing the phases of drug development. Additionally, while all IND-Enabling studies are preclinical, not all preclinical trials are sufficient to be considered IND-Enabling. 4.We note that your pipeline table has been amended to extend the blue area across the entire preclinical column for the indications related to atopic dermatitis and asthma. Please confirm that all preclinical trials in this area have been completed. Cell Line License Agreement - WuXi Biologics (Hong Kong) Limited, page 110 5.Please revise your disclosure to quantify the low six figure license fee. You may contact Tracie Mariner at 202-551-3744 or Daniel Gordon at 202-551-3486 if you have questions regarding comments on the financial statements and related matters. Please contact Arzhang Navai at 202-551-4676 or Suzanne Hayes at 202-551-3675 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Melanie Neary
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United States securities and exchange commission logo
June 16, 2023
Michael Henderson, M.D.
Chief Executive Officer
Apogee Therapeutics, LLC
221 Crescent St., Building 17, Suite 102b
Waltham, MA 02453
Re:Apogee Therapeutics, LLC
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted June 5, 2023
CIK No. 0001974640
Dear Michael Henderson:
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 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.
DRS/A
Prospectus Summary, page 1
1.Stating, implying or predicting that your product candidates are safe, effective or will be
approved is not appropriate. Only the FDA or equivalent foreign government entity have
the authority to determine that a product candidate is safe and/or effective. Please delete
your statements that APG777 and APG808 have "the potential for significantly improved
dosing over standard of care," as they inappropriately assume the product candidates are
effective.
FirstName LastNameMichael Henderson, M.D.
Comapany NameApogee Therapeutics, LLC
June 16, 2023 Page 2
FirstName LastName
Michael Henderson, M.D.
Apogee Therapeutics, LLC
June 16, 2023
Page 2
2.We note your response to comment 5 and continue to object to the predicted timing of
your Phase 2 trials in instances when your Phase 1 trials have not yet begun. These
predictions make assumptions about the INDs related to your Phase 1and 2 trials, the
results of your Phase 1 trials, enrollment in your Phase 1 trials and potential delays, or
lack of delays in clinical trials. Given the assumptions inherent in these predictions, we
continue to object to the predicted timing of your Phase 2 trials. Please revise your
disclosure and pipeline table accordingly.
Our Pipeline , page 3
3.Please revise your pipeline table to use the column heading "preclinical," rather than
"IND-Enabling." Preclinical is a term the FDA uses in discussing the phases of drug
development. Additionally, while all IND-Enabling studies are preclinical, not all
preclinical trials are sufficient to be considered IND-Enabling.
4.We note that your pipeline table has been amended to extend the blue area across the
entire preclinical column for the indications related to atopic dermatitis and asthma.
Please confirm that all preclinical trials in this area have been completed.
Cell Line License Agreement - WuXi Biologics (Hong Kong) Limited, page 110
5.Please revise your disclosure to quantify the low six figure license fee.
You may contact Tracie Mariner at 202-551-3744 or Daniel Gordon at 202-551-3486 if
you have questions regarding comments on the financial statements and related matters. Please
contact Arzhang Navai at 202-551-4676 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Melanie Neary