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Zentalis Pharmaceuticals, Inc.
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Zentalis Pharmaceuticals, Inc.
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Zentalis Pharmaceuticals, Inc.
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2024-10-10
Zentalis Pharmaceuticals, Inc.
References: September 12, 2024
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Zentalis Pharmaceuticals, Inc.
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2022-06-22
Zentalis Pharmaceuticals, Inc.
References: May 26, 2022
Zentalis Pharmaceuticals, Inc.
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Zentalis Pharmaceuticals, Inc.
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4 company response(s)
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2020-03-13
Zentalis Pharmaceuticals, Inc.
References: March 11, 2020
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2020-03-13
Zentalis Pharmaceuticals, Inc.
References: February 6, 2020
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-02 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2025-04-01 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | 333-286122 | Read Filing View |
| 2024-10-17 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | 001-39263 | Read Filing View |
| 2024-10-10 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2024-09-12 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | 001-39263 | Read Filing View |
| 2022-06-29 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2022-06-22 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2022-06-09 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2022-05-26 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2022-05-12 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-07-27 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-07-27 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-07-14 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-03-31 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-03-31 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-03-13 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-03-13 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-03-11 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-02-11 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-01 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | 333-286122 | Read Filing View |
| 2024-10-17 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | 001-39263 | Read Filing View |
| 2024-09-12 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | 001-39263 | Read Filing View |
| 2022-06-29 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2022-06-09 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2022-05-12 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-07-14 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-03-11 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-02-11 | SEC Comment Letter | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-02 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2024-10-10 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2022-06-22 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2022-05-26 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-07-27 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-07-27 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-03-31 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-03-31 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-03-13 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
| 2020-03-13 | Company Response | Zentalis Pharmaceuticals, Inc. | N/A | N/A | Read Filing View |
2025-04-02 - CORRESP - Zentalis Pharmaceuticals, Inc.
CORRESP 1 filename1.htm Document Zentalis Pharmaceuticals, Inc. 10275 Science Center Dr., Suite 200 San Diego, California 92121 April 2, 2025 Via EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Zentalis Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed March 26, 2025 File No. 333-286122 To whom it may concern: Pursuant to Rule 461(a) under the Securities Act of 1933, as amended, Zentalis Pharmaceuticals, Inc. (the “ Company ”) hereby respectfully requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-286122) be accelerated by the Securities and Exchange Commission to 4:00 p.m., Washington D.C. time, on April 4, 2025 or as soon as practicable thereafter. The Company requests that we be notified of such effectiveness by a telephone call to Nathan Ajiashvili of Latham & Watkins LLP at (212) 906-2916 and that such effectiveness also be confirmed in writing. Very truly yours, Zentalis Pharmaceuticals, Inc. By: /s/ Julie Eastland Julie Eastland President and Chief Executive Officer cc: Andrea Paul, Zentalis Pharmaceuticals, Inc. Nathan Ajiashvili, Latham & Watkins LLP Salvatore Vanchieri, Latham & Watkins LLP
2025-04-01 - UPLOAD - Zentalis Pharmaceuticals, Inc. File: 333-286122
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 1, 2025 Julie Eastland Chief Executive Officer Zentalis Pharmaceuticals, Inc. 10275 Science Center Drive, Suite 200 San Diego, CA 92121 Re: Zentalis Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed March 26, 2025 File No. 333-286122 Dear Julie Eastland: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Tyler Howes at 202-551-3370 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Salvatore Vanchieri, Esq. </TEXT> </DOCUMENT>
2024-10-17 - UPLOAD - Zentalis Pharmaceuticals, Inc. File: 001-39263
October 17, 2024
Cam Gallagher
Interim Chief Financial Officer
Zentalis Pharmaceuticals, Inc.
1359 Broadway
Suite 801
New York, New York 10018
Re:Zentalis Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2023
Filed February 27, 2024
File No. 001-39263
Dear Cam Gallagher:
We have completed our review of your filings. We remind you that the company and
its management are responsible for the accuracy and adequacy of their disclosures,
notwithstanding any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2024-10-10 - CORRESP - Zentalis Pharmaceuticals, Inc.
CORRESP
1
filename1.htm
Document
October 10, 2024
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention: Ibolya Ignat
Angela Connell
Re: Zentalis Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2023
Filed February 27, 2024
File No. 001-39263
To the addressees set forth above:
Zentalis Pharmaceuticals, Inc. (“Zentalis” or the “Company”) hereby submits to the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) this letter setting forth the Company’s response to the comments contained in the Staff’s letter dated September 12, 2024 (the “Comment Letter”) regarding the Company’s Form 10-K for the fiscal year ended December 31, 2023. For ease of reference, each comment contained in the Comment Letter is printed in bold below and is followed by the Company’s response.
Form 10-Q or the Fiscal Quarter Ended June 30, 2024
Notes to Condensed Consolidated Financial Statements
3. Significant Transactions, page 12
1.Please explain to us how you applied your revenue recognition policy to the elements of the license agreement you entered into with Immunome, Inc., including references to the paragraphs within ASC 606 that support your accounting. Please also confirm that you will disclose your revenue recognition policy in future filings and provide us with a draft of your intended disclosure revisions.
Response: The Company respectfully acknowledges the Staff’s comment.
The Company entered into the license agreement (the “Immunome License Agreement”) and concurrent stock issuance agreement (the “Immunome Stock Issuance Agreement,” and together with the Immunome License Agreement, the “Immunome Agreements”) with Immunome, Inc. (“Licensee” or “Immunome”) in January 2024 with no subsequent amendments to the Immunome Agreements as of September 30, 2024. Per the Immunome License Agreement, the Company licensed to the Licensee an exclusive, worldwide, royalty-bearing, sublicensable license under certain intellectual property, including intellectual property associated with proprietary antibody-drug conjugate (“ADC”) platform technology,
Zentalis Pharmaceuticals, Inc. • 10275 Science Center Drive, Suite 200, San Diego, CA 92121 • 858.263.4333
ROR1 antibodies, and an ADC targeting ROR1, to exploit products covered by or incorporating the licensed intellectual property rights. The license includes pre-clinical development rights, development rights, commercial rights and a license to manufacture the product candidate. The Company was responsible for the timely transfer of know-how necessary or reasonably useful to exploit the technology to the Licensee. This transfer did not include any services by or on behalf of the Company.
To determine if the arrangement meets the definition of a collaborative arrangement, the Company referenced the guidance in ASC 808-10-20. As the arrangement did not involve a joint operating activity, the Company is no longer an active participant in the research and was no longer exposed to the significant risks and rewards of the research, management concluded the arrangement did not meet the definition of a collaborative arrangement. Management then referred to the guidance in ASC 606, Revenue from Contracts with Customers (ASC 606). To determine if the Licensee meets the definition of a customer, the Company referenced the guidance in ASC 606-10-15-3. As the Licensee did contract with the Company to obtain goods (a research and development platform, antibodies and rights) that are an output of the entity’s ordinary activities (research and development) in exchange for consideration, management determined that the Licensee meets the definition of a customer and recognized revenue by applying the steps outlined in ASC 606-10-05-4 to depict the transfer of promised goods to the customer in an amount that reflects the consideration to which the Company expects to be entitled.
In the first step of the analysis, management is required to identify the contracts with the customer using the guidance outlined in ASC 606-10-25-1. Management identified two contracts with the customer: the Immunome License Agreement and the Immunome Stock Issuance Agreement. As the Immunome Agreements were negotiated as a package with a single commercial objective and executed simultaneously, the contracts were accounted for as a single contract in accordance with ASC 606-10-25-9. No other written, oral or implied contracts preceded these agreements.
The second step of the analysis requires management to identify the material performance obligations in a contract with a customer in accordance with ASC 606-10-25-14. The guidance defines a performance obligation as (a) a good or service (or bundle of goods or services) that is distinct or (b) a series of distinct goods or services that are substantially the same and that have the same pattern of transfer to the customer. At the time of execution of the Immunome Agreements, the Company considered all the performance obligations included in the contract consisting of the license of intellectual property and transfer of know-how to determine whether they are distinct in accordance with ASC 606-10-25-18 through ASC 606-10-25-22. Based on the Company’s analysis, the Company concluded there to be a single performance obligation in accordance with ASC 606-10-55-56 since the Licensee cannot fully benefit from the exclusive license on its own, or with other resources readily available, without the transfer of know-how. The Immunome Agreements do not include any other significant ongoing performance obligations in the form of a joint steering committee or material transfer support.
After the contracts with the customer and performance obligations in the contract were determined, management performed the third step of the analysis requiring the determination of the transaction price as defined in ASC 606-10-32-2. The Company received upfront consideration in the form of $15.0 million in cash and 2,298,586 unregistered shares of the Licensee’s common stock and may receive material consideration in the form of development and regulatory milestones for platform products, sales milestones and royalties on commercial sales. At inception, all milestone payments are considered remote as they are based on future milestones not considered probable of achievement at the inception of the
2
contracts and were not included in the transaction price. The Company will determine the transaction price and recognize revenue for sales-based royalty payments in the period in which the sales occur under the sales-based royalty exception allowed under ASC 606-10-55-65. The unregistered share consideration of the Licensee contained a lock-up arrangement whereby the Company agreed that it would hold and not sell greater than 50% of the shares until the six-month anniversary of the transaction date. To value the shares, management considered the guidance in ASC 820-10-35-6B as subsequently clarified in ASU 2022-03 which states that, while the entity must be able to access the market, it does not need to be able to sell the particular asset on the measurement date to be able to measure fair value on the basis of the price in that market. As such, the fair value of the unregistered common stock received as of the transaction date was based on the closing stock price of the Licensee’s common stock on the transaction date of $11.12 per share, or $25.6 million for all shares received. The aggregate transaction price was determined to be $15.0 million in cash and $25.6 million in unregistered common stock, or $40.6 million in total.
In step four of the analysis, management is required to allocate the transaction price to the performance obligation in the contract. As only one material performance obligation was identified in step two of the analysis, all of the transaction price was allocated to the single performance obligation to transfer the license of intellectual property and transfer of know-how.
Finally, step five of the analysis supports the recognition of revenue when (or as) the entity satisfies a performance obligation by transferring control of the promised good(s) or service(s) to a customer. Such transfer of control can occur over time or at a point in time. To determine if the performance obligation to transfer the intellectual property and transfer of know-how is satisfied over time, management considered the guidance in ASC 606-10-25-27 and ASC 606-10-55-62. As the Immunome Agreements represent a right to use the functional intellectual property as it exists at the time of the Immunome Agreements and does not meet either of the criteria within ASC 606-10-55-62, the Company recognized the transaction price as revenue at the point in time that the transfer of control of the intellectual property and know-how occurred.
In future periodic reports filed with the Commission, the Company will provide the following revised disclosure to clarify its revenue recognition policy and the Immunome Agreements with Immunome:
Policy
Revenue Recognition and Collaborative Arrangements
The Company generates revenues from payments received under collaborative agreements and license agreements.
At contract execution, we analyze our collaborative arrangements and license agreements to assess whether both parties are active participants in the activities and are exposed to significant risks and rewards and therefore are within the scope of ASC 808, Collaborative arrangements (“ASC 808”). ASC 808 does not address the recognition and measurement of payments from collaborative arrangements and instead refers companies to use other authoritative accounting literature. For collaboration arrangements within the scope of ASC 808 that contain multiple elements, we first determine which elements of the collaboration reflect a vendor-customer relationship and therefore are within the scope of ASC 606,
3
Revenue from Contracts with Customers. When we determine elements of a collaboration agreement do not reflect a vendor-customer relationship, we consistently apply a reasonable and rational policy election we made by analogizing to authoritative accounting literature. We evaluate the income statement classification for presentation of amounts due from or owed to other participants in a collaboration arrangement based on the nature of each separate activity.
To determine revenue recognition for contracts with customers, we perform the following five steps: (i) identify the contract(s) with the customer; (ii) identify the performance obligations in the contract, including whether they are distinct in the context of the contract; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligations.
From time to time, we amend our agreements. When this occurs, we are required to assess (1) if the additional goods or services are distinct from the other performance obligations in the previous agreement(s) and (2) if the goods or services are transferred at a stand-alone selling price. If we conclude the goods and/or services in the amendment are distinct from the performance obligations in the original agreement and at a stand-alone selling price, we account for the amendment as a separate agreement. If we conclude the goods and/or services are not distinct and are sold at a stand-alone selling price, we then assess whether the remaining goods or services are distinct from those already provided. If the goods and/or services are distinct from what we have already provided, then we treat the amendment as a termination of the existing contract and allocate the total remaining transaction price from the original agreement and the additional transaction price from the amendment to the remaining goods and/or services. If the goods and/or services are not distinct from what we have already provided, we update the transaction price and allocate it to the remaining performance obligations and adjust revenue previously recognized based on an updated measure of progress for the partially satisfied performance obligations.
Footnote
Immunome
In January 2024, the Company and Immunome, Inc. (“Immunome”) entered into an exclusive, worldwide license agreement under which Immunome licensed from Zentalis ZPC-21, a preclinical ROR1 antibody-drug conjugate (“ADC”) and proprietary ADC technology platform (the “Immunome License Agreement”). Simultaneously, the Company and Immunome entered into a stock issuance agreement (the “Immunome Stock Issuance Agreement,” and together with the Immunome License Agreement, the “Immunome Agreements”). The upfront consideration from Immunome amounted to $40.6 million, which consisted of $15.0 million in cash and approximately 2.3 million shares (quantified using a 30-day volume average price) of Immunome stock valued at approximately $25.6 million on the date of acquisition and presented within marketable securities, available for sale on the condensed consolidated balance sheet. Changes to the fair value of the Immunome stock are recorded as a component of investment and other income, net within the condensed consolidated statement of operations. The Company is eligible to receive up to $275.0 million in development, regulatory and sales milestones as well as tiered royalties on net sales of licensed products.
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The Company determined that the Immunome Agreements fall within the scope of ASC 606, Revenue from Contracts with Customers (ASC 606) as Immunome has contracted to obtain goods and services that are an output of ordinary activities and is a customer. Furthermore, subsequent to the execution of the Immunome Agreements, the Company is no longer an active participant in the research and is no longer exposed to the significant risks and rewards of the research. Management of the Company determined there was one combined performance obligation for the Immunome Agreements and know-how given the deliverables are not distinct. The Company evaluated the performance obligation within the Immunome Agreements and determined the combined performance obligation was satisfied at a point in time with Immunome as the Immunome Agreements represents a right to use the functional intellectual property as it exists at the time of the Immunome Agreements, the customer has significant risk and rewards of ownership of the asset and the customer has accepted the asset with the transfer of know-how within the quarter ended March 31, 2024. In addition, variable consideration consisting of milestone payments was evaluated based on the Company’s analysis that the possibility of achieving any of the milestone payments was remote, and therefore determined to be constrained and excluded from the transaction price. Royalties will be recognized when the underlying sales occur based on estimates and a true-up of the estimated royalty revenue to the actual royalties earned will be recorded when royalty reports are received.
No License revenue related to the transaction price was recognized during the three months ended September 30, 2024 and 2023. During the nine months ended September 30, 2024 and 2023, the Company recognized $40.6 million and zero in License revenue related to the transaction price. During the nine months ended September 30, 2024 and 2023, the Company did not recognize revenue from milestone payments or royalties.
2.As a related matter, please revise your future filings to disclose the key terms of each of your license agreements and strategic collaborations, including your obligations under each agreement, the related financial provisions and your accounting treatment for each agreement. As an example, your accounting treatment
2024-09-12 - UPLOAD - Zentalis Pharmaceuticals, Inc. File: 001-39263
September 12, 2024
Cam Gallagher
Interim Chief Financial Officer
Zentalis Pharmaceuticals, Inc.
1359 Broadway
Suite 801
New York, New York 10018
Re:Zentalis Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2023
Filed February 27, 2024
File No. 001-39263
Dear Cam Gallagher:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comments.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Form 10-Q or the Fiscal Quarter Ended June 30, 2024
Notes to Condensed Consolidated Financial Statements
3. Significant Transactions, page 12
1.Please explain to us how you applied your revenue recognition policy to the elements of
the license agreement you entered into with Immunome, Inc., including references to the
paragraphs within ASC 606 that support your accounting. Please also confirm that you
will disclose your revenue recognition policy in future filings and provide us with a draft
of your intended disclosure revisions.
As a related matter, please revise your future filings to disclose the key terms of each of
your license agreements and strategic collaborations, including your obligations under
each agreement, the related financial provisions and your accounting treatment for each
agreement. As an example, your accounting treatment for $4.2 million of excess proceeds
received from the April 2022 direct offer to Pfizer as a reduction of research and 2.
September 12, 2024
Page 2
development expense over the term of the collaboration suggests that you are accounting
for this agreement under ASC 808. Please confirm and revise your disclosure in future
filings accordingly to clarify.
In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
Please contact Ibolya Ignat at 202-551-3636 or Angela Connell at 202-551-3426 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-06-29 - UPLOAD - Zentalis Pharmaceuticals, Inc.
United States securities and exchange commission logo
June 29, 2022
Melissa Epperly
Chief Financial Officer
Zentalis Pharmaceuticals, Inc.
1359 Broadway
Suite 1710
New York, New York 10018
Re:Zentalis Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2021
Filed February 24, 2022
File No. 001-39263
Dear Ms. Epperly:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-06-22 - CORRESP - Zentalis Pharmaceuticals, Inc.
CORRESP 1 filename1.htm Document June 22, 2022 Ms. Ibolya Ignat Ms. Mary Mast Division of Corporation Finance Office of Life Sciences United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: Zentalis Pharmaceuticals, Inc. Form 10-K for the Fiscal Year Ended December 31, 2021 Filed February 24, 2022 File No. 001-339263 Dear Ms. Ignat and Ms. Mast: Zentalis Pharmaceuticals, Inc. (the “Company”, “Zentalis,” “we” or “our”) is pleased to respond to the comments from the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) received by electronic mail on June 9, 2022 related to the Company’s Form 10-K for the fiscal year ended December 31, 2021, filed with the Commission on February 24, 2022. References herein to the “Prior Response Letter” refer to the response letter dated May 26, 2022 submitted by the Company in response to the comments of the Staff received by the Company on May 12, 2022. Form 10-K for the Fiscal Year Ended December 31, 2021 Consolidated Financial Statements Notes to Consolidated Financial Statements 3. Significant Transactions, page F-16 1. We refer to your response to prior comment 1. While we acknowledge your response, please provide us further information so that we may better understand your accounting analysis. In this regard: •Explain to us how your May 2020 collaboration agreement with Zentera was evaluated in accordance with ASC 810 subsequent to the Series B financing, and provide us your analysis. Address significant terms such as the contract transfer, sale, and termination provisions, as well as the existence of a joint steering or similar committee as applicable, and explain the implications to your analysis. •Please address the guidance in ASC 810-10-25-23 and paragraphs 810-10-25-21 through 25-38 as they relate to the other investors holding interests in Zentera subsequent to Zentera’s Series B financing during 2021. •Please explain to us why Zentera’s President and CMO is not considered a de facto agent under ASC 810-10-25-43. If de facto agent determination for Zentera’s President and CMO is applicable, please revise your accounting analysis to account for this fact as appropriate. Company Response: The Company respectfully acknowledges the Staff’s comment, and has included each of the Staff’s requests in italics below, followed by the Company’s response to the Staff. Explain to us how your May 2020 collaboration agreement with Zentera was evaluated in accordance with ASC 810 subsequent to the Series B financing, and provide us your analysis. Address significant terms such as the contract transfer, sale, and termination provisions, as well as the existence of a joint steering or similar committee as applicable, and explain the implications to your analysis. Our May 2020 collaboration and license agreement with Zentera (the “Collaboration Agreement”) granted Zentera an exclusive, royalty-bearing license under certain Zentalis technologies (ZN-c3, ZN-d5 and ZN-c5 or, collectively, the “Collaboration Products”) to develop and commercialize the Collaboration Products in China, Macau, Hong Kong and Taiwan (the “Zentera Collaboration Territory”), subject to certain rights with respect to the Collaboration Products that we retained. 1 Milestones/Royalties/Development Costs. Under the Collaboration Agreement, we are eligible to receive future development and regulatory milestones of up to $4.45 million per Collaboration Product and royalties on sale of Collaboration Products in the Zentera Collaboration Territory at a mid- to high-single digit percentage, subject to certain reductions. Zentera is responsible for the costs of developing the Collaboration Products in the Zentera Collaboration Territory while we are responsible for the costs of development outside the Zentera Collaboration Territory. Sublicense/Assignment. Zentera has the right to sublicense or assign its rights under the Collaboration Agreement subject to certain protective restrictions and an obligation to pay us a portion of sublicensing income received by Zentera or its affiliates in connection with any such transaction. Termination. The Collaboration Agreement may be terminated by Zentera for convenience if Chinese regulatory approval is not received by certain dates or after Chinese regulatory approval has been received. Each party has the right to terminate the Collaboration Agreement for cause if the other party breaches its obligations and does not cure such breach in a defined time period. Zentalis has the right to terminate the agreement if certain milestones are not met by certain predetermined dates. Either party has the right to terminate the agreement in the event of the other party’s bankruptcy. In the event of a termination of the Collaboration Agreement by Zentera, the rights to the Collaboration Products in the Zentera Collaboration Territory revert to Zentalis and Zentera may obtain the rights to receive certain royalties from Zentalis for certain product sales originating in the Zentera Collaboration Territory. We evaluated the Collaboration Agreement, in accordance with ASC 810, first to determine whether it gave us the contractual power to direct the activities of Zentera that most significantly impact Zentera’s economic performance. We note that, while Zentera’s activities under the Collaboration Agreement constitute a significant portion of the research and development performed by Zentera to date, the purpose and design of Zentera was not limited to activities under the Collaboration Agreement. Zentera was formed to discover, develop, license and /or acquire technologies and intellectual property to develop drug candidates in China. However, as the initial focus of Zentera did relate to activities related to the collaboration with us, we assessed whether our rights under the Collaboration Agreement gave us power to direct Zentera’s most significant activities. In this context, we considered the governance provisions within the Collaboration Agreement, noting that the Collaboration Agreement provides for the creation of a joint steering committee to oversee and coordinate the development of the Collaboration Products in the Zentera Collaboration Territory. The Collaboration Agreement calls for the joint steering committee to consist of six members, with three of the members selected by Zentalis and three selected by Zentera. The Zentera representatives on the joint steering committee are not related to or affiliated with Zentalis. In the event that the joint steering committee is unable to reach a consensus on a decision, the Collaboration Agreement provides for Zentera to have final decision-making authority for matters pertaining to activities relating to the Zentera Collaboration Territory, while Zentalis has the final decision-making authority for matters pertaining to activities outside the Zentera Collaboration Territory. For certain critical matters, neither party has final decision-making authority, and the Collaboration Agreement calls for such matters to be subject to third party mediation in the event that Zentera and Zentalis are not able to come to a resolution. Based on our assessment of the terms of the Collaboration Agreement, we have concluded that the Collaboration Agreement does not give Zentalis contractual power to direct the activities of Zentera that most significantly impact Zentera’s economic performance. Please address the guidance in ASC 810-10-25-23 and paragraphs 810-10-25-21 through 25-38 as they relate to the other investors holding interests in Zentera subsequent to Zentera’s Series B financing during 2021. ASC 810-10-25-21 through 25-36 addresses the concept of “determining the variability to be considered” in the VIE model. In the case of Zentera, the purpose and design of Zentera was to discover, develop, license and/or acquire technologies and intellectual property to develop drug candidates in China, with the ultimate goal of producing profitable operations and generating returns for the Zentera investors. The variability affecting expected losses and expected residual returns for Zentera is typical for early-stage biotechnology companies - significant losses are expected to be generated for a number of years as drug candidates are researched and developed; profits, when and if realized, are the result of successful development efforts resulting in the eventual sale, out-licensing or successful commercialization of such drug candidates. ASC 810-10-25-23 states the following: “For purposes of paragraphs 810-10-25-21 through 25-36, interest holders include all potential variable interest holders (including contractual, ownership, or other pecuniary interests in the legal entity). After determining the variability to consider, the reporting entity can determine which interests are designed to absorb that variability. The cash flow and fair value are methods that can be used to measure the amount of variability (that is, expected losses and expected residual returns) of a legal entity. However, a method that is used to measure the amount of variability does not provide an appropriate basis for determining which variability should be considered in applying the Variable Interest Entities Subsections.” 2 In assessing “which interests are designed to absorb” Zentera’s variability, we look to the equity structure of Zentera, which consists of common stock and preferred stock. In the event that Zentera produces profitable operations, the equity structure is such that common and preferred stockholders will share those profits on a pro rata basis, commensurate with levels of share ownership. Losses are absorbed initially by common stockholders as a result of liquidation preferences provided to the preferred stockholders, with a return of capital to the preferred stockholders prior to such a return of capital to common stockholders. However, as the design and purpose of the entity, as stated above, is to incur significant losses for a number of years in pursuit of developing drug products for regulatory approval, the existence of liquidation preferences does not significantly protect preferred stockholders from absorbing losses. Preferred stockholders are very much at risk of absorbing losses, along with having the potential to share in residual returns. Therefore, in assessing ASC 810-10-25-23, we concluded that both the common and preferred stock are interests designed to absorb Zentera’s variability. ASC 810-10-25-37 states that “(t)he initial determination of whether a legal entity is a VIE shall be made on the date at which a reporting entity becomes involved with the legal entity.” Zentera was determined to be a VIE on the date at which Zentalis became involved with the entity and remained a VIE throughout the periods under assessment. ASC 810-10-25-38 addresses considerations around consolidation based on variable interests. As disclosed in the Prior Response Letter, we assessed whether we were the primary beneficiary in accordance with these paragraphs. We concluded that we were the primary beneficiary until the date of the Series B preferred stock financing and we were not the primary beneficiary for any period subsequent to that date. Please explain to us why Zentera’s President and CMO is not considered a de facto agent under ASC 810-10-25-43. If de facto agent determination for Zentera’s President and CMO is applicable, please revise your accounting analysis to account for this fact as appropriate. ASC 810-10-25-43 states that the following are considered to be de facto agents of a reporting entity: •A party that cannot finance its operations without subordinated financial support from the reporting entity, for example, another VIE of which the reporting entity is the primary beneficiary. Analysis: This point relates to a business entity and not an individual and is therefore not applicable as it relates to the Zentera President and CMO. •A party that received its interests as a contribution or a loan from the reporting entity. Analysis: Zentalis did not fund, loan, or issue the Zentera equity interest held by the Zentera President and CMO. The Zentera President and CMO personally purchased Zentera Series B preferred shares under the same terms and conditions as other purchasers of the Series B preferred shares. The only other Zentera equity interest held by the President and CMO consists of time-based option awards granted to him by the Zentera board in connection with his role as President and CMO of Zentera. •An officer, employee, or member of the governing board of the reporting entity. Analysis: The President and CMO of Zentera is not an officer, employee, or member of the governing board of Zentalis, nor is he related to Zentalis in any other way. •A party that has an agreement that it cannot sell, transfer, or encumber its interests in the VIE without the prior approval of the reporting entity. The right of prior approval creates a de facto agency relationship only if that right could constrain the other party’s ability to manage the economic risks or realize the economic rewards from its interests in a VIE through the sale, transfer, or encumbrance of those interests. However, a de facto agency relationship does not exist if both the reporting entity and the party have the right of prior approval and the rights are based on mutually agreed terms by willing, independent parties. Analysis: The CMO and President of Zentera does not have an agreement that he cannot sell, transfer, or encumber his interest in Zentera without the prior approval of Zentalis. •A party that has a close business relationship like the relationship between a professional service provider and one of its significant clients. Analysis: The Zentera President and CMO had no business relationship with Zentalis or any Zentalis executives prior to his appointment to the role of President and CMO of Zentera. The Zentera President and CMO was hired by Zentera as a result of an executive search led by an external party, not by Zentalis or any Zentalis employee. Based on this assessment, we concluded that the Zentera President and CMO is not a de facto agent of Zentalis under ASC 810-10-25-43. 3 If you have any questions or further comments about this response, please contact me by email at mepperly@zentalis.com or by phone at (215) 290-7271. Sincerely, /s/ Melissa Epperly Melissa Epperly Chief Financial Officer Zentalis Pharmaceuticals, Inc. 4
2022-06-09 - UPLOAD - Zentalis Pharmaceuticals, Inc.
United States securities and exchange commission logo
June 9, 2022
Melissa Epperly
Chief Financial Officer
Zentalis Pharmaceuticals, Inc.
1359 Broadway
Suite 1710
New York, New York 10018
Re:Zentalis Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2021
Filed February 24, 2022
File No. 001-39263
Dear Ms. Epperly:
We have reviewed your May 26, 2022 response to our comment letter and have the
following comment. In our comment we may ask you to provide us with information so we may
better understand your disclosure.
Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional
comments. Unless we note otherwise, our references to prior comments are to comments in our
May 12, 2022 letter.
Form 10-K for the Fiscal Year Ended December 31, 2021
Consolidated Financial Statements
Notes to Consolidated Financial Statements
3. Significant Transactions, page F-16
1.We refer to your response to prior comment 1. While we acknowledge your response,
please provide us further information so that we may better understand your accounting
analysis. In this regard:
•Explain to us how your May 2020 collaboration agreement with Zentera was
evaluated in accordance with ASC 810 subsequent to the Series B financing, and
provide us your analysis. Address significant terms such as the contract transfer, sale,
and termination provisions, as well as the existence of a joint steering or similar
FirstName LastNameMelissa Epperly
Comapany NameZentalis Pharmaceuticals, Inc.
June 9, 2022 Page 2
FirstName LastName
Melissa Epperly
Zentalis Pharmaceuticals, Inc.
June 9, 2022
Page 2
committee as applicable, and explain the implications to your analysis.
•Please address the guidance in ASC 810-10-25-23 and paragraphs 810-10-25-21
through 25-38 as they relate to the other investors holding interests in Zentera
subsequent to Zentera's Series B financing during 2021.
•Please explain to us why Zentera's President and CMO is not
considered a de facto agent under ASC 810-10-25-43. If de facto agent determination
for Zentera's President and CMO is applicable, please revise your accounting analysis
to account for this fact as appropriate.
You may contact Ibolya Ignat at 202-551-3636 or Mary Mast at 202-551-3613 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-05-26 - CORRESP - Zentalis Pharmaceuticals, Inc.
CORRESP 1 filename1.htm Document May 26, 2022 Ms. Ibolya Ignat Ms. Mary Mast Division of Corporation Finance Office of Life Sciences United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: Zentalis Pharmaceuticals, Inc. Form 10-K for the Fiscal Year Ended December 31, 2021 Filed February 24, 2022 File No. 001-339263 Dear Ms. Ignat and Ms. Mast: Zentalis Pharmaceuticals, Inc. (the “Company”, “Zentalis,” “we” or “our”) is pleased to respond to the comments from the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) received by electronic mail on May 12, 2022 related to the Company’s Form 10-K for the fiscal year ended December 31, 2021, filed with the Commission on February 24, 2022. Form 10-K for the Fiscal Year Ended December 31, 2021 Consolidated Financial Statements Notes to Consolidated Financial Statements 3. Significant Transactions, page F-16 1. You disclose that after Zentera's July 2021 Series B convertible preferred offering and changes to its corporate governance, you no longer individually have the ability to direct the activities that most significantly impact Zentera's economic performance, and explain, that beginning in July 2021, the financial position and results of operations of Zentera are no longer included in your consolidated financial statements. Please address the following: •Provide us with a comprehensive accounting analysis relating to your deconsolidation of Zentera that includes the terms of and your assessment of the contractual arrangements and corporate governance of Zentera prior to and subsequent to the July 2021 convertible preferred offering. •Provide us an analysis of the significance of Zentera to your operations prior to and after deconsolidation. Please address the collaboration and license agreements each of your subsidiaries have entered into with your joint venture, Zentera. •Explain to us the purpose and design of Zentera, the terms and characteristics of your financial interest in Zentera, and your business purpose for holding the financial interest. •Tell us if there are any contractual arrangements subsequent to deconsolidation that would allow you to increase your interest or control in Zentera in the future, and if so, the terms of any agreements that would give you those rights and your assessment of how those terms affected your determination to deconsolidate Zentera. •Clarify what your initial investment amount was in this joint venture as well as how you determined this amount. In this regard, tell us if you formed Zentera. •Tell us whether you identified any related parties for purposes of your consolidation analysis under ASC 710. If so, tell us how you considered those related parties when concluding it was appropriate to deconsolidate Zentera. In this respect, we note on page 106 that your President and Chief Executive Officer serves as Chief Executive Officer and a member of the board of directors of Zentera and your Chief Operating Officer serves as a member of the board of directors of Zentera. Tell us how many board members are on Zentera’s board of directors. •In your response, address which paragraphs within the authoritative accounting guidance you relied upon to support your accounting. Company Response: The Company respectfully acknowledges the Staff’s comment, and has included each of the Staff’s requests in italics below, followed by the Company’s response to the Staff. 1 Provide us with a comprehensive accounting analysis relating to your deconsolidation of Zentera that includes the terms of and your assessment of the contractual arrangements and corporate governance of Zentera prior to and subsequent to the July 2021 convertible preferred offering. In May 2020, Zentalis participated in the initial funding of Zentera, a joint venture focused on the development and commercialization of product candidates in the Greater China market. Zentalis participated in the funding through a contribution of intellectual property in exchange for shares of common stock. Other participants in the initial funding of Zentera purchased Series A preferred stock. Dr. Anthony Sun, Zentalis’ former President and CEO, was named Zentera CEO and Zentalis held two of four total board seats and approximately 60% of the entity’s outstanding equity, in the form of common stock ownership. Series A preferred stock investors held the remaining two seats and approximately 40% of the entity’s outstanding equity, in the form of preferred stock ownership. In July 2021, Zentera completed a Series B preferred stock financing event in which Zentalis did not participate. As a result of the Series B preferred stock financing, the Zentalis ownership percentage was diluted from approximately 60% to approximately 40%. Upon the formation of Zentera, we assessed the accounting for Zentalis’ investment in Zentera in accordance with ASC 810. After determining that no scope exception applies under the consolidation guidance of ASC 810-10-15-10, we concluded that Zentalis does have a variable interest in Zentera as the value of our investment changes with changes in the fair value of the net assets of Zentera. Zentalis participated significantly in the design of Zentera and a scope exception to the variable interest model does not apply. Furthermore, as Zentera does not have enough equity to finance its activities without additional subordinated financial support under ASC 810-10-15-14(a), we concluded that Zentera is a variable interest entity (“VIE”). A VIE must be consolidated if the reporting entity is deemed to have both (1) power and (2) benefits – that is, it has (1) the power to direct the activities of a VIE that most significantly impact the VIE’s economic performance (e.g., the VIE’s revenues, expenses, margins, gains and losses, cash flows, financial position) and (2) the obligation to absorb losses of the VIE that potentially could be significant to the VIE or the right to receive benefits from the VIE that potentially could be significant to the VIE. As Zentalis holds a variable interest in Zentera (through its common stock ownership), Zentalis does have the obligation to absorb losses and receive the benefits of Zentera on a pro-rata basis. Upon the initial funding of Zentera, we identified the key activities that most significantly affected Zentera’s economic performance to be the following: (1) decisions related to the financing of Zentera’s operations, including the issuance of common and preferred stock and entry into debt arrangements; (2) strategic decisions related to potential in-licensing of technologies or pursuit of new product candidates; (3) identifying and hiring key employees and oversight of the establishment of operating processes; and (4) development decisions related to the key product candidates. To assess which party controls these activities, we considered the Zentera key governance documents, the articles of incorporation, the investor rights agreement and the voting agreement. Per the terms of the Zentera governance documents, the key long-term financing and strategic decisions (items (1) and (2) above) require Zentera board approval and could not be controlled independently by any party. There are no kick-out rights held by any of the investors or board members. The voting agreement indicated specific decisions that would require a majority of the board which indicates both protective and participatory rights for all board members. No key decisions are subject to direct shareholder approval, but it is noted that preferred shares and common shares all hold voting rights proportional to the number of such outstanding shares. Decisions related to the hiring of employees and oversight of the establishment of operating processes (item (3) above) were controlled by Dr. Sun in his role as Zentera CEO. Key development decisions (item (4) above) were also controlled by Dr. Sun. Prior to the Series B preferred stock financing, these were deemed to be the activities that most significantly impact Zentera’s economic performance, and such decisions were either controlled by no individual party (items (1) and (2)) or by Zentalis through Dr. Sun’s role as CEO of Zentera (items (3) and (4)). We therefore concluded that Zentalis was the primary beneficiary of Zentera in accordance with ASC 810-10-05-8A and consolidation under the Variable Interest Model was appropriate. Through March 2021, Dr. Sun and the Zentera board continued to be involved in the day-to-day decisions of Zentera as the Zentera team and operations grew, including identifying and hiring key employees, developing operating processes, and making development decisions related to the key product candidates. In March 2021, upon completion of an executive search led by an external party, Zentera hired a President and Chief Medical Officer (“CMO”) to provide executive oversight for all day-to-day operations of Zentera. This individual is based in China and was hired to be a full-time executive in charge of the local Zentera operations. It is worth noting that all Zentera employees reported to this President and CMO and no employees reported to Dr. Sun with the exception of the CMO who reports to both the board and Dr. Sun, and board approval would be required to remove or replace the President and CMO. In July 2021, upon the completion of the Series B preferred stock financing, the President and CMO of Zentera was added to the Zentera board of directors (increasing the total number of board members to five) and Zentalis’ voting interest decreased to approximately 40%. The Series B preferred stock financing provided resources for Zentera to continue the 2 development of existing product candidates, hire additional resources, and potentially acquire and pursue additional in-process assets. As Zentera matured as an organization, the activities which most significantly impact its economic performance progressed. We reassessed the key activities that most significantly affected Zentera’s economic performance at that time and concluded such activities to be the following: (1) decisions related to the financing of Zentera’s operations, including the issuance of common and preferred stock and entry into debt arrangements; (2) strategic decisions related to potential in-licensing of technologies or pursuit of new product candidates; (3) development decisions related to the key product candidates, including decisions regarding the timing, size, and design of clinical trials specific to the Chinese market; (4) decisions related to the pursuit of regulatory approval in China, including interaction with Chinese regulatory agencies; and (5) hiring and personnel decisions to support the growing operations. Items (1) and (2) continued to be controlled by the board of directors of Zentera with no individual party controlling such decisions. We then assessed which party controlled items (3), (4), and (5). We considered the relationship of the Zentera President and CMO in the context of Zentalis. This individual is based in China and dedicated to the Zentera role in a full-time capacity. This individual was identified by an independent external recruiting agency and was not affiliated with Zentalis in any way prior to being hired in this role. The preferred stockholders and Zentalis, through their board representation, concurred on the decision to hire the President and CMO. Zentalis does not have the ability to unilaterally remove the President and CMO from his role in management or on the board of directors. This individual is not considered to be an agent or a representative of either Zentalis or the preferred stockholders. At that time, with five total directors, Zentalis’ concurrence was no longer required for key decisions to be reached at the board level. While Dr. Sun continued to provide strategic input and maintain the title of Zentera CEO, all employees reported to the Zentera President and CMO, who was appointed to the Zentera board of directors in connection with the Series B financing, was in charge of day-to-day operations at Zentera and was responsible for key operational activities and decisions driving Zentera's performance. In addition, Zentalis no longer had a majority voting interest. Based on the combination and weighting of these facts, we concluded that Zentalis no longer controlled activities (3), (4), and (5), and, therefore, no longer controlled the activities that most significantly impacted Zentera’s economic performance. Based on the above information, we concluded that, effective July 13, 2021, Zentalis is not the primary beneficiary of Zentera. As such, consolidation of Zentera following the appointment of the President and CMO to the board of directors and the Series B preferred stock financing is no longer appropriate. Provide us an analysis of the significance of Zentera to your operations prior to and after deconsolidation. Please address the collaboration and license agreements each of your subsidiaries have entered into with your joint venture, Zentera. The carrying value of the consolidated Zentera assets totaled $17.2 million and $15.0 million at December 31, 2020 and June 30, 2021, respectively, prior to deconsolidation, and represented approximately 4.7% and 5.3% of the consolidated total assets of Zentalis at the respective dates. The carrying value of the consolidated Zentera liabilities totaled $0.1 million and $0.6 million at December 31, 2020 and June 30, 2021, respectively, prior to deconsolidation, and represented approximately less than 0.2% and 1.7% of the consolidated total liabilities of Zentalis at the respective dates. The consolidated net loss of Zentera totaled $1.5 million and $3.0 million for the year ended December 31, 2020 and for the six months ended June 30, 2021, respectively, and represented approximately 1.3% and 2.8% of the consolidated net loss of Zentalis for the respective periods. The Company respectfully advises the Staff that all material information related to the collaboration and license agreements between any of the Company’s subsidiaries and Zentera are disclosed in the Company’s public filings with the Commission. Under the collaboration and license agreements entered into between each of Zentalis’ subsidiaries and Zentera, no royalties or milestone payments have been paid or received. Under such agreements, Zentera reimburses Zentalis for certain development costs. Such reimbursements totaled $4.5 million and $5.2 million for the year ended December 31, 2020 and for the six months ended June 30, 2021, respectively, with such reimbursements eliminated in consolidation until the date of deconsolidation. Subsequent to deconsolidation, Zentalis received reimbursements totaling $5.3 million during the year ended December 31, 2021, with such amounts recognized as contra-research and development expenses. Explain to us the purpose and design of Zentera, the terms and characteristics of your financial interest in Zentera, and your business purpose for holding the financial interest. Zentera was formed to discover, develop, license and/or acquire technologies and intellectual property to develop drug candidates in China. In May 2020, Zentalis participated in the Zentera financing via a contribution of intellectual property. Zentera licensed from Zentalis the development, manufacturing and commercialization rights for ZN-c3, ZN-c5 and ZN-d5 in the Zentera Collaboration Territory which refers to China, Macau, Hong Kong and Taiwan. Simultaneously, Zentalis is developing these same product candidates for the rest of world. Zentera continues to expand its pipeline beyond these candidates through internal research and development and possible asset acquisition. Zentalis and Zentera continue to collaborate in the development and advancement of the assets mentioned above within each respective territory. Zentalis plans
2022-05-12 - UPLOAD - Zentalis Pharmaceuticals, Inc.
United States securities and exchange commission logo
May 12, 2022
Anthony Y. Sun, M.D
Chief Executive Officer, President and Chairman
Zentalis Pharmaceuticals, Inc.
1359 Broadway
Suite 1710
New York, New York 10018
Re:Zentalis Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2021
Filed February 24, 2022
File No. 001-39263
Dear Mr. Sun:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment. In our comment, we may ask you to provide us
with information so we may better understand your disclosure.
Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2021
Consolidated Financial Statements
Notes to Consolidated Financial Statements
3. Significant Transactions, page F-16
1.You disclose that after Zentera's July 2021 Series B convertible preferred offering and
changes to its corporate governance, you no longer individually have the ability to direct
the activities that most significantly impact Zentera's economic performance, and explain,
that beginning in July 2021, the financial position and results of operations of Zentera are
no longer included in your consolidated financial statements. Please address the
following:
•Provide us with a comprehensive accounting analysis relating to your deconsolidation
of Zentera that includes the terms of and your assessment of the contractual
arrangements and corporate governance of Zentera prior to and subsequent to the July
FirstName LastNameAnthony Y. Sun, M.D
Comapany NameZentalis Pharmaceuticals, Inc.
May 12, 2022 Page 2
FirstName LastName
Anthony Y. Sun, M.D
Zentalis Pharmaceuticals, Inc.
May 12, 2022
Page 2
2021 convertible preferred offering.
•Provide us an analysis of the significance of Zentera to your operations prior to and
after deconsolidation. Please address the collaboration and license agreements each of
your subsidiaries have entered into with your joint venture, Zentera.
•Explain to us the purpose and design of Zentera, the terms and characteristics of your
financial interest in Zentera, and your business purpose for holding the financial
interest.
•Tell us if there are any contractual arrangements subsequent to deconsolidation that
would allow you to increase your interest or control in Zentera in the future, and if so,
the terms of any agreements that would give you those rights and your assessment of
how those terms affected your determination to deconsolidate Zentera.
•Clarify what your initial investment amount was in this joint venture as well as how
you determined this amount. In this regard, tell us if you formed Zentera.
•Tell us whether you identified any related parties for purposes of your consolidation
analysis under ASC 810. If so, tell us how you considered these related parties when
concluding it was appropriate to deconsolidate Zentera. In this respect, we note on
page 106 that your President and Chief Executive Officer serves as Chief Executive
Officer and a member of the board of directors of Zentera and your Chief Operating
Officer serves as a member of the board of directors of Zentera. Tell us how many
board members are on Zentera's board of directors.
•In your response, address which paragraphs within the authoritative accounting
guidance you relied upon to support your accounting.
In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
You may contact Ibolya Ignat at 202-551-3636 or Mary Mast at 202-551-3613 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-07-27 - CORRESP - Zentalis Pharmaceuticals, Inc.
CORRESP
1
filename1.htm
CORRESP
ZENTALIS PHARMACEUTICALS, INC.
530 Seventh Avenue, Suite 2201
New York, NY 10018
July 27, 2020
Via EDGAR Transmission
United States Securities
and Exchange Commission
Division of Corporation Finance
100
F Street, N.E.
Mail Stop 4720
Washington, D.C. 20549
Attention: Alan Campbell
Re:
Zentalis Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed on July 27, 2020
Dear Mr. Campbell:
In accordance with Rule 461 under the Securities Act of 1933, as amended, we hereby request the acceleration of the effective date of the
above-referenced Registration Statement of Zentalis Pharmaceuticals, Inc. (the “Company”) so that it will become effective on July 29, 2020, at 4:00 p.m. Eastern Time or as soon thereafter as practicable, or at such later time as
the Company or its counsel may request via telephone call to the staff.
Please call Nathan Ajiashvili of Latham & Watkins LLP,
counsel to the Company, at (212) 906-2916, or in his absence, Salvatore Vanchieri at (212) 906-4605, to provide notice of effectiveness or if you have any other
questions or concerns regarding this matter.
We understand that the staff of the United States Securities and Exchange Commission will
consider this request as confirmation by the Company that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.
Sincerely yours,
Zentalis Pharmaceuticals, Inc.
By: /s/ Anthony Y. Sun,
M.D.
Anthony Y. Sun, M.D.
President and Chief Executive Officer
cc:
Nathan Ajiashvili, Esq.
Salvatore Vanchieri, Esq.
2020-07-27 - CORRESP - Zentalis Pharmaceuticals, Inc.
CORRESP 1 filename1.htm CORRESP July 27, 2020 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Alan Campbell Re: Zentalis Pharmaceuticals, Inc. Registration Statement on Form S-1 Ladies and Gentlemen: Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Securities Act”), we wish to advise that as of the time of this filing, the underwriters have not yet made any distribution of the Preliminary Prospectus of Zentalis Pharmaceuticals, Inc. (the “Registrant”) dated July 27, 2020. However, the underwriters are taking steps to see that all underwriters, brokers or dealers participating in the public offering of shares of the Registrant’s common stock pursuant to the above-captioned Registration Statement, as amended (the “Registration Statement”), are promptly furnished with sufficient copies of the preliminary and final prospectus to enable them to comply with the prospectus delivery requirements of Sections 5(b)(1) and (2) of the Securities Act. We wish to advise you that the participating underwriters have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. We hereby join in the request of the Registrant that the effectiveness of the above-captioned Registration Statement be accelerated to 4:00 p.m. Eastern Time, on Wednesday, July 29, 2020, or as soon thereafter as practicable. [Signature page follows] Very truly yours, MORGAN STANLEY & CO. LLC JEFFERIES LLC SVB LEERINK LLC As representatives of the Underwriters MORGAN STANLEY & CO. LLC By: /s/ Kalli Dirks Name: Kalli Dirks Title: Executive Director JEFFERIES LLC By: /s/ Michael Brinkman Name: Michael Brinkman Title: Managing Director SVB LEERINK LLC By: /s/ Gabriel Cavazos Name: Gabriel Cavazos Title: Managing Director
2020-07-14 - UPLOAD - Zentalis Pharmaceuticals, Inc.
United States securities and exchange commission logo
July 14, 2020
Anthony Sun, M.D.
Chief Executive Officer
Zentalis Pharmaceuticals, Inc.
530 Seventh Avenue, Suite 2201
New York, New York 10018
Re:Zentalis Pharmaceuticals, Inc.
Draft Registration Statement on Form S-1
Submitted July 10, 2020
File No. 377-03289
Dear Dr. Sun:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours prior
to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for
acceleration. We remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
Please contact Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Nathan Ajiashvili
2020-03-31 - CORRESP - Zentalis Pharmaceuticals, Inc.
CORRESP 1 filename1.htm CORRESP March 31, 2020 Via EDGAR Transmission United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Mail Stop 4720 Washington, D.C. 20549 Attention: Chris Edwards Re: Zentalis Pharmaceuticals, LLC Registration Statement on Form S-1 Filed March 6, 2020 Registration No. 333-236959 Dear Mr. Edwards: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request the acceleration of the effective date of the above-referenced Registration Statement so that it will become effective on April 2, 2020, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, or at such later time as Zentalis Pharmaceuticals, LLC (the “Company”) or its counsel may request via telephone call to the staff. Please contact Nathan Ajiashvili of Latham & Watkins LLP, counsel to the Company, at (212) 906-2916, or in his absence, Salvatore Vanchieri at (212) 906-4605, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter. Sincerely yours, Zentalis Pharmaceuticals, LLC By: /s/ Anthony Y. Sun Anthony Y. Sun, M.D. President and Chief Executive Officer cc: Nathan Ajiashvili, Esq. Salvatore Vanchieri, Esq.
2020-03-31 - CORRESP - Zentalis Pharmaceuticals, Inc.
CORRESP 1 filename1.htm CORRESP March 31, 2020 United States Securities and Exchange Commission 100 F Street, N.E. Mail Stop 4720 Washington, D.C. 20549 Attention: Chris Edwards Re: Zentalis Pharmaceuticals, LLC Registration Statement on Form S-1 (File No. 333-236959) Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended, we wish to advise that as of the date hereof, approximately 1,344 copies of the Preliminary Prospectus dated March 30, 2020 were distributed to prospective underwriters, institutional investors and prospective dealers in connection with the above-captioned Registration Statement. We wish to advise you that the participating underwriters have informed us that they have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. We hereby join in the request of the registrant that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated to 4:00 p.m. Eastern Time, on Thursday, April 2, 2020 or as soon thereafter as practicable. [Signature page follows] Very truly yours, MORGAN STANLEY & CO. LLC JEFFERIES LLC SVB LEERINK LLC As representatives of the Underwriters MORGAN STANLEY & CO. LLC By: /s/ Kalli Dirks Name: Kalli Dirks Title: Executive Director JEFFERIES LLC By: /s/ Michael Brinkman Name: Michael Brinkman Title: Managing Director SVB LEERINK LLC By: /s/ Gabriel Cavazos Name: Gabriel Cavazos Title: Managing Director [Signature Page to Acceleration Request]
2020-03-13 - CORRESP - Zentalis Pharmaceuticals, Inc.
CORRESP 1 filename1.htm CORRESP 53rd at Third 885 Third Avenue New York, New York 10022-4834 Tel: +1.212.906.1200 Fax: +1.212.751.4864 www.lw.com FIRM / AFFILIATE OFFICES Beijing Moscow Boston Munich Brussels New York Century City Orange County Chicago Paris March 13, 2020 Dubai Riyadh Düsseldorf San Diego Frankfurt San Francisco Hamburg Seoul Hong Kong Shanghai Houston Silicon Valley London Singapore Los Angeles Tokyo Madrid Washington, D.C. Milan VIA EDGAR AND OVERNIGHT DELIVERY United States Securities and Exchange Commission 100 F Street, N.E. Mail Stop 4720 Washington, D.C. 20549 Attention: Rolf Sundwall Daniel Gordon Chris Edwards Mary Beth Breslin Re: Zentalis Pharmaceuticals, LLC Registration Statement on Form S-1 Filed March 6, 2020 File No. 333-236959 Ladies and Gentlemen: On behalf of Zentalis Pharmaceuticals, LLC, a limited liability company organized under the laws of Delaware and following a statutory conversion, a corporation organized under the laws of Delaware (the “Company”), we are transmitting this letter in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission by letter dated March 11, 2020 with respect to the Company’s above-captioned Registration Statement on Form S-1 (the “Registration Statement”). The bold and numbered paragraphs below correspond to the numbered paragraphs in the Staff’s letter and are followed by the Company’s responses. For the Staff’s convenience, we are also sending, by courier, copies of this letter. Unless otherwise indicated, capitalized terms used herein have the meanings assigned to them in the Registration Statement. March 13, 2020 Page 2 Financial Statements Consolidated Balance Sheets, page F-3 1. Please revise to disclose the redemption value of your convertible preferred units on the face of the balance sheet. Refer to Regulation S-X, Item 5-02.27(b). Response: The Company respectfully advises the Staff that it will revise the disclosure in a pre-effective amendment to the Registration Statement. Notes to Consolidated Financial Statements 8. Convertible Preferred Units, page F-19 2. Please provide your analysis supporting the classification of your convertible preferred units outside of permanent equity during 2019. In your response, tell us how the issuance of your Series C Preferred Units amended the terms or conditions of your Series A and B Preferred Units, and whether classification outside of permanent equity may have been appropriate in earlier periods. Response: We assessed the classification of our Preferred Units as of December 31, 2018 and 2019 in accordance with the guidance in ASC 480-10-S99-3A, which states that “ASR 268 requires preferred securities that are redeemable for cash or other assets to be classified outside of permanent equity if they are redeemable…upon the occurrence of an event that is not solely within the control of the issuer.” Example 2 within that guidance states that “(a) preferred security that is not required to be classified as a liability under other applicable GAAP may have a redemption provision that states it may be called by the issuer upon an affirmative vote by the majority of its board of directors. While some might view the decision to call the security as an event that is within the control of the company because the governance structure of the company is vested with the power to avoid redemption, if the preferred security holders control a majority of the votes of the board of directors through direct representation on the board of directors or through other rights, the preferred security is redeemable at the option of the holder and classification in temporary equity is required. In other words, any provision that requires approval by the board of directors cannot be assumed to be within the control of the issuer. All of the relevant facts and circumstances should be considered.” Our Limited Liability Company Agreement includes provisions for various “Deemed Liquidation Events” that require the approval of a majority of our Board of Directors and a majority vote of our preferred unit holders voting together as a single class. In the event of a Deemed Liquidation Event, the preferred unit holders would effectively achieve redemption of their securities because of the existence of distribution preferences. We therefore assessed whether the preferred unit holders had the ability to unilaterally effect a Deemed Liquidation Event. As of December 31, 2018, our Board of Directors consisted of four members. Two such members (Anthony Sun and Cam Gallagher) were designated by the holders of a majority March 13, 2020 Page 3 of outstanding Class A common units. One member of the Board of Directors (Karan Takhar) was designated by Matrix Capital Management Master Fund, L.P. (“Matrix Capital”) and one member (David Goel) was designated by Matrix Capital and approval of holders of at least 70% of the of the outstanding Series B preferred units. Neither Mr. Sun nor Mr. Gallagher is a holder of preferred units. Because a majority vote of the Board of Directors is required to effect a Deemed Liquidation Event, and as the preferred unit holders only held two seats on the Board of Directors, we concluded that a Deemed Liquidation Event or any other redemption of the preferred units was “solely within the control of the issuer.” We considered all rights and privileges associated with the preferred units and concluded that there were no facts or circumstances that indicated the preferred unit holders could force a redemption as of December 31, 2018. Therefore, all preferred units were presented within permanent equity at that date. As of December 31, 2019, our Board of Directors consisted of five members. The four members described above remained on the board. Upon the issuance of Series C preferred units, the holders of Series C preferred units were granted the right to designate the fifth member of the Board of Directors. David Johnson was appointed to the board as a result of a majority vote of the Series C preferred unit holders. Mr. Johnson is also a holder of Series C preferred units. Therefore, upon the issuance of the Series C preferred units and the appointment of Mr. Johnson to the Board of Directors, preferred unit holders as a class became represented by a majority of our directors. With a majority of the Board of Directors, preferred unit holders as a class obtained the ability to effect a Deemed Liquidation Event. A redemption of the preferred units was thus deemed to be outside the sole control of the issuer and all preferred units were reclassified to mezzanine equity presentation. We hope that the foregoing has been responsive to the Staff’s comments and look forward to resolving any outstanding issues as quickly as possible. Please do not hesitate to contact me at 212-906-2916 with any questions or further comments you may have regarding this filing or if you wish to discuss the above. Sincerely, /s/ Nathan Ajiashvili Nathan Ajiashvili of LATHAM & WATKINS LLP Enclosures cc: (via e-mail) Anthony Y. Sun, M.D., Chief Executive Officer and President, Zentalis Pharmaceuticals, LLC Cheston Larson, Latham & Watkins LLP Matthew Bush, Latham & Watkins LLP Divakar Gupta, Cooley LLP Richard Segal, Cooley LLP Alison Haggerty, Cooley LLP
2020-03-13 - CORRESP - Zentalis Pharmaceuticals, Inc.
CORRESP 1 filename1.htm CORRESP 53rd at Third 885 Third Avenue New York, New York 10022-4834 Tel: +1.212.906.1200 Fax: +1.212.751.4864 www.lw.com FIRM / AFFILIATE OFFICES Beijing Moscow Boston Munich Brussels New York Century City Orange County Chicago Paris Dubai Riyadh FOIA CONFIDENTIAL TREATMENT REQUEST UNDER 17 C.F.R. §200.83 Düsseldorf San Diego Frankfurt San Francisco Hamburg Seoul Hong Kong Shanghai The entity requesting confidential treatment is: Houston Silicon Valley London Singapore Los Angeles Tokyo Zentalis Pharmaceuticals, LLC Madrid Washington, D.C. 530 Seventh Avenue, Suite 2201 Milan New York, New York 10018 Certain confidential information in this letter has been omitted and provided separately to the Securities and Exchange Commission. Confidential treatment has been requested by Zentalis Pharmaceuticals, LLC with respect to the omitted portions, which are identified in this letter by the mark “[***].” March 13, 2020 VIA EDGAR AND HAND DELIVERY CONFIDENTIAL U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Mail Stop 4720 Washington, D.C. 20549 Attention: Rolf Sundwall Daniel Gordon Chris Edwards Mary Beth Breslin Re: Zentalis Pharmaceuticals, LLC | Anticipated Price Range and Share-Based Compensation | Registration Statement on Form S-1 (File No. 333-236959) Dear Mr. Sundwall: On behalf of Zentalis Pharmaceuticals, LLC, (the “Company”), we submit this letter (this “Letter”) to the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”). The Company confidentially submitted a draft of the above-referenced Registration Statement (the “Registration Statement”) to the Commission on January 8, 2020, resubmitted to the March 13, 2020 Page 2 Commission on February 14, 2020, and subsequently filed the Registration Statement with the Commission on March 6, 2020. The purpose of this Letter is to respond to an outstanding comment relating to share-based compensation that was provided to the Company in a letter from the Staff dated February 6, 2020. Because of the commercially sensitive nature of the information contained herein, this submission is accompanied by the Company’s request for confidential treatment of selected portions of this Letter pursuant to Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. §200.83. A redacted letter has been filed on EDGAR, omitting the confidential information contained in the Letter. For the convenience of the Staff we are providing to the Staff copies of this Letter by hand delivery. In this Letter, we have recited the prior comment from the Staff in italicized, bold type and have followed the comment with the Company’s response. 8. Once you have an estimated offering price or range, please explain to us how you determined the fair value of the units underlying your equity issuances and the reasons for any differences between the recent valuations of your units leading up to the IPO and the estimated offering price. This information will help facilitate our review of your accounting for equity issuances including equity compensation and beneficial conversion features. Estimated Preliminary IPO Price Range The Company supplementally advises the Staff that, while not yet reflected in the Registration Statement, based on discussions with the Company’s board of directors (the “Board”) and reflecting input from the lead underwriters (the “Underwriters”) of the Company’s proposed initial public offering of its common stock (“IPO”), if the Company were to commence marketing of the transaction today, the Company presently anticipates that the estimated price range (assuming a one-to-one conversion ratio of the Company’s units to shares of common stock to be effective prior to the effectiveness of the Registration Statement)1 would be approximately $[***] per share to $[***] per share (the “Preliminary IPO Price Range”), with a midpoint of approximately $[***] per share (the “Preliminary Assumed IPO Price”). The Company advises the Staff that the final range to be included in a pre-effective amendment to the Registration Statement will include a price range of no more than $2.00, if the maximum price is $10.00 per share or less, or 20% of the high end of the range, if the maximum price is greater than $10.00 per share, unless otherwise approved by the Staff. The Company’s final range to be included in a pre-effective amendment to the Registration Statement remains under discussion between the Company and the Underwriters, and a bona fide price range will be included in an amendment to the Registration Statement prior to any distribution of the preliminary prospectus in connection with the Company’s road show. 1 The Company advises the Staff that the Company intends to adjust the one-to-one conversion ratio prior to the filing of an amendment to the Registration Statement that includes the Preliminary IPO Price Range, in which case, proportionate changes would be made to the Price Change. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY ZENTALIS PHARMACEUTICALS, LLC. March 13, 2020 Page 3 Summary of Recent Common Unit Grants and Valuation The Company is supplementally providing information and analysis with respect to equity-based compensation granted to employees and consultants under its equity incentive plans since January 1, 2019. The Company periodically grants Class B common units (the “Class B Common Units”) to certain of its employees, directors and consultants. These Class B Common Units are issued as “profits interests” as the common units receive distributions only if a certain threshold, which was set by the Board to equal the then total fair value of the Company’s equity as of the grant date for such grant (the “Applicable Grant Date Threshold”), is exceeded. The Applicable Grant Date Threshold impacts the fair value of the Company’s Class B Common Units because distributions, if any, are made in accordance with the priorities set forth in the Company’s limited liability company agreement. Class B Common Units with a lower Applicable Grant Date Threshold are entitled to receive distributions before Class B Common Unit holders with a higher Applicable Grant Date Threshold. The estimated fair value of the Company’s Class B Common Units has been determined as of each grant date, with input from management, considering third-party valuations of Class B Common Units, as well as management’s assessment of additional objective and subjective factors that it believed were relevant to the estimated fair value of the Class B Common Units. The valuation methodology as described below has been applied as there has been no public market to date for the common units of the Company. The third-party valuations were performed consistent with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “Practice Guide”), which prescribes several valuation approaches for determining the value of an enterprise, such as the cost, market and income approaches. In accordance with the Practice Guide, the Company considered the following methods for allocating the enterprise value across its classes and series of units to determine the estimated fair value of its Class B Common Units at each valuation date. Option Pricing Method (“OPM”). The OPM estimates the value of the common equity of the Company by treating the rights of the holders of common equity as equivalent to that of call options on any value of the enterprise above certain break points of value based upon the liquidation preferences of the holders of the Company’s preferred units, as well as their rights to participation. Thus, the value of the common units can be determined by estimating the value of its portion of each of these call option rights. Consequently, the common unit has value only if the funds available for distribution to unitholders exceed the value of the liquidation preference at the time of a liquidity event. Probability-Weighted Expected Return Method (“PWERM”). The PWERM is a scenario-based analysis that estimates the value per unit based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes considered by the Company, as well as the economic and control rights of each unit class. Hybrid Method. The Hybrid Method is a hybrid between the PWERM and OPM, estimating the probability-weighted value across multiple scenarios, but using the OPM to estimate the allocation of value within one or more of those scenarios. Weighting allocations are assigned to the OPM and PWERM methods factoring possible future liquidity events. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY ZENTALIS PHARMACEUTICALS, LLC. March 13, 2020 Page 4 Additionally, as the common units represent a non-marketable interest in a private enterprise, an adjustment to the preliminary value estimates must be made to account for the lack of liquidity that a unitholder may experience. This adjustment is commonly referred to as a discount for lack of marketability (“DLOM”). In order for the Board to determine the estimated fair value of the Class B Common Units, the OPM methodology was utilized for the independent third-party valuations of the Class B Common Units as of December 4, 2018 (the “December 2018 Valuation”). The Hybrid Method was utilized for the independent third-party valuations of the Class B Common Units as of September 6, 2019 (the “September 2019 Valuation”) and December 3, 2019 (the “December 2019 Valuation”) because the Company had improved visibility into the timing of a potential IPO. At each grant date, management evaluated any recent events and their potential impact on the estimated fair value per unit of the Class B Common Units. For grants of awards made on dates for which there was no contemporaneous independent third-party valuation, management determined the estimated fair value of the Class B Common Units on the date of grant taking into consideration the immediately preceding valuation report as well as other pertinent information available to it at the time of the grant. If deemed appropriate, the Company reassessed the fair value of the aforementioned awards based on a straight-line method between the valuation preceding and subsequent to the grant date. In connection with valuations as of and prior to the December 2018 Valuation, the Company considered a combination of the guideline public company method and the precedent transaction method, both forms of the market approach, to estimate the Company’s equity value, and then allocated value to the common units using the OPM. For the precedent transaction method, the most recent arm’s length convertible preferred unit financing was considered. For the guideline public company method, various financial metrics of similar development-stage publicly traded biotechnology guideline companies were considered. For both the September 2019 Valuation and the December 2019 Valuation, the valuation methodology changed to the use of a Hybrid Method incorporating the OPM and PWERM methodologies. The change in methodology reflected the Company’s improved visibility into the timing of a potential IPO, but still considered the uncertainty around the Company’s value if an IPO was not achieved. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY ZENTALIS PHARMACEUTICALS, LLC. March 13, 2020 Page 5 The following table summarizes by grant date the number of Class B Common Units granted since January 1, 2019, as well as the associated Applicable Grant Date Threshold and the estimated fair value per Class B Common Unit on the grant date at the Applicable Grant Date Threshold. Grant Date Number of Class B Common Units Granted Applicable Grant Date Threshold Estimated Fair Value Per Unit 1/31/2019 42,000 $ 143,800,076 $ 1.88 3/18/2019 5,500 $ 143,800,076 $ 1.95 4/1/2019 25,000 $ 143,800,076 $ 1.98 5/21/2019 3,000 $ 143,800,076 $ 2.01 6/3/2019 500 $ 143,800,076 $ 2.04 6/17/2019 15,000 $ 143,800,076 $ 2.04 9/10/2019 262,545 $ 309,824,355 $ 2.14 9/16/2019 15,000 $ 309,824,355 $ 2.14 12/3/2019 714,000 $ 309,824,355 $ 3.06 12/6/2019 8,000 $ 309,824,355 $ 3.06 12/9/2019 5,000 $ 309,824,355 $ 3.06 1/6/2020 70,000 $ 309,824,355 $ 3.06 The Company has not granted any additional equity awards since January 6, 2020. January 2019 to June 2019 Class B Common Unit Grants. The Company’s Board determined that the Applicable Grant Date Threshold for grants of Class B Common Units was $143,800,076.77, and management estimated the fair value of the Company’s Class B Common Units ranged from $1.88 to $2.04 per unit for the grants awarded from January 31, 2019 to June 17, 2019 based on objective and subjective factors that it believed were relevant and the results of the December 2018 Valuation. The Applicable Grant Date Threshold was supported by the value reflected in the recently closed Series B Convertible Preferred Unit offering. In the December 2018 Valuation, the independent third-party valuation specialist relied on the OPM methodology to derive and allocate the implied equity value for the Company. In conjunction with the OPM methodology, the valuation firm utilized both the guideline public company method and the precedent transaction or backsolve method, to determine the implied total value of the Company. The guideline public company method considered various financial metrics of publicly traded guideline companies, including growth metrics, valuation multiples and venture capital rates of return commensurate with the stage of the Company at the time of the valuation. In addition, both a protective put-option analysis based on the Asian Protective Put Method and an option-based approach based on the Finnerty Model were performed in an effort to estimate the appropriate DLOM for the Class B Common Units. After consideration of the above, the DLOM was concluded to be 25% for the December 2018 Valuation. The December 2018 Valuation estimated the fair value of the Class B Common Units to range from $1.85 to $2.01 based on the applicable participation threshold. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY ZENTALIS PHARMACEUTICALS, LLC. March 13, 2020 Page 6 As the Company progressed toward the initiation of a Series C Preferred Unit private financing that was completed in September 2019, the valuation firm considered the receipt of the proposed terms from existing and other potential investors to purchase $85.0 million of the Company’s Series C Convertible Preferred Units at $17.50 per unit (the “Proposed Series C Terms”) to determine the fair value of Class B Common Unit awards granted. Subsequent to the issuance of the awards from January 31, 2019 to June 17, 2019, the Company concluded on the Class B Common Unit fair value related to the aforementioned awards in light of the September 2019 Valuation (see below). As no significant milestones occurred between the December 2018 and September 2019 Valuation, the Company’s concluded fair value was based on a straight-line method between the December 2018 Valuation and the September 2019 Valuation which resulted in a weighted-average grant date estimated fair value of $1.94 per unit. The concluded grant date estimated fair value for these grants is reflected in stock-based compensation expense within the Company’s statement of operations for the year ended December 31, 2019 included in the Registration Statement. September 2019 Class B Common Unit Grants. The Company’s Board determined that the Applicable Grant Date Threshold for grants of Class B Common Units was $309,824,355.00, and management estimated the fair va
2020-03-11 - UPLOAD - Zentalis Pharmaceuticals, Inc.
March 11, 2020
Anthony Y. Sun, M.D.
Chief Executive Officer
Zentalis Pharmaceuticals, LLC
530 Seventh Avenue, Suite 2201
New York, New York 10018
Re:Zentalis Pharmaceuticals, LLC
Registration Statement on Form S-1
Filed March 6, 2020
File No. 333-236959
Dear Dr. Sun:
We have reviewed your 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Form S-1 filed March 6, 2020
Financial Statements
Consolidated Balance Sheets, page F-3
1.Please revise to disclose the redemption value of your convertible preferred units on the
face of the balance sheet. Refer to Regulation S-X, Item 5-02.27(b).
Notes to Consolidated Financial Statements
8. Convertible Preferred Units, page F-19
2.Please provide your analysis supporting the classification of your convertible preferred
units outside of permanent equity during 2019. In your response, tell us how the issuance
of your Series C Preferred Units amended the terms or conditions of your Series A and B
FirstName LastNameAnthony Y. Sun, M.D.
Comapany NameZentalis Pharmaceuticals, LLC
March 11, 2020 Page 2
FirstName LastName
Anthony Y. Sun, M.D.
Zentalis Pharmaceuticals, LLC
March 11, 2020
Page 2
Preferred Units, and whether classification outside of permanent equity may have been
appropriate in earlier periods.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Rolf Sundwall at 202-551-3105 or Daniel Gordon at 202-551-3486 if
you have questions regarding comments on the financial statements and related matters. Please
contact Chris Edwards at 202-551-6761 or Mary Beth Breslin at 202-551-3625 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Nathan Ajiashvili
2020-02-11 - UPLOAD - Zentalis Pharmaceuticals, Inc.
February 6, 2020
Anthony Y. Sun, M.D.
Chief Executive Officer
Zentalis Pharmaceuticals, LLC
530 Seventh Avenue, Suite 2201
New York, New York 10018
Re:Zentalis Pharmaceuticals, LLC
Draft Registration Statement on Form S-1
Submitted January 8, 2020
CIK No. 0001725160
Dear Dr. Sun:
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
Prospectus Summary
Overview, page 1
1.We note your statements throughout the prospectus that your product candidates have the
potential to have a "best-in-class" product profile. This term suggests that your product
candidates are effective, likely to be approved and compare favorably to competitive
products. It is premature and inappropriate for you to make such statements or
implications. Accordingly, please delete all references throughout your registration
statement to best-in-class product profiles. If you wish to distinguish your product
candidates from other treatments that are marketed or are being developed for your target
indications, such disclosure should be accompanied by cautionary language that the
FirstName LastNameAnthony Y. Sun, M.D.
Comapany NameZentalis Pharmaceuticals, LLC
February 6, 2020 Page 2
FirstName LastName
Anthony Y. Sun, M.D.
Zentalis Pharmaceuticals, LLC
February 6, 2020
Page 2
statements are not intended to give any indication that your product candidate has been
proven effective or that it will receive regulatory approval.
2.We note the your statement that you are developing "clinically differentiated"
therapeutics. Please explain this term. Please also clarify your reference to oncology
targets that have been "validated clinically." Please also define "SERD," "BCL-2,"
"EGFR," "NCE," and "third generation inhibitor" where they are first used.
ZN-e4 (EGFR Inhibitor), page 3
3.We note statements comparing ZN-e4 to osimertinib. As this comparison is not based on
head-to-head studies, please tell us why you believe it is appropriate to include
this comparison. In your response, please tell us whether you expect to be able to rely on
such comparison to support marketing approval for ZN-e4 from the FDA or other
comparable regulators.
Risk Factors
There is currently no FDA-approved oral SERB, page 15
4.We note your statement here that the data collected in preclinical and clinical trials
demonstrated "promising results" and similar disclosure throughout your prospectus, such
as your statement that "compelling" data was observed in the clinical trials to date
including "high potency and selectivity." As safety and efficacy determinations are solely
within the FDA's authority and they continue to be evaluated throughout all phases of
clinical trials, please remove these references. In the Business section, you may present
objective data resulting from your trials without including conclusions related to efficacy.
We are an "emerging growth company," and we cannot be certain if the reduced reporting
requirements applicable to emerging growth companies, page 64
5.Please revise the last paragraph to reflect, if true, that you have elected to take advantage
of the extended transition period for complying with new or revised accounting standards.
Use of Proceeds, page 71
6.Please revise your disclosure in this section to indicate how far the proceeds from the
offering will allow you to proceed in the Phase 1/2 clinical trials for ZN-c3 and ZN-e4 and
in the Phase 1 trial for ZN-d5. Please also disclose the amount and sources of other funds
needed to complete these clinical trials. Refer to Instruction 3 to Item 504 of Regulation
S-K.
Corporate Conversion, page 78
7.Please revise to clarify how many shares of common stock will be issued for each class of
common and preferred units.
FirstName LastNameAnthony Y. Sun, M.D.
Comapany NameZentalis Pharmaceuticals, LLC
February 6, 2020 Page 3
FirstName LastName
Anthony Y. Sun, M.D.
Zentalis Pharmaceuticals, LLC
February 6, 2020
Page 3
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Use of Estimates
Determination of the Fair Value of Class B Common Units, page 92
8.Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the units underlying your equity issuances and the reasons for
any differences between the recent valuations of your units leading up to the IPO and the
estimated offering price. This information will help facilitate our review of your
accounting for equity issuances including equity compensation and beneficial conversion
features.
Business
Our History and Team, page 96
9.Please explain the role of your scientific advisory board and business advisory board and
clarify, here or in the appropriate section of your filing, how members are compensated.
ZN-c5, an Oral SERD for the Treatment of ER+/HER2- Breast Cancer, page 99
10.We note your comparisons to fulvestrant and RAD1901 on on pages 99-105, as well as to
additional products in the graphic on page 111. We note similar comparative disclosures
in the discussions of ZN-c3, ZN-d5 and ZN-e4. As these results were not based on head-
to-head studies, please tell us why you believe it is appropriate to include this comparison.
In your response, please tell us whether you expect to be able to rely on such comparisons
to support marketing approval for any of the product candidates from the FDA or other
comparable regulators.
Phase 1/2 Clinical Trial of ZN-c5
Interim and Preliminary Efficacy Results, page 109
11.Here and elsewhere in the document where you discuss results of studies demonstrating
complete response and partial response, please clarify how you defined these terms.
Licensing Agreements and Strategic Collaborations
Recurium IP Holdings, LLC, page 129
12.Please revise to include the ownership percentage of Recurium Equity LLC at the time the
offering closes, along with the corresponding development and regulatory milestone
payments and royalties.
Mayo Foundation for Medical Education and Research, page 130
13.Please disclose when the last-to-expire licensed patent is currently scheduled to expire.
For the SciClone agreement, please revise to clarify the duration of the royalty
obligation and the term of the agreement. Please also revise to clarify the duration of the
Pfizer agreement.
FirstName LastNameAnthony Y. Sun, M.D.
Comapany NameZentalis Pharmaceuticals, LLC
February 6, 2020 Page 4
FirstName LastNameAnthony Y. Sun, M.D.
Zentalis Pharmaceuticals, LLC
February 6, 2020
Page 4
SciClone Pharmaceuticals International (Cayman) Development Ltd., page 130
14.The disclosure of your accounting policy for revenue under collaborative arrangements on
page F-11 suggests you may be eligible to receive additional milestone payments as well
as the reimbursement of research and development expenses under your collaboration and
license agreement with SciClone. Please revise to disclose the total aggregate milestone
payments you may become eligible to receive as well as a discussion of potential
reimbursements of research and development expenses.
Executive Compensation
Director Compensation, page 163
15.Please provide the compensation information for the compensation received by Mr.
Gallagher in fiscal year 2019.
Certain Relationships and Related Party Transactions, page 164
16.Please disclosure the nature of the affiliation between Kalyra Pharmaceuticals and
Recurium IP Holdings, LLC and the executive officers and directors listed in this section.
Basis of Presentation, page F-8
17.Please provide your analysis supporting the determination that Kalyra Pharmaceuticals,
Inc. is a variable interest entity, that you hold a variable interest in Kalyra, and that you
are the primary beneficiary.
2. Summary of Significant Accounting Policies
Revenue under Collaborative Agreements, page F-11
18.Please revise to disclose your determination of performance obligations under the
agreement, including judgements made concerning the timing of satisfaction and in the
allocation of the transaction price, if any. Refer to ASC 606-10-50-12 and 606-10-50-17.
In addition, include disclosure of your policies for recognizing revenues from milestone
payments and future royalties.
Exhibits
19.Please file the agreements with Mayo Foundation for Medical Education and
Research, SciClone Pharmaceuticals International and Pfizer, Inc., or tell us why those
agreements are not required to be filed.
General
20.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.
FirstName LastNameAnthony Y. Sun, M.D.
Comapany NameZentalis Pharmaceuticals, LLC
February 6, 2020 Page 5
FirstName LastName
Anthony Y. Sun, M.D.
Zentalis Pharmaceuticals, LLC
February 6, 2020
Page 5
You may contact Rolf Sundwall at 202-551-3105 or Daniel Gordon at 202-551-3486 if
you have questions regarding comments on the financial statements and related matters. Please
contact Chris Edwards at 202-551-6761 or Mary Beth Breslin at 202-551-3625 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Nathan Ajiashvili