Correspondence 0001193125-23-011057 from Crinetics Pharmaceuticals, Inc. (CRNX) (CIK 0001658247) (CRNX)
Crinetics Pharmaceuticals, Inc. (CRNX) (CIK 0001658247)
Date: Jan. 19, 2023 · CIK: 0001658247 · Accession: 0001193125-23-011057
AI Filing Summary & Sentiment
File numbers found in text: 001-38583
Referenced dates: December 20, 2022
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CORRESP 1 filename1.htm CORRESP 10222 Barnes Canyon Road, Bldg. 2, San Diego, California 92121 (858) 450-6464 www.crinetics.com January 19, 2023 Via EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F. Street, N.E. Washington, D.C. 20549 Attn: Ibolya Ignat Angela Connell Re: Crinetics Pharmaceuticals, Inc. Form 10-K for the Fiscal Year Ended December 31, 2021 Filed March 30, 2022 File No. 001-38583 To the addressees set forth above: This letter sets forth the response of Crinetics Pharmaceuticals, Inc. (the “Company,” “we,” “our” and “us”) to the comments provided by the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in its comment letter dated December 20, 2022 (the “Comment Letter”) with respect to the Company’s Form 10-K for the Fiscal Year Ended December 31, 2021 filed with the Commission on March 30, 2022. For your convenience, we have reproduced the comment of the Staff exactly as given in the Comment Letter in bold and italics below and set forth below the comment the Company’s response. Form 10-K for the Fiscal Year Ended December 31, 2021 Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Estimates Stock-based compensation expense, page 72 1. You state that you establish the volatility rate used to determine the fair value of your equity awards based on the historical volatility of a group of similar companies in the biotechnology industry that are publicly traded. As the company has been a public company since 2018, please tell us why you believe this methodology is appropriate. In this regard, tell us what your estimated expected volatility would have been for each year presented if you only considered the company’s expected and historical volatility rates and not the volatility rates of your peers. Further, explain why you did not use these company only rates in estimating the fair value of your stock options for those respective periods, and tell us when you no longer intend to consider the volatility rates of publicly traded peers in this estimate. We refer you to ASC718-10-55-37, and question 6 in SAB Topic 14.D.1. Lastly, please explain why the volatility used to estimate your stock option awards in 2021, 86%, is different from the volatility used for your ESPP volatility estimate, 91%. Direct us to disclosure included in your quarterly report for the period ended September 30, 2022 where the assumptions used to determine the fair value of your ESPP awards is discussed. Securities and Exchange Commission January 19, 2023 Page 2 Response: The Company respectfully acknowledges the Staff’s comment. The Company uses the Black-Scholes-Merton option-pricing model to calculate the fair value of stock options granted. Inputs into this option-pricing model include the exercise price of the option, the expected term of the option, the current price of the underlying share, the expected volatility of the price of the underlying share, the expected dividends on the underlying share, and the risk-free interest rate for the expected term of the option. The Company generally begins its estimation of the expected volatility rate by analyzing historical realized volatility. ASC 718-10-55-37(a) indicates that historical realized volatility should be measured over a period commensurate with the expected term of the option. While the Company’s shares have been publicly traded since July 2018, the length of time its shares have been publicly traded is shorter than the expected term of its options. To compensate for the limitation in Company-specific historical data, the Company has historically used the volatilities of life sciences companies with profiles similar to the Company, its peer group, in its calculation as it believes this best represents the expected volatilities over the expected term. Use of the volatility of similar entities by newly public entities is permitted by ASC 718-10-55-37(c). Additionally, in SAB Topic 14.D.1, the Staff stated that it would not object to a public entity basing its estimate of expected volatility on the volatility of similar entities for those periods for which it does not have sufficient information available. The Company acknowledges that the Staff believes that at least two years of daily or weekly historical data could provide a reasonable basis on which to base an estimate of expected volatility if a company has no reason to believe that its future volatility will differ materially during the expected term, as applicable, from the volatility calculated from this past information. However, the Company believes that its historical volatility since becoming a public company may not be indicative of its future volatility over the expected term since the shorter time horizon may not properly capture volatility that may be expected to occur over a longer period as a result of achievement (or lack thereof) of development or other milestones, common to the life sciences and pharmaceutical industries, and therefore the Company utilized peer group data commensurate with its expected term. Per the requirements of SAB Topic 14.D.1, from period to period, the Company has consistently applied this approach and will continue to do so until such time it has enough historical data or believes the volatility of its own market-traded shares best represent expected volatility. The Company believes its current process is consistent with ASC 718-10-55-38, which requires entities to consider adjustments to the historical volatility amounts where appropriate to derive expected volatility. The Company will continue to evaluate its historical volatility and whether circumstances indicate that the new or different information would be useful to estimate its expected volatility. The weighted average volatility of the Company’s peer group over the expected term of the stock options granted by the Company was approximately 86% and 78% for the years ended December 2021 and 2020, respectively, and the Company’s historical weighted average volatility of stock options for the same periods was approximately 68% and 63%, respectively. Given that the Company’s shares have been publicly traded since July 2018, the Company’s historical volatility rates for 2019 would have been based off less than two years of historical data and therefore have not been provided. The resulting impact of using the Company’s historical volatility rate rather than the volatility rate of the Company’s peer group would have been less than 1% of the Company’s total operating expenses for each of the years ended December 31, 2021 and 2020, respectively, and therefore considered insignificant. Volatilities used to estimate the value of stock option awards in 2021 differ from those used to value ESPP awards due to the difference in the expected terms of these awards. The Company’s ESPP expense for the nine-month period ended September 30, 2022, represented an immaterial amount of the total stock-based compensation expense and therefore the Company did not deem it necessary to disclose the inputs for the valuation of such awards. The Company will include such inputs in future annual and quarterly reports to be filed with the Commission. Equity Method Investment, page 72 2. Please provide us with a detailed analysis supporting your conclusion that Radionetics does not have sufficient equity at risk to finance its activities without additional subordinated financial support and therefore meets the definition of a variable interest entity (VIE). Address the following in your response: • Explain how you determined that Radionetics would not be able to obtain other non-subordinated sources of financing, if necessary. Securities and Exchange Commission January 19, 2023 Page 3 • Address your considerations of both quantitative and qualitative factors, to the extent considered in determining the sufficiency of equity at risk, using the guidance in ASC 810-10-25-45 through 810-10-25-47. • Ensure that your analysis focuses on whether Radionetics was structured, by design, not to have sufficient equity at risk. In this regard, ASC 810-10-15-14 states that the phrase “by design” refers to legal entities that meet the conditions in this paragraph because of the way they are structured. • ASC 810-10-25-47 states that the design of the legal entity and the apparent intentions of the parties that created the legal entity are important qualitative considerations. Clarify for us whether the formation of Radionetics was essentially the spin-off of your nonpeptide platform into a separate entity funded with $30 million in private financing provided by 5AM Ventures and Frazier Healthcare Partners and how this factored into your analysis. Response: The Company respectfully acknowledges the Staff’s comment. The Company considered the consolidation guidance in ASC 810-10-15-14 related to variable interest entities (“VIE”) and determined that Radionetics is a VIE. ASC 810-10-15-14 states, “A legal entity shall be subject to consolidation under the guidance in the Variable Interest Entities Subsections if, by design, any of the following conditions exist. (The phrase by design refers to legal entities that meet the conditions in this paragraph because of the way they are structured. For example, a legal entity under the control of its equity investors that originally was not a VIE does not become one because of operating losses. The design of the legal entity is important in the application of these provisions.) a. The total equity investment (equity investments in a legal entity are interests that are required to be reported as equity in that entity’s financial statements) at risk is not sufficient to permit the legal entity to finance its activities without additional subordinated financial support provided by any parties, including equity holders. For this purpose, the total equity investment at risk has all of the following characteristics: 1. Includes only equity investments in the legal entity that participate significantly in profits and losses even if those investments do not carry voting rights 2. Does not include equity interests that the legal entity issued in exchange for subordinated interests in other VIEs 3. Does not include amounts provided to the equity investor directly or indirectly by the legal entity or by other parties involved with the legal entity (for example, by fees, charitable contributions, or other payments), unless the provider is a parent, subsidiary, or affiliate of the investor that is required to be included in the same set of consolidated financial statements as the investor 4. Does not include amounts financed for the equity investor (for example, by loans or guarantees of loans) directly by the legal entity or by other parties involved with the legal entity, unless that party is a parent, subsidiary, or affiliate of the investor that is required to be included in the same set of consolidated financial statements as the investor. Paragraphs 810-10-25-45 through 25-47 discuss the amount of the total equity investment at risk that is necessary to permit a legal entity to finance its activities without additional subordinated financial support …” The design and purpose of Radionetics’ formation was to develop and commercialize existing technology owned by Crinetics through a world-wide license to Radionetics. While 5AM Ventures (“5AM”) and Frazier Healthcare Partners (“Frazier”) formed Radionetics in September 2021 prior to completing the license arrangement with Crinetics on October 15, 2021, Crinetics actively participated in discussions about the structure and corporate governance throughout 2021 with 5AM and Frazier, including establishing how the board of directors, joint development committee, and joint patent committee would be determined and maintained. The formation of Radionetics was, by design, to separate the technology comprised of a pipeline of novel, targeted nonpeptide radiotherapeutics for the treatment of a broad range of oncology indications that Crinetics was not actively developing, thus allowing for specific funding to advance these technologies. As a development stage entity, by design, Radionetics has multiple phases that include the development of a pipeline of oncology indications (“phase 1”) and commercialization (“phase 2”). The Company evaluated the sufficiency of Radionetics’ equity at risk related to phase 1. Securities and Exchange Commission January 19, 2023 Page 4 ASC 810-10-25-45 through 25-47 Assessment “25-45 An equity investment at risk of less than 10 percent of the legal entity’s total assets shall not be considered sufficient to permit the legal entity to finance its activities without subordinated financial support in addition to the equity investment unless the equity investment can be demonstrated to be sufficient. The demonstration that equity is sufficient may be based on either qualitative analysis or quantitative analysis or a combination of both. Qualitative assessments, including, but not limited to, the qualitative assessments described in (a) and (b), will in some cases be conclusive in determining that the legal entity’s equity at risk is sufficient. If, after diligent effort, a reasonable conclusion about the sufficiency of the legal entity’s equity at risk cannot be reached based solely on qualitative considerations, the quantitative analyses implied by (c) shall be made. In instances in which neither a qualitative assessment nor a quantitative assessment, taken alone, is conclusive, the determination of whether the equity at risk is sufficient shall be based on a combination of qualitative and quantitative analyses.” “a. The legal entity has demonstrated that it can finance its activities without additional subordinated financial support.” Radionetics has demonstrated that it cannot finance its activities without subordinated financial support since Radionetics’ financing has been in the form of subordinated debt (i.e., convertible notes). The license and related technology acquired from Crinetics through the License Agreement will require substantial additional investment in research and development, including clinical trials, in order to bring Radionetics’ planned products to market. If successful, multiple rounds of funding will be required to progress a single drug candidate through clinical trials, let alone a pipeline of drug candidates. Given that Radionetics’ intellectual property is still in its infancy, the Company does not believe Radionetics’ intangible assets could be used as collateral for an unsubordinated loan. Furthermore, the Company believes that Radionetics’ shareholders would likely need to guarantee any third-party debt. Therefore, it is the Company’s judgment that Radionetics has not demonstrated that it can finance its activities without additional subordinated financial support. “b. The legal entity has at least as much equity invested as other entities that hold only similar assets of similar quality in similar amounts and operate with no additional subordinated financial support.” Given the nature of Radionetics’ business is aimed to develop a pipeline of nonpeptide radiopharmaceuticals for the treatment of a broad range of oncology indications, the nature of its assets, geographical areas, capital structure and operations are similar to those other life science startups which often do not have sufficient equity to finance its activities without additional subordinated financial support. Radionetics will likely require multiple rounds of equity financing to progress a single drug candidate through clinical trials, let alone a pipeline of drug candidates. The Company estimates that advancing these technologies will require funding