Crinetics Pharmaceuticals Inc
For the period ended Jun 30, 2024. Filed Aug 8, 2024.
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Jun 30, 2024 · Filed Aug 8, 2024
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Notes to Condensed Consolidated Financial Statements
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Notes to Unaudited Condensed Consolidated Financial Statements
- ORGANIZATION AND BASIS OF PRESENTATION
Description of Business
Crinetics Pharmaceuticals, Inc. (the “Company”) is a clinical-stage pharmaceutical company incorporated in Delaware on November 18, 2008, and based in San Diego, California. The Company is focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. In January 2017, the Company established a wholly-owned Australian subsidiary, Crinetics Australia Pty Ltd (“CAPL”), in order to conduct various preclinical and clinical activities for its development candidates.
Unaudited Interim Financial Information
The accompanying interim condensed consolidated balance sheet as of June 30, 2024, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2024 and 2023, the condensed consolidated statements of stockholders’ equity for the three and six months ended June 30, 2024 and 2023, and the condensed consolidated statements of cash flows for the six months ended June 30, 2024 and 2023, and the related disclosures are unaudited. In management’s opinion, the unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of June 30, 2024 and the results of its operations and cash flows for the six months ended June 30, 2024 and 2023 in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The results for the three and six months ended June 30, 2024 are not necessarily indicative of the results expected for the full fiscal year or any other interim period.
These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2023, included in the Company's Annual Report on Form 10-K filed with the SEC on February 28, 2024. The condensed consolidated balance sheet as of December 31, 2023, has been derived from the audited consolidated financial statements as of that date, but does not include all of the information and footnotes required by GAAP for complete financial statements.
Principles of Consolidation and Foreign Currency Transactions
The condensed consolidated financial statements include the accounts of the Company and CAPL. All intercompany accounts and transactions have been eliminated in consolidation. The functional currency of both the Company and CAPL is the U.S. dollar. Assets and liabilities that are not denominated in the functional currency are remeasured into U.S. dollars at foreign currency exchange rates in effect at the balance sheet date except for nonmonetary assets, which are remeasured at historical foreign currency exchange rates in effect at the date of transaction. Net realized and unrealized gains and losses from foreign currency transactions and remeasurement are reported in other income (expense), in the condensed consolidated statements of operations and comprehensive loss and were not material for all periods presented.
Segment Reporting
Operating segments are identified as components of an enterprise about which discrete financial information is available for evaluation by the chief operating decision-maker ("CODM") in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business inone operating segment.
Liquidity
From inception, the Company has devoted substantially all of its efforts to drug discovery and development, and conducting preclinical studies and clinical trials. The Company has a limited operating history, and the sales and income potential of the Company’s business and market are unproven. Successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure. The Company has experienced net losses and negative cash flows from operating activities since its inception and has an accumulated deficit of$794.7 million as of June 30, 2024.
As of June 30, 2024, the Company had$863.0 million in unrestricted cash, cash equivalents and investment securities, which the Company believes is sufficient to meet its funding requirements for at least the next 12 months.
The Company expects to continue to incur net losses for the foreseeable future and believes it will need to raise substantial additional capital to accomplish its business plan over the next several years. The Company plans to continue to fund its losses from operations and capital funding needs through a combination of equity offerings, debt financings or other sources, including potential collaborations, licenses, and other similar arrangements. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations and prospects. There can be no assurance as to the availability or terms upon which such financing and capital might be available in the future.
- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
During the six months ended June 30, 2024, there were no changes to our significant accounting policies as described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023.
Net Loss Per Share
Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock and dilutive common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. Dilutive common stock equivalents are comprised of common stock subject to repurchase and stock options outstanding under the Company’s stock option plan. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities on loss per share would be antidilutive.
Potentially dilutive securities (in common stock equivalent shares) not included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows (in thousands):
| As of June 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Stock options | 14,138 | 12,423 |
| Restricted stock units | 1,430 | 843 |
| Employee stock purchase plan | 231 | 268 |
| Total | 15,799 | 13,534 |
Recent Accounting Pronouncements
ASU 2023-07
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280) Improvements to Reportable Segment Disclosures(“Topic 280”), which modifies the disclosure and presentation requirements of reportable segments. The amendments in the update require the disclosure of significant segment expenses that are regularly provided to the CODM and included within each reported measure of segment profit and loss. The amendments also require disclosure of all other segment items by reportable segment and a description of its composition. Additionally, the amendments require disclosure of the title and position of the CODM and an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. Lastly, the amendment requires that a public entity that has a single reportable segment provide all the disclosures required by ASU 2023-07 and all existing segment disclosures in Topic 280. This update is effective for annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact that this guidance will have on the presentation of its condensed consolidated financial statements and accompanying notes.
ASU 2023-09
In December 2023, the FASB issued ASU No. 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. ASU 2023-09 requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for public entities with annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that this guidance will have on the presentation of its condensed consolidated financial statements and accompanying notes.
- INVESTMENT SECURITIES
The Company reports its available-for-sale investment securities at their estimated fair values. The following is a summary of the available-for-sale investment securities held by the Company as of June 30, 2024 and December 31, 2023 (in thousands):
| AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | FairMarketValue | |
|---|---|---|---|---|
| Available-for-sale investment securities: | ||||
| U.S. government obligations | $269,618 | $14 | $(99) | $269,533 |
| Agency obligations | 7,806 | — | (5) | 7,801 |
| Certificates of deposit | 735 | — | — | 735 |
| Corporate debt securities | 282,822 | 118 | (218) | 282,722 |
| Total | $560,981 | $132 | $(322) | $560,791 |
| AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | FairMarketValue | |
|---|---|---|---|---|
| Available-for-sale investment securities: | ||||
| U.S. government obligations | $279,577 | $731 | $(99) | $280,209 |
| Agency obligations | 21,271 | 16 | (17) | 21,270 |
| Certificates of deposit | 2,450 | 2 | (12) | 2,440 |
| Corporate debt securities | 196,399 | 526 | (170) | 196,755 |
| Commercial paper | 2,984 | — | — | 2,984 |
| Total | $502,681 | $1,275 | $(298) | $503,658 |
As of June 30, 2024 and December 31, 2023, available-for-sale investment securities by contractual maturity were as follows (in thousands):
| As of June 30, 2024 | As of December 31, 2023 | |||
|---|---|---|---|---|
| AmortizedCost | FairMarketValue | AmortizedCost | FairMarketValue | |
| Available-for-sale investment securities: | ||||
| Due in one year or less | $444,738 | $444,621 | $414,031 | $414,406 |
| Due after one year through five years | 116,243 | 116,170 | 88,650 | 89,252 |
| Total | $560,981 | $560,791 | $502,681 | $503,658 |
The following is a summary of the available-for-sale investment securities by length of time in a net loss position as of June 30, 2024 and December 31, 2023 (in thousands):
| Less Than 12 Months | More Than 12 Months | Total | ||||
|---|---|---|---|---|---|---|
| FairMarketValue | GrossUnrealizedLosses | FairMarketValue | GrossUnrealizedLosses | FairMarketValue | GrossUnrealizedLosses | |
| Available-for-sale investment securities: | ||||||
| U.S. government obligations | $153,626 | $(99) | $— | $— | $153,626 | $(99) |
| Agency obligations | 7,801 | (5) | — | — | 7,801 | (5) |
| Certificates of deposit | 245 | — | 490 | — | 735 | — |
| Corporate debt securities | 188,674 | (218) | — | — | 188,674 | (218) |
| Total | $350,346 | $(322) | $490 | $— | $350,836 | $(322) |
| Less Than 12 Months | More Than 12 Months | Total | ||||
|---|---|---|---|---|---|---|
| FairMarketValue | GrossUnrealizedLosses | FairMarketValue | GrossUnrealizedLosses | FairMarketValue | GrossUnrealizedLosses | |
| Available-for-sale investment securities: | ||||||
| U.S. government obligations | $10,400 | $(11) | $12,374 | $(88) | $22,774 | $(99) |
| Agency obligations | 8,170 | (3) | 5,484 | (14) | 13,654 | (17) |
| Certificates of deposit | 244 | (1) | 1,213 | (11) | 1,457 | (12) |
| Corporate debt securities | 3,595 | — | 32,612 | (170) | 36,207 | (170) |
| Total | $22,409 | $(15) | $51,683 | $(283) | $74,092 | $(298) |
The Company reviewed its investment holdings as of June 30, 2024 and December 31, 2023 and determined that the decline in fair value is attributable to changes in interest rates and not credit quality, and as the Company does not intend to sell the investments and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost basis, which may be maturity. Therefore, there wereno allowances for credit losses as of June 30, 2024 and December 31, 2023.
- FAIR VALUE MEASUREMENTS
Investment Securities
The Company holds investment securities that consist of highly liquid, investment grade debt securities. The Company determines the fair value of its investment securities based upon one or more valuations reported by its investment accounting and reporting service provider. The investment service provider values the securities using a hierarchical security pricing model that relies primarily on valuations provided by an industry-recognized valuation service. Such valuations may be based on trade prices in active markets for identical assets or liabilities (Level 1 inputs) or valuation models using inputs that are observable either directly or indirectly (Level 2 inputs), such as quoted prices for similar assets or liabilities, yield curves, volatility factors, credit spreads, default rates, loss severity, current market and contractual prices for the underlying instruments or debt, and broker and dealer quotes, as well as other relevant economic measures.
Financial assets measured at fair value on a recurring basis as of June 30, 2024 and December 31, 2023 were as follows (in thousands):
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Investment securities: | ||||
| U.S. government obligations | $269,533 | $— | $— | $269,533 |
| Agency obligations | — | 7,801 | — | 7,801 |
| Certificates of deposit | — | 735 | — | 735 |
| Corporate debt securities | — | 282,722 | — | 282,722 |
| Total assets measured at fair value | $269,533 | $291,258 | $— | $560,791 |
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Investment securities: | ||||
| U.S. government obligations | $280,209 | $— | $— | $280,209 |
| Agency obligations | — | 21,270 | — | 21,270 |
| Certificates of deposit | — | 2,440 | — | 2,440 |
| Corporate debt securities | — | 196,755 | — | 196,755 |
| Commercial paper | — | 2,984 | — | 2,984 |
| Total assets measured at fair value | $280,209 | $223,449 | $— | $503,658 |
The Company’s policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer. There wereno transfers into or out of Level 3 during thesix months ended June 30, 2024 and 2023.
- BALANCE SHEET DETAILS
Prepaid expenses and other current assets consisted of the follo wing (in thousands):
| June 30,2024 | December 31,2023 | |
|---|---|---|
| Prepaid clinical costs | $1,655 | $2,574 |
| Prepaid research and development costs | 905 | 1,238 |
| Australian tax incentive receivable | 290 | 747 |
| Prepaid insurance | 334 | 857 |
| Prepaid subscriptions | 2,317 | 1,130 |
| Interest receivable | 3,483 | 3,051 |
| Due from Radionetics (Note 11) | 119 | 90 |
| Landlord improvements receivable | 890 | 5,210 |
| Receivable for common stock issued | 318 | 253 |
| Other | 1,512 | 448 |
| Total | $11,823 | $15,598 |
Property and equipment, net consisted of the following (in thousands):
| June 30,2024 | December 31,2023 | |
|---|---|---|
| Leasehold improvements | $11,000 | $9,837 |
| Lab equipment | 5,318 | 4,253 |
| Office equipment | 2,100 | 1,854 |
| Computers and software | 60 | 5 |
| Property and equipment at cost | 18,478 | 15,949 |
| Less accumulated depreciation and amortization | (6,231) | (5,068) |
| Total | $12,247 | $10,881 |
Accounts payable and accrued expenses consisted of the following (in thousands):
| June 30,2024 | December 31,2023 | |
|---|---|---|
| Accounts payable | $8,872 | $6,548 |
| Accrued clinical trial costs | 4,373 | 5,527 |
| Accrued research and development costs | 4,527 | 2,312 |
| Accrued outside services and professional fees | 5,125 | 1,726 |
| Accrued landlord improvements | 19 | 3,816 |
| Other accrued expenses | 1,081 | 3,267 |
| Total | $23,997 | $23,196 |
- OPERATING LEASES
In February 2018, the Company entered into a non-cancellable operating lease, as amended in March 2018, for a facility in San Diego, California (the "2018 Lease"). The 2018 Lease has an initial term ofseven years which expires in August 2025, and the Company has an option to extend the term of the 2018 Lease for an additional five years, a termination option subject to early termination fees and an option to sublease the facility. The 2018 Lease is subject to base lease payments and additional charges for common area maintenance and other costs and includes certain lease incentives and tenant improvement allowances. The Company’s estimated incremental fully collateralized borrowing rate of 8.0% was used in its present value calculation as the 2018 Lease does not have a stated rate and the implicit rate was not readily determinable.
In 2022, the Company entered into a lease agreement for laboratory and office space in San Diego, California (the "2022 Lease").
Under the terms of the 2022 Lease, the Company's expected future monthly minimum lease payments of $0.5 million, with six months of rent abatement in the first year, start on the earlier of (i) the date which is ten (10) months after substantial completion of demolition work, or (ii) the date of the substantial completion of improvements and first occupancy for business purposes, and the term expires on the date immediately preceding the one hundred thirty-seventh (137th) monthly anniversary of this lease payment start date. Lease payments are subject to annual 3% increases. The Company is also responsible for certain operating expenses and taxes during the term of the 2022 Lease. The 2022 Lease provides the Company with specified tenant improvement and landlord work allowances. The Company has (i) two options to extend the term of the 2022 Lease for an additional period of five (5) years each, and (ii) a right of first offer on adjacent space to the new facility, subject to the terms and conditions of the 2022 Lease. The 2022 Lease commenced in 2023 when the building was ready and available for its intended use. Asof the date of the recording of the 2022 Lease, the Company isnot reasonably certain that these options will be exercised. In September 2023, the Company recorded a right-of-use asset and corresponding lease liability in the accompanying condensed consolidated balance sheets in connection with the 2022 Lease.
In December 2023, the Company entered into a lease amendment to the 2022 Lease that moved the initial payment date and start of the hundred thirty-seventh month from September 2023 to November 2023. The amendment was a modification that did not result in a new contract as the modification did not provide the Company additional right-of-use assets. As a result, the Company recorded a $0.7 million reduction to right-of-use assets and lease liabilities in the accompanying condensed consolidated balance sheets.
The Company’s estimated incremental fully collateralized borrowing rate of 8.6% was used in its present value calculation as the 2022 Lease does not have a stated rate and the implicit rate was not readily determinable. The rate was determined using a synthetic credit rating analysis.
Under the terms of the 2018 Lease and 2022 Lease, the Company provided the lessors with irrevocable letters of credit in the amounts of $0.5 million and $0.8 million, respectively. The lessors are entitled to draw on the letters of credit in the event of any default by the Company under the terms of the leases.
As of June 30, 2024, the Company's future minimum payments under non-cancellable operating lease, were as follows (in thousands):
| Year ending December 31, | MinimumPayments |
|---|---|
| 2024 (six months) | $3,857 |
| 2025 | 7,468 |
| 2026 | 6,795 |
| 2027 | 6,999 |
| 2028 | 7,209 |
| Thereafter | 50,975 |
| Total future minimum lease payments | 83,303 |
| Less imputed interest | (29,985) |
| Total operating lease liabilities | 53,318 |
| Less operating lease liabilities, current | (7,445) |
| Operating lease liabilities, non-current | $45,873 |
Operating lease cost was $2.1 million and $4.3 million for the three and six months ended June 30, 2024, respectively. Operating lease cost was $0.3 million and $0.6 million for the three and six months ended June 30, 2023, respectively. As of June 30, 2024 and December 31, 2023, the Company’s weighted average remaining term was 10.6 years and 11.1 years, respectively. As of June 30, 2024 and December 31, 2023, the Company’s weighted-average discount rate was 8.6% and 8.6%, respectively.
Cash paid for amounts included in the measurement of lease liabilities for operating cash flow from operating leases was $0.3 million and $0.6 million for the three and six months ended June 30, 2024, respectively. Cash paid for amounts included in the measurement of lease liabilities for operating cash flow from operating leases was $0.3 million and $0.6 million for the three and six months ended June 30, 2023, respectively.
- COMMITMENTS AND CONTINGENCIES
Litigation
From time to time, the Company may be subject to various claims and suits arising in the ordinary course of business. The Company does not expect that the resolution of these matters will have a material adverse effect on its financial position or results of operations.
- REVENUE RECOGNITION
Sanwa Kagaku Kenkyusho Co., Ltd
On February 25, 2022, the Company and Sanwa Kagaku Kenkyusho Co., Ltd. ("Sanwa"), entered into a license agreement (the “Sanwa License”) whereby the Company granted Sanwa an exclusive license to develop and commercialize paltusotine in Japan.
Under the Sanwa License, Sanwa has the right to receive data obtained by the Company through certain paltusotine studies. The Company assessed the Sanwa License and concluded that Sanwa is a customer within the agreement. Sanwa will assume all costs associated with clinical trials and regulatory applications associated with these processes in Japan. Further, the Company retains all rights to develop and commercialize the product outside Japan. The Company also granted Sanwa the right to purchase supply of paltusotine for clinical and commercial requirements at cost plus a pre-negotiated percentage which was a market rate and therefore not a material right.
The Company determined that its performance obligations under the Sanwa License comprised the license and data exchange. Certain professional services, such as the Company's participation on committees, were deemed to be immaterial to the context of the contract.
In exchange, the Company received a $13.0 million nonrefundable, upfront payment and will be eligible to receive up to an additional $25.5 million in milestone payments related to the achievement of certain development, regulatory and commercial goals. In addition, upon market approval of paltusotine in Japan, the Company will be eligible to receive certain sales-based royalties. Initially, the Company determined that the transaction price amounted to the upfront payment of $13.0 million.
During the six months ended June 30, 2024, the Company achieved a $1.0 million milestone for the first indication of the development milestones. As of June 30, 2024, the Company updated its estimated transaction price to $14.0 million and recorded a cumulative catch-up adjustment of $0.4 million during the six months ended June 30, 2024. As there have been no sales to date, no sales-based milestones or royalties were recognized to date. Further, using the most-likely-method, the other developmental milestone payments continued to be considered fully constrained.
The control of the license was transferred to Sanwa at the inception of the contract and the Company does not have an ongoing performance obligation to support or maintain the licensed intellectual property. Revenue allocated to the data exchange obligation is recognized over time using the cost-to-cost measure as this method represents a faithful depiction of progress toward the ongoing paltusotine studies in the U.S. and related data transfer. Revenue is recognized on a gross basis as the Company is the principal.
Deferred revenue consisted of the following (in thousands):
| Three months ended June 30, | Six months ended June 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Deferred revenues at beginning of period | $7,204 | $7,736 | $6,806 | $8,341 |
| Unearned revenue from cash received during the period, excluding amounts recognized as revenue during the period | — | — | 550 | — |
| Revenue recognized that was included in deferred revenues as of the beginning of the period | (324) | (584) | (476) | (1,189) |
| Deferred revenues at end of period | $6,880 | $7,152 | $6,880 | $7,152 |
During the three and six months ended June 30, 2024, $0.3 million and $0.9 million, respectively, of the $14.0 million estimated transaction price was recognized as revenues in the accompanying condensed consolidated statements of operations and comprehensive loss. During thethree and six months ended June 30, 2023, $0.6 million and $1.2 million, respectively, of the $14.0 million estimated transaction price was recognized as revenues in the accompanying condensed consolidated statements of operations and comprehensive loss. Deferred revenues are expected to be recognized over the duration of certain paltusotine studies conducted by the Company.
On June 14, 2022, the Company and Sanwa, entered into a clinical supply agreement (the "Sanwa Clinical Supply Agreement") whereby the Company is responsible for manufacturing and supplying certain materials to Sanwa for specified activities under the Sanwa License. During each of the three and six months ended June 30, 2024, the Company recognized $0.1 million, respectively, of revenues from the Sanwa Clinical Supply Agreement in the accompanying condensed consolidated statements of operations and comprehensive loss. During each of thethree and six months ended June 30, 2023, the Company recognized $0.4 million of revenues from the Sanwa Clinical Supply Agreement in the accompanying condensed consolidated statements of operations and comprehensive loss.
Cellular Longevity, Inc., doing business as Loyal
On March 24, 2023, the Company and Cellular Longevity Inc., doing business as Loyal ("Loyal") entered into a license agreement (the “Loyal License”) whereby the Company granted Loyal an exclusive license to develop and commercialize CRN01941, a somatostatin receptor type 2 agonist, for veterinary use. In exchange the Company received a $0.1 million nonrefundable, upfront payment and preferred stock in Loyal valued at approximately $2.0 million. The Company will also be eligible to receive certain single-digit sales-based royalties if the licensed intellectual property is approved for veterinary use.
During the three and six months ended June 30, 2024, the Company didnot recognize any revenues from the Loyal License. During the three and six months ended June 30, 2023, the Company recognized zero and $2.1 million, respectively, of revenues from the Loyal License in the accompanying condensed consolidated statements of operations and comprehensive loss. As of June 30, 2024, the shares of Loyal preferred stock issued and to be issued to the Company valued at $2.0 million is included in other assets in the accompanying condensed consolidated balance sheets. The Loyal preferred stock does not have a readily determinable fair value and is recorded at cost less impairment. The Company assesses equity securities without a readily determinable fair value for changes in observable prices each period, noting none.
- STOCKHOLDERS’ EQUITY
Stock Offerings
On March 1, 2024, the Company completed a private placement offering of 8,333,334 shares of its common stock at a price of $42.00 per share. Net proceeds from the offering were approximately $335.5 million, after offering costs of approximately $14.5 million. On
March 19, 2024, the Company registered for resale the shares issued and sold in the Private Placement, pursuant to the Registration Rights Agreement entered into with the Purchasers, dated February 27, 2024.
ATM Offerings
On August 13, 2019, the Company entered into a Sales Agreement (as amended, the “2019 Sales Agreement”) with SVB Leerink LLC and Cantor Fitzgerald & Co. (collectively, the “Sales Agents”), under which the Company could, from time to time, sell up to $150.0 million of shares of its common stock through the Sales Agents (the “2019 ATM Offering”). The 2019 ATM Offering was terminated upon the filing by the Company of its Registration Statement on Form S-3ASR on June 21, 2024.
On June 21, 2024, the Company entered into a Sales Agreement (the “2024 Sales Agreement”) with the Sales Agents under which the Company may, from time to time, sell up to $350.0 million of shares of its common stock through the Sales Agents (the “2024 ATM Offering”).
During the three and six months ended June 30, 2024, the Company issued 0 and 1,223,775 shares of common stock pursuant to the 2019 ATM Offering for net proceeds of approximately $0 and $43.4 million, respectively, after deducting commissions. No shares of common stock were issued pursuant to the 2024 ATM Offering.
- EQUITY INCENTIVE PLANS
2021 Employment Inducement Incentive Award Plan
The Company adopted the 2021 Employment Inducement Incentive Award Plan (the "2021 Inducement Plan") in December 2021. The Company initially reserved 1,500,000 shares of the Company’s common stock for issuance pursuant to awards granted under the 2021 Inducement Plan. The terms of the 2021 Inducement Plan are substantially similar to the terms of the Company’s 2018 Incentive Award Plan with the exception that awards may only be made to an employee who has not previously been an employee or member of the board of directors of the Company if the award is in connection with commencement of employment. In 2022, the Company amended the 2021 Inducement Plan to increase the numberof shares of the Company’s common stock available for future issuance under the 2021 Inducement Plan to 5,000,000 shares. In November 2023, the Company amended the 2021 Inducement Plan to increase the number of shares of the Company’s common stock available for future issuance under the 2021 Inducement Plan to 7,500,000 shares. As of June 30, 2024,1,857,809 shares of common stock were available for future issuance under the 2021 Inducement Plan.
2018 Incentive Award Plan
The Company adopted the 2018 Incentive Award Plan (the “2018 Plan”) in July 2018. Under the 2018 Plan, which expires in July 2028, the Company may grant equity-based awards to individuals who are employees, officers, directors or consultants of the Company. Options issued under the 2018 Plan will generally expireten years from the date of grant and vest over afour-year period. As of June 30, 2024,2,868,497 shares of common stock were available for future issuance under the 2018 Plan.
The 2018 Plan contains a provision that allows annual increases in the number of shares available for issuance on the first day of each calendar year through January 1, 2028, in an amount equal to the lesser of: (i)5% of the aggregate number of shares of the Company’s common stock outstanding on December 31 of the immediately preceding calendar year, or (ii) such lesser amount determined by the Company. Under this evergreen provision, on January 1, 2024, an additional 3,408,761 shares became available for future issuance under the 2018 Plan.
2015 Stock Incentive Plan
The Company adopted the 2015 Stock Incentive Plan (the “2015 Plan”) in February 2015, which provided for the issuance of equity awards to the Company’s employees, members of its board of directors and consultants. In general, options issued under this plan vest over four years and expire after 10 years. Subsequent to the adoption of the 2018 Plan, no additional equity awards can be made under the 2015 Plan.
2018 Employee Stock Purchase Plan
The Company adopted the 2018 Employee Stock Purchase Plan (the “ESPP”) in July 2018. The ESPP permits participants to purchase common stock through payroll deductions of up to 20% of their eligible compensation. As of June 30, 2024,2,157,852 shares of common stock were available for issuance under the ESPP.
The ESPP contains a provision that allows annual increases in the number of shares available for issuance on the first day of each calendar year through January 1, 2028, in an amount equal to the lesser of: (i)1% of the aggregate number of shares of the Company’s common stock outstanding on December 31 of the immediately preceding calendar year, or (ii) such lesser amount determined by the Company. Under this evergreen provision, on January 1, 2024, an additional 681,752 shares became available for future issuance under the ESPP.
Stock Awards
Stock Options
Activity under the Company’s stock option plans during thesix months ended June 30, 2024 was as follows:
| Weighted- · Weighted- · Aggregate | ||||
|---|---|---|---|---|
| Average · Average · Intrinsic | ||||
| Options | Exercise | Remaining | Value | |
| Outstanding | Price | Term | (000’s) | |
| Balance at December 31, 2023 | 12,627,124 | $18.96 | ||
| Granted | 3,061,753 | $43.60 | ||
| Exercised | (1,230,857) | $16.64 | ||
| Forfeited and expired | (319,775) | $23.08 | ||
| Balance at June 30, 2024 | 14,138,245 | $24.40 | 8.0 | $288,961 |
| Vested and expected to vest at June 30, 2024 | 14,138,245 | $24.40 | 8.0 | $288,961 |
| Exercisable at June 30, 2024 | 5,796,606 | $18.69 | 6.7 | $151,303 |
Aggregate intrinsic value is calculated as the difference at a specific point in time between the closing price of the Company’s common stock on June 28, 2024, the last trading day of the quarter, and the exercise price of stock options that had exercise prices below the closing price. The aggregate intrinsic value of options exercised during the six months ended June 30, 2024 and 2023 was $34.0 million and $0.8 million, respectively.
Restricted Stock Units
The Company’s restricted stock unit activity during thesix months ended June 30, 2024, was as follows:
| Weighted- | ||
|---|---|---|
| Restricted Stock | Average | |
| Units | Grant Date | |
| Outstanding | Fair Value | |
| Balance at December 31, 2023 | 813,634 | $19.71 |
| Granted | 897,686 | $43.54 |
| Vested | (243,910) | $19.85 |
| Forfeited | (37,574) | $31.46 |
| Balance at June 30, 2024 | 1,429,836 | $34.34 |
Fair Value of Stock Awards
The Company estimates the fair value of all stock option grants and the ESPP using the Black-Scholes option pricing model and recognizes forfeitures as they occur. The following table summarizes the weighted average assumptions used to estimate the fair value of stock options granted under the Company’s stock option plans for the periods presented below:
| Stock Option Awards | Three months ended June 30, | Six months ended June 30, | ||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Expected option term | 6.0 years | 6.0 years | 6.0 years | 6.0 years |
| Expected volatility | 66% | 65% | 66% | 66% |
| Risk free interest rate | 4.5% | 3.6% | 4.3% | 4.0% |
| Expected dividend yield | —% | —% | —% | —% |
The weighted-average fair value of stock options awarded was $29.32 and $27.73 per share during thethree and six months ended June 30, 2024, respectively, and $12.56 and $12.38 per share during the three and six months ended June 30, 2023, respectively.
The following table summarizes the weighted average assumptions used to estimate the fair value of the ESPP for the periods presented below:
| ESPP | Three and six months Ended June 30, | |
|---|---|---|
| 2024 | 2023 | |
| Expected term | 1.1 years | 1.1 years |
| Expected volatility | 74% | 57% |
| Risk free interest rate | 5.1% | 4.9% |
| Expected dividend yield | —% | —% |
The weighted-average fair value of the ESPP was $22.07 per share during each of the three and six months ended June 30, 2024, respectively, and $9.15 per share during each of the three and six months ended June 30, 2023, respectively.
The key assumptions used in determining the fair value of equity awards, and the Company’s rationale, were as follows: (i) Expected term - the expected term for stock options represents the period that the stock options are expected to be outstanding and has been estimated using the simplified method, due to limited historical exercise behavior. The expected term using the simplified method is an average of the contractual option term and its vesting period; the expected term for awards granted under the ESPP represents the term the awards are expected to be outstanding; (ii) Expected volatility - the expected volatility assumption is based on the historical volatility of the Company's common stock;(iii) Risk-free interest rate - the risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities that approximate the expected terms of awards; and (iv) Expected dividend yield - the expected dividend yield assumption iszero as the Company has never paid dividends and has no present intention to do so in the future.
Restricted stock units are valued using the closing price of our common stock on the date of grant.
Stock-Based Compensation Expense
Stock-based compensation expense for the equity awards issued by the Company to employees and non-employees for the periods presented below was as follows (in thousands):
| Three months ended June 30, | Six months ended June 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Included in research and development | $11,491 | $5,602 | $19,056 | $10,280 |
| Included in general and administrative | 7,449 | 4,573 | 13,338 | 7,991 |
| Total stock-based compensation expense | $18,940 | $10,175 | $32,394 | $18,271 |
As of June 30, 2024, unrecognized stock-based compensation cost related to option awards, restricted stock units, and ESPP was $148.4 million, $44.7 million and $3.2 million, respectively, which is expected to be recognized over a remaining weighted-average period of 2.1 years,3.2 years and 1.4 years, respectively.
- INVESTMENT IN RADIONETICS
Investment in Radionetics
In October 2021, the Company entered into a Collaboration and License Agreement (the "Radionetics License") with Radionetics Oncology, Inc. ("Radionetics"), in which the Company granted Radionetics an exclusive worldwide license to its technology for the development of radiotherapeutics and related radio-imaging agents in exchange for 50,500,000 shares of common stock of Radionetics, which represented an initial majority stake in Radionetics of 64%, and a warrant (the "Radionetics Warrant") to purchase the greater of 3,407,285 additional shares of Radionetics common stock or the number of additional shares of Radionetics common stock that would allow the Company to maintain an aggregate equity interest of 22% of the fully diluted capitalization of Radionetics.
Radionetics is a variable interest entity ("VIE") due to having insufficient equity to finance its activities without additional subordinated financial support. The Company evaluated whether it is the primary beneficiary of Radionetics by evaluating Radionetics’ key activities: (1) conducting research and development, (2) making financing decisions, and (3) determining the strategic direction of Radionetics. Decisions about research and development activities are made by unanimous vote of members of the research and development committee, in which no individual party has unilateral decision-making power. Decisions about financing and strategic direction rest with Radionetics’ board of directors, and no party was determined to be in control, given the Radionetics board of directors was comprised of three members for which each of Crinetics, 5AM Ventures ("5AM") and Frazier Healthcare Partners ("Frazier") were entitled to appoint and replace, as needed, their board designee, and a fourth member mutually agreed upon by the other three board members. Radionetics’ management was separate from the Company and was determined by Radionetics’ board of directors. As the Company did not control any of Radionetics' key activities, it was not the primary beneficiary of the VIE and did not consolidate the financial results of Radionetics.
The Company accounts for its investment in Radionetics common stock under the equity method of accounting due to its ability to exercise significant influence. The Company records its share of Radionetics income (loss) outside of operations in the statements of operations and comprehensive loss on a quarterly lag. The Company's equity method investment in Radionetics was written down to zero during the first quarter of 2022 as a result of the allocation of the Company’s share of losses of the investee.
In August 2023, Radionetics completed a refinancing that included a number of transactions that were negotiated by the Company as a package (the “August 2023 Radionetics Transaction”). In connection with the August 2023 Radionetics Transaction, (1) the Company exercised the Radionetics Warrant to purchase 3,407,285 shares of Radionetics common stock with an exercise price of $0.00001 per share, (2) the Company exchanged 32,344,371 shares of Radionetics common stock for Radionetics preferred stock on a one-for-one basis, (3) the Company invested $5.0 million to purchase 14,404,656 sharesof preferred stock in Radionetics along with other new and existing investors who participated in the financing, and (4) the Company and Radionetics agreed to amend the Radionetics
Licenseto include additional sales milestones of up to $15 million. Radionetics’ convertible notes held by other investors were also converted to Radionetics preferred stock and certain Radionetics common shares held by other investors were cancelled in connection with the August 2023 Radionetics Transaction.
The August 2023 Radionetics Transaction was a VIE reconsideration event. The Company determined that Radionetics continues to be a VIE due to Radionetics having insufficient equity to finance its activities without additional subordinated financial support. The Company also reevaluated whether it is the primary beneficiary of Radionetics and noted there were no changes to Radionetics’ key activities or the conclusion that the Company does not control any of these activities. The size of Radionetics’ board of directors was increased from four to six members. Crinetics, 5AM and Frazier are each entitled to appoint and replace, as needed, their board designee, the fourth member is Radionetics’ CEO, and the fifth and sixth members must be mutually agreed upon by the other four board members. All changes to board composition are subject to shareholder approval with common and preferred shareholders having equal votes. Radionetics’ management continues to be entirely separate from the Company and determined by the Radionetics’ board of directors. As the Company does not control any of Radionetics' key activities, it is not the primary beneficiary and does not consolidate the financial results of Radionetics. Accordingly, the Company continues to account for its investment in Radionetics under the equity method of accounting due to its ability to exercise significant influence.
The Company determined that its preferred stock investment in Radionetics represents in-substance common stock. The preferred stock investment is substantially similar to common stock in that it does not have a substantive liquidation preference since the preferred stock will participate in substantially all of Radionetics losses, the conversion ratio for preferred stock into common stock is on a one-for-one basis without any significant restrictions or contingencies, and the preferred stock lacks redemption features, among other factors.
The Company is not obligated to fund losses incurred by Radionetics. The Company’s $5.0 million purchase of preferred stock in the August 2023 Radionetics Transaction was alongside new and existing investors and did not fund previous losses.
In connection with the August 2023 Radionetics Transaction, the Company exercised the Radionetics Warrant, which had a fair value of $0.7 million, and purchased $5.0 million of preferred stock. These transactions resulted in a $5.7 million increase in the Company’s investment in Radionetics. As a result of the August 2023 Radionetics Transaction, the Company experienced net dilution in its ownership of Radionetics from a 55% ownership stake in Radionetics common stock to a 31% combined ownership stake in Radionetics common and preferred stock. No gain was recorded upon dilution since cumulative losses that had been suspended exceeded the gain on dilution. Additionally, in December 2023, Radionetics completed a financing to sell additional shares of preferred stock to other investors.
The amendment to the Radionetics License in connection with the August 2023 Radionetics Transaction did not result in additional revenue at the time of modification and the sales-based milestone and royalty payments will only be recognized when the milestones or sales occur.
In June 2024, the Company amended the Radionetics License to reduce the number of development targets. Following the amendment to the Radionetics License, ownership of the non-licensed targets reverted back to the Company and the Company is eligible to receive total potential sales milestones in excess of $300.0 million and single-digit royalties on net sales. In July 2024, Radionetics announced the formation of a strategic partnership with Eli Lilly and Company, or Lilly. Under the terms of the agreement, Radionetics received a $140.0 million upfront cash payment and Lilly obtained the exclusive right to acquire Radionetics for $1.0 billion upon conclusion of an exercise period. During the exercise period, Radionetics will continue to build out a proprietary pipeline of therapeutic assets. As of June 30, 2024, the Company owned approximately 25% of Radionetics consisting of common and preferred stock.
During the three and six months ended June 30, 2024, the Company recorded equity method losses ofzero and $0.5 million, respectively, in the accompanying condensed consolidated statements of operations and comprehensive loss, as a result of the allocation of the Company’s share of Radionetics eligible losses, which is recorded on a quarterly lag. During each of the three and six months ended June 30, 2023, the Company didnot record any equity method losses in the accompanying condensed consolidated statements of operations and comprehensive loss, as a result of the allocation of the Company’s share of Radionetics eligible losses, which is recorded on a quarterly lag. As of June 30, 2024 the Company's investment in Radionetics was written down to zero. As of December 31, 2023, the Company’s investment in Radionetics of $0.5 million is recorded as a long-term asset in the accompanying condensed consolidated balance sheets.
Other Items
R. Scott Struthers, Ph.D., the Company’s President and Chief Executive Officer, serves as chairman of the Radionetics board of directors. Pursuant to such arrangement, Dr. Struthers receives consideration in the form of both equity and a $50,000 annual retainer for his service as a board member of Radionetics. As of June 30, 2024, Dr. Struthers has an approximately 1.3% ownership stake in Radionetics consisting of common stock.
As of June 30, 2024 and December 31, 2023, the Company had $0.1 million due from Radionetics for reimbursement of certain expenses paid on behalf of Radionetics. These amounts are recorded within prepaid expenses and other current assets in the accompanying condensed consolidated balance sheets. The Company received reimbursements from Radionetics of $49,000 and
$80,000 for the three and six months ended June 30, 2024, respectively, and $19,000 and $32,000 for the three and six months ended June 30, 2023, respectively.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.