Kura Oncology Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
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Sep 30, 2024 · Filed Nov 7, 2024
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Notes to Condensed Financial Statements (unaudited)
Notes to Unaudited Condensed Financial Statements
- Organization and Basis of Presentation
The Company
Kura Oncology, Inc. is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Our pipeline consists of small molecule product candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes, and we intend to pair them with molecular or cellular diagnostics to identify those patients most likely to respond to treatment. We are conducting clinical trials of three product candidates: ziftomenib, KO-2806 and tipifarnib. We also have additional programs that are at a discovery stage. We own global commercial rights to all of our programs and product candidates. We plan to advance our product candidates through a combination of internal development and strategic partnerships while maintaining significant development and commercial rights.
References in these Notes to Unaudited Condensed Financial Statements to the “Company,” “we,” “our” or “us,” refer to Kura Oncology, Inc.
Basis of Presentation
The accompanying unaudited condensed financial statements should be read in conjunction with the audited financial statements and notes thereto in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the Securities and Exchange Commission on February 27, 2024, from which we derived our balance sheet as of December 31, 2023. The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying unaudited condensed financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited condensed financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of our management, necessary to a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of results for a full year.
The preparation of the unaudited condensed financial statements in accordance with GAAP requires our management to make estimates and assumptions that affect the amounts reported on our unaudited condensed financial statements and accompanying notes. The amounts reported could differ under different estimates and assumptions. On an ongoing basis, we evaluate our estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from management’s estimates.
- Summary of Significant Accounting Policies
Employee Retention Credit
Under the Coronavirus Aid, Relief, and Economic Security Act of 2020, or CARES Act, we were eligible to claim the employee retention credit, which is a refundable tax credit against certain employment taxes. For the nine months ended September 30, 2023, we recognized $2.8 million of employee retention credits related to wages paid to our employees from July 2020 through September 2021 within operating expenses as a reduction to personnel costs in the unaudited condensed statements of operations and comprehensive loss. We filed for the credit with the Internal Revenue Service in the first quarter of 2023. As of September 30, 2024, an employee retention credit receivable of $2.8 million was included within prepaid expenses and other current assets on the unaudited condensed balance sheets.
Allowance for Credit Losses
For available-for-sale securities in an unrealized loss position, we first assess whether we intend to sell, or if it is more likely than not that we will be required to sell, the security before recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the security’s amortized cost basis is written down to fair value through earnings. For available-for-sale securities that do not meet the aforementioned criteria, we evaluate whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, we consider the severity of the impairment, any changes in interest rates, market conditions, changes to the underlying credit ratings and forecasted recovery, among other factors. The credit-related portion of unrealized losses, and any subsequent improvements, are recorded in interest and other income through an allowance account. Any impairment that has not been recorded through an allowance for credit losses is included in other comprehensive income on the unaudited condensed statements of operations and comprehensive loss.
We elected the practical expedient to exclude the applicable accrued interest from both the fair value and amortized costs basis of our available-for-sale securities for purposes of identifying and measuring an impairment. Accrued interest receivable on available-for-sale securities is recorded in prepaid expenses and other current assets on our unaudited condensed balance sheets. Our accounting policy is to not measure an allowance for credit loss for accrued interest receivable and to write-off any uncollectible accrued interest receivable as a reversal of interest income in a timely manner, which we consider to be in the period in which we determine the accrued interest will not be collected by us.
Concentration of Credit Risk
Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash, cash equivalents and short-term investments. We maintain deposits in federally insured financial institutions in excess of federally insured limits. We have established guidelines to limit our exposure to credit risk by placing investments with high credit quality financial institutions, diversifying our investment portfolio and placing investments with maturities that maintain safety and liquidity. We periodically review and modify these guidelines to maximize trends in yields and interest rates without compromising safety and liquidity.
Net Loss per Share
Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, which includes the shares related to outstanding pre-funded warrants, but excludes other potential common stock equivalents. Pre-funded warrants are considered outstanding for the purposes of computing basic and diluted net loss per share because shares may be issued for little additional consideration, and are fully vested and exercisable. Diluted net loss per share is calculated by dividing net loss by the weighted-average number of common shares and common stock equivalents outstanding for the period. As we have reported net loss for the three and nine months ended September 30, 2024 and 2023, dilutive net loss per common share is the same as basic net loss per common share for those periods. Common stock equivalents outstanding are comprised of stock options, restricted stock units, performance-based restricted stock units, warrants and employee stock purchase plan rights and are only included in the calculation of diluted earnings per common share when net income is reported and their effect is dilutive. Common stock equivalents outstanding at September 30, 2024 and 2023 totaling approxim ately 15,136,000 and 12,664,000, respectively, were excluded from the computation of dilutive weighted-average shares outstanding because their effect would be anti-dilutive.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies that we adopt as of the specified effective date. We have evaluated recently issued accounting pronouncements and, based on our preliminary assessment, we do not believe any will have a material impact on our unaudited condensed financial statements or related footnote disclosures.
- Investments
We invest in available-for-sale securities consisting of U.S. Treasury securities, money market funds, corporate debt securities, non-U.S. government debt securities, and U.S. Agency bonds. Available-for-sale securities are classified as either cash and cash equivalents or short-term investments on our unaudited condensed balance sheets.
The following tables summarize, by major security type, our short-term investments that are measured at fair value on a recurring basis, in thousands:
| Maturities (years) | Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | |
|---|---|---|---|---|---|
| Cash equivalents: | |||||
| Money market funds | 1 or less | $15,510 | $— | $— | $15,510 |
| Short-term investments: | |||||
| U.S. Treasury securities | 2 or less | 404,701 | 1,117 | (1) | 405,817 |
| Total | $420,211 | $1,117 | $(1) | $421,327 | |
| Maturities (years) | Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | |
|---|---|---|---|---|---|
| Cash equivalents: | |||||
| Money market funds | 1 or less | $13,590 | $— | $— | $13,590 |
| Short-term investments: | |||||
| U.S. Treasury securities | 2 or less | 300,388 | 395 | (569) | 300,214 |
| Corporate debt securities | 2 or less | 64,591 | 4 | (825) | 63,770 |
| Non-U.S. government debt securities | 1 or less | 15,000 | — | (273) | 14,727 |
| U.S. Agency bonds | 1 or less | 7,931 | — | (3) | 7,928 |
| Total short-term investments | 387,910 | 399 | (1,670) | 386,639 | |
| Total | $401,500 | $399 | $(1,670) | $400,229 | |
Short-term investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date, which reflects management’s intention to use the proceeds from sales of these securities to fund our operations, as necessary. As of September 30, 2024 and December 31, 2023, short-term investments of $390.7 million and $336.6 million, respectively, had maturities less than one year, and short-term investments of $15.1 million and $50.0 million, respectively, had maturities between one to two years. We had no realized gains or losses for the nine months ended September 30, 2024 and 2023.
As of September 30, 2024, one available-for-sale security with a fair market value of $4.9 millionwas in a gross unrealized loss position, but it has not been in a continuous unrealized loss position for greater than 12 months. We do not intend to sell such available-for-sale security, and it is not more likely than not that we will be required to sell such security prior to recovery of its amortized cost basis. We haveno allowance for credit losses as of September 30, 2024 and December 31, 2023. Unrealized gains and losses that are not credit-related are included in accumulated other comprehensive income (loss).
Accrued interest receivable on available-for-sale securitieswas $1.9 million and $1.1 million as of September 30, 2024 and December 31, 2023, respectively. We have not written off any accrued interest receivables for the nine months ended September 30, 2024 and 2023.
- Fair Value Measurements
As of September 30, 2024 and December 31, 2023, we had cash equivalents and short-term investments measured at fair value on a recurring basis.
Available-for-sale securities consist of money market funds and U.S. Treasury securities, which are measured at fair value using Level 1 inputs, and corporate debt securities, non-U.S. government debt securities, and U.S. Agency bonds which are measured at fair value using Level 2 inputs. We determine the fair value of Level 2 related securities with the aid of valuations provided by third parties using proprietary valuation models and analytical tools. These valuation models and analytical tools use market pricing or prices for similar instruments that are both objective and publicly available, including matrix pricing or reported trades, benchmark yields, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids and/or offers. We validate the fair values of Level 2 financial instruments by comparing these fair values to a third-party pricing source.
The following tables summarize, by major security type, our cash equivalents and short-term investments that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy, in thousands:
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| Cash equivalents: | ||||
| Money market funds | $15,510 | $15,510 | $— | $— |
| Short-term investments: | ||||
| U.S. Treasury securities | 405,817 | 405,817 | — | — |
| Total | $421,327 | $421,327 | $— | $— |
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| Cash equivalents: | ||||
| Money market funds | $13,590 | $13,590 | $— | $— |
| Short-term investments: | ||||
| U.S. Treasury securities | 300,214 | 300,214 | — | — |
| Corporate debt securities | 63,770 | — | 63,770 | — |
| Non-U.S. government debt securities | 14,727 | — | 14,727 | — |
| U.S. Agency bonds | 7,928 | — | 7,928 | — |
| Total short-term investments | 386,639 | 300,214 | 86,425 | — |
| Total | $400,229 | $313,804 | $86,425 | $— |
We believe that our term loan facility bears interest at a rate that approximates prevailing market rates for instruments with similar characteristics and, accordingly, the carrying value of the term loan facility approximates fair value. The fair value of our term loan facility is determined using Level 2 inputs in the fair value hierarchy.
- Balance Sheet Detail
Property and equipment consisted of the following, in thousands:
| September 30, 2024 | December 31, 2023 | |
|---|---|---|
| Laboratory and computer equipment | $1,632 | $1,657 |
| Leasehold improvements | 1,543 | 1,543 |
| Furniture and fixtures | 1,210 | 1,111 |
| Property and equipment, gross | 4,385 | 4,311 |
| Less: accumulated depreciation | (3,070) | (2,452) |
| Property and equipment, net | $1,315 | $1,859 |
Accounts payable and accrued expenses consisted of the following, in thousands:
| September 30, 2024 | December 31, 2023 | |
|---|---|---|
| Accounts payable | $3,006 | $2,300 |
| Accrued compensation and benefits | 12,482 | 13,153 |
| Accrued clinical trial research and development expenses | 10,950 | 7,737 |
| Accrued other research and development expenses | 8,060 | 9,265 |
| Other accrued expenses | 2,468 | 1,302 |
| Total accounts payable and accrued expenses | $36,966 | $33,757 |
- Leases
We currently have three operating leases for administrative and research and development office and lab space in San Diego, California and Boston, Massachusetts that expire between August 2025 and July 2031. Under the terms of the operating leases, we are required to pay our proportionate share of property taxes, insurance and normal maintenance costs. Two of our leases include renewal options for anadditional five years, which were not included in the determination of the right of use, or ROU, asset or lease liability as the renewal was not reasonably certain at the inception of the lease. Our Boston lease, San Diego corporate headquarters lease, and San Diego lease for lab and office space provided for $1.3 million, $1.0 million and $0.1 million, respectively, in reimbursements for allowable tenant improvements and rent credits, which effectively reduced the total lease payments owed.
Maturities of lease liabilities as of September 30, 2024 are as follows, in thousands:
| Year Ending December 31, | |
|---|---|
| 2024 (remaining) | $272 |
| 2025 | 1,964 |
| 2026 | 1,344 |
| 2027 | 1,371 |
| 2028 | 1,398 |
| Thereafter | 3,740 |
| Total lease payments | 10,089 |
| Less: imputed interest | (2,932) |
| Total operating lease liabilities | $7,157 |
As of September 30, 2024 and December 31, 2023, the weighted-average discount rate was 11.2% and 10.4%, respectively, and the weighted-average remaining lease term was 5.9 years and 6.2 years, respectively. Total cash paid for amounts included in the measurement of operating lease liabilities was $1.3 million and $1.7 million for the nine months ended September 30, 2024 and 2023, respectively. No operating lease ROU assets were obtained in exchange for operating lease liabilities for thenine months ended September 30, 2024 and 2023. Total operating lease expense for the three months ended September 30, 2024 and 2023 was approximately $0.5 million in both periods. Total operating lease expense for the nine months ended September 30, 2024 and 2023 was approximately $1.5 million in both periods.
- Stockholders’ Equity
On January 26, 2024, we completed a private placement in which we sold to certain institutional accredited investors an aggregate of 1,376,813 shares of our common stock at a purchase price of $17.25 per share and pre-funded warrants to purchase up to an aggregate of 7,318,886 shares of common stock at a purchase price of $17.2499 per pre-funded warrant (representing the $17.25 per share purchase price less the exercise price of $0.0001 per warrant share), or the Private Placement. Net proceeds from the Private Placement, after deducting expenses, were approximately $145.8 million. The common stock and pre-funded warrants met the accounting standards guidance for equity classification, and proceeds were allocated between common stock and pre-funded warrant based on their relative fair value. As of September 30, 2024, pre-funded warrants to purchase 139,131 of such shares of common stock had been exercised and 7,179,755 remained outstanding.
In June 2023, we completed a public offering in which we sold an aggregate of 5,660,871 shares of common stock at a price of $11.50 per share as well as pre-funded warrantsto purchase 3,034,782 shares of our common stock at a price of $11.4999 per pre-funded warrant (representing the $11.50 per share purchase price less the exercise price of $0.0001 per warrant share). Net proceeds from the public offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $93.6 million. As of September 30, 2024, pre-funded warrants to purchase 860,869 of such shares of common stock had been exercised and 2,173,913 remained outstanding.
In November 2023, we entered into a Sales Agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., or the ATM Facility, under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million. We have not sold any shares of our common stock under the ATM Facility.
- Share-Based Compensation
The following table summarizes share-based compensation expense for all share-based compensation arrangements, in thousands:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| Research and development | $3,570 | $3,223 | $11,218 | $9,430 |
| General and administrative | 4,754 | 3,867 | 14,048 | 11,485 |
| Total share-based compensation expense | $8,324 | $7,090 | $25,266 | $20,915 |
As of September 30, 2024, unrecognized estimated compensation expense related to stock options and restricted stock units was approximately $47.2 million and $12.8 million, resp ectively, which is expected to be recognized over a weighted average period of approxim ately 2.6 years and 2.7 years for stock options and restricted stock units, respectively. In May 2023, we granted an aggregate of 1,313,100 performance-based restricted stock units, or PSUs, to certain executives. The PSUs vest in six equal tranches upon the achievement of certain milestones and service conditions. As of September 30, 2024, we determined that the vesting of the PSUs was not probable and have not included the PSUs in share-based compensation expense or unrecognized estimated compensation expense.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.