[10-Q] IDEAYA Biosciences, Inc. Quarterly Earnings Report
BK Technologies Corp. (BKTI) – Schedule 13G/A (Amendment 1)
The filing discloses that investor Mikhail Stiskin, through his wholly-owned entities Hilve Holdings Ltd. (Cyprus) and Valdor Global DMCC (UAE), now beneficially owns 253,164 BKTI common shares, or 6.9 % of the 3,673,594 shares outstanding as of 8 May 2025. Ownership is held entirely with sole voting and dispositive power; no shares are held jointly.
Breakdown: Hilve Holdings directly holds 220,833 shares (6.0 %); Valdor Global DMCC holds 32,331 shares (0.9 %). The positions exceed the 5 % threshold that triggers a passive Schedule 13G filing, indicating the shares were acquired without intent to influence control of the issuer. The date of the reportable event is 30 Jun 2025, and signatures are dated 5 Aug 2025.
No financial metrics, purchase prices, or transaction dates beyond the ownership snapshot are provided. The filing simply updates beneficial ownership and does not announce any corporate action, change-in-control effort, or strategic agreement.
BK Technologies Corp. (BKTI) – Schedule 13G/A (Emendamento 1)
La comunicazione rivela che l'investitore Mikhail Stiskin, tramite le sue società interamente controllate Hilve Holdings Ltd. (Cipro) e Valdor Global DMCC (EAU), detiene ora la proprietà effettiva di 253.164 azioni ordinarie BKTI, pari al 6,9% delle 3.673.594 azioni in circolazione al 8 maggio 2025. La proprietà è detenuta interamente con pieno potere di voto e disposizione; nessuna azione è detenuta congiuntamente.
Ripartizione: Hilve Holdings detiene direttamente 220.833 azioni (6,0%); Valdor Global DMCC detiene 32.331 azioni (0,9%). Le posizioni superano la soglia del 5% che richiede la presentazione di un Schedule 13G passivo, indicando che le azioni sono state acquisite senza l’intento di influenzare il controllo dell’emittente. La data dell’evento segnalabile è il 30 giugno 2025, mentre le firme sono datate 5 agosto 2025.
Non sono forniti dati finanziari, prezzi di acquisto o date di transazione oltre allo snapshot della proprietà. La comunicazione aggiorna semplicemente la proprietà effettiva e non annuncia alcuna azione societaria, tentativo di cambio di controllo o accordo strategico.
BK Technologies Corp. (BKTI) – Schedule 13G/A (Enmienda 1)
La presentación revela que el inversor Mikhail Stiskin, a través de sus entidades de propiedad total Hilve Holdings Ltd. (Chipre) y Valdor Global DMCC (EAU), posee ahora beneficiosamente 253,164 acciones ordinarias de BKTI, o el 6,9% de las 3,673,594 acciones en circulación al 8 de mayo de 2025. La propiedad se mantiene completamente con poder exclusivo de voto y disposición; no hay acciones en propiedad conjunta.
Desglose: Hilve Holdings posee directamente 220,833 acciones (6,0%); Valdor Global DMCC posee 32,331 acciones (0,9%). Las posiciones superan el umbral del 5% que obliga a presentar un Schedule 13G pasivo, indicando que las acciones fueron adquiridas sin intención de influir en el control del emisor. La fecha del evento reportable es el 30 de junio de 2025 y las firmas están fechadas el 5 de agosto de 2025.
No se proporcionan métricas financieras, precios de compra ni fechas de transacción más allá del estado de propiedad. La presentación simplemente actualiza la propiedad beneficiosa y no anuncia ninguna acción corporativa, intento de cambio de control o acuerdo estratégico.
BK Technologies Corp. (BKTI) – Schedule 13G/A (수정 1)
이 제출서류는 투자자 Mikhail Stiskin이 전액 소유한 Hilve Holdings Ltd.(키프로스)와 Valdor Global DMCC(UAE)를 통해 현재 253,164 BKTI 보통주를 실질적으로 보유하고 있으며, 이는 2025년 5월 8일 기준 총 3,673,594주 중 6.9%에 해당함을 공개합니다. 소유권은 전적으로 단독 의결권 및 처분권을 보유하며, 공동 보유 주식은 없습니다.
내역: Hilve Holdings는 직접 220,833주 (6.0%)를 보유하고 있으며, Valdor Global DMCC는 32,331주 (0.9%)를 보유하고 있습니다. 이 지분은 5% 이상의 기준을 초과하여 수동적 Schedule 13G 제출 대상이며, 이는 발행사의 지배권에 영향을 미칠 의도 없이 주식을 취득했음을 나타냅니다. 보고 가능한 사건 날짜는 2025년 6월 30일이며, 서명일은 2025년 8월 5일입니다.
재무 지표, 매입 가격 또는 소유권 현황 외의 거래 날짜는 제공되지 않습니다. 이 제출서는 단순히 실질 소유권을 업데이트하며, 어떠한 기업행위, 지배권 변경 시도 또는 전략적 합의도 발표하지 않습니다.
BK Technologies Corp. (BKTI) – Schedule 13G/A (Amendement 1)
Le dépôt révèle que l’investisseur Mikhail Stiskin, via ses entités entièrement détenues Hilve Holdings Ltd. (Chypre) et Valdor Global DMCC (ÉAU), détient désormais de manière bénéficiaire 253 164 actions ordinaires BKTI, soit 6,9 % des 3 673 594 actions en circulation au 8 mai 2025. La propriété est détenue intégralement avec le pouvoir exclusif de vote et de disposition ; aucune action n’est détenue conjointement.
Répartition : Hilve Holdings détient directement 220 833 actions (6,0 %) ; Valdor Global DMCC détient 32 331 actions (0,9 %). Les positions dépassent le seuil de 5 % qui déclenche un dépôt passif Schedule 13G, indiquant que les actions ont été acquises sans intention d’influencer le contrôle de l’émetteur. La date de l’événement déclarable est le 30 juin 2025, et les signatures sont datées du 5 août 2025.
Aucune donnée financière, prix d’achat ou date de transaction au-delà de l’instantané de propriété n’est fournie. Le dépôt met simplement à jour la propriété bénéficiaire et n’annonce aucune action corporative, tentative de changement de contrôle ou accord stratégique.
BK Technologies Corp. (BKTI) – Schedule 13G/A (Änderung 1)
Die Einreichung offenbart, dass der Investor Mikhail Stiskin über seine vollständig kontrollierten Gesellschaften Hilve Holdings Ltd. (Zypern) und Valdor Global DMCC (VAE) nun wirtschaftlich 253.164 BKTI-Stammaktien besitzt, was 6,9 % der 3.673.594 ausstehenden Aktien zum 8. Mai 2025 entspricht. Das Eigentum wird vollständig mit alleinigem Stimm- und Verfügungsrecht gehalten; keine Aktien werden gemeinsam gehalten.
Aufschlüsselung: Hilve Holdings hält direkt 220.833 Aktien (6,0 %); Valdor Global DMCC hält 32.331 Aktien (0,9 %). Die Positionen überschreiten die 5 %-Schwelle, die eine passive Schedule 13G-Meldung auslöst, was darauf hinweist, dass die Aktien ohne Absicht zur Einflussnahme auf die Kontrolle des Emittenten erworben wurden. Das meldbare Ereignisdatum ist der 30. Juni 2025, die Unterschriften sind auf den 5. August 2025 datiert.
Es werden keine finanziellen Kennzahlen, Kaufpreise oder Transaktionsdaten über den Eigentumsstand hinaus angegeben. Die Einreichung aktualisiert lediglich das wirtschaftliche Eigentum und kündigt keine Unternehmensmaßnahmen, Kontrollwechselversuche oder strategische Vereinbarungen an.
- None.
- None.
Insights
TL;DR: Disclosure of a 6.9 % passive stake by Mikhail Stiskin; limited direct impact on BKTI operations.
This amendment shows Stiskin accumulating just under 7 % of BKTI through two offshore entities. Because the stake is filed under Schedule 13G rather than 13D, the investor certifies no activist intent. For a micro-cap (≈3.7 m shares outstanding), any 5 %+ holder can affect liquidity and voting dynamics, but the absence of control ambitions suggests neutral-to-slightly-positive sentiment: a sophisticated investor is willing to build a meaningful position. There is no information about purchase cost, financing sources, or future plans, so valuation impact should be minimal unless Stiskin later converts to an activist stance (would require a 13D).
BK Technologies Corp. (BKTI) – Schedule 13G/A (Emendamento 1)
La comunicazione rivela che l'investitore Mikhail Stiskin, tramite le sue società interamente controllate Hilve Holdings Ltd. (Cipro) e Valdor Global DMCC (EAU), detiene ora la proprietà effettiva di 253.164 azioni ordinarie BKTI, pari al 6,9% delle 3.673.594 azioni in circolazione al 8 maggio 2025. La proprietà è detenuta interamente con pieno potere di voto e disposizione; nessuna azione è detenuta congiuntamente.
Ripartizione: Hilve Holdings detiene direttamente 220.833 azioni (6,0%); Valdor Global DMCC detiene 32.331 azioni (0,9%). Le posizioni superano la soglia del 5% che richiede la presentazione di un Schedule 13G passivo, indicando che le azioni sono state acquisite senza l’intento di influenzare il controllo dell’emittente. La data dell’evento segnalabile è il 30 giugno 2025, mentre le firme sono datate 5 agosto 2025.
Non sono forniti dati finanziari, prezzi di acquisto o date di transazione oltre allo snapshot della proprietà. La comunicazione aggiorna semplicemente la proprietà effettiva e non annuncia alcuna azione societaria, tentativo di cambio di controllo o accordo strategico.
BK Technologies Corp. (BKTI) – Schedule 13G/A (Enmienda 1)
La presentación revela que el inversor Mikhail Stiskin, a través de sus entidades de propiedad total Hilve Holdings Ltd. (Chipre) y Valdor Global DMCC (EAU), posee ahora beneficiosamente 253,164 acciones ordinarias de BKTI, o el 6,9% de las 3,673,594 acciones en circulación al 8 de mayo de 2025. La propiedad se mantiene completamente con poder exclusivo de voto y disposición; no hay acciones en propiedad conjunta.
Desglose: Hilve Holdings posee directamente 220,833 acciones (6,0%); Valdor Global DMCC posee 32,331 acciones (0,9%). Las posiciones superan el umbral del 5% que obliga a presentar un Schedule 13G pasivo, indicando que las acciones fueron adquiridas sin intención de influir en el control del emisor. La fecha del evento reportable es el 30 de junio de 2025 y las firmas están fechadas el 5 de agosto de 2025.
No se proporcionan métricas financieras, precios de compra ni fechas de transacción más allá del estado de propiedad. La presentación simplemente actualiza la propiedad beneficiosa y no anuncia ninguna acción corporativa, intento de cambio de control o acuerdo estratégico.
BK Technologies Corp. (BKTI) – Schedule 13G/A (수정 1)
이 제출서류는 투자자 Mikhail Stiskin이 전액 소유한 Hilve Holdings Ltd.(키프로스)와 Valdor Global DMCC(UAE)를 통해 현재 253,164 BKTI 보통주를 실질적으로 보유하고 있으며, 이는 2025년 5월 8일 기준 총 3,673,594주 중 6.9%에 해당함을 공개합니다. 소유권은 전적으로 단독 의결권 및 처분권을 보유하며, 공동 보유 주식은 없습니다.
내역: Hilve Holdings는 직접 220,833주 (6.0%)를 보유하고 있으며, Valdor Global DMCC는 32,331주 (0.9%)를 보유하고 있습니다. 이 지분은 5% 이상의 기준을 초과하여 수동적 Schedule 13G 제출 대상이며, 이는 발행사의 지배권에 영향을 미칠 의도 없이 주식을 취득했음을 나타냅니다. 보고 가능한 사건 날짜는 2025년 6월 30일이며, 서명일은 2025년 8월 5일입니다.
재무 지표, 매입 가격 또는 소유권 현황 외의 거래 날짜는 제공되지 않습니다. 이 제출서는 단순히 실질 소유권을 업데이트하며, 어떠한 기업행위, 지배권 변경 시도 또는 전략적 합의도 발표하지 않습니다.
BK Technologies Corp. (BKTI) – Schedule 13G/A (Amendement 1)
Le dépôt révèle que l’investisseur Mikhail Stiskin, via ses entités entièrement détenues Hilve Holdings Ltd. (Chypre) et Valdor Global DMCC (ÉAU), détient désormais de manière bénéficiaire 253 164 actions ordinaires BKTI, soit 6,9 % des 3 673 594 actions en circulation au 8 mai 2025. La propriété est détenue intégralement avec le pouvoir exclusif de vote et de disposition ; aucune action n’est détenue conjointement.
Répartition : Hilve Holdings détient directement 220 833 actions (6,0 %) ; Valdor Global DMCC détient 32 331 actions (0,9 %). Les positions dépassent le seuil de 5 % qui déclenche un dépôt passif Schedule 13G, indiquant que les actions ont été acquises sans intention d’influencer le contrôle de l’émetteur. La date de l’événement déclarable est le 30 juin 2025, et les signatures sont datées du 5 août 2025.
Aucune donnée financière, prix d’achat ou date de transaction au-delà de l’instantané de propriété n’est fournie. Le dépôt met simplement à jour la propriété bénéficiaire et n’annonce aucune action corporative, tentative de changement de contrôle ou accord stratégique.
BK Technologies Corp. (BKTI) – Schedule 13G/A (Änderung 1)
Die Einreichung offenbart, dass der Investor Mikhail Stiskin über seine vollständig kontrollierten Gesellschaften Hilve Holdings Ltd. (Zypern) und Valdor Global DMCC (VAE) nun wirtschaftlich 253.164 BKTI-Stammaktien besitzt, was 6,9 % der 3.673.594 ausstehenden Aktien zum 8. Mai 2025 entspricht. Das Eigentum wird vollständig mit alleinigem Stimm- und Verfügungsrecht gehalten; keine Aktien werden gemeinsam gehalten.
Aufschlüsselung: Hilve Holdings hält direkt 220.833 Aktien (6,0 %); Valdor Global DMCC hält 32.331 Aktien (0,9 %). Die Positionen überschreiten die 5 %-Schwelle, die eine passive Schedule 13G-Meldung auslöst, was darauf hinweist, dass die Aktien ohne Absicht zur Einflussnahme auf die Kontrolle des Emittenten erworben wurden. Das meldbare Ereignisdatum ist der 30. Juni 2025, die Unterschriften sind auf den 5. August 2025 datiert.
Es werden keine finanziellen Kennzahlen, Kaufpreise oder Transaktionsdaten über den Eigentumsstand hinaus angegeben. Die Einreichung aktualisiert lediglich das wirtschaftliche Eigentum und kündigt keine Unternehmensmaßnahmen, Kontrollwechselversuche oder strategische Vereinbarungen an.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 |
For the transition period from to
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of August 1, 2025, the registrant had
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated products, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions described under the sections in this Quarterly Report on Form 10-Q entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report on Form 10-Q. These forward-looking statements are subject to numerous risks, including, without limitation, the following:
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Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not occur or be achieved, and actual results could differ materially from those projected in the forward-looking statements. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
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IDEAYA Biosciences, Inc.
Form 10-Q for Quarterly Period Ended June 30, 2025
Table of Contents
PART I—FINANCIAL INFORMATION |
4 |
Item 1. Financial Statements (Unaudited) |
4 |
Condensed Balance Sheets |
4 |
Condensed Statements of Operations and Comprehensive Loss |
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Condensed Statements of Stockholders’ Equity |
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Condensed Statements of Cash Flows |
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Notes to Condensed Financial Statements (Unaudited) |
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. Quantitative and Qualitative Disclosures About Market Risk |
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Item 4. Controls and Procedures |
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PART II—OTHER INFORMATION |
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Item 1. Legal Proceedings |
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Item 1A. Risk Factors |
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds |
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Item 3. Defaults Upon Senior Securities |
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Item 4. Mine Safety Disclosures |
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Item 5. Other information |
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Item 6. Exhibits |
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SIGNATURES |
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PART I—FINANCIAL INFORMATION
Item 1. Financial Statements (UNAUDITED).
IDEAYA Biosciences, Inc.
Condensed Balance Sheets
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IDEAYA Biosciences, Inc.
Condensed Statements of Operations and Comprehensive Loss
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The accompanying notes are an integral part of these condensed financial statements.
5
IDEAYA Biosciences, Inc.
Condensed Statements of Stockholders’ Equity
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|
|
|
Additional |
|
|
Other |
|
|
|
|
|
Total |
|
||||||
|
|
Common Stock |
|
|
Paid-In |
|
|
Comprehensive |
|
|
Accumulated |
|
|
Stockholders' |
|
|||||||||
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Income (Loss) |
|
|
Deficit |
|
|
Equity |
|
||||||
Balances as of March 31, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||
Issuance of common stock related to at-the-market offering program, net of issuance costs |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Issuance of common stock upon exercise of stock options |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Employee stock purchase plan (ESPP) purchase |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balances as of June 30, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Balances as of March 31, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of common stock related to at-the-market offering program, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Issuance of common stock upon exercise of stock options |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Employee stock purchase plan (ESPP) purchase |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balances as of June 30, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
The accompanying notes are an integral part of these condensed financial statements.
6
IDEAYA Biosciences, Inc.
Condensed Statements of Stockholders’ Equity
(in thousands, except share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
|
Additional |
|
|
Other |
|
|
|
|
|
Total |
|
||||||
|
|
Common Stock |
|
|
Paid-In |
|
|
Comprehensive |
|
|
Accumulated |
|
|
Stockholders' |
|
|||||||||
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Income (Loss) |
|
|
Deficit |
|
|
Equity |
|
||||||
Balances as of December 31, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||
Issuance of common stock related to at-the-market offering program, net of issuance costs |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of common stock upon exercise of stock options |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Employee stock purchase plan (ESPP) purchase |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Other comprehensive income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balances as of June 30, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Balances as of December 31, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||
Issuance of common stock related to at-the-market offering program, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Issuance of common stock upon exercise of stock options |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Employee stock purchase plan (ESPP) purchase |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balances as of June 30, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
The accompanying notes are an integral part of these condensed financial statements.
7
IDEAYA Biosciences, Inc.
Condensed Statements of Cash Flows
(in thousands)
(Unaudited)
|
|
Six Months Ended June 30, |
|
||||
|
|
2025 |
|
2024 |
|
||
Cash flows from operating activities |
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
|
|
||
Depreciation and amortization |
|
|
|
|
|
||
Net accretion of discounts on marketable securities |
|
|
( |
) |
|
( |
) |
Stock-based compensation |
|
|
|
|
|
||
Amortization of right-of-use assets |
|
|
|
|
|
||
Changes in assets and liabilities |
|
|
|
|
|
||
Prepaid expenses and other assets |
|
|
( |
) |
|
( |
) |
Accounts payable |
|
|
|
|
|
||
Accrued and other liabilities |
|
|
|
|
|
||
Lease liabilities |
|
|
|
|
( |
) |
|
Net cash used in operating activities |
|
|
( |
) |
|
( |
) |
Cash flows from investing activities |
|
|
|
|
|
||
Purchases of property and equipment, net |
|
|
( |
) |
|
( |
) |
Purchases of marketable securities |
|
|
( |
) |
|
( |
) |
Maturities of marketable securities |
|
|
|
|
|
||
Net cash provided by (used in) investing activities |
|
|
|
|
( |
) |
|
Cash flows from financing activities |
|
|
|
|
|
||
Proceeds from issuance of common stock related to at-the-market offering program, net of issuance costs |
|
|
|
|
|
||
Proceeds from ESPP purchase |
|
|
|
|
|
||
Proceeds from exercise of common stock options |
|
|
|
|
|
||
Net cash provided by financing activities |
|
|
|
|
|
||
Net increase in cash, cash equivalents and restricted cash |
|
|
|
|
|
||
Cash, cash equivalents and restricted cash |
|
|
|
|
|
||
Cash, cash equivalents and restricted cash, at beginning of period |
|
|
|
|
|
||
Cash, cash equivalents and restricted cash, at end of period |
|
$ |
|
$ |
|
||
|
|
|
|
|
|
||
Reconciliation of cash, cash equivalents and restricted cash |
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
$ |
|
||
Restricted cash |
|
|
|
|
|
||
Cash, cash equivalents and restricted cash |
|
$ |
|
$ |
|
||
|
|
|
|
|
|
||
Supplemental disclosure of cash flow information: |
|
|
|
|
|
||
Cash paid for interest |
|
$ |
— |
|
$ |
|
|
|
|
|
|
|
|
||
Supplemental non-cash investing and financing activities: |
|
|
|
|
|
||
Right-of-use asset obtained in exchange for a new operating lease liability |
|
$ |
|
$ |
— |
|
|
Purchases of property and equipment in accounts payable and accrued liabilities |
|
|
|
|
|
||
Unpaid at-the-market offering program costs |
|
$ |
— |
|
$ |
|
The accompanying notes are an integral part of these condensed financial statements.
8
IDEAYA Biosciences, Inc.
Notes to Condensed Financial Statements (Unaudited)
1. Organization
Description of the Business
IDEAYA Biosciences, Inc. (the “Company”) is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies to address unmet medical needs in cancer. The Company is headquartered in South San Francisco, California and was incorporated in the State of Delaware in June 2015.
Follow-On Offering
On July 11, 2024, the Company completed an underwritten public follow-on offering. The offering consisted of
At-the-Market Offering
On January 19, 2024, the Company entered into an Open Market Sales Agreement (the “January 2024 Sales Agreement”) with Jefferies relating to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of common stock having aggregate gross proceeds of up to $
During the six months ended June 30, 2025, the Company sold an aggregate of
The Company may cancel its at-the-market offering program at any time upon written notice, pursuant to its terms.
Liquidity
The Company has incurred significant losses and negative cash flows from operations in all periods since inception and had an accumulated deficit of $
The Company has financed its operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK.
To date, none of the Company’s product candidates have been approved for sale, and the Company has not generated any revenue from commercial products since inception. Management expects operating losses to continue and increase for the foreseeable future, as the Company progresses clinical development activities for its lead product candidates. The Company’s prospects are subject to risks, expenses and uncertainties frequently encountered by companies in the biotechnology industry as discussed under Risks and Uncertainties in Note 2. While the Company has been able to raise multiple rounds of financing, there can be no assurance that in the event the Company requires additional financing, such financing will be available on terms which are favorable or at all. Failure to generate sufficient cash flows from operations, raise additional capital or reduce certain discretionary spending would have a material adverse effect on the Company’s ability to achieve its intended business objectives.
9
As of June 30, 2025, the Company had cash, cash equivalents and marketable securities of approximately $
2. Summary of Significant Accounting Policies
Basis of Presentation
These condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the United States Securities and Exchange Commission (“SEC”) for interim reporting.
Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted. Accordingly, the unaudited condensed financial statements should be read in conjunction with the audited financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on February 18, 2025.
Unaudited Condensed Financial Statements
The accompanying financial information for the three and six months ended June 30, 2025 and June 30, 2024 are unaudited. The unaudited condensed financial statements have been prepared on the same basis as the annual audited financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s financial position as of June 30, 2025 and December 31, 2024, its results of operations for the three and six months ended June 30, 2025 and June 30, 2024 and cash flows for the six months ended June 30, 2025 and June 30, 2024. The results for interim periods are not necessarily indicative of the results expected for the full fiscal year or any other periods.
Use of Estimates
Risks and Uncertainties
The Company operates in a dynamic and highly competitive industry and is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, contract manufacturers, contract research organizations and collaboration partners, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical studies and clinical trials and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting. The Company believes that changes in any of the following areas could have a material adverse effect on the Company’s future financial position, results of operations, or cash flows: ability to obtain future financing; advances and trends in new technologies and industry standards; results of clinical trials and collaboration activities; regulatory approval and market acceptance of the Company’s products; development of sales channels; certain strategic relationships; litigation or claims against the Company based on intellectual property, patent, product, regulatory or other factors; and the Company’s ability to attract and retain employees necessary to support its growth.
Products developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that the products will receive the necessary approvals, or that any approved
10
products will be commercially viable. If the Company was denied approval, approval was delayed or the Company was unable to maintain approval, it could have a materially adverse impact on the Company. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, consultants and other third parties.
The Company has expended and will continue to expend substantial funds to complete the research, development and clinical testing of product candidates. The Company also will be required to expend additional funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and distribution of products that receive regulatory approval. The Company may require additional funds to commercialize its products. The Company is unable to entirely fund these efforts with its current financial resources. If adequate funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, reduce the scope of or eliminate one or more of its research or development programs which would materially and adversely affect its business, financial condition and operations.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents and marketable securities. Substantially all the Company’s cash, cash equivalents and marketable securities are held by three financial institutions that management believes are of high credit quality. Such deposits may, at times, exceed federally insured limits.
The Company’s investment policy addresses credit ratings, diversification, and maturity dates.
Summary of Significant Accounting Policies
There have been no material changes in the accounting policies from those disclosed in the financial statements and the related notes included in the Company’s Annual Report on Form 10-K, filed with the SEC on February 18, 2025.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) under its accounting standard codifications (“ASC”) or other standard setting bodies and adopted by the Company as of the specified effective date, unless otherwise discussed below.
New Accounting Pronouncements Adopted
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which improves reportable segment disclosure requirements through enhanced disclosures about significant segment expenses. These amendments enhance interim disclosure requirements, require disclosure of the title and position of the chief operating decision maker (“CODM”), require disclosure of significant segment expenses that are regularly provided to the CODM, clarify circumstances for disclosure of more than one segment profit or loss measure and require that a public entity that has a single reportable segment provide all disclosures required by ASC 280 and amendments. This ASU update is effective for fiscal years beginning after December 15, 2023 for the Company’s annual report, and interim periods within fiscal years beginning after December 15, 2024. The Company
New Accounting Pronouncements, Not yet Adopted
11
In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative, which modifies the disclosure or presentation requirements related to variety of FASB Accounting Standard Codification topics. The effective date for each amendment will be the date on which the SEC’s removal of that related disclosure from Regulation S-X or Regulation S-K is effective. If by June 30, 2027, the SEC has not removed the applicable requirement from Regulation S-X or Regulation S-K, the pending content of the associated amendment will be removed from the Codification and will not become effective for any entities. The Company is currently evaluating the effect of adopting this ASU.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which amends the guidance in ASC 740, Income Taxes. The ASU is intended to improve the transparency of income tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. The ASU’s amendments are effective for public business entities for annual periods beginning after December 15, 2024. Entities are permitted to early adopt the standard “for annual financial statements that have not yet been issued or made available for issuance.” Adoption is either prospectively or retrospectively; the Company will adopt this ASU on a prospective basis. This ASU will likely result in additional disclosures.
In November 2024, the FASB issued ASU 2024-03 - Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. The ASU requires more detailed disclosures about the types of expenses in commonly presented expense captions such as cost of sales, selling, general and administrative expenses and research and development expenses. This includes separate footnote disclosure for expenses such as purchases of inventory, employee compensation, depreciation and intangible asset amortization. Public business entities are required to apply the guidance prospectively and may apply it retrospectively. The ASU's amendments are effective for public business entities for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Public business entities are required to apply the guidance prospectively and may apply it retrospectively. This ASU will likely result in additional disclosures.
In January 2025, the FASB issued ASU 2025-01 - Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date. The amendments in this ASU clarify that ASU 2024-03 is effective for public business entities for annual reporting periods beginning after December 15, 2026 and interim reporting periods within annual reporting periods beginning after December 15, 2027. This ASU will likely result in additional disclosures.
3. Fair Value Measurement and Marketable Securities
The Company applies fair value accounting for all financial assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:
Level 1—Observable inputs, such as quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2—Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3—Unobservable inputs which reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as consider counterparty credit risk in its assessment of fair value.
12
As of June 30, 2025, financial assets measured and recognized at fair value are as follows (in thousands):
|
|
|
|
June 30, 2025 |
|
|||||||||||||
|
|
|
|
Amortized |
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
||||
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. government securities |
|
Level 2 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Corporate bonds |
|
Level 2 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Commercial paper |
|
Level 2 |
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
|
||
Subtotal |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Money market funds |
|
Level 1 |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Cash |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Total fair value of assets |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Included in cash and cash equivalents(1) |
|
|
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
|
||
Included in marketable securities, current(2) |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Included in marketable securities, non-current(3) |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total fair value of assets |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
(1) $
purchase dates within 90 days of maturity dates.
(2) The Company’s short-term marketable securities mature in one year or less.
(3) The Company’s long-term marketable securities mature between one and three years.
As of December 31, 2024, financial assets measured and recognized at fair value are as follows (in thousands):
|
|
|
|
December 31, 2024 |
|
|||||||||||||
|
|
|
|
Amortized |
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
||||
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. government securities |
|
Level 2 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Corporate bonds |
|
Level 2 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Commercial paper |
|
Level 2 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Subtotal |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Money market funds |
|
Level 1 |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Cash |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Total fair value of assets |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Included in cash and cash equivalents(1) |
|
|
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
|
||
Included in marketable securities, current(2) |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Included in marketable securities, non-current(3) |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total fair value of assets |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
(1) $
purchase dates within 90 days of maturity dates.
(2) The Company’s short-term marketable securities mature in one year or less.
(3) The Company’s long-term marketable securities mature between one and three years.
13
As of June 30, 2025 and December 31, 2024, all marketable securities had a remaining maturity of less than
As of June 30, 2025 and December 31, 2024, certain securities were held in an unrealized loss position. Based on review of the portfolio of marketable securities and the creditworthiness of the underlying issuer, the Company determined that the decline in fair value below cost did not result from credit-related factors. Additionally, the Company does not intend to sell these securities, nor will it be required to sell before recovery of the amortized cost basis at maturity. As a result,
4. Balance Sheet Components
Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
|
Useful Life |
|
June 30, |
|
December 31, |
|
||
|
(In Years) |
|
2025 |
|
2024 |
|
||
Laboratory equipment |
|
$ |
|
$ |
|
|||
Computer equipment |
|
|
|
|
|
|||
Software |
|
|
|
|
|
|||
Leasehold improvements |
|
|
|
|
|
|||
Furniture and fixtures |
|
|
|
|
|
|||
Total property and equipment |
|
|
|
|
|
|
||
Less: Accumulated depreciation and amortization |
|
|
|
( |
) |
|
( |
) |
Property and equipment, net |
|
|
$ |
|
$ |
|
Depreciation and amortization expense was $
Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2025 |
|
|
2024 |
|
||
Accrued research and development expenses |
|
$ |
|
|
$ |
|
||
Accrued salaries and benefits |
|
|
|
|
|
|
||
Legal and professional fees |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Accrued liabilities |
|
$ |
|
|
$ |
|
14
5. Operating Leases
In June 2023, the Company entered into a lease agreement for approximately
In May 2024, the Company amended its 5000 Shoreline Court facility lease agreement to expand the size of the original premises by adding approximately
The Company's lease at 7000 Shoreline Court, South San Francisco, California, expired in September 2024.
In November 2023, the Company entered into a lease agreement for approximately
Future minimum lease payments under operating leases included on the Company's condensed balance sheet are as follows:
As of June 30, 2025 |
|
Operating Leases |
|
|
2025 |
|
$ |
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
Thereafter |
|
|
|
|
Total future minimum lease payments |
|
|
|
|
Less: imputed interest |
|
|
( |
) |
Total operating lease liabilities |
|
$ |
|
The following table summarizes other information about the Company’s operating leases:
|
|
As of |
||
|
|
June 30, 2025 |
|
December 31, 2024 |
Remaining Lease Term |
|
|
||
Discount Rate |
|
|
15
Operating lease costs were $
Variable lease costs were $
During the six months ended June 30, 2025 and June 30, 2024, cash paid for amounts included in the measurement of lease liabilities were $
6. Commitments and Contingencies
Contingencies
From time to time, the Company may be involved in litigation related to claims that arise in the ordinary course of its business activities. The Company accrues for these matters when it is probable that future expenditures will be made and these expenditures can be reasonably estimated. As of June 30, 2025, the Company does not believe that any such matters, individually or in the aggregate, will have a material adverse effect on the Company’s financial position, results of operations or cash flows.
Indemnification
The Company enters into standard indemnification arrangements in the ordinary course of business with vendors, clinical trial sites and other parties. Pursuant to these arrangements, the Company indemnifies, holds harmless and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party. The term of these indemnification agreements is generally perpetual any time after the execution of the agreement. The maximum potential amount of future payments the Company could be required to make under these arrangements is not determinable. The Company has never incurred costs to defend lawsuits or settle claims related to these indemnification agreements. Accordingly, the Company has not recorded a liability related to such indemnification agreements as of June 30, 2025.
7. Income Taxes
For the three and six months ended June 30, 2025 and June 30, 2024, the Company did
The Company was under audit in California for the 2020–2021 tax years, and the audit was concluded with no proposed adjustments as of the quarter ended June 30, 2025.
In July 2025, Congress passed and the President signed into law H.R. 1, the One Big Beautiful Bill Act ("Tax Act") which addresses certain business tax provisions enacted as a part of the 2017 Tax Cuts and Jobs Act including restoration of
16
8. Common Stock
As of June 30, 2025 and December 31, 2024, the Company’s certificate of incorporation authorized the Company to issue
On July 11, 2024, the Company completed an underwritten public follow-on offering. The offering consisted of
As of June 30, 2025, the following aggregate warrants to purchase shares of the Company’s common stock were issued and outstanding:
Issue Date |
|
Expiration Date |
|
Exercise Price per Share |
|
|
Number of Shares subject to Outstanding Warrants |
|
||
|
None |
|
$ |
|
|
|
|
|||
|
None |
|
$ |
|
|
|
|
|||
|
None |
|
$ |
|
|
|
(1) In September 2024,
cashless exercised and
The warrants are classified as a component of Stockholders’ Equity within Additional Paid-in-Capital. The warrants
are classified as equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, are indexed to the Company’s common stock and meet the equity classification criteria. The warrants will not expire until they are fully exercised.
The Company had reserved common stock for future issuance as follows:
|
|
June 30, |
|
December 31, |
|
|
2025 |
|
2024 |
Exercise of outstanding options under the 2015, 2019 and 2023 Plans |
|
|
||
Shares available for grant under the 2019 Plan |
|
|
||
Shares available for grant under the 2023 Inducement Plan |
|
|
||
Shares available under the Employee Stock Purchase Plan |
|
|
||
Pre-funded warrants issued and outstanding |
|
|
||
Total |
|
|
17
9. Stock-Based Compensation
2023 Inducement Plan
On February 24, 2023, the Company adopted the IDEAYA Biosciences, Inc. 2023 Employment Inducement Award Plan (the “2023 Inducement Plan”), pursuant to which the Company reserved
In June 2024, the Company amended the 2023 Employment Inducement Award Plan, increasing the number of shares available for issuance by
In May 2025, the Company further amended the 2023 Employment Inducement Award Plan, increasing the number of shares available for issuance by
As of June 30, 2025, the number of shares available for issuance under the 2023 Inducement Plan was
2019 Incentive Award Plan
In May 2019, the Company’s board of directors adopted and the Company’s stockholders approved the 2019 Incentive Award Plan (the “2019 Plan”), under which the Company may grant cash and equity-based incentive awards to the Company’s employees, consultants and directors. Following the effectiveness of the 2019 Plan, the Company will not make any further grants under the 2015 Equity Incentive Plan (the “2015 Plan”). However, the 2015 Plan continues to govern the terms and conditions of the outstanding awards granted under it. Shares of common stock subject to awards granted under the 2015 Plan that are forfeited or lapse unexercised and which following the effective date of the 2019 Plan are not issued under the 2015 Plan will be available for issuance under the 2019 Plan.
Options granted under the 2019 Plan may be either incentive stock options (“ISOs”) or nonqualified stock options (“NSOs”). ISOs may be granted only to Company employees (including officers and directors who are also employees). NSOs may be granted to Company employees, directors and consultants.
The 2019 Plan is subject to an annual increase on the first day of each year beginning in 2020 and ending in 2029, equal to the lesser of
As of June 30, 2025, the number of shares available for issuance under the 2019 Plan was
2015 Equity Incentive Plan
In 2015, the Company established its 2015 Plan which provides for the granting of stock options to employees, directors and consultants of the Company. Options granted under the 2015 Plan may be either ISOs or NSOs.
2019 Employee Stock Purchase Plan
In May 2019, the Company’s board of directors adopted and the Company’s stockholders approved the 2019 Employee Stock Purchase Plan (the “ESPP”). The ESPP provides eligible employees with the opportunity to acquire an ownership interest in the Company through periodic payroll deductions up to
18
The ESPP is intended to constitute an “employee stock purchase plan” under Section 423(b) of the Internal Revenue Code of 1986, as amended. A total of
As of June 30, 2025, the number of shares available for issuance under the ESPP was
Stock-Based Compensation Expense
Total stock-based compensation expense recorded related to awards granted to employees and non-employees was as follows (in thousands):
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||
|
|
2025 |
|
2024 |
|
|
2025 |
|
2024 |
|
||||
Research and development |
|
$ |
|
$ |
|
|
$ |
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
||||
Total stock-based compensation expense |
|
$ |
|
$ |
|
|
$ |
|
$ |
|
Stock Options
Activity under the Company’s 2015 and 2019 Plans and 2023 Inducement Plan is set forth below:
|
|
Outstanding Options |
|
|
|
|
|
|
|
|||||||
|
|
Shares |
|
|
Weighted- |
|
|
Weighted- |
|
|
Aggregate Intrinsic Value (Millions) |
|
||||
Balance, January 1, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Options granted |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Options exercised |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Options canceled |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Options expired |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Balance, June 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable as of June 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested and expected to vest as of |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
19
The weighted-average grant-date fair value of options granted during the six months ended June 30, 2025 and June 30, 2024 was $
As of June 30, 2025 and December 31, 2024, total unrecognized stock-based compensation expense for stock options was $
Black-Scholes Assumptions
The fair values of options were calculated using the assumptions set forth below:
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
Expected term |
|
|
|
|
||||
Expected volatility |
|
|
|
|
||||
Risk-free interest rate |
|
|
|
|
||||
Dividend yield |
|
|
|
|
Expected term. The expected term represents the weighted-average period the stock options are expected to remain outstanding and is based on the options’ vesting terms and contractual terms.
Expected Volatility. The expected volatility is based on the Company’s historical stock price volatility. The historical stock price volatility is calculated based on a period of time commensurate with the expected term assumption for each grant.
Risk-Free Interest Rate. The risk-free rate assumption is based on U.S. Treasury instruments whose term was consistent with the expected term of the Company’s stock options.
Expected Dividend Rate. The Company has not paid and does not anticipate paying any dividends in the near future. Accordingly, the Company has estimated the dividend yield to be
The Company accounts for forfeitures as they occur.
Fair Value of Common Stock
The fair value of the Company’s common stock is determined based on the market price on the date of grant.
10. Significant Agreements
GSK Collaboration, Option and License Agreement
In June 2020, the Company entered into the Collaboration, Option and License Agreement (the “GSK Collaboration Agreement”), with an affiliate of GSK plc, GLAXOSMITHKLINE INTELLECTUAL PROPERTY (NO. 4) LIMITED (“GSK”), pursuant to which the Company and GSK have entered into a collaboration for its synthetic lethality programs targeting MAT2A, Pol Theta and Werner Helicase (“Werner” or “WRN”).
Pursuant to the GSK Collaboration Agreement, GSK paid the Company $
GSK Collaboration - Pol Theta Program
Pursuant to the GSK Collaboration Agreement, GSK holds a global, exclusive license to develop and commercialize Pol Theta products arising out of the Pol Theta program. The Company and GSK collaborated on preclinical
20
research for the Pol Theta program, and GSK is leading clinical development of IDE705 (GSK101) for the Pol Theta program. GSK is responsible for all research and development costs for the Pol Theta program.
In August 2023, the Company earned a $
The Company has the potential to achieve an additional $
GSK Collaboration - Werner Helicase Program
Pursuant to the GSK Collaboration Agreement, GSK holds a global, exclusive license to develop and commercialize WRN products arising out of the WRN program. The Company and GSK collaborated on preclinical research for the WRN program, and GSK is sponsoring and leading clinical development of IDE275 (GSK959) for the WRN program, with the Company responsible for
In October 2024, the Company earned a $
The Company has the potential to earn up to an additional $
Upon commercialization, the Company will be eligible to receive commercial milestones of up to $
Novartis License Agreement
In September 2018, the Company entered into a License Agreement with Novartis to develop and commercialize Novartis’ LXS196 (also known as IDE196), a Phase 1 protein kinase C (“PKC”) inhibitor, for the treatment of cancers having GNAQ and GNA11 mutations. The Company renamed Novartis’ LXS196 oncology as IDE196, and which has a non-proprietary name of darovasertib. Under the license agreement, Novartis granted to the Company a worldwide, exclusive, sublicensable license to research, develop, manufacture, and commercialize certain defined compounds and products, including IDE196 and certain other PKC inhibitors, as well as companion diagnostic products, collectively referred to as the licensed products, for any purpose. The Company paid Novartis an upfront payment of $
In March 2025, the FDA granted Breakthrough Therapy designation (“BTD”) for darovasertib, a potential first-in-class protein kinase C (“PKC”) inhibitor, for the neoadjuvant treatment of adult patients with primary uveal melanoma (“UM”) for whom enucleation has been recommended. Under the license agreement with Novartis, the Company paid Novartis a $
Subject to completion of certain clinical and regulatory development milestones, the Company agreed to make additional milestone payments in the aggregate of up to $
21
million, and subject to achievement of certain commercial sales milestones, the Company agreed to make milestone payments in the aggregate of up to $
The Company owns or controls all commercial rights in its darovasertib program in UM, including in MUM and in primary UM, subject to certain economic obligations pursuant to its exclusive, worldwide license to darovasertib with Novartis.
Pfizer Clinical Trial Collaboration and Supply Agreements
In March 2020, the Company entered into a Clinical Trial Collaboration and Supply Agreement with Pfizer, Inc. (as amended in September 2020, April 2021, September 2021 and May 2023, the “Pfizer Agreement”). Pursuant to the Pfizer Agreement, Pfizer supplies the Company with their MEK inhibitor, binimetinib, and their cMET inhibitor, crizotinib, to evaluate combinations of darovasertib independently with each of the Pfizer compounds, in patients with tumors harboring activating GNAQ or GNA11 mutations. Under the Pfizer Agreement, the Company is the sponsor of the combination studies and will provide darovasertib and pay for the costs of the combination studies. Pfizer will provide binimetinib and crizotinib for use in the clinical trial at no cost to the Company. The Pfizer Agreement provides that the Company and Pfizer will jointly own clinical data generated from the clinical trial and will also jointly own inventions, if any, relating to the combined use of darovasertib and binimetinib, or independently, to the combined use of darovasertib and crizotinib. The Company and Pfizer have formed a joint development committee responsible for coordinating all regulatory and other activities under the agreement.
In March 2022, the Company and Pfizer entered into a Second Clinical Trial Collaboration and Supply Agreement, as amended in May 2023 (the “Second Pfizer Agreement”), pursuant to which the Company is evaluating darovasertib and crizotinib as a combination therapy in MUM in a planned Phase 2/3 potential registration-enabling clinical trial. Pursuant to the Second Pfizer Agreement, the Company is the sponsor of the combination trial and the Company will provide darovasertib and pay for the costs of the combination trial, and Pfizer will provide crizotinib for the planned combination trial at no cost to the Company for up to an agreed-upon number of MUM patients. The Company and Pfizer will jointly own clinical data from the planned combination trial and all inventions relating to the combined use of darovasertib and crizotinib. The Company and Pfizer have formed a joint development committee responsible for coordinating all regulatory and other activities under the Second Pfizer Agreement.
Separately, in March 2022, the Company and Pfizer also entered into a Third Clinical Trial Collaboration and Supply Agreement (the “Third Pfizer Agreement”), pursuant to which the Company could, subject to preclinical validation and FDA feedback and guidance, evaluate darovasertib and crizotinib, as a combination therapy in cMET-driven tumors such as NSCLC and/or HCC in a Phase 1 clinical trial. Pursuant to the Third Pfizer Agreement, the Company was the sponsor of the planned combination trial, and the Company would provide darovasertib and pay for the costs of the combination trial. Pfizer would provide crizotinib for the planned combination trial at no cost to the Company. Pursuant to Amendment No. 1 to the Second Pfizer Agreement, as described below, the Company and Pfizer terminated the Third Pfizer Agreement.
In May 2023, the Company continued its relationship with Pfizer by entering into Amendment No. 4 to the Pfizer Agreement relating to the supply of crizotinib in support of this Phase 2 clinical trial, pursuant to which Pfizer will continue to provide the Company with an additional defined quantity of crizotinib at no cost.
Also, in May 2023, the Company expanded its relationship with Pfizer to support the Phase 2/3 registrational trial to evaluate darovasertib and crizotinib as a combination therapy in MUM by entering into Amendment No. 1 to the Second Pfizer Agreement. Under Amendment No. 1 to the Second Pfizer Agreement, Pfizer will provide the Company with a first defined quantity of crizotinib at no cost, as well as an additional second defined quantity of crizotinib at a lump-sum cost. The Third Pfizer Agreement was terminated by the Company and Pfizer under Amendment No. 1 to the Second Pfizer Agreement.
22
In December 2024, the Company entered into Amendment No. 5 to the Pfizer Agreement for the supply of crizotinib in the Phase 1/2 clinical trial for Pfizer to provide us a defined quantity of crizotinib at defined costs.
Cancer Research UK and University of Manchester Exclusive Option and License Agreement
The Company entered into an exclusive license under the Evaluation, Option and License Agreement with Cancer Research Technologies Ltd., also known as Cancer Research United Kingdom Ltd. (“CRT”), and the University of Manchester, pursuant to which the Company holds an exclusive worldwide license rights covering a broad class of PARG inhibitors.
In January 2022, the Company exercised its option for an exclusive worldwide license covering a broad class of poly (ADP-ribose) glycohydrolase (“PARG”), inhibitors from CRT, and the University of Manchester, and in connection therewith, paid a one-time option exercise fee of £
In April 2023, the Company incurred an obligation to pay milestone payments in an aggregate amount of £
The Company will be obligated to make additional payments to CRT aggregating up to £
The Company will also pay low single-digit tiered royalties, and potentially also sales-based milestones, to CRT based on net sales of licensed products. In addition, in the event the Company sublicenses the intellectual property, it will also be obligated to pay CRT a specified percentage of any sublicense revenue.
Amgen Clinical Trial Collaboration and Supply Agreement
In July 2022, the Company entered into a clinical trial collaboration and supply agreement with Amgen Inc. (the “Amgen CTCSA”), to clinically evaluate IDE397 in combination with AMG 193, the Amgen investigational MTA-cooperative PRMT5 inhibitor, in patients having MTAP-null solid tumors, in a Phase 1/2 clinical trial. In February 2025, the Company and Amgen mutually agreed to wind down the IDE397 and AMG 193 clinical combination study and will not pursue dose expansion.
Gilead Clinical Study Collaboration and Supply Agreement
In November 2023, the Company entered into a Clinical Study Collaboration and Supply Agreement with Gilead Sciences, Inc. (“Gilead”), (the “Gilead CSCSA”), to clinically evaluate IDE397 in combination with Trodelvy (sacituzumab govitecan-hziy), a Trop-2 directed antibody drug conjugate (“ADC”), in patients having MTAP-deletion urothelial cancer (“UC”), in a Phase 1 clinical trial.
In February 2025, the Company expanded its clinical study collaboration and entered into an additional Clinical Study Collaboration and Supply Agreement with Gilead (the “Second Gilead CSCSA”), to evaluate the IDE397 and Trodelvy combination in MTAP-deletion NSCLC.
The Company is the study sponsor and Gilead will provide the supply of Trodelvy. Gilead will bear internal or external costs incurred in connection with its supply of Trodelvy. The Company will bear all internal and external costs and expenses associated with the conduct of the combination study. The Company and Gilead each retain commercial rights to its respective compounds, including with respect to use as a monotherapy agent or combination agent.
Merck Clinical Trial Collaboration and Supply Agreement
23
In March 2024, the Company entered into a Clinical Trial Collaboration and Supply Agreement (“Merck CTCSA”), with Merck (known as MSD outside of the United States and Canada) to evaluate IDE161 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with high microsatellite instability (“MSI-High”) and microsatellite stable (“MSS”) endometrial cancer. Pursuant to the Merck CTCSA, the Company is the sponsor of the combination study, and the Company will provide the IDE161 compound and pay for the costs of the combination study. Merck will provide KEYTRUDA at no cost to the Company. The Company and Merck will jointly own clinical data from the combination. Each party retains commercial rights to its respective compounds, including with respect to use as a monotherapy or combination agent.
KEYTRUDA®is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Biocytogen Option and License Agreement
In July 2024, the Company entered into an Option and License Agreement (the “Biocytogen Option and License Agreement”), pursuant to which Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”), granted us an option for an exclusive worldwide license from Biocytogen to develop and commercialize products in connection with a potential first-in-class B7H3/PTK7 topoisomerase-I-inhibitor-payload BsADC program (the “Option”). Under the terms of the Biocytogen Option and License Agreement, the Company paid Biocytogen an upfront fee and an exercise fee totaling $
Biocytogen is eligible to receive additional development and regulatory milestone payments and commercial milestone payments, as well as low to mid single-digit royalties on net sales. Total potential milestone payments equal an aggregate of $
Hengrui Pharma License Agreement
In December 2024, the Company entered into an exclusive License Agreement (the “Hengrui Pharma License Agreement”) with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”), pursuant to which Hengrui Pharma granted the Company an exclusive worldwide license outside of Greater China, for IDE849 (SHR-4849), a potential first-in-class Phase 1 DLL3 TOP1i ADC. In April 2025, the Company received U.S. IND clearance for the initiation of a Phase 1 clinical trial to evaluate IDE849 in solid tumors.
Under the terms of the Hengrui Pharma License Agreement, Hengrui Pharma is eligible to receive upfront and milestone payments totaling $
24
11. Revenue Recognition
The Company recognizes revenue in accordance with ASC 606 for the GSK Collaboration Agreement (see Note 10. Significant Agreements).
Disaggregation of Revenue
The Company recognized
The Company identified the following
(i) Preclinical and Phase 1 Monotherapy clinical research and development services under the MAT2A program (“MAT2A R&D Services”)
(ii) Preclinical research services and the related license to IDEAYA-owned technology under the Pol Theta program (“Pol Theta R&D Services”)
(iii) Preclinical research services and the related license to IDEAYA-owned technology under the WRN program (“WRN R&D Services”)
(iv) Material right associated with the option to license IDEAYA-owned technology under the MAT2A program (“Option”)
(v) Material right associated with the option to license to IDEAYA-owned technology under the MAT2A program to the extent necessary for preclinical activities in preparation for the MAT2A Combination Trial (“Preclinical MAT2A License”)
(vi) Material right associated with the supply of MAT2A product for the MAT2A Combination Trial (“MAT2A Supply”)
The Company completed all performance obligations related to the upfront payment under the GSK Collaboration Agreement as of December 31, 2023. Since December 31, 2023, the Company has no accounts receivable and no contract liabilities related to the GSK Collaboration Agreement. Because the Company completed all performance obligations, future collaboration revenue recognized under the GSK Collaboration Agreement is only related to milestone payments as they are earned.
In August 2023, the Company earned a $
In October 2024, the Company earned a $
25
Significant Judgments
In applying ASC 606 to the GSK Collaboration Agreement, the Company made the following judgment that significantly affect the timing and amount of revenue recognition:
(i) Determination of the transaction price, including whether any variable consideration is included at inception of the contract
The transaction price is the amount of consideration that the Company expects to be entitled to in exchange for transferring promised goods or services to the customer. The transaction price must be determined at inception of a contract and may include amounts of variable consideration. However, there is a constraint on inclusion of variable consideration in the transaction price if there is uncertainty at inception of the contract as to whether such consideration will be recognized in the future.
The decision as to whether or not it is probable that a significant reversal of revenue will occur in the future, depends on the likelihood and magnitude of the reversal and is highly susceptible to factors outside the Company’s influence (for example, the Company cannot determine the outcome of clinical trials; the Company cannot determine if or when the counterparty will initiate or complete clinical trials; and the Company cannot determine if or when an regulatory agency provides any approval). In addition, the uncertainty is not expected to be resolved for a long period and finally, the Company has limited experience in the field. Therefore, at inception of the GSK Collaboration Agreement, development and regulatory milestones were fully constrained and were not included in the transaction price based on the factors noted above.
The Company constrains estimates of other variable consideration, such as reimbursable program costs, to amounts that are not expected to result in a significant revenue reversal in the future. The Company re-evaluates the transaction price, including the estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
12. Net Loss Per Share Attributable to Common Stockholders
The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders (in thousands, except share and per share data):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||
|
|
2025 |
|
2024 |
|
|
2025 |
|
2024 |
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
||||
Net loss attributable to common stockholders |
|
$ |
( |
) |
$ |
( |
) |
|
$ |
( |
) |
$ |
( |
) |
Denominator: |
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average common shares outstanding, basic and diluted(1) |
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share attributable to common stockholders, basic and diluted |
|
$ |
( |
) |
$ |
( |
) |
|
$ |
( |
) |
$ |
( |
) |
(1) The shares underlying the pre-funded warrants to purchase shares of the Company’s common stock have been included in the
calculation of the weighted-average number of shares outstanding, basic and diluted, for the three and six months ended June 30,
2025.
26
The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive:
|
|
As of June 30, |
||
|
|
2025 |
|
2024 |
Options to purchase common stock |
|
|
||
Total |
|
|
13. Segment Information
The Company operates and manages its business as
In addition to the significant expense categories included within net income presented on the Company's condensed statements of operations and comprehensive loss, see below for disaggregated research and development expenses:
|
|
Three Months Ended |
|
||||
|
|
June 30, 2025 |
|
June 30, 2024 |
|
||
External clinical development expenses(1): |
|
|
|
|
|
||
Darovasertib |
|
$ |
|
$ |
|
||
IDE397(2) |
|
|
|
|
|
||
IDE161 |
|
|
|
|
|
||
Personnel related and stock-based compensation |
|
|
|
|
|
||
Other research and development expenses(3) |
|
|
|
|
|
||
Total research and development expenses |
|
$ |
|
$ |
|
|
|
Six Months Ended |
|
||||
|
|
June 30, 2025 |
|
June 30, 2024 |
|
||
External clinical development expenses(1): |
|
|
|
|
|
||
Darovasertib |
|
$ |
|
$ |
|
||
IDE397(2) |
|
|
|
|
|
||
IDE161 |
|
|
|
|
|
||
Personnel related and stock-based compensation |
|
|
|
|
|
||
Other research and development expenses(3) |
|
|
|
|
|
||
Total research and development expenses |
|
$ |
|
$ |
|
(1) External clinical development expenses include manufacturing and clinical trial costs. These expenses are primarily for services
provided by external consultants, CMOs (“Contract Manufacturing Organizations”) and CROs (“Contract Research
Organizations”).
(2) IDE397 includes costs from the Amgen CTCSA.
(3) Other research and development expenses include manufacturing and clinical trial costs for preclinical and earlier clinical stage
programs. These expenses are primarily for services provided by external consultants, CMOs and CROs.
14. Subsequent Events
The Company evaluated all subsequent events from June 30, 2025 through the filing date of this Quarterly Report on Form 10-Q and determined there were no significant events that required recognition or disclosure.
27
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described, in or implied, by these forward-looking statements. Please also see the section of this Quarterly Report on Form 10-Q titled “Note Regarding Forward-Looking Statements.”
Overview
We are a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our clinical development strategy is to evaluate our product candidates in rational combinations, where appropriate, and earlier in the course of disease in the adjuvant and neoadjuvant settings which we believe has the potential to maximize their impact. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.
Our clinical pipeline currently consists of six potential first-in-class product candidates, as follows:
28
We are also advancing three pre-clinical development programs towards the submission of investigational new drug, or IND, applications:
Since our inception, we have invested significantly in capabilities for identifying and validating new precision medicine targets and biomarkers for patient selection and have established multiple research collaborations to support our internal discovery and development efforts. We have also partnered with leading pharmaceutical companies, including GSK, Pfizer and Gilead to support clinical development activities for our pipeline programs.
Corporate Update
We do not have any products approved for sale and have not generated any product revenue since inception. We have funded our operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK. As of June 30, 2025, we had cash, cash equivalents and marketable securities of approximately $991.9 million, consisting primarily of money market funds, U.S. government securities, commercial paper and corporate bonds.
Since our inception in June 2015, we have devoted substantially all of our resources to discovering and developing our product candidates. We have incurred significant operating losses to date and expect that our operating expenses will increase significantly as we advance our product candidates through preclinical and clinical development; seek regulatory approval, and prepare for, and, if approved, proceed to commercialization; acquire, discover, validate and develop additional product candidates; obtain, maintain, protect and enforce our intellectual property portfolio; and hire additional personnel. For information about our specific program costs and expenses, see Note 10. Significant Agreements.
Our net losses were $149.7 million and $92.3 million for the six months ended June 30, 2025 and June 30, 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $772.5 million.
Our ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of one or more of our product candidates, ourselves, or for some programs, in collaboration with our strategic partners.
Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of our product candidates.
29
As of June 30, 2025, we had cash, cash equivalents and short-term and long-term marketable securities of approximately $991.9 million.
We believe that our cash, cash equivalents, and short-term and long-term marketable securities will be sufficient to fund our planned operations for at least twelve months from the date of the issuance of our Quarterly Report on Form 10-Q filed August 5, 2025.
These funds will support our efforts through potential achievement of multiple preclinical and clinical milestones across multiple programs.
Components of Operating Results
Collaboration Revenues
To date, we have not generated any revenue from product sales, and we do not expect to generate any revenue from product sales unless and until we are able to initiate a registrational clinical trial, obtain regulatory approval and commercialize one of our product candidates in the future. Our revenue consists exclusively of collaboration revenue under the GSK Collaboration Agreement, including amounts that are recognized related to previously received upfront payments and amounts due and payable to us for research and development services. The amount of revenue recognized related to the GSK Collaboration Agreement, including as related to the previously received upfront payment or to certain development milestone payments, may vary considerably by period and certain components thereof may generally decrease year-over-year as we satisfy remaining performance obligations, for example, relating to the Pol Theta and WRN R&D Services. Since December 31, 2023, we have fully recognized the contract liabilities related to the upfront payment and reimbursements for the research and development performance obligations under the GSK Collaboration Agreement. There are no remaining contract liabilities as of June 30, 2025 as we concluded all the research and development performance obligations under the GSK Collaboration Agreement. The future revenue recognition is contingent on additional milestones earned, profit sharing and royalties on any net product sales under our collaborations. We expect that any revenue we recognize or generate under the GSK Collaboration Agreement will fluctuate from period to period due to period to period variability in milestone payments and other payments.
Operating Expenses
Research and Development Expenses
Substantially all of our research and development expenses consist of expenses incurred in connection with the discovery and development of our product candidates. These expenses include certain payroll and personnel-related expenses, including salaries, employee benefit costs and stock-based compensation expenses for our research and product development employees, fees to third parties to conduct certain research and development activities on our behalf including fees to CMOs and CROs in support of manufacturing and clinical activity for darovasertib, IDE397, IDE849, IDE161, IDE275 / GSK959, IDE705 / GSK 101, and consulting costs, costs for laboratory supplies, costs for product licenses and allocated overhead, including rent, equipment, depreciation, information technology costs and utilities. We expense both internal and external research and development expenses as they are incurred.
We have entered into various agreements with CMOs and CROs. Our research and development accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development provided, but not yet invoiced, are included in accrued liabilities on the condensed balance sheet. If the actual timing of the performance of services or the level of effort varies from the original estimates, we will adjust the accrual accordingly. Payments made to CMOs and CROs under these arrangements in advance of the performance of the related services are recorded as prepaid expenses and other current assets until the services are rendered.
Costs of certain activities, such as preclinical studies, are generally recognized based on an evaluation of the progress to completion of specific tasks. Nonrefundable payments made prior to the receipt of goods or services that will be used or rendered for future research and development activities are deferred and capitalized as prepaid expenses and other current assets on our condensed balance sheet. The capitalized amounts are recognized as expense as the goods are delivered or the related services are performed.
We do not allocate our internal costs by product candidate, including internal costs, such as payroll and other personnel expenses, laboratory supplies and allocated overhead. With respect to internal costs, several of our departments support multiple product candidate research and development programs, and therefore the costs cannot
30
be allocated to a particular product candidate or development program. The following table summarizes our external clinical development expenses by program:
|
|
Three Months Ended |
|
||||
|
|
June 30, 2025 |
|
March 31, 2025 |
|
||
External clinical development expenses(1): |
|
|
|
|
|
||
Darovasertib |
|
$ |
25,091 |
|
$ |
23,018 |
|
IDE397(2) |
|
|
3,790 |
|
|
3,741 |
|
IDE161 |
|
|
1,568 |
|
|
2,448 |
|
Personnel related and stock-based compensation |
|
|
17,201 |
|
|
15,814 |
|
Other research and development expenses(3) |
|
|
26,576 |
|
|
25,865 |
|
Total research and development expenses |
|
$ |
74,226 |
|
$ |
70,886 |
|
|
|
Six Months Ended |
|
||||
|
|
June 30, 2025 |
|
June 30, 2024 |
|
||
External clinical development expenses(1): |
|
|
|
|
|
||
Darovasertib |
|
$ |
48,109 |
|
$ |
25,764 |
|
IDE397(2) |
|
|
7,531 |
|
|
6,991 |
|
IDE161 |
|
|
4,016 |
|
|
4,754 |
|
Personnel related and stock-based compensation |
|
|
33,015 |
|
|
26,789 |
|
Other research and development expenses(3) |
|
|
52,441 |
|
|
33,040 |
|
Total research and development expenses |
|
$ |
145,112 |
|
$ |
97,338 |
|
We are focusing substantially all of our resources on the development of our product candidates. We expect our research and development expenses to increase substantially during the next few years, as we seek to initiate and/or advance clinical trials for our product candidates, complete our clinical program, pursue regulatory approval of our product candidates and prepare for a possible commercial launch. Predicting the timing or the cost to complete our clinical program or validation of our commercial manufacturing and supply processes is difficult and delays may occur because of many factors, including factors outside of our control. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development. Furthermore, we are unable to predict when or if our product candidates will receive regulatory approval with any certainty.
General and Administrative Expenses
General and administrative expenses consist primarily of payroll and personnel-related expenses, including salaries, employee benefit costs and stock-based compensation expense, professional fees for legal, patent, consulting, accounting and tax services, allocated overhead, including rent, equipment, depreciation, information technology costs and utilities, and other general operating expenses not otherwise classified as research and development expenses.
We anticipate that our general and administrative expenses will increase, as a result of increased personnel costs, including salaries, benefits and stock-based compensation expense, patent costs for our product candidates, expanded infrastructure and higher consulting, legal and accounting services associated with maintaining compliance with our Nasdaq stock exchange listing and requirements of the Securities and Exchange Commission, or the SEC, investor relations costs and director and officer insurance policy premiums associated with being a public company.
31
Other Income
Interest Income and Other Income, Net
Interest income and other income, net consists primarily of interest income earned on our cash, cash equivalents and marketable securities.
Results of Operations
A discussion regarding our financial condition and results of operations for the three months ended June 30, 2025 compared to the three months ended March 31, 2025 and six months ended June 30, 2025 compared to the six months ended June 30, 2024 is presented below.
Comparison of Three Months Ended June 30, 2025 and March 31, 2025
The following table summarizes our results of operations for the periods indicated (in thousands):
|
|
Three Months Ended |
|
|
|
|
|
||||||
|
|
June 30, 2025 |
|
March 31, 2025 |
|
Change |
|
% Change |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
74,226 |
|
$ |
70,886 |
|
$ |
3,340 |
|
|
5 |
% |
General and administrative |
|
|
14,580 |
|
|
13,503 |
|
|
1,077 |
|
|
8 |
% |
Loss from operations |
|
|
(88,806 |
) |
|
(84,389 |
) |
|
(4,417 |
) |
|
5 |
% |
Interest income and other income, net |
|
|
11,315 |
|
|
12,211 |
|
|
(896 |
) |
|
(7 |
%) |
Net loss |
|
$ |
(77,491 |
) |
$ |
(72,178 |
) |
$ |
(5,313 |
) |
|
7 |
% |
Research and Development Expenses
Research and development expenses increased by $3.3 million, or 5%, during the three months ended June 30, 2025 compared to the three months ended March 31, 2025 primarily due to $1.5 million in personnel-related expenses and $1.8 million in fees paid to CROs, CMOs, and consultants related to the advancement of our lead product candidates through preclinical and clinical studies.
General and Administrative Expenses
General and administrative expenses increased by $1.1 million, or 8%, during the three months ended June 30, 2025 compared to the three months ended March 31, 2025. The increase in general and administrative expense was primarily due to $1.1 million in personnel-related expenses to support our growth.
Interest Income and Other Income, Net
Interest income decreased by $0.9 million, or 7%, during the three months ended June 30, 2025 compared to the three months ended March 31, 2025, primarily due to lower investment balances.
32
Comparison of Six Months Ended June 30, 2025 and June 30, 2024
The following table summarizes our results of operations for the periods indicated (in thousands):
|
|
Six Months Ended |
|
|
|
|
|
||||||
|
|
June 30, 2025 |
|
June, 30, 2024 |
|
Change |
|
% Change |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
145,112 |
|
$ |
97,338 |
|
$ |
47,774 |
|
|
49 |
% |
General and administrative |
|
|
28,083 |
|
|
18,606 |
|
|
9,477 |
|
|
51 |
% |
Loss from operations |
|
|
(173,195 |
) |
|
(115,944 |
) |
|
(57,251 |
) |
|
49 |
% |
Interest income and other income, net |
|
|
23,526 |
|
|
23,600 |
|
|
(74 |
) |
|
(0 |
%) |
Net loss |
|
$ |
(149,669 |
) |
$ |
(92,344 |
) |
$ |
(57,325 |
) |
|
62 |
% |
Research and Development Expenses
Research and development expenses increased by $47.8 million, or 49%, during the six months ended June 30, 2025 compared to the six months ended June 30, 2024 primarily due to $37.4 million in fees paid to CROs, CMOs, and consultants related to the advancement of our lead product candidates through preclinical and clinical studies, $6.2 million in personnel-related expenses and $4.2 million in costs for laboratory supplies, facilities and information technology costs to support our research and development programs.
General and Administrative Expenses
General and administrative expenses increased by $9.5 million, or 51%, during the six months ended June 30, 2025 compared to the six months ended June 30, 2024 primarily due $5.2 million in personnel-related expenses and $4.3 million in consulting services and legal patent expenses to support our growth.
Interest Income and Other Income, Net
Interest income decreased by $0.1 million during the six months ended June 30, 2025 compared to the six months ended June 30, 2024 primarily due to lower interest rates.
Liquidity and Capital Resources; Plan of Operations
Sources of Liquidity
We have funded our operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK. As of June 30, 2025, we had cash, cash equivalents and marketable securities of approximately $991.9 million, consisting primarily of money market funds, U.S. government securities, commercial paper, and corporate bonds.
On January 19, 2024, we entered into a new Open Market Sales Agreement, or the January 2024 Sales Agreement, with Jefferies LLC, or Jefferies, relating to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of common stock, par value $0.0001 per share, or common stock, having aggregate gross proceeds of up to $350.0 million through Jefferies as sales agent.
During the six months ended June 30, 2025, we sold an aggregate of 984,000 shares of our common stock for an aggregate net proceeds of $25.0 million at a weighted average sales price of approximately $26.00 per share under the at-the-market offering pursuant to the January 2024 Sales Agreement with Jefferies as sales agent. As of June 30, 2025, approximately $156.6 million of common stock remained available to be sold pursuant to the January 2024 Sales Agreement.
The Company may cancel its at-the-market program at any time upon written notice, pursuant to its terms.
33
Material Cash Requirements
We have incurred net losses since our inception. For the six months ended June 30, 2025 and June 30, 2024, we had net losses of $149.7 million and $92.3 million, respectively, and we expect to incur substantial additional losses in future periods. As of June 30, 2025, we had an accumulated deficit of $772.5 million. Based on our current business plan, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operations for at least the next 12 months from the issuance date of this Quarterly Report on Form 10-Q.
To date, we have not generated any product revenue. We do not expect to generate any meaningful product revenue unless and until we obtain regulatory approval of and commercialize any of our product candidates, and we do not know when, or if, it will occur. We expect to continue to incur significant losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for our product candidates, and begin to commercialize any approved products. We are subject to all of the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. Moreover, we expect to incur additional costs associated with operating as a public company.
We will continue to require additional capital to develop our product candidates and fund operations for the foreseeable future. We may seek to raise capital through private or public equity or debt financings, collaboration or other arrangements with corporate sources, or through other sources of financing. Adequate additional funding may not be available to us on acceptable terms or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategies. We anticipate that we will need to raise substantial additional capital, the requirements for which will depend on many factors, including:
A change in the outcome of any of these or other variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we will continue to require additional capital to meet operational needs and capital requirements associated with such operating plans. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments or engage in certain merger, consolidation or asset sale transactions.
Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. If we are unable to raise additional funds when needed, we may be required to delay, reduce, or terminate some or all of our development programs and clinical trials. We may also be required to sell or license to others rights to our product candidates in certain territories or indications that we would prefer to develop and commercialize ourselves.
34
In June 2023, we entered into a lease agreement for approximately 44,000 square feet of laboratory and office facilities at 5000 Shoreline Court, South San Francisco, California. The lease term is 120 months, and we have an option to extend the lease term for a total of two consecutive five-year periods. The lease commenced in August 2024.
In May 2024, we amended our 5000 Shoreline Court facility lease agreement to expand the size of the original premises by adding approximately 11,321 rentable square feet of additional space. The amendment to the lease term commenced in January 2025.
In November 2023, we entered into a lease agreement for approximately 5,700 square feet of space at 11710 El Camino Real, San Diego, California for corporate office space. The lease commenced in December 2023 and expires in March 2028. We have an option to renew the lease for three years.
We enter into contracts in the normal course of business with third-party contract organizations for preclinical and clinical studies and testing, manufacture and supply of our preclinical and clinical materials and providing other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice, and therefore, we believe that our non-cancellable obligations under these agreements are not material.
For more information see also Notes 5. Operating Leases, 6. Commitments and Contingencies, 7. Income Taxes and 10. Significant Agreements, each in the unaudited interim condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Adequate additional funding may not be available to us on acceptable terms or at all.
See the section of this Quarterly Report on Form 10-Q titled “Part I, Item 1A. – Risk Factors” for additional risks associated with our substantial capital requirements.
Off-Balance Sheet Arrangements
We have not entered into any off-balance sheet arrangements as defined in the rules and regulations of the SEC.
Summary Statement of Cash Flows
The following table sets forth the primary sources and uses of cash, cash equivalents, and restricted cash for each of the periods presented below (in thousands):
|
|
Six Months Ended June 30, |
|
||||
|
|
2025 |
|
2024 |
|
||
Net cash provided by (used in): |
|
|
|
|
|
||
Operating activities |
|
$ |
(122,816 |
) |
$ |
(76,695 |
) |
Investing activities |
|
|
125,735 |
|
|
(285,414 |
) |
Financing activities |
|
|
27,348 |
|
|
388,294 |
|
Net increase in cash, cash equivalents and restricted cash |
|
$ |
30,267 |
|
$ |
26,185 |
|
Cash Flows from Operating Activities
Net cash used in operating activities was $122.8 million for the six months ended June 30, 2025. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $149.7 million, adjusted for net non-cash charges of $18.0 million and changes in net operating assets and liabilities of $8.9 million. Our non-cash charges consisted of $22.1 million in stock-based compensation, $1.3 million in depreciation and $1.0 million of the amortization of right of use assets, partially offset by $6.5 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities consisted primarily due to cash inflows from $2.4 million in accounts payable, $7.7 million accrued and other liabilities in support of research and manufacturing activities and $1.2 million in lease liabilities, partially offset by outflows of $2.5 million in prepaid and other assets.
35
Net cash used in operating activities was $76.7 million for the six months ended June 30, 2024. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $92.3 million, adjusted for net non-cash charges of $5.3 million and changes in net operating assets and liabilities of $10.4 million. Our non-cash charges consisted of $16.0 million in stock-based compensation, $1.2 million in depreciation and $0.9 million of the amortization of right of use assets, partially offset by $13.0 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities consisted primarily due to cash inflows from $9.2 million in accounts payable and $5.6 million accrued and other liabilities due to CRO fees in support of research and manufacturing activities, partially offset by outflows from $3.5 million in prepaid and other assets and $1.0 million in lease liabilities.
Cash Flows from Investing Activities
Net cash provided by investing activities was $125.7 million for the six months ended June 30, 2025, which consisted primarily of $232.8 million used to purchase marketable securities and $2.0 million used to purchase property and equipment, offset by $360.5 million provided by maturities of marketable securities.
Net cash used in investing activities was $285.4 million for the six months ended June 30, 2024, which consisted primarily of $640.5 million used to purchase marketable securities and $2.3 million used to purchase property and equipment, partially offset by $357.4 million provided by maturities of marketable securities.
Cash Flows from Financing Activities
Net cash provided by financing activities was $27.3 million for the six months ended June 30, 2025, which consisted primarily of $25.0 million in net proceeds from at-the-market offerings, $1.5 million in proceeds from exercise of common stock options and $0.8 million in proceeds from ESPP purchase.
Net cash provided by financing activities was $388.3 million for the six months ended June 30, 2024, which consisted primarily of $380.0 million of net proceeds from at-the-market offerings and $7.5 million of proceeds from exercise of common stock options and $0.8 million of proceeds from ESPP purchases.
Critical Accounting Policies
Our financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported revenue recognized and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
For more detail on our critical accounting policies, refer to Note 2 in the unaudited interim condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, and the notes to the financial statements appearing elsewhere in our Annual Report on Form 10-K filed with the SEC on February 18, 2025. For the six months ended June 30, 2025, there were no material changes to our critical accounting policies from those disclosed in our Annual Report on Form 10-K filed with the SEC on February 18, 2025.
36
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Sensitivity
The market risk inherent in our financial instruments and in our financial position represents the potential loss arising from adverse changes in interest rates or exchange rates. As of June 30, 2025, we had cash, cash equivalents and marketable securities of approximately $991.9 million, consisting of bank deposits, interest-bearing money market funds, investments in U.S. government securities, commercial paper and corporate bonds, for which the fair value would be affected by changes in the general level of U.S. interest rates. Even if the fair value of certain government securities, commercial paper, and corporate bonds is affected by changes in U.S. interest rates, the principal of such instruments will be due to us upon maturity.
The primary objective of our investment activities is to preserve capital to fund our operations. We also seek to maximize income from our investments without assuming significant risk. Because our investments are primarily short-term in duration and our holdings in U.S. government treasury bonds mature prior to our expected need for liquidity, we believe that our exposure to interest rate risk is not significant.
While we have recently seen, we do not believe that inflation, or exchange rate fluctuations have had a significant impact on our results of operations for any periods presented herein.
Item 4. Controls and Procedures.
Limitations on Effectiveness of Controls and Procedures
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Principal Executive Officer and Principal Financial Officer, evaluated, as of the end of the period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(e) and 15d-15(e) of the Exchange Act that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors.
In addition to other information contained elsewhere in this Quarterly Report on Form 10-Q, you should carefully consider the risk factors discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K filed with the SEC on February 18, 2025, or our Annual Report, which could materially affect our business, financial condition, or future results. As of the date of this Quarterly Report on Form 10-Q, there have been no material changes to the risk factors disclosed in our Annual Report.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Unregistered Sales of Equity Securities
None.
Use of Proceeds from the Sale of Registered Securities
Not applicable.
Issuer Purchases of Equity Securities
None.
Item 3. Defaults Upon Senior Securities.
Not applicable.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other information.
Trading Plans
During the three months ended June 30, 2025, no Section 16 officers and directors
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Exhibit Index
Item 6. Exhibits.
Exhibit Number |
|
Exhibit Description |
|
Incorporated by Reference |
|
Filed Herewith |
||||
|
|
|
|
Form |
|
Date |
|
Number |
|
|
|
|
|
|
|
|
|
|
|
|
|
3.1 |
|
Amended and Restated Certificate of Incorporation. |
|
8-K |
|
5/28/2019 |
|
3.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
3.2 |
|
Amended and Restated Bylaws. |
|
8-K |
|
5/28/2019 |
|
3.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.1 |
|
Reference is made to Exhibits 3.1 through 3.2. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4.2 |
|
Form of Common Stock Certificate. |
|
S-1/A |
|
5/13/2019 |
|
4.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.3 |
|
Description of Common Stock. |
|
10-K |
|
2/18/2025 |
|
4.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.4 |
|
Form of April 2023 Pre-funded Warrant. |
|
8-K |
|
4/27/2023 |
|
4.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.5 |
|
Form of October 2023 Pre-funded Warrant. |
|
8-K |
|
10/27/2023 |
|
4.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.6 |
|
Form of July 2024 Pre-funded Warrant. |
|
8-K |
|
7/11/2024 |
|
4.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.1# |
|
Non-Employee Director Compensation Program. |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
10.2# |
|
Employment Agreement by and between IDEAYA Biosciences, Inc. and Joshua Bleharski, Ph.D. |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
10.3# |
|
Amendment to IDEAYA Biosciences, Inc. 2023 Employment Inducement Award Plan. |
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
31.1 |
|
Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
31.2 |
|
Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
32.1* |
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
101.INS |
|
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
101.SCH |
|
Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents. |
|
|
|
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
104 |
|
Cover Page Interactive Data File (embedded with the Inline XBRL document). |
|
|
|
|
|
|
|
X |
# Indicates management contract or compensatory plan.
* The certification attached as Exhibit 32.1 that accompanies this Quarterly Report on Form 10-Q is not deemed filed with the SEC and is not to be incorporated by reference into any filing of IDEAYA Biosciences, Inc. under the
40
Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-Q, irrespective of any general incorporation language contained in such filing.
41
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereto duly authorized.
|
|
IDEAYA Biosciences, Inc. |
||
|
|
|
|
|
Date: August 5, 2025 |
|
By: |
|
/s/ Yujiro Hata |
|
|
|
|
Yujiro Hata |
|
|
|
|
President and Chief Executive Officer |
|
|
|
|
(Principal Executive Officer) |
|
|
|
|
|
Date: August 5, 2025 |
|
By: |
|
/s/ Joshua Bleharski, Ph.D. |
|
|
|
|
Joshua Bleharski, Ph.D. |
|
|
|
|
Chief Financial Officer |
|
|
|
|
(Principal Financial Officer) |
|
|
|
|
|
42