[10-Q] Inhibikase Therapeutics, Inc. Quarterly Earnings Report
Inhibikase Therapeutics (IKT) reported items in its Form 10-Q showing corporate and development activity ahead of a planned Phase 2b study in pulmonary arterial hypertension (PAH). The company expects to initiate a ~150鈥憄atient Phase 2b trial in the second half of 2025 and used non鈥慼uman primate safety studies and a bioequivalence trial in healthy volunteers to set dosing.
Financing and equity actions are material: a private placement included issuance of shares and multiple warrant tranches exercisable at $1.37 and $1.49 with exercise and ownership caps, and 19,665,131 pre鈥慺unded warrants were outstanding at June 30, 2025. An at鈥憈he鈥憁arket agreement with HCW was terminated effective December 11, 2024; a separate Sales Agreement with Jefferies and a related shelf registration were in place as of June 27, 2025. The company acquired CorHepta, issuing shares including contingent and performance鈥慴ased shares and recognized a $7,357,294 R&D write鈥憃ff related to IPR&D.
Inhibikase Therapeutics (IKT) ha riportato nel suo Modulo 10-Q elementi relativi alle attivit脿 aziendali e di sviluppo in vista di uno studio di fase 2b pianificato per l'ipertensione arteriosa polmonare (PAH). La societ脿 prevede di avviare uno studio di fase 2b di circa 150 pazienti nella seconda met脿 del 2025 e ha utilizzato studi di sicurezza su primati non umani e uno studio di bioequivalenza su volontari sani per definire il dosaggio.
Operazioni finanziarie ed azionarie di rilievo: un collocamento privato ha comportato l'emissione di azioni e pi霉 tranche di warrant esercitabili a $1,37 e $1,49 con limiti di esercizio e di propriet脿; al 30 giugno 2025 risultavano in circolazione 19.665.131 warrant pre-finanziati. Un accordo at-the-market con HCW 猫 stato terminato con efficacia dal 11 dicembre 2024; al 27 giugno 2025 risultavano invece in essere un Sales Agreement con Jefferies e una relativa registrazione shelf. La societ脿 ha acquisito CorHepta, emettendo azioni comprendenti azioni condizionate e legate a performance, e ha rilevato una svalutazione R&S di $7.357.294 relativa a IPR&D.
Inhibikase Therapeutics (IKT) inform贸 en su Formulario 10-Q sobre actividades corporativas y de desarrollo previas a un estudio planificado de fase 2b en hipertensi贸n arterial pulmonar (PAH). La compa帽铆a espera iniciar un ensayo de fase 2b de aproximadamente 150 pacientes en la segunda mitad de 2025 y emple贸 estudios de seguridad en primates no humanos y un ensayo de bioequivalencia en voluntarios sanos para establecer la dosificaci贸n.
Hay acciones financieras y de capital significativas: una colocaci贸n privada incluy贸 la emisi贸n de acciones y varias series de warrants ejercitables a $1.37 y $1.49 con l铆mites de ejercicio y de propiedad, y al 30 de junio de 2025 hab铆a 19.665.131 warrants prefinanciados en circulaci贸n. Un acuerdo at-the-market con HCW se rescindi贸 con efecto del 11 de diciembre de 2024; al 27 de junio de 2025 estaban vigentes un Sales Agreement con Jefferies y una correspondiente inscripci贸n en shelf. La compa帽铆a adquiri贸 CorHepta, emitiendo acciones que incluyen acciones contingentes y por rendimiento, y registr贸 una baja de I+D por $7.357.294 relacionada con IPR&D.
Inhibikase Therapeutics(IKT)電� Form 10-Q鞐愳劀 韽愲彊毵リ碃順堨晻(PAH) 雽�靸� 鞓堨爼霅� 2b靸� 鞁滍棙鞚� 鞎炿憪瓿� 須岇偓 氚� 臧滊皽 頇滊彊 甏�霠� 靷暛鞚� 氤搓碃頄堨姷雼堧嫟. 須岇偓電� 2025雲� 頃橂皹旮办棎 鞎� 150氇� 攴滊鞚� 2b靸� 鞁滍棙鞚� 鞁滌瀾頃� 鞓堨爼鞚措┌, 牍勳澑臧� 鞓侅灔毳� 鞎堨爠靹� 鞁滍棙瓿� 瓯搓皶頃� 歆�鞗愳瀽毳� 雽�靸侅溂搿� 頃� 靸濍頃欖爜霃欕摫靹� 鞁滍棙鞚� 韱淀暣 韴棳霟夓潉 靹れ爼頄堨姷雼堧嫟.
鞛愱笀 臁半嫭 氚� 歆�攵� 甏�霠� 臁办箻臧� 欷戩殧頃╇媹雼�: 靷 氚滍枆鞐愲姅 欤检嫕 氚滍枆瓿� 頄夓偓臧�鞎� $1.37 氚� $1.49鞚� 鞐煬 鞗岆煱韸� 韸鸽灉旃橁皜 韽暔霅橃棃鞙茧┌ 頄夓偓 氚� 靻岇湢 頃滊弰臧� 鞝侅毄霅橃棃瓿�, 2025雲� 6鞗� 30鞚� 旮办 19,665,131臧滌潣 頂勲Μ韼�霐旊摐 鞗岆煱韸戈皜 氚滍枆霅橃柎 鞛堨棃鞀惦媹雼�. HCW鞕�鞚� 鞁滌灔氚滍枆(at-the-market) 瓿勳暯鞚� 2024雲� 12鞗� 11鞚茧秬搿� 膦呺霅橃棃瓿�, 2025雲� 6鞗� 27鞚� 旮办 Jefferies鞕�鞚� 韺愲Г瓿勳暯(Sales Agreement) 氚� 甏�霠� 靺疙攧 霌彪鞚� 鞙犿毃頄堨姷雼堧嫟. 須岇偓電� CorHepta毳� 鞚胳垬頃橂┐靹� 臁瓣贝攵� 氚� 靹标臣 旮半皹 欤检嫕鞚� 韽暔頃� 欤检嫕鞚� 氚滍枆頄堦碃, IPR&D 甏�霠� 鞐瓣惮臧滊皽 靻愳儊彀啇 $7,357,294毳� 鞚胳嫕頄堨姷雼堧嫟.
Inhibikase Therapeutics (IKT) a indiqu茅 dans son Form 10-Q des 茅l茅ments relatifs 脿 ses activit茅s corporatives et de d茅veloppement en amont d'une 茅tude de phase 2b pr茅vue pour l'hypertension art茅rielle pulmonaire (PAH). La soci茅t茅 pr茅voit de lancer un essai de phase 2b d'environ 150 patients au second semestre 2025 et s'est appuy茅e sur des 茅tudes de s茅curit茅 chez des primates non humains et un essai de bio茅quivalence chez des volontaires sains pour d茅terminer le dosage.
Les op茅rations de financement et d'茅mission d'actions sont significatives : un placement priv茅 a inclus l'茅mission d'actions et plusieurs tranches de warrants exer莽ables 脿 $1,37 et $1,49 avec des plafonds d'exercice et de d茅tention, et 19 665 131 warrants pr茅pay茅s 茅taient en circulation au 30 juin 2025. Un accord at鈥憈he鈥憁arket avec HCW a 茅t茅 r茅sili茅 avec effet au 11 d茅cembre 2024 ; au 27 juin 2025, un Sales Agreement avec Jefferies et une inscription shelf associ茅e 茅taient en place. La soci茅t茅 a acquis CorHepta en 茅mettant des actions, y compris des actions conditionnelles et li茅es 脿 la performance, et a comptabilis茅 une d茅pr茅ciation R&D de 7 357 294 $ li茅e 脿 l'IPR&D.
Inhibikase Therapeutics (IKT) gab in seinem Form 10-Q Angaben zu Unternehmens- und Entwicklungsaktivit盲ten im Vorfeld einer geplanten Phase鈥�2b鈥慡tudie bei pulmonaler arterieller Hypertonie (PAH) bekannt. Das Unternehmen erwartet, in der zweiten H盲lfte 2025 eine Phase鈥�2b鈥慡tudie mit rund 150 Patienten zu starten und nutzte Sicherheitsstudien an nicht鈥憁enschlichen Primaten sowie eine Bio盲quivalenzstudie bei gesunden Freiwilligen zur Festlegung der Dosierung.
Finanzierungs鈥� und Eigenkapitalma脽nahmen sind wesentlich: Eine Privatplatzierung umfasste die Ausgabe von Aktien und mehrere Tranchen von Warrants, die zu $1,37 bzw. $1,49 aus眉bbar sind, mit Aus眉bungs鈥� und Eigentumsbeschr盲nkungen; am 30. Juni 2025 waren 19.665.131 vorab finanzierte Warrants ausstehend. Ein At鈥憈he鈥憁arket鈥慉bkommen mit HCW wurde zum 11. Dezember 2024 beendet; zum 27. Juni 2025 bestanden ein Sales Agreement mit Jefferies und eine zugeh枚rige Shelf鈥慠egistrierung. Das Unternehmen erwarb CorHepta, gab dabei unter anderem bedingte und leistungsabh盲ngige Aktien aus und verbuchte eine F&E鈥慉bschreibung in H枚he von $7.357.294 im Zusammenhang mit IPR&D.
- Planned Phase 2b trial for IKT鈥�001 in pulmonary arterial hypertension of ~150 patients expected to start in H2 2025
- Completed supporting studies: non鈥慼uman primate safety studies and a bioequivalence clinical trial that informed dose selection
- Financing completed: private placement with shares and warrants and an effective Form S鈥�3 shelf with Jefferies provides capital channels
- Potential dilution: 19,665,131 pre鈥慺unded warrants outstanding and multiple warrant tranches with exercise prices that could dilute current shareholders
- Contingent acquisition consideration: CorHepta acquisition included contingent and performance鈥慴ased shares; some amounts depend on future milestones and remain uncertain
- R&D write鈥憃ff: $7,357,294 was written off as research and development expense immediately following the acquisition
Insights
TL;DR: Financing activity reduces short鈥憈erm dilution risk but creates contingent equity and warrants that may dilute shareholders.
The company has completed a significant private placement that included shares and multiple warrant series with exercise prices of $1.37 and $1.49 and ownership caps that limit single鈥慽nvestor concentration. Termination of the HCW ATM removes a prior sales channel; the Jefferies Sales Agreement and effective shelf registration provide an alternate path for future ATM sales though no shares were sold under that agreement as of June 30, 2025. The outstanding 19,665,131 pre鈥慺unded warrants and contingently issuable acquisition shares represent potential dilution that investors should quantify relative to fully diluted share counts. The $7.36 million R&D write鈥憃ff from the CorHepta acquisition materially affected operating expense for the period.
TL;DR: Clinical progress toward a Phase 2b PAH trial and supporting nonclinical/BE work are positive development milestones.
IKT completed non鈥慼uman primate safety studies and a bioequivalence trial in healthy volunteers that informed dose selection for IKT鈥�001. The company intends to start a Phase 2b trial of approximately 150 PAH patients in the second half of 2025, a meaningful step toward demonstrating efficacy and advancing regulatory discussions. Execution risks remain typical for clinical programs, including enrollment, manufacturing for trials, and establishing an appropriate safety profile in IND鈥慹nabling data.
Inhibikase Therapeutics (IKT) ha riportato nel suo Modulo 10-Q elementi relativi alle attivit脿 aziendali e di sviluppo in vista di uno studio di fase 2b pianificato per l'ipertensione arteriosa polmonare (PAH). La societ脿 prevede di avviare uno studio di fase 2b di circa 150 pazienti nella seconda met脿 del 2025 e ha utilizzato studi di sicurezza su primati non umani e uno studio di bioequivalenza su volontari sani per definire il dosaggio.
Operazioni finanziarie ed azionarie di rilievo: un collocamento privato ha comportato l'emissione di azioni e pi霉 tranche di warrant esercitabili a $1,37 e $1,49 con limiti di esercizio e di propriet脿; al 30 giugno 2025 risultavano in circolazione 19.665.131 warrant pre-finanziati. Un accordo at-the-market con HCW 猫 stato terminato con efficacia dal 11 dicembre 2024; al 27 giugno 2025 risultavano invece in essere un Sales Agreement con Jefferies e una relativa registrazione shelf. La societ脿 ha acquisito CorHepta, emettendo azioni comprendenti azioni condizionate e legate a performance, e ha rilevato una svalutazione R&S di $7.357.294 relativa a IPR&D.
Inhibikase Therapeutics (IKT) inform贸 en su Formulario 10-Q sobre actividades corporativas y de desarrollo previas a un estudio planificado de fase 2b en hipertensi贸n arterial pulmonar (PAH). La compa帽铆a espera iniciar un ensayo de fase 2b de aproximadamente 150 pacientes en la segunda mitad de 2025 y emple贸 estudios de seguridad en primates no humanos y un ensayo de bioequivalencia en voluntarios sanos para establecer la dosificaci贸n.
Hay acciones financieras y de capital significativas: una colocaci贸n privada incluy贸 la emisi贸n de acciones y varias series de warrants ejercitables a $1.37 y $1.49 con l铆mites de ejercicio y de propiedad, y al 30 de junio de 2025 hab铆a 19.665.131 warrants prefinanciados en circulaci贸n. Un acuerdo at-the-market con HCW se rescindi贸 con efecto del 11 de diciembre de 2024; al 27 de junio de 2025 estaban vigentes un Sales Agreement con Jefferies y una correspondiente inscripci贸n en shelf. La compa帽铆a adquiri贸 CorHepta, emitiendo acciones que incluyen acciones contingentes y por rendimiento, y registr贸 una baja de I+D por $7.357.294 relacionada con IPR&D.
Inhibikase Therapeutics(IKT)電� Form 10-Q鞐愳劀 韽愲彊毵リ碃順堨晻(PAH) 雽�靸� 鞓堨爼霅� 2b靸� 鞁滍棙鞚� 鞎炿憪瓿� 須岇偓 氚� 臧滊皽 頇滊彊 甏�霠� 靷暛鞚� 氤搓碃頄堨姷雼堧嫟. 須岇偓電� 2025雲� 頃橂皹旮办棎 鞎� 150氇� 攴滊鞚� 2b靸� 鞁滍棙鞚� 鞁滌瀾頃� 鞓堨爼鞚措┌, 牍勳澑臧� 鞓侅灔毳� 鞎堨爠靹� 鞁滍棙瓿� 瓯搓皶頃� 歆�鞗愳瀽毳� 雽�靸侅溂搿� 頃� 靸濍頃欖爜霃欕摫靹� 鞁滍棙鞚� 韱淀暣 韴棳霟夓潉 靹れ爼頄堨姷雼堧嫟.
鞛愱笀 臁半嫭 氚� 歆�攵� 甏�霠� 臁办箻臧� 欷戩殧頃╇媹雼�: 靷 氚滍枆鞐愲姅 欤检嫕 氚滍枆瓿� 頄夓偓臧�鞎� $1.37 氚� $1.49鞚� 鞐煬 鞗岆煱韸� 韸鸽灉旃橁皜 韽暔霅橃棃鞙茧┌ 頄夓偓 氚� 靻岇湢 頃滊弰臧� 鞝侅毄霅橃棃瓿�, 2025雲� 6鞗� 30鞚� 旮办 19,665,131臧滌潣 頂勲Μ韼�霐旊摐 鞗岆煱韸戈皜 氚滍枆霅橃柎 鞛堨棃鞀惦媹雼�. HCW鞕�鞚� 鞁滌灔氚滍枆(at-the-market) 瓿勳暯鞚� 2024雲� 12鞗� 11鞚茧秬搿� 膦呺霅橃棃瓿�, 2025雲� 6鞗� 27鞚� 旮办 Jefferies鞕�鞚� 韺愲Г瓿勳暯(Sales Agreement) 氚� 甏�霠� 靺疙攧 霌彪鞚� 鞙犿毃頄堨姷雼堧嫟. 須岇偓電� CorHepta毳� 鞚胳垬頃橂┐靹� 臁瓣贝攵� 氚� 靹标臣 旮半皹 欤检嫕鞚� 韽暔頃� 欤检嫕鞚� 氚滍枆頄堦碃, IPR&D 甏�霠� 鞐瓣惮臧滊皽 靻愳儊彀啇 $7,357,294毳� 鞚胳嫕頄堨姷雼堧嫟.
Inhibikase Therapeutics (IKT) a indiqu茅 dans son Form 10-Q des 茅l茅ments relatifs 脿 ses activit茅s corporatives et de d茅veloppement en amont d'une 茅tude de phase 2b pr茅vue pour l'hypertension art茅rielle pulmonaire (PAH). La soci茅t茅 pr茅voit de lancer un essai de phase 2b d'environ 150 patients au second semestre 2025 et s'est appuy茅e sur des 茅tudes de s茅curit茅 chez des primates non humains et un essai de bio茅quivalence chez des volontaires sains pour d茅terminer le dosage.
Les op茅rations de financement et d'茅mission d'actions sont significatives : un placement priv茅 a inclus l'茅mission d'actions et plusieurs tranches de warrants exer莽ables 脿 $1,37 et $1,49 avec des plafonds d'exercice et de d茅tention, et 19 665 131 warrants pr茅pay茅s 茅taient en circulation au 30 juin 2025. Un accord at鈥憈he鈥憁arket avec HCW a 茅t茅 r茅sili茅 avec effet au 11 d茅cembre 2024 ; au 27 juin 2025, un Sales Agreement avec Jefferies et une inscription shelf associ茅e 茅taient en place. La soci茅t茅 a acquis CorHepta en 茅mettant des actions, y compris des actions conditionnelles et li茅es 脿 la performance, et a comptabilis茅 une d茅pr茅ciation R&D de 7 357 294 $ li茅e 脿 l'IPR&D.
Inhibikase Therapeutics (IKT) gab in seinem Form 10-Q Angaben zu Unternehmens- und Entwicklungsaktivit盲ten im Vorfeld einer geplanten Phase鈥�2b鈥慡tudie bei pulmonaler arterieller Hypertonie (PAH) bekannt. Das Unternehmen erwartet, in der zweiten H盲lfte 2025 eine Phase鈥�2b鈥慡tudie mit rund 150 Patienten zu starten und nutzte Sicherheitsstudien an nicht鈥憁enschlichen Primaten sowie eine Bio盲quivalenzstudie bei gesunden Freiwilligen zur Festlegung der Dosierung.
Finanzierungs鈥� und Eigenkapitalma脽nahmen sind wesentlich: Eine Privatplatzierung umfasste die Ausgabe von Aktien und mehrere Tranchen von Warrants, die zu $1,37 bzw. $1,49 aus眉bbar sind, mit Aus眉bungs鈥� und Eigentumsbeschr盲nkungen; am 30. Juni 2025 waren 19.665.131 vorab finanzierte Warrants ausstehend. Ein At鈥憈he鈥憁arket鈥慉bkommen mit HCW wurde zum 11. Dezember 2024 beendet; zum 27. Juni 2025 bestanden ein Sales Agreement mit Jefferies und eine zugeh枚rige Shelf鈥慠egistrierung. Das Unternehmen erwarb CorHepta, gab dabei unter anderem bedingte und leistungsabh盲ngige Aktien aus und verbuchte eine F&E鈥慉bschreibung in H枚he von $7.357.294 im Zusammenhang mit IPR&D.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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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.
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As of August 7, 2025, the registrant had
Table of Contents
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PART I. |
FINANCIAL INFORMATION |
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Item 1. |
Condensed Consolidated Financial Statements (Unaudited) |
1 |
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Condensed Consolidated Balance Sheets as of June 30, 2025 (Unaudited) and December 31, 2024 |
1 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2025 and 2024 (Unaudited) |
2 |
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Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2025 and 2024 (Unaudited) |
3 |
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Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2025 and 2024 (Unaudited) |
5 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
6 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
21 |
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
31 |
Item 4. |
Controls and Procedures |
31 |
PART II. |
OTHER INFORMATION |
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Item 1. |
Legal Proceedings |
32 |
Item 1A. |
Risk Factors |
32 |
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
34 |
Item 3. |
Defaults Upon Senior Securities |
35 |
Item 4. |
Mine Safety Disclosures |
35 |
Item 5. |
Other Information |
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Item 6. |
Exhibits |
36 |
Signatures |
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We own various United States (“U.S.”) federal trademark applications and unregistered trademarks, including our company name and logo, that we use in connection with the operation of our business. This Quarterly Report on Form 10-Q (this “Quarterly Report”) includes our trademarks and trade names which are protected under applicable intellectual property laws and are our property. This Quarterly Report also contains trademarks, trade names and service marks of other companies, which are the property of their respective owners. Solely for convenience, trademarks, trade names and service marks referred to in this Quarterly Report may appear without the ®, ™ or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent permitted under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by these other parties.
From time to time, we may use our website, our LinkedIn account at https://www.linkedin.com/company/inhibikase-therapeutics/ and our YouTube account at https://www.youtube.com/user/Inhibikase to distribute material information about us and for complying with our disclosure obligations under Regulation FD. Our financial and other material information is routinely posted to and accessible on the Investors section of our website, available at https://www.inhibikase.com/. Investors are encouraged to review the Investors section of our website because we may post material information on that site that is not otherwise disseminated by us. Information that is contained in and can be accessed through our website or our social media are not incorporated into, and does not form a part of, this Quarterly Report.
i
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
All statements included or incorporated by reference in this Quarterly Report, other than statements or characterizations of historical fact, are forward-looking statements. These forward-looking statements are based on our current expectations, estimates, approximations and projections about our industry and business, management’s beliefs, and certain assumptions made by us, all of which are subject to change. Forward-looking statements can often be identified by words such as “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “could,” “potential,” “continue,” “ongoing,” and similar expressions and variations or negatives of these words. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors. These forward-looking statements speak only as of the date of this Quarterly Report. We undertake no obligation to revise or update publicly any forward-looking statement for any reason, except as otherwise required by law. In this Annual Report, unless otherwise indicated, the “Company”, “we,” “us” or “our” refer to Inhibikase Therapeutics, Inc., a Delaware corporation and its subsidiaries, IKT Securities Corporation, a Massachusetts corporation, and CorHepta Pharmaceuticals, Inc., a Delaware corporation.
These forward-looking statements include, among other things, statements about:
ii
iii
PART I—FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (Unaudited).
Inhibikase Therapeutics, Inc.
Condensed Consolidated Balance Sheets
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June 30, |
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December 31, |
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(unaudited) |
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(Note 3) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Marketable securities |
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Prepaid research and development |
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Deferred offering costs |
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Prepaid expenses and other current assets |
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Total current assets |
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Equipment and improvements, net |
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Right-of-use asset |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Lease obligation, current |
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Accrued expenses and other current liabilities |
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Contingent consideration liability |
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Total current liabilities |
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Total liabilities |
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Commitments and contingencies (see Note 16) |
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Stockholders’ equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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( |
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( |
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Accumulated deficit |
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( |
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( |
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Total stockholders' equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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See accompanying notes to condensed consolidated financial statements.
1
Inhibikase Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
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Three Months Ended June 30, |
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Six months ended June 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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Costs and expenses: |
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Research and development |
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$ |
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$ |
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$ |
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$ |
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Selling, general and administrative |
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Change in fair value contingent consideration |
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( |
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Total costs and expenses |
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Loss from operations |
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Interest income |
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Net loss |
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( |
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( |
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( |
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( |
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Other comprehensive income (loss), net of tax |
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Unrealized gain (loss) on marketable securities |
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( |
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( |
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Comprehensive loss |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
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Net loss per share – basic and diluted |
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$ |
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$ |
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$ |
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$ |
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Weighted-average number of shares – basic and diluted |
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See accompanying notes to condensed consolidated financial statements.
2
Inhibikase Therapeutics, Inc.
Condensed Consolidated Statements of Stockholders' Equity
(Unaudited)
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Common Stock |
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Shares |
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Amount |
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Additional |
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Accumulated Other Comprehensive Loss |
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Accumulated |
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Total |
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Balance at December 31, 2024 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Issuance of common stock, pre-funded warrants and warrants, net of issuance costs |
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— |
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— |
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Contingently issuable common stock subject to vesting criteria (see Note 10) |
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— |
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— |
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— |
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Other comprehensive income |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
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Balance at March 31, 2025 |
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( |
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( |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Issuance of common stock, pre-funded warrants and warrants, net of issuance costs |
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— |
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— |
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— |
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Issuance of common stock, stock options exercised |
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— |
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— |
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Other comprehensive loss |
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— |
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— |
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— |
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( |
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— |
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( |
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Net loss |
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— |
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— |
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— |
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— |
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( |
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( |
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Balance at June 30, 2025 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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3
Inhibikase Therapeutics, Inc.
Condensed Consolidated Statements of Stockholders' Equity
(Unaudited)
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Common Stock |
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Shares |
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Amount |
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Additional |
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Accumulated Other Comprehensive Income (Loss) |
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Accumulated |
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Total |
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Balance at December 31, 2023 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Issuance of common stock, pre-funded warrants and warrants, net of issuance costs |
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— |
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— |
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Other comprehensive loss |
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— |
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— |
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— |
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( |
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— |
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( |
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Net loss |
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— |
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— |
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— |
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— |
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( |
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( |
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Balance at March 31, 2024 |
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( |
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( |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Issuance of common stock, pre-funded warrants and warrants, net of issuance costs |
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— |
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— |
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Other comprehensive income |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
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( |
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Balance at June 30, 2024 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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See accompanying notes to condensed consolidated financial statements.
4
Inhibikase Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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Six months ended June 30, |
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2025 |
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2024 |
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Cash flows from operating activities |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
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Stock-based compensation expense |
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Write-off of in-process research and development |
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Change in fair value of contingent consideration |
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( |
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Changes in operating assets and liabilities: |
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Operating lease right‑of‑use assets |
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Prepaid expenses and other assets |
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Prepaid research and development |
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( |
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( |
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Accounts payable |
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Operating lease liabilities |
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( |
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( |
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Accrued expenses and other current liabilities |
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( |
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Net cash used in operating activities |
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( |
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( |
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Cash flows from investing activities |
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Purchases of equipment and improvements |
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( |
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Purchases of investments - marketable securities |
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( |
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Maturities of investments - marketable securities |
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Acquired in-process research and development |
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( |
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Net cash provided by (used in) investing activities |
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( |
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Cash flows from financing activities |
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Proceeds from issuance of common stock, pre-funded warrants and warrants, net of issuance costs |
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Issuance of common stock from exercise of stock options |
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Net cash provided by financing activities |
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Net increase (decrease) in cash and cash equivalents |
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( |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period |
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$ |
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$ |
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Supplemental disclosures of cash flow information |
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Issuance costs |
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$ |
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$ |
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Non cash investing and financing activities |
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Non-cash financing costs |
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$ |
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$ |
( |
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CorHepta transaction costs |
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$ |
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$ |
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Contingent consideration |
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$ |
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$ |
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Deferred offering costs included in accounts payable and accrued expenses |
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$ |
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$ |
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See accompanying notes to condensed consolidated financial statements.
5
Inhibikase Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
Inhibikase Therapeutics, Inc. is a clinical-stage pharmaceutical company developing a protein kinase inhibitor therapeutic to modify the course of cardiopulmonary disease that arises from aberrant signaling through the Abelson Tyrosine Kinases and type III receptor tyrosine kinases including platelet derived growth factor receptors and c-KIT. The Company’s lead product candidate is IKT-001, a novel oral prodrug of the anticancer agent imatinib, an FDA approved drug for certain blood and stomach cancers. The Company plans to seek approval from the FDA for IKT-001 for the treatment of Pulmonary Arterial Hypertension (“PAH”) as an orphan indication. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that impacts approximately 50,000 Americans. IKT-001 is designed to improve tolerance to imatinib's active ingredient which may allow for improved safety and efficacy. The Company previously completed non-human primate safety studies and a bioequivalence clinical trial in healthy volunteers to determine the doses of IKT-001 that are equivalent to imatinib mesylate and the results have been utilized to set the doses for the Company's forthcoming Phase 2b clinical study. The Phase 2b study, known as IMPROVE-PAH, is expected to be initiated in the second half of 2025 and will be a multi-center, randomized, double-blind, placebo-controlled study of approximately 150 PAH patients.
2. Liquidity
As of June 30, 2025, the Company had cash, cash equivalents and marketable securities of approximately $
The Company has incurred recurring losses and at June 30, 2025, had an accumulated deficit of approximately $
To date, the Company has funded its operations primarily through public offerings of its common stock, private placements of its common stock (and pre-funded warrants) and sales of common stock through at-the-market (“ATM”) offerings. In December 2020, June 2021, January 2023, May 2024 and October 2024, the Company raised approximately $
The Company is subject to a variety of risks similar to other early-stage life science companies including, but not limited to, the successful development, regulatory approval, and market acceptance of the Company’s product candidates, development by its competitors of new technological innovations, protection of proprietary technology, and raising additional working capital. The Company has incurred significant research and development expenses, general and administrative expenses related to its product candidate programs and negative cash flows from operations. The Company anticipates costs and expenses to increase in the future as the Company continues to develop and pursue regulatory approval of IKT-001.
The Company may seek to fund its operations through additional public equity, private equity, or debt financings, as well as other sources. However, the Company may be unable to raise additional working capital, or if it is able to raise additional capital, it may be unable to do so on commercially favorable terms (see Note 8). In addition, potential proceeds from the exercise of the Series A-1 Warrants or the Series B-1 Warrants may not be available to the Company in a timely fashion, or at all. The Company’s failure to raise capital or enter into such other arrangements would have a negative impact on the Company’s business, financial viability, results of operations and financial condition and the Company’s ability to continue to develop its product candidates.
The Company estimates that its cash and cash equivalents and marketable securities at June 30, 2025 is sufficient to fund its normal operations for at least the next twelve months from the date of issuance of these consolidated financial statements.
The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The unaudited condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.
Basis of Presentation of Interim Financial Statements
The accompanying unaudited condensed consolidated financial statements were prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for interim financial statements and, in the opinion of management, include all normal and recurring adjustments necessary to present fairly the results of the interim periods shown. The
6
December 31, 2024 balance sheet was derived from the December 31, 2024 audited financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles (“US GAAP”) have been condensed or omitted pursuant to such SEC rules and regulations. Management believes that the disclosures made are adequate to make the information presented not misleading. The results for the interim periods are not necessarily indicative of results to be expected for the fiscal year ending December 31, 2025. The unaudited condensed consolidated financial statements contained herein should be read in conjunction with the Company’s annual audited financial statements and notes thereto for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K filed with the SEC.
The unaudited condensed consolidated financial statements have been prepared in conformity with US GAAP, which prescribes elimination of all significant intercompany accounts and transactions in the accounts of the Company and its wholly-owned subsidiaries, IKT Securities Corporation, Inc. and CorHepta Pharmaceuticals, Inc. Any reference in these notes to applicable guidance is meant to refer to the authoritative US GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and are generally adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.
The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. The JOBS Act permits an emerging growth company such as the Company to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. The Company has elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, the Company will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that it either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company.
Use of Estimates
The preparation of the Company’s financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company utilizes certain estimates in the determination of its liquidity and working capital adequacy, contingent consideration, the fair value of its stock options and warrants and deferred tax valuation allowances, and to record expenses relating to research and development contracts and accrued expenses. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results could differ from such estimates.
Segment Information
Operating segments are defined as components of an enterprise for which separate discrete information is available for evaluation by the chief operating decision maker or decision-making group in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business as one operating and reporting segment, which is the business of developing protein kinase inhibitor therapeutics.
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on its condensed consolidated financial statements and disclosures.
On December 14, 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. The Company is currently evaluating the impact of the ASU, but does not expect any material impact upon adoption.
7
On 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. The Company is currently evaluating the effect of adopting this ASU.
Concentrations of Credit Risk
The Company has no significant off-balance sheet risks, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Financial instruments that subject the Company to credit risk primarily consist of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash to the extent recorded on the condensed consolidated balance sheets.
The Company has not experienced any losses in such accounts and management believes that the Company does not have significant credit risk with respect to such cash and cash equivalents and marketable securities.
Revenue Recognition
The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers. The Company did
Research and Development Costs
Costs incurred in the research and development of the Company’s product candidates are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, and include salaries and benefits, stock compensation, research-related subcontractors and consultants, supplies and overhead costs and in-process research and development. Advance payments made to suppliers and contract research organizations are classified as prepaid research and development and are expensed as research and development as the supplies are consumed and the contract services are provided.
During the three and six months ended June 30, 2025, the Company did
Leases
The Company accounts for its leases under ASC Topic 842, Leases (“ASC 842”). ASC 842 requires a lessee to record a right-of-use asset and a corresponding lease liability for most lease arrangements on the Company's condensed and consolidated balance sheet. Under the standard, disclosure of key information about leasing arrangements to assist users of the condensed and consolidated financial statements with assessing the amount, timing and uncertainty of cash flows arising from leases is required.
Leases are classified as either finance leases or operating leases. A lease is classified as a finance lease if any one of the following criteria are met: the lease transfers ownership of the asset by the end of the lease term, the lease contains an option to purchase the asset that is reasonably certain to be exercised, the lease term is for a major part of the remaining useful life of the asset or the present value of the lease payments equals or exceeds substantially all of the fair value of the asset. A lease is classified as an operating lease if it does not meet any of these criteria.
For all leases at the lease commencement date, a right-of-use asset and a lease liability are recognized. The right-of-use asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease.
8
The right-of-use asset is initially measured at cost, which primarily comprises the initial amount of the lease liability, plus any initial direct costs incurred if any, less any lease incentives received. All right-of-use assets are reviewed for impairment. The lease liability is initially measured at the present value of the lease payments, discounted using the interest rate implicit in the lease or, if that rate cannot be readily determined, the secured incremental borrowing rate for the same term as the underlying lease.
Lease payments included in the measurement of the lease liability comprise the following: the fixed noncancelable lease payments, payments for optional renewal periods where it is reasonably certain the renewal period will be exercised, and payments for early termination options unless it is reasonably certain the lease will not be terminated early.
Lease cost for operating leases consists of the lease payments plus any initial direct costs, primarily brokerage commissions, and is recognized on a straight-line basis over the lease term. Included in lease cost are any variable lease payments incurred in the period that are not included in the initial lease liability and lease payments incurred in the period for any leases with an initial term of 12 months or less. Lease cost for finance leases consists of the amortization of the right-of-use asset on a straight-line basis over the lease term and interest expense determined on an amortized cost basis. The lease payments are allocated between a reduction of the lease liability and interest expense.
The Company has made an accounting policy election to not recognize leases with an initial term of 12 months or less within its condensed consolidated balance sheets and to recognize those lease payments on a straight-line basis in its condensed consolidated statements of operations and comprehensive loss over the lease term.
Equipment and Improvements
Equipment and improvements are stated at cost, less accumulated depreciation.
|
|
Estimated Useful Economic Life |
Leasehold property improvements, right-of-use assets |
|
|
Furniture and office equipment |
|
|
IT equipment |
|
Fair Value Measurement
The Company has certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements.
· Level 1 — Fair values are determined utilizing quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access;
· Level 2 — Fair values are determined by utilizing quoted prices for identical or similar assets and liabilities in active markets or other market observable inputs such as interest rates, yield curves and foreign currency spot rates; and
· Level 3 — Inputs are unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.
The Company’s financial assets and financial liabilities, which include cash equivalents and marketable securities and accounts payable, have been initially valued at the transaction price, and marketable securities are subsequently revalued at the end of each reporting period, utilizing third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market-based approaches, to determine value.
Marketable Securities
The Company's marketable securities consist of U.S. Treasury securities with maturities of less than one year which are classified as available-for-sale and included in current assets on the condensed consolidated balance sheets. Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported as a component of stockholders’ equity in accumulated other comprehensive loss. AG真人官方ized gains and losses, if any, are included in other income, net in the condensed consolidated statements of operations and comprehensive loss.
9
Available-for-sale securities are reviewed for possible impairment at least quarterly, or more frequently if circumstances arise that may indicate impairment. When the fair value of the securities declines below the amortized cost basis, impairment is indicated and it must be determined whether it is other than temporary. Impairment is considered to be other than temporary if the Company: (i) intends to sell the security, (ii) will more likely than not be forced to sell the security before recovering its cost, or (iii) does not expect to recover the security’s amortized cost basis. If the decline in fair value is considered other than temporary, the cost basis of the security is adjusted to its fair market value and the realized loss is reported.
Asset Acquisitions
The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs which would meet the definition of a business. Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets.
For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Common stock issued as consideration in an asset acquisition is generally measured based on the acquisition date fair value of the equity interests issued. Direct transaction costs are recognized as part of the cost of an asset acquisition. The Company also evaluates which elements of a transaction should be accounted for as a part of an asset acquisition and which should be accounted for separately. Consideration deposited into escrow accounts are evaluated to determine whether it should be included as part of the cost of an asset acquisition or accounted for as contingent consideration.
The costs of an asset acquisition, including transaction costs, are allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. Goodwill is not recognized in an asset acquisition. Any difference between the cost of an asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative fair values. However, as of the date of acquisition, if certain assets are carried at fair value under other applicable GAAP, the consideration is first allocated to those assets with the remainder allocated to the non-monetary identifiable assets based on relative fair value basis.
Contingent Consideration Liabilities
The Company recognizes contingent consideration issued in connection with asset acquisitions when it is probable that a liability has been incurred and the amount of that liability can be reasonably estimated.
The Company remeasures the contingent consideration liability to fair value at each reporting date, until the contingency is resolved or expires, with changes in the fair value of the contingent consideration liability included within operating expenses on the Company’s condensed consolidated statements of operations and comprehensive loss.
The Company’s marketable securities are all classified within Level 1 of the fair value hierarchy and are valued based on quoted prices in active markets. For cash, cash equivalents and accounts payable, the carrying amounts approximate fair value, because of the short maturity of these instruments, and therefore fair value information is not included in the table below. Contingent consideration related to the acquisition of CorHepta (see Note 10) is classified within Level 3 of the fair value hierarchy as the determination of fair value uses considerable judgment and represents the Company’s best estimate of an amount that could be realized in a market exchange for the asset or liability.
The following table summarizes cash equivalents, marketable securities and contingent consideration measured at their fair value on a recurring basis as of June 30, 2025 and December 31, 2024:
10
|
|
Fair Value Measurements as of June 30, 2025: |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Marketable securities, available-for-sale: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasury obligations |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Contingent consideration (see Note 10) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
Fair Value Measurements as of December 31, 2024: |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Marketable securities, available-for-sale: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasury obligations |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The following table provides a rollforward of the contingent consideration related to the acquisition of CorHepta (see Note 10):
|
|
Three months ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Balance, beginning |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Additions |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Payments |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Change in fair value |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
||
Balance, ending |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Marketable securities consisted of the following as of:
June 30, 2025 |
|
Amortized Cost |
|
|
Unrealized Gain |
|
|
Unrealized Loss |
|
|
Fair Value |
|
||||
Marketable securities, available-for-sale: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasury obligations |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Total |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
December 31, 2024 |
|
Amortized Cost |
|
|
Unrealized Gain |
|
|
Unrealized Loss |
|
|
Fair Value |
|
||||
Marketable securities, available-for-sale: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasury obligations |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Total |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
As of June 30, 2025, the Company held one U.S. Treasury debt security that was in an unrealized loss position totaling $
11
$
The Company received proceeds of $
Equipment and Improvements, net |
|
|||||||
|
|
June 30, |
|
|
December 31, |
|
||
Furniture and office equipment |
|
$ |
|
|
$ |
|
||
IT equipment |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Less: Accumulated depreciation |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
Depreciation expense for the three and six months ended June 30, 2025 was $
Accrued expenses and other current liabilities consist of the following:
|
|
June 30, |
|
|
December 31, |
|
||
Accrued consulting |
|
$ |
|
|
$ |
|
||
Accrued compensation |
|
|
|
|
|
|
||
Accrued research and development |
|
|
|
|
|
|
||
Accrued other |
|
|
|
|
|
|
||
Total accrued expenses and other current liabilities |
|
$ |
|
|
$ |
|
||
8. ATM Program/Open Market Sales Agreement
On February 1, 2024, the Company entered into an ATM with H.C. Wainwright & Co., LLC, as sales agent (“HCW”), pursuant to which the Company may, from time to time, issue and sell shares of its common stock, in an aggregate offering price of up to $
On June 20, 2025, the Company entered into an Open Market Sale AgreementSM (the “Sales Agreement”) with Jefferies LLC, as sales agent ("Jefferies"), pursuant to which the Company may, from time to time, issue and sell shares of its common stock, in an aggregate offering price of up to $
12
Subject to the terms and conditions of the Sales Agreement, Jefferies will use its commercially reasonable efforts to sell the shares of the Company's common stock from time to time, based upon the Company’s instructions. The Company has no obligation to sell any of the shares of its common stock, and may at any time suspend sales under the Sales Agreement or terminate the Sales Agreement in accordance with its terms. The Company has provided Jefferies with customary indemnification rights, and Jefferies will be entitled selling commissions of up to
9. Stockholders’ Equity
Each share of common stock is entitled to
Share Issuances
On October 21, 2024, the Company announced the closing of a private placement of approximately $
On May 20, 2024, the Company entered into a securities purchase agreement with a single institutional investor in connection with a registered direct offering and concurrent private placement with the same institutional investor (collectively the "May 2024 Offering"). The May 2024 Offering consisted of (i)
13
On May 20, 2024, the Company also entered into a warrant inducement agreement with the same investor to exercise certain outstanding warrants that the Company issued in January 2023 ("January 2023 Existing Warrants"). Pursuant to the warrant inducement agreement, the investor agreed to exercise outstanding warrants to purchase an aggregate of
The repricing of the January 2023 Existing Warrants and issuance of the Series C Common Warrants and the Series D Common Warrants is considered a modification of the January 2023 Existing Warrants under the guidance of ASU 2021-04. The modification is consistent with the "Equity Issuance" classification under that guidance as the reason for the modification was to induce the holder to exercise their warrants, resulting in the imminent exercise of the January 2023 Existing Warrants, which raised equity capital and generated net proceeds for the Company of approximately $
10. Acquisition of CorHepta
On
The Company remeasures the initial contingent consideration recognized at acquisition shown below to fair value at each reporting date and recorded a change in fair value of $
The Company determined that the transaction represented an asset acquisition as defined by ASC 805 as substantially all of the value was attributed to a single intangible asset, in-process research and development (“IPR&D”). As a result, the consideration transferred was allocated to the identifiable tangible and intangible assets acquired and liabilities assumed based on their relative fair values resulting in approximately $
The fair value of consideration transferred was determined as follows:
14
|
|
Shares |
|
|
Share Price at Closing |
|
|
Fair Value at Acquisition |
|
|||
Fully vested shares |
|
|
|
|
$ |
|
|
$ |
|
|||
Contingent consideration |
|
|
|
|
|
|
|
|
|
|||
Transaction costs incurred by the Company |
|
|
|
|
|
|
|
|
|
|||
Fair value of consideration |
|
|
|
|
|
|
|
$ |
|
|||
The allocation of consideration transferred is as follows:
Acquired IPR&D |
|
$ |
|
|
Cash |
|
|
|
|
Current liabilities |
|
|
( |
) |
Fair value of consideration |
|
$ |
|
The IPR&D had not reached technological feasibility and had no alternative future use at the acquisition date, and therefore, the acquired IPR&D asset of $
11. ABLi License Agreement
On May 5, 2025, the Company entered into a license agreement (the "License Agreement) with ABLi Therapeutics, Inc. ("ABLi"), pursuant to which the Company granted ABLi an exclusive, sub-licensable, royalty-bearing license under the Licensed IP (as defined in the License Agreement) to develop, manufacture, and commercialize risvodetinib (IKT-148009) globally. Under the terms of the License Agreement, ABLi is solely responsible for all further development and commercialization activities of Risvodetinib and will bear all costs incurred in connection with these efforts. If ABLi does not meet certain milestones with respect to the Licensed Material within 18 months, then the License Agreement will automatically terminate.
The Company assessed the transaction under ASC 606 and identified a single, combined performance obligation to transfer the exclusive license and associated materials, know-how, and trademarks to ABLi. The Company satisfied its performance obligation at a point in time upon completing these transfers in May 2025.
In exchange for the exclusive license rights, ABLi made a non-refundable, non-creditable payment of one dollar. In addition, the Company is eligible to receive development and regulatory milestone payments up to $
As of June 30, 2025, the Company received aggregate payments of one dollar from ABLi from the upfront payment, thus the Company has recognized all of the initial transaction price. The Company evaluated the likelihood of the Company achieving the specified milestones and determined that the likelihood is not yet probable and as such no accrual of these payments is required as of June 30, 2025.
The Company also reimbursed ABLi $
12. Stock-Based Compensation
2020 Equity Incentive Plan
The Company’s 2020 Plan was established for granting stock incentive awards to directors, officers, employees and consultants to the Company. On June 7, 2024, the stockholders of the Company approved an amendment to the 2020 Plan, pursuant to which the number of shares of Common Stock reserved and available for issuance under the 2020 Plan increased by
15
January 3, 2025, the stockholders of the Company approved an amendment to the 2020 Plan, pursuant to which the number of shares of Common Stock reserved and available for issuance under the 2020 Plan increased by
Restricted Stock
In connection with the acquisition of CorHepta in February 2025 (see Note 10), the Company issued a combined
For the restricted shares with service-based vesting conditions, stock-based compensation expense is recognized on a straight-line basis over the service period, which is generally the vesting term. For restricted shares with performance-based vesting conditions, stock-based compensation expense is recognized over the requisite service period when it is probable that the performance condition will be achieved.
The weighted-average grant date fair value of the restricted shares issued in connection with the asset acquisition was $
Stock Options
During the six months ended June 30, 2025, the Company granted
During the six months ended June 30, 2024, the Company granted
For awards with performance conditions in which the award does not vest unless the performance condition is met, the Company recognizes expense if, and to the extent that, the Company estimates that achievement of the performance condition is probable. If the Company concludes that vesting is probable, the Company recognizes expense from the date the Company reaches this conclusion through the estimated vesting date.
16
Stock-Based Compensation Expense
The following table summarizes the stock-based compensation expense for stock options granted to employees and non-employees:
|
|
Three Months Ended June 30, |
|
|
Six months ended June 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Research and development |
|
$ |
|
* |
$ |
( |
) |
|
$ |
|
* |
$ |
|
|||
Selling, general and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
*
13. Warrants
In January 2025, in connection with the October 2024 Offering, the Company issued
14. Net Loss Per Share
The following table presents the calculation of basic and diluted net loss per share applicable to common stockholders. Basic net loss per share is calculated by dividing net loss attributable to common shareholders by the weighted-average number of shares outstanding during the period which includes
|
|
Three Months Ended June 30, |
|
|
Six months ended June 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average number of shares outstanding – basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share applicable to common stockholders – basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
The Company’s potentially dilutive securities have been excluded from the computation of diluted net loss per share applicable to common stockholders, prior to the application of the treasury stock method, because their effect would have been antidilutive for the periods presented. Therefore the weighted average number of shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The potentially dilutive securities that have been excluded from the computation of diluted net loss per share include stock options and warrants to purchase common stock, restricted common stock and shares of common stock issued as contingent consideration in connection with the acquisition of CorHepta, for which the vesting conditions have not been met.
|
|
Six months ended June 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Options to purchase shares of stock |
|
|
|
|
|
|
||
Warrants to purchase shares of stock |
|
|
|
|
|
|
||
Contingently issuable shares (see Note 10): |
|
|
|
|
|
|
||
Restricted common stock |
|
|
|
|
|
|
||
Contingent consideration |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
17
15. Income Taxes
During the three and six months ended June 30, 2025 and 2024, there was
On July 3, 2025, the United States Congress passed, and on July 4, 2025, President Trump signed into law, budget reconciliation bill H.R. 1 referred to as the One Big Beautiful Bill (“OBBB”). The OBBB contains several changes to corporate taxation including modifications to capitalization of research and development expenses, limitations on deductions for interest expense and accelerated fixed asset depreciation. The Company is still in the process of evaluating the OBBB and currently does not expect it to have a material impact on its condensed consolidated financial statements.
16. Commitments and Contingencies
Litigation
From time to time, the Company may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. When the Company is aware of a claim or potential claim, it assesses the likelihood of any loss or exposure. If it is probable that a loss will result and the amount of the loss can be reasonably estimated, the Company will record a liability for the loss. In addition to the estimated loss, the recorded liability would include probable and estimable legal costs associated with the claim or potential claim. Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm the Company’s business. The Company is not currently a party to any material litigation or legal proceedings.
Lease
On April 18, 2022, the Company entered into an operating lease agreement for office space located in Lexington, Massachusetts (the "Office Lease"). On August 8, 2022, the Company commenced occupancy of the leased space. The lease runs through
The Company accounts for the Office Lease under the provisions of ASC 842. The Company recorded a right-of-use asset and a corresponding operating lease liability on the Company's condensed consolidated balance sheets upon the accounting commencement date in August 2022. The lease liability was measured at the accounting commencement date utilizing a
As of June 30, 2025, a security deposit of approximately $
Future minimum lease payments under this lease at June 30, 2025, are presented by calendar year as follows:
Year |
|
|
|
|
2025 |
|
$ |
|
|
Total lease payments |
|
|
|
|
Less: imputed interest |
|
|
( |
) |
Present value of operating lease liabilities |
|
$ |
|
|
17. Segment Information
18
The Company views its operations and manages its business as
|
Three months ended June 30, |
|
|||||
|
2025 |
|
|
2024 |
|
||
Costs and expenses: |
|
|
|
|
|
||
Research and development (excluding stock-based compensation) expense: |
|
|
|
|
|
||
PAH |
$ |
|
|
$ |
|
||
Parkinson's disease |
|
|
|
|
|
||
Other programs |
|
|
|
|
|
||
Selling, general and administrative (excluding stock-based compensation) |
|
|
|
|
|
||
Change in fair value contingent consideration |
|
( |
) |
|
|
|
|
Stock-based compensation expense |
|
|
|
|
|
||
Total costs and expenses |
|
|
|
|
|
||
Loss from operations |
|
( |
) |
|
|
( |
) |
Interest income |
|
|
|
|
|
||
Net loss |
$ |
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
||
|
Six months ended June 30, |
|
|||||
|
2025 |
|
|
2024 |
|
||
Costs and expenses: |
|
|
|
|
|
||
Research and development (excluding stock-based compensation) expense: |
|
|
|
|
|
||
PAH(1) |
$ |
|
|
$ |
|
||
Parkinson's disease |
|
|
|
|
|
||
Other programs |
|
|
|
|
|
||
Selling, general and administrative (excluding stock-based compensation) |
|
|
|
|
|
||
Change in fair value contingent consideration |
|
( |
) |
|
|
|
|
Stock-based compensation expense |
|
|
|
|
|
||
Total costs and expenses |
|
|
|
|
|
||
Loss from operations |
|
( |
) |
|
|
( |
) |
Interest income |
|
|
|
|
|
||
Net loss |
$ |
( |
) |
|
$ |
( |
) |
(1)
18. Subsequent Event
Third-party clinical trial supply organization
In July 2025, the Company entered into a clinical trial supply agreement in the amount of approximately $
Third-party clinical research organization
On August 8, 2025, the Company entered into an arrangement with a contract research organization to support the Company's forthcoming PAH Phase 2b clinical study known as IMPROVE-PAH in the amount of approximately $
19
20
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q (this “Quarterly Report”) and our audited financial statements and related notes thereto for the year ended December 31, 2024 included in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission (the “SEC”) on March 27, 2025 (the “Annual Report”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks, uncertainties, and assumptions. Factors that might cause future results to differ materially from those projected in the forward-looking statements include, but are not limited to, those set forth in our Annual Report and in other filings with the SEC.
Overview
We are a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension (“PAH”), that arise from aberrant signaling through the Abelson Tyrosine Kinase, and type III receptor tyrosine kinases including platelet derived growth factor receptors and c-KIT. Our lead product candidate is IKT-001, a prodrug of imatinib mesylate, for PAH which is an orphan indication. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans. We have completed non-human primate safety studies and a bioequivalence clinical trial in healthy volunteers to determine the doses of IKT-001 that are equivalent to imatinib mesylate and the results have been utilized to set the doses for a forthcoming Phase 2b study for approximately 150 PAH patients that we expect to initiate in the second half of 2025.
We were previously pursuing risvodetinib (also known as IkT-148009), a selective inhibitor of the non-receptor Abelson Tyrosine Kinases that targets the treatment of Parkinson’s disease, but we have discontinued and outlicensed this program.
IKT-001 and PAH
IKT-001 emerged from our medicinal chemistry program that aimed to develop improvements to drugs that inhibit Abelson Tyrosine Kinase and type III receptor tyrosine kinases. IKT-001, a novel oral prodrug of imatinib mesylate, was designed to improve areas of the molecule that might play a role in the gastrointestinal (“GI”) side effects commonly observed with oral imatinib mesylate. A three-part dose finding/dose equivalence study in 66 healthy volunteers (known as ‘the 501 trial’) was completed with IKT-001 in 2023. The study was designed to evaluate the 96-hour single-dose pharmacokinetics of imatinib delivered as IKT-001 and determine the dose relationship between IKT-001 and imatinib mesylate. Based on this study it was determined that bioequivalence was established with a 300 mg dose of IKT-001 to a dose of 230 mg of imatinib mesylate while a 500 mg dose of IKT-001 was established as bioequivalent to a dose of 383 mg of imatinib mesylate. These doses are adequate to cover the target systemically and were similar to the doses of imatinib mesylate used in the Phase 3 IMPRES trial in PAH.
On January 19, 2024, we met with the Food and Drug Administration (“FDA”) Hematological Malignancy Review Team (“Review Team”) in a Pre-New Drug Application (“pre-NDA”), meeting to discuss our bioequivalence studies of IKT-001 and its path to approval. All questions were addressed and summarized in official meeting minutes the issued by the FDA on February 12, 2024. During the meeting, we inquired whether additional clinical studies would be needed to seek approval and discussed manufacturing and quality control requirements for approval. The Review Team acknowledged that the 505(b)(2) pathway appeared to be the appropriate pathway for approval of IKT-001. The Review Team also discussed the possible difference between IKT-001 and imatinib mesylate absorption in the gut and recommended that we evaluate whether IKT-001 and imatinib mesylate behave differently with respect to certain gut transporters that regulate absorption. This evaluation was completed and determined that IKT-001 and imatinib mesylate have similar behavior toward the transporters P-glycoprotein (“PGP”) and the Breast Cancer Resistance Protein (“BCRP”). Finally, a number of recommendations were discussed to prevent the potential mix-up between IKT-001 and imatinib mesylate either at the pharmacy or by patients for two drugs delivering the same active ingredient. The Company discussed alternate dosage forms for IKT-001 relative to imatinib mesylate as the primary mitigation strategy.
PAH is a rare disease of the pulmonary microvasculature found in 15 to 50 persons per million within the United States and Europe. The global PAH market size was valued at $7.66 billion in 2023 and is estimated to grow at a compound annual growth rate of 5.4% between 2024 to 2030. Most of the treatments that constitute the standard of care (e.g. ERAs, PDE5s, prostacyclins) primarily act as vasodilators. In 2024, sotatercept was approved for the treatment of PAH on top of standard-of-care (“SOC”). Sotatercept is recombinant fusion protein that acts as a trap for transforming growth factor-beta superfamily ligands, including activin A and bone
21
morphogenetic protein 9. These ligands may play a role in the development and progression of PAH by promoting cell proliferation and fibrosis.
The success of sotatercept has created renewed enthusiasm around the anti-proliferative pathways in PAH. As previously mentioned, imatinib inhibits Abelson Tyrosine Kinase and type III receptor tyrosine kinases and through these pathways inhibits platelet-derived growth factor receptor which are involved in cell proliferation and migration as well as stem cell factor receptor (c-KIT) which modulates mast cell and hematopoietic stem cell activity. Through these targets imatinib may inhibit vascular cell proliferation, migration and fibrosis. Thus, targeting the type III receptor tyrosine kinase pathway may provide an alternate mechanism for disease modification in PAH.
The first reports of the use of imatinib in PAH were published in 2005 and 2006. A Phase 2, randomized control trial, was subsequently conducted showing clinical benefit of imatinib in PAH. In 2013, the outcome of a Phase 3 trial (IMPRES) evaluating imatinib mesylate as a treatment for PAH was reported, demonstrating that imatinib may improve key parameters associated with PAH. In this study, imatinib improved exercise capacity and hemodynamics in patients with advanced PAH but approval was precluded because of the bleeding risk associated with concomitant anti-coagulant therapy and the high discontinuation rate in the imatinib group.
As we considered revisiting the use of imatinib in PAH, we recognized that changes in SOC for these patients may have alleviated much of the safety risk previously observed for imatinib in PAH patients. This analysis prompted us to file a pre-IND (“PIND”) meeting request to discuss the application of IKT-001 as a potential disease-modifying treatment for PAH. To evaluate this further, members of the Company met with the FDA Division of Cardiology and Nephrology in a PIND meeting to discuss our plan to utilize IKT-001 in a Phase 2b efficacy, safety and tolerability study in PAH. At the meeting, the FDA confirmed that IKT-001 would be viewed as a New Molecular Entity (“NME”) and that the appropriate path for approval remained to be the 505(b)(2) statute. This opens up the possibility of IKT-001 being granted NME status and market exclusivity on approval. The FDA requested at the PIND meeting that we conduct a cell-culture based study of the human Ether-a-go-go-related Gene (“hERG”) ion channel, a standard cardiovascular safety test performed for any NME for which a new Investigative New Drug Application (“IND”) is to be opened. IKT-001 was not found to be a significant inhibitor of hERG. Following completion of this study, the IND was filed with the FDA on August 9, 2024 and we were cleared to initiate a Phase 2b trial on September 9, 2024.
On October 21, 2024, we closed a private placement with gross proceeds of approximately $110 million, before deducting placement fees and offering expenses, to support this program. If the warrants issued in such offering are exercised for cash, the total gross proceeds from the financing may be up to $275 million. We intend to use the net proceeds from the private placement to finance the initiation of a Phase 2b trial in PAH and for general corporate purposes. We have had discussions with the FDA regarding Orphan Drug Designation (“ODD”) for delivery of imatinib by IKT-001 for PAH and plan to apply for ODD once the required pre-clinical studies are complete.
More recently, a contemporary study published in the American Journal of Respiratory and Critical Care Medicine in an open label, single arm, four (4) center study with seventeen (17) patients confirmed that imatinib 100-400mg was well tolerated (with zero discontinuations for tolerance or side effects) in WHO Group 1 PAH population, and demonstrated a treatment effect on total pulmonary resistance (“TPR”) that compares favorably with other novel therapies for PAH, including sotatercept and seralutinib. Acknowledging the limitations of cross study comparisons and the small size of the study, we believe this recent study supports our thesis that systemic exposure of imatinib can be well tolerated and provide strong efficacy to patients suffering from PAH.
During the first half of 2025, we considered potential study designs and obtained feedback from various key opinion leaders before finalizing a clinical trial protocol for our forthcoming Phase 2b study, known as IMPROVE-PAH. IMPROVE-PAH is a multi-center, randomized, double-blind, placebo-controlled study of approximately 150 PAH participants. Participants under IMPROVE-PAH will be randomized 1:1:1 to receive 300 mg IKT-001, 500 mg IKT-001, or placebo once daily for 26 weeks, in addition to stable background PAH therapy. Our bioequivalence studies previously confirmed that 500 mg IKT-001 has comparable exposure in humans to 380 mg of imatinib mesylate. The primary efficacy endpoint is change in pulmonary vascular resistance (PVR) at Week 26. Secondary endpoints include 6-minute walk distance (6MWD), WHO functional class, and pharmacokinetics. Exploratory endpoints include echocardiographic and hemodynamic measures, NT-proBNP, IL-6, EmPHasis-10 score, and the incidence of clinical worsening events. Safety will be assessed by the incidence and severity of treatment emergent adverse events. The study protocol also includes an interim safety review for study continuance by the Data Safety Monitoring Board with at least fifty (50) patients at 12-weeks of follow-up. We expect to initiate IMPROVE-PAH in the second half of 2025 and will assess whether IKT-001 offers a clinically meaningful reduction in PVR with acceptable tolerability in patients with moderate to severe PAH. Results may inform the potential of IKT-001 as a novel anti-proliferative treatment option targeting vascular remodeling pathways in PAH.
22
We currently have commercialization rights to IKT-001 and patent protection in the United States until 2033 for IKT-001 with upcoming patent application filings potentially extending patent protection for certain methods of treatment using IKT-001 until 2045.
Components of Operating Results
Operating Expenses
Research and Development
Research and development activities account for a significant portion of our operating expenses. We record research and development expenses as incurred. Research and development expenses incurred by us for the discovery and development of our product candidates and prodrug technologies include:
A portion of our research and development expenses are direct external expenses, which we track on a program-specific basis from inception of the program.
Program expenses include expenses associated with our most advanced product candidates and the discovery and development of compounds that are potential future candidates. We also track external expenses associated with our third-party research and development efforts. All external costs are tracked by therapeutic indication. We do not track personnel or other operating expenses incurred for our research and development programs on a program-specific basis. These expenses primarily relate to salaries and benefits, stock-based compensation and office consumables.
At this time, we can only estimate the nature, timing and costs of the efforts that will be necessary to complete the development of, and obtain regulatory approval for, any of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from sales or licensing of our product candidates. This is due to the numerous risks and uncertainties associated with drug development, including the uncertainty of:
23
A change in any of these variables with respect to the development of any of our product candidates would significantly change the costs, timing and viability associated with the development of that product candidate. We expect our research and development expenses to increase for the next several years as we continue to implement our business strategy, advance our current programs, expand our research and development efforts, seek regulatory approvals for any product candidates that successfully complete clinical trials, access and develop additional product candidates and incur expenses associated with hiring additional personnel to support our research and development efforts. In addition, product candidates in later stages of clinical development generally incur higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.
Our direct research and development expenses consist principally of external costs, such as fees paid to investigators, consultants, central laboratories and CROs in connection with our clinical studies, and costs related to acquiring and manufacturing clinical study materials. We allocate salary and benefit costs directly related to specific programs. We do not allocate personnel-related discretionary bonus or stock-based compensation costs, laboratory and related expenses, depreciation or other indirect costs that are deployed across multiple projects under development and, as such, the costs are separately classified as other research and development expenses in the table below:
|
|
Three Months Ended June 30, |
|
|
|
|
||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
Parkinson's disease |
|
$ |
42,196 |
|
|
$ |
2,666,108 |
|
|
$ |
(2,623,912 |
) |
PAH |
|
|
2,738,794 |
|
|
|
— |
|
|
|
2,738,794 |
|
Other research and development expenses |
|
|
2,489,977 |
|
|
|
409,722 |
|
|
|
2,080,255 |
|
Total research and development expenses |
|
$ |
5,270,967 |
|
|
$ |
3,075,830 |
|
|
$ |
2,195,137 |
|
|
|
|
|
|
|
|
|
|
|
|||
|
|
Six months ended June 30, |
|
|
|
|
||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
Parkinson's disease |
|
$ |
184,616 |
|
|
$ |
5,010,004 |
|
|
$ |
(4,825,388 |
) |
PAH(1) |
|
|
12,069,638 |
|
|
|
— |
|
|
|
12,069,638 |
|
Other research and development expenses |
|
|
3,530,292 |
|
|
|
817,105 |
|
|
|
2,713,187 |
|
Total research and development expenses |
|
$ |
15,784,546 |
|
|
$ |
5,827,109 |
|
|
$ |
9,957,437 |
|
(1) This amount includes a one-time (non-cash) charge of $7.4 million for the acquired IPR&D related to the CorHepta acquisition.
Selling, General and Administrative
Selling, general and administrative expenses include personnel related expenses, such as salaries, benefits, travel and non-cash stock-based compensation expense, expenses for outside professional services and allocated expenses. Outside professional services consist of legal, accounting and audit services, investor relations services and other consulting fees. Allocated expenses consist of rent expenses related to our office in Lexington, Massachusetts not otherwise included in research and development expenses.
We are incurring additional expenses as compared to when we were a private company, including expenses related to compliance with the rules and regulations of the SEC and those of Nasdaq, additional insurance expenses, investor relations activities and other administrative and professional services. We also are increasing our administrative headcount as a public company and as we advance our product candidates through clinical development, which will also likely require us to increase our selling, general and administrative expenses.
24
Results of Operations
Comparison of the Three Months Ended June 30, 2025 and 2024
The following table sets forth the significant components of our results of operations:
|
|
For the three months ended June 30, |
|
|
Change |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
($) |
|
|
(%) |
|
||||
Research and development |
|
$ |
(5,270,967 |
) |
|
$ |
(3,075,830 |
) |
|
$ |
(2,195,137 |
) |
|
|
71.4 |
|
Selling, general and administrative |
|
|
(5,919,731 |
) |
|
|
(1,974,705 |
) |
|
|
(3,945,026 |
) |
|
|
199.8 |
|
Change in fair value contingent consideration |
|
|
358,420 |
|
|
|
— |
|
|
|
358,420 |
|
|
|
100.0 |
|
Loss from operations |
|
|
(10,832,278 |
) |
|
|
(5,050,535 |
) |
|
|
(5,781,743 |
) |
|
|
114.5 |
|
Interest income |
|
|
916,755 |
|
|
|
90,927 |
|
|
|
825,828 |
|
|
|
908.2 |
|
Net loss |
|
$ |
(9,915,523 |
) |
|
$ |
(4,959,608 |
) |
|
$ |
(4,955,915 |
) |
|
|
99.9 |
|
Research and Development
Research and development expenses increased by $2,195,137 or 71.4% to $5,270,967 from $3,075,830 in the prior comparable period. The $2.2 million increase in research and development expenses was primarily due to an increase of $2.7 million in PAH expenses, a decrease of $2.6 million in the discontinued risvodetinib (IkT-148009) program and a net increase of $2.1 million in other research and development expenses, including $0.7 million of stock-based compensation expense related to the acquisition of CorHepta Pharmaceuticals, Inc (“CorHepta”).
Selling, General and Administrative
Selling, general and administrative expenses increased by $3,945,026 or 199.8% to $5,919,731 from $1,974,705 in the prior comparable period. The $3.9 million increase was primarily driven by an increase of $1.4 million in personnel-related costs, including severance costs for the Company's former Chief Financial Officer, and $2.5 million in increased stock-based compensation expense.
Change in Fair Value Contingent Consideration
Change in fair value contingent consideration increased by $358,420 or 100% from $0 in the prior comparable period. The increase is a result of the change in fair value of the contingent consideration related to the CorHepta transaction from March 31, 2025 to June 30, 2025.
Interest Income
Interest income increased by $825,828 or 908.2% to $916,755 from $90,927 in the prior comparable period. The increase was driven by interest earned on our cash, cash equivalents and marketable securities.
Comparison of the Six Months Ended June 30, 2025 and 2024.
The following table sets forth the significant components of our results of operations:
|
|
For the six months ended June 30, |
|
|
Change |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
($) |
|
|
(%) |
|
||||
Research and development |
|
$ |
(15,784,546 |
) |
|
$ |
(5,827,109 |
) |
|
$ |
(9,957,437 |
) |
|
|
170.9 |
|
Selling, general and administrative |
|
|
(11,169,022 |
) |
|
|
(4,005,786 |
) |
|
|
(7,163,236 |
) |
|
|
178.8 |
|
Change in fair value contingent consideration |
|
|
1,523,284 |
|
|
|
— |
|
|
|
1,523,284 |
|
|
|
100.0 |
|
Loss from operations |
|
|
(25,430,284 |
) |
|
|
(9,832,895 |
) |
|
|
(15,597,389 |
) |
|
|
158.6 |
|
Interest income |
|
|
1,836,026 |
|
|
|
223,652 |
|
|
|
1,612,374 |
|
|
|
720.9 |
|
Net loss |
|
$ |
(23,594,258 |
) |
|
$ |
(9,609,243 |
) |
|
$ |
(13,985,015 |
) |
|
|
145.5 |
|
25
Research and Development
Research and development expenses increased by $9,957,437 or 170.9% to $15,784,546 from $5,827,109 in the prior comparable period. The increase was primarily due to a $3.7 million increase in PAH program and other research and development expenses, together with a $8.4 million research and development expense related to the CorHepta transaction comprising a one-time (non-cash) expense charge for the acquired IPR&D related to the CorHepta acquisition cost of $7.4 million and $1.0 million of stock-based compensation expense. These increases were offset by a decrease of $4.8 million in the discontinued risvodetinib (IkT-148009) program.
Selling, General and Administrative
Selling, general and administrative expenses increased by $7,163,236 or 178.8% to $11,169,022 from $4,005,786 in the prior comparable period. The $7.2 million increase was primarily driven by an increase of $2.1 million in personnel-related costs including, severance costs for the Company's former Chief Executive Officer and Chief Financial Officer, $0.9 million in legal, consulting and compliance related fees, and an increase of $4.1 million in stock-based compensation expense.
Change in Fair Value Contingent Consideration
Change in fair value contingent consideration increased by $1,523,284 or 100% from $0 in the prior comparable period. The increase is a result of the change in fair value of the contingent consideration related to the CorHepta transaction from the transaction date on February 21, 2025 to June 30, 2025.
Interest Income
Interest income increased by $1,612,374 or 720.9% to $1,836,026 from $223,652 in the prior comparable period. The increase was driven by interest earned on our cash, cash equivalents and marketable securities.
Liquidity and Capital Resources
Sources of Liquidity
From our inception up until our December 2020 initial public offering, we funded our operations primarily through private, state and federal contracts and grants. In October 2024, we raised approximately $99.6 million in net proceeds from its October 2024 Offering.
On June 20, 2025, we entered into an Open Market Sale AgreementSM (the “Sales Agreement”) with Jefferies LLC, as sales agent ("Jefferies"), pursuant to which we may, from time to time, issue and sell shares of our common stock through or to Jefferies. Under the terms of the Sales Agreement, Jefferies may sell the shares of our common stock at market prices by any method that is deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act of 1033, as amended. As of June 30, 2025, no shares of our common stock have been sold under the Sales Agreement.
At June 30, 2025, we had cash, cash equivalents and marketable securities of $87.7 million.
We have incurred recurring losses and at June 30, 2025 had an accumulated deficit of $118.0 million.
Future Funding Requirements
To date, we have not generated any revenue from the sale of commercial products. We do not expect to generate any significant revenue from product sales unless and until we obtain regulatory approval of and successfully commercialize any of our product candidates and we do not know when, or if, this 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 future 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. We anticipate that we will need substantial additional funding in connection with our continuing operations.
26
Until we can generate a sufficient amount of revenue from the commercialization of our product candidates, if ever, we expect to finance our incremental cash needs through a combination of equity offerings, debt financings, working capital lines of credit, grant funding and potential licenses and collaboration agreements. Additional working capital may not be available on commercially reasonable terms, if at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, reduce or discontinue the development or commercialization of one or more of our product candidates. If we raise additional funds through the issuance of additional debt or equity securities, it could result in dilution to our existing stockholders, increased fixed payment obligations and the existence of securities with rights that may be senior to those of our common stock. If we incur indebtedness, we could become subject to covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Additionally, any future collaborations we enter into with third parties may provide capital in the near term but limit our potential cash flow and revenue in the future. Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
Since our inception, we have incurred significant losses and negative cash flows from operations. We have an accumulated deficit of $118.0 million at June 30, 2025. We expect to incur substantial additional losses in the future as we conduct and expand our research and development activities.
We may seek to fund our operations through public equity or private equity or debt financings, as well as other sources. However, we may be unable to raise additional working capital, or if we are able to raise additional working capital, we may be unable to do so on commercially favorable terms. Our failure to raise capital or enter into such other arrangements if and when needed would have a negative impact on our business, results of operations and financial condition and our ability to continue to develop our product candidates.
We believe that our existing cash, cash equivalents and marketable securities as of June 30, 2025, will enable us to fund our operating requirements for at least the next twelve months following the date of this Quarterly Report. However, we have based these estimates on assumptions that may prove to be wrong, and we could deplete our working capital sooner than planned.
The timing and amount of our operating expenditures will depend largely on:
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 may need additional funds to meet operational needs and capital requirements associated with such operating plans.
27
Cash Flows
The following table sets forth a summary of the primary sources and uses of cash for each of the periods presented below:
|
|
Six months ended June 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Net cash used in operating activities |
|
$ |
(9,677,761 |
) |
|
$ |
(8,921,392 |
) |
Net cash provided by (used in) investing activities |
|
|
30,898,080 |
|
|
|
(768,587 |
) |
Net cash provided by financing activities |
|
|
31,771 |
|
|
|
3,611,255 |
|
Net increase (decrease) in cash and cash equivalents |
|
$ |
21,252,090 |
|
|
$ |
(6,078,724 |
) |
Net Cash Flows Used in Operating Activities
Net cash flows used in operating activities for the six months ended June 30, 2025, totaled $9,677,761, and consisted primarily of a net loss of $23.6 million adjusted for non-cash stock compensation of $6.3 million, a write-off of in-process research and development of $7.4 million, a decrease in the fair value of contingent consideration of $1.5 million, an increase in accounts payable of $1.6 million, an increase in accrued expenses and other current liabilities of $0.3 million and a net decrease in other operating assets and liabilities of $0.1 million.
Net cash flows used in operating activities for the six months ended June 30, 2024, totaled $8,921,392, and consisted primarily of a net loss of $9.6 million adjusted for non-cash stock compensation of $0.1 million, a decrease in prepaid research and development of $0.1 million, an increase in accounts payable of $0.9 million, and a decrease in accrued expenses and other current liabilities of $0.2 million.
Cash Provided by (Used in) Investing Activities
Net cash flows provided by investing activities for the six months ended June 30, 2025, totaled $30,898,080, of which $31.4 million was provided by maturity of marketable securities and $0.4 million related to acquired in-process research and development associated with the CorHepta acquisition discussed above.
Net cash flows used in investing activities for the six months ended June 30, 2024, totaled $768,587, of which $9.2 million was used for the purchase of marketable securities investments and $8.4 million was provided by maturity of marketable securities.
Cash Provided by Financing Activities
Net cash flows provided by financing activities for the six months ended June 30, 2025, totaled $31,771, which consisted of net proceeds from the issuance of common stock related to option exercises and pre-funded warrants in connection with our registered direct offering and concurrent private placement closed in May 2024 (collectively, the “May 2024 Offering”).
Net cash flows provided by financing activities for the six months ended June 30, 2024, totaled $3,611,255, which consisted of net proceeds from issuance of common stock and pre-funded warrants in connection with our May 2024 Offering and our at-the-market offering.
Contractual Obligations and Commitments
On April 18, 2022, we entered into an operating lease agreement through September 30, 2025 for our office space in Lexington, Massachusetts. The Lexington lease contains escalating payments during the lease period. Upon execution of this lease agreement, we prepaid one month of rent, applied to the first month's rent, and a security deposit, which will be held in escrow and credited at the termination of the lease. Our total lease obligation at June 30, 2025 is $37,944, consisting of minimum annual rental obligations for fiscal year 2025.
Critical Accounting Policies and Significant Judgments and Estimates
This discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the reported 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,
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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. While our significant accounting policies are described in more detail in the notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report, we believe that the following accounting policies are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
Research and Development Expenses
We record research and development expenses to operations as incurred. Research and development expenses represent costs incurred by us for the discovery and development of our product candidates and the development of our RAMP™ drug discovery program and prodrug technologies and include: employee-related expenses, such as salaries, benefits, travel and non-cash stock-based compensation expense; external research and development expenses incurred under arrangements with third parties, such as CROs, preclinical testing organizations, clinical testing organizations, CMOs, academic and non-profit institutions and consultants; costs to acquire technologies to be used in research and development that have not reached technological feasibility and have no alternative future use; license fees; and other expenses, which include direct and allocated expenses for laboratory, facilities and other costs.
As part of the process of preparing financial statements, we are required to estimate and accrue expenses. A portion of our research and development expenses is comprised of external costs, which we track on a program-specific basis. We record the estimated expenses of research and development activities conducted by third-party service providers as they are incurred and provided within research and development expense in the condensed consolidated statements of operations and comprehensive loss. These services include the conduct of clinical studies, preclinical studies and consulting services. These costs are a significant component of our research and development expenses. Typically, upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred, except for payments relating to intellectual property rights with future alternative use which will be expensed when the intellectual property is in use. Non-refundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.
Costs for research and development activities are recognized based on costs incurred. We make significant judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, we adjust our accrued estimates. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed may vary from our estimates and could result in us reporting amounts that are too high or too low in any particular period. Our accrued expenses are dependent, in part, upon the receipt of timely and accurate reporting from external clinical research organizations and other third-party service providers. Due to the nature of estimates, we cannot assure you that we will not make changes to our estimates in the future as we become aware of additional information about the status or conduct of our clinical trials and other research activities.
Contingent Consideration Liabilities
We evaluate acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets.
On February 21, 2025, we entered into an Agreement and Plan of Merger and Reorganization (“Merger Agreement”) with Project IKT Merger Sub, Inc., a Delaware corporation and our wholly-owned subsidiary (“Merger Sub”) and CorHepta Pharmaceuticals, Inc. a Delaware corporation (“CorHepta”). We determined that the transaction represented an asset acquisition as defined by ASC 805 as substantially all of the value was attributed to a single intangible asset, in-process research and development (“IPR&D”).
The fair value was determined based on our share price at closing. We agreed to issue 4,979,101 shares of our common stock to the shareholders of CorHepta, of which (i) 829,849 shares were fully vested on the acquisition date, (ii) 2,489,030 shares represented contingent consideration and will vest no later than February 21, 2026, subject to the achievement of certain milestones, and (iii) 1,660,222 shares represented post-merger compensation expense, subject to both service- and performance-based vesting conditions.
As of the acquisition date, the achievement of one of the contingent consideration milestones was deemed probable, and the fair value of the related shares was included in the purchase price of the acquisition. We remeasure the initial contingent consideration recognized at acquisition to fair value at each reporting date and recorded a change in fair value of $358,420 and $1,523,284 for the three and six month period ended June 30, 2025, which is included within operating expenses. We will recognize a contingent consideration liability and corresponding expense for the remaining contingent consideration shares in future periods when it is probable that a liability has been incurred and the amount of that liability can be reasonably estimated. As of June 30, 2025, the remaining performance-based vesting conditions are not probable and cannot be estimated.
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The IPR&D had not reached technological feasibility and had no alternative future use at the acquisition date, and therefore, the acquired IPR&D asset of $7,357,294 was written-off as research and development expense in our condensed consolidated statements of operations and comprehensive loss immediately following the acquisition in accordance with ASC 730.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk.
As a smaller reporting company, we are not required to provide disclosure regarding quantitative and qualitative market risk.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our principal executive officer and principal financial officer evaluated the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15(b) and 15d-15(b) under the Exchange Act as of the end of the period covered by this Quarterly Report. Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including the Chief Executive Officer and the Chief Financial Officer, to allow timely decisions regarding required disclosures. Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on that evaluation, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures were effective at a 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 (as such term is defined in Rules 13a-15(f) under the Exchange Act) during the three and six months ended June 30, 2025, 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 material litigation or legal proceedings. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors.
Other than the risks included below that have been amended and restated, there have been no material changes from the risk factors previously disclosed in our most recent Annual Report on Form 10-K as filed with the SEC on March 27, 2025.
Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.
The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that may affect our ability to profitably sell our product and product candidates, if approved. The United States government, state legislatures and foreign governments also have shown significant interest in implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs.
The Affordable Care Act was intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms.
There have been significant ongoing judicial, administrative, executive and legislative efforts to modify or eliminate the Affordable Care Act since its enactment. For example, the Tax Act enacted on December 22, 2017, repealed the shared responsibility payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code, commonly referred to as the individual mandate.
The Affordable Care Act has also been subject to challenges in the courts. On December 14, 2018, a Texas U.S. District Court Judge ruled that the Affordable Care Act is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. On December 18, 2019, the Fifth Circuit U.S. Court of Appeals held that the individual mandate is unconstitutional and remanded the case to the Texas District Court to reconsider its earlier invalidation of the entire Affordable Care Act. An appeal was taken to the U.S. Supreme Court which upheld the Affordable Care Act in June of 2021. There have been no significant judicial challenges since then.
Other legislative changes have been adopted since the Affordable Care Act was enacted, including aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and will remain in effect through 2031. Under current legislation, the actual reductions in Medicare payments may vary up to 4%. The Consolidated Appropriations Act (CAA), which was signed into law by President Biden in December 2022, made several changes to sequestration of the Medicare program. Section 1001 of the CAA delays the 4% Statutory Pay-As-You-Go Act of 2010, or “PAYGO” sequester for two years, through the end of calendar year 2024. Triggered by the enactment of the American Rescue Plan Act of 2021, the 4% cut to the Medicare program would have taken effect in January 2023. The CAA’s health care offset title includes Section 4163, which extends the 2% Budget Control Act of 2011 Medicare sequester for six months into fiscal year 2032 and lowers the payment reduction percentages in fiscal years 2030 and 2031.
The American Taxpayer Relief Act of 2012 reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. Further, with passage of the Inflation Reduction Act (IRA) in August 2022, Congress authorized Medicare beginning in 2026 to negotiate lower prices for certain costly single-source drug and biologic products that do not have competing generics or biosimilars. This provision is limited in terms of the number of pharmaceuticals whose prices can be negotiated in any given year and it only applies to drug products that have been approved for at least 9 years and biologics that have been licensed for 13 years. Drugs and biologics that have been approved for a single rare disease or condition are categorically excluded from price negotiation. In addition, the new legislation provides that if pharmaceutical companies raise prices in Medicare faster than the rate of inflation, they must pay rebates back to the government for the difference. The IRA also caps Medicare out-of-pocket drug costs at an estimated $4,000 a year in 2024 and, thereafter beginning in 2025, at $2,000 a year. The IRA permits the U.S. Department of Health and Human Services or “HHS” to implement many of these provisions through guidance, as opposed to regulation, for the initial years. HHS has and will continue to issue and update guidance as
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these programs are implemented. On August 15, 2024, HHS announced the agreed-upon prices of the first ten drugs that were subject to price negotiations, which take effect in January 2026. HHS will select up to fifteen additional products covered under Part D for negotiation in 2025. Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program. The Medicare Drug Price Negotiation Program is currently subject to legal challenges. The outcome of this litigation as well as the effects of the IRA on the pharmaceutical industry cannot yet be fully determined but is likely to be significant.
On April 15, 2025, the Trump Administration published Executive Order 14273, “Lowering Drug Prices by Once Again Putting Americans First,” which generally directs the federal government to take measures to reduce drug prices, including eliminating the so-called “pill penalty” under the Inflation Reduction Act that creates a distinction between small molecule and large molecule products for purposes of determining when a drug may be eligible for drug price negotiation. On May 12, 2025, the Trump Administration published Executive Order 14297, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” which generally, among other things, directs the federal government to establish and communicate most-favored-nation price targets to pharmaceutical manufacturers to bring prices for American patients in line with comparably developed nations. Further, the Executive Order directs the federal government to support regulatory paths to allow direct-to-patient sales for companies that meet these targets. It also states that the Administration will take additional aggressive action (for example, examining whether marketing approvals should be modified or rescinded or opening the door for individual drug importation waivers) should manufacturers fail to offer American consumers the most-favored-nation lowest price. It also directs the Secretary of Commerce and the U.S. Trade Representative to “take all necessary and appropriate action to ensure foreign countries are not engaged in any act, policy, or practice that may be unreasonable or discriminatory or that may impair United States national security . . . including by suppressing the price of pharmaceutical products below fair market value in foreign countries.” Notably, a similar “Most Favored Nation” pricing rule enacted under the first Trump Administration was subject to an injunction resulting from judicial challenges to the rule, which was formally rescinded by the former Biden Administration in August 2021.
In addition, at the state level, legislatures have increasingly passed legislation and implemented regulations similar to those under consideration at the federal level, as well as laws designed to control pharmaceutical and biotherapeutic product pricing, including restrictions on pricing or reimbursement at the state government level, limitations on discounts to patients, marketing cost disclosure and transparency measures, restrictions or other limitations on patient assistance, and, in some cases, policies to encourage importation from other countries (subject to federal approval) and bulk purchasing. Certain states are also pursuing cost containment efforts through Prescription Drug Affordability Boards and similar entities.
We expect that healthcare reform measures that have and may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for our product and product candidates, if approved, and could seriously harm our future revenues. Any reduction in reimbursement from Medicare, Medicaid, or other government programs may result in a similar reduction in payments from private payers. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain and maintain profitability of our product and product candidates, if approved.
We are dependent on third-party manufacturers which are located in China, and any inability to obtain products from any such manufacturers could harm our business.
Our current and future product candidates are expected to be manufactured in whole or in part by companies that are located in China. This concentration exposes us to risks associated with doing business globally. The political, legal and cultural environment in China is rapidly evolving, and any change that impairs our ability to obtain products from manufacturers in that region could have a material adverse effect on our business, operating results and financial condition.
Political uncertainty in the United States may result in significant changes to U.S. trade policies, treaties and tariffs, potentially involving trade policies and tariffs regarding China, including the potential disallowance of tax deductions for imported merchandise or the imposition of unilateral tariffs on imported products. For example, in 2025, the United States imposed significant tariffs on imports from other countries, including a baseline tariff of 10% on imports into the United States and higher tariffs on multiple designated countries (including the EU Member States, China, Canada, and Mexico), such as “reciprocal” tariffs at varying rates. Such tariffs have prompted retaliatory measures from several countries, which may further escalate. On April 9, 2025, the United States announced that the imposition of most “reciprocal” tariffs would be paused for 90 days pending negotiations with the relevant countries. While certain tariffs have been suspended, modified or temporarily reduced, we cannot predict the results of the U.S. government's trade negotiations or the outcome of ongoing legal challenges to specific tariff policies. Pharmaceutical products are currently excluded from the baseline and “reciprocal” tariffs imposed by the United States; however, such tariffs still apply to the raw materials and other products necessary for the manufacture and formulation of our marketed products and product candidates. In addition, the current U.S. administration has expressed an intent to impose tariffs on pharmaceutical imports, with the stated policy objective of reshoring pharmaceutical manufacturing to the United States. Among other means, such tariffs may be imposed by the United States under Section 232 of the Trade Expansion Act of 1962, as amended, pursuant to which the U.S. Department of
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Commerce recently initiated an investigation to determine the effects of importing pharmaceuticals and pharmaceutical ingredients on national security. Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets. Any changes in political, trade, regulatory, and economic conditions, including U.S. trade policies, could have a material adverse effect on our financial condition or results of operations.
Regulators and legislators in the U.S. are increasingly scrutinizing and restricting certain personal data transfers and transactions involving foreign countries. For example, the Biden Administration’s executive order Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern as implemented by Department of Justice regulations issued in December 2024, prohibits data brokerage transactions involving certain sensitive personal data categories, including health data, genetic data, and biospecimens, to countries of concern, including China. The regulations also restrict certain investment agreements, employment agreements and vendor agreements involving such data and countries of concern, absent specified cybersecurity controls. Actual or alleged violations of these regulations may be punishable by criminal and/or civil sanctions, and may result in exclusion from participation in federal and state programs.
These developments, or the perception that any of them could occur, may have a material adverse effect on global economic conditions and the stability of global financial markets, and may significantly reduce global trade and, in particular, trade between China and the United States. Any of these factors could depress economic activity, restrict our sourcing from suppliers and have a material adverse effect on our business, financial condition and results of operations and affect our strategy. We cannot predict whether any of the countries in which our product candidates or raw materials are currently manufactured or may be manufactured in the future will be subject to additional trade restrictions imposed by the United States and foreign governments, nor can we predict the likelihood, type or effect of any such restrictions.
Changes in U.S. tax law could adversely affect our business and financial condition.
The laws, rules and regulations dealing with U.S. federal, state, and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department. For example, the One Big Beautiful Bill Act (the “OBBBA”) was signed into law on July 4, 2025 and made significant changes to U.S. federal tax law. Changes to tax laws (which changes may have retroactive application) could adversely affect us or holders of our common stock. For example, under Section 174 of the Internal Revenue Code of 1986, as amended (the “IRC”), in taxable years beginning after December 31, 2021, expenses that are incurred for research and development performed outside the U.S. will be capitalized and amortized, which may have an adverse effect on our cash flow. The OBBBA provides that for taxable years beginning after December 31, 2024, expenses that are incurred for research and development performed in the U.S. may, at the taxpayer’s election, be immediately deducted or capitalized and amortized. In addition, the OBBBA provides that for taxable years beginning after December 31, 2021 and before January 1, 2025, certain eligible taxpayers generally may elect to retroactively deduct expenses for research and development performed in the U.S. in such taxable years by filing amended tax returns for such taxable years, and all other taxpayers that are not eligible to make such an election and that amortized expenses for research and development performed in the U.S. in such taxable years generally may elect to accelerate and deduct the remaining unamortized amounts of such research and development expenses (i) in the first taxable year beginning after December 31, 2024, or (ii) ratably over the two-taxable year period beginning with the first taxable year beginning after December 31, 2024. In recent years, many changes have been made to applicable tax laws and changes are likely to continue to occur in the future.
It cannot be predicted whether, when, in what form, or with what effective dates, new tax laws may be enacted, or regulations and rulings may be enacted, promulgated or issued under existing or new tax laws, which could result in an increase in our or our shareholders’ tax liability or require changes in the manner in which we operate in order to minimize or mitigate any adverse effects of changes in tax law or in the interpretation thereof. We urge investors to consult with their legal and tax advisers regarding the implications of potential changes in tax laws on an investment in our common stock.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Unregistered Sales of Equity Securities
None.
Issuer Repurchases of Equity Securities
None.
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Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
(c) Rule 10b5-1 Trading Plans
None of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act)
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Item 6. Exhibits.
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Incorporated by Reference to SEC Filing |
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Exhibit |
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Filed Exhibit Description |
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Form |
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Exhibit |
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File No. |
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Date Filed |
3.1 |
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Amended and Restated Certificate of Incorporation of Inhibikase Therapeutics, Inc. |
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8-K |
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3.1 |
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001-39676 |
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12/29/2020 |
3.2 |
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Certificate of Amendment to Amended and Restated Certificate of Incorporation of Inhibikase Therapeutics, Inc. |
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8-K |
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3.1 |
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001-39676 |
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06/29/2023 |
3.3 |
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Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Inhibikase Therapeutics, Inc. |
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8-K |
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3.1 |
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000-39676 |
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01/06/2025 |
3.4 |
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Amended and Restated Bylaws of Inhibikase Therapeutics, Inc. |
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8-K |
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3.2 |
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001-39676 |
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12/29/2020 |
4.1 |
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Specimen common stock certificate of the Registrant |
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S-1 |
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4.1 |
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333-240036 |
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07/23/2020 |
10.1*# |
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Amendment No. 3 to the Inhibikase Therapeutics, Inc. 2020 Equity Incentive Plan |
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31.1* |
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Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2* |
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Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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32.1** |
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Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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32.2** |
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Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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101.INS |
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Inline XBRL Instance Document |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema Document |
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104 |
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Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101) |
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(#) A contract, compensatory plan or arrangement to which a director or executive officer is a party or in which one or more directors or executive officers are eligible to participate.
(*) Filed herewith.
(†) Annexes, schedules and/or exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company agrees to furnish supplementally a copy of any omitted attachment to the SEC on a confidential basis upon request.
(^) Portions of this exhibit (indicated by asterisks) have been omitted in accordance with Item 601(b)(10) of Regulation S-K.
(**) Exhibits 32.1 and 32.2 are being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall such exhibits be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act or the Exchange Act, except as otherwise stated in any such filing.
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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 thereunto duly authorized.
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Inhibikase Therapeutics, Inc. |
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Date: August 14, 2025 |
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By: |
/s/ Mark Iwicki |
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Mark Iwicki |
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Chief Executive Officer (Principal Executive Officer) |
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Date: August 14, 2025 |
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By: |
/s/ David McIntyre |
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David McIntyre |
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Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
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Source:
FAQ
When does IKT plan to start the Phase 2b trial for IKT鈥�001?
What financing and equity instruments did IKT issue or have outstanding as of June 30, 2025?
Was the HCW at鈥憈he鈥憁arket (ATM) agreement still active?
Did IKT enter any new sales agreements for potential ATM issuances?
What were the accounting impacts from the CorHepta acquisition?
