[10-Q] Clearside Biomedical, Inc. Quarterly Earnings Report
Clearside Biomedical (CLSD) reported cash and cash equivalents of $9.4 million as of June 30, 2025 and total assets of $15.3 million, against total liabilities of $64.1 million, driven largely by a $55.7 million liability related to the sale of future royalties. The company recorded a $12.7 million net loss for the six months ended June 30, 2025 and an accumulated deficit of $368.0 million. License and other revenue for the six months was $2.8 million, including a $1.5 million milestone from Arctic Vision.
In July 2025 the company initiated a formal strategic review and retained Piper Sandler, paused internal R&D and implemented a workforce reduction, estimating third-quarter severance charges of approximately $2.6 million. Management states that, based on current plans, cash on hand is insufficient to fund operations for the next 12 months, and the company disclosed substantial doubt about its ability to continue as a going concern. The company also failed to regain Nasdaq's $1.00 minimum bid requirement and expects a delisting notice, while seeking stockholder approval for a possible reverse split.
Clearside Biomedical (CLSD) ha dichiarato disponibilità liquide e mezzi equivalenti di $9.4 milioni al 30 giugno 2025 e attività totali per $15.3 milioni, a fronte di passività totali pari a $64.1 milioni, principalmente riconducibili a una passività di $55.7 milioni derivante dalla cessione di royalties future. La società ha registrato una perdita netta di $12.7 milioni nei sei mesi terminati il 30 giugno 2025 e un deficit accumulato di $368.0 milioni. I ricavi da licenze e altre entrate per il semestre sono stati di $2.8 milioni, comprendenti un pagamento milestone di $1.5 milioni da Arctic Vision.
Nel luglio 2025 la società ha avviato una revisione strategica formale e ha incaricato Piper Sandler, sospendendo la R&D interna e attuando una riduzione del personale, stimando oneri per liquidazioni nel terzo trimestre di circa $2.6 milioni. La direzione dichiara che, secondo i piani attuali, la liquidità disponibile non è sufficiente a finanziare le operazioni per i prossimi 12 mesi e la società ha espresso seri dubbi sulla sua capacità di continuare come azienda in funzionamento. Inoltre non è riuscita a ripristinare il requisito minimo del prezzo di quotazione di Nasdaq di $1,00 e si aspetta una notifica di delisting, mentre chiede l'approvazione degli azionisti per un possibile raggruppamento azionario (reverse split).
Clearside Biomedical (CLSD) informó efectivo y equivalentes de efectivo por $9.4 millones al 30 de junio de 2025 y activos totales por $15.3 millones, frente a pasivos totales de $64.1 millones, impulsados en gran medida por un pasivo de $55.7 millones relacionado con la venta de royalties futuras. La compañía registró una pérdida neta de $12.7 millones en los seis meses terminados el 30 de junio de 2025 y un déficit acumulado de $368.0 millones. Los ingresos por licencias y otras partidas para el semestre fueron de $2.8 millones, que incluyen un hito de $1.5 millones de Arctic Vision.
En julio de 2025 la empresa inició una revisión estratégica formal y contrató a Piper Sandler, pausó la I+D interna e implementó una reducción de plantilla, estimando cargos por indemnizaciones en el tercer trimestre de aproximadamente $2.6 millones. La dirección indica que, según los planes actuales, el efectivo disponible no es suficiente para financiar las operaciones durante los próximos 12 meses, y la compañía declaró dudas sustanciales sobre su capacidad para continuar como empresa en funcionamiento. Además no logró restablecer el requisito mínimo de oferta de Nasdaq de $1.00 y espera una notificación de exclusión, mientras busca la aprobación de los accionistas para una posible consolidación inversa de acciones (reverse split).
Clearside Biomedical(CLSD)는 2025년 6월 30일 기준 현금 및 현금성자산 $9.4 million과 총자산 $15.3 million을 보고했으며, 총부채는 $64.1 million으로 그중 $55.7 million은 향후 로열티 매각과 관련된 부채가 주된 원인입니다. 회사는 2025년 6월 30일로 끝난 6개월 동안 $12.7 million 순손실을 기록했고 누적 적자는 $368.0 million입니다. 해당 반기 라이선스 및 기타 수익은 $2.8 million으로, 여기에는 Arctic Vision로부터의 마일스톤 $1.5 million이 포함되어 있습니다.
2025년 7월 회사는 공식적인 전략 검토를 시작하고 Piper Sandler를 선임했으며, 내부 R&D를 중단하고 인력 감축을 시행하여 3분기 퇴직 관련 비용을 약 $2.6 million으로 추정했습니다. 경영진은 현재 계획 기준으로 보유 현금이 향후 12개월간 운영을 지원하기에 부족하다고 보고했으며, 계속기업으로서의 존속 가능성에 대해 중대한 의문을 제기했습니다. 또한 나스닥의 최소 입찰가 $1.00 요건을 회복하지 못해 상장폐지 통지를 받을 것으로 예상하고 있으며, 가능한 역병합(주식 병합)을 위해 주주 승인을 구하고 있습니다.
Clearside Biomedical (CLSD) a déclaré des liquidités et équivalents de trésorerie de $9,4 millions au 30 juin 2025 et un actif total de $15,3 millions, contre des passifs totaux de $64,1 millions, principalement dus à une dette de $55,7 millions liée à la cession de redevances futures. La société a enregistré une perte nette de $12,7 millions pour les six mois clos le 30 juin 2025 et un déficit cumulé de $368,0 millions. Les revenus de licences et autres pour le semestre se sont élevés à $2,8 millions, incluant un jalon de $1,5 millions versé par Arctic Vision.
En juillet 2025, la société a lancé une revue stratégique formelle et engagé Piper Sandler, mis en pause la recherche et développement interne et procédé à une réduction des effectifs, estimant des charges de licenciement au troisième trimestre d’environ $2,6 millions. La direction indique que, sur la base des plans actuels, la trésorerie disponible est insuffisante pour financer les opérations au cours des 12 prochains mois, et la société a exprimé des doutes importants quant à sa capacité à poursuivre son activité. Elle n’a pas non plus réussi à rétablir l’exigence minimale de cours du Nasdaq de 1,00 $ et s’attend à recevoir un avis de radiation, tout en sollicitant l’approbation des actionnaires pour un éventuel regroupement d’actions (reverse split).
Clearside Biomedical (CLSD) meldete Zahlungsmittel und Zahlungsmitteläquivalente in Höhe von $9,4 Millionen zum 30. Juni 2025 und Gesamtvermögen von $15,3 Millionen, bei Gesamtschulden von $64,1 Millionen, wobei ein wesentlicher Anteil auf eine Verbindlichkeit von $55,7 Millionen im Zusammenhang mit dem Verkauf künftiger Lizenzzahlungen entfällt. Das Unternehmen verzeichnete für die sechs Monate zum 30. Juni 2025 einen Nettoverlust von $12,7 Millionen und einen angesammelten Fehlbetrag von $368,0 Millionen. Lizenz- und sonstige Erträge beliefen sich im Halbjahr auf $2,8 Millionen, darunter eine Meilensteinzahlung von $1,5 Millionen von Arctic Vision.
Im Juli 2025 leitete das Unternehmen eine formelle strategische Überprüfung ein und beauftragte Piper Sandler, setzte die interne R&D aus und führte einen Personalabbau durch; für das dritte Quartal werden Abfindungskosten von etwa $2,6 Millionen erwartet. Das Management gibt an, dass nach aktuellen Plänen die vorhandenen Mittel nicht ausreichen, um den Geschäftsbetrieb für die nächsten 12 Monate zu finanzieren, und äußerte erhebliche Zweifel an der Fortführungsfähigkeit des Unternehmens. Zudem konnte die Gesellschaft die Nasdaq-Mindestnotierungsanforderung von $1,00 nicht wiedererlangen und rechnet mit einer Delisting-Benachrichtigung, während sie die Zustimmung der Aktionäre für eine mögliche Aktienzusammenlegung (Reverse Split) anstrebt.
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Insights
TL;DR: Acute liquidity pressure and going-concern disclosure make near-term financing or asset transactions likely; operating losses continue.
The balance sheet shows $9.4M cash versus significant obligations, including a $55.7M royalty liability accreting at an effective rate of 21.8%. Operating cash used was $10.6M over six months, and the company posted a $12.7M H1 net loss. While license milestones added $2.8M of revenue and clinical progress (ODYSSEY positive topline) is an asset, the combination of low cash, a going-concern statement, Nasdaq noncompliance and workforce reductions materially increase financing and execution risk.
TL;DR: Strategic review and retained advisor may unlock asset value, but royalty sale structure and limited cash complicate transaction timing.
Management retained Piper Sandler to evaluate options including sale, license or monetization of assets. The Purchase and Sale Agreement with HCR transfers royalty streams to a third party and includes a change-in-control option mechanics that could affect transaction pricing. Pausing R&D and converting employees to consultants suggests immediate cost containment but may limit near-term operational value in negotiations. Outcomes depend on market interest in the SCS platform, milestone certainty, and ability to bridge liquidity until closing.
Clearside Biomedical (CLSD) ha dichiarato disponibilità liquide e mezzi equivalenti di $9.4 milioni al 30 giugno 2025 e attività totali per $15.3 milioni, a fronte di passività totali pari a $64.1 milioni, principalmente riconducibili a una passività di $55.7 milioni derivante dalla cessione di royalties future. La società ha registrato una perdita netta di $12.7 milioni nei sei mesi terminati il 30 giugno 2025 e un deficit accumulato di $368.0 milioni. I ricavi da licenze e altre entrate per il semestre sono stati di $2.8 milioni, comprendenti un pagamento milestone di $1.5 milioni da Arctic Vision.
Nel luglio 2025 la società ha avviato una revisione strategica formale e ha incaricato Piper Sandler, sospendendo la R&D interna e attuando una riduzione del personale, stimando oneri per liquidazioni nel terzo trimestre di circa $2.6 milioni. La direzione dichiara che, secondo i piani attuali, la liquidità disponibile non è sufficiente a finanziare le operazioni per i prossimi 12 mesi e la società ha espresso seri dubbi sulla sua capacità di continuare come azienda in funzionamento. Inoltre non è riuscita a ripristinare il requisito minimo del prezzo di quotazione di Nasdaq di $1,00 e si aspetta una notifica di delisting, mentre chiede l'approvazione degli azionisti per un possibile raggruppamento azionario (reverse split).
Clearside Biomedical (CLSD) informó efectivo y equivalentes de efectivo por $9.4 millones al 30 de junio de 2025 y activos totales por $15.3 millones, frente a pasivos totales de $64.1 millones, impulsados en gran medida por un pasivo de $55.7 millones relacionado con la venta de royalties futuras. La compañía registró una pérdida neta de $12.7 millones en los seis meses terminados el 30 de junio de 2025 y un déficit acumulado de $368.0 millones. Los ingresos por licencias y otras partidas para el semestre fueron de $2.8 millones, que incluyen un hito de $1.5 millones de Arctic Vision.
En julio de 2025 la empresa inició una revisión estratégica formal y contrató a Piper Sandler, pausó la I+D interna e implementó una reducción de plantilla, estimando cargos por indemnizaciones en el tercer trimestre de aproximadamente $2.6 millones. La dirección indica que, según los planes actuales, el efectivo disponible no es suficiente para financiar las operaciones durante los próximos 12 meses, y la compañía declaró dudas sustanciales sobre su capacidad para continuar como empresa en funcionamiento. Además no logró restablecer el requisito mínimo de oferta de Nasdaq de $1.00 y espera una notificación de exclusión, mientras busca la aprobación de los accionistas para una posible consolidación inversa de acciones (reverse split).
Clearside Biomedical(CLSD)는 2025년 6월 30일 기준 현금 및 현금성자산 $9.4 million과 총자산 $15.3 million을 보고했으며, 총부채는 $64.1 million으로 그중 $55.7 million은 향후 로열티 매각과 관련된 부채가 주된 원인입니다. 회사는 2025년 6월 30일로 끝난 6개월 동안 $12.7 million 순손실을 기록했고 누적 적자는 $368.0 million입니다. 해당 반기 라이선스 및 기타 수익은 $2.8 million으로, 여기에는 Arctic Vision로부터의 마일스톤 $1.5 million이 포함되어 있습니다.
2025년 7월 회사는 공식적인 전략 검토를 시작하고 Piper Sandler를 선임했으며, 내부 R&D를 중단하고 인력 감축을 시행하여 3분기 퇴직 관련 비용을 약 $2.6 million으로 추정했습니다. 경영진은 현재 계획 기준으로 보유 현금이 향후 12개월간 운영을 지원하기에 부족하다고 보고했으며, 계속기업으로서의 존속 가능성에 대해 중대한 의문을 제기했습니다. 또한 나스닥의 최소 입찰가 $1.00 요건을 회복하지 못해 상장폐지 통지를 받을 것으로 예상하고 있으며, 가능한 역병합(주식 병합)을 위해 주주 승인을 구하고 있습니다.
Clearside Biomedical (CLSD) a déclaré des liquidités et équivalents de trésorerie de $9,4 millions au 30 juin 2025 et un actif total de $15,3 millions, contre des passifs totaux de $64,1 millions, principalement dus à une dette de $55,7 millions liée à la cession de redevances futures. La société a enregistré une perte nette de $12,7 millions pour les six mois clos le 30 juin 2025 et un déficit cumulé de $368,0 millions. Les revenus de licences et autres pour le semestre se sont élevés à $2,8 millions, incluant un jalon de $1,5 millions versé par Arctic Vision.
En juillet 2025, la société a lancé une revue stratégique formelle et engagé Piper Sandler, mis en pause la recherche et développement interne et procédé à une réduction des effectifs, estimant des charges de licenciement au troisième trimestre d’environ $2,6 millions. La direction indique que, sur la base des plans actuels, la trésorerie disponible est insuffisante pour financer les opérations au cours des 12 prochains mois, et la société a exprimé des doutes importants quant à sa capacité à poursuivre son activité. Elle n’a pas non plus réussi à rétablir l’exigence minimale de cours du Nasdaq de 1,00 $ et s’attend à recevoir un avis de radiation, tout en sollicitant l’approbation des actionnaires pour un éventuel regroupement d’actions (reverse split).
Clearside Biomedical (CLSD) meldete Zahlungsmittel und Zahlungsmitteläquivalente in Höhe von $9,4 Millionen zum 30. Juni 2025 und Gesamtvermögen von $15,3 Millionen, bei Gesamtschulden von $64,1 Millionen, wobei ein wesentlicher Anteil auf eine Verbindlichkeit von $55,7 Millionen im Zusammenhang mit dem Verkauf künftiger Lizenzzahlungen entfällt. Das Unternehmen verzeichnete für die sechs Monate zum 30. Juni 2025 einen Nettoverlust von $12,7 Millionen und einen angesammelten Fehlbetrag von $368,0 Millionen. Lizenz- und sonstige Erträge beliefen sich im Halbjahr auf $2,8 Millionen, darunter eine Meilensteinzahlung von $1,5 Millionen von Arctic Vision.
Im Juli 2025 leitete das Unternehmen eine formelle strategische Überprüfung ein und beauftragte Piper Sandler, setzte die interne R&D aus und führte einen Personalabbau durch; für das dritte Quartal werden Abfindungskosten von etwa $2,6 Millionen erwartet. Das Management gibt an, dass nach aktuellen Plänen die vorhandenen Mittel nicht ausreichen, um den Geschäftsbetrieb für die nächsten 12 Monate zu finanzieren, und äußerte erhebliche Zweifel an der Fortführungsfähigkeit des Unternehmens. Zudem konnte die Gesellschaft die Nasdaq-Mindestnotierungsanforderung von $1,00 nicht wiedererlangen und rechnet mit einer Delisting-Benachrichtigung, während sie die Zustimmung der Aktionäre für eine mögliche Aktienzusammenlegung (Reverse Split) anstrebt.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
For the quarterly period ended
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Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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PART I - FINANCIAL INFORMATION |
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Item 1. |
Financial Statements (unaudited) |
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Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024 |
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PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
CLEARSIDE BIOMEDICAL, INC.
Consolidated Balance Sheets
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See accompanying notes to the consolidated financial statements.
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CLEARSIDE BIOMEDICAL, INC.
Consolidated Statements of Operations
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|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Net loss per share of common stock — basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Weighted average shares outstanding — basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Unrealized loss on available-for-sale investments |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
Comprehensive loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
See accompanying notes to the consolidated financial statements.
4
CLEARSIDE BIOMEDICAL, INC.
Consolidated Statements of Stockholders’ Deficit
(in thousands, except share data)
(unaudited)
|
|
Six Months Ended June 30, 2025 |
|
|||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|||||
|
|
Common Stock |
|
|
Additional |
|
|
Accumulated |
|
|
Stockholders' |
|
||||||||
|
|
Shares |
|
|
Amount |
|
|
Paid-In-Capital |
|
|
Deficit |
|
|
Deficit |
|
|||||
Balance at December 31, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||
Issuance of common stock under at-the-market |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Vesting and settlement of restricted stock units |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Issuance of common stock under employee stock |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance at March 31, 2025 |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|||
Issuance of common stock under at-the-market |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance at June 30, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||
|
|
Six Months Ended June 30, 2024 |
|
|||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
Total |
|
||||||
|
|
Common Stock |
|
|
Additional |
|
|
Accumulated |
|
|
Comprehensive |
|
|
Stockholders' |
|
|||||||||
|
|
Shares |
|
|
Amount |
|
|
Paid-In-Capital |
|
|
Deficit |
|
|
Loss |
|
|
Deficit |
|
||||||
Balance at December 31, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
( |
) |
|||
Issuance of common stock under registered direct |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Issuance of common stock under at-the-market |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Exercise of stock options |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Vesting and settlement of restricted stock units |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Issuance of common stock under employee |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Balance at March 31, 2024 |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|||
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance at June 30, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|||
See accompanying notes to the consolidated financial statements.
5
CLEARSIDE BIOMEDICAL, INC.
Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
|
|
Six Months Ended |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Operating activities |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
||
Non-cash interest expense on liability related to the sales of |
|
|
|
|
|
|
||
Depreciation |
|
|
|
|
|
|
||
Share-based compensation expense |
|
|
|
|
|
|
||
Change in fair value of warrant liabilities |
|
|
( |
) |
|
|
( |
) |
Issuance costs allocated to warrant liabilities |
|
|
|
|
|
|
||
Amortization and accretion of available-for-sales investments, net |
|
|
|
|
|
( |
) |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
|
( |
) |
|
|
|
|
Other assets and liabilities |
|
|
( |
) |
|
|
( |
) |
Accounts payable and accrued liabilities (includes $ |
|
|
( |
) |
|
|
( |
) |
Deferred revenue |
|
|
|
|
|
|
||
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
Investing activities |
|
|
|
|
|
|
||
Acquisition of property and equipment |
|
|
( |
) |
|
|
( |
) |
Purchase of short-term investments |
|
|
|
|
|
( |
) |
|
Net cash used in investing activities |
|
|
( |
) |
|
|
( |
) |
Financing activities |
|
|
|
|
|
|
||
Proceeds from issuance of common stock and warrants under |
|
|
|
|
|
|
||
Proceeds from at-the-market sales agreement, net of issuance costs |
|
|
|
|
|
|
||
Payments on royalty purchase and sale agreement |
|
|
( |
) |
|
|
|
|
Proceeds from exercise of stock options |
|
|
|
|
|
|
||
Proceeds from shares issued under employee stock purchase plan |
|
|
|
|
|
|
||
Net cash (used in) provided by financing activities |
|
|
( |
) |
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
( |
) |
|
|
( |
) |
Cash and cash equivalents, beginning of period |
|
|
|
|
|
|
||
Cash and cash equivalent, end of period |
|
$ |
|
|
$ |
|
||
Supplemental disclosure |
|
|
|
|
|
|
||
Purchase of property and equipment included in accrued liabilities |
|
$ |
|
|
$ |
|
||
See accompanying notes to the consolidated financial statements.
6
CLEARSIDE BIOMEDICAL, INC.
Notes to the Consolidated Financial Statements
(unaudited)
1. The Company
Clearside Biomedical, Inc. (the “Company”) is a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®). Incorporated in the State of Delaware on
The Company’s activities since inception have primarily consisted of developing product and technology rights, raising capital and performing research and development activities. The Company is subject to a number of risks and uncertainties similar to those of other life science companies at a similar stage of development, including, among others, the need to obtain adequate additional financing, successful development efforts including regulatory approval of products, compliance with government regulations, successful commercialization of potential products, protection of proprietary technology and dependence on key individuals.
Liquidity
The Company had cash and cash equivalents of $
Historically, the Company has funded its operations primarily through the sale of common stock and convertible preferred stock, the issuance of warrants, the issuance of long-term debt, and license agreements.
On February 6, 2024, the Company entered into a securities purchase agreement with institutional investors and an existing stockholder, pursuant to which the Company issued and sold, in a registered direct offering (the “Registered Direct Offering”): (i) an aggregate of
On January 31, 2024 (the “Amendment Effective Date”), the Company entered into a fourth amendment to the license agreement (as amended, the “Emory License Agreement”) with Emory University and Georgia Tech Research Corporation (collectively, the “Licensor”) pursuant to which the parties agreed to reduce the Sublicense Percentage (as defined in the Emory License Agreement) from a low double digit percentage to a high single digit percentage that the Company will pay the Licensor applicable to any fees or payments paid to the Company by any Sublicensee (as defined in the Emory License Agreement) of the Licensed Patents and/or Licensed Technology (each as defined in the Emory License Agreement), excluding (i) amounts paid to the Company by a Sublicensee to reimburse the Company for certain research and development costs pursuant to a written agreement between the Company and such Sublicensee, (ii) the value of intellectual property transferred or granted to the Company if necessary or helpful to the development or commercialization of Licensed Products (as defined in the Emory License Agreement) and (iii) amounts paid for shares of the Company’s stock. The payment to Licensor of any such Sublicense Percentage is due within 30 days of receipt by the Company of a qualifying payment from a Sublicensee, provided however, with respect to any qualifying payments received by the Company from a Sublicensee after July 1, 2023 but prior to January 1, 2025, the payment to Licensor of any such Sublicensee Percentage was due to Licensor by March 31, 2025. The parties also agreed to a revised annual license maintenance fee due each year (the “Maintenance Fee”) starting in 2023 through 2028, as follows: $
In May 2023, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co. ("Cantor") under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $
7
Agreement. During the six months ended June 30, 2024, the Company sold
The Company has suffered recurring losses and negative cash flows from operations since inception and anticipates incurring additional losses until such time, if ever, that it can generate significant revenue. The Company has no current source of revenue to sustain present activities. The Company does not expect to generate other meaningful revenue until and unless the Company's licensees successfully commercialize XIPERE and the Company has fulfilled its obligations under the Purchase and Sale Agreement, its other licensees receive regulatory approval and successfully commercialize its product candidates, or the Company commercializes its product candidates either on its own or with a third party. In the absence of product or other revenues, the amount, timing, nature or source of which cannot be predicted, the Company’s losses will continue as it conducts its research and development activities.
The Company will continue to need to obtain additional financing to fund future operations, including completing the development, partnering and potential commercialization of its primary product candidates. The Company will need to obtain financing to complete the development and conduct clinical trials for the regulatory approval of its product candidates if requested by regulatory bodies. If such product candidates were to receive regulatory approval, the Company would need to obtain financing to prepare for the potential commercialization of its product candidates, if the Company decides to commercialize the products on its own.
These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the financial statements are issued. Based on its current plans and forecasted expenses, the Company does not expect its cash and cash equivalents will enable the Company to fund its planned operating expenses and capital expenditure requirements for the next 12 months from the date of this filing.
Accordingly, the Company’s consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should the Company be unable to continue as a going concern.
Until the Company can generate sufficient revenue, the Company will need to finance future cash needs through public or private equity offerings, license agreements, debt financings or restructurings, collaborations, strategic alliances and marketing or distribution arrangements.
2. Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The Company's consolidated financial statements include the results of the financial operations of Clearside Biomedical, Inc. and Royalty Sub, which was formed for the purposes of the transactions contemplated by the Purchase and Sale Agreement described in Note 5. All intercompany balances and transactions have been eliminated.
The Company’s consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”). In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s consolidated financial position and results of operations for the interim periods presented. The results for the three and six months ended June 30, 2025 are not indicative of results to be expected for the full year ending December 31, 2025, any other interim periods or any future year or period. These unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and related footnotes, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025.
During the six months ended June 30, 2025, the Company recorded an immaterial out of period adjustment of $
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of income and expenses during the reporting periods. Significant items subject to such estimates and assumptions include the estimate of the total amount of future royalty revenue and milestone payments to be generated over the life of the Purchase and Sale Agreement described in Note 5, certain assumptions used in the valuation of warrant liabilities, revenue recognition, the accounting for useful lives to calculate depreciation and amortization, clinical trial expense accruals, share-based compensation expense and income tax valuation allowance. Actual results could differ from these estimates.
8
Revenue Recognition
The Company recognizes revenue from its contracts with customers under Financial Accounting Standards Board ("FASB") Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers. The Company’s primary revenue arrangements are license agreements, which typically include upfront payments, regulatory and commercial milestone payments and royalties based on future product sales. The arrangements may also include payments for the Company’s SCS Microinjector devices as well as payments for assistance and oversight of the customer’s use of the Company’s technology. In determining the amount of revenue to be recognized under these agreements, the Company performs the following steps: (i) identifies the promised goods and services to be transferred in the contract, (ii) identifies the performance obligations, (iii) determines the transaction price, (iv) allocates the transaction price to the performance obligations and (v) recognizes revenue as the performance obligations are satisfied.
The Company receives payments from its customers based on billing schedules established in each contract. Upfront and other payments may require deferral of revenue recognition to a future period until the Company performs its obligations under the arrangement. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.
Research and Development Costs
Research and development costs are charged to expense as incurred and include:
Costs for certain development activities, such as clinical trial activities, are recognized based on an evaluation of the estimated total costs for the clinical trial, progress to completion of specific tasks using data such as participant enrollment, pass-through expenses, clinical site activations, data from the clinical sites or information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual contracts and any subsequent amendments, which may differ from the patterns of costs incurred, and are reflected in the consolidated financial statements as prepaid expenses or accrued liabilities.
Share-Based Compensation
Compensation cost related to share-based awards granted to employees, directors and consultants is measured based on the estimated fair value of the award at the grant date. The Company estimates the fair value of stock options using a Black-Scholes option pricing model. The fair value of restricted stock units granted is measured based on the market value of the Company’s common stock on the date of grant. Share-based compensation costs are expensed on a straight-line basis over the relevant vesting period. The Reduction in Force implemented in July 2025 did not change the vesting terms and conditions of the share-based awards.
Compensation cost related to shares purchased through the Company’s employee stock purchase plan, which is considered compensatory, is based on the estimated fair value of the shares on the offering date, including consideration of the discount and the look-back period. The Company estimates the fair value of the shares using a Black-Scholes option pricing model. Compensation expense is recognized over the six-month withholding period prior to the purchase date.
All share-based compensation costs are recorded in general and administrative or research and development costs in the consolidated statements of operations based upon the recipient's underlying role within the Company.
Cash Equivalents
Cash equivalents consist of short-term, highly liquid investments with an original term of three months or less at the date of purchase.
9
Concentration of Credit Risk Arising From Cash Deposits in Excess of Insured Limits
The Company maintains its cash in bank deposits that at times may exceed federally insured limits. The Company has not experienced any loss in such accounts. The Company believes it is not exposed to any significant risks with respect to its cash balances.
Liability Related to the Sales of Future Royalties and Non-Cash Interest Expense
In connection with the Purchase and Sale Agreement, the Company recognizes a liability related to the sales of future royalties under ASC 470-10, Debt and ASC 835-30, Interest - Imputation of Interest. The initial funds received by the Company pursuant to the terms of the Purchase and Sale Agreement were recorded as a liability and are accreted under the effective interest method up to the estimated amount of future royalties and milestone payments to be made under the Purchase and Sale Agreement. The issuance costs were recorded as a direct deduction to the carrying amount of the liability and are being amortized under the effective interest method over the estimated period the liability will be repaid. The Company estimates the total amount of future royalty revenue and milestone payments to be generated over the life of the Purchase and Sale Agreement, and a significant increase or decrease in these estimates could materially impact the liability balance and the related interest expense. If the timing of the receipt of royalty payments or milestones is materially different from the original estimates, the Company will prospectively adjust the effective interest and the related amortization of the liability and related issuance costs.
Warrant Liabilities
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity (ASC 480) and ASC 815, Derivatives and Hedging (ASC 815). The assessment considers whether the warrants (i) are freestanding financial instruments pursuant to ASC 480, (ii) meet the definition of a liability pursuant to ASC 480, and (iii) meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company's own stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
For warrants that meet all criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital, on the consolidated statement of stockholders’ deficit at the time of issuance. For warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance and on each consolidated balance sheet date thereafter.
The Company’s warrant liabilities are measured at fair value using a simulation model which takes into account, as of the valuation date, factors including the current exercise price, the expected life of the warrant, the current price of the Company's common stock, the expected volatility, the risk-free interest rate for the term of the warrant and the likelihood of achieving certain future milestone events and the related impact to the price of the Company's common stock. The warrant liabilities are revalued at each reporting period and changes in fair value are recognized in other income (expense) in the consolidated statements of operations. The selection of the appropriate valuation model and the inputs and assumptions that are required to determine the valuation requires significant judgment and requires management to make estimates and assumptions that affect the reported amount of the related liability and reported amounts of the change in fair value. Actual results could differ from those estimates, and changes in these estimates are recorded when known. See Note 7 for further details.
Recently Issued Accounting Pronouncements
In December 2023, the FASB issued Accounting Standards Update ("ASU") 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU is intended to enhance the transparency and decision usefulness of income tax disclosures primarily related to the rate reconciliation and income taxes paid information. The main provisions to the rate reconciliation disclosure require public entities to disclose, on an annual basis, specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. The main provisions to the income taxes paid disclosure require that all entities disclose on an annual basis: the amount of income taxes paid disaggregated by federal, state and foreign taxes and the amount of income taxes paid disaggregated by individual jurisdictions in which income taxes paid meets a quantitative threshold. This ASU also requires all entities to disclose income (loss) from continuing operations before income tax expense (benefit) disaggregated between domestic and foreign and income tax expense (benefit) from continuing operations disaggregated by federal, state and foreign. The Company adopted ASU 2023-09 on January 1, 2025 and the adoption did not have a material impact on its consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures. This ASU requires disclosure of disaggregated income statement expense information about specific categories including purchases of inventory, employee compensation expense, depreciation and amortization in the notes to the
10
financial statements. This ASU is effective January 1, 2027 for annual reporting periods and January 1, 2028 for interim reporting periods. The Company is currently evaluating the anticipated impact of this ASU on its consolidated financial statements.
3. Property and Equipment, Net
Property and equipment, net consisted of the following (dollar amounts in thousands):
|
|
Estimated |
|
June 30, |
|
|
December 31, |
|
||
Furniture and fixtures |
|
|
$ |
|
|
$ |
|
|||
Machinery and equipment |
|
|
|
|
|
|
|
|||
Computer equipment |
|
|
|
|
|
|
|
|||
Leasehold improvements |
|
|
|
|
|
|
|
|
||
Work in process |
|
|
|
|
|
|
|
|
||
Total property and equipment |
|
|
|
|
|
|
|
|
||
Less: Accumulated depreciation |
|
|
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
|
|
$ |
|
|
$ |
|
||
4. Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2025 |
|
|
2024 |
|
||
Accrued research and development |
|
$ |
|
|
$ |
|
||
Accrued income taxes |
|
|
|
|
|
|
||
Accrued employee costs |
|
|
|
|
|
|
||
Accrued professional fees |
|
|
|
|
|
|
||
Accrued expense |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
||
5. Royalty Purchase and Sale Agreement
On August 8, 2022 (the “Closing Date”), the Company, through its wholly owned subsidiary Clearside Royalty LLC, a Delaware limited liability company ("Royalty Sub"), entered into the Purchase and Sale Agreement (the "Purchased and Sale Agreement") with entities managed by HealthCare Royalty Management, LLC ("HCR"), pursuant to which Royalty Sub sold to HCR certain of its rights to receive royalty and milestone payments payable to Royalty Sub under the Arctic Vision License Agreement (as defined in Note 10), the Bausch License Agreement (as defined in Note 10), that certain License Agreement, effective as of July 3, 2019, by and between the Company and Aura Biosciences, Inc. (the “Aura License Agreement”), that certain Option and License Agreement, dated as of August 29, 2019, by and between REGENXBIO Inc. and the Company (the “REGENXBIO License Agreement”), and any and all out-license agreements following the Closing Date for, or related to XIPERE or the SCS Microinjector technology (to be used in connection with compounds or products of any third parties) delivered, in whole or in part, by means of the SCS Microinjector technology) (collectively, "Post-Closing License Agreement"), excluding, for the avoidance of doubt, any in-licensed or internally developed therapies following the Closing Date (collectively, the “Royalties”), in exchange for up to $
Under the terms of the Purchase and Sale Agreement, Royalty Sub received an initial payment of $
11
of $
On December 22, 2023, the Company, through its wholly owned subsidiary Royalty Sub, entered into the Letter Agreement with the Agent amending the Purchase and Sale Agreement. Pursuant to the terms of the Letter Agreement, Royalty Sub and Agent mutually agreed that Royalty Sub waived any and all rights to the First Milestone Payment in connection with the closing of the transactions contemplated by the Purchase and Sale Agreement and agreed to the release of the First Milestone Payment to Agent.
Issuance costs pursuant to the Purchase and Sale Agreement consisting primarily of advisory and legal fees, totaled $
The following table summarizes the activity of the Purchase and Sale Agreement (in thousands):
Balance at December 31, 2023 |
|
$ |
|
|
Non-cash interest expense |
|
|
|
|
Balance at December 31, 2024 |
|
|
|
|
Payments |
|
|
( |
) |
Non-cash interest expense |
|
|
|
|
Balance at June 30, 2025 |
|
$ |
|
|
|
|
|
|
|
Effective interest rate |
|
|
% |
|
6. Common Stock
At the Company's 2025 annual meeting of stockholders held on May 30, 2025, the Company's stockholders approved an amendment to the Company's Amended and Restated Certificate of Incorporation to increase the Company's authorized number of shares of common stock from 200,000,000 to 400,000,000 . As of June 30, 2025, the Company was authorized to issue 400,000,000 shares of common stock, $0.001 par value. As of June 30, 2025 and December 31, 2024, there were 78,495,760 and 76,578,383 shares of common stock outstanding, respectively.
7. Common Stock Warrants
In September 2016, in connection with a loan agreement, the Company issued warrants to purchase up to
On February 6, 2024, the Company entered into a securities purchase agreement with institutional investors and an existing stockholder, pursuant to which the Company issued and sold, in a registered direct offering (i) an aggregate of
The combined purchase price of each Share and accompanying Warrant was $
12
in the fair value of the Warrants during the period are recorded in other income, net in the consolidated statements of operations. The issuance costs allocated to common stock were recorded as a reduction to additional paid in capital.
The following table summarizes the change in fair value of the warrant liabilities (in thousands):
Fair value of warrants at issuance February 9, 2024 |
|
$ |
|
|
Change in fair value during the period |
|
|
( |
) |
Fair value of warrants at December 31, 2024 |
|
|
|
|
Change in fair value during the period |
|
|
( |
) |
Fair value of warrants at June 30, 2025 |
|
$ |
|
The following table summarizes certain key inputs for the valuation of the Warrants at June 30 2025:
Common stock price |
|
$ |
|
|
|
Exercise price per share |
|
$ |
|
|
|
Expected volatility |
|
|
|
% |
|
Risk-free interest rate |
|
|
|
% |
|
Contractual term (in years) |
|
|
|
|
|
Expected dividend yield |
|
|
|
% |
As described in Note 2, the measurement of the warrant liabilities is impacted by the likelihood of achieving certain future milestone events and the related impact to the Company’s stock price. In determining the likelihood of achieving certain future milestone events, the Company considers its current financial position and ability to fund future clinical activities as described in Note 1. The Company utilizes publicly available information from external parties to assess the related impact to the Company’s stock price from the success of these activities.
As described in Note 1, the Company is exploring strategic alternatives. Following the decision to explore such alternatives and related announcement in July 2025, the Company experienced a significant decline in its traded stock price. This decline, coupled with the increased uncertainty in the Company’s future financial viability, has led to a further decline in the fair value of the Company's warrant liabilities subsequent to June 30, 2025.
8. Share-Based Compensation
Share-based compensation is accounted for in accordance with the provisions of ASC 718, Compensation-Stock Compensation.
Stock Options
The Company has granted stock option awards to employees, directors and consultants from its 2011 Stock Incentive Plan (the “2011 Plan”) and its 2016 Equity Incentive Plan (the “2016 Plan”). The estimated fair value of options granted is determined as of the date of grant using the Black-Scholes option pricing model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the awards.
Share-based compensation expense for options granted under the 2016 Plan is reflected in the consolidated statements of operations as follows (in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
13
The following table summarizes the activity related to stock options granted under the 2011 Plan and the 2016 Plan during the six months ended June 30, 2025:
|
|
|
|
|
Weighted |
|
||
|
|
Number of |
|
|
Average |
|
||
|
|
Shares |
|
|
Exercise Price |
|
||
Options outstanding at December 31, 2024 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Forfeited |
|
|
( |
) |
|
|
|
|
Options outstanding at June 30, 2025 |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Options exercisable at December 31, 2024 |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Options exercisable at June 30, 2025 |
|
|
|
|
|
|
||
As of June 30, 2025, the Company had $
Restricted Stock Units
The Company has granted restricted stock units (“RSUs”) to employees and consultants under the 2016 Plan. The shares underlying the RSU awards have vesting terms of four years from the date of grant subject to the recipient's continuous service and subject to accelerated vesting in specified circumstances. The fair value of the RSUs granted is measured based on the market value of the Company’s common stock on the date of grant and is recognized ratably over the requisite service period, which is generally the vesting period of the awards.
The total share-based compensation expense related to RSUs is reflected in the consolidated statements of operations as follows (in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The following table summarizes the activity related to RSUs during the six months ended June 30, 2025:
|
|
|
|
|
Weighted Average |
|
||
|
|
Number of |
|
|
Grant Date |
|
||
|
|
Shares |
|
|
Fair Value |
|
||
Non-vested RSUs outstanding at December 31, 2024 |
|
|
|
|
$ |
|
||
Vested |
|
|
( |
) |
|
|
|
|
Non-vested RSUs outstanding at June 30, 2025 |
|
|
|
|
|
|
||
As of June 30, 2025, the Company had $
14
Employee Stock Purchase Plan
The 2016 Employee Stock Purchase Plan (the “2016 ESPP”) became effective on June 1, 2016. The 2016 ESPP is considered a compensatory plan and the fair value of the discount and the look-back period are estimated using the Black-Scholes option pricing model and expense is recognized over the six-month withholding period prior to the purchase date.
The share-based compensation expense recognized for the 2016 ESPP is reflected in the consolidated statements of operations as follows (in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
During the six months ended June 30, 2025, the Company issued
9. Commitments and Contingencies
Lease Commitment Summary
In November 2022, the Company signed an amended office lease agreement to lease approximately
The Company recognizes a right-of-use asset for the right to use the underlying asset for the lease term, and a lease liability, which represents the present value of the Company’s obligation to make payments over the lease term.
Equipment leases with an initial term of 12 months or less are not recorded with operating lease liabilities. The Company recognizes expense for these leases on a straight-line basis over the lease term. The equipment leases were deemed to be immaterial.
Georgia Tech License Agreement
As described in Note 1, the Company entered into a fourth amendment to the Georgia Tech License Agreement pursuant to which the parties agreed to revised Maintenance Fee payments in exchange for a reduction to the contractual Sublicense Percentage owed by the Company on certain fees and other payments it may receive from future sublicensing activities. The Company paid the $
Year Ending December 31, |
|
Amount |
|
|
2025 |
|
$ |
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
Total |
|
$ |
|
|
Contract Service Providers
In the course of the Company’s normal business operations, it has agreements with contract service providers to assist in the performance of its research and development, clinical research and manufacturing. Substantially all of these contracts are on an as needed basis.
10. License and Other Agreements
Bausch + Lomb
On October 22, 2019, the Company entered into a License Agreement (as amended, the "Bausch License Agreement") with Bausch + Lomb (“Bausch”). Pursuant to the Bausch License Agreement, the Company has granted an exclusive license to Bausch to develop, manufacture, distribute, promote, market and commercialize XIPERE using the Company’s proprietary SCS Microinjector (the “Device”), as well as specified other steroids, corticosteroids and NSAIDs in combination with the Device (together with
15
XIPERE, the “Products”), subject to specified exceptions, in the United States and Canada (the “Territory”) for the treatment of ophthalmology indications, including non-infectious uveitis.
Pursuant to the Bausch License Agreement, Bausch paid the Company an aggregate of $
The Company was responsible for all development expenses for XIPERE in the Territory until the Company's New Drug Application ("NDA") was approved by the U.S. Food and Drug Administration ("FDA"), subject to specified exceptions, as well as manufacturing costs in connection with the NDA. The Company was also responsible for all clinical and development expenses conducted to satisfy the FDA’s requests in the complete response letter issued on October 18, 2019 related to the NDA. Following FDA approval of XIPERE, which occurred in October 2021, Bausch is responsible for all such expenses.
Arctic Vision (Hong Kong) Limited
On March 10, 2020, the Company entered into a License Agreement (the “Arctic License Agreement”) with Arctic Vision (Hong Kong) Limited (“Arctic Vision”). Pursuant to the Arctic License Agreement, the Company has granted an exclusive license to Arctic Vision to develop, distribute, promote, market and commercialize XIPERE, subject to specified exceptions, in China, Hong Kong, Macau, Taiwan and South Korea (the “Arctic Territory”). Under the terms of the Arctic License Agreement, neither party may commercialize XIPERE in the other party’s territory. Arctic Vision has agreed to use commercially reasonable efforts to pursue the development and commercialization of XIPERE for indications associated with uveitis in the Arctic Territory. In addition, upon receipt of the Company’s consent, Arctic Vision will have the right, but not the obligation, to develop and commercialize XIPERE for additional indications in the Arctic Territory.
Pursuant to the Arctic License Agreement, Arctic Vision has paid the Company an aggregate of $
In August 2021, the Company entered into an amendment to the Arctic License Agreement to expand the territories covered by the license to include India and the ASEAN Countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam). In September 2021, the Company entered into a second amendment to the Arctic Vision License Agreement to expand the Arctic Territory to include Australia and New Zealand. The Company received an aggregate of $
BioCryst Pharmaceuticals, Inc.
On November 1, 2023, the Company entered into the BioCryst License Agreement pursuant to which the Company granted BioCryst an exclusive, worldwide and sublicensable license to the Company’s SCS Microinjector for the delivery of BioCryst’s proprietary plasma kallikrein inhibitor known as avoralstat for the treatment and prevention of diabetic macular edema.
The Company received an upfront license fee payment of $
BioCryst will be responsible for all development, regulatory and commercialization activities for avoralstat. The Company is responsible for supplying SCS Microinjectors to meet BioCryst’s reasonable needs.
16
Other
The Company periodically enters into short-term agreements with other customers to evaluate the potential use of its proprietary SCS Microinjector with third-party product candidates for the treatment of various diseases. Funds received from these agreements are recognized as revenue over the term of the agreement.
11. Fair Value Measurements
The Company’s material financial instruments at June 30, 2025 and December 31, 2024 consisted of cash and cash equivalents. The fair values of cash and cash equivalents, other current assets and accounts payable approximate their respective carrying values due to the short term nature of these instruments and are classified as Level 1 in the fair value hierarchy. The fair value of the warrant liabilities (see Note 7) require significant unobservable inputs and is classified as Level 3 in the fair value hierarchy.
There were
12. Related Party Transactions
A member of the Company's Board of Directors was the chief executive officer of a company that is a vendor of the Company until January 2025. As of December 31, 2024, the Company has recorded $
The chair of the board of directors of BioCryst also serves on the Company’s Board of Directors. The Company has recorded $
A member of the Company's Board of Directors is the chief financial officer of Aura Biosciences. The Company has recorded $
13. Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period, without consideration of the dilutive effect of potential common stock equivalents. Diluted net loss per share gives effect to all dilutive potential shares of common stock outstanding during this period. For all periods presented, the Company’s potential common stock equivalents, which included stock options, restricted stock units and common stock warrants, have been excluded from the computation of diluted net loss per share as their inclusion would have the effect of reducing the net loss per share. Therefore, the denominator used to calculate both basic and diluted net loss per share is the same in all periods presented.
The Company’s potential common stock equivalents that have been excluded from the computation of diluted net loss per share for all periods presented because of their antidilutive effect consisted of the following:
|
|
Six Months Ended |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Outstanding stock options |
|
|
|
|
|
|
||
Non-vested restricted stock units |
|
|
|
|
|
|
||
Common stock warrants |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
14. Subsequent Event
On July 17, 2025, the Company announced plans to explore a full range of strategic alternatives to advance its SCS platform and drug development pipeline to maximize stockholder value. The Company has retained Piper Sandler, a leading investment bank with substantial experience in the biotechnology industry, to support it with the strategic evaluation process. Strategic alternatives under consideration include the sale, license, monetization and/or divestiture of one or more of the Company’s assets and technologies, collaboration, partnership, merger, acquisition, joint ventures, or other strategic transactions. If a strategic alternative is not available, the Company will be required to take additional actions to fund the Company’s operations, or it may be forced to file for bankruptcy or wind down its operations. In connection with such process and in order to extend the Company’s resources, the Company
17
implemented a plan pursuant to which all Company employees had their employment with the Company terminated and transitioned into consulting roles with the Company. The reduction in force is expected to be completed during the third quarter of 2025.
The Company estimates that it will incur charges of approximately $
18
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Certain statements contained in this Quarterly Report on Form 10-Q may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words or phrases “would be,” “will allow,” “intends to,” “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “project,” or similar expressions, or the negative of such words or phrases, are intended to identify “forward-looking statements.” We have based these forward-looking statements on our current expectations and projections about future events. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to these differences include those below and elsewhere in this Quarterly Report on Form 10-Q and our other filings with the Securities and Exchange Commission, or SEC, under the heading “Risk Factors”. Statements made herein are as of the date of the filing of this Form 10-Q with the SEC and should not be relied upon as of any subsequent date. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim, any obligation to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited consolidated financial statements and related notes that appear in Item 1 of this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and related notes for the year ended December 31, 2024 appearing in our Annual Report on Form 10-K filed with the SEC on March 27, 2025.
Overview
We are a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space, or SCS®. Our novel SCS injection platform, utilizing our proprietary SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Our SCS injection platform can be used in conjunction with existing drugs designed for delivery to the SCS, novel therapies and future therapeutic innovations. We believe our proprietary suprachoroidal administration platform has the potential to become a standard for delivery of therapies intended to treat chorioretinal diseases.
We are leveraging our SCS injection platform with an internal research and development pipeline targeting retinal diseases and through external collaborations with other companies. We have our own pipeline of small molecule product candidates for administration via our SCS Microinjector, and we also strategically partner with companies developing other ophthalmic therapeutic innovations to be administered using our SCS injection technology. Our first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, was approved by the U.S. Food and Drug Administration, or the FDA, in October 2021. Approval of XIPERE was a significant milestone for us as it is the first approved therapeutic delivered into the SCS, the first commercial product developed by us and the first therapy for macular edema associated with uveitis.
We believe that we have a broad therapeutic platform for developing product candidates to treat serious eye diseases.
19
In connection with our July 2025 announcement of plans to explore strategic alternatives and in order to extend resources, we paused all internal research and development programs during the pendency of this process. The current development status of our pipeline of internal product candidates and external collaborations is summarized in the charts below:
Clinical Development Pipeline
CLS-AX (axitinib injectable suspension)
CLS-AX, our most advanced product candidate, is our proprietary suspension of the tyrosine kinase inhibitor, or TKI, axitinib for suprachoroidal injection delivered via our SCS Microinjector. CLS-AX is a Phase 3 ready asset for administration to the SCS as a long-acting therapy for neovascular age-related macular degeneration, or wet AMD, a retinal degenerative disease that causes a progressive loss of central vision.
ODYSSEY Phase 2b Clinical Trial
Based on the results from our OASIS trial, we conducted ODYSSEY, a randomized, active-controlled, double-masked, parallel-group, multicenter, 36-week, Phase 2b clinical trial of CLS-AX in participants with wet AMD previously treated with intravitreal anti-vascular, or VEGF, which is the standard of care therapy for the treatment of wet AMD. A total of 60 participants were treated for 36 weeks and randomized to either CLS-AX (1 mg) or aflibercept (2 mg) with a 2:1 randomization schedule (40 participants in CLS-AX arm and 20 participants in aflibercept arm). CLS-AX was administered by suprachoroidal injection via our SCS Microinjector, and aflibercept was administered via intravitreal injection. Participants in the trial were determined to have active disease with a median duration of wet AMD diagnosis of 9.9 months. Eligible participants underwent diagnostic imaging at their screening visit, followed by masked reading center confirmation of persistent active disease.
In October 2024, we announced positive topline results from the ODYSSEY trial. The ODYSSEY trial achieved its primary and secondary outcomes including the mean change from baseline in BCVA, changes from baseline in visual function and ocular anatomy, the need for supplemental treatment, treatment burden as measured by total injections over the trial duration, and safety measures.
20
Participants in the trial maintained stable BCVA throughout the trial as measured by the mean change in BCVA from baseline to week 36. In addition, participants maintained stable central subfield retinal thickness, or CSRT, throughout the trial as measured by the mean change in CSRT from baseline to week 36, as confirmed by the independent reading center.
In terms of durability, after receiving the baseline CLS-AX dose, 100% (40/40) of participants went 3 months without receiving any additional treatment, 90% (35/39) of participants went 4 months without receiving any additional treatment, 81% (30/37) of participants went five months without receiving any additional treatment and 67% (26/39) of participants went 6 months without receiving any additional treatment before mandatory re-dosing at week 24. If intervention were strictly based on the disease activity assessment criteria, 100% (40/40) of participants would have gone 3 months without receiving any additional treatment, 95% (37/39) of CLS-AX participants would have gone 4 months without receiving any additional treatment, 87% (32/37) of participants would have gone five months without receiving any additional treatment and 79% (30/38) of participants would have gone six months without receiving any additional treatment before mandatory re-dosing at week 24.
Additionally, we observed reduced injection frequency by 84% in the 24 weeks after baseline compared to the average monthly injections in the 24 weeks prior to screening.
CLS-AX was well-tolerated with a safety profile through 36 weeks that included mandatory re-dosing of CLS-AX at week 24. There were no reported ocular serious adverse events, or SAEs, and no treatment or injection procedure-related SAEs. All ocular adverse events were considered clinically mild in both groups. We observed similar discontinuation rates in the CLS-AX and aflibercept arms.
CLS-AX Phase 3
We conducted an End-of-Phase 2 meeting with the FDA in the first quarter of 2025 and gained alignment on the essential components of a potential Phase 3 program, which would include two pivotal, non-inferiority Phase 3 trials with aflibercept 2 mg as a comparator.
Preclinical
We have evaluated various small molecules that may be utilized as potential treatment options for back of the eye diseases utilizing our SCS Microinjector for delivery in the suprachoroidal space. Our preclinical pipeline includes two small molecules evaluated using in vivo models for the potential treatment of geographic atrophy, or GA, CLS-AX for the treatment of diabetic retinopathy and the combination of CLS-AX and a steroid, triamcinolone acetonide, for the treatment of diabetic macular edema.
External Collaborations Pipeline
In order to expand the global reach of our suprachoroidal injection platform, we have strategically partnered some of our assets for development and/or commercialization and intend to continue partnering our assets. By entering into these partnerships, we have been able to expand the use of our suprachoroidal injection platform to other indications and geographies globally. We currently have collaborations with Bausch + Lomb, Arctic Vision, REGENXBIO, Inc., Aura Biosciences and BioCryst Pharmaceuticals, Inc.
Commercial Product
XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, was approved by the FDA in October 2021. XIPERE is the first approved therapeutic delivered into the SCS, the first commercial product developed by us and the first therapy for macular edema associated with uveitis. XIPERE commercialization rights are licensed to Bausch + Lomb in the United States and Canada and Arctic Vision in the Asia Pacific region, not including Japan. In July 2025, Health Canada granted approval for XIPERE for the treatment of uveitic macular edema.
Operating Outlook and Strategic Review
We have incurred net losses since our inception. In recent years, our operations have consisted primarily of conducting preclinical studies and clinical trials, raising capital and undertaking other research and development initiatives. To date, we have primarily generated revenue through upfront payments and milestone payments related to license agreements and from collaboration agreements, and we have primarily financed our operations through public offerings and private placements of our equity securities, issuance of warrants, issuances of convertible promissory notes and loan agreements. As of June 30, 2025, we had an accumulated deficit of $368.0 million. We recorded net losses of $4.5 million and $7.6 million for the three months ended June 30, 2025 and 2024, respectively, and net losses of $12.7 million and $19.4 million for the six months ended June 30, 2025 and 2024, respectively.
In July 2025, we announced plans to explore a full range of strategic alternatives to advance our SCS platform and drug development pipeline to maximize stockholder value. We have retained Piper Sandler, a leading investment bank with substantial experience in the biotechnology industry, to support us with the strategic evaluation process. Strategic alternatives under consideration
21
include the sale, license, monetization and/or divestiture of one or more of our assets and technologies, collaboration, partnership, merger, acquisition, joint ventures or other strategic transactions. If a strategic alternative is not available, we will be required to take additional actions to fund our operations, or we may be forced to file for bankruptcy or wind down our operations.
Based on our current plans and forecasted expenses and our cash and cash equivalents, we do not believe we will be able to fund our operations for the next 12 months from the date of this filing. These factors raise substantial doubt regarding our ability to continue as a going concern. Our consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should we be unable to continue as a going concern.
Macroeconomic Conditions
Unfavorable conditions in the economy in the United States and abroad may negatively affect the growth of our business and our results of operations. For example, macroeconomic events, rising inflation, the U.S. Federal Reserve raising interest rates, and conflicts in Ukraine, Russia and the Middle East have led to economic uncertainty globally. The effect of macroeconomic conditions may not be fully reflected in our results of operations until future periods. If, however, economic uncertainty increases or the global economy worsens, our business, financial condition and results of operations may be harmed. For further discussion of the potential impacts of macroeconomic events on our business, financial condition, and operating results, see “Risk Factors” included in Part I, Item 1A of the Annual Report on Form 10-K filed with the SEC on March 27, 2025.
Recent Developments
Strategic Review and Reduction in Force
As discussed in more detail under “—Operating Outlook and Strategic Review” above, in July 2025, we announced plans to explore a full range of strategic alternatives to advance our SCS platform and drug development pipeline to maximize stockholder value. In connection with such process, and in order to extend our resources, we implemented a plan pursuant to which we terminated the employment of all employees and transitioned such persons into consulting roles. We estimate that we will incur charges of approximately $2.6 million for severance and other employee termination-related costs in the third quarter of 2025. The estimated charges that we expect to incur are subject to a number of assumptions, and actual results may differ materially from these estimates. We may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, our workforce reduction. The reduction in force is expected to be completed during the third quarter of 2025.
Minimum Bid Price Requirement
On February 7, 2025, we received a letter from Nasdaq, notifying us that, from December 18, 2024 to February 4, 2025, the closing bid price for our common stock was below $1.00. In accordance with Nasdaq Listing Rule 5810(c)(3)(A) we were provided an initial period of 180 calendar days, or until August 6, 2025, to regain compliance with Nasdaq’s bid price requirement (the “Minimum Bid Price Requirement”). We did not regain compliance by August 6, 2025, and as a result we expect that Nasdaq will provide notice that our common stock will be subject to delisting. We intend to appeal any delisting determination to a Nasdaq hearings panel and our common stock will remain listed on the Nasdaq Global Market until the completion of the appeal process, during which time we may regain compliance the Minimum Bid Price Requirement if our minimum bid price of listed securities closes at $1.00 per share or more for a minimum of 10 consecutive business days. In addition, on August 4, 2025, we filed a proxy statement seeking approval by our stockholders to effect a reverse split of our outstanding common stock at a ratio ranging from 1-for-5 and 1-for-15 (the “Reverse Stock Split”). If approved by stockholders, this Reverse Stock Split Proposal would permit (but not require) our board of directors to effect a reverse stock split of our common stock at any time before August 29, 2026, by a ratio of not less than 1-for-5 and not more than 1-for-15, inclusive, and a corresponding proportionate reduction in the total number of authorized shares of the Company’s common stock (the “Authorized Shares Reduction”), with such ratio to be determined by the our board of directors in its sole discretion. Our board of directors’ primary objective in proposing the Reverse Stock Split and Authorized Shares Reduction is to raise the per share trading price of our common stock. Our board of directors believes that the Reverse Stock Split and Authorized Shares Reduction will result in a higher per share trading price, which is intended to enable us to maintain the listing of our common stock on The Nasdaq Global Market and generate greater investor interest in the Company.
Components of Operating Results
License and Other Revenue
We have not generated any revenue from the sale of XIPERE and we do not expect to generate any other product revenue unless or until we obtain regulatory approval for and commercialize our other product candidates, either on our own or with a third party. The revenue received under the Bausch license agreement, as well as other certain payments from our licensees, will be recorded as non-cash revenue until we have fulfilled our obligations under the Purchase and Sale Agreement. Our revenue in recent years has been generated primarily from our license agreements. We are seeking to enter into additional licenses and other agreements with third parties to evaluate the potential use of our proprietary SCS Microinjector with the third party’s product candidates for the treatment of
22
various eye diseases. These agreements may include payments to us for technology access, upfront license payments, regulatory and commercial milestone payments and royalties.
Costs of Goods Sold
Cost of goods sold are related to the sales of our SCS Microinjector kits to our licensees for approved products.
Research and Development
Research and development expenses have historically consisted primarily of costs incurred for the research and development of our preclinical and clinical product candidates, which include:
We expense research and development costs to operations as incurred. These costs include preclinical activities, such as manufacturing and stability and toxicology studies, that are supportive of a product candidate itself. In addition, there are expenses related to clinical trials and similar activities for each program, including costs associated with CROs. Clinical costs are recognized based on the terms of underlying agreements, as well as an evaluation of the progress to completion of specific tasks using data such as participant enrollment, clinical site activations and additional information provided to us by our vendors about their actual costs incurred. Expenses related to activities that support more than one development program or activity, such as salaries, share-based compensation and depreciation, are not classified as direct preclinical costs or clinical costs and are separately classified as unallocated.
The following table shows our research and development expenses by program for the three and six months ended June 30, 2025 and 2024 (in thousands).
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
CLS-AX (wet AMD program) |
|
$ |
200 |
|
|
$ |
1,763 |
|
|
$ |
664 |
|
|
$ |
4,021 |
|
GA (geographic atrophy) |
|
|
90 |
|
|
|
— |
|
|
|
465 |
|
|
|
— |
|
Total |
|
|
290 |
|
|
|
1,763 |
|
|
|
1,129 |
|
|
|
4,021 |
|
Unallocated |
|
|
1,294 |
|
|
|
2,840 |
|
|
|
4,918 |
|
|
|
6,197 |
|
Total research and development expense |
|
$ |
1,584 |
|
|
$ |
4,603 |
|
|
$ |
6,047 |
|
|
$ |
10,218 |
|
Our expenses related to clinical trials are based on estimates of participant enrollment and related expenses at clinical investigator sites as well as estimates for the services received and efforts expended under contracts with research institutions, consultants and CROs that conduct and manage clinical trials on our behalf. We generally accrue expenses related to clinical trials based on contracted amounts applied to the level of participant enrollment and activity according to the protocol. If future timelines or contracts are modified based upon changes in the clinical trial protocol or scope of work to be performed, we would modify our estimates of accrued expenses accordingly on a prospective basis.
As discussed in more detail under “—Operating Outlook and Strategic Review” above, in July 2025, we announced plans to explore a full range of strategic alternatives to advance our SCS platform and drug development pipeline to maximize stockholder value. We paused all internal research and development programs during the pendency of this process. Accordingly, we expect research and development expenses will continue to decrease in future periods relative to the corresponding periods of 2024.
23
General and Administrative
General and administrative expenses consist primarily of salaries and other related costs, including share-based compensation, for personnel in executive, finance and administrative functions. General and administrative costs historically included commercial pre-launch preparations for XIPERE, and also include facility related costs not otherwise included in research and development expenses, as well as professional fees for legal, patent, consulting, and accounting and audit services.
Interest Income
Interest income consists of the accrued interest and interest income earned on our cash and cash equivalents.
Other Income, Net
Other income, net consists of expenses allocated to the warrants issued in connection with our registered direct offering in February 2024 and the change in fair value of the warrants during the period.
Non-cash Interest Expense on Liability Related to the Sales of Future Royalties
Non-cash interest expense on liability related to the sales of future royalties consists of imputed interest on the carrying value of the liability and the amortization of the related issuance costs.
Income Tax Expense
Income tax expense consists of taxes incurred in foreign jurisdictions.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles or U.S. GAAP. The preparation of these consolidated financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the consolidated balance sheets and the reported amounts of expenses during the reporting periods. In accordance with U.S. GAAP, we evaluate our estimates and judgments on an ongoing basis. Significant estimates include certain assumptions used in royalty financing obligation, certain assumptions used in the valuation of warrant liabilities and certain assumptions used to estimate research and development expenses, including clinical trials. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
We define our critical accounting policies, in accordance with U.S. GAAP, as those that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. During the six months ended June 30, 2025, there were no significant changes to our critical accounting policies disclosed in our audited consolidated financial statements for the year ended December 31, 2024, which are included in our Annual Report on Form 10-K, as filed with the SEC on March 27, 2025.
24
Results of Operations for the Three Months Ended June 30, 2025 and 2024
The following table sets forth our results of operations for the three months ended June 30, 2025 and 2024.
|
|
Three Months Ended |
|
|
Period-to-Period |
|
||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
|
|
(in thousands) |
|
|||||||||
License and other revenue |
|
$ |
492 |
|
|
$ |
90 |
|
|
$ |
402 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
|
1,584 |
|
|
|
4,603 |
|
|
|
(3,019 |
) |
General and administrative |
|
|
2,476 |
|
|
|
3,077 |
|
|
|
(601 |
) |
Total operating expenses |
|
|
4,060 |
|
|
|
7,680 |
|
|
|
(3,620 |
) |
Loss from operations |
|
|
(3,568 |
) |
|
|
(7,590 |
) |
|
|
4,022 |
|
Interest income |
|
|
115 |
|
|
|
419 |
|
|
|
(304 |
) |
Other income, net |
|
|
1,720 |
|
|
|
1,917 |
|
|
|
(197 |
) |
Non-cash interest expense on liability |
|
|
(2,762 |
) |
|
|
(2,340 |
) |
|
|
(422 |
) |
Net loss |
|
|
(4,495 |
) |
|
|
(7,594 |
) |
|
|
3,099 |
|
License and other revenue. In the three months ended June 30, 2025 and 2024, we recognized $0.5 million and $90,000, respectively, of revenue associated with our license agreements. License revenue and other revenue in both periods consisted of revenue for training, services and the sales of our SCS Microinjector kits to our licensees.
Research and development. Research and development expenses decreased by $3.0 million from $4.6 million for the three months ended June 30, 2024 to $1.6 million for the three months ended June 30, 2025. This decrease was primarily due to a $1.6 million decrease in costs related to the CLS-AX program due to the completion of ODYSSEY, our Phase 2b clinical trial, a $0.8 million decrease in employee related costs and $0.4 million decrease related to a research and development tax credit received in the three months ended June 20, 2025.
General and administrative. General and administrative expenses decreased by $0.6 million from $3.1 million for the three months ended June 30, 2024 to $2.5 million for the three months ended June 30, 2025. This decrease was primarily due to a $0.6 million decrease in employee related costs.
Interest income. Interest income decreased by $0.3 million from $0.4 million for the three months ended June 30, 2024 to $0.1 million for the three months ended June 30, 2025. The decrease was due to the lower balance of our cash and cash equivalents.
Other income, net. Other income, net was $1.7 million for the three months ended June 30, 2025 and $1.9 million for the three months ended June 30, 2024. The change was due to a smaller decline in the fair value of the warrant liabilities from the December 31, 2024 valuation date to June 30, 2025 than as compared to the decline in fair value from the February 2024 issuance date to June 30, 2024.
Non-cash interest expense on liability related to the sales of future royalties. Non-cash interest expense on liability related to the sales of future royalties was $2.8 million and $2.3 million for the three months ended June 30, 2025 and 2024, respectively, and was comprised of imputed interest on the liability related to the sales of future royalties and the amortization of the associated issuance costs.
25
Results of Operations for the Six Months Ended June 30, 2025 and 2024
The following table sets forth our results of operations for the six months ended June 30, 2025 and 2024.
|
|
Six Months Ended |
|
|
Period-to-Period |
|
||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
|
|
(in thousands) |
|
|||||||||
License and other revenue |
|
$ |
2,822 |
|
|
$ |
320 |
|
|
$ |
2,502 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Cost of goods sold |
|
|
248 |
|
|
|
— |
|
|
|
248 |
|
Research and development |
|
|
6,047 |
|
|
|
10,218 |
|
|
|
(4,171 |
) |
General and administrative |
|
|
5,300 |
|
|
|
5,901 |
|
|
|
(601 |
) |
Total operating expenses |
|
|
11,595 |
|
|
|
16,119 |
|
|
|
(4,524 |
) |
Loss from operations |
|
|
(8,773 |
) |
|
|
(15,799 |
) |
|
|
7,026 |
|
Interest income |
|
|
278 |
|
|
|
767 |
|
|
|
(489 |
) |
Other income, net |
|
|
1,927 |
|
|
|
418 |
|
|
|
1,509 |
|
Non-cash interest expense on liability |
|
|
(5,435 |
) |
|
|
(4,743 |
) |
|
|
(692 |
) |
Loss before income taxes |
|
|
(12,003 |
) |
|
|
(19,357 |
) |
|
|
7,354 |
|
Income tax expense |
|
|
715 |
|
|
|
— |
|
|
|
715 |
|
Net loss |
|
$ |
(12,718 |
) |
|
$ |
(19,357 |
) |
|
$ |
6,639 |
|
License and other revenue. In the six months ended June 30, 2025 and 2024, we recognized $2.8 million and $0.3 million, respectively, of revenue associated with our license agreements. License revenue and other revenue for the six months ended June 30, 2025 consisted of $1.5 million in milestones from Arctic Vision and $1.3 million in other revenue for training, services and the sales of our SCS Microinjector kits to our licensees. License revenue and other revenue for the six months ended June 30, 2024 consisted of $0.3 million for training, services and the sales of our SCS Microinjector kits to our licensees.
Cost of goods sold. In the six months ended June 30, 2025, we recognized $0.2 million in cost of goods sold related to the sales of our SCS Microinjector kits to our licensees of approved products.
Research and development. Research and development expenses decreased by $4.2 million from $10.2 million for the six months ended June 30, 2024 to $6.0 million for the six months ended June 30, 2025. This decrease was primarily due to a $3.4 million decrease in costs related to the CLS-AX program due to the completion of ODYSSEY, our Phase 2b clinical trial, a $0.5 million decrease in employee related costs, a 0.4 million decrease in consulting fees and $0.4 million decrease related to a research and development tax credit received in the six months ended June 30, 2025. This decrease was partially offset by a $0.4 million increase in costs related to the GA program.
General and administrative. General and administrative expenses decreased by $0.6 million from 5.9 million for the six months ended June 30, 2024 to $5.3 million for the six months ended June 30, 2025. This decrease was primarily due to a $0.6 million decrease in employee related costs.
Interest income. Interest income decreased by $0.5 million from $0.8 million for the six months ended June 30, 2024 to $0.3 million for the six months ended June 30, 2025. The decrease was due to the lower balance of our cash and cash equivalents.
Other income, net. Other income, net was $1.9 million for the six months ended June 30, 2025 and $0.4 million for the six months ended June 30, 2024. The change was due to a decline in in the fair value of the warrant liabilities from the December 31, 2024 valuation date to June 30, 2025 than as compared to the decline in fair value from the February 2024 issuance date to June 30, 2024.
Non-cash interest expense on liability related to the sales of future royalties. Non-cash interest expense on liability related to the sales of future royalties was $5.4 million and $4.7 million for the six months ended June 30, 2025 and 2024, respectively, and was comprised of imputed interest on the liability related to the sales of future royalties and the amortization of the associated issuance costs.
Income tax expense. Income tax expense is due to taxes on milestone revenue incurred in foreign jurisdictions.
Liquidity and Capital Resources
Sources of Liquidity
We have funded our operations primarily through the proceeds of public offerings of our common stock, sales of convertible preferred stock, issuance of warrants and the issuance of long-term debt. As of June 30, 2025, we had cash and cash equivalents of
26
$9.4 million. We invest any cash in excess of our immediate requirements primarily with a view to liquidity and capital preservation. As of June 30, 2025, our funds were held in cash and money market funds.
On February 6, 2024, we entered into a securities purchase agreement, pursuant to which we issued and sold, in a registered direct offering: (i) an aggregate of 11,111,111 shares of our common stock; and (ii) warrants to purchase up to 11,111,111 shares of common stock, or Warrants. The combined purchase price of each share and accompanying Warrant was $1.35. The exercise price for the Warrants is $1.62 per share. The Warrants are currently exercisable and will expire on August 9, 2029. The net proceeds to us from the Registered Direct Offering were $13.9 million.
On January 31, 2024, or the Amendment Effective Date, we entered into a fourth amendment to the license agreement, or the Emory License Agreement, with Emory University and Georgia Tech Research Corporation, or, collectively, the Licensor, pursuant to which the parties agreed to reduce the Sublicense Percentage (as defined in the Emory License Agreement) from a low double digit percentage to a high single digit percentage that we will pay the Licensor applicable to any fees or payments paid to us by any Sublicensee (as defined in the Emory License Agreement) of the Licensed Patents and/or Licensed Technology (each as defined in the Emory License Agreement), excluding (i) amounts paid to us by a Sublicensee to reimburse us for certain research and development costs pursuant to a written agreement between us and such Sublicensee, (ii) the value of intellectual property transferred or granted to us if necessary or helpful to the development or commercialization of Licensed Products (as defined in the Emory License Agreement) and (iii) amounts paid for shares of our stock. The payment to Licensor of any such Sublicense Percentage is due within 30 days of receipt by us of a qualifying payment from a Sublicensee, provided however, with respect to any qualifying payments received by us from a Sublicensee prior to January 1, 2025, the payment to Licensor of any such Sublicensee Percentage is due to Licensor by March 31, 2025. The parties also agreed to a revised annual license maintenance fee due each year, or the Maintenance Fee, starting in 2023 through 2028, as follows: $0.3 million for 2023 through 2025, $0.4 million for each of 2026 and 2027 and $0.5 million for 2028. We paid the Maintenance Fee for 2023 in February 2024 and the Maintenance Fee for 2024 in October 2024. The remaining annual Maintenance Fee payments are due on October 1st of each year.
In May 2023, we entered into a Controlled Equity OfferingSM Sales Agreement, or the Sales Agreement, with Cantor Fitzgerald & Co., or Cantor, under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, having an aggregate offering price of up to $50.0 million through Cantor as our sales agent. During the six months ended June 30, 2025, we sold 1,649,796 shares of our common stock for net proceeds of $1.4 million under the Sales Agreement. During the six months ended June 30, 2024, we sold 339,912 shares of our common stock for net proceeds of $0.5 million under the Sales Agreement.
Funding Requirements
Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, research and development costs to build our product candidate pipeline, legal and other regulatory expenses and general overhead costs as we explore strategic alternatives. In addition, we have certain contractual obligations for future payments. Refer to Note 5 to our consolidated financial statements included in this Quarterly Report on Form 10-Q.
The successful development of our product candidates is highly uncertain. As such, at this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the remainder of the development of CLS-AX or any future product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from product sales. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:
A change in the outcome of any of these variables with respect to the development of any of our product candidates would significantly change the costs and timing associated with the development of that candidate.
Until such time, if ever, as we can generate substantial product revenue, we may seek to finance our cash needs through a combination of equity offerings, debt financings and potential collaboration, license and development agreements. Other than potential payments we may receive under our license and other agreements, we do not currently have any committed external source of funds, though, as described above, we may also be able to sell our common stock under the Sales Agreement subject to the terms of that agreement and depending on market conditions. We expect that we will require additional capital to fund our ongoing operations. Additional funds may not be available to us on a timely basis, on commercially reasonable terms, or at all. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and disruptions to, and volatility in, the credit and financial markets in the United States and worldwide and related macroeconomic changes, such as rising inflation. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be
27
diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
If we raise funds through additional collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, including any future collaboration or licensing arrangement for XIPERE outside of the territories in which we have previously licensed or granted options to license XIPERE, we may be required to relinquish additional rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
We also incur costs as a public company, including costs and expenses for fees to members of our board of directors, accounting and finance personnel costs, directors and officers insurance premiums, audit and legal fees, investor relations fees and expenses for compliance with reporting requirements under the Exchange Act and rules implemented by the SEC and Nasdaq.
Outlook
We have suffered recurring losses and negative cash flows from operations since inception and anticipate incurring additional losses until such time, if ever, that we can generate significant milestone payments and royalties from XIPERE and other licensing arrangements or revenues from other product candidates. We will need additional financing to fund our operations. Our plans primarily consist of raising additional capital, potentially in a combination of equity or debt financings, monetizing royalties, or restructurings, or potentially entering into additional collaborations, partnerships and other strategic arrangements.
Based on our current plans and forecasted expenses, including the impact of our recent announcement to explore strategic alternatives, we do not believe our cash and cash equivalents will be able to fund our operations for the next 12 months from the date of this filing. In order to conserve our cash balance we have paused all internal research and development programs which can be resumed if we are able to raise additional capital.
These factors raise substantial doubt regarding our ability to continue as a going concern. Our consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should we be unable to continue as a going concern.
Cash Flows
The following is a summary of the net cash flows (used in) provided by our operating, investing and financing activities (in thousands):
|
|
Six Months Ended |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Net cash (used in) provided by: |
|
|
|
|
|
|
||
Operating activities |
|
$ |
(10,559 |
) |
|
$ |
(13,531 |
) |
Investing activities |
|
|
(9 |
) |
|
|
(11,494 |
) |
Financing activities |
|
|
(76 |
) |
|
|
14,343 |
|
Net change in cash and cash equivalents |
|
$ |
(10,644 |
) |
|
$ |
(10,682 |
) |
During the six months ended June 30, 2025 and 2024, our operating activities used net cash of $10.6 million and $13.5 million, respectively. The net cash used in operating activities for the six months ended June 30, 2025 was due to ongoing research and development expenses to develop our pipeline, as well as the supporting general and administrative costs. The net cash used in operating activities for the six months ended June 30, 2024 was due to ongoing research and development expenses to develop our pipeline and costs for ODYSSEY, as well as the supporting general and administrative costs.
During the six months ended June 30, 2025 and 2024, our investing activities used net cash of $9,000 and $11.5 million, respectively. The net cash used in investing activities for the six months ended June 30, 2025 consisted of the acquisition of property and equipment. The net cash used in investing activities for the six months ended June 30, 2024 consisted of $11.0 million for the purchase of short-term investments and $0.5 million for the acquisition of property and equipment.
During the six months ended June 30, 2025 our financing activities used net cash of $76,000. During the six months ended June 30, 2024, our financing activities provided net cash of $14.3 million. The net cash used in financing activities for the six months ended June 30, 2025 consisted primarily of $1.5 million payment related to the royalty purchase and sale agreement, partially offset by proceeds of $1.4 million from the sale of shares of our common stock under the Sales Agreement. The net cash provided by financing activities for the six months ended June 30, 2024 consisted primarily of $13.9 million of net proceeds from the sale of shares of our
28
common stock and warrants in a registered direct offering and $0.5 million of net proceeds from the sale of shares of our common stock under the Sales Agreement.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this report at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There has been no change in our internal control over financial reporting during the quarter ended June 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. We have not experienced any material impact to our internal control over financial reporting.
29
PART II – OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be subject to litigation and claims arising in the ordinary course of business. We are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results, cash flows or financial condition.
Item 1A. Risk Factors
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. In addition to the other information set forth in this quarterly report on Form 10-Q, you should carefully consider the factors described in “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025.
Risks Related to Our Financial Position and Capital Needs
We do not currently have sufficient working capital to fund our planned operations for the next twelve months and substantial doubt exists as to our ability to continue as a going concern.
Our historical financial statements have been prepared under the assumption that we will continue as a going concern. As of June 30, 2025, we had an accumulated deficit of $368.0 million and had cash and cash equivalents of $9.4 million. While we have begun to implement cost reductions in 2025, we have finite cash resources available to fund our operations. As part of cost reductions, we implemented a plan pursuant to which we terminated all employees and transitioned such persons into consulting roles. We estimate that we will incur charges of approximately $2.6 million for severance and other employee termination-related costs in the third quarter of 2025. The estimated charges that we expect to incur are subject to a number of assumptions, and actual results may differ materially from these estimates. We may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, our workforce reduction. The reduction in force is expected to be completed during the third quarter of 2025.
In July 2025, we announced plans to explore a full range of strategic alternatives to advance our SCS platform and drug development pipeline to maximize stockholder value. We have retained Piper Sandler, a leading investment bank with substantial experience in the biotechnology industry, to support us with the strategic evaluation process. Strategic alternatives under consideration include the sale, license, monetization and/or divestiture of one or more of our assets and technologies, collaboration, partnership, merger, acquisition, joint ventures or other strategic transactions.
These conditions raise substantial doubt about our ability to continue as a going concern within one year after the date the financial statements are issued. Based on our current plans and forecasted expenses and our cash and cash equivalents, we do not believe we will be able to fund our operations for the next 12 months from the date of this filing. Until we can generate sufficient revenue, if ever, to fund our operations, we will need to finance future cash needs through public or private equity offerings, license agreements, debt financings or restructurings, collaborations, strategic alliances and marketing or distribution arrangements.
The perception of our ability to continue as a going concern may make it more difficult for us to obtain financing for the continuation of our operations and could result in the loss of confidence by investors and employees. Additional financing may not be available to us when needed or, if available, it may not be obtained on commercially reasonable terms. If we are not able to obtain the necessary additional financing and if a strategic alternative is not available, we may be forced to file for bankruptcy or wind down our operations.
Our activities to evaluate and pursue potential strategic alternatives may not result in any transaction or enhance stockholder value.
We have begun evaluating and exploring a variety of strategic alternatives focused on maximizing stockholder value, including, but not limited to, an acquisition, merger, reverse merger, other business combination, sales of assets or other strategic transactions. Our ability to successfully execute on a strategic alternative is dependent on a number of factors and we may not be able to execute upon a transaction or other strategic alternative upon favorable terms within an advantageous timeframe and recognize significant value for our assets, if at all. Additionally, the negotiation and consummation of a transaction or other strategic alternative may be costly and time-consuming. Any executed strategic alternative may not maximize or even enhance stockholder value, could result in total costs and expenses that are greater than expected, could make it more difficult to attract and retain qualified personnel and may disrupt our operations, each of which could have a material adverse effect on our business.
The market price of our common stock may reflect a market assumption that a strategic alternative will occur, and a failure to complete a strategic alternative could result in negative investor perceptions and could cause a decline in the market price of our common stock, which could adversely affect our ability to access the equity and financial markets, as well as our ability to explore and
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enter into different strategic alternatives. There can be no certainty that any strategic alternative will be completed, be on attractive terms, enhance stockholder value or deliver the anticipated benefits, and successful integration or execution of the strategic alternatives will be subject to additional risks. In addition, potential strategic alternatives that require stockholder approval may not be approved by our stockholders. If we do not successfully consummate a strategic alternative, our board of directors may decide to pursue a dissolution and liquidation of our company. In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such liquidation, the amount of cash that will need to be reserved for commitments and contingent liabilities. Depending on these factors, the amount available for distribution to our common stockholders could be as low as zero and result in a total loss of investment to our stockholders.
Risks Related to Ownership of Our Common Stock
If we fail to meet all applicable requirements of Nasdaq and Nasdaq determines to delist our common stock, the delisting could adversely affect the market liquidity of our common stock and the market price of our common stock could decrease.
On February 7, 2025, we received a letter from Nasdaq, notifying us that, from December 18, 2024 to February 4, 2025, the closing bid price for our common stock was below $1.00. In accordance with Nasdaq Listing Rule 5810(c)(3)(A) we were provided an initial period of 180 calendar days, or until August 6, 2025, to regain compliance with Nasdaq’s Minimum Bid Price Requirement. We did not regain compliance by August 6, 2025, and as a result we expect that Nasdaq will provide notice that our common stock will be subject to delisting. We intend to appeal any delisting determination to a Nasdaq hearings panel and our common stock will remain listed on the Nasdaq Global Market until the completion of the appeal process, during which time we may regain compliance the Minimum Bid Price Requirement if our minimum bid price of listed securities closes at $1.00 per share or more for a minimum of 10 consecutive business days. In addition, on August 4, 2025, we filed a proxy statement seeking approval by our stockholders to effect a reverse split of our outstanding common stock at a ratio ranging from 1-for-5 and 1-for-15. If approved by stockholders, this Reverse Stock Split Proposal would permit (but not require) our board of directors to effect a reverse stock split of our common stock at any time before August 29, 2026, by a ratio of not less than 1-for-5 and not more than 1-for-15, inclusive, and a corresponding proportionate reduction in the total number of authorized shares of the Company’s common stock, with such ratio to be determined by the our board of directors in its sole discretion. Our board of directors’ primary objective in proposing the Reverse Stock Split and Authorized Shares Reduction is to raise the per share trading price of our common stock. Our board of directors believes that the Reverse Stock Split and Authorized Shares Reduction will result in a higher per share trading price, which is intended to enable us to maintain the listing of our common stock on The Nasdaq Global Market and generate greater investor interest in the Company.
There can be no assurance that we will regain compliance with the requirements for listing our common stock on Nasdaq. If we are unable to satisfy the Nasdaq criteria for continued listing, our common stock would be subject to delisting. A delisting of our common stock could negatively impact us by, among other things, reducing the liquidity and market price of our common stock; reducing the number of investors willing to hold or acquire our common stock, which could negatively impact our ability to raise equity financing; decreasing the amount of news and analyst coverage of us; and limiting our ability to issue additional securities or obtain additional financing in the future. In addition, delisting from Nasdaq may negatively impact our reputation and, consequently, our business.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Sales of Unregistered Securities
None.
Issuer Purchases of Equity Securities
None.
Item 5. Other Information
During the quarter ended June 30, 2025, none of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act)
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Item 6. Exhibits
Exhibit No. |
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Description |
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3.1 |
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Amended and Restated Certificate of Incorporation (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37783) filed with the SEC on June 7, 2016). |
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3.2 |
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Certificate of Amendment to Amended and Restated Certificate of Incorporation (incorporated herein by reference to Exhibit 3.1 to the Registrant's Current Report on Form 8-K (File No. 001-37783) filed with the SEC on June 23, 2022). |
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3.3 |
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Certificate of Amendment to Amended and Restated Certificate of Incorporation (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37783) filed with the SEC on May 30, 2025). |
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3.4 |
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Amended and Restated Bylaws (incorporated herein by reference to Exhibit 3.2 to the Registrant's Current Report on Form 8-K (File No. 001-37783) filed with the SEC on June 7, 2016). |
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10.1* |
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Separation Agreement, by and between Registrant and George Lasezkay, dated as of July 17, 2025. |
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10.2* |
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Consulting Agreement, by and between Registrant and George Lasezkay, dated as of July 17, 2025. |
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10.3* |
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Separation Agreement, by and between Registrant and Charles Deignan, dated as of July 17, 2025. |
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10.4* |
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Consulting Agreement, by and between Registrant and Charles Deignan, dated as of July 17, 2025. |
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10.5* |
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Separation Agreement, by and between Registrant and Victor Chong, dated as of July 17, 2025. |
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10.6* |
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Consulting Agreement, by and between Registrant and Victor Chong, dated as of July 17, 2025. |
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31.1* |
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Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act. |
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31.2* |
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Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act. |
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32.1** |
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Certifications of Principal Executive Officer and Principal Financial Officer under Section 906 of the Sarbanes-Oxley Act. |
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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 with Embedded Linkbase Documents |
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104 |
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Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibits 101) |
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Filed herewith. |
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These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in 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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Clearside Biomedical, Inc. |
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Date: August 8, 2025 |
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By: |
/s/ Charles A. Deignan |
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Charles A. Deignan |
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Chief Financial Officer |
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(On behalf of the Registrant and as |
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