KALA BIO Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
KALA BIO reported its Q4 and full year 2024 financial results, highlighting progress in its Phase 2b CHASE trial of KPI-012 for Persistent Corneal Epithelial Defect (PCED). The company has randomized 87 patients and expects topline data in Q3 2025.
Key financial highlights include:
- Raised $10.75 million in private placement financing
- Cash position of $51.2 million as of December 31, 2024
- Q4 2024 net loss of $8.2 million ($1.74 per share)
- Full year 2024 net loss of $38.5 million ($10.15 per share)
The company's cash runway extends into Q1 2026. KALA's lead product candidate, KPI-012, targets PCED, which affects approximately 100,000 patients in the U.S. The CHASE trial could potentially serve as the first of two pivotal studies required for FDA approval.
KALA BIO ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando i progressi nel suo trial CHASE di Fase 2b per KPI-012 per il Difetto Epitheliale Corneale Persistente (PCED). L'azienda ha randomizzato 87 pazienti e prevede di avere dati preliminari nel terzo trimestre del 2025.
I principali punti salienti finanziari includono:
- Raccolti 10,75 milioni di dollari in finanziamenti tramite collocamento privato
- Posizione di liquidità di 51,2 milioni di dollari al 31 dicembre 2024
- Perdita netta del quarto trimestre 2024 di 8,2 milioni di dollari (1,74 dollari per azione)
- Perdita netta dell'intero anno 2024 di 38,5 milioni di dollari (10,15 dollari per azione)
Il capitale disponibile dell'azienda si estende fino al primo trimestre del 2026. Il principale candidato prodotto di KALA, KPI-012, è destinato al PCED, che colpisce circa 100.000 pazienti negli Stati Uniti. Il trial CHASE potrebbe potenzialmente servire come il primo di due studi fondamentali richiesti per l'approvazione della FDA.
KALA BIO informó sus resultados financieros del cuarto trimestre y del año completo 2024, destacando los avances en su ensayo CHASE de Fase 2b de KPI-012 para el Defecto Epitelial Corneal Persistente (PCED). La empresa ha aleatorizado a 87 pacientes y espera datos preliminares en el tercer trimestre de 2025.
Los aspectos financieros clave incluyen:
- Recaudados 10,75 millones de dólares en financiamiento privado
- Posición de efectivo de 51,2 millones de dólares al 31 de diciembre de 2024
- Pérdida neta del cuarto trimestre de 2024 de 8,2 millones de dólares (1,74 dólares por acción)
- Pérdida neta del año completo 2024 de 38,5 millones de dólares (10,15 dólares por acción)
La liquidez de la empresa se extiende hasta el primer trimestre de 2026. El principal candidato a producto de KALA, KPI-012, se dirige al PCED, que afecta a aproximadamente 100,000 pacientes en los EE. UU. El ensayo CHASE podría potencialmente servir como el primero de dos estudios clave requeridos para la aprobación de la FDA.
KALA BIO는 2024년 4분기 및 연간 재무 결과를 발표하며 KPI-012의 2b상 CHASE 시험에서의 진전을 강조했습니다. 이 회사는 87명의 환자를 무작위로 배정했으며, 2025년 3분기에 주요 데이터를 기대하고 있습니다.
주요 재무 하이라이트는 다음과 같습니다:
- 사모펀드에서 1,075만 달러를 모금했습니다.
- 2024년 12월 31일 기준 현금 보유액은 5,120만 달러입니다.
- 2024년 4분기 순손실은 820만 달러(주당 1.74달러)입니다.
- 2024년 전체 순손실은 3,850만 달러(주당 10.15달러)입니다.
회사의 현금 유동성은 2026년 1분기까지 지속됩니다. KALA의 주요 제품 후보인 KPI-012는 약 100,000명의 미국 환자에게 영향을 미치는 PCED를 대상으로 하고 있습니다. CHASE 시험은 FDA 승인을 위한 두 개의 주요 연구 중 첫 번째가 될 가능성이 있습니다.
KALA BIO a publié ses résultats financiers du quatrième trimestre et de l'année complète 2024, mettant en avant les progrès de son essai CHASE de Phase 2b sur KPI-012 pour le Défaut Épithélial Corneal Persistant (PCED). L'entreprise a randomisé 87 patients et s'attend à des données préliminaires au troisième trimestre 2025.
Les principaux points financiers incluent:
- 10,75 millions de dollars levés lors d'un placement privé
- Position de trésorerie de 51,2 millions de dollars au 31 décembre 2024
- Perte nette du quatrième trimestre 2024 de 8,2 millions de dollars (1,74 dollar par action)
- Perte nette de l'année complète 2024 de 38,5 millions de dollars (10,15 dollars par action)
La trésorerie de l'entreprise s'étend jusqu'au premier trimestre 2026. Le principal candidat produit de KALA, KPI-012, cible le PCED, qui touche environ 100 000 patients aux États-Unis. L'essai CHASE pourrait potentiellement servir de premier des deux études pivotales requises pour l'approbation de la FDA.
KALA BIO hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und Fortschritte in seiner Phase 2b CHASE-Studie zu KPI-012 für den Persistierenden Epithelialen Hornhautdefekt (PCED) hervorgehoben. Das Unternehmen hat 87 Patienten randomisiert und erwartet im dritten Quartal 2025 erste Ergebnisse.
Wichtige finanzielle Highlights sind:
- 10,75 Millionen Dollar in einer Privatplatzierung gesammelt
- Liquiditätsposition von 51,2 Millionen Dollar zum 31. Dezember 2024
- Nettoverlust im vierten Quartal 2024 von 8,2 Millionen Dollar (1,74 Dollar pro Aktie)
- Nettoverlust für das gesamte Jahr 2024 von 38,5 Millionen Dollar (10,15 Dollar pro Aktie)
Die Liquidität des Unternehmens reicht bis ins erste Quartal 2026. Das Hauptprodukt von KALA, KPI-012, zielt auf PCED ab, das etwa 100.000 Patienten in den USA betrifft. Die CHASE-Studie könnte potenziell die erste von zwei entscheidenden Studien sein, die für die FDA-Zulassung erforderlich sind.
- Raised $10.75 million in private placement financing from notable investors
- Strong cash position of $51.2 million with runway into Q1 2026
- Phase 2b CHASE trial could potentially serve as first of two pivotal studies for FDA approval
- Targeting large market opportunity with 100,000 PCED patients in U.S.
- Net loss increased to $38.5 million in 2024 from previous year
- R&D expenses increased to $22.1 million in 2024 from $18.6 million in 2023
- 13 enrolled patients did not meet central reading center verification criteria
- Trial timeline extended with topline data delayed to Q3 2025
Insights
KALA's Q4/FY2024 update provides a balanced view of the company's progress. The most significant development is the continuation of the Phase 2b CHASE trial for KPI-012 in PCED, with 87 patients randomized to date. However, the company has extended enrollment due to 13 patients whose PCED status couldn't be verified by the central reading center, pushing the topline data readout to 3Q25 from the previous timeline.
The $10.75 million private placement from respected life science investors like SR One and Cormorant strengthens their financial position. With $51.2 million cash as of December 31, 2024, KALA has runway into 1Q 2026, which importantly extends beyond the critical CHASE trial readout.
Financially, the $38.5 million net loss ($10.15/share) for 2024 reflects the company's pre-commercial stage, with R&D expenses increasing to $22.1 million (up from $18.6M) as clinical development advances. The potential market opportunity is significant, with PCED affecting approximately 100,000 patients in the US and no FDA-approved products for all PCED etiologies.
If successful, the CHASE trial could serve as the first of two pivotal trials for BLA submission, potentially accelerating KPI-012's path to market. The company is also exploring additional indications for KPI-012 including Limbal Stem Cell Deficiency, potentially expanding its commercial opportunity.
The CHASE trial developments reveal important nuances about KALA's clinical execution. Having randomized 87 patients marks substantial progress, but the need to extend enrollment after 13 patients failed central verification indicates challenges in patient selection protocols. This verification disconnect between investigators and the central reading center highlights the complexity of accurately diagnosing PCED in a standardized fashion.
The delayed timeline (now 3Q25 for topline data) represents a calculated decision to ensure adequate statistical power rather than a fundamental study issue. The potential for CHASE to serve as one of two pivotal trials underscores its robustness as a Phase 2b study with registration-quality design elements.
KPI-012's multifactorial mechanism targeting growth factors, protease inhibitors, matrix proteins and neurotrophic factors addresses the complex pathophysiology of persistent corneal defects. This approach differentiates it from single-mechanism therapies by potentially addressing all PCED etiologies, regardless of underlying cause.
The strategic expansion to Latin American trial sites suggests a commitment to diverse patient enrollment and potentially accelerated recruitment. The exploration of additional indications like Limbal Stem Cell Deficiency (100,000 US patients) demonstrates pipeline leverage, while the preclinical KPI-014 program for retinal degeneration indicates the broader applicability of their MSC-S platform technology beyond anterior segment disorders.
-- Randomized 87 patients to date in Phase 2b CHASE trial of KPI-012 in Persistent Corneal Epithelial Defect (PCED) --
-- Continuing enrollment into 2Q25; currently targeting topline data in 3Q25 --
-- Raised
-- Cash resources of
ARLINGTON, Mass., March 31, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today reported financial results for the fourth quarter and full year ended December 31, 2024 and provided a corporate update.
“We are well-positioned this year to execute our clinical and strategic priorities, with KPI-012 at the center of our efforts,” said Todd Bazemore, interim Chief Executive Officer of KALA BIO. “We are encouraged by the potential of KPI-012 to address all underlying etiologies of PCED and significantly improve patient outcomes. With the recent uptick in enrollment in the Phase 2b CHASE trial, we have now randomized 87 patients. Upon review of only the masked screening and baseline data, we have decided to extend enrollment to account for 13 patients who were enrolled and treated based on the investigators’ determination of the presence of a PCED which was subsequently not verified by the central reading center. We now plan to report topline results in the third quarter of 2025. If successful the CHASE trial could serve as the first of two pivotal trials required to support a BLA submission, bringing us one step closer to potentially delivering the first FDA-approved treatment option for all patients with PCED regardless of etiology.”
Mr. Bazemore continued, “Additionally, we recently completed a
Fourth Quarter and Recent Business Highlights:
KALA’s innovative pipeline is based on its proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA believes the multifactorial mechanism of action of its MSC-S platform technology may enable it to generate product candidates for a range of ocular orphan diseases and is evaluating the potential development of this technology for multiple rare, front- and back-of-the-eye diseases.
KALA’s lead product candidate, KPI-012 contains growth factors, protease inhibitors, matrix proteins and neurotrophic factors to potentially correct the impaired corneal healing that is an underlying etiology of multiple severe ocular diseases.
KALA is initially developing KPI-012 for the treatment of PCED, a persistent, non-healing corneal defect or wound that is refractory to conventional treatments which, if left untreated, can lead to significant complications, including infection, corneal perforation/scarring and vision loss. PCED has an estimated incidence of approximately 100,000 patients in the U.S., representing a potentially sizeable market opportunity as there are currently no U.S. Food and Drug Administration (FDA)-approved prescription products with a broad indication covering all underlying etiologies of PCED.
- KALA continues to enroll patients in the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial evaluating KPI-012 for the treatment of PCED and plans to report topline data in the third quarter of 2025. The Company has also activated clinical trial sites in Latin America. Contingent on positive results and subject to discussion with regulatory authorities, the Company believes the CHASE Phase 2b trial could potentially serve as the first of two pivotal studies required to support the submission of a Biologics License Application (BLA) to the FDA.
- KALA is also exploring the potential of KPI-012 for additional rare, front-of-the-eye diseases, including Limbal Stem Cell Deficiency (LSCD) and other corneal diseases. LSCD is characterized by the loss or deficiency of limbal epithelial stem cells, which can result in recurrent epithelial breakdown, conjunctivalization, inflammation, neovascularization and other sequalae that can lead to significant symptomology and a loss of corneal clarity and vision impairment. Like PCED, LSCD represents a potentially substantial market opportunity, with an estimated incidence of 100,000 patients in the U.S.
KPI-014, KALA’s preclinical program to evaluate the utility of its MSC-S platform for inherited retinal degenerative diseases, contains neurotrophic factors, growth factors, anti-inflammatory or immune-modulatory factors and antioxidant inhibitors with the potential to protect and preserve retinal cell function. Secretomes have demonstrated a neuroprotective effect in both in vitro and in vivo models of retinal degeneration. KALA believes KPI-014 could offer a gene-agnostic approach for the treatment of rare inherited retinal diseases, such as Retinitis Pigmentosa and Stargardt Disease.
Corporate Updates:
- In December 2024, KALA announced the completion of a private placement financing, raising aggregate gross proceeds of
$10.75 million . The financing included participation from both new and existing investors, including SR One, Cormorant Asset Management, Woodline Partners and another life sciences-focused investor. In the private placement, KALA sold 1,340,603 shares of its common stock at a price of$6.44 per share and 3,286 shares of its Series I Preferred Stock at a price of$644.00 per share.
Financial Results:
Cash Position: As of December 31, 2024, KALA had cash and cash equivalents of
Financial Results for the Three Months Ended December 31, 2024:
- G&A Expenses: For the quarter ended December 31, 2024, general and administrative (G&A) expenses were
$4.2 million , compared to$4.6 million for the same period in 2023. This decrease was primarily due to a decrease in employee-related costs. - R&D Expenses: For the quarter ended December 31, 2024, research and development (R&D) expenses were
$5.3 million , compared to$4.7 million for the same period in 2023. The increase was primarily due to an increase in KPI-012 development costs, as KALA advances the clinical development of KPI-012, and employee-related costs. - Loss on Fair Value Remeasurement of Contingent Consideration: The was no gain or loss on fair value remeasurement of contingent consideration, in connection with the Combangio acquisition, for the quarter ended December 31, 2024. For the quarter ended December 31, 2023, the loss on fair value remeasurement of continent consideration was
$0.3 million . - Operating Loss: For the quarter ended December 31, 2024 loss from operations was
$9.5 million , compared to$9.6 million for the same period in 2023. - Net Loss: For the quarter ended December 31, 2024, net loss was
$8.2 million , or$1.74 per share, compared to a net loss of$8.6 million , or$3.18 per share, for the same period in 2023. The weighted average number of shares used to calculate net loss per share was 4.7 million for the quarter ended December 31, 2024 and 2.7 million for the quarter ended December 31, 2023.
Financial Results for the Full Year Ended December 31, 2024:
- G&A Expenses: For the full year ended December 31, 2024, G&A expenses were
$18.3 million , compared to$20.6 million for the same period in 2023. The decrease was primarily due to a decrease in administrative and professional service fees and a decrease in employee-related costs, partially offset by an increase in stock-based compensation expense. - R&D Expenses: For the full year ended December 31, 2024, R&D expenses were
$22.1 million , compared to$18.6 million for the same period in 2023. The increase was primarily due to an increase in development costs, as KALA advances the clinical development of KPI-012, and an increase in employee-related costs. - Gain on Fair Value Remeasurement of Deferred Purchase Consideration: There was no gain or loss on fair value remeasurement of Deferred Purchase Consideration for the full year ended December 31, 2024 due to the final settlement of the liability in March 2023. For the full year ended December 31, 2023, the gain on fair value remeasurement of deferred purchase consideration was
$0.2 million . - Loss on Fair Value Remeasurement of Contingent Consideration: For the full year ended December 31, 2024, the loss on fair value remeasurement of continent consideration, in connection with the Combangio acquisition, was
$0.5 million , compared to$0.7 million for the same period in 2023. - Operating Loss: For the full year ended December 31, 2024, loss from operations was
$41.0 million , compared to$39.7 million for the same period in 2023. - Net Loss: For the full year ended December 31, 2024, net loss was
$38.5 million , or$10.15 per share, compared to a net loss of$42.2 million , or$17.35 per share, for the same period in 2023. The weighted average number of shares used to calculate net loss per share was 3.8 million for the full year ended December 31, 2024, and 2.4 million for the full year ended December 31, 2023.
About KALA BIO, Inc.
KALA is a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye. KALA’s biologics-based investigational therapies utilize KALA’s proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA’s lead product candidate, KPI-012, is a human MSC-S, which contains numerous human-derived biofactors, such as growth factors, protease inhibitors, matrix proteins and neurotrophic factors that can potentially correct the impaired corneal healing that is an underlying etiology of multiple severe ocular diseases. KPI-012 is currently in clinical development for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing, for which it has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration. KALA is also targeting the potential development of KPI-012 for the treatment of Limbal Stem Cell Deficiency and other rare corneal diseases that threaten vision and has initiated preclinical studies to evaluate the potential utility of its MSC-S platform for retinal degenerative diseases, such as Retinitis Pigmentosa and Stargardt Disease. For more information on KALA, please visit www.kalarx.com.
Forward Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. Any statements in this press release about KALA’s future expectations, plans and prospects, including but not limited to statements about KALA’s expectations with respect to potential advantages of KPI-012 and its MSC-S platform; the clinical utility of KPI-012 for PCED; anticipated timelines to report topline data for the CHASE Phase 2b clinical trial of KPI-012; KALA’s belief that the Chase Phase 2b trial could serve as the first of two pivotal trials required to support the submission of a BLA to the FDA; KALA’s plans to pursue research and development of KPI-012 and its MSC-S platform for other indications; expectations about the potential benefits and future operation of the CIRM award; KALA’s ability to achieve the specified milestones and obtain the full funding under the CIRM award; the sufficiency of KALA’s existing cash resources for the period anticipated; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: KALA’s ability to comply with the requirements under the CIRM award; uncertainties inherent in the initiation and conduct of preclinical studies and clinical trials; uncertainties regarding availability and timing of data from clinical trials; whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials; whether results of the Phase 1b clinical trial of KPI-012 will be indicative of results for any future clinical trials and studies of KPI-012, including the CHASE Phase 2b clinical trial; whether interim data from a clinical trial will be predictive of the results of the trial; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; KALA’s ability to retain and hire key personnel; KALA’s ability to comply with the covenants under its loan agreement, including the requirement that its common stock continue to be listed on The Nasdaq Stock Market; the sufficiency of cash resources and need for additional financing and other important factors, any of which could cause KALA’s actual results to differ from those contained in the forward-looking statements, discussed in the “Risk Factors” section of KALA’s Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and other filings KALA makes with the Securities and Exchange Commission. These forward-looking statements represent KALA’s views as of the date of this press release and should not be relied upon as representing KALA’s views as of any date subsequent to the date hereof. KALA does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Financial Tables:
| KALA BIO, Inc. Balance Sheet Data (in thousands) (unaudited) | |||||
| December 31, 2024 | December 31, 2023 | ||||
| Cash and cash equivalents | |||||
| Total assets | 55,483 | 55,949 | |||
| Working capital (1) | 35,841 | 44,524 | |||
| Current portion of long-term debt | 10,336 | — | |||
| Long-term debt, net of discounts | 20,102 | 34,190 | |||
| Other long-term liabilities | 6,093 | 5,909 | |||
| Total stockholders’ equity | 12,332 | 7,504 | |||
(1) The Company defines working capital as current assets less current liabilities. See the Company’s consolidated financial statements for further information regarding its current assets and current liabilities.
| KALA BIO, Inc. Consolidated Statement of Operations (In thousands, except share and per share data) (Unaudited) | |||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Costs and expenses: | |||||||||||||||
| General and administrative | |||||||||||||||
| Research and development | 5,258 | 4,718 | 22,094 | 18,586 | |||||||||||
| Gain on fair value remeasurement of deferred purchase consideration | — | — | — | (230 | ) | ||||||||||
| Loss on fair value remeasurement of contingent consideration | — | 278 | 549 | 740 | |||||||||||
| Total costs and expenses | 9,459 | 9,619 | 40,983 | 39,663 | |||||||||||
| Loss from operations | (9,459 | ) | (9,619 | ) | (40,983 | ) | (39,663 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Interest income | 478 | 610 | 2,056 | 2,711 | |||||||||||
| Interest expense | (1,392 | ) | (1,468 | ) | (5,783 | ) | (5,814 | ) | |||||||
| Grant income | 2,198 | 1,855 | 6,199 | 4,825 | |||||||||||
| Other expense, net | — | (5 | ) | — | (4,258 | ) | |||||||||
| Total other income (expense) | 1,284 | 992 | 2,472 | (2,536 | ) | ||||||||||
| Net loss | ) | ) | ) | ) | |||||||||||
| Net loss per share attributable to common stockholders—basic and diluted | ) | ) | ) | ) | |||||||||||
| Weighted average shares outstanding—basic and diluted | 4,694,611 | 2,712,475 | 3,796,047 | 2,432,008 | |||||||||||
Investor Contact:
Taylor Steiner
taylor.steiner@precisionaq.com
212-362-1200
FAQ
What are the key findings from KALA BIO's Q4 2024 financial results?
How many patients has KALA enrolled in the Phase 2b CHASE trial for KPI-012?
What is the market potential for KALA's PCED treatment?
When will KALA report topline data from the Phase 2b CHASE trial?
How long will KALA's current cash resources last?
