KALA BIO Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update
KALA BIO Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update
-- Advancing ongoing Phase 2b CHASE trial of KPI-012 for PCED; topline data targeted by year-end 2024 --
-- Exploring opportunities to expand KPI-012 into additional corneal indications --
-- Cash resources as of December 31, 2023, together with proceeds from the March 2024 private placement and anticipated funding remaining from CIRM award, expected to fund operations into 3Q 2025 --
— 推進正在進行的針對 PCED KPI-012 的 CHASE 第 2b 期試驗；目標是在 2024 年年底之前提供頭條數據 —
--探索將 KPI-012 擴展到其他角膜適應症的機會-
— 截至2023年12月31日的現金資源，加上2024年3月私募的收益和CIRM獎勵的預期剩餘資金，預計將爲2025年第三季度的運營提供資金——
ARLINGTON, Mass., March 29, 2024 (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, 2023 and provided a corporate update.
馬薩諸塞州阿靈頓，2024年3月29日（GLOBE NEWSWIRE）——致力於罕見和嚴重眼部疾病創新療法研究、開發和商業化的臨床階段生物製藥公司KALA BIO, Inc.（納斯達克股票代碼：KALA）今天公佈了截至2023年12月31日的第四季度和全年財務業績，並提供了公司最新情況。
"In 2023, we focused on clinical execution, advancing our Phase 2b CHASE trial of KPI-012 for the treatment of PCED. In March 2023, we announced positive safety data from the first cohort of patients, reinforcing the promising safety and tolerability profile of high dose KPI-012, and allowing us to progress into the multicenter, randomized, double-masked efficacy cohort, which we are targeting to read out by year-end 2024," said Mark Iwicki, Chair and Chief Executive Officer of KALA BIO. "Based on its multifactorial mechanism of action, we believe KPI-012 may address a significant unmet need, potentially offering patients and physicians a highly differentiated product profile and the first therapy for PCED that addresses the multiple underlying etiologies of the disease. We look forward to topline data from the CHASE trial, as we work to establish KPI-012 as a safe, well-tolerated, easily administered and effective treatment for the nearly 100,000 patients living with PCED in the U.S."
“2023 年，我們專注於臨床執行，推進了用於治療 PCED 的 KPI-012 的 2b 期 CHASE 試驗。2023 年 3 月，我們公佈了來自第一批患者的積極安全數據，強化了高劑量 KPI-012 令人鼓舞的安全性和耐受性，使我們得以進入多中心、隨機、雙面罩的療效隊列，我們的目標是在2024年年底之前宣讀該隊列。” KALA BIO董事長兼首席執行官馬克·伊維基說。“基於其多因素作用機制，我們認爲 KPI-012 可以解決尚未滿足的重大需求，有可能爲患者和醫生提供高度差異化的產品概況和第一種針對該疾病多種潛在病因的PCED療法。我們期待着來自CHASE試驗的主要數據，因爲我們正在努力將 KPI-012 確立爲一種安全、耐受性好、易於施用且有效的治療方法，適用於美國近10萬名PCED患者。”
Fourth Quarter and Recent Business Highlights:
第四季度和近期業務亮點：
Development-Stage Pipeline:
KALA is advancing an innovative pipeline 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 products 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.
開發階段的管道：
KALA 正在推進基於其專有的間充質幹細胞分泌組 (MSC-S) 平台的創新產品線。KALA認爲，其MSC-S平台技術的多因素作用機制可能使其能夠爲一系列眼部孤兒病生產產品，並且正在評估該技術在多種罕見的前眼和眼後疾病方面的潛在發展。
KPI-012 combines 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.
KPI-012 結合了生長因子、蛋白酶抑制劑、基質蛋白和神經營養因子，有可能糾正角膜癒合受損，角膜癒合受損是多種嚴重眼部疾病的潛在病因。
KALA is initially developing KPI-012 for the treatment of persistent corneal epithelial defect (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. and represents a sizeable market opportunity; there are currently no U.S. Food and Drug Administration (FDA)-approved prescription products with a broad indication for all underlying etiologies of PCED.
KALA 最初正在開發用於治療持續性角膜上皮缺損 (PCED) 的 KPI-012，這是一種持續的、無法癒合的角膜缺損或傷口，是傳統治療難以治癒的，如果不加以治療，可能會導致嚴重的併發症，包括感染、角膜穿孔/疤痕和視力喪失。據估計，PCED在美國的發病率約爲100,000名患者，這是一個巨大的市場機會；目前沒有經美國食品藥品監督管理局（FDA）批准的針對PCED所有潛在病因的廣泛適應症的處方產品。
- KALA is actively enrolling patients in the primary safety and efficacy portion of the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial evaluating KPI-012 for the treatment of PCED and is targeting to announce topline data by year-end 2024.
- If the results are positive, and subject to discussion with regulatory authorities, KALA believes the CHASE Phase 2b trial could serve as the first of two pivotal trials required to support the submission of a Biologics License Application (BLA) to the FDA.
- KALA 正在積極招募患者參加 CHASE（Secretome 療法後的角膜癒合）2b 期臨床試驗的主要安全性和有效性部分，該試驗旨在評估 KPI-012 治療PCED，並計劃在 2024 年年底之前公佈主要數據。
- 如果結果是積極的，並且有待與監管機構進行討論，KALA認爲CHASE的2b期試驗可以作爲支持向FDA提交生物製劑許可申請（BLA）所需的兩項關鍵試驗中的第一項。
KALA is also evaluating the potential of KPI-012 for additional rare, front-of-the-eye diseases, such as Limbal Stem Cell Deficiency (LSCD) and other corneal diseases that threaten vision. LSCD is characterized by the loss or deficiency of limbal epithelial stem cells, which can result in recurrent epithelial breakdown, neovascularization, conjunctivalization, inflammation and other sequalae that can lead to loss of corneal clarity and vision impairment. Like PCED, LSCD represents a substantial market opportunity, with an estimated incidence of 100,000 patients in the U.S.
KALA 還在評估 KPI-012 可能導致其他罕見的前眼疾病，例如邊緣幹細胞缺乏症 (LSCD) 和其他威脅視力的角膜疾病。LSCD的特徵是邊緣上皮幹細胞的流失或缺乏，這可能導致反覆的上皮分解、新生血管形成、結膜形成、炎症和其他後遺症，從而導致角膜清晰度下降和視力受損。與PCED一樣，LSCD代表着巨大的市場機會，估計美國的發病率爲100,000名患者。
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 and has initiated preclinical studies to evaluate the utility of KPI-014 for conditions such as Retinitis Pigmentosa and Stargardt Disease.
KPI-014 是 KALA 的臨床前項目，旨在評估其 MSC-S 平台對遺傳性視網膜退行性疾病的效用，它含有神經營養因子、生長因子、抗炎或免疫調節因子和抗氧化抑制劑，有可能保護和維持視網膜細胞功能。分泌組在兩者中均顯示出神經保護作用 體外 和 在活體中 視網膜變性的模型。KALA 認爲，KPI-014 可以爲罕見的遺傳性視網膜疾病的治療提供一種與基因無關的方法，並已啓動臨床前研究，以評估 KPI-014 對色素性視網膜炎和斯塔加特病等疾病的效用。
Corporate:
In December 2023 and March 2024, KALA announced private placement financings with an institutional investor, priced at-the-market under Nasdaq rules. Aggregate gross proceeds from the financings were approximately $2.0 million and $8.6 million, respectively.
企業：
2023年12月和2024年3月，KALA宣佈與機構投資者進行私募融資，根據納斯達克規則在市場上定價。融資總收益分別約爲200萬美元和860萬美元。
Financial Results:
財務業績：
Cash Position: As of December 31, 2023, KALA had cash and cash equivalents of $50.9 million, compared to $56.1 million as of September 30, 2023. This decrease reflects cash used in operations and gross proceeds of $2.0 million received from KALA's December 2023 private placement financing. Based on its current plans, KALA anticipates that its cash resources as of December 31, 2023, together with gross proceeds of $8.6 million received from its March 2024 private placement financing and anticipated funding under the CIRM award, will enable it to fund operations into the third quarter of 2025.
現金狀況：截至2023年12月31日，KALA的現金及現金等價物爲5,090萬美元，而截至2023年9月30日爲5,610萬美元。這一減少反映了運營中使用的現金以及從KALA2023年12月的私募融資中獲得的200萬美元總收益。根據其目前的計劃，KALA預計，截至2023年12月31日的現金資源，加上從2024年3月的私募融資中獲得的860萬美元總收益和CIRM獎勵下的預期融資，將使其能夠爲2025年第三季度的運營提供資金。
Financial Results for the Three Months Ended December 31, 2023:
截至2023年12月31日的三個月的財務業績：
- SG&A Expenses: For the quarter ended December 31, 2023, selling, general and administrative (SG&A) expenses were $4.6 million, compared to $5.8 million for the same period in 2022. The decrease was primarily due to the sale of KALA's commercial portfolio to Alcon Inc. (Alcon) in July 2022.
- R&D Expenses: For the quarter ended December 31, 2023, research and development (R&D) expenses were $4.7 million, compared to $3.3 million for the same period in 2022. The increase was primarily due to an increase in KPI-012 development costs and employee-related costs.
- Loss on Fair Value Remeasurement of Deferred Purchase Consideration: There was no gain or loss on fair value remeasurement of deferred purchase consideration, in connection with the acquisition of Combangio, for the quarter ended December 31, 2023 due to the settlement of the liability in March 2023. The loss on fair value remeasurement of deferred purchase consideration was $0.4 million for the same period in 2022.
- Loss on Fair Value Remeasurement of Contingent Consideration: For the quarter ended December 31, 2023, the loss on fair value remeasurement of continent consideration, in connection with the Combangio acquisition, was $0.3 million, compared to a loss of $0.7 million for the same period in 2022.
- Operating Loss: For the quarter ended December 31, 2023, loss from operations was $9.6 million, compared to $10.3 million for the same period in 2022.
- Net Loss: For the quarter ended December 31, 2023, net loss was $8.6 million, or $3.18 per share, compared to a net loss of $12.8 million, or $7.97 per share, for the same period in 2022. The weighted average number of shares used to calculate net loss per share was 2.7 million for the quarter ended December 31, 2023, and 1.6 million for the quarter ended December 31, 2022.
- 銷售和收購費用：截至2023年12月31日的季度，銷售、一般和管理（SG&A）支出爲460萬美元，而2022年同期爲580萬美元。下降的主要原因是2022年7月將KALA的商業投資組合出售給了愛爾康公司（Alcon）。
- 研發費用：截至2023年12月31日的季度，研發（R&D）支出爲470萬美元，而2022年同期爲330萬美元。增長主要是由於 KPI-012 開發成本和員工相關成本的增加。
- 延期購買對價公允價值調整虧損：由於2023年3月的負債結算，截至2023年12月31日的季度，與收購Combangio相關的遞延購買對價的公允價值調整沒有損益。2022年同期遞延收購對價的公允價值調整虧損爲40萬美元。
- 或有對價的公允價值調整虧損：截至2023年12月31日的季度，與收購Combangio有關的大陸對價公允價值調整的虧損爲30萬美元，而2022年同期的虧損爲70萬美元。
- 營業虧損：截至2023年12月31日的季度，運營虧損爲960萬美元，而2022年同期爲1,030萬美元。
- 淨虧損：截至2023年12月31日的季度，淨虧損爲860萬美元，合每股虧損3.18美元，而2022年同期的淨虧損爲1,280萬美元，合每股虧損7.97美元。截至2023年12月31日的季度，用於計算每股淨虧損的加權平均股票數量爲270萬股，截至2022年12月31日的季度爲160萬股。
Financial Results for the Full Year Ended December 31, 2023:
截至2023年12月31日的全年財務業績：
- Net Product Revenues: KALA did not recognize product revenues in the full year ended December 31, 2023 as a result of the sale of its commercial portfolio to Alcon in July 2022. For the full year ended December 31, 2022, Kala reported net product revenues of $3.9 million.
- Cost of Product Revenues: KALA did not record cost of product revenues in the full year ended December 31, 2023 as a result of the sale of its commercial portfolio to Alcon in July 2022. For the full year ended December 31, 2022, cost of product revenues was $2.6 million.
- SG&A Expenses: For the full year ended December 31, 2023, SG&A expenses were $20.6 million, compared to $65.0 million for the same period in 2022. The decrease was primarily due to the sale of KALA's commercial portfolio to Alcon.
- R&D Expenses: For the full year ended December 31, 2023, R&D expenses were $18.6 million, compared to $17.7 million for the same period in 2022. The increase was primarily due to an increase in KPI-012 development costs and employee-related costs, partially offset by a decrease in other research and development costs, which primarily included preclinical studies related to KALA's former pipeline programs and facility related costs.
- (Gain) Loss on Fair Value Remeasurement of Deferred Purchase Consideration: For the full year ended December 31, 2023, the gain on fair value remeasurement of deferred purchase consideration, in connection with the acquisition of Combangio, was $0.2 million, compared to a loss of $0.6 million for the same period in 2022.
- Loss (Gain) on Fair Value Remeasurement of Contingent Consideration: For the full year ended December 31, 2023, the loss on fair value remeasurement of continent consideration, in connection with the Combangio acquisition, was $0.7 million, compared to a gain of $0.3 million for the same period in 2022.
- Operating Loss: For the full year ended December 31, 2023, loss from operations was $39.7 million, compared to $81.7 million for the same period in 2022.
- Loss on Extinguishment of Debt: For the full year ended December 31, 2023, KALA did not report a loss on extinguishment of debt, compared to a loss of $2.6 million in the same period in 2022 as a result of a partial prepayment of outstanding principal and related fees under its loan agreement with Oxford Finance LLC in connection with the closing of the sale of its commercial business to Alcon.
- Gain on Sale of Commercial Business: For the full year ended December 31, 2023, KALA did not report a gain on sale of commercial business, compared to a gain of $47.0 million for the same period in 2022 related to the sale of its commercial business to Alcon.
- Net Loss: For the full year ended December 31, 2023, net loss was $42.2 million, or $17.35 per share, compared to a net loss of $44.8 million, or $29.48 per share, for the same period in 2022. The weighted average number of shares used to calculate net loss per share was 2.4 million for the full year ended December 31, 2023, and 1.5 million for the full year ended December 31, 2022.
- 淨產品收入：由於2022年7月向愛爾康出售了其商業投資組合，KALA沒有確認截至2023年12月31日的全年產品收入。在截至2022年12月31日的全年中，Kala公佈的淨產品收入爲390萬美元。
- 產品收入成本：由於2022年7月向愛爾康出售了其商業投資組合，KALA在截至2023年12月31日的全年中沒有記錄產品收入成本。在截至2022年12月31日的全年中，產品收入成本爲260萬美元。
- 銷售和收購費用：截至2023年12月31日的全年銷售和收購支出爲2,060萬美元，而2022年同期爲6,500萬美元。下降的主要原因是向愛爾康出售了KALA的商業投資組合。
- 研發費用：在截至2023年12月31日的全年中，研發費用爲1,860萬美元，而2022年同期爲1,770萬美元。這一增長主要是由於 KPI-012 開發成本和員工相關成本的增加，但部分被其他研發成本的減少所抵消，其中主要包括與 KALA 以前的管道項目和設施相關成本相關的臨床前研究。
- 延期購買對價公允價值調整的虧損（收益）：在截至2023年12月31日的全年中，與收購Combangio相關的遞延收購對價的公允價值調整收益爲20萬美元，而2022年同期的虧損爲60萬美元。
- 或有對價公允價值調整的虧損（收益）：在截至2023年12月31日的全年中，與收購Combangio相關的大陸對價公允價值調整虧損爲70萬美元，而2022年同期的收益爲30萬美元。
- 營業虧損：截至2023年12月31日的全年運營虧損爲3,970萬美元，而2022年同期爲8,170萬美元。
- 債務清償損失：在截至2023年12月31日的全年中，KALA沒有報告債務清償損失，而2022年同期的虧損爲260萬美元，這是由於根據與牛津金融有限責任公司簽訂的貸款協議部分預付了與愛爾康商業業務出售有關的未償本金和相關費用。
- 出售商業業務的收益：在截至2023年12月31日的全年中，KALA沒有報告出售商業業務的收益，而2022年同期與向愛爾康出售商業業務相關的收益爲4,700萬美元。
- 淨虧損：截至2023年12月31日的全年中，淨虧損爲4,220萬美元，合每股虧損17.35美元，而2022年同期的淨虧損爲4,480萬美元，合每股虧損29.48美元。截至2023年12月31日的全年用於計算每股淨虧損的加權平均股票數爲240萬股，截至2022年12月31日的全年爲150萬股。
About KALA BIO, Inc.
關於 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.
KALA是一家臨床階段的生物製藥公司，致力於罕見和嚴重眼部疾病的創新療法的研究、開發和商業化。KALA 基於生物製劑的研究療法使用 KALA 專有的間充質幹細胞分泌組 (MSC-S) 平台。KALA 的主要候選產品 KPI-012 是人類 MSC-S，它含有許多人類衍生的生物因子，例如生長因子、蛋白酶抑制劑、基質蛋白和神經營養因子，有可能糾正角膜癒合受損，而角膜癒合受損是多種嚴重眼部疾病的潛在病因。KPI-012 目前正在臨床開發中，用於治療持續性角膜上皮缺損 (PCED)，這是一種罕見的角膜癒合受損疾病，已獲得美國食品藥品監督管理局的孤兒藥和快速通道認定。KALA 還着眼於 KPI-012 的潛在開發，用於治療邊緣幹細胞缺乏症和其他威脅視力的罕見角膜疾病，並已啓動臨床前研究，以評估其 MSC-S 平台對視網膜退行性疾病（例如色素性視網膜炎和斯塔加特病）的潛在效用。有關 KALA 的更多信息，請訪問 www.kalarx.com。
Forward-Looking Statements:
前瞻性陳述：
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.
本新聞稿包含1995年《私人證券訴訟改革法》所指的前瞻性陳述，涉及重大風險和不確定性。本新聞稿中關於 KALA 未來預期、計劃和前景的任何聲明，包括但不限於關於 KALA 對 KPI-012 及其 MSC-S 平台潛在優勢的期望的聲明；KPI-012 在 PCED 中的臨床用途；報告 KPI-012 CHASE 2b 期臨床試驗的預期時間表；KALA 認爲大通銀行 2b 期試驗可以作爲支持所需的兩項關鍵試驗中的第一項向食品和藥物管理局提交BLA；KALA計劃研究和開發關鍵績效指標-012 及其用於其他指標的 MSC-S 平台；對CIRM獎勵潛在收益和未來運營的預期；KALA實現指定里程碑並根據CIRM獎勵獲得全額資金的能力；KALA現有現金資源在預期期間的充足性；以及其他包含 “預測”、“相信”、“繼續”、“可能”、“估計”、“預期”、“打算” 等字樣的陳述” “可能”、“可能”、“計劃”、“潛在”、“預測”、“項目”、“應該”、“目標”、“將”、“將” 和類似的表述構成前瞻性-外觀陳述。由於各種重要因素，實際結果可能與此類前瞻性陳述所示結果存在重大差異，包括：KALA遵守CIRM獎項要求的能力；啓動和進行臨床前研究和臨床試驗所固有的不確定性；臨床試驗數據可用性和時間方面的不確定性；早期臨床試驗或不同疾病適應症的試驗結果是否將表明正在進行或未來試驗的結果；1b期的結果KPI-012 的臨床試驗將表明未來任何 KPI-012 臨床試驗和研究的結果，包括 CHASE 的 2b 期臨床試驗；臨床試驗的中期數據是否可以預測試驗結果；與臨床試驗監管審查和上市批准申請相關的不確定性；KALA 留住和僱用關鍵人員的能力；KALA 遵守其貸款協議契約的能力，包括要求其普通股繼續下去在納斯達克股票上市市場；現金資源的充足性、對額外融資的需求和其他重要因素，所有這些都可能導致KALA的實際業績與前瞻性陳述中包含的業績有所不同，KALA的10-K表年度報告、最新的10-Q表季度報告以及KALA向美國證券交易委員會提交的其他文件的 “風險因素” 部分對此進行了討論。這些前瞻性陳述代表了KALA截至本新聞稿發佈之日的觀點，不應將其視爲KALA自本新聞稿發佈之日之後的任何日期的觀點。除非法律要求，否則KALA不承擔任何義務更新任何前瞻性陳述，無論是由於新信息、未來事件還是其他原因。
Financial Tables:
財務表：
| KALA BIO, Inc. | ||||||
| Balance Sheet Data | ||||||
| (in thousands) | ||||||
| (unaudited) | ||||||
| December 31, | December 31, | |||||
| 2023 | 2022 | |||||
| Cash and cash equivalents | $ | 50,895 | $ | 70,495 | ||
| Total assets | 55,949 | 86,820 | ||||
| Working capital(1) | 44,524 | 60,257 | ||||
| Long-term debt, net of discounts | 34,190 | 37,937 | ||||
| Other long-term liabilities | 5,909 | 4,224 | ||||
| Total stockholders' equity | 7,504 | 18,974 | ||||
| (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. | ||||||
| 資產負債表數據 | ||||||
| （以千計） | ||||||
| （未經審計） | ||||||
| 十二月三十一日 | 十二月三十一日 | |||||
| 2023 | 2022 | |||||
| 現金和現金等價物 | $ | 50,895 | $ | 70,495 | ||
| 總資產 | 55,949 | 86,820 | ||||
| 營運資金(1) | 44,524 | 60,257 | ||||
| 扣除折扣後的長期債務 | 34,190 | 37,937 | ||||
| 其他長期負債 | 5,909 | 4,224 | ||||
| 股東權益總額 | 7,504 | 18,974 | ||||
| (1) 公司將營運資金定義爲流動資產減去流動負債。有關其流動資產和流動負債的更多信息，請參閱公司的合併財務報表。 | ||||||
| KALA BIO, Inc. | ||||||||||||
| Consolidated Statement of Operations | ||||||||||||
| (In thousands, except share and per share data) | ||||||||||||
| (Unaudited) | ||||||||||||
| Three Months Ended | Year Ended | |||||||||||
| December 31, | December 31, | |||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||
| Product revenues, net | $ | — | $ | — | $ | — | $ | 3,892 | ||||
| Costs and expenses: | ||||||||||||
| Cost of product revenues | — | — | — | 2,560 | ||||||||
| Selling, general and administrative | 4,623 | 5,831 | 20,567 | 65,035 | ||||||||
| Research and development | 4,718 | 3,323 | 18,586 | 17,653 | ||||||||
| Loss (gain) on fair value remeasurement of deferred purchase consideration | — | 433 | (230) | 638 | ||||||||
| Loss (gain) on fair value remeasurement of contingent consideration | 278 | 664 | 740 | (288) | ||||||||
| Total operating expenses | 9,619 | 10,251 | 39,663 | 85,598 | ||||||||
| Loss from operations | (9,619) | (10,251) | (39,663) | (81,706) | ||||||||
| Other income (expense): | ||||||||||||
| Interest income | 610 | 354 | 2,711 | 664 | ||||||||
| Interest expense | (1,468) | (1,577) | (5,814) | (7,266) | ||||||||
| Grant income | 1,855 | — | 4,825 | — | ||||||||
| Loss on extinguishment of debt | — | — | — | (2,583) | ||||||||
| Gain on sale of commercial business | — | — | — | 46,995 | ||||||||
| Other income (expense), net | (5) | (1,369) | (4,258) | (926) | ||||||||
| Total other income (expense) | 992 | (2,592) | (2,536) | 36,884 | ||||||||
| Net loss | $ | (8,627) | $ | (12,843) | $ | (42,199) | $ | (44,822) | ||||
| Net loss per share attributable to common stockholders—basic and diluted | $ | (3.18) | $ | (7.97) | $ | (17.35) | $ | (29.48) | ||||
| Weighted average shares outstanding—basic and diluted | 2,712,475 | 1,611,375 | 2,432,008 | 1,520,611 | ||||||||
| KALA BIO, Inc. | ||||||||||||
| 合併運營報表 | ||||||||||||
| （以千計，股票和每股數據除外） | ||||||||||||
| （未經審計） | ||||||||||||
| 三個月已結束 | 年終了 | |||||||||||
| 十二月三十一日 | 十二月三十一日 | |||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||
| 產品收入，淨額 | $ | — | $ | — | $ | — | $ | 3,892 | ||||
| 成本和支出： | ||||||||||||
| 產品收入成本 | — | — | — | 2,560 | ||||||||
| 銷售、一般和管理 | 4,623 | 5,831 | 20,567 | 65,035 | ||||||||
| 研究和開發 | 4,718 | 3,323 | 18,586 | 17,653 | ||||||||
| 遞延購買對價公允價值調整的虧損（收益） | — | 433 | (230) | 638 | ||||||||
| 公允價值重新計量或有對價的虧損（收益） | 278 | 664 | 740 | (288) | ||||||||
| 運營費用總額 | 9,619 | 10,251 | 39,663 | 85,598 | ||||||||
| 運營損失 | (9,619) | (10,251) | (39,663) | (81,706) | ||||||||
| 其他收入（支出）： | ||||||||||||
| 利息收入 | 610 | 354 | 2,711 | 664 | ||||||||
| 利息支出 | (1,468) | (1,577) | (5,814) | (7,266) | ||||||||
| 補助金收入 | 1,855 | — | 4,825 | — | ||||||||
| 債務消滅造成的損失 | — | — | — | (2,583) | ||||||||
| 出售商業業務的收益 | — | — | — | 46,995 | ||||||||
| 其他收入（支出），淨額 | (5) | (1,369) | (4,258) | (926) | ||||||||
| 其他收入總額（支出） | 992 | (2,592) | (2,536) | 36,884 | ||||||||
| 淨虧損 | $ | (8,627) | $ | (12,843) | $ | (42,199) | $ | (44,822) | ||||
| 歸屬於普通股股東的每股淨虧損——基本虧損和攤薄後 | $ | (3.18) | $ | (7.97) | $ | (17.35) | $ | (29.48) | ||||
| 加權平均流通股——基本股和攤薄後股票 | 2,712,475 | 1,611,375 | 2,432,008 | 1,520,611 | ||||||||
Investor Contact:
Hannah Deresiewicz
hannah.deresiewicz@sternir.com
212-362-1200
投資者聯繫人：
漢娜·德雷西維奇
hannah.deresiewicz@sternir.com
212-362-1200
譯文內容由第三人軟體翻譯。