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 --
— 推进正在进行的针对 PCED KPI-012 的 CHASE 第 2b 期试验；目标是在 2024 年年底之前提供头条数据 —
--探索将 KPI-012 扩展到其他角膜适应症的机会-
— 截至2023年12月31日的现金资源，加上2024年3月私募的收益和CIRM奖励的预期剩余资金，预计将为2025年第三季度的运营提供资金——
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.
马萨诸塞州阿灵顿，2024年3月29日（GLOBE NEWSWIRE）——致力于罕见和严重眼部疾病创新疗法研究、开发和商业化的临床阶段生物制药公司KALA BIO, Inc.（纳斯达克股票代码：KALA）今天公布了截至2023年12月31日的第四季度和全年财务业绩，并提供了公司最新情况。
"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，我们专注于临床执行，推进了用于治疗 PCED 的 KPI-012 的 2b 期 CHASE 试验。2023 年 3 月，我们公布了来自第一批患者的积极安全数据，强化了高剂量 KPI-012 令人鼓舞的安全性和耐受性，使我们得以进入多中心、随机、双面罩的疗效队列，我们的目标是在2024年年底之前宣读该队列。” KALA BIO董事长兼首席执行官马克·伊维基说。“基于其多因素作用机制，我们认为 KPI-012 可以解决尚未满足的重大需求，有可能为患者和医生提供高度差异化的产品概况和第一种针对该疾病多种潜在病因的PCED疗法。我们期待着来自CHASE试验的主要数据，因为我们正在努力将 KPI-012 确立为一种安全、耐受性好、易于施用且有效的治疗方法，适用于美国近10万名PCED患者。”
Fourth Quarter and Recent Business Highlights:
第四季度和近期业务亮点：
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.
开发阶段的管道：
KALA 正在推进基于其专有的间充质干细胞分泌组 (MSC-S) 平台的创新产品线。KALA认为，其MSC-S平台技术的多因素作用机制可能使其能够为一系列眼部孤儿病生产产品，并且正在评估该技术在多种罕见的前眼和眼后疾病方面的潜在发展。
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 结合了生长因子、蛋白酶抑制剂、基质蛋白和神经营养因子，有可能纠正角膜愈合受损，角膜愈合受损是多种严重眼部疾病的潜在病因。
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 最初正在开发用于治疗持续性角膜上皮缺损 (PCED) 的 KPI-012，这是一种持续的、无法愈合的角膜缺损或伤口，是传统治疗难以治愈的，如果不加以治疗，可能会导致严重的并发症，包括感染、角膜穿孔/疤痕和视力丧失。据估计，PCED在美国的发病率约为100,000名患者，这是一个巨大的市场机会；目前没有经美国食品药品监督管理局（FDA）批准的针对PCED所有潜在病因的广泛适应症的处方产品。
- 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 正在积极招募患者参加 CHASE（Secretome 疗法后的角膜愈合）2b 期临床试验的主要安全性和有效性部分，该试验旨在评估 KPI-012 治疗PCED，并计划在 2024 年年底之前公布主要数据。
- 如果结果是积极的，并且有待与监管机构进行讨论，KALA认为CHASE的2b期试验可以作为支持向FDA提交生物制剂许可申请（BLA）所需的两项关键试验中的第一项。
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 还在评估 KPI-012 可能导致其他罕见的前眼疾病，例如边缘干细胞缺乏症 (LSCD) 和其他威胁视力的角膜疾病。LSCD的特征是边缘上皮干细胞的流失或缺乏，这可能导致反复的上皮分解、新生血管形成、结膜形成、炎症和其他后遗症，从而导致角膜清晰度下降和视力受损。与PCED一样，LSCD代表着巨大的市场机会，估计美国的发病率为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 的临床前项目，旨在评估其 MSC-S 平台对遗传性视网膜退行性疾病的效用，它含有神经营养因子、生长因子、抗炎或免疫调节因子和抗氧化抑制剂，有可能保护和维持视网膜细胞功能。分泌组在两者中均显示出神经保护作用 体外 和 在活体中 视网膜变性的模型。KALA 认为，KPI-014 可以为罕见的遗传性视网膜疾病的治疗提供一种与基因无关的方法，并已启动临床前研究，以评估 KPI-014 对色素性视网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.
企业：
2023年12月和2024年3月，KALA宣布与机构投资者进行私募融资，根据纳斯达克规则在市场上定价。融资总收益分别约为200万美元和860万美元。
Financial Results:
财务业绩：
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.
现金状况：截至2023年12月31日，KALA的现金及现金等价物为5,090万美元，而截至2023年9月30日为5,610万美元。这一减少反映了运营中使用的现金以及从KALA2023年12月的私募融资中获得的200万美元总收益。根据其目前的计划，KALA预计，截至2023年12月31日的现金资源，加上从2024年3月的私募融资中获得的860万美元总收益和CIRM奖励下的预期融资，将使其能够为2025年第三季度的运营提供资金。
Financial Results for the Three Months Ended December 31, 2023:
截至2023年12月31日的三个月的财务业绩：
- 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.
- 销售和收购费用：截至2023年12月31日的季度，销售、一般和管理（SG&A）支出为460万美元，而2022年同期为580万美元。下降的主要原因是2022年7月将KALA的商业投资组合出售给了爱尔康公司（Alcon）。
- 研发费用：截至2023年12月31日的季度，研发（R&D）支出为470万美元，而2022年同期为330万美元。增长主要是由于 KPI-012 开发成本和员工相关成本的增加。
- 延期购买对价公允价值调整亏损：由于2023年3月的负债结算，截至2023年12月31日的季度，与收购Combangio相关的递延购买对价的公允价值调整没有损益。2022年同期递延收购对价的公允价值调整亏损为40万美元。
- 或有对价的公允价值调整亏损：截至2023年12月31日的季度，与收购Combangio有关的大陆对价公允价值调整的亏损为30万美元，而2022年同期的亏损为70万美元。
- 营业亏损：截至2023年12月31日的季度，运营亏损为960万美元，而2022年同期为1,030万美元。
- 净亏损：截至2023年12月31日的季度，净亏损为860万美元，合每股亏损3.18美元，而2022年同期的净亏损为1,280万美元，合每股亏损7.97美元。截至2023年12月31日的季度，用于计算每股净亏损的加权平均股票数量为270万股，截至2022年12月31日的季度为160万股。
Financial Results for the Full Year Ended December 31, 2023:
截至2023年12月31日的全年财务业绩：
- 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.
- 净产品收入：由于2022年7月向爱尔康出售了其商业投资组合，KALA没有确认截至2023年12月31日的全年产品收入。在截至2022年12月31日的全年中，Kala公布的净产品收入为390万美元。
- 产品收入成本：由于2022年7月向爱尔康出售了其商业投资组合，KALA在截至2023年12月31日的全年中没有记录产品收入成本。在截至2022年12月31日的全年中，产品收入成本为260万美元。
- 销售和收购费用：截至2023年12月31日的全年销售和收购支出为2,060万美元，而2022年同期为6,500万美元。下降的主要原因是向爱尔康出售了KALA的商业投资组合。
- 研发费用：在截至2023年12月31日的全年中，研发费用为1,860万美元，而2022年同期为1,770万美元。这一增长主要是由于 KPI-012 开发成本和员工相关成本的增加，但部分被其他研发成本的减少所抵消，其中主要包括与 KALA 以前的管道项目和设施相关成本相关的临床前研究。
- 延期购买对价公允价值调整的亏损（收益）：在截至2023年12月31日的全年中，与收购Combangio相关的递延收购对价的公允价值调整收益为20万美元，而2022年同期的亏损为60万美元。
- 或有对价公允价值调整的亏损（收益）：在截至2023年12月31日的全年中，与收购Combangio相关的大陆对价公允价值调整亏损为70万美元，而2022年同期的收益为30万美元。
- 营业亏损：截至2023年12月31日的全年运营亏损为3,970万美元，而2022年同期为8,170万美元。
- 债务清偿损失：在截至2023年12月31日的全年中，KALA没有报告债务清偿损失，而2022年同期的亏损为260万美元，这是由于根据与牛津金融有限责任公司签订的贷款协议部分预付了与爱尔康商业业务出售有关的未偿本金和相关费用。
- 出售商业业务的收益：在截至2023年12月31日的全年中，KALA没有报告出售商业业务的收益，而2022年同期与向爱尔康出售商业业务相关的收益为4,700万美元。
- 净亏损：截至2023年12月31日的全年中，净亏损为4,220万美元，合每股亏损17.35美元，而2022年同期的净亏损为4,480万美元，合每股亏损29.48美元。截至2023年12月31日的全年用于计算每股净亏损的加权平均股票数为240万股，截至2022年12月31日的全年为150万股。
About KALA BIO, Inc.
关于 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是一家临床阶段的生物制药公司，致力于罕见和严重眼部疾病的创新疗法的研究、开发和商业化。KALA 基于生物制剂的研究疗法使用 KALA 专有的间充质干细胞分泌组 (MSC-S) 平台。KALA 的主要候选产品 KPI-012 是人类 MSC-S，它含有许多人类衍生的生物因子，例如生长因子、蛋白酶抑制剂、基质蛋白和神经营养因子，有可能纠正角膜愈合受损，而角膜愈合受损是多种严重眼部疾病的潜在病因。KPI-012 目前正在临床开发中，用于治疗持续性角膜上皮缺损 (PCED)，这是一种罕见的角膜愈合受损疾病，已获得美国食品药品监督管理局的孤儿药和快速通道认定。KALA 还着眼于 KPI-012 的潜在开发，用于治疗边缘干细胞缺乏症和其他威胁视力的罕见角膜疾病，并已启动临床前研究，以评估其 MSC-S 平台对视网膜退行性疾病（例如色素性视网膜炎和斯塔加特病）的潜在效用。有关 KALA 的更多信息，请访问 www.kalarx.com。
Forward-Looking Statements:
前瞻性陈述：
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.
本新闻稿包含1995年《私人证券诉讼改革法》所指的前瞻性陈述，涉及重大风险和不确定性。本新闻稿中关于 KALA 未来预期、计划和前景的任何声明，包括但不限于关于 KALA 对 KPI-012 及其 MSC-S 平台潜在优势的期望的声明；KPI-012 在 PCED 中的临床用途；报告 KPI-012 CHASE 2b 期临床试验的预期时间表；KALA 认为大通银行 2b 期试验可以作为支持所需的两项关键试验中的第一项向食品和药物管理局提交BLA；KALA计划研究和开发关键绩效指标-012 及其用于其他指标的 MSC-S 平台；对CIRM奖励潜在收益和未来运营的预期；KALA实现指定里程碑并根据CIRM奖励获得全额资金的能力；KALA现有现金资源在预期期间的充足性；以及其他包含 “预测”、“相信”、“继续”、“可能”、“估计”、“预期”、“打算” 等字样的陈述” “可能”、“可能”、“计划”、“潜在”、“预测”、“项目”、“应该”、“目标”、“将”、“将” 和类似的表述构成前瞻性-外观陈述。由于各种重要因素，实际结果可能与此类前瞻性陈述所示结果存在重大差异，包括：KALA遵守CIRM奖项要求的能力；启动和进行临床前研究和临床试验所固有的不确定性；临床试验数据可用性和时间方面的不确定性；早期临床试验或不同疾病适应症的试验结果是否将表明正在进行或未来试验的结果；1b期的结果KPI-012 的临床试验将表明未来任何 KPI-012 临床试验和研究的结果，包括 CHASE 的 2b 期临床试验；临床试验的中期数据是否可以预测试验结果；与临床试验监管审查和上市批准申请相关的不确定性；KALA 留住和雇用关键人员的能力；KALA 遵守其贷款协议契约的能力，包括要求其普通股继续下去在纳斯达克股票上市市场；现金资源的充足性、对额外融资的需求和其他重要因素，所有这些都可能导致KALA的实际业绩与前瞻性陈述中包含的业绩有所不同，KALA的10-K表年度报告、最新的10-Q表季度报告以及KALA向美国证券交易委员会提交的其他文件的 “风险因素” 部分对此进行了讨论。这些前瞻性陈述代表了KALA截至本新闻稿发布之日的观点，不应将其视为KALA自本新闻稿发布之日之后的任何日期的观点。除非法律要求，否则KALA不承担任何义务更新任何前瞻性陈述，无论是由于新信息、未来事件还是其他原因。
Financial Tables:
财务表：
| 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. | ||||||
| 资产负债表数据 | ||||||
| （以千计） | ||||||
| （未经审计） | ||||||
| 十二月三十一日 | 十二月三十一日 | |||||
| 2023 | 2022 | |||||
| 现金和现金等价物 | $ | 50,895 | $ | 70,495 | ||
| 总资产 | 55,949 | 86,820 | ||||
| 营运资金(1) | 44,524 | 60,257 | ||||
| 扣除折扣后的长期债务 | 34,190 | 37,937 | ||||
| 其他长期负债 | 5,909 | 4,224 | ||||
| 股东权益总额 | 7,504 | 18,974 | ||||
| (1) 公司将营运资金定义为流动资产减去流动负债。有关其流动资产和流动负债的更多信息，请参阅公司的合并财务报表。 | ||||||
| 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. | ||||||||||||
| 合并运营报表 | ||||||||||||
| （以千计，股票和每股数据除外） | ||||||||||||
| （未经审计） | ||||||||||||
| 三个月已结束 | 年终了 | |||||||||||
| 十二月三十一日 | 十二月三十一日 | |||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||
| 产品收入，净额 | $ | — | $ | — | $ | — | $ | 3,892 | ||||
| 成本和支出： | ||||||||||||
| 产品收入成本 | — | — | — | 2,560 | ||||||||
| 销售、一般和管理 | 4,623 | 5,831 | 20,567 | 65,035 | ||||||||
| 研究和开发 | 4,718 | 3,323 | 18,586 | 17,653 | ||||||||
| 递延购买对价公允价值调整的亏损（收益） | — | 433 | (230) | 638 | ||||||||
| 公允价值重新计量或有对价的亏损（收益） | 278 | 664 | 740 | (288) | ||||||||
| 运营费用总额 | 9,619 | 10,251 | 39,663 | 85,598 | ||||||||
| 运营损失 | (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) | ||||||||
| 补助金收入 | 1,855 | — | 4,825 | — | ||||||||
| 债务消灭造成的损失 | — | — | — | (2,583) | ||||||||
| 出售商业业务的收益 | — | — | — | 46,995 | ||||||||
| 其他收入（支出），净额 | (5) | (1,369) | (4,258) | (926) | ||||||||
| 其他收入总额（支出） | 992 | (2,592) | (2,536) | 36,884 | ||||||||
| 净亏损 | $ | (8,627) | $ | (12,843) | $ | (42,199) | $ | (44,822) | ||||
| 归属于普通股股东的每股净亏损——基本亏损和摊薄后 | $ | (3.18) | $ | (7.97) | $ | (17.35) | $ | (29.48) | ||||
| 加权平均流通股——基本股和摊薄后股票 | 2,712,475 | 1,611,375 | 2,432,008 | 1,520,611 | ||||||||
Investor Contact:
Hannah Deresiewicz
hannah.deresiewicz@sternir.com
212-362-1200
投资者联系人：
汉娜·德雷西维奇
hannah.deresiewicz@sternir.com
212-362-1200
译文内容由第三方软件翻译。