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KALA BIO Reports First Quarter 2024 Financial Results and Provides Corporate Update

KALA BIO Reports First Quarter 2024 Financial Results and Provides Corporate Update

KALA BIO公佈2024年第一季度財務業績並提供公司最新情況
Kala Pharmaceuticals ·  05/14 12:00

-- Patient enrollment ongoing in Phase 2b CHASE trial of KPI-012 for PCED; targeting topline data by year-end 2024 --

— PCED KPI-012 的 2b 期 CHASE 試驗正在進行患者入組;目標是在 2024 年年底之前獲得頭號數據 —

-- Evaluating opportunities to expand KPI-012 development into other corneal diseases, including LSCD and to explore KPI-014 in rare inherited retinal diseases --

— 評估將 KPI-012 的發展擴展到包括 LSCD 在內的其他角膜疾病的機會,並探索 KPI-014 在罕見遺傳性視網膜疾病中的應用 —

-- Cash resources of $48.5 million as of March 31, 2024 together with anticipated funding remaining from CIRM award expected to fund operations into 3Q 2025 --

— 截至2024年3月31日,現金資源爲4,850萬美元,預計CIRM獎勵中剩餘的資金將爲2025年第三季度的運營提供資金——

ARLINGTON, Mass., May 14, 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 first quarter ended March 31, 2024 and provided a corporate update.

馬薩諸塞州阿靈頓,2024年5月14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2024年3月31日的第一季度財務業績,並提供了公司最新情況。

"In 2024, we are acutely focused on advancing our clinical program for KPI-012 in PCED, a rare, devastating disease caused by an array of underlying etiologies, many of which cannot be treated with currently approved therapeutic options," said Mark Iwicki, Chair and Chief Executive Officer of KALA BIO. "Given its multifactorial mechanism of action and based on clinical data to-date, we believe KPI-012 has the potential to address the multiple impaired corneal healing processes that cause PCED and provide patients a well-tolerated, easily administered and effective therapy. We are targeting topline data from our ongoing Phase 2b CHASE trial by year end which, if successful, could serve as the first of two pivotal trials required to support a BLA submission."

KALA BIO董事長兼首席執行官Mark Iwicki表示:“2024年,我們將集中精力推進PCED KPI-012 的臨床計劃,這是一種罕見的毀滅性疾病,由一系列潛在病因引起,其中許多病因無法使用目前批准的治療方案進行治療。”“鑑於其多因素作用機制和迄今爲止的臨床數據,我們認爲,KPI-012 有可能解決導致 PCED 的多種角膜癒合過程受損,併爲患者提供耐受性良好、易於施用和有效的治療。我們的目標是在年底之前獲得正在進行的2b CHASE試驗的主要數據,如果成功,該試驗可能成爲支持BLA提交所需的兩項關鍵試驗中的第一項。”

Mr. Iwicki continued, "In parallel, we remain committed to exploring the potential of our platform technology more broadly, as we work to establish KALA as a leader in the emerging field of mesenchymal stem cell secretome therapy. We believe KPI-012 represents a pipeline-in-a-product opportunity and plan to leverage our investigational new drug-enabling activities in PCED to support follow-on indications across a range of corneal diseases, while also exploring the potential for KPI-014, our second asset, across a range of rare, inherited retinal diseases."

Iwicki先生繼續說:“同時,我們將繼續致力於更廣泛地探索平台技術的潛力,努力將KALA打造成間充質幹細胞分泌組療法新興領域的領導者。我們認爲,KPI-012 是產品上市的機會,並計劃利用我們在PCED中正在研究的新藥賦能活動來支持一系列角膜疾病的後續適應症,同時探索我們的第二大資產 KPI-014 在一系列罕見的遺傳性視網膜疾病中的潛力。”

First Quarter and Recent Business Highlights:

第一季度和近期業務亮點:

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.

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。

KALA's lead product candidate, 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.

KALA 的主要候選產品 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,而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 we believe 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,我們認爲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 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 are targeting the announcement of topline data by year-end 2024. 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 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, 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 繼續招募患者參加 CHASE(Secretome 療法後的角膜癒合)2b 期臨床試驗,該試驗評估 KPI-012 治療PCED,並計劃在 2024 年年底之前公佈頭號數據。該公司認爲,CHASE的2b期試驗有可能作爲支持向美國食品藥品管理局提交生物製劑許可申請(BLA)的兩項關鍵研究中的第一項,這取決於積極的結果並有待與監管機構的討論。
  • KALA 還在探索 KPI-012 治療其他罕見眼前疾病的可能性,包括邊緣幹細胞缺乏症 (LSCD) 和其他角膜疾病。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。

Financial Results:

財務業績:

Cash Position: As of March 31, 2024, KALA had cash and cash equivalents of $48.5 million, compared to $50.9 million as of December 31, 2023. This decrease reflects cash used in operations, partially offset by gross proceeds of $8.6 million received from KALA's March 2024 private placement financing. Based on its current plans, KALA anticipates that its cash resources as of March 31, 2024, together with anticipated funding under the CIRM award, will enable it to fund operations into the third quarter of 2025.

現金狀況:截至2024年3月31日,KALA的現金及現金等價物爲4,850萬美元,而截至2023年12月31日爲5,090萬美元。這一減少反映了運營中使用的現金,但部分被KALA2024年3月私募融資的860萬美元總收益所抵消。根據其目前的計劃,KALA預計,截至2024年3月31日的現金資源,加上CIRM獎勵下的預期資金,將使其能夠爲2025年第三季度的運營提供資金。

First Quarter 2024 Financial Results:

2024 年第一季度財務業績:

  • G&A Expenses: For the quarter ended March 31, 2024, general and administrative (G&A) expenses were $5.4 million, compared to $6.0 million for the same period in 2023. The decrease was primarily due to a decrease in administrative and professional service fees, partially offset by an increase in stock-based compensation costs and employee related costs.
  • R&D Expenses: For the quarter ended March 31, 2024, research and development (R&D) expenses were $6.4 million, compared to $4.0 million for the same period in 2023. The increase was primarily due to an increase in KPI-012 development costs and employee-related costs, as we advance the clinical development of KPI-012, and an increase in other research and development costs.
  • Gain on Fair Value Remeasurement of Deferred Purchase Consideration: For the quarter ended March 31, 2024, there was no gain or loss on fair value remeasurement of deferred purchase consideration, in connection with the acquisition of Combangio. For the same period in 2023, there was a gain of $0.2 million.
  • Loss on Fair Value Remeasurement of Contingent Consideration: For the quarter ended March 31, 2024, the loss on fair value remeasurement of continent consideration, in connection with the Combangio acquisition, was $0.2 million, compared to a loss of $1.8 million for the same period in 2023.
  • Operating Loss: For the quarter ended March 31, 2024, loss from operations was $11.9 million, compared to $11.7 million for the same period in 2023.
  • Net Loss: For the quarter ended March 31, 2024, net loss was $11.8 million, or $4.20 per share, compared to a net loss of $14.5 million, or $6.99 per share, for the same period in 2023. The weighted average number of shares used to calculate net loss per share was 2.8 million for the quarter ended March 31, 2024, and 2.1 million for the quarter ended March 31, 2023.
  • 併購費用:截至2024年3月31日的季度,一般和行政(G&A)支出爲540萬美元,而2023年同期爲600萬美元。下降的主要原因是行政和專業服務費的減少,但股票薪酬成本和員工相關成本的增加部分抵消了這一減少。
  • 研發費用:截至2024年3月31日的季度,研發(R&D)支出爲640萬美元,而2023年同期爲400萬美元。增長的主要原因是,隨着我們推進 KPI-012 的臨床開發,KPI-012 的開發成本和員工相關成本的增加,以及其他研發成本的增加。
  • 延期購買對價公允價值調整的收益:在截至2024年3月31日的季度中,與收購Combangio相關的遞延收購對價的公允價值調整沒有損益。在2023年同期,收益爲20萬美元。
  • 或有對價的公允價值調整虧損:截至2024年3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20萬美元,而2023年同期的虧損爲180萬美元。
  • 營業虧損:截至2024年3月31日的季度,運營虧損爲1190萬美元,而2023年同期爲1170萬美元。
  • 淨虧損:截至2024年3月31日的季度,淨虧損爲1180萬美元,合每股虧損4.20美元,而2023年同期的淨虧損爲1,450萬美元,合每股虧損6.99美元。截至2024年3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280萬股,截至2023年3月31日的季度爲210萬股。

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)
March 31, December 31,
2024 2023
Cash and cash equivalents $ 48,478 $ 50,895
Total assets 53,033 55,949
Working capital (1) 38,208 44,524
Long-term debt, net of discounts 28,510 34,190
Other long-term liabilities 5,983 5,909
Total stockholders' equity 6,661 7,504
KALA BIO, Inc.
資產負債表數據
(以千計)
(未經審計)
3月31日 十二月三十一日
2024 2023
現金和現金等價物 $ 48,478 $ 50,895
總資產 53,033 55,949
營運資金 (1) 38,208 44,524
扣除折扣後的長期債務 28,510 34,190
其他長期負債 5,983 5,909
股東權益總額 6,661 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.
(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
March 31,
2024 2023
Costs and expenses:
General and administrative $ 5,422 $ 6,030
Research and development 6,351 4,036
Gain on fair value remeasurement of deferred purchase consideration (230)
Loss on fair value remeasurement of contingent consideration 158 1,847
Total operating expenses 11,931 11,683
Loss from operations (11,931) (11,683)
Other income (expense):
Interest income 504 675
Interest expense (1,455) (1,474)
Grant income 1,075
Other (expense) income, net (1,973)
Net loss $ (11,807) $ (14,455)
Net loss per share attributable to common stockholders—basic and diluted $ (4.20) $ (6.99)
Weighted average shares outstanding—basic and diluted 2,813,210 2,069,186
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
3月31日
2024 2023
成本和支出:
一般和行政 $ 5,422 $ 6,030
研究和開發 6,351 4,036
對延期購買對價進行公允價值調整後的收益 (230)
或有對價公允價值重新計量的損失 158 1,847
運營費用總額 11,931 11,683
運營損失 (11,931) (11,683)
其他收入(支出):
利息收入 504 675
利息支出 (1,455) (1,474)
補助金收入 1,075
其他(支出)收入,淨額 (1,973)
淨虧損 $ (11,807) $ (14,455)
歸屬於普通股股東的每股淨虧損——基本虧損和攤薄後 $ (4.20) $ (6.99)
加權平均流通股——基本股和攤薄後股票 2,813,210 2,069,186

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。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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