KALA BIO, Inc. KALA
We are a biopharmaceutical company in transition, evaluating the development of a dedicated, on-premises artificial intelligence (AI) infrastructure platform for the biotechnology industry. Our current focus is leveraging our mesenchymal stem cell secretome ("MSC-S") platform to test development of a scalable AI platform-as-a-service business to deploy secure, purpose-built AI systems directly within biotech and pharmaceutical client environments. We have historically been engaged in the research, development and commercialization of innovative therapies for rare and severe diseases of the front and back of the eye. Our lead product candidate was KPI-012, MSC-S, which we acquired from Combangio, Inc. ("Combangio") on November 15, 2021. KPI-012 was in clinical development for the treatment of persistent corneal epithelial defects ("PCED"), a rare disease of impaired corneal healing. Based on the results of a Phase 1b clinical safety and efficacy trial of KPI-012 in patients with PCED, we submitted an investigational new drug application to the U.S. Food and Drug Administration ("FDA"), which was accepted in December 2022. In February 2023, we dosed our first patient in the United States in our CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial of KPI-012 for PCED (the "CHASE trial"). By September 2025, the CHASE trial did not meet its primary endpoints, and we determined to discontinue our development of KPI-012 and the MSC-S platform. We have since expanded upon our business to evaluate strategic alternatives for our legacy MSC-S assets and capitalize on the substantial intellectual property (IP), proprietary biological datasets, and research experience generated during the clinical trials by starting development of an AI platform.
Valuation FY2025 figures against the last close
Annual financial statements
Income statement
| Fiscal year | FY2025 | FY2024 | FY2023 | FY2022 | FY2021 | FY2020 | FY2019 | FY2018 | FY2017 | FY2016 |
|---|---|---|---|---|---|---|---|---|---|---|
| Revenue | $0 | $0 | $0 | $3.9M | $11.2M | $6.4M | $6.1M | — | $0 | $0 |
| R&D | — | — | — | — | — | $18.4M | $27.3M | $29.3M | $29.0M | $25.0M |
| SG&A | $23.6M | $18.3M | $20.6M | $65.0M | $105.1M | $81.1M | $65.0M | $35.4M | $10.9M | $7.6M |
| Total operating expenses | $39.2M | $41.0M | $39.7M | $85.6M | $141.5M | $102.6M | $94.3M | $64.7M | $39.9M | $32.7M |
| Operating income | -$39.2M | -$41.0M | -$39.7M | -$81.7M | -$130.2M | -$96.2M | -$88.2M | -$64.7M | -$39.9M | -$32.7M |
| Interest expense | $3.3M | $5.8M | $5.8M | $7.3M | $8.4M | $8.6M | $8.5M | $3.3M | $1.0M | $767.0K |
| Pre-tax income | -$27.0M | -$38.5M | -$42.2M | -$44.8M | -$142.6M | -$104.3M | -$94.3M | -$66.7M | -$42.2M | -$33.2M |
| Income tax | $0 | $0 | $0 | $0 | $0 | $0 | $0 | $0 | $0 | $0 |
| Net income | -$27.0M | -$38.5M | -$42.2M | -$44.8M | -$142.6M | -$104.3M | -$94.3M | -$66.7M | -$42.2M | -$33.2M |
| EPS, basic | -3.31 | -10.15 | -17.35 | -29.48 | -108.32 | -1.99 | — | — | — | — |
| EPS, diluted | -3.31 | -10.15 | -17.35 | -29.48 | -108.32 | -1.99 | -2.76 | -2.49 | -3.71 | -28.07 |
| Shares, diluted (wtd. avg.) | 8.1M | 3.8M | 2.4M | 1.5M | 1.3M | 52.4M | — | — | — | — |
Balance sheet
| Fiscal year | FY2025 | FY2024 | FY2023 | FY2022 | FY2021 | FY2020 | FY2019 | FY2018 | FY2017 | FY2016 |
|---|---|---|---|---|---|---|---|---|---|---|
| Cash and equivalents | $7.6M | $51.2M | $50.9M | $70.5M | $92.1M | $77.3M | $85.4M | $183.1M | $114.7M | $45.6M |
| Short-term investments | — | — | — | — | — | $76.3M | — | — | — | — |
| Receivables | — | — | — | $195.0K | $15.3M | $9.6M | $11.6M | — | — | — |
| Inventory | — | — | — | — | $8.6M | $5.2M | $4.6M | $4.1M | — | — |
| Total current assets | $9.5M | $52.8M | $52.9M | $85.9M | $124.4M | $171.4M | $105.5M | $177.0M | $115.2M | $45.6M |
| Property, plant and equipment | — | $749.0K | $753.0K | $400.0K | $2.7M | $3.2M | $2.7M | $2.2M | $786.0K | $594.0K |
| Total assets | $9.5M | $55.5M | $55.9M | $86.8M | $139.4M | $221.6M | $154.3M | $221.0M | $116.5M | $46.3M |
| Accounts payable | $986.0K | $628.0K | $919.0K | $2.8M | $4.9M | $1.7M | $2.5M | $5.4M | $1.2M | $997.0K |
| Short-term debt | — | $10.3M | — | $5.0M | — | — | — | — | $6.7M | $556.0K |
| Total current liabilities | $2.5M | $17.0M | $8.3M | $25.7M | $37.4M | $22.2M | $24.8M | $17.0M | $14.9M | $5.5M |
| Long-term debt | — | $20.1M | $34.2M | $37.9M | $78.9M | $72.2M | $71.2M | $70.2M | $12.0M | $9.1M |
| Total liabilities | $2.5M | $43.2M | $48.4M | $67.8M | $122.6M | $121.6M | $124.6M | $116.0M | $26.9M | $15.7M |
| Retained earnings | -$694.9M | -$667.9M | -$629.4M | -$587.2M | -$542.4M | -$399.8M | -$295.5M | -$201.1M | -$134.4M | -$92.1M |
| Total equity | $7.0M | $12.3M | $7.5M | $19.0M | $16.8M | $100.0M | $29.7M | $105.0M | $89.7M | -$87.8M |
Cash flow
| Fiscal year | FY2025 | FY2024 | FY2023 | FY2022 | FY2021 | FY2020 | FY2019 | FY2018 | FY2017 | FY2016 |
|---|---|---|---|---|---|---|---|---|---|---|
| Operating cash flow | -$32.0M | -$29.4M | -$27.9M | -$78.9M | -$108.2M | -$90.7M | -$92.7M | -$54.1M | -$34.1M | -$27.3M |
| Depreciation and amortisation | $317.0K | $259.0K | $303.0K | $537.0K | $975.0K | $912.0K | $843.0K | $352.0K | $287.0K | $297.0K |
| Stock-based compensation | $7.0M | $8.4M | $7.5M | $7.0M | $16.1M | $13.3M | $10.0M | $8.6M | $3.6M | $2.1M |
| Capital expenditure | — | — | — | — | — | — | $1.3M | $1.6M | $480.0K | $153.0K |
| Investing cash flow | -$15.0K | -$208.0K | -$429.0K | $62.7M | $70.8M | -$78.2M | -$1.3M | -$1.6M | -$480.0K | -$153.0K |
| Financing cash flow | -$11.6M | $29.9M | $8.5M | -$7.9M | $42.6M | $160.6M | $9.0M | $124.1M | $103.7M | $67.2M |
Figures as tagged in each year's own filing, in US dollars. A year restated by a later filing shows the restated figure. Capital expenditure, dividends and buybacks are cash out, shown positive. A line the filer does not report is not listed. Latest from accession 0001104659-26-043782.
Plot the figures US dollars
- Revenue
- Gross profit
- Net income
| Fiscal year | FY2016 | FY2017 | FY2018 | FY2019 | FY2020 | FY2021 | FY2022 | FY2023 | FY2024 | FY2025 |
|---|---|---|---|---|---|---|---|---|---|---|
| Revenue | $0 | $0 | — | $6.1M | $6.4M | $11.2M | $3.9M | $0 | $0 | $0 |
| Gross profit | — | — | — | — | — | — | — | — | — | — |
| Net income | -$33.2M | -$42.2M | -$66.7M | -$94.3M | -$104.3M | -$142.6M | -$44.8M | -$42.2M | -$38.5M | -$27.0M |
Recent filings and events
- Delisting notice The exchange has told the company it no longer meets the rules for staying listed - usually price, market cap, or filings that are late. Item 3.01
- Other event The catch-all. The company chose to disclose something that fits no other item, so the content is whatever it says it is. Item 8.01
- Shareholder rights changed The terms attaching to the shares themselves have changed. Item 3.03
- Charter or fiscal year changed A change to the company's governing documents, or to when its year ends. Item 5.03
- Other event Item 8.01
- Annual report filed A new 10-K. The figures and the business description on this site come from it. Form 10-K
- Material agreement signed The company entered an agreement outside the ordinary course of business - a large contract, a credit facility, a merger agreement. Item 1.01
- Unregistered share sale Shares issued outside a registered offering. Dilution, and for a small company often the way it is funded. Item 3.02
- Regulation FD disclosure Something the company told the market and had to tell everyone at once - usually a slide deck or a press release. Item 7.01
- Officer or director change Someone at the top arrived or left. The item covers everything from a board retirement to a chief executive being removed, and only the filing itself says which. Item 5.02
- Officer or director change Item 5.02
- Material agreement signed Item 1.01
Item numbers are Form 8-K's own, and a filing date is up to four business days after the thing it reports. The same feed across the whole market.
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