KALA BIO, Inc. announces $10.75 million private placement to advance clinical development of KPI-012 for severe eye diseases.
Quiver AI Summary
KALA Bio, Inc., a clinical-stage biopharmaceutical company focused on innovative therapies for severe eye diseases, announced a private placement of common stock and Series I Convertible Non-Redeemable Preferred Stock, generating approximately $10.75 million in gross proceeds. This funding involved key institutional investors and aims to support the clinical development of KPI-012, which is in a Phase 2b trial for treating persistent corneal epithelial defect. With over 40 clinical trial sites active, KALA expects to report topline data by the second quarter of 2025. The company anticipates that the net proceeds will sustain operations into early 2026 and plans to register the shares sold in this placement with the SEC.
Potential Positives
- KALA BIO secured approximately $10.75 million in gross proceeds through a private placement, enhancing its financial resources for ongoing operations.
- The company is actively enrolling patients for the ongoing Phase 2b CHASE trial of KPI-012, with 80% of enrollment complete, indicating positive momentum in clinical development.
- Funds from the private placement are intended to advance the development of KPI-012, which has received Orphan Drug and Fast Track designations from the FDA, demonstrating potential market value and regulatory support.
Potential Negatives
- Entering into a private placement for shares indicates potential liquidity issues, as the company may be seeking capital to sustain its operations.
- The private placement involves unregistered securities, limiting the options for investors and potentially creating challenges for raising future capital.
- The reliance on the completion of the private placement and patient recruitment for clinical trials highlights uncertainties regarding the company's operational and funding stability.
FAQ
What is the purpose of KALA BIO's recent private placement?
KALA BIO aims to raise approximately $10.75 million to advance its clinical development of KPI-012 and for general corporate purposes.
Who participated in KALA BIO's private placement?
The private placement included new and existing investors such as SR One, Cormorant Asset Management, and Woodline Partners.
What is KPI-012 developed for?
KPI-012 is developed for treating persistent corneal epithelial defect, a rare disease affecting corneal healing.
When does KALA BIO expect to report topline data?
KALA BIO anticipates reporting topline data from the CHASE trial in the second quarter of 2025.
What regulatory designations has KPI-012 received?
KPI-012 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$KALA Hedge Fund Activity
We have seen 7 institutional investors add shares of $KALA stock to their portfolio, and 11 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- VIRTU FINANCIAL LLC removed 31,101 shares (-100.0%) from their portfolio in Q3 2024
- RENAISSANCE TECHNOLOGIES LLC added 21,473 shares (+inf%) to their portfolio in Q3 2024
- GEODE CAPITAL MANAGEMENT, LLC added 18,225 shares (+96.5%) to their portfolio in Q3 2024
- OCONNOR, A DISTINCT BUSINESS UNIT OF UBS ASSET MANAGEMENT AMERICAS (LLC) added 15,109 shares (+10.2%) to their portfolio in Q3 2024
- TWO SIGMA INVESTMENTS, LP added 14,005 shares (+inf%) to their portfolio in Q3 2024
- SASSICAIA CAPITAL ADVISERS LLC removed 12,000 shares (-100.0%) from their portfolio in Q3 2024
- VANGUARD GROUP INC added 3,284 shares (+6.5%) to their portfolio in Q3 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
ARLINGTON, Mass., Dec. 30, 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 announced that it has entered into a securities purchase agreement with a select group of institutional accredited investors for the sale, in a private placement, of shares of its common stock and shares of its Series I Convertible Non-Redeemable Preferred Stock (the “Series I Preferred Stock”), for aggregate gross proceeds of approximately $10.75 million, before deducting offering expenses.
The private placement 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 has agreed to sell 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. The private placement is expected to close on or about December 31, 2024, subject to the satisfaction of customary closing conditions.
Based on its current plans, KALA anticipates that its existing cash resources, together with the net proceeds from the private placement, will enable it to fund operations into the first quarter of 2026. KALA intends to use the net proceeds from the private placement to advance the clinical development of KPI-012 for the treatment of persistent corneal epithelial defect, as well as for general corporate purposes. KALA is actively recruiting patients for enrollment in the ongoing Phase 2b CHASE trial of KPI-012 with over 40 clinical trial sites open and enrolling. “We appreciate the support of our new and existing stockholders in this financing, which comes at an important time for our company,” said Mark Iwicki, Chair and Chief Executive Officer of KALA BIO. “With over 80% of enrollment now complete in the CHASE trial, we remain on track to report topline data in the second quarter of 2025. If successful, this trial may serve as the first of two pivotal trials required to support a BLA submission.”
The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. KALA has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the “SEC”) registering the resale of the shares of common stock issued in the private placement and the shares of common stock issuable upon conversion of the Series I Preferred Stock issued in the private placement no later than the 30
th
day after the closing of the private placement.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of securities of KALA in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.
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.
Cautionary Note Regarding 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 the expected closing of the private placement, the sufficiency of KALA’s cash resources for the period anticipated; the anticipated use of net proceeds from the private placement; anticipated timelines to report topline data for the CHASE trial; KALA’s belief that the CHASE trial could serve as the first of two pivotal trials required to support the submission of a BLA to the FDA; and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” 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: whether the conditions for the closing of the private placement will be satisfied; market conditions; 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 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; and other factors discussed in the “Risk Factors” section of KALA’s Annual Report on Form 10-K, most recently filed Quarterly Report on Form 10-Q and other filings KALA makes with the SEC. 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.
Investor Contact:
Taylor Steiner
taylor.steiner@precisionaq.com
212-362-1200
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