After announcing a few strategic initiatives, Kala Pharmaceuticals Inc. (NASDAQ: KALA) shares were up 23.98% to trade at $6.98 at the time of our last check.
What actions has KALA taken?
The U.S. Food and Drug Administration (FDA) received an investigational new drug (IND) application from Kala Pharmaceuticals (KALA) for KPI-012 to treat persistent corneal epithelial defect (PCED). Kala Pharmaceuticals continues to be on target to launch a Phase 2b clinical study of KPI-012 for PCED in the fourth quarter of 2022, pending FDA acceptance of the IND. In the first quarter of 2024, topline safety and effectiveness findings from the study are anticipated.
In the event that it is successful, this study might be the first of the two pivotal tests required to back up the submission of a biologics license agreement (BLA) to the FDA. Following the FDA’s approval of the IND for KPI-012, KALA will receive the second tranche of the securities private placement announced earlier today. Combined with the cash already on hand, Kala anticipates that this will allow it to extend its planned financial runway into the first quarter of 2025.
KALA made an equity initiative:
Additionally, Kala Pharmaceuticals entered into a legally binding agreement with a life sciences-focused investor for the sale of shares of its common stock and Series E Convertible Non-Redeemable Preferred Stock (Series E Preferred) in a private placement priced at the market in accordance with Nasdaq rules for gross proceeds of up to $31 million.
According to the terms of the deal, KALA has agreed to sell a total of 76,813 shares of its ordinary stock at a price of $5.75 per share and a total of 9,666 shares of its Series E Preferred stock at a price of $575.00 per share in a first tranche, generating a total gross profit of almost $6 million. It’s anticipated that the first tranche would conclude on or around December 1, 2022.
How would this aid KALA’s growth?
Kala Pharmaceuticals (KALA) will take a significant step toward its objective of fulfilling the promise of mesenchymal stem cell secretome (MSC-S)-based therapeutics to treat severe ocular disorders by submitting the IND for PCED. The achievement also comes at a good time given the investment commitment made earlier today by a life sciences-focused investor, which demonstrates confidence in the ability of KALA’s MSC-S platform to address large unmet needs across a range of rare ophthalmic disorders.