Agile Finalizes $35M Term Loan Facility As Twirla PDUFA Date Looms

Agile Therapeutics Inc AGRX shares are advancing Tuesday after the company announced clinching of a term loan facility.

The micro-cap biotech that focuses on women's health said late Monday it has finalized a senior secured term loan credit facility with Perceptive Advisors to provide it funding up to $35 million.

The facility will disburse term loans in three tranches. Following the satisfaction of customary closing condition, the company was funded with $5 million.

The company noted that out of the remaining $30 million, $15 million will be disbursed if Twirla, its experimental hormonal contraceptive patch, is approved by the FDA, and $15 million upon the achievement of certain revenue milestones.

Agile is allowed to pay only interests on the loan until Feb. 2023.

Related to the credit agreement, the company issued Perceptive warrants to purchase 1.4 million shares of its common stock at $3.74 per share exercise price for 70,000 shares and at $4.67 per share for the remaining 700,000 shares.

Binary Event Looms

Agile is awaiting a key binary event this weekend, with the FDA expected to give its verdict on its Twirla hormonal contraceptive patch. The catalyst assumes importance due to the fact that the company had faced two rejections for Twirla in the past.

The third time could prove to be charm for Agile, going by an Adcom panel vote that favored approval of Twirla. The company saw another twist in the tale, with the FDA delaying the decision by three months even after the positive Adcom verdict.

Cash Flow Projection Signals Adequacy

"This strategic debt financing coupled with our current cash increases our balance sheet strength and positions us well to continue our commercialization strategy for Twirla®, with an expected FDA decision less than one week away," said Al Altomari, CEO of Agile.

Agile said its existing estimated cash on hand as of December and the $20 million in loan proceeds it is eligible to get upon Twirla approval will allow it to fund its operations through the end of 2020.

Agile's stock was rallying 7.48% to $4.31 per share.

Related Links:

The Week Ahead In Biotech: SMID-Cap Earnings In The Spotlight

13 Key NASH Drug Candidates To Watch For In A Potential $30-Billion Market