Home Uncategorized Aeglea BioTherapeutics raises $ 45 million through registered direct offer

Aeglea BioTherapeutics raises $ 45 million through registered direct offer

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Image source: Aeglea BioTherapeutics


Aeglea BioTherapeutics ( ANGLE) announced on Thursday that it had raised $ 45 million in gross revenue through registered direct placement of institutional investors.


The deal includes 10,752,688 common shares at $ 1.60 per share and pre-funded warrants to purchase 17,372,397 common shares at $ 1.5999 per warrant, representing a placement price per ordinary share less a strike price of $ 0.0001 .


Notably, the stock closed on Wednesday at $ 1.58 a share, meaning the deal was valued with a premium to the market, a rare occurrence for registered directors.


Participating investors included Bain Capital Life Sciences, Great Point Partners, Nantahala Capital Management and Sio Capital Management.


Aeglea develops human enzymes as innovative solutions for rare metabolic diseases. The main candidate of the campaign is pegsilarginase for patients with Arginase 1 Deficiency (ARGD-1)


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a rare, progressive disease characterized by high levels of arginine, an amino acid that helps the body build proteins.

People, primarily children living with ARG1-D, experience severe mobility limitations associated with spasticity, seizures, developmental delay, intellectual disability, and early mortality.


On April 12, 2022, the company announced that it had submitted to the FDA its first application for a license for biologics for pegsilarginase, along with a request for a priority review.



Pipeline


In addition to pegylarginase for ARG1-D, Aeglea is in phase 1 studies with AGLE-177 for homocystinuria, a genetic disease in which the body is unable to process the amino acid methionine.



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Image source: Aeglea BioTherapeutics



Investment dissertation



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Investors punished Aeglea in December 2021 when it published data from Phase 3 pegylarginase tests for ARG1-D.


Although the company reached the main endpoint of the study, showing that the drug achieved an 80% reduction in plasma arginine, investors were disappointed with the secondary endpoint of improving mobility.


The data showed that pegzylarginase improved motility compared with placebo, but the difference was not statistically significant.


We believe that in December, investors overdid it, but the shares did not resume.


We believe that investors with a high risk tolerance may want to explore Aeglea at current levels as essentially a call option for FDA pegzylarginase approval:


  • That $ 45 million significantly increases the $ 68.6 million in cash and equivalents that Aeglea had as of March 31, 2022.
    • The new amount should provide a runway in the second half of 2023.
  • There are no approved treatments for ARG1-D.
  • Pegzylarginase has received several regulatory designations from the FDA, including:
    • A rare childhood disease
    • Breakthrough therapy
    • Fast track
    • Orphan drug
  • He also received an orphan prescription from the European Medicines Agency.
  • We believe Aeglea has a good chance of gaining FDA approval given the results of Phase 3.

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