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the ear, nose, and throat. The Watertown, MA-based company’s proprietary technology, XTreo, is an implantable drug delivery device intended to precisely and consistently deliver medicine to affected tissue in a single dose that lasts months. The company’s lead therapeutic target is chronic rhinosinusitis, an inflammatory condition affecting the sinuses.
The Lyra drug delivery technology has three components. A biocompatible mesh scaffold maximizes the surface area for the release of a drug. A matrix of polymers that have elastic properties gives the implant “shape memory” to adapt to nasal passages. The third component is a polymer-drug complex, which the company says can be customized to release the desired dose of a drug at a certain rate.
Lead program LYR-120 uses the Lyra technology to administer mometasone furoate (MF), a steroid that is the active ingredient in several medications approved to treat runny and stuffy noses caused by allergies. In severe cases, chronic rhinosinusitis can be treated by sinus surgery. Lyra is developing LYR-120, which can be quickly implanted during a brief physician’s visit, as an alternative to such surgery. The therapy is intended to last up to six months. Preliminary Phase 2 data are expected in the first quarter of 2021.
A second program, LYR-220, is being developed for treatment of chronic rhinosinusitis in patients who have undergone sinus surgery but continue to need treatment to manage their symptoms. The company aims to start a proof-of-concept clinical trial for LYR-220 by the end of 2021. Lyra believes its technology could address other diseases, though those conditions weren’t specified in its IPO filing. Lyra says that it plans to apply the IPO proceeds toward clinical development of LYR-120 and LYR-220, as well as for additional research and development.
Lyra’s largest shareholder is Perceptive Advisors, with 32.4 percent, followed by North Bridge Venture Partners with 17.3 percent, according to the filing. The company has set a preliminary $57.5 million goal for its IPO. If it completes the stock offering, the company’s shares will trade on the Nasdaq exchange under the stock symbol “LYRA.”
Meanwhile, Israel-based Ayala is planning an IPO to finance mid-stage tests of two drugs it licensed from Bristol Myers Squibb (NYSE: BMY).
Ayala’s lead drug candidate, AL101, is an injectable small molecule intended to block gamma secretase, an enzyme that activates the Notch signaling pathway, which is involved in both solid tumors and blood cancers, the company says in its IPO filing. In 2017, Ayala licensed the compound from Bristol, which had tested the drug in three Phase 1 studies. Those clinical trials were not successful, but Ayala notes clinical activity was observed in cancers in which Notch activation drove the disease.
AL101 is currently in Phase 2 testing in adenoid cystic carcinoma, a rare form of adenocarcinoma, a type of cancer affecting glandular tissue. The drug is also being developed for triple-negative breast cancer and T cell acute lymphoblastic leukemia, a rare form of T cell specific leukemia.
The second Ayala program from Bristol, AL102, is also a gamma-secretase inhibitor. Ayala is preparing to start Phase 2 tests of the drug as a treatment for desmoid tumors, which occur in connective tissue. The company is also collaborating with Novartis (NYSE: NVS) to develop AL102 as a treatment for multiple myeloma by itself and with the pharmaceutical giant’s B-cell maturation antigen therapies.
Ayala’s largest shareholder is the Israel Biotech Fund, which holds a 35.5 percent stake, according to the filing. Ayala says it will use the IPO cash to finance mid-stage tests of AL101, and to advance AL102 into Phase 2 testing. Ayala set a preliminary $50 million target for the IPO. The company has applied for a listing on the Nasdaq under the stock symbol “AYLA.”