NEWS AND PRESS RELEASES

March 31, 2020 Anida Pharma announces Orphan Drug Designation for AP-001


Cambridge, Massachusetts, March 31, 2020 --- Anida Pharma, a preclinical stage
biopharmaceutical company focused on developing treatments for vision and hearing
loss, today announced that the U.S. Food and Drug Administration (FDA) has granted
Orphan Drug Designation to AP-001 for the prevention of retinopathy of prematurity
(ROP).
“This is a significant milestone in our development of a safe and efficacious treatment
for ROP which can be administered to infants at risk to prevent the development of the
condition. No such treatment currently exists and the simple administration of AP-001
as an eye drop from birth through to full gestational age could become a game-changer
in treatment of these children”, said Per Gjorstrup MD PhD, Anida President and CEO,
“and further encourage our ongoing development towards clinical studies”.
The FDA’s Office of Orphan Drug Products grants orphan status to support
development of medicines for underserved patient populations, or rare disorders, that
affect fewer than 200,000 people in the U.S. Orphan drug designation provides to Anida
certain benefits, including market exclusivity upon regulatory approval if received,
exemption of FDA application fees and tax credits for qualified clinical trials.




June 7, 2018                                                                                                                                                               Anida Pharma to present at the 11 th Hershey Conference onDevelopmental Brain Injury


Cambridge, Massachusetts, June 7, 2018 --- Anida Pharma, a preclinical stage
biopharmaceutical company, today presented data on its lead candidate AP-001 on
amelioration of neonatal brain ischemia and stroke. In collaboration with the laboratories
of Drs. Donna Ferriero and Fernando Gonzales at UCSF and Dr. Henrik Hagberg at
Gothenburg University, the presented data showed that AP-001 administered
systemically post-insult prominently reduced infarct size and tissue loss in a model of
neonatal stroke and in the Vannucci model of neonatal brain ischemia, respectively.
“We are very pleased with the outcomes of both studies and the investigators
assessment that the program merits further development towards clinical investigation”
said Per Gjorstrup, MD PhD, Anida President and CEO.

About AP-001: also known as neuroprotectin D1 (NPD1; protectin D1; PD1), AP-001 is
a pleiotropic endogenous lipid-derived small molecule, which in a broad range of
experimental studies is shown to dampen inflammation, while preventing death of
affected host tissue cells, including oxidative stress, and stimulating tissue repair,
including neurogenesis.




June 5, 2018                                                                                                                                                                                            Anida Pharma receives a second patent for the protection from drug-induced hearing loss


Cambridge, Massachusetts, June 5, 2018 --- Anida Pharma, a preclinical stage
biopharmaceutical company, today announced that the United States Patent and Trade
Mark Office has issued a second patent to Anida for the protection from and treatment
of hearing loss and related conditions. “Our second patent, US 9,987,244, in the field
adds significant strength to the further development of AP-001 for a broad range of
conditions related to hearing loss” said Per Gjorstrup MD PhD, Anida President and
CEO.

About AP-001: also known as neuroprotectin D1 (NPD1; protectin D1; PD1), AP-001 is
a pleiotropic endogenous lipid-derived small molecule, which in a broad range of
experimental studies is shown to dampen inflammation, while preventing death of
affected host tissue cells, including oxidative stress, and stimulating tissue repair,
including neurogenesis.




April 13, 2018                                                                                                                                                                                      Anida Pharma receives positive feedback in FDA pre-IND review for itshearing loss program.


Cambridge, Massachusetts, April 13, 2018 --- Anida Pharma, a preclinical stage
biopharmaceutical company, today announced it has successfully completed a pre-IND
(Investigational New drug) review with the U.S. Food and Drug Administration (FDA).
“We are highly encouraged by the confirmation we received from the FDA on our
proposal for IND-enabling preclinical studies and first-in-man clinical studies to bring
AP-001 forward as a prophylactic treatment for the prevention of drug-induced hearing
loss”, said Per Gjorstrup MD PhD, Anida President and CEO. In particular children
treated for blastomas have a high risk of hearing loss due to the toxic side-effects of
cisplatin, but also carboplatin, as a common base in curative treatments. AP-001 is
intended to be delivered locally to the ears to avoid any interference with the
chemotherapy. No such treatment is approved today.
About AP-001: also known as neuroprotectin D1 (NPD1; protectin D1; PD1), AP-001 is
a pleiotropic endogenous lipid-derived small molecule, which in a broad range of
experimental studies is shown to dampen inflammation, while preventing death of
affected host tissue cells, including oxidative stress, and stimulating tissue repair,
including neurogenesis, collectively contributing to prevention of hearing loss.




February 13, 2018                                                                                                                                                                                            Anida Pharma to present at American Association for Research inOtolaryngology at the 41 st Annual Mid-Winter Meeting, ARO 2018


Cambridge, Massachusetts, February 13, 2018 --- Anida Pharma, a preclinical stage
biopharmaceutical company, today presented data on its lead candidate AP-001 for the
protection of drug-induced hearing loss. Building on excellent in vitro data showing
regulation of reactive oxygen species formation by controlling key enzymes in addition
to downregulating stressed-induced inflammation, AP-001 was shown to dose-
dependently protect from cisplatin-induced hearing loss in a commonly accepted
translational model. Administered to the middle ear as prophylactic treatment, as
intended in the clinic, AP-001 at the top dose gave full protection. “We are extremely
satisfied with the in vivo data now obtained and confirmation of the relevance of the
mechanistic data for otoprotection that we obtained in cellular experiments” said Per
Gjorstrup MD PhD, Anida President and CEO. “We also want to acknowledge the
excellent collaboration with the hearing loss research group at Southern Illinois
University”.

About AP-001: also known as neuroprotectin D1 (NPD1; protectin D1; PD1), AP-001 is
a pleiotropic endogenous lipid-derived small molecule, which in a broad range of
experimental studies is shown to dampen inflammation, while preventing death of
affected host tissue cells, and also stimulating tissue repair, including neurogenesis.




June 19, 2017                                                                                                                                                                                               Anida Pharma receives positive feedback in FDA pre-IND review for itsocular program.


Cambridge, Massachusetts, June 19, 2017 --- Anida Pharma, a preclinical stage
biopharmaceutical company, today announced it has successfully completed a pre-IND
(Investigational New drug) review with the U.S. Food and Drug Administration (FDA).
“We much appreciate the positive feedback we received from the FDA on our proposal
for IND-enabling preclinical studies and first-in-man clinical studies for ophthalmic
indications with AP-001 with a focus on retinal disease, including age-related macular
degeneration (AMD) and retinopathy of prematurity (ROP)”, said Per Gjorstrup MD PhD,
Anida President and CEO. “In particular, this may become a first treatment indicated for
the prevention of ROP to be delivered as a non-invasive eye drop”.

About AP-001: also known as neuroprotectin D1 (NPD1; protectin D1; PD1), AP-001 is
a pleiotropic endogenous lipid-derived small molecule, which in a broad range of
experimental studies is shown to prevent ocular neovascularization, through control of
inflammation and oxidative stress, while directly regulating cell death pathways and
stimulating tissue repair.




September 7, 2018                                                                                                                                       Anida Pharma to present at the Inner Ear Biology at the 55 th AnnualMeeting in Berlin, IEB 2018


Cambridge, Massachusetts, September 7, 2018 --- Anida Pharma, a preclinical stage
biopharmaceutical company, today presented data on its lead candidate AP-001 for the
protection of drug-induced hearing loss. Extending on previously presented data at ARO
2018 AP-001 was now shown to have prolonged action and a favorable dissociation
between pharmacodynamics and perilymph pharmacokinetics. “The information of
prolonged protection, and achieving that even without specific formulation needs, points
to a significant clinical advantage as does the rapid distribution of AP-001 to the
perilymph following transtympanic administration” said Per Gjorstrup MD PhD, Anida
President and CEO.




October 18, 2016                                                                                                                                                                                               Anida Pharma receives patent for the protection from drug-induced hearingloss


Cambridge, Massachusetts, October 18, 2016 --- Anida Pharma, a preclinical stage
biopharmaceutical company, today announced that the United States Patent and Trade
Mark Office has issued a patent to Anida broadly covering protection from and
treatment of hearing loss and related conditions. “As leaders in the field of developing
treatments for hearing loss the now issued patent, US 9,468,620, offers additional
protection beyond the already issued composition of matter patent licensed to Anida”
said Per Gjorstrup MD PhD, Anida President and CEO. “The patent adds to Anida’s
strong position in other indications of particular development interest for us, US patent
9,340,483 for the treatment of ALS, as well as US patent 9,315,447 broadly covering
ophthalmic indications, giving us a strong position moving forward”.

About AP-001: also known as neuroprotectin D1 (NPD1; protectin D1; PD1), AP-001 is
a pleiotropic endogenous lipid-derived small molecule, which in a broad range of
experimental studies is shown to dampen inflammation, while preventing death of
affected host tissue cells, including oxidative stress, and stimulating tissue repair,
including neurogenesis.




December 13, 2018 Anida Pharma announces positive preclinical ocular pharmacokinetic study


Cambridge, Massachusetts, December 13, 2018 --- Anida Pharma, a preclinical stage
biopharmaceutical company, today announced positive data in a pivotal ocular
pharmacokinetic study performed in rabbits.
“As major step forward for Anida’s ocular program our lead drug candidate, AP-001,
well distributed to the retina following its administration as an eye drop” said Per
Gjorstrup MD PhD, Anida President and CEO. Administered on a single occasion
without the need of prodrug properties or specific formulation AP-001 at a concentration
of 0.1% resulted in retinal drug levels to indicate the potential for once or at the most
twice daily administration. “This is an important step towards our goal of developing AP-
001 as an eye drop to broadly treat retinal conditions and indicates that AP-001 has
properties making it uniquely suited to be developed as an eye drop”. The study was
conducted in collaboration with Experimur LLC, a premiere toxicology CRO, and
performed to the standards for GLP investigations.

About AP-001: also known as neuroprotectin D1 (NPD1; protectin D1; PD1), AP-001 is
a pleiotropic endogenous lipid-derived small molecule, which in a broad range of
experimental studies is shown to dampen inflammation, while preventing death of
affected host tissue cells, including oxidative stress, and stimulating tissue repair,
including neurogenesis.





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