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Kaléo Announces Executive Appointments and New Government Business Unit 

Richmond, Virginia (August 10, 2022) – Kaléo, a fully integrated pharmaceutical company dedicated to inventing, manufacturing, and commercializing life-transforming products for certain serious and life-threatening medical conditions, today announced the appointment of a Chief Commercial Officer as well as the formation of a new Government Sector business unit.

“This addition to Kaléo’s executive leadership enhances our existing team to position us for future growth,” said Kaléo President and CEO Ronald Gunn. “The Government Sector is a new market vertical which diversifies our business and expands our commitment to address the unmet needs of patient populations throughout the world with our proven innovative drug delivery platform.”

Alfred Tenuto has been named chief commercial officer responsible for growing Kaléo’s brand pharmaceutical business through optimization of its current products, such as the AUVI-Q® (epinephrine injection, USP) auto-injector, and integration of new products for incremental commercial growth. Mr. Tenuto joined Kaléo from Covis Pharma USA, where he served as executive vice president of U.S. commercial and president of the company consecutively. Mr. Tenuto also held leadership positions at Eli Lilly and VIVUS and has more than 25 years of pharmaceutical and medical industry experience.

Mark A. Herzog has been named vice president, global corporate affairs, defense and homeland security, responsible for leading Kaléo’s newly formed Government Sector business unit. Mr. Herzog has more than 25 years government affairs experience at the national and international level spanning the biopharmaceutical and clinical laboratory industries. Additionally, Mr. Herzog has participated in the launch of eight FDA approved combination products.

The Government Sector Business Unit will focus on domestic and international procurement of Kaléo’s Rapid Opioid Countermeasure System (ROCS), as well as expanding utilization of Kaléo’s innovative drug delivery platform in new chemical defense countermeasures for military and civilian stockpiles. Approved by the FDA in March 2022, ROCS is a 10 mg Naloxone Auto-Injector (naloxone hydrochloride injection) indicated for the emergency treatment of people 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon, is suspected. The product was delivered to the U.S. Department of Defense under budget and five months ahead of schedule. Visit naloxoneautoinjector.com for more information.

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About Kaléo

Kaléo is a fully integrated pharmaceutical company dedicated to inventing, manufacturing, and commercializing life-transforming products for certain serious and life-threatening medical conditions. Kaléo’s innovative auto-injection technologies are protected by an extensive intellectual property portfolio of more than 200 issued patents as well as being the first to meet the U.S. Food and Drug Administration (FDA) draft guidance standard for 99.999% device reliability. Kaléo is headquartered in Richmond, Virginia in the United States. For more information, visit kaleo.com.

AUVI-Q Indication

AUVI-Q® (epinephrine injection, USP) is a prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions.

Important Safety Information

AUVI-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after using AUVI-Q. Each AUVI-Q contains a single dose of epinephrine. AUVI-Q should only be injected into your outer thigh, through clothing if necessary. If you inject a young child or infant with AUVI-Q, hold their leg firmly in place before and during the injection to prevent injuries. Do not inject AUVI-Q into any other part of your body, such as into veins, buttocks, fingers, toes, hands, or feet. If this occurs, seek immediate medical treatment and make sure to inform the healthcare provider of the location of the accidental injection. Only a healthcare provider should give additional doses of epinephrine if more than two doses are necessary for a single allergic emergency.

Rarely, patients who use AUVI-Q may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following symptoms at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.

If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use AUVI-Q. Be sure to tell your healthcare provider about all the medicines you take, especially medicines for asthma. Also tell your healthcare provider about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, heart problems or high blood pressure, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

Common side effects include fast, irregular or ‘pounding’ heartbeat, sweating, shakiness, headache, paleness, feelings of over excitement, nervousness, or anxiety, weakness, dizziness, nausea and vomiting, or breathing problems. These side effects usually go away quickly, especially if you rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Please see the full Prescribing Information and the Patient Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Naloxone Auto-Injector Indication

Naloxone Auto-Injector 10 mg is an opioid antagonist indicated for use by military personnel and chemical incident responders for:

• The emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected.
• Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues.

Important Safety Information

Contraindications – Naloxone Auto-Injector (NAI) 10 mg is contraindicated in individuals with hypersensitivity to naloxone hydrochloride or to any of the other ingredients in NAI 10 mg.

Warnings – Use in patients who are opioid dependent may cause abrupt opioid withdrawal. Use of a product that delivers a dose lower than 10 mg of naloxone HCl may be preferable in treatment of a patient with known opioid dependence.

Precautions – Due to the duration of action of naloxone HCl relative to the opioid, keep the patient under continued surveillance and administer additional naloxone HCl, as necessary, while awaiting emergency medical assistance.

Adverse Events – The following adverse reactions were observed in more than one subject in clinical studies evaluating NAI: dizziness, feeling hot, headache, and injection site erythema.

Please see the full Prescribing Information.

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