Impel Pharmaceuticals Announces Strategic Repriortization, Continues Focus on Maximizing Trudhesa® Commercial Opportunity

Cost-Saving Measures Eliminate Pipeline Programs and Reduce Headcount by 16 Percent

Company will Continue to Drive Trudhesa Growth Via 90 Field-Based Sales Representatives and Other Commercial Efforts

Trudhesa Growth Momentum Continues, with 58 Percent Increase in New Prescriptions from Q2 2022 to Q4 2022 Following Expansion of Sales Force

SEATTLE, Feb. 22, 2023 (GLOBE NEWSWIRE) -- Impel Pharmaceuticals (NASDAQ: IMPL), a commercial-stage pharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, today announced that it will implement an operational streamlining plan that will include a reduction of employee and non-employee expenses, largely impacting the research and development functions of the organization. The Company plans to reprioritize spend to capitalize on the continued positive momentum in payor and prescriber uptake of Trudhesa^® (dihydroergotamine mesylate) nasal spray (0.725 mg per spray).

“Today’s announcement is part of a measured effort aimed at best positioning Impel to achieve its business objectives by streamlining clinical development expenses in order to focus resources on maximizing the growing commercial potential of Trudhesa,” said Adrian Adams, Chairman of the Board and Chief Executive Officer of Impel Pharmaceuticals. “I must emphasize that this decision was not taken lightly, nor was it due to a lack of hard work or dedication from the employees affected by this reprioritization. We are grateful for their service and recognize their contributions to Impel’s progress to date.”

The plan will halt research and development efforts on INP105 (olanzapine) to address acute agitation and aggression in autism spectrum disorder. The resulting reduction in operating expenses is expected to be primarily driven by lower non-employee-related general and administrative and research and development expenses, and the 16 percent reduction in headcount.

Aligned with this, the Company also announced that Stephen Shrewsbury, M.D., current Chief Medical Officer, will depart from the Company effective March 31, 2023.

“I would like to thank Dr. Shrewsbury for his contributions to Impel and, more broadly, for helping increase our understanding of the upper nasal space and positively changing expectations about the therapeutic potential of nasally administered medicines,” said Adams. “Dr. Shrewsbury, along with the team under his leadership, played a pivotal role in developing the Company’s proprietary Precision Olfactory Delivery (POD^®) technology and conducting the clinical development that led to the successful first-cycle approval of Trudhesa by the FDA.”

Following these and other strategic measures, the Company projects it will have sufficient capital to fund operations into Q3 2023 and allow the Company to prioritize its efforts to fully maximize the positive momentum and significant commercial opportunity of Trudhesa in the large and rapidly growing acute migraine market. Trudhesa has continued its strong launch trajectory and finished 2022 with 58,424 prescriptions. Based upon third-party data, it is estimated that at the end of 2022, after its first full year of launch, Trudhesa already accounted for 4.3 percent of branded acute migraine prescriptions (nTRx) among prescribers. In July 2022, Impel expanded its sales force by 50 percent, from 60 to 90 sales professionals, to capitalize on prescription momentum and the large business opportunity. New Trudhesa quarterly prescriptions increased by 58 percent from Q2 to Q4 2022 driven by this expanded, more efficient sales force. In addition, reimbursement of all shipments finished the year at over 60 percent and refill rates remained high with an average of 63 percent at the end of 2022.

Along with increased focus on the commercialization of Trudhesa, Impel will continue with its evaluation of strategic and financing initiatives and opportunities to fully leverage the therapeutic potential of its proprietary POD technology and expertise with both small and large molecules in multiple disease areas.

About Impel Pharmaceuticals
Impel Pharmaceuticals is a commercial-stage pharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs. Impel offers treatments that pair its proprietary POD^® technology with well-established therapeutics. In September 2021, Impel received U.S. FDA approval for its first product, Trudhesa^® nasal spray, which is approved in the U.S. for the acute treatment of migraine with or without aura in adults. In addition to Trudhesa, the Company continues to address patient needs via licensing and partnerships.

About Impel’s Precision Olfactory Delivery (POD^®) Technology
Impel’s proprietary POD^® technology is able to deliver a range of therapeutic molecules and formulations into the vascular-rich upper nasal space, believed to be a gateway for unlocking the previously unrealized full potential of these molecules. By delivering predictable doses of drug directly to the upper nasal space, Impel’s precision performance technology has the goal of enabling increased and consistent absorption of drug, overriding the high variability associated with other nasal delivery systems, yet without the need for an injection. While an ideal target for drug administration, to date no technology has been able to consistently deliver drugs to the upper nasal space. By utilizing this route of administration, Impel Pharmaceuticals has been able to demonstrate blood concentration levels for its investigational therapies that are comparable to intramuscular (IM) administration and can even reach intravenous (IV)-like systemic levels quickly, which could transform the treatment landscape for a broad range of disorders. Importantly, the POD^® technology offers propellant-enabled delivery of dry powder and liquid formulations that eliminates the need for coordination of breathing, allowing for self- or caregiver-administration in a manner that may improve patient outcome, comfort, and potentially, compliance.

About Trudhesa^®
Indication
Trudhesa^® is used to treat an active migraine headache with or without aura in adults. Do not use Trudhesa to prevent migraine when you have no symptoms. It is not known if Trudhesa is safe and effective in children.

Important Safety Information

Do not use Trudhesa if you:

• Have any disease affecting your heart, arteries, or blood circulation.
• Are taking certain anti-HIV medications known as protease inhibitors (such as ritonavir or nelfinavir).
• Are taking a macrolide antibiotic such as clarithromycin or erythromycin.
• Are taking certain antifungals such as ketoconazole or itraconazole.
• Have taken certain medications such as triptans or ergot-type medications for the treatment or prevention of migraine within the last 24 hours.
• Have taken any medications that constrict your blood vessels or raise your blood pressure.
• Have severe liver or kidney disease.
• Are allergic to ergotamine or dihydroergotamine.

Before taking Trudhesa, tell your doctor if:

• You have high blood pressure, chest pain, shortness of breath, heart disease; or risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease or you are postmenopausal, or male over 40); or problems with blood circulation in your arms, legs, fingers, or toes.
• You have or had any disease of the liver or kidney.
• You are taking any prescription or over-the-counter medications, including vitamins or herbal supplements.
• You are pregnant, planning to become pregnant or are nursing, or have ever stopped medication due to an allergy or bad reaction.
• This headache is different from your usual migraine attacks.
  

The use of Trudhesa should not exceed dosing guidelines and should not be used on a daily basis. Serious cardiac (heart) events, including some that have been fatal, have occurred following the use of dihydroergotamine mesylate, particularly with dihydroergotamine for injection, but are extremely rare.

You may experience some nasal congestion or irritation, altered sense of taste, sore throat, nausea, vomiting, dizziness, and fatigue after using Trudhesa.
Contact your doctor immediately if you experience:

• Numbness or tingling in your fingers and toes
• Severe tightness, pain, pressure, heaviness, or discomfort in your chest
• Muscle pain or cramps in your arms or legs
• Cold feeling or color changes in one or both legs or feet
• Sudden weakness
• Slurred speech
• Swelling or itching
  

The risk information provided here is not comprehensive. To learn more, talk about Trudhesa with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at www.Trudhesa.com or 1-800-555-DRUG. You can also call 1-833-TRUDHESA (1-833-878-3437) for additional information.

Cautionary Note on Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, the potential clinical benefits of Trudhesa^®, the market opportunities of Trudhesa within the migraine market, the speed of uptake and market growth of Trudhesa, the effectiveness of the Trudhesa sales force, and Impel’s cash runway. Forward-looking statements can be identified by words such as: “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” or the negative or plural of these words or similar expressions. These statements are subject to numerous risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including but not limited to, Impel’s ability to maintain regulatory approval of Trudhesa, its ability to execute its commercialization strategy for Trudhesa, its ability to develop, manufacture and commercialize any other product candidates including plans to address additional indications for which Impel may pursue regulatory approval, whether results of preclinical studies or clinical trials will be indicative of the results of future trials, and the effects of COVID-19 on its clinical programs and business operations. Many of these risks are described in greater detail in Impel’s filings with the Securities and Exchange Commission. Any forward-looking statements in this press release speak only as of the date of this press release. Impel assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Impel, POD and the Impel logo are trademarks of Impel Pharmaceuticals Inc. To learn more about Impel Pharmaceuticals, please visit our website at https://impelpharma.com.