Formerly known as Impel Neuropharma Inc, Impel Pharmaceuticals Inc is a commercial-stage biopharmaceutical company, developing and commercializing treatments for central nervous system disorders in the United States. The approved asset is Trudhesa, an upper nasal formulation of dihydroergotamine for the treatment of migraine. IMPL is now developing INP105 (upper nasal formulation of Olanzepine) as a treatment for acute agitation and aggression in autism spectrum disorder. INP107 is an upper nasal formulation of carbidopa/levodopa being developed in late phase clinical trial (completed Phase 2a) as a treatment for off episodes in Parkinson’s disease. All the assets are wholly owned by IMPL and the upper nasal drug delivery route is an easy and potentially effective route of administration for these CNS indications. The drug absorption via the upper nasal route is high and thus has a high likelihood of good efficacy outcomes.
Trudhesa is a reliable treatment option for migraine and its real-time clinical applicability has been reported to be promising.
These drugs can be self-administered by POD devices and on-demand access to treatment can be ensured without the need for injections and hospitalization.
Recent events
November 14th, 2022 – Impel Pharmaceuticals announced third quarter 2022 financial results and provides a corporate update
November 14th, 2022 – Impel Pharmaceuticals reported third-quarter 2022 financial results
August 15th, 2022 – Impel Pharmaceuticals reported second quarter 2022 financial results.
Addressable markets
The global acute migraine treatment market was valued at USD 4.3 billion and is expected to hit USD 9.26 million by 2030 at a CAGR of 8.9% in the forecasted period.
The global autism spectrum disorder treatment market was valued at USD 2063 million in 2022 and is expected to reach USD 3630 billion by 2032 at a CAGR of 5.3%
By 2021, the global Parkinson’s disease treatment market size was estimated to be USD 4.28 billion and expected to grow at a CAGR of 12.1% until 2030.
Current finances
While the company has USD 79.9 M as cash and short-term investment, it has a whooping USD 107.7 M as debt and liabilities.
IMPL revenue grew by 8934.1% over the past year and is forecasted to grow by at least 44% every year.
The notable risk of IMPL is the company has a cash runway of less than a year risking the dilution of shareholders. The free cash flow continues to shrink at the rate of 40% per year. The short-term assets are not covering short-term and long-term liabilities, which is mention-worthy. Other than the given revenue generation, the company is not profitable and is not expected to be profitable over the next three years.
Insider activity
Competitors
Atossa therapeutics is developing (Z)-endoxifen as a potential treatment for cancer. The product is a selective estrogen receptor modulator (SERM) and an active metabolite of tamoxifen. At higher doses, (Z)-endoxifen is effective against certain breast cancer-causing proteins. The experimental drug is being evaluated as a preventive option in certain individuals at-risk of breast cancer. Z-endoxifen has been approved as a treatment for breast cancer in the United States and the company is running several clinical trials including phase II clinical trials.
Seelos Therapeutics is developing treatments for various unmet needs in rare disorders and neurological disorders including CNS disorders. Some of the other indications being focused on are acute suicidal ideation and behavior in major depressive disorder and post-traumatic stress disorder. Some of these indications have no approved therapy and hence it is a multibillion-dollar opportunity. The company owns a variety of pipelines that are being investigated in pre-clinical to phase IIb/III studies.
Summary
Despite not receiving much attention from the media or investors, the company has been steadily working towards the successful launch of this innovative new drug. With a strong team in place and a well-designed plan for the launch of the drug, Impel Pharmaceuticals is well-positioned to make a significant impact in the market. While the company may have slipped under the radar in the past, it is definitely one to keep an eye on in the future as it continues to move its pipeline forward and scale up the commercial operation. The bigger question is will the Trudhesa reduce the need for cash?