Aclaris Provides Q4 and Corporate Update, Charging Hard into 2023
By Mark Terry
February 23, 2023
Aclaris Therapeutics, headquartered in Wayne, Pa., announced its fourth quarter and full year 2022 financial report, as well as a corporate update. This year is expected to be a very busy one for the company, which focuses on drugs for immuno-inflammatory diseases.
At the top of the list are three expected readouts for the year. The company is expecting topline data in the second half of the year for its Phase IIb study of ATI-450-RA-202 for rheumatoid arthritis. They expect topline data in March for the Phase II trial of ATI-450-HS- for hidradenitis suppurativa (HS). And Aclaris is expecting topline data for a Phase IIa trial of ATI-450-PsA-201 for psoriatic arthritis by the end of the year.
Robert Doody, Jr., Aclaris’s Vice President of Investor Relations, told BioBuzz, “For our topical JAK inhibitor ATI-1777, we have a Phase IIb data readout expected in atopic dermatitis mid-year 2023. And lastly, for our earlier clinical drug, ATI-2138, we have a multiple ascending dose trial in healthy volunteers expected in the second half of 2023, which if positive could lead us into clinical development in ulcerative colitis.”
In a press statement, company CEO, Doug Manion, M.D., said, “In addition to the enthusiasm related to our upcoming development-stage milestones, we also continue to benefit from the output of our KINect discovery engine, and the ability to identify novel development candidates, which we believe will not only position us to continue to build long-term shareholder value, but also enable us to further fulfill our mission of delivering new therapeutic options for patients.”
Aclaris’s approach focuses on the kinome, a subset of the human genome made up of about 518 protein kinases. This family of genes is responsible for signal transduction that controls cellular responses.
The company’s proprietary KINect platform speeds drug identification by combining a proprietary chemical library of kinase inhibitors, their own expertise in structure-based drug design, and custom kinase assays. Using its modeling software, Aclaris can describe the structure of viable drug-like compounds from its library to optimize reversible binding to the target kinase. This allows for a selective covalent bond with a cysteine residue near the ATP site on the specific kinase target.
Doody says, “The biggest update we provided today was that we tightened up our guidance that the first readout for the HS trial with ATI-450 would be in March, which tightened up the guidance a bit, which was previously March/April.”
On the financial front, Aclaris reported aggregate cash, cash equivalents and marketable securities of $229.8 million as of December 31, 2022. This included proceeds from the fourth quarter under a license agreement with Pediatrix Therapeutics. The company believes this will be enough to fund operations through the end of 2025.
Net loss for the fourth quarter was $27.6 million, with total revenue of $7.8 million. The revenue was driven by $6.7 million of revenue from the Pediatrix deal.
The deal with Shanghai, China-based Pediatrix was inked in November 2022. Under the license agreement, Aclaris granted Pediatrix exclusive rights to develop and commercialize ATI-1777 in Greater China. ATI-1777 is a “soft” JAK 1/3 inhibitor for atopic dermatitis. Aclaris holds the rights to develop the drug in the rest of the world.
Pediatrix paid $5 million upfront to Aclaris, which is eligible for up to $91 million in various milestone payments. Aclaris is also eligible for tiered low-to-high single-digit percentage royalties on net sales in Greater China, which includes Mainland China, Hong Kong, Macau and Taiwan.
Research and development expenses for the quarter were $21.1 million and general and administrative expenses were $7.1 million for the same period. Net loss for the year was $86.9 million, with total annual revenue of $29.8 million.
With numerous mid-stage readouts in the works, Doody told BioBuzz, “I believe we are well-positioned as we have a very balanced pipeline of drugs which emanate from our proprietary drug development KINect platform.”
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Mark Terry is a freelance writer, editor, novelist and ghostwriter. He holds a degree in microbiology & public health and spent 18 years in infectious disease research and clinical and research genetics prior to his transition to a writing career. His areas of expertise include biotechnology, pharma, clinical diagnostics, and medical practice management. He has written literally thousands of articles, as well as market research reports, white papers, more than 20 books, and many other written materials. He currently lives in Michigan with his family.
