PolarityTE Inc (NASDAQ: PTE) reported a Q1 EPS loss of $(0.24), missing the consensus of $(0.12) loss, but better than $(0.39) loss a year ago. Sales of $4.71 million increased 31% sequentially and over 400% on a Y/Y basis.
SkinTE revenues were up 44% Q/Q to $1.73 million, and Contract services revenues were $2.98 million, compared to $2.39 million in Q4 2020 and $505k in Q1 2020.
SkinTE Biologic License Application (BLA) Update: In light of the FDA's announcement related to 'enforcement discretion' that states that 361 HCT/P products will not be extended beyond May 31, the company will now transition to the BLA pathway for SkinTE and will terminate commercial sales of SkinTE and wind down commercial operations.
It will file an investigational new drug application (IND) for SkinTE under Section 351 of the Public Health Service Act.
Roughly $3.0 million of total property and equipment is related to commercial SkinTE operations, of which the company has determined approximately $2.5 million can be repurposed primarily as R&D equipment.
PolarityTE is reiterating its guidance on submitting an IND to the FDA in the second half of 2021.
What is the 351 versus 361 Regulatory Framework? The FDA generally regulates regenerative medicine technologies through Sections 351 and 361 of the Public Health Service Act.
These two regulatory pathways differ markedly in terms of the time, effort, and expense required to bring a product to market in the U.S.
351 products are regulated as drugs or biologics, while 361 products, comparatively, are largely unregulated.
Earlier this week, data from the diabetic foot ulcer trial showed that 70% of patients receiving SkinTE plus SOC had wound closure at 12 weeks versus 34% of patients receiving SOC alone.
Price Action: PTE shares dropped 14.5% at $1.06 during the premarket session on the last check Friday.
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