UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission file number: 001-41173 NexGel, Inc. (Exact name of registrant as specified in its charter) | Delaware | 26-4042544 | (State o ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission file number: 001-41173 WASHINGTON D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2022 OR NexGel, Inc. (Exact name of registrant as specified in its charter) | Delaware | 26-4042544 | ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission file number: 001-36278 NexGel, Inc. (Exact name of registrant as specified in its charter) Delaware 26-4042544 (State or ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission file number: 001-36278 NexGel, Inc. (Exact name of registrant as specified in its charter) Delaware 26 ...

Product Development and Innovation - The company manufactures high water content, electron beam cross-linked, aqueous polymer hydrogels for applications in wound care, medical diagnostics, transdermal drug delivery, and cosmetics[11]. - The company has launched nine distinct consumer products under the MedaGel and LumaGel Beauty brands, focusing on OTC remedies and cosmetic solutions[16]. - SilverSeal®, a product under the MedaGel brand, has shown statistically significant improvements in scar reduction compared to traditional treatments, with a market expected to grow to $45 billion by 2028[18][19]. - Recent studies indicate SilverSeal® is up to 99% effective in reducing common bacteria, fungi, and yeasts after superficial skin injuries[20]. - The company has filed for a patent on its first medical device, NEXDrape, which is designed for patients with impaired skin, targeting a significant and growing market[25]. - NEXDrape aims to provide a gentle alternative to current adhesive surgical drapes, with benefits including no skin irritation and reduced risk of infection[26]. - The company is developing NEXDerm, an adhesive tape for securing medical devices, which is expected to be a pain-free alternative to Tegaderm, incorporating antimicrobial technology[27]. Manufacturing and Capacity - The manufacturing facility operates at only 5% capacity, with the potential to produce approximately 1.4 billion square inches of product annually at full capacity[15]. - A facility accelerator upgrade costing approximately $570,000 is expected to enhance manufacturing efficiency[15]. - The facility has a manufacturing space of 13,500 square feet, currently operating at only 5% capacity, with the potential to produce approximately 1.4 billion square inches of product annually[15]. - The company maintains a sufficient inventory of raw materials to avoid production disruptions, with principal suppliers including Berry Global, Inc. and DeWolf Chemical, Inc.[34]. - The FDA classifies most of the company's hydrogel products as Class I exempt devices, reducing regulatory burdens for the majority of its offerings[40]. Market Strategy and Sales - The company is implementing a strategy for custom and white label opportunities, allowing other brands to incorporate its hydrogel products into their offerings[22]. - The company is exploring partnerships for retail distribution of new products, aiming to address various market opportunities including OTC pharmaceutical drug delivery and beauty applications[21]. - The company has recently hired two salespeople to expand its customer base and marketing efforts[14]. - Three major customers accounted for approximately 42% of the company's revenue in 2021, with individual contributions of 15%, 14%, and 13%[37]. Research and Development - Research and development costs increased from approximately $0 in 2020 to $31,000 in 2021, with expectations for further increases as the medical device business grows[47]. - The company does not intend to commercialize its medical devices directly but will seek licensing and partnership arrangements to bring products to market[30]. Employment and Operations - The company has ten full-time employees as of December 31, 2021, with plans to utilize outside consultants for additional services as needed[48]. - The company operates from a leased facility of approximately 16,500 square feet in Langhorne, Pennsylvania, with the lease expiring on January 31, 2026[49]. - The company is registered as a device manufacturer with the FDA and intends to comply with all regulatory requirements for its products[43]. Risks and Challenges - The FDA's approval for the 510(k) premarket submission of NEXDrape and NEXDerm is not guaranteed, which poses a risk to the product development timeline[26].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission file number: 001-36278 NexGel, Inc. (Exact name of registrant as specified in its charter) Delawar ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission file number: 001-36278 NexGel, Inc. (Exact name of registrant as specified in its charter) Delaware 26- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: March 31, 2021 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission file number: 001-36278 NexGel, Inc. (Exact name of registrant as specified in its charter) | Delaware | 26-4042544 | | - ...

Revenue Concentration - The company reported that three major customers accounted for approximately 78% of its revenue for the year ended December 31, 2020, with individual contributions of 45%, 22%, and 11% respectively[20] - The company has been supplying its major customers for over fifteen years and does not anticipate any change in their intentions to use its services[20] Business Strategy - The company is implementing a new strategy to transition into a consumer products business focused on proprietary branded products and white label opportunities[14] - The company has historically served as a contract manufacturer, supplying gels to third parties who incorporate them into their own products[14] Research and Development - The company did not incur any research and development costs for the years ended December 31, 2020, and 2019, and plans to commit resources to R&D only as cash resources allow[30] - The company has not incurred any research and development costs for the years ended December 31, 2020, and 2019, and plans to commit resources to R&D only as cash resources allow[30] Employee and Operations - As of December 31, 2020, the company had eight full-time employees, with five involved in manufacturing and regulatory matters[32] - The company currently has eight full-time employees, with five involved in manufacturing and regulatory matters[32] Product and Market Focus - The company specializes in high water content, electron beam cross-linked, aqueous polymer hydrogels used for various applications including wound care and drug delivery[14] - The company’s hydrogels are marketed for applications including drug delivery, moist wound dressings, and cosmetic uses[15] - The company’s hydrogels are marketed for various applications, including drug delivery, wound care, and cosmetic uses[15] Intellectual Property - The company holds patent rights to one patent in Europe, which is set to expire in September 2021, and has exclusive licenses for two issued patents related to transdermal patches[21] - The company has a patent in Europe covering the use of lignin for inhibiting restenosis and thrombosis formation, which is set to expire in September 2021[21] Supply Chain - The company relies on several principal suppliers for raw materials, including Berry Global, Inc., DeWolf Chemical, Inc., and Univar Inc.[17] Regulatory Compliance - The company is currently registered as a device manufacturer and human tissue distributor with the FDA and intends to register as a drug facility when required[26] - The company is currently registered as a device manufacturer and human tissue distributor with the FDA and intends to register as a drug facility when required[26] Inventory Management - The company maintains sufficient inventory of components to avoid significant production disruptions[17]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2020 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission file number: 001-36278 NexGel, Inc. (Exact name of registrant as specified in its charter) Delaware 26-4042544 (Stat ...