NexGel(NXGL)

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NexGel(NXGL) - 2022 Q3 - Quarterly Report
2022-11-08 22:27
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 | ...
NexGel(NXGL) - 2022 Q2 - Quarterly Report
2022-08-10 21:07
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 ...
NexGel(NXGL) - 2022 Q1 - Quarterly Report
2022-05-13 00:29
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 ...
NexGel(NXGL) - 2021 Q4 - Annual Report
2022-03-21 20:13
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].
NexGel(NXGL) - 2021 Q3 - Quarterly Report
2021-11-10 20:28
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 ...
NexGel(NXGL) - 2021 Q2 - Quarterly Report
2021-08-16 19:46
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- ...
NexGel(NXGL) - 2021 Q1 - Quarterly Report
2021-05-17 14:54
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 | | - ...
NexGel(NXGL) - 2020 Q4 - Annual Report
2021-03-31 20:58
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]
NexGel(NXGL) - 2020 Q3 - Quarterly Report
2020-11-16 19:56
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 ...
NexGel(NXGL) - 2020 Q2 - Quarterly Report
2020-08-14 20:05
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 Securities registered pursuant to Section 12(b) of the Act: None. Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such repo ...