Germantown biotech expands manufacturing capacity, headcount ahead of potential product launch – Washington … – The Business Journals
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Germantown’s Precigen Inc., a clinical-stage biotech developing gene and cell therapies for cancers and other diseases, is taking steps to get an experimental treatment to regulators for review this year — which could pave the path for a market launch in 2025.
The 26-year-old Precigen (NASDAQ: PGEN) has been advancing an immunotherapy to treat a rare disease most common in kids called recurrent respiratory papillomatosis, or RRP. It’s on track to wrap up a phase 2 clinical trial in the second quarter that, if successful, could set it up for the Food and Drug Administration’s signoff to get it to patients next year.
“2024 is poised to be a transformative year for us at Precigen, especially as we transition from a clinical to a commercial company,” President and CEO Helen Sabzevari said on a company earnings call Tuesday.
To prepare for its first-ever sale of its own product — it has historically generated revenue from licensing deals and services — Precigen is expanding its manufacturing capacity within its Germantown facility by converting existing office space, a company spokesperson told me. Tied to that expansion, it has already increased its headcount across positions in manufacturing, quality control and quality assurance, and expects to bring on more employees “as we proceed towards potential commercialization,” the spokesperson said.
The facility, which also has lab space, spans 61,000 square feet. The company also has R&D space in Ghent, Belgium.
“There’ll be some increased expenditures with the build-out of commercialization and manufacturing capabilities. But through financial management, we’re trying to reduce spend in other areas of the company,” Harry Thomasian, its chief financial officer, said on Tuesday’s earnings call.
The product has gotten to this point through a research and development agreement with the National Cancer Institute’s Center for Cancer Research. It previously scored Breakthrough Therapy Designation and an accelerated approval pathway from the FDA, to help speed up the research and development process.
The therapy, dubbed PRGN-2012, triggers the body’s immune response to cells that have been infected with human papillomavirus, or HPV. That’s because in RRP, the HPV virus can cause benign tumors on the vocal cord and trachea, impeding speech and breath. And in the absence of good treatment options, the best bet is surgery to remove those tumors.
“It’s like mowing your grass, and then they keep coming back,” Sabzevari said on the earnings call. “In the order to really address this disease, you have to get to the root,” she added.
RRP is thought to affect between 15,000 and 20,000 patients in the U.S., and roughly 125,000 outside of the country. It most frequently affects children; vaccination against HPV can be effective in preventing RRP, and about half of U.S. teenagers are immunized.
“A relatively small group” of specialty physicians “are managing the large majority of patients,” Jim Shaffer, head of commercial operations for Precigen, said on Tuesday’s earnings call.
To that end, the company expects to build a specialty sales team to focus on major metro areas “and very efficiently be able to increase awareness, launch and then promote our product once approved,” said Shaffer, who Precigen tapped in September to help position itself for a 2025 product launch.
Shaffer was most recently CEO of Raleigh, North Carolina’s Aer Therapeutics, after serving as chief business officer for Eiger Biopharmaceuticals and chief commercial officer for Halozyme Therapeutics, both of California.
Precigen is also pushing other therapies through clinical trials, including an immunotherapy in cervical cancers and multiple CAR T-cell therapies in ovarian cancer, acute myeloid leukemia, and other types of blood cancers and solid tumors.
Those UltraCAR-T programs, as they’re called, “have garnered significant interest from potential partners due to the safety, preliminary efficacy and manufacturing advantages,” Sabzevari said in a statement Tuesday.
Precigen closed 2023 with $62.9 million in cash, cash equivalents and investments. Its revenue in 2023 fell 76.9% from the prior year because nearly all licensing deals have ended as the company shifted its focus to developing therapies, it said in its Securities and Exchange Commission filings.
The business suffered a net loss of $95.9 million in 2023, for multiple reasons including compensation and other expenses. It also cut selling, general and administrative costs by 16% in 2023 year over year, to $40.4 million, mainly due to a reduction in legal and insurance costs, the company reported.
Its R&D expenses in 2023 also increased by 3% to $48.6 million, “primarily due to additional investments in our personnel, mostly through adding additional head count to support the growth in the company’s development activities,” Thomasian said on the call. Precigen counted more than 200 employees as of December, according to its SEC filings.
Precigen, formerly Intrexon Corp., was founded in 1998 and went public in 2013. The business had restructured in 2019 and rebranded in 2020. Sabzevari took over around that time when Randal Kirk, Intrexon’s longtime chief and major backer, shifted to the executive chairman role.
© 2023 American City Business Journals. All rights reserved. Use of and/or registration on any portion of this site constitutes acceptance of our User Agreement (updated January 24, 2023) and Privacy Policy (updated December 19, 2023). The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of American CityBusiness Journals.
This article was autogenerated from a news feed from CDO TIMES selected high quality news and research sources. There was no editorial review conducted beyond that by CDO TIMES staff. Need help with any of the topics in our articles? Schedule your free CDO TIMES Tech Navigator call today to stay ahead of the curve and gain insider advantages to propel your business!
Germantown’s Precigen Inc., a clinical-stage biotech developing gene and cell therapies for cancers and other diseases, is taking steps to get an experimental treatment to regulators for review this year — which could pave the path for a market launch in 2025.
The 26-year-old Precigen (NASDAQ: PGEN) has been advancing an immunotherapy to treat a rare disease most common in kids called recurrent respiratory papillomatosis, or RRP. It’s on track to wrap up a phase 2 clinical trial in the second quarter that, if successful, could set it up for the Food and Drug Administration’s signoff to get it to patients next year.
“2024 is poised to be a transformative year for us at Precigen, especially as we transition from a clinical to a commercial company,” President and CEO Helen Sabzevari said on a company earnings call Tuesday.
To prepare for its first-ever sale of its own product — it has historically generated revenue from licensing deals and services — Precigen is expanding its manufacturing capacity within its Germantown facility by converting existing office space, a company spokesperson told me. Tied to that expansion, it has already increased its headcount across positions in manufacturing, quality control and quality assurance, and expects to bring on more employees “as we proceed towards potential commercialization,” the spokesperson said.
The facility, which also has lab space, spans 61,000 square feet. The company also has R&D space in Ghent, Belgium.
“There’ll be some increased expenditures with the build-out of commercialization and manufacturing capabilities. But through financial management, we’re trying to reduce spend in other areas of the company,” Harry Thomasian, its chief financial officer, said on Tuesday’s earnings call.
The product has gotten to this point through a research and development agreement with the National Cancer Institute’s Center for Cancer Research. It previously scored Breakthrough Therapy Designation and an accelerated approval pathway from the FDA, to help speed up the research and development process.
The therapy, dubbed PRGN-2012, triggers the body’s immune response to cells that have been infected with human papillomavirus, or HPV. That’s because in RRP, the HPV virus can cause benign tumors on the vocal cord and trachea, impeding speech and breath. And in the absence of good treatment options, the best bet is surgery to remove those tumors.
“It’s like mowing your grass, and then they keep coming back,” Sabzevari said on the earnings call. “In the order to really address this disease, you have to get to the root,” she added.
RRP is thought to affect between 15,000 and 20,000 patients in the U.S., and roughly 125,000 outside of the country. It most frequently affects children; vaccination against HPV can be effective in preventing RRP, and about half of U.S. teenagers are immunized.
“A relatively small group” of specialty physicians “are managing the large majority of patients,” Jim Shaffer, head of commercial operations for Precigen, said on Tuesday’s earnings call.
To that end, the company expects to build a specialty sales team to focus on major metro areas “and very efficiently be able to increase awareness, launch and then promote our product once approved,” said Shaffer, who Precigen tapped in September to help position itself for a 2025 product launch.
Shaffer was most recently CEO of Raleigh, North Carolina’s Aer Therapeutics, after serving as chief business officer for Eiger Biopharmaceuticals and chief commercial officer for Halozyme Therapeutics, both of California.
Precigen is also pushing other therapies through clinical trials, including an immunotherapy in cervical cancers and multiple CAR T-cell therapies in ovarian cancer, acute myeloid leukemia, and other types of blood cancers and solid tumors.
Those UltraCAR-T programs, as they’re called, “have garnered significant interest from potential partners due to the safety, preliminary efficacy and manufacturing advantages,” Sabzevari said in a statement Tuesday.
Precigen closed 2023 with $62.9 million in cash, cash equivalents and investments. Its revenue in 2023 fell 76.9% from the prior year because nearly all licensing deals have ended as the company shifted its focus to developing therapies, it said in its Securities and Exchange Commission filings.
The business suffered a net loss of $95.9 million in 2023, for multiple reasons including compensation and other expenses. It also cut selling, general and administrative costs by 16% in 2023 year over year, to $40.4 million, mainly due to a reduction in legal and insurance costs, the company reported.
Its R&D expenses in 2023 also increased by 3% to $48.6 million, “primarily due to additional investments in our personnel, mostly through adding additional head count to support the growth in the company’s development activities,” Thomasian said on the call. Precigen counted more than 200 employees as of December, according to its SEC filings.
Precigen, formerly Intrexon Corp., was founded in 1998 and went public in 2013. The business had restructured in 2019 and rebranded in 2020. Sabzevari took over around that time when Randal Kirk, Intrexon’s longtime chief and major backer, shifted to the executive chairman role.
© 2023 American City Business Journals. All rights reserved. Use of and/or registration on any portion of this site constitutes acceptance of our User Agreement (updated January 24, 2023) and Privacy Policy (updated December 19, 2023). The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of American CityBusiness Journals.
This article was autogenerated from a news feed from CDO TIMES selected high quality news and research sources. There was no editorial review conducted beyond that by CDO TIMES staff. Need help with any of the topics in our articles? Schedule your free CDO TIMES Tech Navigator call today to stay ahead of the curve and gain insider advantages to propel your business!
