Tumors caused by recurrent respiratory papillomatosis are benign, but that does not mean that they are not serious. In this strange disease, growths are formed in the respiratory tract that restricts the ability of a patient to breathe and talk. The FDA recently approved a pregrain medication that addresses the RRP root cause, which makes immunotherapy the first pharmacological treatment for the disorder.
The first movement advantage for Precigen Therapy, known in development as PGN-2012 and marked as Papzimes, brings great success sales expectations. But regulatory approval is just an obstacle. Last year, they pretend, based in Germantown, Maryland, has been performing an act of balance with his pipeline and finances to support the Papzimes, now first marketed the product. The balance is not over, since the company’s regulatory presentations point to financial challenges in next year.
In RRP, chronic human papillomava infection (HPV) 6 or HPV 11 leads to papillomas, or benign tumors, in respiratory tract. The surgical elimination of these growth is the standard of care, but is not healing and requires repeated procedures in the life of a patient. In strange cases, these tumors can become cancerous. They pretend it estimates that 27,000 adults in the US and more than 125,000 patients outside the US. Have PVP.
Papzimeros is a standard immunotherapy that uses an adenoviral gorilla vector to deliver a genetic payload to patient’s cells. This genetic load causes cells to express a fusion antigen that causes an immune response against cells infected with HPV6 and HPV11. The company says that the engineering virus used for Papzimes allows reduction and offers a greater useful load capacity for genetic load compared to other viral vectors.
The presentation of Precigen that seeks the accelerated approval of the FDA for the Papzimes was based on a unique and open arm study that and PVP patients who required three or more surgeries per year. Immunotherapy was administered as four subcutaneous injections in 12 weeks. Papzimes do not complete surgery spare patients. Patients should undergo a surgical reduction of visible papillomas before receiving immunotherapy.
In the fundamental portion of phase study 1/2, 51.4% of patients achieved a complete response, defined as surgical interventions in the 12 months after treatment. Most patients kept thesis responses for two years. Treatment -related problems were classified as mild to moderate and serious ads were reported. Duration A telephone conference of August 18, the CEO Helen Sabzevari, said that additional clinical data up to 36 months will be presented at an upcoming medical conference.
In a presentation at the Annual Health Health Conference JP Morgan in January, Precigen said that his immunotherapy could become a great success seller in PVP and also sacrifices the potential of directions promoted by HPV6 and HPV11. After the FDA of immunotherapy approach, the Precigen established a list price of $ 115,000 per road, or $ 460,000 for a complete treatment course. Sabzevari said it will depend on doctors to determine if a patient needs a reduction, but pointed out the two -year data as evidence of the durability of immunotherapy. The list price is significant higher than the price estimate of $ 200,000 per patient of Citizens JMP. But as is the case with freshly released medications, they are pregnant will take time to recognize income.
The financial position of the pregnan is not strong. In its second financial report published on August 12, the company reported a cash position of $ 59.7 million to June 30 and did not compromise an additional source of financing. Capital is not enough to finance operations for a year, and “these conditions and events raise substantial doubts about the company’s ability to continue as a company,” they said in the report. The financial projection excluded the potential income of the Papzimes, and the company will need effective to support the manufacture and commercialization of newly approved immunotherapy. However, the FDA’s decision was a standard approach, which causes a pretty of the regulatory and financial obligations of a confirmatory clinical trial.
An offer of shares is a way in which the pregnancan could raise more money. The biotechnology actions were closed at $ 4.18 each on Friday, which is 273% higher than where the shares were quoted a year ago when a restructuring stopped preclinical work and reduced 20% of the staff focused on the company on RRP therapy. Shortly after the restructuring, they pretended to raise $ 30 million in an offer of shares to support their plans for Papzimes. The recent increase in precigen shares is still below the projection of Citizens JMP, which increased its target price after the FDA approach from $ 6 to $ 8 per share, and HC Wainright, which maintained an objective price of $ 8.50 for pre -enhancement shares.
At the end of 2024, they pretended to raise $ 79 million in a private location with selected investors, including Randal Kirk, executive president of the company. With the increase in the price of the precigin shares after the Papzimeos approach, those shareholders are now recovering their money and more selling those shares. Precigen will not receive any processing of that sale.
Meanwhile, Precigen has manufacturing or its new insured therapy. Just before the announcement of the Papzimes approach, Precigen entered a three -year supply with the Catalant contract manufacturer, according to a regulatory presentation. Financial terms were not revealed. In a statement sent by email, Precigen Financial Director Harry Thomasian Jr. said that Precigan has been executing “a very robust and directed” launching “launching strategy”, which added that it is completely founded and has bone in the last quarters.
“We feel very good with our financial situation related to the launch itself,” said Thomasian.
While Papzimeos is the first and only pharmacological treatment available for PVP at this time, competition is coming. Immunotherapy based on DNA plasmids of Inovios, Ino-3107, also addresses HPV6 and HPV11. Unlike Precigen therapy, Ino-3107 does not require a viral vector, which reduces the risk of the body producing antibodies to neutralize it.
Inovio plans to complete a continuous presentation for Ino-3107 “in the coming months,” the company said in its report of the financial results of the second quarter of 2025. But as is prigigen and many other biotechnology companies in the current challenging financial environment, Inovio has limited capital. Inovio, who reported a cash position of $ 47.5 million at the end of the second quarter, raised additional $ 22.5 million in an offer of July securities. Biotechnology with headquarters in Philadelphia Suburban said that it hopes that the combined processing process was the last 2026-a financial timeline similar to that of Prigigen.
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