Oragenics Inc (AMEX: OGEN) trading volume and price has spiked in recent days. Oragenics develops, markets and sells probiotics under the brand names Evora and ProBiora. The company has established two exclusive worldwide channel collaborations with Intrexon Corporation, a synthetic biology company which allow it access to Intrexon’s proprietary technologies with the goal of accelerating new antibiotic development. These antibiotics can work against resistant strains of bacteria and for the development of biotherapeutics for oral mucositis and other diseases and conditions of the oral cavity, throat, and esophagus. In addition to the Fast Track designation, AG013 has already been granted Orphan Drug status in the European Union.
FDA grants fast track designation for the development of AG013 for Oral Mucositis
Oragenics announced that the FDA has granted fast track designation for the product and the company expects to file An Investigational New Drug update and to initiate a phase 2 study in the United States and Europe in early 2017. The fast track is a process which facilitates the development and review of drugs to treat serious conditions and designed to respond to key unmet medical needs. By allowing for more frequent meetings and communication with the FDA. The company described this as another significant milestone in the path to provide a new therapy for cancer patients who developed the condition.
Oral mucositis is one of the most commonly reported side-effects associated with cancer chemotherapy – affecting up to 500,000 patients each year. If severe, these side-effects can affect the patient’s cancer treatment regime. At present, there is no approved drug to prevent the condition and current therapies are mainly comforting in nature – addressing only relief from symptoms but not treating the underlying causes.
Oragenics had earlier announced that NYSE had accepted the plan to regain compliance with the continued listing standards by 10. November 2017, subject to periodic review for compliance. Oragenics trades under the ticker OGEN.
On 30 June 2016, the company announced the closing of a private placement of 9,045,679 shares of OGEN common stock to three accredited investors – raising gross proceeds of approximately $4.687 billion. The purchase price per OGEN share was $0.5159. The midpoint of the closing quote on June 29, 2016. The net proceeds, after payment of offering expenses, will be used for R&D activities and for general corporate purposes. The President and CEO, Dr Alan Joslin, said that the company was pleased that the largest shareholders continue to recognise its potential and its efforts to become the world leader in the use of novel antibiotics against infectious diseases and in the treatment for oral mucositis.
The bottom line on OGEN
The financials as of 30 September 30, 2016 showed cash and cash equivalents of $5.11 million and total current assets of $5.28 million against total shareholders equity of $ 4.48 million. The company earned no revenues and incurred total operating expenses of $2.02 million, leading to a loss from continuing operations of $2.02 million. OGEN has spiked in price and volume leading people knowledgeable with investing to revisit the company’s prospects. As always, complete your own due diligence before making any decisions on any investment.