SANTA MONICA, CA / FinancialPress / November 28, 2017 / In February 2016, Thomas Equels, a man who had held several different positions at Hemispherx Biopharma (HEB), was appointed to replace Dr. William Carter as Chief Executive Officer at the company and tasked by the Board to turn the struggling company around. A year-and-a-half of steady developments later, and it looks like Equels is coming through on that directive.
In a recent interview with Mike Elliott on CEO Live, Equels showed that the management shake-up and corporate culture change was what the company needed. Cutting right to the chase, Equels said, “The fact is that, in the past 18 months, we have accomplished more than we accomplished in the prior 10 years.” Equels put an exclamation point to that comment in adding that the new team is “dedicated to the efficient execution of priority goals.”
The interview coincided with Hemispherx releasing the results from the third quarter and nine months ended September 2017, along with a progress update and a new corporate presentation bringing investors up to speed on all that has been accomplished since Equels took the helm. Sales for the first three quarters of the year came in at $387,000, up from $76,000 in the same period in 2016. The company benefited from trimming operating expenses by $500,000 and a revaluation of redeemable warrants to cut the quarterly net loss to $1.3 million from $2.9 million in the year prior quarter. Cash and cash equivalents at the end of September were $2.3 million.
While the company continues to operate at a loss, not exactly an uncommon occurrence with life sciences companies, it is making strides advancing its two immunological assets, Alferon and Ampligen, both of which are manufactured at the company’s FDA licensed cGMP facility in New Brunswick, NJ. Hemispherx recently put about $8 million into the facility for new equipment, bringing the total investment to over $30 million.
Alferon, the only natural interferon in the global market, is FDA approved for the treatment of genital warts in adults caused by human papillomavirus (HPV) and marketed and distributed through an alliance with Asembia. Alferon is also approved in Argentina for the same indication, as well as in patients who fail or become intolerant to recombinant (synthetic) interferon.
Hemispherx is looking to scale and overcome sales limitations by upgrading the manufacturing process to utilize a 600-liter bioreactor that can produce 1,200 vials, as compared to the prior 6-liter flask that could only produce 12 vials. Currently, the facility has undergone renovation following a flood and is now ready for production again, pending FDA certification and additional funding needed to facilitate restarting manufacturing.
While Alferon could represent a market opportunity greater than $90 million in the future with relatively small market penetration, the gem of the pipeline right now is Ampligen, a novel RNA compound and TLR3 agonist hypothesized to be able to treat an array of indications – such as pancreatic cancer, ovarian cancer, colorectal cancer, melanoma, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and influenza – that is easier and less expensive to manufacture than Alferon. Evidence so far indicates that Ampligen can provide a benefit to patients either as a stand-alone therapy or as part of a combination regimen.
Moreover, the lead indication for Ampligen, CFS, is an area of great unmet medical need with a complete lack of any real competition worldwide.
In August, Hemispherx won marketing approval for Ampligen in Argentina for the treatment of severe ME/CFS, a condition of unknown cause characterized by fatigue lasting more than six months that generally worsens with activity, but doesn’t improve with rest. The approval of Ampligen for severe ME/CFS was a watershed moment, as there are no other drugs anywhere approved for the indication. The approval from ANMAT, the Argentinian health authority, could pave the way to introducing Ampligen to patients in need throughout Latin America.
Ampligen is the only drug in late-stage development in the U.S. for ME/CFS, a disorder that affects about one million Americans, including about 70,000 people with the severe form of the condition. Current treatments are simply aimed at relieving symptoms, with no specific therapeutic approved for ME/CFS. Mid- and late-stage trials of Ampligen have shown it to be generally safe and well-tolerated (>100,000 IV doses administered) and to provide a clinically meaningful therapeutic benefit. The company remains in discussions with the FDA on the shortest pathway to commercialization, which is going to include additional phase 3 research.
Ampligen is available in Europe through an Early Access Program run by Netherlands-based Impatients N.V. (d/b/a myTomorrows). Hemispherx amended an agreement with Impatients in May 2016, with the first shipments delivered to for use in the E.U. and Turkey for patients suffering from CFS and pancreatic cancer.
In the U.S., Ampligen is available for CFS under a cost recovery program, meaning that the company cannot make a profit on the treatment, but can breakeven. To that end, the new Hemispherx received an approval from the FDA to increase the price of a vial of Ampligen to $200 from the $75 previously received.
Equels and his team spearheaded all of these initiatives that have resulted in a pipeline that was relatively stagnant to becoming very dynamic, and a company moving towards more consistent (and greater) cash flow, while in the process cutting the burn rate by over half and still hitting milestones.
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