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ORMP: Data from Phase 1 Trial of Oral GLP-1 in 2Q19…

By David Bautz, PhD

NASDAQ:ORMP

READ THE FULL ORMP RESEARCH REPORT

Business Update

Oramed Pharmaceuticals Inc. (ORMP) is a biotechnology company with a proprietary oral protein delivery platform technology. The lead development candidate is ORMD-0801, an oral insulin, that is currently being tested in both type 1 (T1D) and type 2 diabetics (T2D). The company is also developing ORMD-0901, an oral glucagon-like peptide-1 (GLP-1).

ORMD-0801 Update

Type 1 Diabetics: In June 2018, the company initiated both a clamp study and a food effect study, and while these studies are enrolling T1D patients and healthy controls, investors should be aware that the data gleaned from these studies will be equally applicable to an approval in T2D. The clamp study is enrolling T1D patients with HbA1c levels ≤ 10% between the ages of 18-50. The clamp study was originally developed in 1979 as a means of testing how well a patient metabolizes glucose and their insulin sensitivity (DeFronzo et al., 1979). A clamp study is a requirement of all regulatory agencies around the world for performing pharmacodynamic studies of diabetes drugs in development. We anticipate results from this study in the first half of 2019.

The food effect study is a single blind, five period, randomized, placebo controlled crossover study that is designed to evaluate the pharmacokinetics and pharmacodynamics of ORMD-0801 as a function of when the drug is administered in relation to meals. Up to 48 subjects (half healthy volunteers and half T1D patients) will be enrolled. We anticipate data from this study in mid-2019.

Type 2 Diabetics: In April 2018, Oramed initiated a 90-day dose-ranging Phase 2b clinical trial designed to measure the effect of ORMD-0801 on glycated hemoglobin (HbA1c). This is a prerequisite prior to initiating Phase 3 clinical trials. Recently, Oramed announced that the trial is over 75% enrolled. The company had previously found a statistically significant improvement in HbA1c following just 28 days of treatment in the company’s prior Phase 2 clinical trial. High levels of blood glucose results in its binding to hemoglobin (becoming glycated). Since red blood cells survive for an average of 90 days, it typically takes this amount of time to determine the true effect a drug may be having on reducing glycated hemoglobin. We anticipate approximately 285 patients being enrolled in the trial, which will test 16, 24, and 32 mg doses of ORMD-0801 given once, twice, or three times a day. Topline results should be available before the end of 2019.

NASH Study: On Oct. 4, 2018, Oramed announced the initiation of an exploratory proof-of-concept study to evaluate ORMD-0801 in patients suffering from nonalcoholic steatohepatitis (NASH). The study will test the ability of ORMD-0801 to reduce liver fat, inflammation, and fibrosis in NASH patients. NASH is inflammation and damage to the liver brought about by a buildup of fat and is the most severe form of nonalcoholic fatty liver disease (NAFLD). It is often a “silent” liver disease as most patients with NASH feel well and are not aware that they have a liver problem. However, NASH can be severe and ultimately lead to cirrhosis, liver failure, and hepatocellular carcinoma. NASH is currently estimated to affect two to five percent of the U.S. population (NIDDK) with the global market estimated to reach $20 billion by 2025 (Allied Market Research).

License Deal in China: In 2015, Oramed signed a Technology License Agreement with Hefei Tianhui Incubation of Technologies Co. Ltd. (HTIT), a Chinese company that owns a GMP-certified API insulin manufacturing facility. The agreement gave HTIT exclusive commercialization rights for ORMD-0801 in China, Macau, and Hong Kong. HTIT purchased $12 million in restricted stock and will pay 10% royalties on net sales along with up to $37.5 million in milestone payments. Oramed has already received $33 million. China represents a vast potential opportunity as there are over 100 million diabetic individuals in the country and approximately 500 million that are pre-diabetic.

On Mar. 26, 2019, Oramed announced that HTIT had an IND application approved by the Center for Drug Evaluation of the Chinese National Medical Products Administration, which will allow for the start of clinical trials for ORMD-0801 in China.



ORMD-0901 Update

On September 17, 2018, Oramed announced that the U.S. FDA has approved the company’s investigational new drug application (IND) to initiate clinical trials for ORMD-0901, an oral formulation of the GLP-1 analog exenatide. GLP-1 analogs mimic the action of GLP-1 and are currently used in the treatment of T2D, with sales of this class of drugs totaling $6.9 billion in 2017 (EvaluatePharma).

On Jan. 22, 2019, the company announced that it initiated a Phase 1 pharmacokinetic (PK) study of ORMD-0901. It is a randomized, single blind, placebo controlled crossover study which will evaluate the safety of ORMD-0901 as well as its PK compared to placebo and open label Byetta® in up to 15 healthy subjects. We anticipate results from this trial the second quarter of 2019.

Intellectual Property Update

On Mar. 28, 2019, Oramed announced the allowance of a U.S. Patent for the technology “Protease Inhibitor-Containing Compositions, Compositions Comprising Same, and Methods for Producing and using Same”, which protects the protease inhibitors associated with the company’s oral insulin technology.

On Apr. 4, 2019, Oramed announced the allowance of a U.S. Patent for the technology “Methods and Compositions for Oral Administration of Exenatide”, which provides IP protection for ORMD-0901, for which the company has recently launched a Phase 1 clinical trial.

Financial Update

On April 10, 2019, Oramed filed form 10-Q with financial results for the first quarter of fiscal year 2019 that ended February 28, 2019. The company reported revenues of $0.67 million, which are related to the license agreement with Hefei Tianhui Incubator of Technologies Co., Ltd. (HTIT) singed in 2015. The revenues originating from that license agreement are recognized through June 2023. Cost of revenues in the first quarter of fiscal year 2019 were $0.06 million, compared to $0.0 million for the first quarter of fiscal year 2018. The increase was due to additional milestone payments received during the three months ending Feb. 28, 2019.

R&D expenses for the first quarter of fiscal year 2019 were $3.1 million, compared to $2.7 million for the first quarter of fiscal year 2018. The increase was primarily due to expenses associated with the Phase 2b and GLP-1 pharmacokinetics clinical trials. G&A expense for the first quarter of fiscal year 2019 were $1.1 million, compared to $1.0 million for the first quarter of fiscal year 2018. The increase was primarily due to increased salaries partially offset by a decrease in stock-based compensation.

As of Feb. 28, 2019, Oramed had approximately $40.8 million in cash, cash equivalents, and short-term and long-term deposits and marketable securities. We estimate that the company has sufficient capital to fund operations for at least the next 18 months. As of Apr. 9, 2019, the company had approximately 17.4 million common shares outstanding and when factoring in stock options and warrants a fully diluted share count of approximately 21.6 million.

Valuation

We value Oramed using a probability adjusted discounted cash flow model that takes into account potential future revenues from ORMD-0801 and ORMD-0901. We currently model for approval of ORMD-0801 in 2024 with first sales in 2025 and approval of ORMD-0901 in 2025 with first sales in 2026. We estimate for peak U.S. sales of ORMD-0801 of approximately $400 million and peak U.S. sales of ORMD-0901 of approximately $500 million. Using a 12% discount rate and a 60% probability of approval for ORMD-0801 and a 45% probability of approval for ORMD-0901 leads to a net present value for those two programs of $181 million and $152 million, respectively. When including the current cash total, potential cash from warrant exercises, and dividing by the fully diluted share count leads to a net present value for Oramed of approximately $18 per share.

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