Elite Pharmaceuticals Inc. (OTCBB: ELTP) announced Apr. 14 that it has entered into a common stock purchase agreement with Lincoln Park Capital Fund LLC ("LPC"), a Chicago-based institutional investor for up to $40 million.
Proceeds from the transaction will be used to develop the company's pipeline of products, including the abuse resistant opioids, and for general corporate purposes.
Will Help Develop Abuse-Resistant Opioids
Commenting on the new financing, Elite's President and CEO, Mr. Nasrat Hakim said, "This commitment from Lincoln Park helps Elite to develop our range of abuse resistant opioids on an accelerated pace. By investing in the clinical development of our abuse deterrent products, we expect to significantly increase the value of these products in anticipation of future product partnerships. There is a great interest in our technology and, as Elite has done since I started here last August, we will continue to aggressively scale up and complete the clinical studies necessary to file these products as soon as possible. Our first filing is expected to be by year's end."
Elite Pharmaceuticals has agreed to file a registration statement with the U.S. Securities & Exchange Commission ("SEC") covering the shares that may be issued to Lincoln Park Capital under the terms of the common stock purchase agreement.
After the SEC has declared the registration statement related to the transaction effective, the company has the right, at its sole discretion over a period of three years to sell up to an aggregate of $40 million of its common stock to LPC under the terms and amounts as set forth in the agreement.
Under the terms of the agreement, there are no upper limits to the price that LPC may pay to purchase Elite's common stock. Elite will control the timing and the amount of shares to be sold. LPC has no right to require any sales and is obligated to purchase common stock as directed by Elite.
Under the terms of the agreement, LPC has agreed not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of Elite's shares of common stock. In consideration for entering into the agreement, Elite has issued shares of common stock to LPC as a commitment fee and will issue additional commitment fee shares in proportion to the amount of shares purchased by LPC under the agreement.
On Apr. 14, ELTP’s share price closed at 37 cents, up 5 cents from the previous day’s close of 32 cents a share.
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FDA Grants Extension on MannKind’s Insulin Therapy Review
In other news, MannKind Corp. (NASDAQ:MNKD) announced that the Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for AFREZZA by three months to Jul.15, 2014 in order to provide time for a full review of information submitted by MannKind in response to the FDA's requests.
AFREZZA (uh-FREZZ-uh) is a novel, ultra rapid-acting mealtime insulin therapy developed by MannKind Corporation to improve glycemic control in adult patients with type 1 or type 2 diabetes. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder delivered using a small, discreet and easy-to-use inhaler. Administered at the start of a meal, AFREZZA Inhalation Powder dissolves immediately upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of administration, compared to 45-90 minutes for injected rapid acting insulin analogs and 90-150 minutes for injected regular human insulin.
Of the 5 analyst firms covering MNKD, 1 rates it a “strong buy,” 3 a “hold” and 1 an "underperform."
On Apr. 14, MNKD’s share price closed at $6.29, down 12 cents from the previous day’s close of $6.41 cents a share.
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OncoSec Medical Relaunches Its Phase-II Study
Meanwhile, OncoSec Medical Inc. (OTCQB: ONCS) share volume soared Apr. 14, with 5,578,453 shares changing hands, nearly double its three-month daily average of 3,359,294 shares.
The surge in stock volume is being spurred in part by the San Diego-based bio-tech company that develops therapies that fight tumors Apr. 7 announcement that it’s relaunched its Phase II cutaneous T-cell lymphoma (CTCL) trial under a protocol amendment.
Yuon Kim, M.D. will serve as principal investigator for the Stanford University study. According to the company, Dr. Kim is an internationally renowned expert in cutaneous lymphomas and director of the multidisciplinary cutaneous lymphoma program at Stanford University Medical Center. Her team of top physicians and clinical/research staff are dedicated to providing excellence in patient care and advancing the development of new and innovative therapies that improve patient survival and quality of life.
On Apr. 14, ONCS’s share price closed at 66 cents, down 9 cents from the previous day’s close of 75 cents a share.
Provectus Pharmaceuticals Completes Phase II Melanoma Drug Study
Finally, Provectus Pharmaceuticals’ (OTC: PVCT) share price on Apr. 14 closed at $2.26, down 8 cents from the share price of $2.34 cents the previous day.
The development-stage pharmaceutical company is developing medicines for oncology and dermatology applications. Provectus product line includes PV-10, a Phase II study completed drug candidate for metastatic melanoma, a Phase I study completed candidate for breast cancer, and a Phase I protocol expansion candidate for liver metastasis.
In addition it is conducting PH-10, a Phase IIc randomized study initiated drug candidate for the treatment of psoriasis, and Phase II study completed candidate for atopic dermatitis. It also develops PH-10 for the treatment of actinic keratosis and severe acne vulgaris.
Moreover, the company develops over-the-counter pharmaceuticals, including GloveAid, a hand cream with antiperspirant and antibacterial properties; Pure-ific line of products to prevent the spread of germs on skin; and Pure-Stick and Pure N Clear acne products.
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