Immune Pharmaceuticals, Inc. (NASDAQ: IMNP) is a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases. Currently, the company is conducting two Phase II clinical trials to test bertilimumab in patients suffering from bullous pemphigoid and ulcerative colitis, respectively.
On September 27th, IMNP announced Positive Results from Ongoing Phase 2 Trial of Bertilimumab in Bullous Pemphigoid. The six subjects in the study experienced a decline in the Bullous Pemphigoid Disease Area Index (BPDAI) Total Activity Score of 85% (p=0.0096). All six subjects in the study achieved a greater than 50% reduction in their BPDAI Total Activity Score by the final assessment, and four of the six patients had a greater than 90% reduction. Bertilimumab was well tolerated in all six subjects, and no serious adverse events were reported.
As per management, these results are quite impressive. Moderate-to-severe bullous pemphigoid is typically managed with 60 mg of prednisone. The improvement seen in these subjects despite such a low prednisone dose and a rapid taper, strongly suggests bertilimumab may provide a clinically meaningful benefit.
Bullous pemphigoid, is an autoimmune condition that is imbibed in the immune system creating and adversely affecting the antibodies that break down the bonds between skin cells in humans. This breaking down of the bonds translates to open sores and severe blisters.
Immune is working towards changing this with bertilimumab, which is a monoclonal antibody that stops the bonds being broken. If bertilimumab could significantly reduce or maybe even eliminate the need for systemic corticosteroids in the treatment of bullous pemphigoid and their significant toxicity, it will be a major step forward in the rapid improvement of what is the most common blistering disease.
The company would continue to enroll subjects into this phase 2 open-label BP trial, which has a target enrollment of around 15 patients, as it initiates plans for a larger clinical trial designed to prove that bertilimumab provides a significant benefit to patients suffering from this severe inflammatory disease.
In fact, these promising preliminary results support the company’s strategy of focusing its human capital and financial resources on bertilimumab and NanoCyclo product candidates while streamlining operations by divesting unrelated oncology business.
Therefore, the company is an interesting biotech play and has various catalysts (in addition to bertilimumab), which the markets are going to be watching very closely as indicative of the future success of the company.
- The company has an orphan drug designation filing with the FDA, which it should have an update before the end of 2017.
- There’s a phase 2 study of the same drug in ulcerative colitis indication, which should announce results during the second quarter of next year.
- There’s also a pivotal initiation for Ceplene, which should be under the sole management of the company’s spinoff Cytovia, in the US.
These are few significant catalysts over the near to medium term and if they come out as “positive,” it could place the stock on a rapid growth trajectory. Immune’s share price is low right now and therefore is a value stock at current prices.
About the Company: Immune Pharmaceuticals is a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases. Its lead program, bertilimumab, is a first-in-class, humanized monoclonal antibody that targets and lowers levels of eotaxin-1, a chemokine that plays a role in immune responses and attracts eosinophils to the site of inflammation.
About Bertilimumab: Bertilimumab is a first-in-class human monoclonal antibody designed to block the protein eotaxin-1, which is responsible for causing inflammation in a significant number of diseases.
- Currently running phase 2 trials in bullous pemphigoid (open-label single arm) and ulcerative colitis (randomized, double-blind, placebo-controlled)
- Strong efficacy signal from BP trial – first six subjects had a significant reduction in disease activity despite an aggressive prednisone taper
- Well-established safety profile – substantial human exposure (n>100 total; >60 IV); no drug associated SAE
- Multiple additional clinical applications including atopic dermatitis, asthma, other eosinophil-driven diseases, glioblastoma, and others
Nanocyclo: Nanoformulation of cyclosporine enables the molecule to better penetrate the skin layers and provide a local anti-inflammatory effect. Cyclosporin is widely used as a systemic agent to prevent organ transplant rejection and has also been approved to treat autoimmune diseases such as rheumatoid arthritis and psoriasis, and for local use in the treatment of dry eye and some forms of keratitis.
Product/pipeline with multiple indications:
Cytovia Spin-off Update: Progress continues on segregating the IMNP oncology assets into Cytovia, Inc., and recruitment of a Cytovia management team in preparation of a spin-off and a distribution of Cytovia’s shares to Immune’s shareholders.
2017 Second quarter financial results:
- The Company recorded no revenue for the six months ended June 30, 2017, and 2016.
- At June 30, 2017, the Company had a working capital deficit of approximately $14.2 million. Accumulated deficit amounted to $104.3 million and $95.6 million at June 30, 2017, and December 31, 2016, respectively. Net loss for the three and six months ended June 30, 2017, was $4.9 million and $8.7 million, respectively.
- Operations since inception have been funded primarily with the proceeds from equity and debt offerings. As of June 30, 2017, the Company had approximately $22,000 in cash.
- The following table summarizes select balance sheet and working capital amounts as at June 30, 2017, and December 31, 2016 ($ in thousands):
Key risk factors and potential stock drivers:
The upcoming updates on the clinical trial targeted enrolment, would drive the future direction of the stock. If these updates support the recent data, stock prices could surge.
IMNP presently has net level losses. Therefore, any crunch in its liquidity and financial flexibility will further impact its business & financial profile.
NASDAQ Letter: on August 23, 2017, the Company received written notice from the Listing Qualifications Department that the Company no longer complies with the minimum stockholders’ equity requirement under the NASDAQ Listing Rule. The Company also does not meet the alternative compliance standards relating to the market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years.
By NASDAQ Listing Rules, the Company has 45 calendar days, or until about October 6, 2017, to submit a plan to regain compliance. If accepted, NASDAQ may grant the Company an extension of up to 180 days. An unfavorable outcome of this matter could impinge to stock performance over the near term.
On Wednesday, October 4th, 2017, IMNP closed at $1.52 on an average volume of 1.69 million shares exchanging hands. Market capitalization is $16.07 million. The current RSI is 60.62
In the past 52 weeks, shares of IMNP have traded as low as $1.01 and as high as 7.15
At $1.52, shares of IMNP are trading above its 50-day moving average (MA) at $1.42 and below its 200-day MA at $2.70
The present support and resistance levels for the stock are at $1.49 & $1.60 respectively.
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