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OHRP > SEC Filings for OHRP > Form 10-Q on 7-Aug-2012All Recent SEC Filings

Show all filings for OHR PHARMACEUTICAL INC | Request a Trial to NEW EDGAR Online Pro

Form 10-Q for OHR PHARMACEUTICAL INC


7-Aug-2012

Quarterly Report


Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.

Certain statements contained in this report, including, without limitation, statements containing the words "believes," "anticipates," "expects," "intends," and words of similar import, constitute "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 or by the Securities and Exchange Commission in its rules, regulations and releases, regarding the Company's financial and business prospects. These forward-looking statements are qualified in their entirety by these cautionary statements, which are being made pursuant to the provisions of such Act and with the intention of obtaining the benefits of the "safe harbor" provisions of such Act. The Company cautions investors that any forward-looking statements it makes are not guarantees of future performance and that actual results may differ materially from those in the forward-looking statements. We assume no obligation to update any forward-looking statements contained in this report, whether as a result of new information, future events or otherwise. Any investment in our common stock involves a high degree of risk. For a general discussion of some of these risks in greater detail, see our "Risk Factors" in the Company's Annual Report on Form 10-K (the "Form 10-K") for the fiscal year ended September 30, 2011, as filed with the Securities and Exchange Commission on January 13, 2012, as amended.

History and Recent Events

Ohr Pharmaceutical, Inc. ("we", "Ohr", the "Company" or the "Registrant") is a Delaware corporation that was organized on August 4, 2009. On that date, the predecessor firm (formerly known as BBM Holdings, Inc. and Prime Resource, Inc., organized on March 29, 2002) completed a reincorporation merger with its wholly-owned subsidiary, Ohr Pharmaceutical, Inc., and ceased to exist as a separate legal entity. The reincorporation merger did not result in any material change in our business, offices, facilities, assets, liabilities, obligations or net worth, or our directors, officers or employees.

On March 19, 2009, the Company acquired in a secured party sale all the patents, related intellectual property, clinical data and other assets related to AVR118 (renamed OHR/AVR118). OHR/AVR118 is in an ongoing Phase II trial for the treatment of cachexia. The Company also exercised its option to acquire the new technology and early stage pharmaceutical compounds from Dr. S. Z. Hirschman, who joined the Company as a consultant and Chief Scientific Advisor.

The Company acquired OHR/AVR118 and related assets in a secured party sale with $100,000 in cash and $500,000 principal amount of 11% convertible secured non-recourse debenture, due June 20, 2011, convertible into common stock at $0.40 per share (the "Convertible Debenture"). The Convertible Debenture was repaid in full on December 29, 2010. The cash portion of the purchase price was financed by short-term loans from an affiliate of Orin Hirschman and another current shareholder, which were repaid on June 3, 2009.

On August 19, 2009, the Company completed the acquisition of Squalamine, Trodusquemine and related compounds from Genaera Liquidating Trust. The Company paid $200,000 in cash for the compounds.

On April 12, 2010, the Company hired Dr. Irach Taraporewala as the Company's full-time CEO and Sam Backenroth as the Company's Vice President of Business Development and Interim CFO. In connection with their employment, Mr. Limpert resigned as an officer and director of the Company.

In December 2010, the Company opened a new clinical site for its ongoing Phase II clinical trial to investigate the efficacy of OHR/AVR118 for the treatment of cancer cachexia at the Ottawa Hospital Cancer Centre.

In June 2011, the Company commenced the Squalamine eye drop program for the treatment of the wet form of macular degeneration. Animal safety and biodistribution data generated using the eye drop formulation of Squalamine were reported in July 2011, with further data being presented at the Association for Research in Vision and Ophthalmology (ARVO) and Macula Society meetings in May and June 2012, respectively.

Product Pipeline

Squalamine

Squalamine is a small molecule anti-angiogenic drug with a novel intracellular mechanism of action. The drug acts against the development of aberrant neovascularization by inhibiting multiple protein growth factors of angiogenesis, including vascular endothelial growth factor ("VEGF"), platelet-derived growth factor ("PDGF") and basic fibroblast growth factor growth factor ("bFGF"), with high potency at nanomolar concentrations. Recent clinical evidence has shown PDGF to be an additional target for the treatment of Wet Age-related Macular Degeneration ("Wet-AMD"). Using an intravenous formulation in over 250 patients in Phase I and Phase II trials for the treatment of Wet-AMD, the trials demonstrated that the molecule had biological effect and maintained and improved visual acuity outcomes, with both early and advanced lesions responding.

Ohr reformulated Squalamine for ophthalmic indications from an intravenous infusion ("IV") to a topical eye drop. Preclinical testing has demonstrated that the eye drop formulation is both safe to ocular tissues and achieves in excess of target anti-angiogenic concentrations in the tissues of the back of the eye. The Company plans on advancing its clinical Wet-AMD program with the novel topical formulation. The topical formulation is designed for enhanced uptake to the back of the eye and decreased potential for side effects. In May 2012, the U.S. Food and Drug Administration ("FDA") awarded Fast Track Designation to the Squalamine eye drop program for the potential treatment of wet-AMD.


Squalamine eye drops are designed for self-administration which may provide several potential advantages over the FDA approved current standards of care (Roche/Genetech's Lucentis® and Regeneron's Eylea® Intravitreal Injections).

- Eye drops versus standard of care which is an intravitreal injection directly into the eye every 4-8 weeks on a chronic basis
- Reduction or elimination of intravitreal injections has the potential to provide patients with improved safety by reducing or eliminating side effects associated with the intravitreal injection procedure
- Inhibition of multiple growth factors (VEGF, PDGF, bFGF) may achieve superior visual acuity outcomes. Clinical evidence has demonstrated that inhibiting VEGF and PDGF together may provide patients with better visual acuity outcomes than anti-VEGF therapy alone
- Cost advantage of a small molecule when compared to the current standards of care which are large molecules

In Phase II clinical trials using the intravenous formulation of Squalamine, stabilization or improvement in visual activity was observed in the vast majority of patients, with both early and advanced lesions responding and few drug-related ocular or systemic effects observed. In a number of patients whose wet-AMD had progressed to an advanced stage, the administration of Squalamine produced beneficial effects and significant improvement in best corrected visual acuity. As opposed to the approved current standard of care therapy, Squalamine does not require direct injection into the eye.

The Company has conducted preclinical testing on the novel topical formulation with the following results:

- Ocular Tolerance and Toxicity: In a dose escalation safety study involving daily eye drop treatment in Dutch belted rabbits over a 28 day period, the formulation proved safe, and exhibited no signs of ocular toxicity or changes in intraocular pressure. Importantly, no macroscopic or histopathological changes to the ocular tissues were noted.

- Single Dose Biodistribution study: A single eye drop was administered to the front of the eye in Dutch belted rabbits. At all evaluated timepoints, drug concentrations in the posterior sclera-choroid region behind the retina at the back of the eye exceeded the tissue concentrations of Squalamine that are known to block the choroidal neovascularization process in Wet-AMD. The study results also demonstrated that the drug was undetectable in the anterior chamber of the eye (aqueous humor), confirming that it does not penetrate through all the layers of the cornea or contact the lens.

- Multi Dose Biodistribution Study: Squalamine eye drops were administered once or twice daily in both eyes for up to 14 days in Dutch belted rabbits. The eyes were excised one full dosing interval
(12 hours when given twice daily, 24 hours when given once daily) after the last administration of Squalamine eye drops to determine concentrations of Squalamine in the posterior ocular tissues ("Trough" level). At all time point and dosing regimens, Trough Squalamine concentrations exceeded tissue concentrations of Squalamine that are known to block the choroidal neovascularization process in Wet-AMD. The study also confirmed that the drug was undetectable in the anterior chamber of the eye and does not contact the lens.

- Long Term Ocular Tolerance and Toxicity: In a 26-week safety and toxicity study in male and female Dutch belted rabbits, Squalamine or placebo eye drops were administered via topical instillation twice a day ("BID") in both eyes. Ophthalmoscopic examinations were conducted throughout the study period to assess ocular toxicity (irritation, redness, swelling, discharge). Blood and urine samples for clinical pathology evaluations were collected, and blood samples for determination of the plasma concentrations of squalamine eye drops and toxicokinetic evaluations were collected from all animals at designated time points. At study termination, necropsy examinations were performed, and organs and optical tissues were microscopically examined.

No adverse effects of treatment were observed in any of the parameters evaluated including clinical findings, body weights, food consumption, ocular irritation, hematology, coagulation, clinical chemistry, urinalysis and macroscopic pathology examinations. Importantly, ophthalmoscopic examinations indicated no signs of clouding of the lens, no corneal opacities or deposits, and no increase in intraocular pressure. In addition, microscopic histopathology evaluations on ocular tissues were normal. Squalamine also did not build up in plasma over long term administration, indicating reduced potential for systemic side effects.

The Company presented preclinical data at the Association for Research and Vision in Opthalmology conference in May 2012, and at the Macula Society meeting in June 2012. In May 2012, the U.S. FDA awarded Fast Track Designation to the Squalamine eye drop program for the potential treatment of wet-AMD. We have met with the FDA regarding future clinical development and expect to commence a Phase II clinical trial in the third calendar quarter of 2012.


Additionally, Squalamine has shown promise in the treatment of solid tumors such as ovarian cancer using the intravenous formulation in significantly higher doses than the eye drop formulation. In a Phase IIa study, patients with stage III and IV refractory and resistant ovarian cancer received Squalamine in conjunction carboplatin, with approximately two thirds of the patients achieving a complete response, partial response or stable disease. Squalamine has been awarded Orphan Drug Status by the FDA for the treatment of late stage resistant or refractory ovarian cancer. Because of funding constraints, Ohr is seeking a development partner to further advance development of this indication.

OHR/AVR118

OHR/AVR118 is a novel immunomodulator with a singular chemical structure that is terminally sterilized and endotoxin-free. The compound is composed of two small peptides, Peptide A, which is 31 amino acids long, and Peptide B, that is 21 amino acids long. Peptide B is unique in that the dinucleotide, diadenosine, is covalently attached to serine at position 18 through a phosphodiester bond. OHR/AVR118 is stable at room temperature and has a favorable safety profile both in animal toxicity studies and in human clinical trials.

Ohr is currently conducting a Phase II clinical trial of OHR/AVR 118 for the treatment of cancer cachexia at a leading cancer center in Canada. Cancer cachexia is a severe wasting disorder characterized by weight loss, muscle atrophy, fatigue, weakness, and significant loss of appetite. This disorder is often seen in late stage cancer patients. OHR/AVR118 has also anecdotally shown to have chemoprotective effects, thus potentially allowing patients to better tolerate chemotherapy and radiation as well as more intensive treatment regimens with ordinary toxic chemotherapeutic agents, while maintaining body weight and avoiding other side effects. There is currently no FDA approved drug for the treatment of cancer cachexia. The Company presented interim data on this current trial at the annual conference of the Society of Cachexia and Wasting Disorders in Barcelona, Spain in December 2009. In December 2010, the Company opened a new clinical site for the ongoing Phase II trial in cancer cachexia at the Ottawa Hospital Cancer Centre and enrolled the first three patients at the new site. Enrollment in the current trial is ongoing. The Company expects to complete enrollment by the end of 2012 and report data in early 2013.

Ohr also owns various other compounds in earlier stages of development that it will seek to develop further through a strategic partnership or on a sponsored basis.

General

The Company is a biotechnology rollup company currently focused on development of the Company's previously acquired compounds. With the addition of our executive management team in April 2010, we have shifted our strategy accordingly to focus on the development of our two later stage lead products, OHR/AVR 118 for the treatment of cancer cachexia, and Squalamine for the treatment of Wet-AMD. We acquired OHR/AVR118 in a secured party sale and Squalamine from the Genaera Liquidating Trust as part of the Company's previous strategy to create a rollup of undervalued biotechnology companies and assets.

We seek to advance our two lead products through later stage clinical trials as well as developing some of our earlier stage products and indications that we are moving forward with minimal capital outlay. We have also started a new initiative to seek and implement strategic alternatives with respect to our products, including licenses, business collaborations and other business combinations or transactions with other pharmaceutical and biotechnology companies. From time to time, we may engage in discussions with third parties regarding the licensure, sale or acquisition of our products and technologies or a merger or sale of the Company; however we currently do not have plans to enter into such a transaction and there is no assurance that the Company will complete such a transaction.

The Company has limited core operating expenses as we have only two full-time employees. In connection with the hiring of our executive management team, we have established an office in New York City. The office is being provided by an affiliate of Mr. Backenroth free of charge with the exception of minimal office related expenses.

The Company will continue to incur ongoing operating losses, which are expected to increase substantially as it funds development of the new pharmaceutical compounds. In addition, losses will be incurred in paying ongoing reporting expenses, including legal and accounting expenses, as necessary to maintain the Company as a public entity. No projected date for potential revenues can be made, and the Company is undercapitalized at present to completely develop, test and market any pharmaceutical product.

Until the Company is able to generate significant revenue from its principal operations, it will remain classified as a development stage company. The Company can give no assurance that it will be successful in such efforts or that its limited operating funds will be adequate to support the Company's operations, nor can there be any assurance of any additional funding being available to the Company. Our independent accountants have included a paragraph in their audit report which expresses doubt about the Company's ability to continue as a "going concern."

Liquidity and Sources of Capital

The Company has insufficient capital to pay for development of its pharmaceutical compounds and ongoing reporting and minimal operating expenses as previously described.


As of June 30, 2012, the Company had cash of $1,445,276 and prepaid expenses of $463,433. Excluding the Company's non-cash derivative liabilities, the Company had current liabilities of $336,395. This translates to total working capital of $1,572,314, which means that our cash reserves are not adequate to fund operations after September 30, 2013.

On June 28, 2012, the Company issued 5,299,002 shares of common stock for total proceeds of $2,914,452 to investors who elected to convert their Series H warrants at an exercise price of $0.55. As of June 30, 2012, the Company had received cash of $1,098,610 out of the total $2,914,452 proceeds, leaving a stock subscription receivable of $1,815,842 at the end of the period. During July 2012, the Company received the $1,724,175 stock subscription thus increasing cash and our working capital by $1,724,175 during July. We expect to receive the remaining $91,667 stock subscription receivable shortly after the date of this filing.

We do not have any source of revenues as of June 30, 2012 and expect to rely on additional financing. The Company plans to seek private capital through the sale of additional stock or borrowing either from principal shareholders or private parties; however we currently do not have plans to enter into such a transaction and there is no assurance that the Company will complete such a transaction.

In view of the lack of financing plans, the Company may be obliged to discontinue operations, which will adversely affect the value of its common stock. See "Risk Factors" in the Form 10-K, as amended.

Subsequent Events

On July 9, 2012, the Company received a notice of exercise for 30,000 warrants to purchase common stock through a cashless exercise. The cashless calculation amounted to 13,333 shares of common stock which were issued on July 17, 2012.

On July 10, 2012, the Company announced data from a long term preclinical study for the Squalamine eye drop program.

Results of Operations

Three Months Ended June 30, 2012

Three months ended June 30, 2012 ("2012") compared to the three months ended
June 30, 2011 ("2011"). Results of operations for the three months ended June
30, 2012 reflect the following changes from the prior period.

                                         2012            2011           Change
Revenue                               $        -     $          -     $         -
Cost of sales                                  -                -               -
Gross Profit                                   -                -               -

Operating Expenses
General and administrative                30,644           18,027          12,617
Professional fees                        133,160           75,107          58,053
Research and development                 353,032          120,952         232,080
Salaries and wages                       117,889           87,445          30,444
Total Operating Expenses                 634,725          301,531         333,194

Operating Income (Loss)                 (634,725 )       (301,531 )      (333,194 )

Interest expense                            (906 )            (84 )          (822 )
Gain/(Loss) on derivative liability      174,867       (2,835,983 )     3,010,850
Other income and expense                      11               50             (39 )
Income (loss) from operations           (460,753 )     (3,137,548 )     2,676,795
Discontinued operations                        -                -               -
Net Income (Loss)                     $ (460,753 )   $ (3,137,548 )   $ 2,676,795

The Company had no net revenues from continuing operations in the three months ended June 30, 2012. The Company's products are in the development stage. Accordingly, the Company also had no cost of revenue from continuing operations in the three months ended June 30, 2012.


General and administrative expenses from continuing operations increased from $18,027 in 2011 to $30,644 in 2012. Professional fees increased from $75,107 in 2011 to $133,160 in 2012. The increase in professional fees and general and administrative expenses during 2012 is primarily due to increased activity relating to its recent clinical trials and increased common stock and warrants issued to consultants for services.

Salaries and wages increased from $87,445 in 2011 to $117,889 in 2012. This increase is primarily due to stock options issued to employees valued at $52,055 in 2012 as compared to $11,975 in 2011. Of the $117,889 and $87,445 paid as salary and wages in 2012 and 2011, respectively, $48,824 and $11,975 were, respectively, the fair value of options issued to officers, and$69,065 and $75,470 were, respectively, of salaries and wages paid in cash and benefits. The Company expects salaries and wages, professional fees, and general and administrative expenses to continue to increase in future periods as development of its products continues.

The Company incurred $353,032 in research and development expenses in 2012 compared to $120,952 in 2011. The increase is a result of the commencement of animal studies and lab tests which began part way through 2010 as well as maintenance and development of the patents that it acquired in 2009. The Company expects research and development expenses to continue to rise as development of its products continues.

The Company issued certain securities to investors at various times that qualify for derivative accounting which requires that the value of these warrants be recorded as a liability instead of within permanent equity. These derivatives are then marked to their fair value at the end of each reporting period with changes being recorded in earnings. As the Company's stock price has stabilized during 2012 and the remaining life of the warrants included within the derivative is passing, the value of these derivatives have decreased, resulting in a decrease in the liability and a non-cash gain on derivative liabilities of $174,867 as compared to an increase in derivative liabilities of $2,835,983 in 2011.

For the three months ended June 30, 2012, the Company recognized a net loss of $460,753 compared to $3,137,548 for the same period in 2011. Excluding the non-cash gain or loss on derivative liabilities as well as the non-cash expense associated with the issuance of stock and warrants to employees and consultants, the Company's net loss for 2012 would have been $398,168 and $265,240 for 2011. Until the Company is able to generate revenues, management expects the Company to continue to incur such net losses.

Nine Months Ended June 30, 2012

Nine months ended June 30, 2012 ("2012") compared to the nine months ended June
30, 2011 ("2011"). Results of operations for the nine months ended June 30, 2012
reflect the following changes from the prior period.

                                            2012             2011            Change
Revenue                                 $          -     $          -     $          -
Cost of sales                                      -                -                -
Gross Profit                                       -                -                -

Operating Expenses
General and administrative                    98,969           70,323           28,646
Professional fees                            358,657          144,458          214,199
Research and development                   1,040,352          438,070          602,282
Salaries and wages                           541,402          214,918          326,484
Total Operating Expenses                   2,039,380          867,769        1,171,611

Operating Income (Loss)                   (2,039,380 )       (867,769 )     (1,171,611 )

Interest expense                                (906 )         (2,433 )          1,527
Gain/(Loss) on derivative liabilities        496,899       (2,945,196 )      3,442,095
Gain on sale of assets                             -           70,500          (70,500 )
Gain on settlement of debt                    21,005                -           21,005
Other income and expense                          49            1,662           (1,613 )
Income (loss) from operations             (1,522,333 )     (3,743,236 )      2,220,903
Discontinued operations                            -                -                -
Net Income (Loss)                       $ (1,522,333 )   $ (3,743,236 )   $  2,220,903


The Company had no net revenues from continuing operations in the nine months ended June 30, 2012. The Company's products are in the development stage. Accordingly, the Company also had no cost of revenue from continuing operations in the nine months ended June 30, 2012.

General and administrative expenses from continuing operations increased from $70,323 in 2011 to $98,969 in 2012. Professional fees increased from $144,458 in 2011 to $358,657 in 2012. The increase in professional fees and general and administrative expenses during 2012 is primarily due to increased activity relating to its recent clinical trials and increased common stock and warrants issued to consultants for services.

Salaries and wages increased from $214,918 in 2011 to $541,402 in 2012. This increase is primarily due to stock options issued to employees valued at $353,772 in 2012 as compared to $35,925 in 2011. Of the $541,402 and $214,918 paid as salary and wages in 2012 and 2011, respectively, $353,772 and $35,925 were the fair values of options issued to officers, and $187,630 and $178,993 were, respectively, salaries and wages paid in cash and benefits. The Company expects salaries and wages, professional fees, and general and administrative expenses to continue to increase in future periods as development of its products continues.

The Company incurred $1,040,352 in research and development expenses in 2012 compared to $438,070 in 2011. The increase is a result of the commencement of animal studies and lab tests which began part way through 2010 as well as maintenance and development of the products that it acquired in 2009. The Company expects research and development expenses to continue to rise as development of its products continues.

The Company issued certain securities to investors at various times that qualify for derivative accounting which requires that the value of these warrants be recorded as a liability instead of within permanent equity. These derivatives are then marked to their fair value at the end of each reporting period with changes being recorded in earnings. As the Company's stock price has stabilized during 2012 and the remaining life of the warrants included within the derivative is passing, the value of these derivatives have decreased, resulting in a decrease in the liability and a non-cash gain on derivative liabilities of $496,899 for 2012 compared to a loss of $2,945,196 in 2011.

For the nine months ended June 30, 2012, the Company recognized a net loss of $1,522,333 compared to $3,743,236 for the same period in 2011. Excluding the non-cash gain or loss on derivative liabilities as well as the non-cash expense associated with the issuance of stock and warrants to employees and consultants, the Company's net loss for 2012 would have been $1,314,030 and $727,765 for . . .

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