BURZYNSKI RESEARCH INSTITUTE INC - 10-Q - Management's Discussion and Analysis of Financial Condition and Results of Operations

Edgar Glimpses |

The following is a discussion of the financial condition of the Company as of , and the results of operations comparing the three months ended and 2016. It should be read in conjunction with the financial statements and the notes thereto included elsewhere in this report and in conjunction with the Annual Report on Form 10-K for the year ended .




Introduction



The Company is primarily engaged as a research and development facility of drugs currently being tested for the use in the treatment of cancer, and provides consulting services. The Company is currently conducting one FDA approved clinical trial initiated in for children and adults with Diffuse Intrinsic Pontine Glioma (DIPG) (protocol "BT-55"). The Company holds the exclusive right in the United States, Canada and Mexico to use, manufacture, develop, sell, distribute, sublicense and otherwise exploit all the rights, titles and interest in Antineoplaston drugs used in the treatment and diagnosis of cancer, once an Antineoplaston drug is approved for sale by the FDA.

On , the FDA granted the Company's request for "orphan drug designation" ("ODD") for the Company's Antineoplastons (A10 & AS2-1 Antineoplaston) for treatment of patients with brain stem glioma and, on , the FDA granted the Company's request for ODD for Antineoplastons (A10 and AS2-1 Antineoplaston) for the treatment of gliomas.

On , the Company announced that the Company had reached an agreement with the FDA for the Company to move forward with a pivotal Phase III clinical trial of combination Antineoplaston therapy plus radiation therapy in patients with newly diagnosed diffuse, intrinsic brainstem gliomas ("DBSG"). The agreement was made under the FDA's Special Protocol Assessment procedure, meaning that the design and planned analysis of the Phase III study of combination Antineoplastons A10 and AS2-1 plus radiation therapy ("RT") in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma (protocol "BT-52"), are acceptable to support a regulatory submission seeking new drug approval. A randomized, international Phase III study of BT-52 will commence upon availability of funds. The study's objective is to compare overall survival of children with newly-diagnosed DBSG who receive combination Antineoplastons A10 and AS2-1 plus RT versus RT alone.




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Partial Clinical Hold on Phase II and Phase III Clinical Trials

In a letter dated , the Company informed the FDA of a serious adverse event in which a patient who was receiving Antineoplastons developed grade 4 hypernatremia and subsequently died. The Antineoplaston-related hypernatremia was categorized by the investigator as possibly related to the study drug. Of the 2,298 patients who have received at least one dose of Antineoplastons, the serious adverse events (SAEs) which have been experienced are as follows: hemoglobin (grade 3: 0.13%; grade 4: 0.04%), extravasation (grade 3: 0.04%), pain (grade 3: 0.04%), fatigue (grade 3: 0.09%; grade 4: 0.04%), fever (grade 3: 0.09%), injection site reaction (grade 3: 0.04%), vomiting (grade 3: 0.09%), hypernatremia (grade 3: 0.09%; grade 4: 1.12%; grade 5: 0.26%), confusion (grade 3: 0.04%), seizure (grade 3: 0.04%), somnolence (grade 3: 0.35%; grade 4: 0.04%), pain: head/headache (grade 3: 0.09%) and pain: joint (grade 3: 0.04%).

On , the FDA placed a partial clinical hold for enrollment of new pediatric patients under single patient protocols or in any of the active Phase II or Phase III studies under investigational new drug application ("IND") 43,742. The FDA imposed this partial clinical hold because, according to the FDA, insufficient information had been submitted by the Company to allow the FDA to determine whether the potential patient benefit justifies the potential risks of treatment use, and that the potential risks are not unreasonable in the context of the disease or condition to be treated. The FDA cited 21 C.F.R. § 312.42(b)(2)(i), 21 C.F.R. § 312.42(b)(1)(iv), and 21 C.F.R. § 312.42(b)(3)(i), as grounds for imposition of a clinical hold; and 21 C.F.R. § 312.305(a)(2), a criteria for expanded access use. The FDA advised the Company that until it resolved the matter to the FDA's satisfaction, the Company could not enroll new pediatric patients in any protocol under such IND. The Company later notified the FDA in a letter that it was closing pediatric protocol BT-10 (under IND 43,742) for enrollment effective , and that it would also terminate the protocol once all active patients had completed the study. As of , all patients discontinued treatment under protocol BT-10 and such protocol was closed as of .

In a teleconference on between the FDA and the Company, followed by a letter of the same date, the FDA notified the Company that the agency was placing IND 43,742 on partial clinical hold, due to a lack of a complete response to the issues raised by the FDA and what the FDA deemed a misleading, erroneous, and incomplete investigator brochure. The FDA cited 21 C.F.R. § 312.42(b)(2)(i) and 21 C.F.R. § 312.42(b)(1)(iii), as grounds for imposition of a clinical hold. The FDA further advised the Company that until it resolved the matter to the FDA's satisfaction, that the Company could not enroll new adult or pediatric patients in any protocol under such IND. The FDA also placed protocol BT-52 on clinical hold due to what the FDA deemed to be an unreasonable and significant risk of illness or injury to human subjects. The FDA cited 21 C.F.R. § 312.42(b)(2)(i) and 21 C.F.R.§ 312.42(B)(1)(i), as grounds for imposition of a clinical hold. The FDA advised the Company that until it resolved the matter to the FDA's satisfaction, the Company could not legally conduct the identified clinical study under such IND. In a teleconference with the FDA on and pursuant to the Company's notification letter dated , the Company notified the FDA that the proposed Phase III protocol BT-54 had been withdrawn from further consideration.

After several amendments to the IND which were reviewed by the FDA, the FDA concluded that BT-52 can be initiated and the partial clinical hold was removed by the FDA on .

Additionally, the Company received IRB approval on for FDA reviewed protocol BT-55 open label, Phase II study of Antineoplaston A10 and AS2-1 in patients with a Diffuse Intrinsic Brainstem Glioma (DIPG) in five treatment groups based on patients age and prior treatment.

On , the Company received a full clinical hold letter from the FDA based on FDA's inspection of S.R. Burzynski's manufacturing facility in . On , the Company requested to change the full clinical hold to partial clinical hold to allow patient #1 to continue the Antineoplaston treatment according to protocol BT-55, since the patient was enrolled before the full clinical hold was imposed. Based on the FDA's position regarding the Company's request on and the Company's teleconference with the FDA on , the Company removed patient #1 from the study.

A temporary restraining order from the US District Court of Rhode Island allowed the resumption of patient #1's Antineoplaston therapy on . As a result of such temporary restraining order, a subsequent letter from the FDA dated informed the Company that the full clinical hold was replaced and a partial clinical hold was imposed. As a result, patient #1 restarted treatment under IND 43742.

On , the FDA issued a letter to the Company in connection with the FDA's inspection of S.R. Burzynski's manufacturing facility in . The Company addressed the issues raised in the letter in a response letter submitted to the FDA on and in subsequent letters.

On , BRI informed the FDA the death of patient #1 on . No new patients can be enrolled to protocol BT-55 or BT-52 until partial hold on IND 43742 is lifted.




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Complaint Filed by the Texas Medical Board Against Dr. Burzynski



On , the Texas Medical Board issued their final ruling regarding the complaint filed on and subsequently amended in and , against Dr. Stanislaw R. Burzynski, who serves as our President and the Chairman of our Board of Directors. The Texas Medical Board made allegations that Dr. Burzynski had acted unprofessionally and failed to meet standards of care under the state's Medical Practice Act. In the final ruling, the Texas Medical Board found that Dr. Burzynski was subject to sanction for various failures that included supervision of foreign medical graduates, untimely and insufficient informed consent, medical record support documentation, tumor measurement reporting inaccuracy, and lack of disclosure of ownership interest in a pharmacy. As a result, Dr. Burzynski was reprimanded. His Texas license was suspended for five years but that suspension was stayed and he was placed under probation under terms and conditions that include having billing practice monitored by a billing monitor for 12 consecutive monitoring cycles, enrolling and completing a physicians education program ethics course, following informed consent protocol, passing the Medical Jurisprudence Examination, and compliance with the Medical Practice Act and other statutes regulating Dr. Burzynski's practice. As requested as part of the terms and conditions, Dr. Burzynski has completed payment of an administrative penalty and restitution, submission of all informed consent forms for review, submission of an ownership interest disclosure form for review, and he has begun continuing medical education. The Company does not believe that the final order will have an adverse impact on current activities at the Burzynski clinic. However, if any outcomes or changes arise relating to similar matters or future allegations, this could result in substantial harm to the Company's business and operations.



Results of Operations


Three Months Ended Compared to Three Months Ended

Research and development costs were approximately $368,000 and $349,000 for the three months ended and 2016, respectively. The increase of $19,000 or 5% was due to increases in personnel costs of $17,000, facility and equipment costs of $14,000, and quality control costs of $3,000, offset by a decrease in material costs of $14,000, and other research and development costs of $1,000 as a result of additional requests from regulatory agencies.

General and administrative expenses were approximately $95,000 and $20,000 for the three months ended and 2016, respectively. The increase of $75,000 or 375% was due to an increase in legal and professional fees of $76,000, offset by a decrease in general and administrative costs of $1,000, as a result of additional requests from regulatory agencies.

The Company had net losses of approximately $461,000 and $370,000 for the three months ended and 2016, respectively. The increase in the net loss from 2016 to 2017 is primarily due to an overall increase in research and development costs and an increase in general and administrative expenses of the Company as described above.

Liquidity and Capital Resources

The Company's operations have been funded entirely by contributions from Dr. Burzynski and from funds generated from Dr. Burzynski's medical practice. Effective , the Company entered into a Research Funding Agreement with Dr. Burzynski (the "Research Funding Agreement"), pursuant to which the Company agreed to undertake all scientific research in connection with the development of new or improved Antineoplastons for the treatment of cancer and Dr. Burzynski agreed to fund the Company's Antineoplaston research for that purpose. Under the Research Funding Agreement, the Company hires such personnel as is required to conduct Antineoplaston research, and Dr. Burzynski funds the Company's research expenses, including expenses to conduct the clinical trials. Dr. Burzynski also provides the Company laboratory and research space as needed to conduct the Company's research activities. The Research Funding Agreement also provides that Dr. Burzynski may fulfill his funding obligations in part by providing the Company such administrative support as is necessary for the Company to manage its business. Dr. Burzynski pays the full amount of the Company's monthly and annual budget of expenses for the operation of the Company, together with other unanticipated but necessary expenses which the Company incurs. In the event the research results in the approval of any additional patents for the treatment of cancer, Dr. Burzynski shall own all such patents, but shall license to the Company the patents based on the same terms, conditions and limitations as are in the current license between Dr. Burzynski and the Company.

The amounts which Dr. Burzynski is obligated to pay under the agreement shall be reduced dollar for dollar by the following: (1) any income which the Company receives for services provided to other companies for research and/or development of other products, less such identifiable marginal or additional expenses necessary to produce such income, or (2) the net proceeds of any stock offering or private placement which the Company receives during the term of the agreement up to a maximum of $1,000,000 in a given Company fiscal year.




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The Research Funding Agreement, as amended, contains an annual automatic renewal provision providing for an additional one-year term, unless one party notifies the other party at least thirty days prior to the expiration of the then current term of the agreement of its intention not to renew the agreement. Subject to the foregoing, the term of the Research Funding Agreement was renewed and extended until . It is expected that the Research Funding Agreement will continue to renew each year prospectively unless terminated under the provisions of the agreement.

The Research Funding Agreement automatically terminates in the event that Dr. Burzynski owns less than fifty percent of the outstanding shares of the Company, or is removed as President and/or Chairman of the Board of the Company, unless Dr. Burzynski notifies the Company in writing of his intention to continue the agreement notwithstanding this automatic termination provision.

The Company estimates that it will spend approximately $1,125,000 during the remaining three quarters of the fiscal year ending . While the Company anticipates that Dr. Burzynski will continue to fund the Company's research and FDA-related costs, there is no assurance that Dr. Burzynski will be able to continue to fund the Company's operations pursuant to the Research Funding Agreement or otherwise. In addition, Dr. Burzynski's medical practice has successfully funded the Company's research activities over the last 25 years and, in 1997, his medical practice was expanded to include traditional cancer treatment options such as chemotherapy, gene-targeted therapy, immunotherapy and hormonal therapy.

Because the Company currently is entirely dependent upon the contributions for research provided by Dr. Burzynski under the Research Funding Agreement, the Company would not be able to continue conducting its clinical trials if Dr. Burzynski ceased funding the Company's research. In such event, the Company would be required to find immediate funding which may not be available on acceptable terms or at all. If this were to occur and the Company were not able to find adequate sources of funding, the Company would be required to cease operations. Even with Dr. Burzynski's continued contributions under the Research Funding Agreement, the Company may be required to seek additional capital through equity or debt financing or the sale of assets until the Company's operating revenues are sufficient to cover operating costs and provide positive cash flow; however, there can be no assurance that the Company will be able to raise such additional capital on acceptable terms to the Company. In addition, there can be no assurance that the Company will ever achieve positive operating cash flow.




Forward-Looking Statements



Certain matters discussed in this quarterly report, except for historical information contained herein, may constitute "forward-looking statements" that are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Forward-looking statements provide current expectations of future events based on certain assumptions. These statements encompass information that does not directly relate to any historical or current fact and often may be identified with words such as "anticipates," "believes," "expects," "estimates," "intends," "plans," "projects" and other similar expressions. Management's expectations and assumptions regarding Company operations and other future results are subject to risks, uncertainties and other factors that could cause actual results to differ materially from the anticipated results or other expectations expressed in the forward-looking statements.

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