SEC Company Response from Regen BioPharma Inc (RGBP, RGBPP) (CIK 0001589150) (RGBP) — Nov 22, 2013
Regen BioPharma Inc (RGBP, RGBPP) (CIK 0001589150)
Date: Nov. 22, 2013 · CIK: 0001589150 · Accession: 0001554795-13-000722
AI Filing Summary & Sentiment
File numbers found in text: 333-191725
Referenced dates: November 8, 2013
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CORRESP
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filename1.htm
November 15 , 2013
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
Attention: Suzanne Hayes, Assistant Director
Michael Seaman
Celia Soehner
Re: Regen Biopharma, Inc.
Registration Statement on Form S-1
File No. 333-191725
Filed on October 15, 2013
Dear Ms. Hayes, Mr. Seaman and Ms. Soehner:
The following responses address the comments of the Staff (the “Staff”)
as set forth in its letter dated November 8, 2013 (the “Comment Letter”) relating to the Registration Statement
on Form S-1 of Regen Biopharma, Inc. (The "Company").
1. The following paragraph has been added to that section of the Form S-1 immediately following the section entitled SUMMARY FINANCIAL
AND OPERATING INFORMATION:
EXEMPTIONS UNDER JUMPSTART OUR BUSINESS STARTUPS ACT
As a company with less than $1.0 billion in revenue
during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart our Business Startups
Act of 2012, or the JOBS Act.
An emerging growth company may take advantage of
specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally
applicable to public companies. As an emerging growth company:
• we are permitted to present
only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial
Condition and Results of Operations;
• we are exempt from the
requirement to obtain an attestation and report from our auditors on the assessment of our internal control over financial reporting
pursuant to the Sarbanes-Oxley Act of 2002;
• we are permitted to provide
less extensive disclosure about our executive compensation arrangements; and
• we are not required to
give our stockholders non-binding advisory votes on executive compensation or golden parachute arrangements.
We may take advantage of these provisions for up
to five years subsequent to the effective date of this registration statement or such earlier time that we are no longer an emerging
growth company. We will cease to be an emerging growth company upon the earliest of (i) the last day of the first fiscal year in
which our annual gross revenues exceed $1 billion, (ii) December 31 of the fiscal year that we become a “large accelerated
filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, or the Exchange Act, which would occur if the
market value of our common stock held by non-affiliates exceeds $700 million as of the last business day of our most recently completed
second fiscal quarter and we have been publicly reporting for at least 12 months or (iii) the date on which we have issued more
than $1 billion in non-convertible debt during the preceding three-year period.
We hereby elect to use the extended transition period
for complying with new or revised accounting standards under Section 102(b)(1).
In addition, the following Risk Factor has been added to that section
of the S-1 labeled RISK FACTORS:
BECAUSE
WE HAVE ELECTED TO DEFER COMPLIANCE WITH NEW OR REVISED ACCOUNTING STANDARDS PURSUANT TO SECTION 102(b)(1) OF THE JOBS ACT OUR
FINANCIAL STATEMENT DISCLOSURE MAY NOT BE COMPARABLE TO SIMILAR COMPANIES.
We
have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1)
of the JOBS Act. This allows us to delay the adoption of new or revised accounting standards that have different effective dates
for public and private companies until those standards apply to private companies. As a result of our election, our financial statements
may not be comparable to companies that comply with public company effective dates.
In
addition, the following disclosure has been added to that section of the S-1 labeled MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Critical Accounting Policies
Section 107 of the JOBS Act provides
that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities
Act for complying with new or revised accounting standards that have different effective dates for public and private companies.
We have elected to take advantage of this extended transition period, and thus, our financial statements may not be comparable
to those of other reporting companies
2. The following revisions have been made:
From Page 19 of the original S-1
The Company has begun development of
HemaXellerate I I, a cellular therapy designed to heal damaged bone marrow. HemaXellerate I is a patient-specific composition of
cells that have been demonstrated to repair damaged bone marrow and stimulate production of blood cells based on previous animal
studies. The initial application of HemaXellerate I will be the treatment of severe aplastic anemia which is characterized by immune-mediated
bone marrow hypoplasia and pancytopenia.
Adipose tissue is collected from the
patient and processed in order to separate , extract and isolate Stromal Vascular Fraction (SVF), a mix of various cell types including
mesenchymal stem cells and endothelial cells. The isolated SVF is then intravenously administered to the patient. The Company believes
that the isolated SVF will generate growth factors with the ability to repair damaged hematopoietic stem cells. Hematopoietic stem
cells are immature cells that can develop into all types of blood cells, including white blood cells, red blood cells, and platelets.
Hematopoietic stem cells are found in the peripheral blood and the bone marrow.
Has been amended to read as:
The Company has begun development of
HemaXellerate I , a cellular therapy designed to heal damaged bone marrow. HemaXellerate I is a patient-specific composition of
cells that have been demonstrated to repair damaged bone marrow and stimulate production of blood cells based on previous animal
studies. The initial application of HemaXellerate I will be the treatment of severe aplastic anemia which is characterized by immune-mediated
bone marrow hypoplasia (underdevelopment or incomplete development of a tissue) and pancytopenia( reduction in the number of blood
cells and platelets).
Adipose tissue is collected from the
patient and processed in order to separate , extract and isolate Stromal Vascular Fraction (SVF), a mix of various cell types including
mesenchymal stem cells and endothelial cells. The isolated SVF is then intravenously administered to the patient. The Company believes
that the isolated SVF will generate growth factors with the ability to repair damaged hematopoietic stem cells. Hematopoietic stem
cells are immature cells that can develop into all types of blood cells, including white blood cells, red blood cells, and platelets.
Hematopoietic stem cells are found in the peripheral blood and the bone marrow.
3. The About Us Section of the prospectus has been amended
to read as follows:
We were incorporated April 24, 2012 under the
laws of the State of Nevada. We are a majority owned subsidiary of Bio Matrix Scientific Group, Inc, a Delaware corporation. We
intend to engage primarily in the development of regenerative medical applications which we intend to license from other entities
up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell
or license those developed applications or, alternatively, advance the application further to Phase III clinical trials.
The primary factor to be considered by us in arriving at a decision to advance an application further to Phase III clinical trials
would be a greater than anticipated indication of efficacy seen in Phase I trials.
The Company has begun development of
HemaXellerate I, a cellular therapy designed to heal damaged bone marrow. HemaXellarate I utilizes a collection of cells harvested
from the patient’s own adipose (fat) tissue to repair damaged bone marrow and stimulate production of blood cells . The initial
application of HemaXellerate I will be the treatment of severe aplastic anemia, a rare and serious condition in which the bone
marrow fails to make enough blood cells: red blood cells, white blood cells, and platelets.
In this application, adipose ( fat)
tissue is collected from the patient and processed in order to separate , extract and isolate Stromal Vascular Fraction (SVF).
SVF preparations contain significant numbers of cellular populations with therapeutic activity that would be relevant to aplastic
anemia; namely:
a) mesenchymal stem
cells (MSC), which suppress pathological immune responses and accelerate hematopoiesis (the formation and development of blood
cells);
b) endothelial cells, which assist in
repairing damaged bone marrow and stimulate hematopoiesis; and
c) T regulatory cells, which possess
anti-inflammatory properties.
The Company believes that the isolated
SVF will generate growth factors with the ability to repair damaged hematopoietic stem cells. Hematopoietic stem cells are immature
cells that can develop into all types of blood cells, including white blood cells, red blood cells, and platelets. Hematopoietic
stem cells are found in the peripheral blood and the bone marrow.
In practice, the physician is shipped
a kit, which is used to collect adipose tissue. The tissue is sent to a processing facility, and a standardized cellular product
is delivered in a ready-to-use manner for administration into the patient intravenously.
On February 5, 2013 Regen filed an Investigational
New Drug (IND) application with the United States Food and Drug Administration to initiate a clinical trial In this study we will
seek to determine the safety and potential efficacy of intravenously administered autologous SVF cells in 10 patients with severe
aplastic anemia that is resistant to immune suppressive therapy.
Also in early stage development by the
Company are HemaXellerate II and DCell Vax.
Unlike HemaXellarate which utilizes
the patient’s own fat tissue to harvest the cells needed to repair damaged bone marrow and stimulate production of blood
cells HemaXellarate II utilizes third party placental tissue to harvest these cells.
DCell Vax
is intended to be a therapy whereby dendritic cells of the cancer patient are harvested from the body , treated with plasmid DNA
that has the ability to block the dendritic cell from expressing indoleamine 2,3-dioxygenase (“IDO”) and subsequently
reimplanted in the cancer patient. A plasmid is a small DNA molecule that is physically separate from, and can replicate
independently of, chromosomal DNA within a cell.
Dendritic cells assist
a part of the immune system known as the adaptive immune system by identify cancer cells as foreign and presenting this information
to other immune cells called T lymphocytes (‘T cells”) enabling the T-cells learn to recognize the tumour as a foreign
invader and respond more strongly to destroy it. IDO is an enzyme that is believed to suppress the body’s immune response
to the cancer cells by suppressing T Cells as well as halting the dendritic cell from activating T cells. The dendritic cells that
are treated with the IDO-blocking plasmid become resistant to the influence of cancer cells which cause the dendritic cell to express
IDO.
The therapeutic
concept behind the HemaXellerate products derives from intellectual property licensed to the Company by Oregon Health & Science
University (US patent No. 6,821,513 “Method for enhancing hematopoiesis” issued Nov. 23, 2004) pursuant to an agreement
entered into by the parties on June 5, 2013. This agreement was terminated by mutual consent on August 8, 2013 due to the fact
that US patent No. 6,821,513 had expired due to nonpayment of the required maintenance fees by Oregon Health & Science University.
The Company has been informed by its counsel and believes that the expiration of US patent No. 6,821,513 signifies that no party
can be sued for future infringement based on the patent. Thus the Company is free to practice the claimed methods recited in the
expired patent in the future without being liable for patent infringement based on the patent.
Regen has filed
applications for patent protection with respect to internally developed intellectual property covering the HemaXellaerate products
in development (61/648898 - Acceleration of Hematopoietic Reconstitution by Placental Endothelial and Endothelial Progenitor Cells
and 61/670791 - Treatment of Hematopoietic Disorders, covering placenta and fat tissue as sources of endothelial cells for therapy).
The therapeutic
concept behind DCell Vax is derived primarily from
(a) intellectual property acquired from Dr. Wei Ping Min on May 1, 2013
(b) Intellectual property licensed to the Company by Benitec Australia
Limited on August 5, 2013
We
generated net losses of $404,363 during the period from April 24, 2012(inception) through June 30, 2013. This condition raises
substantial doubt about our ability to continue as a going concern. Our continuation as a going concern is dependent on our ability
to meet our obligations, to obtain additional financing as may be required and ultimately to attain profitability. Our auditor's
report dated September 19, 2013 expressed substantial doubt about our ability to continue as a going concern.
At June 30, 2013
Selected Balance Sheet Information:
unaudited
Cash
$
3,653
Current assets
3,653
Total assets
$
3,653
Current liabilities
$
0
Total liabilities
0
Total stockholders' equity (deficit)
$
3,653
As of June 30, 2013 we
had $3,653 cash on hand and current liabilities of $0.
We feel we will not be able
to satisfy its cash requirements over the next twelve months and shall be required to seek additional financing.
We currently plan to raise
additional funds primarily by offering securities for cash and applying for grants .
From the period beginning
July 1, 2013 and ending September 23, 2013 the Company’s activities have been primarily focused upon
(a) the development of protocols
for pre-clinical research required to be undertaken with regard to the HemaXellerate I product in development in response to the
US Food and Drug Administration’s comments on the Company’s submitted IND
(b) the development of preclinical
research to be undertaken with regard to the development of dCell Vax
The following actions are
required to be undertaken by the Company in order to address comments made by the US Food and Drug Administration with regards
to the IND filed by the Company for HemaXellerate I
a) demonstration of safety
in an immune deficient model by intravenous administration bracketing the per kilogram dose proposed in the clinical study;
b) augmentation of existing
efficacy data by including details of blood cell responses after treatment.
Pursuant to a Service Agreement
entered into by and between the Company and Dr. Wei-Ping Min , on Sept 24, 2013 the Company began experiments required to be undertaken
in order to address the FDA’s comment concerning efficacy. Studies required to be undertaken in order to address the FDA’s
comments concerning safety are anticipated to begin in December 2013. It is estimated by the Company that completion of efficacy
studies will require 3 months, and the safety studies will be completed in 2 months. It is estimated by the Company that appropriate
review of the data by the FDA will take 30 days. Based on these assumptions, during the six months ending March 31, 2014 the Company
anticipates completion of all actions required to be undertaken with regards to addressing comments made by the US Food and Drug
Administration with regards to the IND filed by the Company for HemaXellerate I. The Company also anticipates commencement of the
Phase I clinical trial for HemaXellerate I anticipated to begin July 2014. The Company intends,