SecProbe.io

CORRESP
1
filename1.htm

May 27, 2014

Mr. Jeffrey P. Riedler

Assistant Director

Securities and Exchange Commission

100 F Street, N.E.

Washington, DC 20549

Re:    Nuvilex,
Inc.

         Form 10-K

         Filed July 29, 2013

         File No. 333-68008

Dear Mr Riedler:

Nuvilex, Inc. a Nevada corporation
(“Company”), hereby provides responses to comments issued in a letter dated April 24, 2014 (“Staff’s Letter”)
regarding the Company’s Annual Report on Form 10-K for the fiscal year ended April 30, 2013 (Form 10-K”), filed with
the Securities and Exchange Commission (“Commission”) on July 29, 2013.

In order to facilitate your review,
we have responded to each of the comments set forth in the Staff’s Letter, on a point-by-point basis. The numbered paragraphs
set forth below respond to the Staff’s comments and correspond to the numbered paragraphs in the Staff’s Letter. As
discussed with the Staff, we propose to file a responsive amendment to the Form 10-K after resolving the issues raised in the comments
below.

Item 1. Business

1.     We note your disclosure that you, SG Austria and Austrianova Singapore Private Limited “are now partners working together
on multiple fronts.” Please expand your disclosure to more specifically describe your partnership activities and arrangements,
including the terms of any material contracts. If any such contracts exist, please also file them as exhibits.

RESPONSE:
In response to the Staff’s comment, we will file the license agreements and the Manufacturing Agreement defined
and discussed below with our next Annual Report on Form 10-K.

12510 Prosperity Drive |
Suite 310 | Silver Spring | Maryland 20904-1643

Office: 917.595.2850 |
Facsimile: 917.595.2851 | Mobile: 917.595.2852 | kwaggoner@nuvilex.com

Mr. Jeffrey P. Riedler

Assistant Director

Securities and Exchange Commission

Page 2

In
addition, we will modify the following disclosure in Footnote 2 to our financial statements in our future filings:

“Subsequent to the year ending April 30, 2013, on or about
July 11, 2013, Nuvilex completed the purchase of BBB, a prior asset of SG Austria. The shares for both ASPL and Nuvilex held in
escrow were returned to their respective original owners and the 100,000,000 restricted Nuvilex shares have now been returned to
the Company Treasury and are therefore not reflected in the financial statements. BBB is now a wholly owned subsidiary of Nuvilex.
Nuvilex, SG Austria, and ASPL are now partners working together on multiple fronts.”

As modified, this disclosure would read as follows in future
filings:

“On May 26, 2011, the Company entered
into an Asset Purchase Agreement (“SG Austria APA”) with SG Austria Private Limited (“SG Austria”) to purchase
100% of the assets and liabilities of SG Austria. As a result, Austrianova Singapore Private Limited ("Austrianova Singapore")
and Bio Blue Bird AG ("Bio Blue Bird"), wholly-owned subsidiaries of SG Austria, were to become wholly owned subsidiaries
of the Company on the condition that the Company pay SG Austria $2.5 million and 100,000,000 shares of the Company’s Common
Stock and for the Company to receive 100,000 shares of Austrianova Singapore’s common stock and nine Bio Blue Bird bearer
shares.

In June
2011, the Company and SG Austria entered into a First Addendum to the SG Austria APA to extend the due date for the sums to
be paid to SG Austria. In June 2012, the Company and SG Austria entered into the Second Addendum to the SG Austria APA for
the same purpose. In June 2013, the Company and SG Austria entered into a Third Addendum to the SG Austria APA. Under the
terms of the Third Addendum, the transaction contemplated by the SG Austria APA was materially changed. The Third Addendum
provided that the Company was to acquire 100% of the equity interests in Bio Blue Bird and receive a 14.5% equity interest in
SG Austria. In addition, the Company received nine bearer shares of Bio Blue Bird. Under the Third Addendum, the Company
paid: (i) $500,000 to retire all outstanding debt of Bio Blue Bird; and (ii) $1.0 million to SG Austria. The Company paid SG
Austria $1,572,195 in cash in exchange for its 14.5% equity interest. The Third Addendum returned the original 100,000,000
shares of Common Stock to the Company treasury and the 100,000 Austrianova Singapore shares to SG Austria.

The acquisition of Bio Blue Bird provided
the Company with exclusive, worldwide licenses to use a proprietary cellulose-based live-cell encapsulation technology for the
development of treatments for all forms of cancer. The licenses are pursuant to patents licensed from Bavarian Nordic A/S and GSF-Forschungszentrum
fur Umwelt u. Gesundeit GmbH. These licenses enable the Company to carry out the research and development of cancer treatments
that are based upon the live-cell encapsulation technology known as “Cell-in-a-Box®.

12510 Prosperity Drive |
Suite 310 | Silver Spring | Maryland 20904-1643

Office: 917.595.2850 |
Facsimile: 917.595.2851 | Mobile: 917.595.2852 | kwaggoner@nuvilex.com

Mr. Jeffrey P. Riedler

Assistant Director

Securities and Exchange Commission

Page 3

In July 2013, the Company also acquired
from Austrianova Singapore the exclusive, worldwide license to use the cellulose-based live-cell encapsulation technology for the
development of a treatment for diabetes and the use of Austrianova Singapore’s “Cell-In-A-Box®”
trademark for this technology. The Company made its first $1,000,000 payment to secure its exclusive, worldwide license to use
the encapsulation technology for the treatment of diabetes on October 30, 2013. The second and final payment of $1,000,000 for
the licensing rights for diabetes was made on February 25, 2014, thereby fulfilling all financial obligations required to be met
by the Company under its licensing agreement with Austrianova Singapore.

On March 20, 2014, the Company and Austrianova
Singapore entered into a Manufacturing Framework Agreement (“Manufacturing Agreement”) to perform the cGMP (Current
Good Manufacturing Practices)-compliant encapsulation of live cells to be used for the Company’s clinical trials in patients
with advanced, inoperable pancreatic cancer and associated conditions and other types of cancers and diabetes. The Manufacturing
Agreement has an indefinite term and may not be terminated by either party except in the case of a continuing and material breach
by the other party and failure to cure such within 60 days following written notice or certain events of bankruptcy.

The Company made and initial payment to
Austrianova Singapore in the amount of $323,500 as part of a “set-up fee” to encapsulate the live cells required by
the Company for use in its clinical trials. Austrianova Singapore was contracted to perform the encapsulation because it developed
and matured the entire Cell-in-a-Box® cellulose-based live-cell encapsulation process that the Company plans to
use in its clinical trials. Austrianova Singapore is considered the world’s foremost expert in this unique and proprietary
technology.

The Cell-in-a-Box® encapsulation
of live cells capable of converting the anticancer prodrug ifosfamide into its cancer-killing form will be performed at Austrianova
Singapore’s cGMP manufacturing facilities currently being constructed in Bangkok, Thailand.

Inno Biologics Sdn. Bhd. in Malaysia was
initially contracted to do the initial cloning of the cells that will ultimately be encapsulated using the Cell-in-a-Box® technology
and then used together with ifosfamide as Nuvilex’s pancreatic cancer treatment. The goal was to produce up to 100 clones
from which the 5-10 best would be selected for use in our encapsulation process. These clones would be used for expanding the cells
to obtain the large numbers that would be needed for clinical trials or stored for safekeeping around the globe or used for other
purposes. Due to a problem that occurred during the initial cloning process, it has been necessary for Inno Biologics to begin
the cloning process again. This is now underway pursuant to a Master Services Agreement. In order that a “fail-safe”
mechanism for the cloning process be instituted, ViruSure GmbH in Vienna, Austria has been contracted to prepare a limited number
of clones that can be stored for possible future expansion should there be any other problems at Inno Biologics. ViruSure was also
selected to expand the clones of cells obtained from Inno Biologics into a Master Cell Bank (“MCB”) and from that a
Working Cell Bank (“WCB”) to supply the large numbers of cells needed for the clinical trials and other purposes. Nuvilex
has already entered into a Master Services Agreement with ViruSure to develop the MCB and the WCB.

12510 Prosperity Drive |
Suite 310 | Silver Spring | Maryland 20904-1643

Office: 917.595.2850 |
Facsimile: 917.595.2851 | Mobile: 917.595.2852 | kwaggoner@nuvilex.com

Mr. Jeffrey P. Riedler

Assistant Director

Securities and Exchange Commission

Page 4

The principal developers of the Cell-in-a-Box®
live cell encapsulation technology, Dr. Walter H. Günzburg and Dr. Brian Salmons, are officers of SGAustria and /or Austrianova
Singapore Pte. Ltd. Since before the filing of the 10-K on July 29, 2013 and well before the execution of the Manufacturing Framework
Agreement referred to above, a close personal and professional relationship has grown steadily between these individuals and officers
of Nuvilex. In fact, Drs. Günzburg and Salmons together are serving as if they were Nuvilex’s Chief Scientific Officer(s),
and are so in all but name only. Nuvilex’s relationship with Drs. Günzburg and Salmons has flourished to the point where
it is now a “partnership" in all but legal terms. The success of SG Austria/Austrianova Singapore and the Company are
co-dependent in almost every respect.

As evidence of the above, Drs. Günzburg and Salmons are
intimately involved in all of the scientific endeavors underway and being planned by Nuvilex. These endeavors include preclinical
and clinical studies to be conducted in the US on behalf of the Company by Translational Drug Development (TD2), one of the most
reputable Contract Research Organizations (CROs) in this country specializing in oncology. These studies concern determining the
effectiveness of our pancreatic cancer treatment in ameliorating the virtually untreatable pain that is associated with advanced
pancreatic cancer and the effects of the treatment on the rate of accumulation of fluid, known as malignant ascites, that occurs
in patients with this disease. Also in the cancer area, Drs. Günzburg and Salmons will be intimately involved in the Company’s
Phase 2b clinical trial that will be conducted in Australia by one of the foremost CROs (Clinical Network Services, “CNS”)
in that country because, in addition to being architects of the Cell-in-a-Box® technology and of Nuvilex’s
pancreatic cancer treatment, they: (i) were both involved in the original Phase 1/2 clinical trials in advanced pancreatic cancer
that were carried out several years ago in Europe; and (ii) are very familiar with CNS and the personnel that will be involved
in the Phase 2b trial. Furthermore, Drs. Günzburg and Salmons have committed to fulfilling a major role in the development
of Nuvilex’s diabetes treatment that is based on the Cell-in-a-Box® technology and Gunzburg and Salmons have
agreed to function as the “Chief Scientific Officers” of Nuvilex for its preclinical studies and clinical trials in
diabetes. In this regard, Drs. Gunzburg and Salmons have introduced Nuvilex to every participant in and component of its program
to develop a medical breakthrough in how diabetes will be treated in the future. Researchers at a major university in Australia,
introduced to Nuvilex by Drs. Günzburg and Salmons, have developed insulin-producing cells from a human hepatocellular carcinoma
cell line. These cells have been exhaustively tested in vitro and found to be capable of producing insulin in direct correlation
to the amount of glucose in their surroundings. Negotiations are underway between Nuvilex and that university for an exclusive,
worldwide license to use these insulin-producing cells in combination with the Cell-in-a-Box® technology in developing a product
for the treatment of insulin-dependent diabetes. This license is contingent on the insulin-producing cells passing a tumorigenicity
test that will be conducted by the University of Veterinary Medicine, Vienna (“UVMV”) where Dr. Günzburg is a
professor in the Department Virology. He will coordinate all of the work for Nuvilex being done by UVMV. This test will show whether
or not these particular cells have the capacity to form tumors.

12510 Prosperity Drive |
Suite 310 | Silver Spring | Maryland 20904-1643

Office: 917.595.2850 |
Facsimile: 917.595.2851 | Mobile: 917.595.2852 | kwaggoner@nuvilex.com

Mr. Jeffrey P. Riedler

Assistant Director

Securities and Exchange Commission

Page 5

Since, Drs. Walter H. Günzburg and Salmons, developers
of the Cell-in-a-Box® technology, have previously worked with these insulin-producing cells and they have them in frozen storage,
the Australian university was approached to obtain permission for these stored cells to be used for tumorigenicity testing. A letter
authorizing the use of these insulin-producing cells for tumorigenicity testing has been received from that institution. The tumorigenicity
of the cells will be determined at the UVMV. A Collaborative Research Agreement between Nuvilex and the UVMV is in the final stages
of negotiations so that the tumorigenicity studies can commence.

The possibility that Nuvilex might conduct some animal studies
in diabetes at the UVMV was the subject of discussions recently with principals at that institution. Nuvilex has prepared a draft
of Collaborative Research Agreement for this purpose which is under review. Nuvilex will finalize this Collaborative Research Agreement
with the UVMV in the near future.

In the majority of diabetes animal models used by others, the
diabetic condition is induced by employing drugs to destroy the normal insulin-producing capability of the pancreas in those animals.
The University of Munich (“UOM”) in Germany operates a 5-million Euro animal farm that houses animals for research
purposes. Scientists at the UOM have developed unique transgenic mouse and pig models of diabetes. Through the use of gene transfer
technologies, mice and pigs that are diabetic at birth have been developed. These model systems probably more closely mimic Type
1 diabetes in humans than any other model systems available world-wide. Through introductions by Drs. Günzburg and Salmons,
the investigators at UOM will join the Nuvilex team of doctors and scientists developing treatment for diabetes using the Cell-in-a-Box®
technology. Nuvilex plans to enter into a Collaborative Research Agreement with the UOM as a first step in the process.

Nuvilex is in the process of developing a Diabetes Consortium
as a result of the introductions by Drs. Gunzburg and Salmons that occurred during the Company’s recent trip to Europe. Principals
of Nuvilex and some of the institutions identified above explored the possibility of joining this Diabetes Consortium. The various
institutions noted above would be part of this Consortium, as would Dr. Walter H. Gunzburg and Dr. Brian Salmons through their
consulting company, Vin-de-Bona Trading Co. Pte. Ltd. The consensus among individuals that could be involved was that the formation
of a Diabetes Consortium would be beneficial to all parties and may be a way of optimizing the development of Nuvilex’s diabetes
product given the free nature of communication that would occur within such a Consortium. Dr. Matthias Löhr, the noted European
gastroenterologist and oncologist who will play a major role in the development of Nuvilex’s pancreatic cancer treatment,
also has a significant interest in the treatment of diabetes. Accordingly, Dr. Löhr would also play a prominent role