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SALE OF IGENICA, INC.
Gerbsman Partners has been retained by Igenica, Inc. to solicit interest for the acquisition of all, or substantially all, the assets of Igenica, Inc.

Igenica Biotherapeutics (Igenica) is a privately held biotechnology company located in Burlingame, California, founded in 2009. Igenica is harnessing the natural tumor microenvironment to deliver a pipeline of high-impact antibody-based cancer therapeutics.

The acquisition of Igenica enables immediate access to proprietary technology and preclinical drug candidates. To date, Igenica has raised six rounds of private financing totaling $83 million in venture capital funded by a premier team of life science investors including The Column Group, OrbiMed, 5AM Ventures and Third Rock Ventures.

Igenica Biotherapeutics has a patent portfolio that consists of twelve (12) families which include twenty-four (24) patent and provisional applications and seven (7) international PCT applications with the intent to protect the company’s antibody platform (so as to make sure this platform is different from the ADC Technology), ADC technology, preclinical and clinical assets.

Igenica has developed:
· A novel technology (sTAg) for Identifying overexpressed proteins on tumor cell surfaces
· A novel method (iTAb) to generate tumor antigen specific monoclonal antibodies
· A novel antibody dependent conjugation platform (SNAP) including a proprietary linker
· Several well characterized drug candidates that show promise in preclinical studies
· One clinical drug candidate, IGN523, which halted development post a phase I dose escalation trial due to lack of efficacy in AML. The company believes that IGN523 may show promise as a combination therapy or for an indication other than AML
· A large, pending patent estate which has ongoing prosecution, but no issued patents as of this date

Igenica has no recurring revenues, product or collaboration related. Its value lies in the preclinical and clinical assets produced by its underlying and proprietary technology.

IMPORTANT LEGAL NOTICE:

The information in this memorandum does not constitute the whole or any part of an offer or a contract.

The information contained in this memorandum relating to Igenica’s Assets has been supplied by Igenica. It has not been independently investigated or verified by Gerbsman Partners or its agents.

Potential purchasers should not rely on any information contained in this memorandum or provided by Igenica, or Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.
Igenica, Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of Igenica’s or Gerbsman Partners’ negligence or otherwise.

Any sale of the Igenica Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of Igenica or Gerbsman Partners. Without limiting the generality of the foregoing, Igenica and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the Igenica Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. This memorandum and the information contained herein are subject to the non-disclosure agreement attached hereto as Exhibit A.

Historical Company Information

Igenica’s foundational vision was to build a biopharmaceutical company with a complete suite of technologies supporting the discovery of antibody-based therapeutics. Our rigorous approach to target discovery and antibody development considers patient profile, tissue expression, the tumor micro-environment and antibody function as primary factors.

Our target discovery platform, sTAg (surface Tagged Antigen), systematically profiles proteins found on the cell surface of primary tumors to identify antibody-accessible antigens as candidate targets. Tumor-specific surface proteins are identified and quantified by applying advanced mass spectrometry analysis.

To identify functional antibodies that are specific to target candidates, we developed a platform, iTAb (in vivo anti-Tumor Antibody), that generates diverse antibodies and screens Ab candidates in vivo, to select antibodies with the most potent anti-tumor activity. This platform has been applied to develop naked functional antibodies, including next-generation immune-oncology therapies for cancer.

Our proprietary site-specific ADC platform technology, SNAP, addresses the major limitations of current and competitive approaches by providing a simple, elegant, chemically-driven method for linking a functional Ab and small molecule cytotoxin. Our SNAP technology results in a highly flexible bi-functional linker that, by design, yields homogeneous ADCs armed with the optimal toxin payload. SNAP is also a highly flexible system that is amenable to any antibody, linker or toxin, and can tune the drug-to-antibody ratio (DAR) to specifically 2, 3, or 4, making it an ideal technology for internally and externally generated programs.

Igenica Company Profile

Igenica is focused on the discovery and development of immune-modulating antibodies and antibody-drug conjugates (ADCs) for the treatment of cancer. We are the only biotherapeutic company that fully powers the ADC development spectrum from a clinically relevant approach to target and functional antibody discovery to ADC creation, accelerating development and the delivery of effective therapies to patients.

Founded in 2009, Igenica is led by a proven team of leaders that have demonstrated success in antibody drug discovery, clinical development and commercialization. Based in Burlingame, Calif., we were well-funded by a premier team of life science investors including The Column Group, OrbiMed, 5AM Ventures and Third Rock Ventures.

Patent description

Igenica Biotherapeutics has a patent portfolio that consists of twelve (12) families which include twenty-four (24) patent and provisional applications and seven (7) international PCT applications with the intent to protect the companies’ platform, ADC technology, preclinical and clinical assets.

Impact of Technology on the Market and Why Igenica Assets are Attractive

We are focused on the development of innovative immunotherapies, functional antibodies directed to the tumor, and antibody-drug conjugates for the treatment of cancer. All of Igenica’s product candidates were discovered using our proprietary product engine.

· iTab platform generates high-affinity antibodies with broad epitope coverage and in vivo anti-tumor efficacy in preclinical models
· SNAP platform can provide homogeneous drug-to-antibody ratios (DARs) of 2, 3, or 4, is adaptable to all payload classes and reduces manufacturing risks of ADCs
· Igenica’s antibodies are of high affinity and cover various elements of immunotherapy
· Combination therapy with Igenica antibodies have the potential to significantly impact anticancer immunotherapy
· Igenica antibodies have been tested in preclinical efficacy models and/or cynomolgus monkeys for safety

Igenica’s Assets

· Intellectual Property
· Numerous preclinical studies demonstrating anti-tumor efficacy in various tumor models, safety and PK/PD assessments in non-human primates
· Procedures and methods for target identification, antibody generation and antibody drug conjugation chemistry

IGN523
Igenica developed IGN523 (anti-CD98) for the treatment of multiple hematologic and solid tumors. Expression of CD98 has been shown to be upregulated in a variety of hematologic malignancies, including AML, and in several types of solid tumors, particularly squamous cell carcinomas. Its elevated expression is correlated with poor prognosis and patient outcome. Previous studies have demonstrated that CD98 functions both in integrin signaling and amino acid transport processes, which support the proliferation, anchorage-independence, invasion, and metastasis of tumor cells (Cancer Cell 2016; 30(5): 792-805; Int. J. Cancer 2015; 137(3): 710-720).
· IGN523 is a high affinity antibody that works through multiple mechanisms of action potentially reducing the risk of developing treatment resistance
· IGN523 has been in a Phase 1 clinical trial in patients with relapsed or refractory acute myeloid leukemia (AML). The trial has been designed to assess the safety, pharmacokinetics, and clinical activity of IGN523
· Preclinical studies indicate that in addition to AML non-small lung cancer patients express high levels of CD98 and could benefit from IGN523 treatment
· Immunohistochemical staining reagents are available to be developed as a patient stratification tool
· IGN523 can be readily produced as master cell bank with contract manufacturer is available

IGN381
IGN381 forms the basis for an innovative approach to immunotherapy by targeting an immune checkpoint target called VISTA or c10orf54 that plays a complimentary role in the tumor micro-environment to other known immune checkpoints. Igenica developed an active antibody program and has humanized a lead candidate. We believe this program is well positioned to complement existing immunotherapy approaches.

· IGN381 is a high affinity mAb with data supporting immune checkpoint inhibition differentiation relative to lead competitor mAb
· Safety of IGN381 has been assessed alone and together with anti-PD1 antibody (pembrolizumab) in a PK/PD 6 weeks repeat-dose study in non-human primates
· Strong evidence of VISTA immune regulatory function in a non-redundant, MDSC-mediated immune regulatory axis
· Extensive expression profiling reveals that VISTA expression pattern is consistent with extensive role on MDSCs and unique among immune checkpoint regulators
· Increased expression in immune infiltrates within tumors may result in decreased overall survival of NSCLC patients
· Igenica has identified a putative heterophilic binding partner for VISTA
· Patent applications on these antibodies and other novel aspects of this program have been filed

IGN786
Discovered using Igenica’s sTAg protoemics technology, SAIL (c16orf54) has not been studied or described in humans previously. Given the expression profile of this target, IGN786 has the potential to be an exquisitely specific targeted therapy for multiple cancer indications with high unmet medical need, including follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), multiple myeloma, and pancreatic cancer. Igenica developed IGN786 as an antibody-drug conjugate using Igenica’s proprietary ADC technology. Igenica has filed patent applications with claims protecting multiple unique aspects of this novel therapeutic agent (Blood Cancer J 2015; 5: e316).

· SAIL is a highly novel ADC target derived from a proteomics-based target discovery approach
· IGN786 leverages Igenica’s SNAP ADC technology to optimally target SAIL-expressing tumors
· Based on the expression profile of SAIL, IGN786 is being developed to address high unmet medical need in multiple hematologic and solid tumor indications
· IGN786 induces tumor regression in multiple AML xenograft models
· IGN786 displays a favorable toxicology profile in non-human primates (NOAEL of 20 mg/kg)

CD39
· Strong evidence CD39 immune regulatory function through purinergic signaling within the CD39/CD73/adenosine pathway
· CD39 expression profile reveals higher levels of expression in tumors, Tregs and myeloid cells within the TME relative to normal tissues
· 9-8B mAb is a high affinity anti-CD39 mAb with data supporting functional blocking of CD39 ATPase activity (Am J Trans Res 2015; 7(6): 1181-1188)
· 9-8B inhibits tumor growth through cell killing in vivo
· 9-8B mAb has been humanized in silico
· Patent applications have been filed on Igenica’s antibodies and methods of treatment

The assets of Igenica will be sold in whole or in part (collectively, the “Igenica Assets”). The sale of these assets is being conducted with the cooperation of Igenica. Igenica and its consultants will be available to assist purchasers with due diligence and a prompt, efficient transition to new ownership.
Igenica, Inc. Key Personnel
· Edward van der Horst — Senior Director Preclinical Drug Development: Edward van der Horst, Ph.D., joined Igenica in 2010 as director of preclinical development, bringing in-depth knowledge of oncology and 15 years of experience in the development of monoclonal antibody therapeutics, target discovery, selection and validation. His contributions and discoveries have led to the development and clinical evaluation of anti-DLL4 and anti-NOTCH2/3 antibodies at OncoMed Pharmaceuticals, Inc., the first clinical stage anti-HER3 antibody at U3 Pharma GmbH (acquired by Daiichi-Sankyo), and Igenica’s first IND filing. Dr. van der Horst studied chemistry at the Heinrich-Heine University, Düsseldorf and the Ludwig-Maximilian University of Munich. For his master’s thesis he conducted research at the Max-Planck Institute of Neurobiology, Munich and holds a Ph.D. in biochemistry from the Max-Planck Institute of Biochemistry, Munich. Dr. van der Horst completed his postdoctoral studies at Tularik, Inc., acquired by Amgen, Inc. in 2004.

· Hans van Houte — CFO: Hans van Houte joined Igenica in 2011 and brings broad financial and operational experience with biotechnology companies. Prior to Igenica, Mr. van Houte served in senior financial roles, including vice president, finance and administration for Trubion Pharmaceuticals, where he led the company’s private financing efforts and managing its IPO preparation. Prior to Trubion, Mr. van Houte was the controller, assistant treasurer and principal accounting officer for Vertex Pharmaceuticals, where he helped build the organization post-IPO to support growth from a $100 million company to a multibillion market cap. Mr. van Houte holds a B.S. in finance and management from Babson College.

Igenica, Inc. Board of Directors
David Goeddel, PhD: Chairman of the Board, Managing Partner, The Column Group.
Mark Goldsmith, MD, PhD: Partner, Third Rock Ventures.
John Diekman, PhD: Founding Partner 5AM Ventures.
Robert Schreiber, PhD: Igenica Co-founder, Alumni endowed Professor of pathology and immunology, Professor of molecular microbiology, co-leader of the tumor immunology program for the Siteman Comprehensive Cancer Center at Washington University School of Medicine and founding Director of the Washington University center for human immunology and immunotherapy programs. Schreiber played a key role in developing the iTAb platform and is an acknowledged leader in the field of cancer immunology and immunotherapy.
The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a nondisclosure agreement (attached hereto as Exhibit A) to have access to key members of the management and intellectual capital teams and the due diligence “war room” documentation (the “Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has an opportunity to inspect and examine the Igenica Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of Igenica, Inc., Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and neither Igenica nor Gerbsman Partners (or their respective, staff, agents, or attorneys) makes any representations as to the accuracy or completeness of the same.

Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the Igenica Assets. Sealed bids must be submitted so that the bid is actually received by Gerbsman Partners no later than Tuesday, February 14, 2017 at 3:00 p.m. Pacific Time (the “Bid Deadline”) at Igenica’s office, located at 863A Mitten Road Ste. 100B2, Burlingame, California 94010. Please also email steve@gerbsmanpartners.com with any bid.

Bids should identify those assets being tendered for in a specific and identifiable way. The attached Igenica fixed asset list may not be complete and Bidders interested in the Igenica’s Assets must submit a separate bid for such assets. Be specific as to the assets desired.

Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase where applicable. All bids must be accompanied by a refundable deposit check in the amount of $200,000 (payable to Igenica, Inc.). The winning bidder will be notified within 3 business days after the Bid Deadline. Non-successful bidders will have their deposit returned to them.

Igenica reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale. Interested parties should understand that it is expected that the highest bid will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.

Igenica will require the successful bidder to close within 7 business days. Any or all of the assets of Igenica will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.

All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the Igenica Assets shall be the sole responsibility of the successful bidder and shall be paid to Igenica at the closing of each transaction.

For additional information, please see below and/or contact:

Steven R. Gerbsman
(415) 456-0628
steve@gerbsmanpartners.com

Kenneth Hardesty
(408) 591-7528
ken@gerbsmanpartners.com

The Bidding Process, Procedures for the Sale of certain Assets and Intellectual Property of Rio Grande Neurosciences, Inc.

Further to Gerbsman Partners sales letters of December 20, 2016 and December 13, 2016 regarding the sale of certain assets of Rio Grande Neurosciences, Inc. (“RGN”), I am attaching an updated Asset Purchase Agreement (“APA”) that is required with any bid, for interested parties bidding on the assets and IP of RGN. Also, I am attaching an “Executive Summary” that supplements the detailed information in the sales letter you have received and an updated “NDA” (Exhibit A). Please also see attached an outline of information in the “due diligence” room at RGN

Ken, Dennis and I will be following up to review the Bidding Process, schedule due diligence meetings and answer any questions regarding the “Date Certain M&A Process”.

Gerbsman Partners has been retained by RGN  to solicit interest for the acquisition of part or substantially all of RGN’s assets, including its Intellectual Property (“IP”), in whole or in part (collectively, the “RGN Assets”).

Any and all the assets of RGN will be sold on an “as is, where is” basis and will be subject to “The Bidding Process for Interested Buyers”, outlined below.

Prior to the bid date of January 24, 2017, I would encourage all interested parties to have their counsel speak with Stephen Juelsgaard, Esq. stevejue@hotmail.com at 650 454–1782 regarding reviewing and negotiating the attached “APA”. He is available to discuss any questions or comments of a legal nature relating to the transactions contemplated by the “APA”.

IMPORTANT LEGAL NOTICE

The information in this memorandum does not constitute the whole or any part of an offer or a contract.

The information contained in this memorandum relating to RGN’s Assets has been supplied by RGN. It has not been independently investigated or verified by Gerbsman Partners or their respective agents.

Potential purchasers should not rely on any information contained in this memorandum or provided by Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.

Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of RGN’s or Gerbsman Partners’ negligence or otherwise.

Any sale of the RGN Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of RGN and Gerbsman Partners. Without limiting the generality of the foregoing, RGN and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the RGN Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. This memorandum and the information contained herein are subject to the non-disclosure agreement attached hereto as Exhibit A.

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a Confidential Disclosure Agreement (attached hereto as Appendix A) to have access to key members of management and intellectual capital teams and the due diligence “war room” documentation (“Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has had an opportunity to inspect and examine the RGN Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and Gerbsman Partners (and their respective staff, agents, or attorneys) do not make any representations as to the accuracy or completeness of the same.

Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the RGN Assets. Each sealed bid must be submitted so that it is received by Gerbsman Partners no later than Monday, January 24, 2017 at 3:00pm Pacific Standard Time (the “Bid Deadline”) at 211 Laurel Grove Avenue, Kentfield, CA 94904. Please also email steve@gerbsmanpartners.com with any bid.

Bids should identify those assets being tendered for in an identifiable way. Specifically, RGN’s three core assets, multicoil transcranial magnetic stimulation, pulsed electromagnetic field technology, and closed-loop transcranial electrical stimulation platform, can be bid on in whole or in part.

Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase. All bids must be accompanied by a refundable deposit in the amount of $200,000 (payable Rio Grande Neurosciences, Inc.). The deposit should be wired to an escrow agent who will be outlined in the next update. The winning bidder will be notified within 3 business days of the Bid Deadline. Unsuccessful bidders will have their deposit returned to them within 3 business days of notification that they are an unsuccessful bidder.

RGN reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale. Interested parties should understand that it is expected that the highest and best bid submitted will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.

RGN will require the successful bidder to close within a 7 day period. Any or all of the assets of RGN will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.

All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the RGN Assets shall be the sole responsibility of the successful bidder and shall be paid to RGN at the closing of each transaction.

For additional information, please see below and/or contact:

Steven R. Gerbsman
Gerbsman Partners
(415) 456-0628
steve@gerbsmanpartners.com

Kenneth Hardesty
Gerbsman Partners
(408) 591-7528
ken@gerbsmanpartners.com

 

gp_nl_header

The Bidding Process, Procedures for the Sale of certain Assets and Intellectual Property of Rio Grande Neurosciences, Inc.

Further to Gerbsman Partners sales letter of December 13, 2016 regarding the sale of certain assets of Rio Grande Neurosciences, Inc.. (“RGN”), I am attaching the Asset Purchase Agreement (“APA”) that is required with any bid, for interested parties bidding on the assets and IP of RGN. Also, I am attaching an “Executive Summary” that supplements the detailed information in the sales letter you have received and an updated “NDA” (Exhibit A).

Ken, Dennis and I will be following up to review the Bidding Process, schedule due diligence meetings and answer any questions regarding the “Date Certain M&A Process”.

Gerbsman Partners has been retained by RGN to solicit interest for the acquisition of part or substantially all of RGN’s assets, including its Intellectual Property (“IP”), in whole or in part (collectively, the “RGN Assets”).

Any and all the assets of RGN will be sold on an “as is, where is” basis and will be subject to “The Bidding Process for Interested Buyers”, outlined below.

Prior to the bid date of January 24, 2017, I would encourage all interested parties to have their counsel speak with Anthony A. Adler, Esq. of Mitchell Silberberg & Knupp aaa@msk.com at 310 312 3186– regarding reviewing and negotiating the attached “APA”. He is available to discuss any questions or comments of a legal nature relating to the transactions contemplated by the “APA”.

IMPORTANT LEGAL NOTICE

The information in this memorandum does not constitute the whole or any part of an offer or a contract.

The information contained in this memorandum relating to RGN’s Assets has been supplied by RGN. It has not been independently investigated or verified by Gerbsman Partners or their respective agents.

Potential purchasers should not rely on any information contained in this memorandum or provided by Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.

Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of RGN’s or Gerbsman Partners’ negligence or otherwise.

Any sale of the RGN Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of RGN and Gerbsman Partners. Without limiting the generality of the foregoing, RGN and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the RGN Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. This memorandum and the information contained herein are subject to the non-disclosure agreement attached hereto as Exhibit A.

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a Confidential Disclosure Agreement (attached hereto as Appendix A) to have access to key members of management and intellectual capital teams and the due diligence “war room” documentation (“Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has had an opportunity to inspect and examine the RGN Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and Gerbsman Partners (and their respective staff, agents, or attorneys) do not make any representations as to the accuracy or completeness of the same.

Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the RGN Assets. Each sealed bid must be submitted so that it is received by Gerbsman Partners no later than Monday, January 24, 2017 at 3:00pm Pacific Standard Time (the “Bid Deadline”) at 211 Laurel Grove Avenue, Kentfield, CA 94904. Please also email steve@gerbsmanpartners.com with any bid.

Bids should identify those assets being tendered for in an identifiable way. Specifically, RGN’s three core assets, multicoil transcranial magnetic stimulation, pulsed electromagnetic field technology, and closed-loop transcranial electrical stimulation platform, can be bid on in whole or in part.

Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase. All bids must be accompanied by a refundable deposit in the amount of $200,000 (payable Rio Grande Neurosciences, Inc.). The deposit information will be supplied in the next “update”.  The winning bidder will be notified within 3 business days of the Bid Deadline.  Unsuccessful bidders will have their deposit returned to them within 3 business days of notification that they are an unsuccessful bidder.

RGN reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale. Interested parties should understand that it is expected that the highest and best bid submitted will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.

RGN will require the successful bidder to close within a 7 day period. Any or all of the assets of RGN will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.

All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the RGN Assets shall be the sole responsibility of the successful bidder and shall be paid to RGN at the closing of each transaction.

For additional information, please see below and/or contact:

Steven R. Gerbsman
Gerbsman Partners
(415) 456-0628
steve@gerbsmanpartners.com

Kenneth Hardesty
Gerbsman Partners
(408) 591-7528
ken@gerbsmanpartners.com

SALE OF Rio Grande Neuroscience, Inc.

Gerbsman Partners (www.gerbsmanpartners.com) has been retained by Rio Grande Neurosciences, Inc. (RGN) (www.RioGrandeNeurosciences.com) to solicit interest for the acquisition of all, or substantially all of, RGN’s assets.

Headquartered in Santa Fe, New Mexico, RGN is a medical device company that has developed a suite of non-invasive brain stimulation (NIBS) technologies for use in treating neurological and psychiatric conditions and enhancing cognitive performance. RGN has raised $6.2 million over 5 years of capital financing. Over $50 million has been invested into the development of these three technologies over time by RGN and predecessor companies ($20 MM invested through Ivivi Health Sciences and $30 MM invested in Cervel Neurotech, both companies acquired by RGN).

IMPORTANT LEGAL NOTICE:

The information in this memorandum does not constitute the whole or any part of an offer or a contract.

The information contained in this memorandum relating to RGN’s Assets (as defined herein) has been supplied by RGN. It has not been independently investigated or verified by Gerbsman Partners or their respective agents.

Potential purchasers should not rely on any information contained in this memorandum or provided by Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.

Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of RGN’s or Gerbsman Partners’ negligence or otherwise.

Any sale of the RGN Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either expressed or implied, of any kind, nature, or type whatsoever from, or on behalf of RGN and Gerbsman Partners. Without limiting the generality of the foregoing, RGN and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the RGN Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. This memorandum and the information contained herein are subject to the Confidential Disclosure Agreement attached hereto as Appendix A.

Company Profile

Rio Grande Neurosciences, Inc. (RGN), a Santa Fe, New Mexico based medical device company, has developed a suite of non-invasive brain stimulation (NIBS) technologies for use in treating neurological and psychiatric conditions and enhancing cognitive performance. The NIBS technologies, also called electroceuticalsTM, include a multicoil transcranial magnetic stimulation (mcTMS) device, a radio-frequency pulsed electromagnetic field (PEMF) technology, and a closed-loop transcranial electrical stimulation (clTES) platform. Each device delivers energy to the central nervous system (CNS) differently and has been studied for different clinical and consumer applications.

Multi-coil TMS, IP from Stanford University and originally developed by Cervel Neurotech, involves selectively modulating brain circuit nodes. This is accomplished with an array of coils that steer induced electrical currents so as to optimally modulate targeted brain regions. Each magnetic coil is independently positioned and powered, thereby steering the electrical current toward unique brain areas not reachable by single-coil devices. RGN’s mcTMS assets include a sought-after intellectual property position for TMS with multiple coils and strong clinical data in the areas of depression and pain. FDA 510k clearance for treatment-resistant depression is expected in Q1 2017.

RGN’s PEMF technology is a portable treatment that inductively delivers a low-power electric field to underlying tissue. PEMF is a Class II FDA-cleared treatment for postoperative pain and edema and in randomized controlled clinical studies has been found to be safe and able to significantly reduce pain, narcotic pain medication use, edema, and inflammatory cytokine production. RGN has repurposed PEMF for treating mild traumatic brain injury and multiple sclerosis, based on studies demonstrating its anti-neuroinflammatory and neuroprotective effects. Preliminary clinical data (Harvard University) indicate that at-home treatment with the PEMF TheraCapTM reduces symptoms in patients with post-concussion syndrome.

The clTES platform has been shown to markedly enhance learning and memory. It includes a proprietary stimulator (NeuroMod16) and electrodes that can deliver conventional (tDCS, tACS, tRNS) or non-conventional (user-specified) waveforms in open or closed-loop systems that are responsive to neurological or physiological events. Each of the 16 channels operates independently in terms of frequency, amplitude, latency, and duration of stimulation. The NeuroMod16 is the only device available with these advanced capabilities.

Founded in 2011 as a start-up company with support from a Los Alamos National Labs (LANL) Venture Accelerator award, RGN has raised $6.2 million over 5 years of capital financing. Over $50 million has been invested into the development of these three technologies over time by RGN and other companies.

RGN’s mission is to address unmet needs in neurology and psychiatry as well as enhance human performance by implementing the NIBS devices described. In the near term, RGN’s technologies are oriented towards populations with depression, pain, brain injury, and multiple sclerosis; very large multibillion dollar markets.

RGN believes its assets are attractive for a number of reasons:

mcTMS

1. RGN’s intellectual property position for mcTMS covers the use of TMS with more than one coil, a position sought by single-coil TMS manufacturers.

2. mcTMS has advantages over single coil TMS, such as the ability to target multiple brain regions simultaneously or in sequence and to steer current to brain areas not addressable by single-coil approaches (e.g., deeper brain structures)

3. mcTMS has been shown to significantly reduce treatment resistant depression and a FDA 510k clearance for that indication is expected in Q1 2017.

4. mcTMS treatment response rates were found to be markedly higher than that reported by single-coil TMS approaches for treatment-resistant depression.

5. Clinical studies (Stanford University) have shown that mcTMS can markedly reduce both acute and chronic pain.

6. Ongoing research at Stanford University has demonstrated proof of principle for a novel mcTMS pulsing method that can enhance plasticity (RGN-owned IP), a foundation for next generation TMS methodology that may be far more efficacious and require fewer treatments.

PEMF

1. PEMF is a portable CE/CSA-marked FDA-cleared treatment for postoperative pain and edema and in randomized controlled clinical studies has been found to be safe and able to significantly reduce pain, narcotic pain medication use, edema, and inflammatory cytokine production.

2. PEMF is currently in use clinically, is reimbursed by Medicare for treating chronic wounds, and can be further commercialized on-label in the US and abroad.

3. PEMF has no known or observed side effects nor any associated adverse events.

4. Preclinical studies have demonstrated that brief treatments with RGN’s PEMF significantly reduce neuroinflammation and promote neuroprotection and that PEMF is protective in animal models of brain injury, stroke, and multiple sclerosis.

5. PEMF operates via induction and therefore the blood brain barrier does not hinder delivery of the therapy to the brain parenchyma, which is a critical challenge for CNS drug development.

6. RGN is studying at-home PEMF treatment, delivered via the TheraCap™, in patients with post-concussion syndrome at Harvard’s Spaulding Rehabilitation Hospital and encouraging clinical pilot results indicate that treatment is resulting in reduced symptoms and enhanced cerebral blood flow.

7. RGN has IRB-approved clinical trials planned to investigate PEMF as (1) a treatment for acute concussion and (2) adjunctive treatment for symptoms associated with multiple sclerosis.

8. Clinical studies confirming PEMF anti-neuroinflammatory and/or neuroprotective effects pave a path toward other high impact indications related to neurodegenerative disease and psychiatric illness.

clTES

1. NeuroMod16 was built in response to the lack of a safe, effective, and reliable commercial device for multichannel electrical brain stimulation.

2. NeuroMod16 is currently integrated into a cl-TES system in which it responds to real time EEG signals and can be integrated into other closed loop systems.

3. The NeuroMod16 delivers cl-TES via RGN’s proprietary electrodes that substantially increase the safety and comfort of TES.

4. The NeuroMod16 and associated electrodes can deliver conventional (tDCS, tACS, tRNS) or non-conventional (user-specified) waveforms with high levels of precision in open or closed-loop systems that are responsive to neurological or physiological events.

5. Each of the 16 channels operates independently in terms of frequency, amplitude, latency, location, and duration of stimulation.

6. The NeuroMod16 is modular and multiple units can be connected to create high density, high spatial resolution cl-TES.

7. The NeuroMod16 is the only device available with these advanced capabilities.

8. RGN electrodes can be implemented in any montage to meet virtually any user need.

9. US Air Force exclusively uses RGN electrodes for brain stimulation.

10. The U.S. Department of Defense has expressed interest in deploying the Neuromod16 as part of a training enhancement protocol that incorporates virtual reality and EEG.

11. The NeuroMod16 is ready for commercialization and partnership with distributors is underway.

Impact of Technology on the Market

RGN’s development of the three NIBS technologies is rooted in the understanding that non-invasive approaches will often be sought before invasive technologies that require surgery and the associated risks. Further, aggregation of three different NIBS technologies and methods is informed by activity in the nascent field of neuromodulation, which is still unfolding which modalities will work best for different clinical conditions or performance goals. Therein, each of RGN’s devices offers a unique value proposition.

mcTMS

1. RGN owns the only multicoil TMS device and the multicoil approach has a number of advantages over single coil TMS devices.

2. Single coil devices exhibit either shallow and focused stimulation (small diameter coils) or deep and diffuse stimulation (large diameter coils), but cannot stimulate deeper brain structures with selectivity.

3. Multicoil TMS employs an array of coils that steer induced electrical currents so as to optimally modulate targeted brain regions not reachable by single-coil devices. This approach has been shown to be clinically effective in depression and results in higher treatment response rates than single-coil TMS devices.

4. FDA 510k clearance is expected in Q1 2017, after which commercialization can be pursued.

5. RGN’s IP position prevents competitors from using multiple coils.

6. New data suggest that a novel multicoil TMS pulsing sequence can enhance plasticity (RGN-owned IP), an approach that may result in a next generation TMS methodology that could dramatically increase efficacy and reduce treatment duration compared to current standards.

7. RGNs novel mcTMS business model is expected to capture significant market share and put pressure on single-coil competitors.

PEMF

1. RGN’s PEMF technology is a non-invasive radiofrequency device that has been shown to have potent anti-inflammatory effects and no side effects in blinded randomized controlled trials and anti-neuroinflammatory and neuroprotective effects in preclinical studies.

2. RGN has transitioned to studying PEMF treatment, via TheraCapTM, as an intervention for neuroinflammation associated with mild traumatic brain injury and multiple sclerosis.

3. Preliminary results from a post-concussion syndrome pilot trial indicate that PEMF promotes resolution of symptoms and mechanistic outcomes are planned.

4. Given continued positive results and regulatory approval, PEMF therapy would become the first labeled treatment for brain injury, a vast market and critical unmet need in neurological therapeutics.

5. Clinical evidence that PEMF reduces neuroinflammation non-invasively would create a clear path toward several other neurological and psychiatric indications with unmet treatment needs.

6. The attractive safety profile and non-invasive nature of PEMF will position it to compete with potential drug competitors with adverse effects and/or be used adjunctively.

clTES

1. RGN’s TES device, the NeuroMod16, was built in response to the lack of a safe, effective, and reliable commercial device for multichannel TES.

2. RGN’s clTES electrodes provide a safe, stable, and comfortable platform for delivering electrical NIBS.

3. The NeuroMod16 and associated electrodes can deliver conventional (tDCS, tACS, tRNS) or non-conventional (user-specified) waveforms in open or closed-loop systems that are responsive to neurological or physiological events.

4. Each of the 16 channels operates independently in terms of frequency, amplitude, latency, and duration of stimulation.

5. The NeuroMod16 is the only device available with these advanced capabilities.

6. RGN can have the NeuroMod16 manufactured at a cost that will allow it to be priced to disrupt the current TES stimulator market.

Intellectual Property Summary

RGN has an expansive portfolio of intellectual property that covers important methods and uses of NIBS. At present, RGN has (U.S.) 13 issued patents, 8 pending patents for mcTMS (some of which are licenses from Stanford University that are assignable), 13 issued patents, 14 pending patents for PEMF, and 2 pending patents for clTES. More detail can be found in Appendix C. The portfolio represents a broad array of strategic variables including:

mcTMS
1. Device for selective deep brain stimulation via multi-coil magnet arrays.
2. Methods for selectively modulating deep areas of the brain with shaped magnetic fields, using sulci as pathways for current flow.
3. Shaping of pulsed magnetic field is changed by altering the polarity of individual magnets with an array.
4. Use of different pulse rates from individual coils in one array and latencies between their discharges to achieve specific neuromodulation effects.
5. Network-based deep brain stimulation using multiple pulsed magnetic sources.

PEMF
1. RGN’s Neurological PEMF portfolio (5 issued and 3 pending) includes a broad set of applications of PEMF in neurological injury and trauma, neurological pain, neurodegenerative disease, stroke, multiple sclerosis, and prophylactic protection of neural tissue (neuroprotection).
2. RGN’s General PEMF portfolio (8 issued and 11 pending) provides broad protection on the configuration of PEMF devices and signals dating back to 1997, and includes integration of PEMF into clothing, wearables (e.g., TheraCap tm), and furniture.
3. RGN also has strong supporting IP for specific applications of PEMF outside of the CNS including wound repair, treatment of degenerative joint disease, cardiovascular disease, and angiogenesis.
4. RGN continues to actively pursue IP development, in part based on over a decade of research into PEMF signal transduction and mechanism(s) of action.
5. RGN has several PEMF patents providing international IP protection.

clTES
1. clTES has an intellectual property position (2 pending patents) that covers methods, devices, and electrodes that enhance the safety, comfort, effectiveness, flexibility, and ease of use of electrical neuromodulation over currently used methods.
2. Methods: The intellectual property position covers a methodology that looks at brain function first to determine the parameters for the delivery of clTES. Dubbed the REVS approach, our methods prescribe Recording brain activity, Evaluating the differences between optimal and dysfunctional brain states, Virtualizing the stimulation parameters to determine the optimal intervention in terms of frequency, amplitude, latency, location, and duration, and finally Stimulating the brain to effect the desired behavioral change.
3. Devices: The intellectual property specifies the parameters for the NeuroMod16 device that is unique among TES devices that are currently on the market. The NeuroMod16 has 16 independent channels that can be monopolar or bipolar in any combination, can deliver any user specified wave form, accepts external triggers for inclusion in clTES systems, has one touch operation for error reduction, and custom software for device control.
4. Electrodes: The intellectual property includes electrode assemblies that have proven safe and effective in multiple peer reviewed papers, have low sensation and side effect profiles, are stable over long periods, and have never caused a burn.

RGN’s Assets

RGN has developed a technology portfolio that spans three modalities of NIBS and has applications in neurological disease and trauma, psychiatric illness, and performance enhancement. These assets fall into a variety of categories, including:

1. Patents, patent applications, and trademarks

2. PEMF 510(k) clearance in post-surgical market, pending mcTMS 510(k) clearance for depression

3. Technology addressing the estimated the multibillion dollar global markets for treating depression, postoperative pain, brain injury, multiple sclerosis, and cognitive enhancement

4. Established and certified reimbursement codes

5. mcTMS clinical trial data for drug-resistant depression and pain

6. PEMF clinical trial data for post-surgical pain, opiate reduction, swelling, inflammation

7. PEMF pilot trial data for treating post-concussion syndrome

8. TES study data for cognitive enhancement

9. DoD research subcontract (through 2017) – Enhancing Learning & Memory with Brain Stimulation

10. Unique and clinically relevant patient data

11. IRB-approved study plans

12. Market supporting clinical trials underway

13. Next generation product designs

14. Product cost reduction designs

15. Manufacturing and design equipment

16. Device inventory for all three technologies

17. Intellectual capital and expertise

The assets of RGN will be sold in whole or in part (collectively, the “RGN Assets”). The sale of these assets is being conducted with the cooperation of RGN. RGN and its employees will be available to assist purchasers with due diligence and a prompt, efficient transition to new ownership. Notwithstanding the foregoing, RGN should not be contacted directly without the prior consent of Gerbsman Partners

Management
Steven Gluckstern, Ed.D., MBA – President & CEO

Steven has served as RGN’s president and CEO since 2011. Previously he has served as Chairman and CEO of Ivivi Health Sciences, Zurich Scudder Investments, and Centre Reinsurance.

Blake Gurfein, Ph.D. – Chief Science Officer
Blake is a neuroimmunologist and faculty member at the University of California San Francisco. Blake worked with RGN as a consultant from 2013-2014 and joined the company as Chief Science Officer in 2014. In this role, Blake oversees basic science and clinical research activities, manages staff, and interfaces with the medical advisory board. Blake has 15 years of experience in neuroscience and immunology research and has been involved in the design, development, and preclinical/clinical investigation of medical devices.

Sean Hagberg, Ph.D. – Chief Strategist
Sean co-founded RGN in 2011 and in 2004 co-founded Ivivi Technologies, which developed RGN’s PEMF technology. Sean is a faculty member at the University of New Mexico and served as Chief Science Officer of Ivivi and led the scientific and clinical research program, including several first-in-human RCTs with using PEMF. Sean has been involved in all aspects of PEMF IP development, testing, basic science through clinical trials and regulatory processes.

Michael Weisend, Ph.D. – Senior Scientist
Mike is a neuroscientist and faculty member at the University of New Mexico, Wright State University, and The Mind Research Network. Mike consulted for RGN from 2011 to 2015 and joined as a senior scientist in late 2015. Mike has 25 years of experience in neuroimaging, brain stimulation, and device development with emphases in memory, epilepsy, mental illness.

Peter Schwartz, Ph.D. – Director of Engineering
Peter is an engineering executive with a background rooted in science, and he has worked with RGN since 2015, spearheading the mcTMS 510(k) effort. Peter has 20 years of experience in research and development of capital equipment ushering inventions from the laboratory through commercialization.

Bret Schneider, M.D. – Senior Scientist

Bret is the principal inventor of multi-coil TMS and has 25 years of experience in neurotechnology development. Bret is also a Consulting Associate Professor of Psychiatry at Stanford University School of Medicine and a practicing psychiatrist.

Board of Directors

Steven Gluckstern, Chairman: CEO, Rio Grande Neurosciences
Stephen Juelsgaard, D.V.M., J.D.: Former General Counsel, Genentech
John Wilkerson: Managing Director, Galen Partners

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a Confidential Disclosure Agreement (attached hereto as Appendix B) to have access to key members of management and intellectual capital teams and the due diligence “war room” documentation (“Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has had an opportunity to inspect and examine the RGN Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and Gerbsman Partners (and their respective staff, agents, or attorneys) do not make any representations as to the accuracy or completeness of the same.

Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the RGN Assets. Each sealed bid must be submitted so that it is received by Gerbsman Partners no later than Monday, January 24, 2017 at 3:00pm Pacific Standard Time (the “Bid Deadline”) at 211 Laurel Grove Avenue, Kentfield, CA 94904. Please also email steve@gerbsmanpartners.com with any bid.

Bids should identify those assets being tendered for in an identifiable way. Specifically, RGN’s three core assets, multicoil transcranial magnetic stimulation, pulsed electromagnetic field technology, and closed-loop transcranial electrical stimulation platform, can be bid on in whole or in part.

Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase. All bids must be accompanied by a refundable deposit in the amount of $200,000 (payable Rio Grande Neurosciences, Inc.). The deposit should be wired to RGN’s attorneys Mitchell Silberberg & Knupp. The winning bidder will be notified within 3 business days of the Bid Deadline. The deposit will be held in trust by RGN’s counsel. Unsuccessful bidders will have their deposit returned to them within 3 business days of notification that they are an unsuccessful bidder.

RGN reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale. Interested parties should understand that it is expected that the highest and best bid submitted will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.

RGN will require the successful bidder to close within a 7 day period. Any or all of the assets of RGN will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.

All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the RGN Assets shall be the sole responsibility of the successful bidder and shall be paid to RGN at the closing of each transaction.

For additional information, please see below and/or contact:

Steven R. Gerbsman
Gerbsman Partners
(415) 456-0628
steve@gerbsmanpartners.com

Kenneth Hardesty
Gerbsman Partners
(408) 591-7528
ken@gerbsmanpartners.com

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Saw “the Bronx Wanderers” in Las Vegas – wow, a great show.

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A must see – http://thebronxwanderers.com

Las Vegas review -THE BRONX WANDERERS…A Father. Two Sons. Living the American Rock N’ Roll Dream…Quite possibly the best two hours of 50′s, 60′s and 70′s rock n’ roll that you will experience on one stage….or should we say, EVER!

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