IPO Report: MultiVir (MVIR)

Francis Gaskins |

multivir IPO, multivir IPO price, multivir IPO date, IPOs this week, stocks to buy now, small-cap stocks MultiVir (MVIR) is a clinical-stage gene therapy company developing a pipeline of novel product candidates for the treatment of multiple oncological indications. It is based in Houston, TX.

Eleven other companies are scheduled to IPO for the week of May 4. The full IPO calendar is available at IPO Premium.

SEC Documents

Manager, Joint-managers: RBC Capital Markets

Co-managers: Nomura, Cantor Fitzgerald, and LifeSci Capital.

End of lockup (180 days): Monday, November 2, 2015

End of 25-day quiet period: Monday, June 1, 2015

MVIR scheduled a $60 million IPO with a market capitalization of $193 million at a price range midpoint of $13 for Wednesday, May 6, 2015 on Nasdaq.

MultiVir IPO Summary

MVIR is a clinical-stage gene therapy company developing a pipeline of novel product candidates for the treatment of multiple oncological indications.

MIVR's gene therapy and oncolytic viral technologies are directed against important therapeutic targets in oncology that are not fully addressed by existing small molecule cancer therapies.

MultiVir IPO Valuation

Glossary

Valuation Ratios

Mrkt Cap (mm)

Price /Sls

Price /Erngs

Price /BkVlue

Price /TanBV

% offered in IPO

MultiVir (MVIR)

$192

no rev

-66.3

3.7

3.8

31%

             

MultiVir IPO Conclusion

Neutral

Gene therapy targeting multiple oncological indications                                                                          

Price to book of 3.7, relatively high                                                                               

P/E of -66, indicating low cash burn rate relative to market cap                                                               

No revenue                                                                              

Shareholders may purchase $20mm on the IPO, 33%                                                                             

Phase 1 clinical trials completed                                                                                   

MultiVir Business

MVIR is a clinical-stage gene therapy company developing a pipeline of novel product candidates for the treatment of multiple oncological indications.

MIVR's gene therapy and oncolytic viral technologies are directed against important therapeutic targets in oncology that are not fully addressed by existing small molecule cancer therapies.

MIVR is employing these technologies to develop two lead product candidates, Ad-p53 and Ad-IL24.

The Ad-p53 product candidate is a genetically modified adenovirus designed to deliver the normal p53 tumor suppressor gene, which targets fundamental molecular defects present in multiple types of cancers.

The Ad-IL24 product candidate is a genetically engineered adenovirus modified to deliver the tumor suppressor gene interleukin-24, or IL24, which has tumor suppressor activities similar to p53 and certain immunostimulatory properties.

MultiVir Clinical Trials

Each of these product candidates has completed Phase 1 clinical trials as a monotherapy, and MIVR plans to advance both product candidates into Phase 1/2 clinical trials that include a randomized, controlled portion in combination with standard cancer therapies.

MIVR believes its product candidates have the potential to address unmet medical needs of cancer patients.

MultiVir History

In November 2009, MIVR acquired certain assets relating to current Ad-p53 and Ad-IL24 product candidates formerly owned by Introgen Therapeutics, Inc. and its affiliate, or Introgen, from our majority stockholder, Pope Investments II, LLC, or Pope, in exchange for the issuance to Pope of a promissory note in the amount of $1.1 million and the assumption of certain obligations Pope agreed to in connection with its purchase of these assets in the bankruptcy of Introgen.

These assets included patents and patent applications, contracts and licenses with various universities and private parties, a 49% equity interest (which was increased to 50% in 2012), in VirRx, Inc., or VirRx and vials of Introgen’s adenoviral p53 and adenoviral-IL24 product candidates.

If any of Ad-p53, Ad-IL24 or Ad-VirRx 007 is commercialized, MIVR will be obligated to make milestone payments to Introgen of $5 million when revenue generated from sales of such product or licensing of such assets first exceeds $50 million, an additional $5 million when such revenues first exceed $100 million, and a final $20 million when such revenues first exceed $500 million.

Certain of MIVR's adenovirus technologies were licensed from the MD Anderson Cancer Center, including those that are utilized in Ad-p53 and Ad-IL24 product candidates.

MIVR also licenses certain adenovirus technologies, including technology that is utilized in Ad-IL24 product candidate, from Columbia University.

MIVR's herpes simplex virus technologies are the subject of an option to exclusively license such technologies from Massachusetts General Hospital, which technologies are utilized in our HSV-Rb-p450 product candidate.

Certain of vaccinia virus technologies are the subject of an option to exclusively license the technologies from Queen Mary University of London.

Other vaccinia virus technologies have been purchased from Loma Linda University. MIVR's own vaccinia virus technologies are utilized in the VV-IL12 product candidate. VirRx has licensed the VirRx 007 technology that is utilized in the Ad-VirRx 007 product candidate from Saint Louis University.

MultiVir Intellectual Property

MVIR has filed or licensed numerous patents and patent applications and possess substantial know-how and trade secrets relating to the development, manufacture and commercialization of gene therapy products.

As of March 31, 2015, MVIR owns or has licensed from academic institutions and third parties 95 issued or allowed patents and 9 pending patent applications with claims directed to compositions and methods relating to MVIR’s Ad-p53 and Ad-IL24 product candidates and other aspects of MVIR’s business. Patents are allowed or issued in 27 jurisdictions, including the United States, much of Europe, China and Japan.

Patent applications are pending in 8 jurisdictions, including the United States, China, and the European Union, which conveys the right to validate in a number of European states upon a determination of allowable subject matter.

Of the 95 issued or allowed patents, MVIR owns 9. MVIR  owns all 9 of the pending patent applications. The remainder of MVIR’s patent portfolio is licensed.

MVIR’s patent portfolio relating to its Ad-p53 product candidate, including both company owned and licensed patents and applications, includes 42 issued or allowed patents and 8 pending patent applications with issued and pending claims directed to Ad-p53 constructs and methods relating to the use of p53 in cancer treatment, alone, or in combination with p53 companion diagnostic assays.

These patents, or any patents issuing from any of these pending patent applications, are expected to expire, excluding possible patent extensions under the Hatch-Waxman Act or international patent term extension laws, as indicated: U.S. patents, between May 2015 and May 2021; a U.S. patent application, if issued, in January 2029 without patent term adjustment; international patents, between November 2016 and January 2029; similarly, international patent applications, if issued, will expire January 2029.

MVIR’s patent portfolio relating to its Ad-IL24 product candidate, including both company IP and licensed IP from Columbia University, described below, includes 35 patents and 1 pending patent applications with issued and pending claims directed to Ad-IL24 constructs and methods relating to IL24 in cancer treatment.

These patents, or any patents issuing from any of these pending patent applications, are expected to expire, excluding possible patent extensions under the Hatch-Waxman Act or international patent term extension laws, on various dates: U.S. patents, between August 2016 and March 2026; international patents, between August 2017 and July 2020 and the international patent application, if issued, in December 2021.

MVIR also owns or has licensed 18 patents, relating to other aspects of its technology, including adenovirus vectors generally, and other cancer treatments that are expected to expire between July 2015 and August 2024.

MultiVir Competition

If MVIR receives regulatory approval for its Ad-p53 and Ad-IL24 product candidates, MVIR will compete with a variety of therapies currently marketed in development for the treatment of liver metastases from colorectal cancer and the treatment of recurrent, unresectable SCCHN, respectively.

The current standard of care for liver metastases from colorectal cancer may include treatment with one or more of the following drugs and drug regimens: 5-FU, FOLFOX (a regimen consisting of leucovorin, 5-FU and oxaliplatin), FOLFIRI (a regimen consisting of leucovorin, 5-FU and irinotecan) and cetuximab. SCCHN may be treated with certain of these same drugs as well as with cisplatin, bevacizumab (Avastin) and radiation.

All of these are well-established therapies and are widely accepted by physicians, patients and third-party payors as the standard of care for treatment of these cancers.

Although MVIR believes that, Ad-p53 and Ad-IL24 may have synergistic effects when taken in combination with these therapies, they also compete directly with these therapies.

There are a number of other companies with marketed products or products in development for the disease states MVIR intends to treat with MVIR’s product candidates, including Amgen, Bayer, Bristol-Myers Squibb, Genentech, Merck, Pfizer, Sanofi-Aventis and Transgene.

These and other of MVIR’s competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than MVIR does and significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of treatments, and commercializing those treatments.

Accordingly, MVIR’s competitors may be more successful than us in developing and obtaining approval for treatments and achieving widespread market acceptance. MVIR’s competitors’ treatments may be  more effective, or more effectively marketed and sold, than any treatment MVIR may commercialize and may render its treatments obsolete or non-competitive before MVIR can recover the expenses of developing and commercializing them.

MultiVir 5% Shareholders Pre-IPO

Pope Investments II, LLC      96.8%

William P. Wells   96.8%

MultiVir Dividends

No dividends are planned.

MultiVir IPO Use of Proceeds

MVIR expects to receive $52 million from its IPO and use it for the following:

$3.0 million to fund research and development expenses for the Phase 1 safety “run-in” portion to confirm the MTD of each of (i) its Ad-p53 Phase 1/2 clinical trial and (ii) its Ad-IL24 Phase 1/2 clinical trial;

$31.0 million to fund research and development expenses for the Phase 2 randomized, controlled portion of either (i) its Ad-p53 Phase 1/2 clinical trial that will evaluate the safety and efficacy of Ad-p53 in patients with liver metastases from colorectal cancer, as well as the development of any related companion diagnostic, or (ii) its Ad-IL24 Phase 1/2 clinical trial that will evaluate the safety and efficacy of Ad-IL24 in combination with chemotherapy in patients with recurrent, unresectable SCCHN (MVIR will select the clinical trial to advance into the Phase 2 portion based upon the results of the respective Phase 1 safety “run-in” portions of such trials);

$565,000 to satisfy its obligations through the anticipated date of this offering under bonus agreements between us and certain of its officers, which will be payable within 30 days of the completion of this offering; and

the remainder for general and administrative expenses (including personnel-related costs), potential future development programs, early-stage research and development, capital expenditures and working capital and other general corporate purposes.

 

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

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