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Summary

  • A development stage emerging therapeutic and diagnostic company focusing on microRNA and its role in oncology.
  • Entered into agreements with an affiliate of the Ohio State University (OSU), to exclusively license a portfolio of approximately 100 pending patent applications.
  • Has not yet initiated any clinical trials or validated its candidate diagnostic tests.

Based in New York, NY, Microlin Bio (NASDAQ:MCLB) scheduled a $30 million IPO on the Nasdaq with a market capitalization of $75 million at a price range midpoint of $11 for Wednesday, June 18, 2014.

The full IPO calendar is available at IPOpremium.

SEC Documents
Manager, Joint managers: Brean Capital, Summer Street Research Partners

Co-Manager: Meyers Associates

End of lockup (180 days): Monday, December 15, 2014

End of 25-day quiet period: Monday, July 14, 2014

Summary

MCLB is a development-stage emerging therapeutic and diagnostic company focusing on microRNA and its role in oncology.

In September 2013, MCLB entered into agreements with the Ohio State Innovation Foundation (OSIF), an affiliate of the Ohio State University (OSU), to exclusively license a portfolio of approximately 100 pending patent applications and over 80 granted patents covering numerous microRNAs.

Valuation

Glossary

Valuation Ratios

Mrkt Cap (MM)

Price /Sls

Price /Erngs

Price /BkVlue

Price /TanBV

% offered in IPO

annualizng 9 mos losses

Microlin Bio

$75

no rev

-8.1

3.5

3.5

40%

Conclusion

The rating on MCLB is negative.

MCLB has not yet initiated any clinical trials or validated its candidate diagnostic tests

To put the conclusions and observations in context, the following is reorganized, edited and summarized from the full S-1 referenced above.

Business

MCLB is a development-stage emerging therapeutic and diagnostic company focusing on microRNA and its role in oncology.

MCLB is incorporated in Delaware in July 2013.

In September 2013, MCLB entered into agreements with the Ohio State Innovation Foundation, an affiliate of the Ohio State University, to exclusively license a portfolio of approximately 100 pending patent applications and over 80 granted patents covering numerous microRNAs.

In addition, MCLB licensed a novel delivery technology for potential use in the development of therapeutic product candidates. MicroRNAs are recently discovered naturally-occurring RNA molecules (composed of 19 to 25 nucleotides) that do not encode proteins but instead regulate gene expression and various biological pathways.

The improper balance of microRNAs is believed to be linked to many diseases, including cancer.

MCLB believes that microRNAs represent a new class of therapeutics and diagnostics that may be more effective in the diagnosis and treatment of cancer, with the potential for mitigated side effects in comparison with conventional small molecule drugs or biologics.

MCLB believes that MCLB will build a strong position in the microRNA field, with not only a strong intellectual property portfolio, but also with a management team, board of directors and scientific advisory board with the experience and expertise in early-stage biotechnology, therapeutic development, nanoparticle delivery and microRNA biology to maximize the potential of its company and its intellectual property.

Since its inception, MCLB's operations have focused primarily on acquiring and in-licensing critical intellectual property rights from OSIF, recruiting a management team and board of directors, who have agreed to serve upon consummation of this offering, and scientific advisory board.

Additionally, MCLB has been engaging in preclinical development activities, developing strategic company plans to identify and develop its therapeutic and diagnostic product candidates and initiating preclinical studies on its lead therapeutic product candidate for lung cancer, LumiralinTM, including in vitro and in vivo animal studies.

No clinical trials or diagnostic tests

MCLB has not yet initiated any clinical trials or validated its candidate diagnostic tests. MCLB's delivery technology, if successfully developed, is expected to be used with other applications for its product candidates.

Dividend Policy

No dividends are planned.

Intellectual Property

MCLB has a portfolio of 100 pending patent applications and over 80 granted patents worldwide, which it has exclusively licensed from OSIF for use in the diagnosis, prognosis and therapy of certain types of cancer.

The portfolio comprises 19 patent families having expiries between 2026 and 2035, not including any patent term adjustments or extensions, which may have been granted or which may be available, respectively.

Protection of the intellectual property is being sought in major markets, including the United States, Europe, China, Japan, Australia and Canada.

Competition

MCLB is aware of many competitors working in both the therapeutic and diagnostic space for microRNA.

Therapeutic competitors include miRagen Therapeutics, Inc., Mirna Therapeutics, Inc., and Regulus Therapeutics, Inc. Diagnostic competitors include Rosetta Genomics Ltd. and Asurgen, Inc.

5% stockholders

Joseph Hernandez 93%

Ohio State Innovation Foundation 7%

Use of proceeds

MCLB expects to net $26 million from its IPO. Proceeds are allocated as follows:

to use the net proceeds to further develop its therapeutic and diagnostic product candidates as well as validate and develop its delivery technology.

MCLB will devote a significant portion of the proceeds to the preclinical development of all four of its candidate therapeutic products, which are related to four types of cancer (lung, ovarian, colorectal and prostate) as well as the initial clinical-enabling and initial clinical work for one of those candidate therapeutic products.

In addition, MCLB intends to allocate a portion of the net proceeds to the validation of its four candidate clinical diagnostic products.

Initially, MCLB plans to continue preclinical studies on its lead therapeutic product candidate for lung cancer, LumiralinTM, including in vitro and in vivo animal studies, and to begin the CLIA validation of OmiraTM, its clinical diagnostic product candidate for ovarian cancer. MCLB expects that the cost for preclinical development of its four therapeutic product candidates up to Phase 1 will be $10 to $14 million, which includes the expenses for the requisite toxicology screening and CMC manufacturing for all therapeutic product candidates, and the pre-IND work for one therapeutic product candidate.

MCLB expects that the cost to validate each of its four diagnostic product candidates will be approximately $1 million per product candidate, which includes the expenses associated with sample acquisition, reagents, data analysis, personnel and laboratory overheard.

MCLB will seek to validate all four of its diagnostic product candidates within the next two years on a staggered but parallel basis.

Further, MCLB intends to devote a portion of the net proceeds primarily to the validation of its delivery its technology which, if successfully developed, could be used for any of its four product candidate applications.

Disclaimer: This MCLP IPO report is based on a reading and analysis of MCLB's S-1 filing, which can be found here, and a separate, independent analysis by IPOdesktop.com. There are no unattributed direct quotes in this article.

Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it. The author has no business relationship with any company whose stock is mentioned in this article.

Source: IPO Preview: Microlin Bio