IPO Report: Mirna Therapeutics (MIRN)

Francis Gaskins  |

Mirna Therapeutics (MIRN) is a clinical-stage biopharmaceutical company developing a broad pipeline of microRNA-based oncology therapeutics. microRNAs are naturally occurring, short ribonucleic acid, or RNA, molecules, or oligonucleotides, that play a critical role in regulating key biological pathways. The company is based in Austin, TX.

Five other companies are scheduled for the week of Sept. 28. The full IPO calendar is available at IPO Premium.

SEC Documents

Manager, Joint-managers: Citigroup, Leerink Partners

Co-managers: Oppenheimer, Cantor Fitzgerald

End of lockup (180 days): Monday, March 28, 2016
End of 10-day quiet period: Saturday, Oct. 10, 2015

Analyst report estimate:  neutral

MIRN scheduled a $65 million IPO with a market capitalization of $234 million at a price range midpoint of $14 for Wednesday, Sept. 30, 2015 on Nasdaq.

MIRN IPO Summary

MIRN is a clinical-stage biopharmaceutical company developing a broad pipeline of microRNA-based oncology therapeutics. microRNAs are naturally occurring, short ribonucleic acid, or RNA, molecules, or oligonucleotides, that play a critical role in regulating key biological pathways.

Misexpression of even a single microRNA can contribute to disease development and tumor suppressor microRNAs are commonly reduced in cancer.

MIRN IPO Valuation

Pre-IPO grade-score summary
Many IPOs in today’s environment are graded C+ and scored 7.
If the pre-IPO grade is below C+ or the score is below 7,
then our analysts may have some concerns about the company’s
outlook and/or its market segment.
If the pre-ipo grade is above C+ or the score is above 7,
then our analysts believe the company’s overall business outlook is very favorable.
C = unprofitable, C+ = profitable

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% offered in IPO

Mirna Therapeutics (MIRN)










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MIRN IPO Conclusion

Neutral, C, 5.5

Concurrent private placement of $16.8mm

Stockholders may purchase $17mm

microRNA replacement therapy

P/E ratio of -11.7 indicating  moderate to heavy cash burn rate relatiive to market cap

Price to book of 2.1, on the low side

Ongoing phase 1 clinical trial

Concurrent private placement

In connection with a research grant awarded to MIRN, the Cancer Prevention and Research Institute of Texas has agreed to purchase from MIRN concurrently with this offering in a private placement approximately $16.8 million of MIRN common stock at a price per share equal to the initial public offering price.


MIRN is a clinical-stage biopharmaceutical company developing a broad pipeline of microRNA-based oncology therapeutics. microRNAs are naturally occurring, short ribonucleic acid, or RNA, molecules, or oligonucleotides, that play a critical role in regulating key biological pathways.

Misexpression of even a single microRNA can contribute to disease development and tumor suppressor microRNAs are commonly reduced in cancer.

MIRN’s scientists and others at leading academic institutions have identified numerous tumor suppressor microRNAs that play key roles in preventing normal cells from becoming cancerous and facilitating proper cancer immunosurveillance.

To enable therapeutic application of these tumor suppressor microRNAs, MIRN pioneered technologies for creating RNA molecules that function as natural microRNAs when they enter human cells.

microRNA replacement therapy

MIRN is now developing mimics of these naturally occurring microRNAs that are designed to restore this tumor suppressor activity and aid appropriate tumor immune response. This approach is known as microRNA replacement therapy.

MIRN believes that microRNA mimics represent a new paradigm in cancer therapy and have the potential to create a new, important class of effective cancer drugs, that can potentially be used alone or in combination with other cancer therapeutics.

Lead product, Phase 1 clinical trial

MIRN’s lead product candidate, MRX34, a mimic of naturally occurring microRNA-34 (miR-34) encapsulated in a liposomal nanoparticle formulation, is the first microRNA mimic to enter clinical development and has demonstrated clinical proof of concept as a single agent in MIRN’s ongoing Phase 1 clinical trial.

miR-34 is one of the most widely published microRNAs and is considered a key regulator of multiple oncogenes across multiple oncogenic pathways. MIRN plans to develop MRX34 as a monotherapy and in combination with other therapeutic modalities, such as targeted therapies and immuno-oncology agents.

microRNAs: A Unique Class in the RNA Therapeutics Space

The landscape of RNA-based therapeutic technologies has rapidly expanded over the past few years, mostly due to advances in the delivery of these molecules to their intended targets.

These new delivery technologies have enabled the use of microRNA mimics, which MIRN believes provide stronger therapeutic activity than other RNA-based approaches.

Since tumor suppressor microRNAs are natural molecules expressed in normal tissues and cells, MIRN also believes that undesired, or so-called "off-target," side effects are less likely to be associated with its microRNA mimic approach.

While other companies in the microRNA field have focused primarily on inhibiting overexpressed microRNAs by antagonists known as anti-miRs or antagomiRs, MIRN has focused on introducing microRNAs that are under-expressed in disease through the use of microRNA mimics.

This is in part due to what MIRN believes is stronger therapeutic activity of microRNA mimics compared to anti-miRs or antagomiRs. Within the group of companies in the microRNA space, MIRN is the first company to clinically employ microRNA mimics.

microRNAs are misexpressed in a broad range of diseases including cancer, obesity, cardiovascular diseases, neurodegenerative diseases and viral infections.

MIRN believes that microRNA-based therapies have the potential to become a new class of drugs with broad therapeutic application due to their ability to modulate multiple disease pathways, their target specificity which minimizes off-target effects, and their potential to work synergistically with other currently marketed drugs.


MIRN is developing a pipeline of tumor suppressor microRNA mimics.

MIRN believes that these mimics have the potential to become promising new oncology therapeutics due to their capacity to regulate many different oncogenes across multiple oncogenic pathways.

MIRN scientists have also discovered functions of microRNAs in numerous diseases other than cancer, which may provide us an opportunity to expand this novel technology into other therapeutic areas of unmet medical need.

MIRN believes these microRNAs represent future partnering or diversification opportunities.

Intellectual property

MIRN intends to continue building on its technology platform, comprised of intellectual property, proprietary methods and know-how in the microRNA field, and also to successfully expand and defend its position as a leader in the microRNA field.

MIRN is pursuing or has been granted therapeutic use patent claims related to several tumor suppressor microRNAs, as well as composition of matter claims for multiple chemistries and structures that are or may be used in or contemplated for use with MIRN’s therapeutic microRNA mimics, including miR-34.

MIRN has an exclusive license to the patent estate covering the SMARTICLES liposomal delivery technology for four of MIRN’s product pipeline candidates, including miR-34, and one additional microRNA, which could be broadened to include certain other tumor suppressor microRNAs. MIRN believes its strong intellectual property position can be used to support internal development as well as out-licensing opportunities.


MIRN is aware of several companies that are working specifically to develop microRNA therapeutics.


miRagen Therapeutics, Inc., or miRagen, a privately held company based in Boulder, Colorado, uses anti-miRs with an initial focus in cardiovascular, metabolic diseases, and hematological cancers.

miRagen is in preclinical development, has entered into a partnership with Laboratoires Servier to focus on three different targets in the cardiovascular and metabolic space and has also expressed interest in pursuing microRNA mimic development, which they call "pro-miRs."


Regulus Therapeutics, Inc., or Regulus (RGLS) $441 million market cap, is a publicly traded company based in Carlsbad, California, which primarily focuses on anti-miRs technology, or the inhibition of overexpressed microRNAs.

Regulus has focused on a number of indications, including hepatitis C, kidney fibrosis and cancer. They initiated their first clinical trial for RG-101, their lead anti-miR therapeutic program, against miR-122 for hepatitis C in March 2014, and initiated a Phase 1 clinical trial evaluating RG-012 in healthy volunteers for the treatment of Alport syndrome in June 2015, while other programs are still in preclinical development.

Regulus has numerous research and development collaborations with large pharmaceutical and biotechnology companies, including AstraZeneca plc, Biogen Idec, Inc., GlaxoSmithKline plc and Sanofi S.A. Santaris Pharma A/S, or Santaris, was a publicly traded company based in Denmark using RNA-targeted antagonist therapy for diseases including metabolic disorders, infectious and inflammatory diseases, cancer and rare genetic disorders.

Santaris (now Roche)

In August 2014, Roche announced the acquisition to Santaris Pharma. Santaris (now Roche) has drug candidates in Phase 1 and Phase 2 clinical trials, and their lead therapeutic product, an antagonist to miR-122, has reached late Phase 2 clinical testing for hepatitis C. EnGenIC is a privately held Australian company developing a nanocell platform for delivery of cancer therapeutics and other therapeutic molecules.


In November 2014, EnGenIC announced initiation of a Phase 1 clinical trial of its delivery system packaged with a miR-16-based microRNA for the treatment of malignant pleural mesothelioma. A patient case study from this study was recently published in the American Journal of Respiratory and Critical Care Medicine.

5% shareholders pre-IPO

Sofinnova Venture Partners VIII, L.P.                              17.8%

Entities Associated with New Enterprise Associates        17.8%

Pfizer Inc.                                 15.0%

State of Texas                          7.1%

Eastern Capital Limited              6.4%

Baxalta US Inc.                                        5.3%

Paul Lammers, M.D., M.Sc.       8.7%

Michael Powell, Ph.D.                17.8%

Matthew Winkler, Ph.D.              7.0%


No dividends are planned.

Use of proceeds

MIRN expects to receive $59 million from its IPO and use it for the following:

$61.0-$71.0 million to fund clinical development expenses for its lead program, MRX34, which includes

$13.0-$16.0 million to complete the Phase 1 clinical trial, including expansion cohorts on multiple indications and/or changes in protocol,

$18.0-$21.0 million to initiate the Phase 2 clinical trial for an indication to be determined, and

$30.0-$34.0 million, which will include the net proceeds from the concurrent private placement, to fund preclinical and clinical studies for the use of MRX34 in combination with standard of care drugs,

$24.0-$28.0 million to fund preclinical and clinical studies for a second product candidate using another to be determined mimic product, and

the remainder for preclinical studies, working capital and other general corporate purposes, which may include pursuit of MIRN’s other research and discovery efforts, expenditures on intellectual property and the acquisition or in-license of other products, product candidates or technologies.


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Symbol Name Price Change % Volume
MIRN SYBX Mirna Therapeutics Inc. n/a n/a n/a 0 Trade



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