IPO Report: aTYR PHARMA (LIFE)

Francis Gaskins |

aTYR PHARMA IPO, aTYR PHARMA IPO price, aTYR PHARMA IPO date, IPOs this week, stocks to buy now, small-cap stocks

aTYR PHARMA (LIFE) engages in the discovery and clinical development of innovative medicines for patients suffering from severe, rare diseases using its knowledge of Physiocrine biology, a newly discovered set of physiological modulators. It is based in San Diego, CA.

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: J.P. Morgan and Citigroup

Co-managers: BMO Capital Markets and William Blair

End of lockup (180 days): Tuesday, November 3, 2015

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

LIFE scheduled a $75 million IPO with a market capitalization of $316 million at a price range midpoint of $14 for Thursday, May 7, 2015 on Nasdaq.

aTYR PHARMA (LIFE) IPO Summary

LIFE engages in the discovery and clinical development of innovative medicines for patients suffering from severe, rare diseases using its knowledge of Physiocrine biology, a newly discovered set of physiological modulators.

LIFE has discovered approximately 300 Physiocrines (physio for life and crine for specific activity), a class of naturally occurring proteins that LIFE believes promote homeostasis, a fundamental process of restoring stressed or diseased tissue to a healthier state.

aTYR PHARMA (LIFE) IPO Valuation

Glossary

Valuation Ratios

Mrkt Cap (mm)

Price /Sls

Price /Erngs

Price /BkVlue

Price /TanBV

% offered in IPO

aTYR PHARMA (LIFE)

$315

no rev

-13.0

2.2

2.1

24%

             

aTYR PHARMA (LIFE) IPO Conclusion

Biological products

Neutral

Price to book of 2.2, relatively low

P/E of -13, indicating moderate cash burn rate relative to market cap

No revenue

Phase 1b/2 clinical trials

Affliates may purchase $15mm of the IPO, 20%

No strategic partners

aTYR PHARMA (LIFE) Business

LIFE engages in the discovery and clinical development of innovative medicines for patients suffering from severe, rare diseases using its knowledge of Physiocrine biology, a newly discovered set of physiological modulators.

LIFE has discovered approximately 300 Physiocrines (physio for life and crine for specific activity), a class of naturally occurring proteins that LIFE believes promote homeostasis, a fundamental process of restoring stressed or diseased tissue to a healthier state.

Physiocrines are extracellular signaling regions of tRNA synthetases, an ancient family of enzymes that catalyze a key step in protein synthesis.

LIFE believes that Physiocrines have evolved over time to modulate important cellular pathways by interacting with various types of cells, including immune and stem cells.

Approximately 100 of these proteins interact with the immune system, which LIFE believes presents a significant therapeutic opportunity to restore affected tissues to a healthier state through natural immuno-modulation mechanisms.

aTYR PHARMA (LIFE) Clinical Trials

In the first quarter of 2014, LIFE completed a double-blind, placebo-controlled Phase 1 clinical trial of Resolaris, the lead development candidate from LIFE's discovery engine, in which LIFE assessed its safety and tolerability in 32 healthy subjects.

Resolaris was shown to be well tolerated at all doses tested, and no serious adverse events were reported.

Based on the favorable clinical safety, tolerability, pharmacokinetic and immunogenicity profile of Resolaris in this trial, LIFE decided to advance Resolaris into clinical trials of patients affected by rare myopathies with an immune component.

LIFE is currently conducting a multi-national exploratory Phase 1b/2 clinical trial of Resolaris in the European Union in adult patients with facioscapulohumeral muscular dystrophy, or FSHD, a severe, rare genetic myopathy in which immune cells invade diseased muscle, and for which there are no approved treatments.

Subject to interactions with regulatory authorities and patient enrollment in accordance with clinical development plans, LIFE expects to report initial results from this clinical trial in the fourth quarter of 2015 or early 2016.

aTYR PHARMA (LIFE) Pipeline

By leveraging its discovery engine and its knowledge of rare diseases, LIFE aims to build a proprietary pipeline of novel product candidates with the potential to treat severe, rare diseases characterized by immune dysregulation. LIFE plans to independently commercialize its Physiocrine-based therapeutics.

LIFE’s scientists were the first to identify the Resokine pathway (reso for restoring skeletal muscle health and kine for activity related to cytokines), an extracellular pathway in human skeletal muscle tissue associated with activities arising from various Physiocrine regions of the histidine aminoacyl tRNA synthetase, or HARS.

LIFE believes that the Resokine pathway, among its various activities, modulates the immune system to promote tissue homeostasis. LIFE believes the Resokine pathway may play an important role in muscle and lung health.

Certain patients with antisynthetase syndrome, a rare auto-immune disease, have antibodies to HARS, which are known as Jo-1 antibodies.

These Jo-1 antibody patients often develop two significant clinical manifestations, skeletal inflammatory myopathy and interstitial lung disease, or ILD. LIFE believes that the binding of Jo-1 antibodies, particularly to the immuno-modulatory domain of HARS, or iMod domain, blocks HARS immuno-modulatory functions and results in the muscle and lung disease in these Jo-1 antibody patients.

aTYR PHARMA (LIFE) Intellectual property

LIFE’s Resolaris patent portfolio is comprised of a number of patent families and includes U.S. Patent No. 8,835,387 covering Resolaris, which issued on September 16, 2014 and is predicted to expire in 2033.

This patent family is jointly owned by LIFE and Pangu Biopharma. Patent applications in the same family as U.S. Patent No. 8,835,387 are pending in a variety of worldwide jurisdictions, including the United States, Australia, Brazil, Canada, China, Europe, India, Japan, Korea, Mexico, New Zealand, Russia and South Africa.

The Resolaris patent portfolio also encompasses additional issued patents and pending patent applications that cover Resolaris and related proteins; these patents and patent applications are wholly owned by us.

This second patent family includes Australian Patent No. 2010327926, which issued August 21, 2014, and related applications that are pending in the United States, Australia, Canada, Europe, China, Japan, and Hong Kong.

Patents that issue from these applications, if any, are expected to expire in 2030. Also included with the Resolaris patent portfolio are pending patent applications to specific methods of use of Resolaris and related proteins, and disease polymorphisms of HARS.

These applications have been filed in the United States as U.S. provisional applications and in some cases under the Patent Cooperation Treaty, or PCT. U.S. provisional applications may be used to establish non-provisional U.S. applications, PCT applications and other national filings worldwide. PCT applications are eligible for filing in most worldwide jurisdictions, including the United States. If issued, these patents are predicted to expire between 2033 and 2034.

LIFE’s iMod.Fc patent portfolio, which covers derivatives of Resokine, including the iMod domain, related splice variants, and next-generation product forms with modified therapeutic activity or pharmacokinetic characteristics, is comprised of a number of patent families and includes U.S. Patent No. 8,404,242, and U.S. Patent No 8,753,638, which issued on March 26, 2013 and June 17, 2014, respectively, and are expected to expire in 2031 and 2030.

This patent family is jointly owned by LIFE and Pangu Biopharma, and includes pending applications in United States, Australia, Canada, Europe, China, Japan, and Hong Kong.

The iMod.Fc patent family also includes patent applications filed on related splice variants of HARS. This patent family includes applications that are pending in the United States, Australia, Canada, Europe, China, India, Japan, Korea, New Zealand, Russia and Hong Kong.

This patent family is jointly owned by us, and LIFE’s subsidiary Pangu Biopharma. Also included within the iMod.Fc patent portfolio are pending applications to specific product forms of iMod.Fc, Resolaris and other HARS splice variants which include patent families to Fc fusion proteins, pegylated forms and variants with substituted D amino acids.

These applications have been filed in the United States as U.S. provisional applications and in some cases under the PCT. If issued, these patents are predicted to expire between 2033 and 2034.

LIFE’s pipeline of Physiocrines is covered by a series of 21 patent families, which covers all 20 human cytosolic tRNA synthetases. These cases are jointly owned by LIFE and Pangu Biopharma, and include pending applications in the United States, Australia, Canada, India, Europe, China and Japan.

Patents that issue from these applications, if any, would be expected to expire in 2031. Additional patent applications have also been separately filed on GARS (Glycyl-tRNA synthetase), DARS (Aspartyl-tRNA synthetase), YARS (tyrosyl-tRNA synthetase), and other tRNA synthetases, and any patents issuing from these patent applications would be expected to expire between 2026 and 2030. LIFE has also exclusively in-licensed from TSRI patents and patent applications related to YARS and specific monomeric forms of tRNA synthetases.

The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which LIFE files, the patent term is generally 20 years from the earliest date of filing the non-provisional patent application from which the patent issued.

aTYR PHARMA (LIFE) Competition

In the area of RMICs, LIFE expects to face competition from a number of companies, academic institutions and other organizations, including Akashi Therapeutics, Inc., BioMarin Pharmaceutical Inc., Catabasis Pharmaceuticals, Inc., FibroGen Inc., F. Hoffmann-La Roche AG, Milo Biotechnology, LLC., Nobelpharma Co.Ltd., Novartis AG, Pfizer, Inc., PTC Therapeutics, Inc., Sarepta Therapeutics, Inc. and Ultragenyx Pharmaceuticals, that are engaged in the clinical development of therapeutics to address muscle loss and muscle weakness in a variety of indications.

More specifically, while there are currently no approved products for the treatment of FSHD, Acceleron Pharma Inc. is developing a clinical candidate, ACE-083, a locally acting protein therapeutic designed to increase muscle mass and strength in patients with neuromuscular disorders and other diseases characterized by a loss of muscle function, including FSHD.

In addition, Facio Therapies recently announced its plans to screen chemical libraries to identify chemical compounds that will boost the expression of proteins known to repress one of the causal genes responsible for FSHD.

In the area of LGMD, LIFE is aware of a number of academic institutions engaged in the clinical development of therapeutics, including Genethon, a not-for-profit research laboratory created by the Association Française contre les Myopathies, or French Muscular Dystrophy Association, which has completed an experimental Phase 1 clinical trial in LGMD 2C using gene therapy; Nationwide Children’s Hospital, which is currently conducting a Phase 1/2a clinical trial of an AAV vector to transport the alpha-sarcoglycan gene into muscles in in LGMD 2D; and NeuroGen Brain and Spine Institute in India, which is currently conducting a Phase 1 clinical trial in an unspecified form of LGMD using stem cell therapy.

In the area of RPICs, including ILD, LIFE expects to face competition from pirfenidone, which is marketed by several companies worldwide, including InterMune Inc. (acquired by F. Hoffmann-La Roche AG Roche), Shionogi Ltd. and GNI Group Ltd., as well as nintedanib, a small molecule tyrosine-kinase inhibitor marketed by Boehringer Ingelheim, both of which were approved by the FDA in October 2014.

LIFE is also aware of a number of companies engaged in the clinical development of therapeutics for lung diseases, including Astra Zeneca plc., Biogen Inc., Bristol-Myers Squibb, FibroGen Inc., Gilead Sciences Inc., Promedior, Inc. and Sanofi S. A.

aTYR PHARMA (LIFE) 5% Shareholders Pre-IPO

CHP II, L.P.       10.16%

Entities affiliated with Polaris Venture Management Co. V, LLC    10.56%

Entities affiliated with Alta Partners Management VIII, LLC           10.27%

Entities affiliated with Domain Partners VIII, L.P.             10.52%

Entities affiliated with FMR LLC 13.56%

Sofinnova Venture Partners IX, L.P.       8.93%

Entities affiliated with Baker Brothers

Life Sciences, L.P.        8.93%

James C. Blair, Ph.D.    10.59%

John K. Clarke 10.76%

Srinivas Akkaraju, M.D., Ph.D.   8.93%

Amir H. Nashat, Sc.D.   10.63%

aTYR PHARMA (LIFE) Dividends

No dividends are planned.

aTYR PHARMA (LIFE) IPO Use of Proceeds

LIFE expects to receive $66 million from its IPO and use it for the following:

$11.0 million to fund its ongoing Phase 1b/2 clinical trial of Resolaris in adult patients with FSHD through completion of the third cohort and the initiation of up to two additional cohorts, and to conduct additional studies to evaluate the safety, tolerability and extended treatment of FSHD;

$16.1 million to fund portions of additional Phase 1b/2 clinical trials of Resolaris in early onset FSHD, LGMD and an additional indication, such as ILD;

$7.9 million to fund the initiation of potential Phase 3 or pivotal clinical trials of Resolaris in adult patients with FSHD;

$15.8 million to advance other research, discovery and development activities; and

the remainder for working capital and other general corporate purposes, including funding the costs of operating as a public company.

 

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Companies

Symbol Name Price Change % Volume
LIFE aTyr Pharma Inc. 3.05 -0.05 -1.61 82,369

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