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IPO Report: BIND Therapeutics (BIND)

By  +Follow September 19, 2013 2:04PM
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BIND Therapeutics ($BIND) is a nanomedicine platform company with major collalaboration partners, and is initially focused on oncology (cancer).  Collaboration partners announced to date in 2013: Amgen (AMGN) market cap of $79 billion; Pfizer (PFE) , market cap of $291 billion; and AstraZeneca (AZN) , market cap of $62 billion.

BIND id one of nine IPOs are scheduled for this week, 12 for next week. The full IPO calendar can be found at IPOpremium

BIND is based in Cambridge, MA, and scheduled a $100 million IPO with a market capitalization of $413 million at a price range mid-point of $15 milliion, Friday, September 20, 2013.

The S-1 was filed September 9, 2013.   Manager, Joint Managers: Credit Suisse; Cowen.  Co-Managers: Stifel; JMP Securities

Summary

Collaboration objectives: to develop Accurins based on therapeutic payloads from their product pipelines, with the potential to achieve a total of over $1 billion in upfront and future milestone payments, including over $450 million in pre-commercial milestones.

Valuation

Accumulated deficit: $82.5 million, which is relatively low for a biopharma with stage 2 trials and a very good slate of collaboration partners. The price-to-book ratio is 3.3, which is very competitive.

Valuation Ratios

Mrkt

Price /

Price /

Price /

Price /

% offered

annualizing Q2 '13

Cap (MM)

Sls

Erngs

BkVlue

TanBV

in IPO

BIND Therapeutics (BIND)

$237

n/a

-9.9

3.3

3.3

30%

             

Glossary

Conclusion

Buy BIND on the IPO.

Business

BIND is a clinical-stage nanomedicine platform company developing Accurins, novel targeted and programmable therapeutics.

Accurins are designed with specified physical and chemical characteristics to target specific cells or tissues and concentrate a therapeutic payload at the site of disease to enhance efficacy while minimizing adverse effects on healthy tissues.

BIND's strategy is to leverage its medicinal nanoengineering platform to develop its own pipeline of Accurins, initially in oncology, as well as Accurins in collaboration with biopharmaceutical companies.

The lead drug candidate, BIND-014, is in Phase 2 clinical trials for non-small cell lung cancer, or NSCLC, and metastatic castrate-resistant prostate cancer, or mCRPC.

Accurins

BIND believes Accurins represent the next stage in the evolution of cancer therapy. Accurins are nanoparticles containing a therapeutic payload and are designed to target tumors at three levels: tissue, cellular and molecular. They combine this triple targeting with a prolonged circulation time to concentrate the therapeutic payload at the targeted disease site, where it is then released in a controlled and timely manner.

Accurins have the potential to significantly increase the net clinical benefit of the therapeutic payload and result in efficacy and safety not currently achievable through other therapeutic approaches.

Accurin graphic
http://gaskinsco.com/accurin.png

Lead product candidate

BIND's lead Accurin drug candidate, BIND-014, is a prostate-specific membrane antigen, or PSMA, targeted Accurin that contains docetaxel. PSMA is a clinically-validated tumor marker expressed on prostate cancer cells and the blood vessels of many types of non-prostate solid tumors, including NSCLC. Docetaxel, marketed as Taxotere, is one of the most commonly used cancer chemotherapy drugs. It is approved by the U.S. Food and Drug Administration, or FDA, for the treatment of breast cancer, NSCLC, mCRPC, head and neck cancer, and gastric cancer.

Taxotere achieved global sales of approximately $3 billion in 2009, the year prior to its loss of marketing exclusivity in the United States, and generic docetaxel continues to be a mainstay in cancer treatment despite its significant side effects. These side effects include neutropenia, anemia, infection, fluid retention and edema, neuropathy, rash, mucositis, fatigue, muscle weakness, nail loss, hair loss and even death.

Clinical trials

In preclinical studies, BIND-014 demonstrated that its ability to destroy tumor cells is differentiated from, and superior to, Taxotere

BIND is in Phase 2 clinical trials to evaluate the level of clinical activity of BIND-014 in NSCLC and mCRPC and expect to report data from these studies in the second half of 2014.

To date, BIND has clinically tested BIND-014 in over 45 patients with advanced or metastatic cancer who failed prior therapies.

In the Phase 1 clinical trial, of the 28 patients who received BIND-014 once every three weeks, to date there has been one complete response in a patient with cervical cancer and three partial responses in patients with NSCLC, mCRPC and ampullary cancer.

A complete response generally refers to the disappearance of all signs of cancer in response to treatment, while a partial response generally refers to a decrease in the size of the tumor or in the extent of cancer in the body.

Five additional patients had stable disease lasting longer than 12 weeks.

Management team

BIND's management team has extensive experience in the development, regulatory approval and commercialization of nanotechnology drugs. Currently, the two leading nanotechnology cancer drugs are Doxil, a liposomal doxorubicin, and Abraxane, an albumin nanoparticle paclitaxel.

BIND's chief executive officer was the president and chief operating officer of SEQUUS Pharmaceuticals, Inc., the company that developed and commercialized Doxil. Both BIND's chief medical officer and BIND's head of regulatory affairs served in those roles at Abraxis Bioscience, Inc., the company that developed Abraxane.

Platform development

BIND's platform originated from the pioneering nanotechnology research at the Massachusetts Institute of Technology and Brigham and Women's Hospital/Harvard Medical School of BIND's scientific founders and directors Dr. Robert Langer and Dr. Omid Farokhzad. BIND's scientists and engineers continue to advance this technology to produce the next generation of targeted nanomedicines.

Intellectual property

BIND protects its medicinal engineering platform through 16 issued U.S. patents and 50 U.S. patent applications, in some cases with foreign counterparts relating to elements of Accurin candidates.

Competition

Current second-line treatments for non-small cell lung cancer (NSCLC) include docetaxel and other chemotherapy agents such as gemcitabine and vinorelbine, as well as molecularly-targeted therapies such as erlotinib and gefitinib, which are used to treat patients with mutations in epidermal growth factor receptor, or EGFR, and crizotinib, which is used in the small subset of patients that have a mutation in anaplastic lymphoma kinase, or ALK.

In addition, two monoclonal antibodies, Bristol-Myers Squibb's nivolumab that targets PD-1, and F. Hoffmann-La Roche Ltd's MPDL3280A that targets PD-L1, are currently in Phase 2 clinical trials for NSCLC. Both are immunomodulators that block the activation of programmed cell death receptor. In mCRPC, in addition to first-line chemotherapy agents such as docetaxel, the treatment paradigm is evolving to include use of hormonal therapies such as abiraterone and enzalutamide prior to the administration of chemotherapies, which therapies are currently mainly used in the post-chemotherapy setting.

Other similar drugs are also being developed. Cabazitaxel (marketed as Jevtana), a second-line taxane chemotherapeutic, is also being tested in clinical studies against docetaxel for efficacy in metastatic castrate-resistant prostate cancer (mCRPC).

In addition, other companies are developing therapies targeting prostate-specific membrane antigen (PSMA) to treat mCRPC, including an antibody-drug conjugate, or ADC, by Progenics Pharmaceuticals, Inc. and a Bispecific T Cell Engager, or BITE, antibody by Bayer Healthcare in collaboration with Amgen.

BIND also faces competition from numerous companies utilizing other nanomedicine platforms to develop targeted therapies, including platforms focused on albumin nanoparticles, liposomes and polymeric nanoparticles.

5% stockholders pre-IO

Entities affiliated with Polaris Venture Partners V, L.P., 18%
Flagship Ventures Fund 2004, L.P., 13.9%
RUSNANO, 11.5%
DHK Investments, LLC, 8.6%
ARCH Venture Fund VII, L.P., 8.5%
NanoDimension, L.P. , 6%

Financing history

Since inception and through March 31, 2013, BIND raised an aggregate of $94.7 million to fund operations, of which $6.5 million was through collaborations and license agreements, $76.2 million was from the sale of preferred stock and convertible debt securities, $4.8 million was from government grants and $7.2 million was from borrowings under an original credit facility as well as capital leases.

As of March 31, 2013, cash and cash equivalents were $11.9 million, of which $3.4 million was held by BIND's Russian subsidiary designated solely for use in its operations. As of March 31, 2013, BIND also had $1.4 million in restricted cash held in the Russian subsidiary.

In addition, in June 2013 BIND issued and sold additional shares of Series D preferred stock to existing investors for $8.7 million in gross proceeds and borrowed $4.5 million under an amended and restated credit facility with Hercules Technology III, L.P., or Hercules, of which $2.3 million was used to repay the outstanding principal balance under the original facility.

Use of proceeds

BIND expects to net $63 million from its IPO. Proceeds are allocated to fund development of BIND-014, and for working capital and general corporate purposes.

BIND believes that the net proceeds from the IPO, together with cash and cash equivalents as of March 31, 2013, borrowings available under the credit facility and research and development funding that BIND expects to receive under existing collaborations, excluding any potential milestone payments, will fund operating expenses and capital expenditure requirements through at least mid-2015.

BIND expects the funding will enable the company to complete its ongoing Phase 2 clinical trials of BIND-014 in NSCLC and mCRPC and, if such trials are successful, to initiate pivotal Phase 3 trials in these indications.

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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By  +Follow September 19, 2013 2:04PM
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