Bellicum Pharmaceuticals (BLCM) is a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including both hematological cancers and solid tumors, as well as orphan inherited blood disorders. It is based in Houston, TX.

Three other companies are scheduled for the week of Dec. 15, 2014. The full IPO calendar is available at IPOpremium.

Manager, Joint-managers: Jefferies, Citigroup, and Piper Jaffray

Co-managers: Trout Capital

BLCM scheduled a $100 million IPO with a market capitalization of $397 million at a price range midpoint of $16 for Thursday, Dec. 18, 2014 on Nasdaq. SEC Documents

Bellicum Pharmaceuticals IPO Overview

BLCM is a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including both hematological cancers and solid tumors, as well as orphan inherited blood disorders.

Bellicum Pharmaceuticals IPO Valuation

Glossary

Valuation Ratios

Mrkt Cap (mm)

Price /Sls

Price /Erngs

Price /BkVlue

Price /TanBV

% offered in IPO

annualizing Sept 9 mos

         

Bellicum Pharmaceuticals (BLCM)

$397

175.1

-30.7

2.8

2.8

25%

             

Bellicum Pharmaceuticals IPO Conclusion

Positive

Cellular immunotherapy for cancer

In Phase 1/2 clinical trials

Shareholders may purchase up to $40mm, 40% of the IPO

2.8 price-to-book, lower end of 'usual' range

P/Eof -31, indicating 'moderate' cash burn rate relative to market cap

Bellicum Pharmaceuticals Business

BLCM is a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including both hematological cancers and solid tumors, as well as orphan inherited blood disorders.

Bellicum Pharmaceuticals Product candidates

BPX-501. BLCM is developing a CaspaCIDe product candidate, BPX-501, as an adjunct T-cell therapy administered after allogeneic HSCT, using donor stem cells. BPX-501 is designed to decrease the risk of including T cells with the transplant by enabling the elimination of donor T cells through the triggering of the CaspaCIDe safety switch upon emergence of GvHD. BPX-501 is currently being evaluated in multiple Phase 1/2 clinical trials in the United States and Europe, with the first top-line data expected in the second half of 2015.

BPX-201. BLCM is developing a DeCIDe product candidate, BPX-201, as a dendritic cell cancer vaccine made from the patient’s own white blood cells, designed to treat mCRPC. It targets the prostate specific membrane antigen, or PSMA, and uses our DeCIDe activation switch technology. BPX-201 is currently being evaluated in an 18-patient Phase 1 clinical trial for mCRPC. BLCM is evaluating opportunities for BPX-201 in combination with other cancer immunotherapies, such as checkpoint inhibitors.

In addition, BLCM's preclinical product candidates are designed to overcome the current limitations of CAR-T and TCR therapies and include the following:

 BPX-401. BLCN is developing a CIDeCAR product candidate, BPX-401, as a next-generation CAR T cell therapy for hematological cancers that express the CD19 antigen.

BPX-601. BLCM is developing a GoCAR-T product candidate, BPX-601, for solid tumors overexpressing PSCA, such as some prostate, pancreatic, bladder, esophageal and gastric cancers.

BPX-701. BLCM is developing a CaspaCIDe TCR product candidate, BPX-701, in collaboration with Leiden University Medical Center, initially for the treatment of PRAME-expressing melanoma, sarcomas and neuroblastoma.

BLCM expects to file INDs for BPX-701 in the second half of 2015 and for BPX-401 and BPX-601 in 2016.

BLCM's IND-enabling activities for each of these preclinical product candidates include manufacturing key components and developing a robust process to produce cell products that comply with regulations of the FDA, and other regulatory agencies. BLCM has developed an efficient and scalable process to manufacture genetically modified T cells of high quality and purity.

This process is being implemented by BLCM's third-party contract manufacturers to produce BPX-501 for BLCM's clinical trials.

Bellicum Pharmaceuticals Grant Revenues

Grant revenues were $1.1 million and $1.8 million for the nine months ended September 30, 2013 and 2014, respectively.

The increase in grant revenues is primarily due to additional costs associated with the grant from CPRIT due to patient enrollment which began in August 2013. The increase is also due to the addition of the grant from the NIH. Funds were awarded in April 2013 and April 2014.

Cellular immunotherapy

Cellular immunotherapy has the potential to transform medicine by harnessing immune cells, principally T cells, to attack and eliminate harmful diseased cells in the body.

Unlike traditional small molecule and biologic therapies which are predictably metabolized and eliminated from the body, cellular immunotherapies are unpredictable and uncontrollable.

Chemical Induction of Dimerization

BLCM is using its proprietary Chemical Induction of Dimerization, or CID, technology platform to engineer and then control components of the immune system in real time. By incorporating BLCM’s CID platform, BLCM’s product candidates may offer better safety and efficacy outcomes than are seen with current cellular immunotherapies.

BLCM is developing next-generation product candidates in some of the most important areas of cellular immunotherapy, including hematopoietic stem cell transplantation, or HSCT, CAR T cell therapy, and dendritic cell vaccines.

HSCT, also known as bone marrow transplantation, has for decades been curative for many patients with hematological cancers or orphan inherited blood disorders.

However, application of HSCT is limited by graft-versus-host-disease, or GvHD, a condition in which the transplanted immune cells recognize the host cells as foreign and attack them.

Since the transplanted cells can persist indefinitely, GvHD does not resolve by itself and is a major cause of transplant-related morbidity and mortality.

CAR T cell therapy

CAR T cell therapy is an innovative approach in which a patient’s T cells are genetically modified to carry chimeric antigen receptors, or CARs, which redirect the T cells against cancer cells.

While high objective response rates have been reported in some hematological malignancies, serious and sometimes fatal toxicities have arisen in patients treated with CAR T cell therapies.

These toxicities include instances in which the CAR T cells have caused high levels of cytokines due to over-activation, referred to as “cytokine release syndrome”, frequent transient neurologic toxicities and cases in which they have attacked healthy organs instead of the targeted tumor, leading to death.

In solid tumors, where the behavior of CAR T cells is particularly unpredictable and results have been inconsistent, researchers are developing enhanced CAR T cell approaches called “armored CARs” that raise even greater safety concerns.

Lastly, despite the integral role that dendritic cells, specialized cells that are key regulators of the immune system that process and present antigens on the cell surface to T cells in order to activate the T cells, play in the immune system, they are difficult to activate appropriately and as a result their use has delivered only modest therapeutic benefit.

Bellicum Pharmaceuticals Intellectual property

To its knowledge, BLCM’s patent estate, on a worldwide basis, includes 74 issued patents (18 of which are in the United States) and 45 pending patent applications (20 of which are in the United States) which BLCM owns or for which BLCM has an exclusive (either in its entirety or within its field of use) commercial license as of November 14, 2014.

Bellicum Pharmaceuticals Competition

While BLCM believes that its proprietary CID platform, differentiated product candidates and scientific expertise in the field of cellular immunotherapy provide us with competitive advantages, BLCM faces potential competition from various sources, including larger and better-funded pharmaceutical, specialty pharmaceutical and biotechnology companies, as well as from academic institutions, governmental agencies and public and private research institutions.

BLCM’s lead product candidate, BPX-501, is an adjunct therapy for HSCT with alternative donors that potentially improves stem cell engraftment, accelerates host immune system recovery and treats GvHD.

The current standard-of-care that addresses some of the safety challenges associated with HSCT, primarily GvHD, is high-dose steroids.

BLCM is aware of other companies that are developing product candidates to improve the outcome of HSCT, including Kiadis Pharma Netherlands B.V. and Molecular Medicine S.p.A.

T-cell based treatments for cancer, such as CAR-T and TCR therapies, have recently been an area of significant research and development by academic institutions and biopharmaceutical companies.

BPX-401, BPX-601 and BPX-701 based on BLCM’s CIDeCAR and Go-CART technologies will compete with product candidates from a number of companies that are currently focused on this therapeutic modality, including Adaptimmune Limited, bluebird bio, Inc., Celgene Corporation, Cellectis SA, GlaxoSmithKline plc, Intrexon Corporation, Juno Therapeutics, Inc., Kite Pharma, Inc., Novartis AG and Pfizer Inc.

BPX-201 based on BLCM’s DeCIDe technology is a dendritic cell-based cancer vaccine for the treatment of metastatic prostate cancer and other solid tumors.

PROVENGE®, marketed by Dendreon Corporation, is the first approved cancer vaccine for the treatment of mCRPC. BLCM is aware of other companies focused on developing cancer vaccines, including Advaxis, Inc., Argos Therapeutics, Inc., Biovest International, Inc., ImmunoCellular Therapeutics, Ltd., Immune Design, Inc., Inovio Pharmaceuticals, Inc., Intrexon Corporation and Northwest Biotherapeutics, Inc.

Bellicum Pharmaceuticals 5% shareholders pre-IPO

Baker Biotech Capital, L.P.        19.4%

McGuyer Investments Ltd.         14.7%

Remeditex Ventures LLC            12.1%

Kevin Slawin, M.D.        10.9%

AVG Ventures, LP         6.1%

RA Capital Healthcare Fund, LP             5.4%    

Kevin M. Slawin, M.D.  10.9%

Bellicum Pharmaceuticals Dividends

No dividends are planned.

Bellicum Pharmaceuticals Use of proceeds

BLCM expects to receive $90 million from its IPO and use it for the following:

$21.0 million to fund its ongoing and planned Phase 1/2 clinical trials of BPX-501;

$30.0 million to fund pre-clinical studies for BPX-401, BPX-601 and BPX-701 and fund the Phase 1/2 clinical trial of BPX-401, partially fund the planned Phase 1/2 clinical trial of BPX-601 and fund the Phase 1/2 clinical trial of BPX-701 as well as preclinical development of its other CAR T and TCR programs;

$4.0 million to fund its ongoing Phase 1/2 clinical trial and its planned Phase 1/2 clinical trial of BPX-201 in combination with checkpoint inhibitors;

$11.0 million to fund the construction of tenant improvements and the purchase of capital equipment at its Houston facility, to accommodate its anticipated personnel needs for the next three years and to support its planned in-house new product discovery and development, as well as process development and manufacturing for U.S. clinical trials of planned product candidates or certain critical components thereof; and

the remainder to fund other working capital purposes, including general operating expenses.