Microsoft word - sngx_scir.doc

November 12, 2013
Grant Zeng, CFA
Small-Cap Research
312-265-9466
[email protected]
scr.zacks.com
111 North Canal Street, Chicago, IL 60606
Soligenix Inc.
(SNGX-OTCBB)
SNGX: On track to advance multiple clinical
SNGX is a development stage biopharmaceutical programs, Balance sheet remains strong--- company focused on cancer supportive care, GI disorders and biodefense. Based on three platform technologies, SNGX has built a diversified pipeline targeting multiple indications. We are optimistic about its lead candidate SGX942 for the treatment of Current Recommendation
Outperform
oral mucositis. SGX942 will enter into Phase II studies soon serving as a major short term catalyst. The Company s oral BDP is in various development stages for a variety of indications, most notably, in pediatric Crohn s disease, where they will be initiating a Phase II/III study in 4Q13. SNGX also is Twelve- Month Target Price
developing vaccines using its ThermoVax technology for biodefense. Valuation is attractive at this time based on the SUMMARY DATA
fundamentals. We rate the shares Outperform. 52-Week High
Risk Level
52-Week Low
Type of Stock
Small-Growth
One-Year Return (%)
Industry
Med-Biomed/Gene
Zacks Rank in Industry
Average Daily Volume (sh)
ZACKS ESTIMATES
Shares Outstanding (mil)
Market Capitalization ($mil)
Revenue
(in millions of $)
Short Interest Ratio (days)
Institutional Ownership (%)
Insider Ownership (%)
Annual Cash Dividend
Dividend Yield (%)
5-Yr. Historical Growth Rates
Sales (%)
Earnings per Share
Earnings Per Share (%)
(EPS is operating earnings before non recurring items) Dividend (%)
P/E using TTM EPS
P/E using 2013 Estimate
P/E using 2014 Estimate
Zacks Projected EPS Growth Rate - Next 5 Years % Zacks Rank
Copyright 2013, Zacks Investment Research. All Rights Reserved. WHAT S NEW
Soligenix Reports Third Quarter 2013 Financial Results With Strong Balance Sheet
On Nov. 12, 2013, Soligenix, Inc. (SNGX) announced its financial results for the third quarter ended September 30, 2013. Grant revenue for the third quarter 2013 were $0.3 million as compared to $0.9 million for the quarter ended September 30, 2012. Revenues decreased by $0.6 million primarily related to the timing of reimbursable costs from the Company's ThermoVax Research and development expenses were $1.2 million as compared to $0.4 million and $4.1 million as compared to $1.7 million for the quarter and nine months ended September 30, 2013 and 2012, respectively. Included in the nine months expenses is a $1.5 million non-cash charge related to the collaboration with Intrexon. General and administrative expenses were $0.7 million as compared to $0.6 million and $1.9 million as compared to $1.8 million for the quarter and nine months ended September 30, 2013 and 2012, respectively. For the quarter ended September 30, 2013, other net income/expense includes a $4.7 million, or $0.25 per share, non-cash charge related to the change in fair value of the liability for warrants issued in the Company's June 25, 2013 registered public offering. GAAP net loss for 3Q13 was $6.6 million, or $0.34 per share, as compared to $0.8 million, or $0.07 per share for 3Q12. Included in the net loss for the quarter ended September 30, 2013 is a non-cash charge of $4.7 million due to the change in fair value of the liability related to warrants issued in the Company's June 25, 2013 registered public offering. Excluding the $4.7 million non-cash charge, net loss was $1.9 million ($0.10 per share) for the 3Q13 compared to net loss of $0.8 million ($0.07 per share) in 3Q12. As of September 30, 2013, the Company's cash position was $6.6 million, which remains strong. . Current cash balance, along with potential grant revenue, will last through the end of 2014 according to
our financial model. The strengthened cash runway allows the Company to initiate a Phase II clinical
study in oral mucositis as well as a Phase II/III study in pediatric Crohn's disease by the end of this year.
Soligenix also remains active and opportunistic in pursuing non-dilutive capital through government grants and contracts. Most notably, the company was awarded two contracts from the US government in September 2013 to support the development of OrbeShield for the treatment of gastrointestinal acute A Huge Win for Soligenix with Two Contracts within One Week
On September 19, 2013, Soligenix announced that it had been awarded a contract valued at up to $26.3
million by the US Department of Health and Human Service s Biomedical Advanced Research and
Development Authority (BARDA). The contract is awarded for the advanced preclinical and
manufacturing development of OrbeShield
(oral beclomethasone 17,21-dipropionate or oral BDP) as a biodefense medical countermeasures (MCMs) for the treatment of gastrointestinal acute radiation syndrome (GI ARS). Zacks Investment Research Page 2 scr.zacks.com
The potential five year contract contains a two year base period, with two contract options that would extend the contract an additional three years. According to management, funding for the two year base period is slightly over $10 million, with potential $5 million for each year for three years following the base period as long as the program meets targeted milestones. Then, on Sept. 25, 2013, Soligenix announced that it had been awarded a contract valued at up to $6.4
million by the US Department of Health and Human Service's National Institutes of Health (NIH)
(specifically funded by the National Institute of Allergy and Infectious Diseases or NIAID).
The NIAID contract is awarded for the advanced preclinical development of OrbeShield beclomethasone 17,21-dipropionate or oral BDP) as a biodefense medical countermeasure (MCM) for the treatment of gastrointestinal acute radiation syndrome (GI ARS). This is a contract for three years which contains a one year base period, with two contract options that would extend the contract an additional year each. The total award will support the development activities necessary to evaluate OrbeShield Both contracts are awarded for the advanced preclinical and manufacturing development of OrbeShield as a biodefense medical countermeasures (MCMs) for the treatment of gastrointestinal These two contracts are a huge win for Soligenix in our view. It not only provides non-dilutive funding for the development of the OrbeShield program for GI ARS, but more importantly validates the technology the company has developed over the years related to OrbeShield. Securing a highly competitive government contract provides important recognition as to the innovative quality and potential therapeutic impact of OrbeShield. OrbeShield Advantages
OrbeShield
is an oral immediate and delayed release BDP formulation that is being developed for the treatment of GI ARS (gastrointestinal acute radiation syndrome). OrbeShield in GI ARS has FDA Fast
Track and Orphan Drug designations.
The GI tract is highly sensitive to ionizing radiation and the destruction of epithelial tissue is one of the
first effects of radiation exposure. The rapid loss of epithelial cells leads to inflammation and infection that
are often the primary cause of death in acute radiation injury. This is the same type of toxicity that occurs
in Soligenix s acute radiation enteritis clinical program with SGX201. As a result, there is a dual avenue
of development for Soligenix, and OrbeShield
is potentially a dual use compound, a desirable characteristic which is a specific priority of Biomedical Advanced Research and Development Authority (BARDA) for ARS and other medical countermeasure indications. In preclinical studies, OrbeShield
has demonstrated positive results in a canine GI ARS model which indicate that dogs treated with OrbeShield demonstrated statistically significant (p=0.04) improvement in survival with dosing at either 2 hours or 24 hours after exposure to lethal doses of total body irradiation (TBI) when compared to control dogs. The median survival was 100 days (p=0.04) when canines were treated 2 hours post exposure, 87 days (p=0.048) when canines were treated 24 hours post exposure. OrbeShield appears to significantly mitigate the damage to the GI epithelium caused by Soligenix plans to conduct a follow-on replication dog study in 1H14 with results available also in
1H14. The FDA has cleared the IND application for OrbeShield
OrbeShield has other advantages beyond the efficacy seen in the canine model to date: Zacks Investment Research Page 3 scr.zacks.com
OrbeShield is an oral formulation, as opposed to injectable like many of the other biodefense vaccines and therapeutics; therefore, if a catastrophic event was to occur, the general population could dose themselves without the need for medical personnel to administer; OrbeShield has demonstrated excellent safety profile in about 350 human subjects with the company s oral BDP formulation; cGMP Manufacturing process already at large commercial scale to produce sufficient quantities of OrbeShield, as needed. Furthermore, Soligenix s OrbeShield is being developed under specific FDA regulatory guidelines called
the Animal Rule. The Animal Rule provides that under certain circumstances, where it is unethical or
not feasible to conduct human efficacy studies, the FDA may grant marketing approval based on
adequate and well-controlled animal studies when the results of those studies establish that the drug is
reasonably likely to produce clinical benefit in humans. Demonstration of the product's safety in humans
is still required.
We think the Animal Rule means a lot for Soligenix, because this can accelerate the development of OrbeShield and other vaccines. Once approved by the FDA, Soligenix will have the opportunity to negotiate a stock-pile contract with the US government. These stock-pile or procurement contracts have been very lucrative for other companies supplying similar drugs to the US government. Soligenix is on track to advance SGX203 for pediatric Crohn s disease
Phase I Clinical Study with SGX203 for the Treatment of Pediatric Crohn's Disease has been
completed
On June 28, 2013, Soligenix (SNGX) announced that it has enrolled and treated all patients in the Phase
I Study BDP-PCD-01; the first clinical study for development of SGX203 (oral beclomethasone 17,21-
dipropionate or oral BDP) for the treatment of pediatric Crohn's disease.
SGX203 has received Fast Track and Orphan Drug designations from the US FDA for the treatment of pediatric Crohn's disease. As a reminder, Soligenix initiated the Phase I clinical study on May 15, 2013. The objective of the
Phase I study BDP-PCD-01 is to determine the pharmacokinetic (PK) and pharmacodynamic (PD) profile
of SGX203 in healthy young male and female adolescents and adults.
This study enrolled 24 subjects between the ages of 18-22, with all assessments completed in May 2013. Preliminary PK results indicate that the PK profile in this population is consistent with the profile established in previous studies in a broader population and supports a convenient twice a day dosing regimen. SGX203 administration (6 mg BDP twice daily over 7 days) was found to be safe and well-tolerated. The study in healthy male and female adolescents and young adults provided important complementary data to that previously obtained, to enable the refinement of the PK model that is fundamental to the pediatric Crohn's disease development program. In addition, the study confirmed the safety profile observed in all previous clinical studies with oral BDP. Phase II/III trial is planned
Soligenix plans to start Phase II/III trial of SGX203 in 1H 2014. Primary endpoint data are expected in 1H
2015.
Zacks Investment Research Page 4 scr.zacks.com
The PK data generated from the Phase I study will be used to refine the PK model previously established with Dr. Jeffrey S. Barrett, PhD, FCP, from The Children's Hospital of Philadelphia. The refined model will provide the justification for limited PK sampling in the planned Phase II/III pediatric clinical study and will help inform the dose selection for the Phase III component of the study. There is currently no cure for Crohn's disease, and there is no one treatment that works for everyone.
Drug therapies usually include anti-inflammatory drugs, immune system suppressors and antibiotics.
There are currently no FDA approved corticosteroid therapies for pediatric Crohn's disease. 80% of
patients with Crohn s disease are treated with steroids off-label as first-line therapy, which may
suppress adrenal function and result in growth retardation. Remicade is the only approved product in
pediatric Crohn s disease in the US, which is used in 30% of patients within first year of diagnosis.
However, Remicade carries a black box warning for potential malignancy (T cell lymphoma). Two
biologics, Cimzia and Tysabri and one corticosteroid Entocort (budesonide) are on the market to treat
Crohn s disease in adult patients, and are currently in trials in pediatric patients.
SGX203 is designed to block inflammation of Crohn s disease throughout the GI tract and is positioned
as a corticosteroid option with less toxicity than the current standard systemic steroid therapy
prednisone.
We believe SGX203 has the potential to meet an important medical need in children with this serious illness. SGX942 For Oral Mucositis
Soligenix acquired SGX942 (formerly IMX942) in December 2012 from Inimex Pharmaceuticals of
Canada. Soligenix is developing SGX942 for the treatment of oral mucositis in head and neck cancer
patients following chemo- or radiation therapy.
SGX942 is a fully synthetic, 5-amino acid peptide with high aqueous solubility and stability. Extensive in
vivo preclinical studies have shown that SGX942 reduces tissue damage associated with
chemotherapy, radiation, trauma and inflammation. Although SGX942 is not directly antimicrobial, it
accelerates pathogen clearance and increases host survival in a broad spectrum of bacterial infections
including Gram positive and negative bacteria, and both drug sensitive and resistant strains, by directly
targeting the host innate immune system.
Soligenix has completed a double-blind, placebo-controlled Phase I clinical trial of SGX942 in 84 healthy
volunteers with both single ascending dose and multiple ascending dose components. SGX942 showed
a strong safety profile when administered IV over 7 days and was consistent with safety results seen in
pre-clinical studies. Drug clearance in humans is rapid and similar to results seen in pre-clinical studies.
Soligenix plans to start a Phase II proof-of-concept multi-center, double-blind, placebo-controlled trial in
approximately 75 patients in the 4Q 2013. This Phase II trial is designed to evaluate the efficacy of
SGX942 (research name for oral mucositis indication) in reduction of the severity of oral mucositis in
head and neck cancer patients undergoing fractionated radiation therapy and/or chemotherapy. The
cGMP manufacture of drug product to initiate the Phase II studies is complete. Results are expected to
be available in 2H14.
Market Opportunity For SGX942 Is Huge
Mucositis is a debilitating condition involving extensive ulceration of the oral cavity that frequently affects
cancer patients undergoing radiation and chemotherapy treatment. Roughly 90% of patients on radiation
(43% severe) and 40% of patients receiving chemotherapy get mucositis. There is an estimated 500,000
cancer patients getting mucositis annually in the United States alone. World-wide, the potential market for
mucositis will exceed $1 billion in the next few years.
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Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes. We believe any treatment that accelerates healing and/or diminishes the rate of appearance of mucositis would have a significant beneficial impact on the quality of life of these patients and may allow for more aggressive chemotherapy. The mechanisms of mucositis have been extensively studied and have been recently linked to the
interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection
of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation
triggered by therapy-induced cell death, rather than as the primary cause of the lesions. As a modulator
of the innate immune system, SGX942 has the potential to target both primary and secondary causes
of mucositis.
Oral mucositis is an area of unmet medical need where there are only limited treatment options. Ccurrently, no drug has been approved for oral mucositis in head and neck cancer. We noticed that there are a few products already on the market for oral mucositis. But the competitive landscape favors SGX942 in our view. Amgen s Kepivance (Palifermin) is the only approved drug for oral mucositis in transplantation; but is
contra-indicated for solid tumor patients. Kepivance is a recombinant form of human keratinocyte growth
factor (KGF), a protein that is naturally produced by the body. Kepivance is indicated to decrease the
incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving
myelotoxic therapy requiring hematopoietic stem cell support. The safety and efficacy of Kepivance have
not been established in patients with non-hematologic malignancies. Kepivance must be IV injected for 3
consecutive days before and 3 consecutive days after treatment for a total of 6 injections. Also,
Kepivance is expensive at about $10,000 per patient.
Access Pharma s MuGard is approved as a medical device and is dispensed in a ready to use mouth
rinse. MuGard is indicated for the management of oral mucositis/stomatitis that may be caused by
radiotherapy and/or chemotherapy.
Three other medical devices on the market are EKR Therapeutics Gelclair, GeoPharma s Mucotrol, and
EUSA Pharma s Caphosol. Gelclair is a prescription mouth gel that is designed and approved for the
management and relief of pain caused by mouth sores. Gelclair is established by mixing the powder in a
glass of water to form the rinse and patients gargle and spit out. Mucotrol is concentrated oral gel wafer
which is indicated for the management and relief of pain from oral lesions associated with oral
mucositis/stomatitis. Caphosol is similar to Gelclair. Patients must mix the contents of two ampoules to
form a rinse and then swish/spit out. These devices attempt to create a protective barrier around the oral
ulceration; however, none of these devices are biologically based.
Apparently, most of the above treatment options for mucositis only address the symptoms and do not address the cause of mucositis, while Soligenix s SGX942 has a new mechanism of action which can address both the primary and the secondary causes of mucositis. We believe that, if approved, SGX942 will command a significant market share of the mucositis market, which could reach $1 billion in the next few years. We believe SGX942 will have peak sales of $300 million and that the potential worldwide market for SGX942 is in excess of $500 million for all applications, including oral mucositis. Zacks Investment Research Page 6 scr.zacks.com
SGX201 for Preventing Acute Radiation Enteritis
SGX201 is a delayed-release formulation of BDP specifically designed for oral use and is designed to
block inflammatory component of radiation enteritis in GI tract of cancer patients receiving pelvic
radiation therapy.
Soligenix completed a 16-subject Phase I/II clinical trial testing SGX201 in prevention of acute radiation
enteritis. Patients with rectal cancer scheduled to undergo concurrent radiation and chemotherapy prior
to surgery were randomized to one of four dose groups. The objectives of the study were to evaluate the
safety and maximal tolerated dose of escalating doses of SGX201, as well as the preliminary efficacy of
SGX201 for prevention of signs and symptoms of acute radiation enteritis. The study demonstrated that
oral administration of SGX201 was safe and well tolerated across all four dose groups. There was also evidence of a potential dose response with respect to diarrhea, nausea and vomiting and the assessment of enteritis. In addition, the incidence of diarrhea was lower than that seen in recent published historical control data in this patient population. This program was supported in part by a $500,000 two-year Small Business Innovation and Research (SBIR) grant awarded by the National Institutes of Health (NIH). Soligenix plans to initiate a Phase II randomized, double-blind, placebo-controlled trial in 1H2014. Data
are expected in 1H2015, assuming continued financial support from NIH. The Company has received
Fast Track designation from the FDA for SGX201 for radiation enteritis. It s possible for continued
government funding for the Phase IIa trial.
External radiation therapy is used to treat most types of cancer. During delivery of treatment, some level
of radiation will also be delivered to healthy tissue, including the bowel, leading to acute and chronic
toxicities. The large and small bowels are very sensitive to radiation and the larger the dose of radiation
the greater the damage to normal bowel tissue. Radiation enteritis is a condition in which the lining of
the bowel becomes swollen and inflamed during or after radiation therapy to the abdomen, pelvis, or
rectum. Most tumors in the abdomen and pelvis need large doses, and almost all patients receiving
radiation to the abdomen, pelvis, or rectum will show signs of acute enteritis.
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Patients with acute enteritis may have nausea, vomiting, abdominal pain and bleeding, among other symptoms. Some patients may develop dehydration and require hospitalization. Symptoms will usually resolve within 2-6 weeks after therapy has ceased. Radiation enteritis is often not a self-limited illness, as over 80% of patients who receive abdominal radiation therapy complain of a persistent change in bowel habits. Moreover, acute radiation injury increases the risk of development of chronic radiation enteropathy, and overall 5% to 15% of the patients who receive abdominal or pelvic irradiation will develop chronic radiation enteritis. Based upon published studies and reports, there are over 100,000 patients annually in the U.S. and over 200,000 patients worldwide, who receive abdominal or pelvic external beam radiation treatment for cancer, and these patients are at risk of developing acute and chronic radiation enteritis. Currently there are no approved therapies for this indication. Based on current preclinical and Phase I/II clinical data, SGX201 has the potential to make a meaningful difference in this indication. orBec® for Treating Chronic GVHD
orBec ® is a two tablet delivery system of BDP specifically designed for oral use that allows for delivery
of immediate and delayed release BDP to treat the gastrointestinal manifestation of chronic GVHD, the
organ system where GVHD is most frequently encountered and highly problematic.
orBec® is intended to reduce the need for systemic immunosuppressive drugs such as prednisone to treat chronic GI GVHD. The active ingredient in orBec® is BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. orBec® has been awarded orphan drug designations in the U.S. and in Europe for the treatment of GI
GVHD. In September 2012, Soligenix received a $300,000 two-year SBIR grant awarded by the NIH to
support a Phase II study for the treatment of chronic GI GVHD. Soligenix plans to initiate a Phase II trial
in 4Q2013 with data expected in 2H14.
GVHD is a major complication of allogeneic hematopoietic cell transplantation. GVHD is an inflammatory disease initiated by T cells in the donor graft that recognize histocompatibility and other tissue antigens of the host, and is mediated by a variety of effector cells and inflammatory cytokines. GVHD presents in both acute and chronic forms. The symptoms of chronic GVHD typically present at between 100 days and three years post-transplant. Chronic GVHD has features resembling autoimmune and other immunologic disorders such as scleroderma, Sjögren syndrome, primary biliary cirrhosis, wasting syndrome, bronchiolitis obliterans, immune cytopenias and chronic immunode ciency. The manifestations of chronic GVHD may be restricted to a single organ or tissue or may be widespread. Chronic GVHD can lead to debilitating consequences, e.g., joint contractures, loss of sight, end-stage lung disease, or mortality resulting from profound chronic immune suppression leading to recurrent or life-threatening infections. Treatment of chronic GVHD is a challenge because it can be refractory to frontline immunosuppression. High-dose systemic corticosteroids are used with some success but carry significant toxicity. The risks of prolonged immunosuppression include local and disseminated infections; Epstein-Barr virus associated lymphoproliferative disease, hypothalamic-pituitary-adrenal ( HPA ) axis suppression, myopathy, glucose intolerance, neuropsychiatric disease and bone demineralization. There are about 6,000 patients annually in the U.S., with a comparable number in Europe that suffer from chronic GVHD. Zacks Investment Research Page 8 scr.zacks.com
VALUATION AND RECOMMENDATION
We maintain an Outperform rating for Soligenix and reiterate our 12-month price target of $4.50 per
share.
Soligenix is a mid-stage development biopharmaceutical company focused on cancer supportive care and GI disorders, two large pharmaceutical markets both in the US and around the world. Soligenix also develops vaccines/oral therapeutics for biodefense. Soligenix has built a diversified pipeline using three proprietary platform technologies. We are especially optimistic about its lead drug candidate SGX942 for the treatment of mucositis. SGX942 will enter into Phase II study in 2H13, which may serve as a major short term catalyst. Results will be available in 2H14, which, if positive, would be a significant de-risking event for Soligenix. SGX942 has a new mechanism of action and will command a significant market share of the oral mucositis market if approved in our view. The Company s oral BDP has the potential to target multiple GI disorders such as Crohn s disease, radiation enteritis and GVHD as well as ARS. Soligenix s vaccines and biodefense therapeutics are being developed under specific FDA regulatory
guidelines called the Animal Rule. The Animal Rule provides that under certain circumstances, where it
is unethical or not feasible to conduct human efficacy studies, the FDA may grant marketing approval
based on adequate and well-controlled animal studies when the results of those studies establish that the
drug is reasonably likely to produce clinical benefit in humans. Demonstration of the product's safety in
humans is still required.
We think the Animal Rule means a lot for Soligenix, because this can accelerate the development of the ricin and anthrax vaccines as well as OrbeShield. Once approved by the FDA, Soligenix will have the opportunity to negotiate a stock-pile contract with the US government. These stock-pile or procurement contracts have been very lucrative for other companies supplying similar drugs to the US government and will provide significant cash flow to Soligenix. Based on our analysis, we think Soligenix shares are undervalued at this time. Currently, shares of Soligenix are trading at around $2.30 per share, which values the Company at $44 million in market cap. We admit that it s always difficult to value a development stage biotech company. Soligenix is no exception. However, we do think that current market value of Soligenix is a deep discount compared to its peers in the same industry. Most small biotech companies of development stage are valued from $50 million to $500 million
depending on how advanced the pipeline is and which indications the company is targeting. Soligenix s
SGX942 for oral mucositis will enter a Phase II clinical study later this year, and the Company s SGX203
for pediatric Crohn s disease will also move to Phase II/III study later this year. Soligenix has multiple
catalysts in the next 12 month or so.
Our price target of $4.50 per share values Soligenix at $86 million in market cap which we think is very conservative. Zacks Investment Research Page 9 scr.zacks.com
Zacks Investment Research Page 10 scr.zacks.com
PROJECTED INCOME STATEMENT
2011
2012
2013
2014
2015
2016
Total Revenues
Gross Income
Operating Income
Pre-Tax Income
Reported Net Income
Reported EPS
Non GAAP Net Income
Non GAAP EPS
Source: Company filings and Zacks estimates Copyright 2013, Zacks Investment Research. All Rights Reserved. HISTORICAL ZACKS RECOMMENDATIONS
DISCLOSURES
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