CARDIUM THERAPEUTICS, INC. – 10-Q – MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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The following discussion and analysis is intended to help you understand our financial condition and results of operations for the three and six months ended
Executive Overview
We are a medical technology company primarily focused on the development and commercialization of novel products and devices. We are currently operating in four primary business lines through our four operating subsidiaries:
Our business is focused on the acquisition, strategic development, and partnering or other monetization of product opportunities or businesses having the potential to address significant unmet medical needs, and having definable pathways to commercialization, and on partnering or other monetization following the achievement of corresponding development objectives. Consistent with our overall business strategy, as our product opportunities and businesses are advanced and corresponding valuations established, we intend to consider various corporate development transactions designed to place our product candidates into larger organizations or with partners having existing commercialization, sales and marketing resources, and a need for innovative products. Such transactions could involve the sale, partnering or other monetization of particular product opportunities or businesses.
We currently report our operations as two operating segments: Pharmaceutical Products, which includes our Activation Therapeutics and Angionetics Biologics businesses, and Nutraceuticals, which includes our To Go Brands nutraceuticals business.
Recent Developments
During the six months ended
Generx (Ad5FGF-4) is a disease-modifying regenerative medicine biologic that is being developed to offer a one-time, non-surgical option for the treatment of myocardial ischemia in patients with stable angina due to coronary artery disease, who might otherwise require surgical and mechanical interventions, such as coronary artery by-pass surgery or balloon angioplasty and stents. Similar to surgical/mechanical revascularization approaches, the goal of our Generx product candidate is to improve blood flow to the heart muscle - but to do so non-surgically, following a single administration from a standard balloon angioplasty catheter. The ASPIRE Phase 3 registration is currently being conducted at up to leading cardiology centers in the
• Advanced forward our Generx ASPIRE Phase 3/ registration study, a 100-patient, randomized and controlled multi-center study currently enrolling patients at up to nine leading cardiology centers in theRussian Federation for patients with myocardial ischemia due to coronary artery disease. The ASPIRE study is designed to further evaluate the safety and effectiveness of our Generx DNA-based angiogenic product candidate, which has already been tested in clinical studies involving 650 patients at more than one hundred medical centers in the U.S.,Europe and elsewhere. The efficacy of Generx is being quantitatively assessed using rest and stress SPECT (Single-Photon Emission Computed Tomography) myocardial imaging to measure improvements in microvascular cardiac perfusion following a one-time, non-surgical, catheter-based administration of Generx. The Cedars-Sinai Medical Center Nuclear Cardiology Core -13-
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Table of Contents Laboratory inLos Angeles, California , is the central core lab for the study and is responsible for the analysis of SPECT myocardial imaging data electronically transmitted from the Russian medical centers participating in the ASPIRE study.The Russian Health Authority has assigned Generx the therapeutic drug trade name of Cardionovo® for marketing and sales inRussia . • Published the article, "Mechanistic, Technical, and Clinical Perspectives in Therapeutic Stimulation ofCoronary Collateral Development by Angiogenic Growth Factors, authored by Gabor M. Rubanyi, M.D., Ph.D., Cardium's Chief Scientific Officer, in the April issue of Molecular Therapy publication. The publication outlines current scientific knowledge about the mechanistic basis of adaptive coronary collateral growth, the biological processes to be targeted by therapeutic angiogenesis, and the optimization of clinical trial designs, including the Generx ASPIRE Phase 3 / registration study.
Excellagen is a syringe-based, professional-use, pharmaceutically-formulated 2.6% fibrillar Type I bovine collagen homogenate that functions as an acellular biological modulator to activate the wound healing process and significantly accelerate the growth of granulation tissue. Excellagen's
• Distribution agreement withKasiak Holdings AG for the marketing and sale of Excellagen inGermany andSwitzerland . • Distribution agreement withAvKARE Inc. , the Company's new sales and distribution partner for Excellagen in Veterans Hospitals and other governmental medical facilities throughoutthe United States . The new agreement and commercialization arrangement with AvKARE effectively replaces an earlier arrangement withAcademy Medical, LLC . Cardium elected to transfer the Excellagen distribution responsibilities to AvKARE, which provides five direct wound care experts and allows Cardium's 25 distributor representatives access to all government accounts. AvKARE services a diverse customer base that includes government (federal, state and municipal) and commercial sectors • NewFDA 510(k) clearance submission for the Company's currentFDA -cleared Excellagen to reflect additional and specific structural and functional properties based on the Company's supplemental research and development activities. • Collaboration agreement with researchers atBoston Children's Hospital , to assess the medical utility of Excellagen as a delivery scaffold to seed autologous mesenchymal fetal stem cells for ex-vivo engineering of tissue grafts for transplantation into infants to repair prenatally diagnosed birth defects. • Agreement withOrbsen Therapeutics Ltd and theNational University of Ireland, Galway , to utilize Excellagen as a delivery agent for Orbsen's proprietary stromal cell therapy in pre-clinical studies for the potential treatment of diabetic foot ulcers. • Presentation at the Symposium on Advanced Wound Care Spring 2013 Meeting highlighting Excellagen's capability of promoting rapid granulation and complete wound dehiscence and healing in three difficult and complex post-surgical wounds, including Mohs surgery. • ISO 13485:2003 certification (a requirement for CE marking) for Excellagen by BSI, one of the world's leading certification bodies, was received in first quarter 2013. With the completion of ISO certification, the Company reported that it had completed its initial submission of required documentation, including the technical file and design dossier for its CE mark application. The Company recently reported that since the initial submission, it has received requests for supplemental information from BSI. Based on the current status, all information requested has been provided to BSI and the Company believes this process should lead to CE mark certification for Excellagen. -14-
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To Go Brands-Integration and Expansion
Since 2007, To Go Brands has been making healthy, great tasting and anti-oxidant-rich phytonutrients and nutraceutical supplements in an array of easy use formats, including drink mixes, chews, powders and capsules, to empower busy lifestyles in today's fast-paced, tech-driven world. The Go Active! product line includes High Octane®, Green Tea Energy Fusion™, Acai Natural Energy Boost™, and Neo-Energy®. The Go Healthy! product line includes Greens to Go®, Extreme Berries to Go®, Healthy Belly®, VitaRocks®, and Neo-Chill™.
• We announced that To Go Brands® expanded its VitaRocks® kids vitamins product line and that retail distribution of the newly-designed products is being broadened into select nationwide Target stores. We also announced that because of the unique manufacturing process of To Go Brands' VitaRocks platform, we now have the flexibility to expand the product line into formulas that could include enzymes, electrolytes, amino acids, vitamins and minerals, as well as nutrients, and into other applications including OTC drugs.
LifeAgain™ Insurance Solutions-Product Development
LifeAgain™
In
Critical Accounting Policies and Estimates
Our condensed consolidated financial statements included under Item 1 in this report have been prepared in accordance with accounting principles generally accepted in
The preparation of financial statements in conformity with accounting principles generally accepted in
Our significant accounting policies are described in the notes to our financial statements.
Results of Operations
Three months ended
Revenues for the three months ended
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Research and development expenses for the three months ended
Selling, general and administrative expenses for the three months ended
Net loss for the three months ended
Six months ended
Revenues for the six months ended
Research and development expenses for the six months ended
Selling, general and administrative expenses for the six months ended
We derive interest income from the investment of our available cash in various short-term obligations, such as certificates of deposit, commercial paper and money market funds. Interest income for the six months ended
Net loss for the six months ended
Liquidity and Going Concern
As of
Net cash used in operating activities was
Our primary source of liquidity has been cash flows from financing activities and in particular proceeds from sales of our debt and equity securities. Net cash provided by financing activities was
Net cash used in investing activities for the six months ended
In
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purchase price of
Our business model is designed to develop a diversified portfolio of product opportunities and businesses, leveraging our skills in late-stage product development in order to bridge the critical gap between promising new technologies and readiness for commercialization - and then to partner or monetize such product opportunities or businesses with established organizations capable of advancing their commercialization. Consistent with our business model and long-term strategy, we have already advanced and monetized a first business unit,
We now have four additional business units in our portfolio: (1) Angionetics Biologics, which includes Cardium's late-stage DNA-based Generx® cardiovascular biologic product candidate; (2) Activation Therapeutics, which includes the Company's regenerative medicine wound healing technology platform, including its Excellagen® advanced wound care product; (3) To Go Brands®, which includes the Company's health sciences and nutraceutical business; and (4)
These portfolio companies and their business, lead product or product candidate, and current commercial status are outlined on the schedule below.
Portfolio Company Business Summary Lead Product Status Activation Advanced Tissue Excellagen® Initial Product Therapeutics Inc. Regeneration for FDA-Cleared Wounds & Biological Delivery Platform Angionetics Cardiovascular Generx® Product Phase 3 Biologics Inc. Growth Factor Candidate Registration Therapeutics Study To Go Brands Inc. Nutrition & Health Portfolio of 30 Nationwide Sciences Products Commercial Sales at 15,000 Retail Locations LifeAgain Insurance National Life BlueMetric Select™ Advancing toward Solutions Inc. Insurance Business Term Life commercialization Focused on Medical Insurance Data Analytics
We intend to consider additional corporate development transactions designed to place our product candidates or businesses into larger organizations or with partners having existing commercialization, sales and marketing resources, and a need for innovative products. Such transactions could involve the sale, partnering or other monetization of particular product opportunities or businesses. In parallel, as our businesses are advanced and corresponding valuations established, we plan to pursue new product opportunities and acquisitions with strong value enhancement potential.
While we may partner or monetize one or more of our product opportunities or businesses consistent with our business model, they cannot be assured and negative cash flow from operations would be expected to continue for the foreseeable future. In order to maintain operations and liquidity, we expect we will need to complete a monetization of one or more product opportunities or business units, and/or complete a financing, before end of year. Our principal business objective in the near term is to complete an additional strategic licensing agreement to advance sales of the Excellagen product family, enter into a distribution arrangement to advance sales of our To Go Brands nutraceuticals business, and/or another corporate transaction. However, we are still a development stage company subject to all the risks and uncertainties that are typical in the lifecycle stage of our business. If we fail to receive sufficient proceeds from the partnering, sale or other monetization of product opportunities or businesses or generate sufficient product sales, or raise funds through additional financings, we will not generate sufficient cash flows to cover our operating expenses. Any additional financings would be expected to be in the form of sale of equity securities.
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Based on recently-issued amendments to Rule 506 and Rule 144A under the Securities Act of 1933 that were implemented under Section 201(a) of the Jumpstart Our Business Startups Act (the "JOBS Act"), and since we do not anticipate raising additional funds under our shelf registration statement or as debt within the next 12 months, such financings may be through the sale of private equity interests to
Our history of recurring losses and uncertainties as to whether our operations will become profitable raise substantial doubt about our ability to continue as a going concern. Our condensed consolidated financial statements do not include any adjustments related to the recoverability of assets or classifications of liabilities that might be necessary should we be unable to continue as a going concern.
Off-Balance Sheet Arrangements
As of
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