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Taxus Cardium Pharm Group Inc (fka CRXM) RSS Feed

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Fact Sheet and investment opportunity related to Gene Bio. Received from the CEO:

The Opportunity: We are a San Diego-based, late-stage biotechnology company focused on the clinical development
and commercialization of angiogenic gene therapy biotherapeutics for strategic niche markets primarily for the
treatment of cardiovascular disease.
Our lead Generx [Ad5FGF-4], is an innovative single, one-time dose, catheter-based, treatment for patients with
refractory angina due to late-stage coronary artery disease, for use by interventional cardiology physiciansimmediately
following a standard angiogram procedure. There are an estimated 1.0 million cardiac angiograms are performed in
the U.S. each year, and an estimated 500,000 of these patients could potentially benefit from Generx therapy, at a
projected $8,000 to $10,000 per dose, representing a $4.0 to $5.0 billion total potential market opportunity for this
patient subgroup alone. There is no special training or medical devices required for physicians to integrate the use of
Generx into their daily practice. These patients have an unmet medical need, and Generx offers a new business with a
billion-dollar market opportunity for physicians.
Investors: We are a majority-owned operating subsidiary of Nostrum Pharmaceuticals LLC, a U.S.-based, privately
owned, fully integrated, pharma company, engaged in the formulation and commercialization of specialty products
and controlled-release, orally administrated, branded, and generic drug products. Nostrum operates multiple
manufacturing facilities, supported by sales, marketing and distribution activities, that sells products to hospitals and
retail drug stores, by Rx prescription only, throughout the United States. Nostrum currently owns approximately 75%
of Gene Biotherapeutics and approximately 25% is owned by public shareholders. Gene Bio investors currently own an
85% interest in Generx, and Huapont Life Sciences, a Chinese-based, publicly traded, pharmaceutical company, owns a
15% interest in Generx, and has an exclusive right to market and sell Generx in mainland China following FDA approval
of Generx in the United States
Business Strategy: Gene Bio has a cost-conserved and outsourced-service provider operating structure, supported by
Nostrum’s corporate infrastructure and capital. We have a highly experienced team thatis currently singularity focused
on (1) the manufacture of our lead product Generx [Ad5FGF-4] by
Fujifilm Diosynth Biotechnologies, located in College Park, Texas; (2) the
conduct of our final 160-patient, FDA-cleared, Phase 3 clinical study,
and (3) FDA approval. The FDA has now cleared the Generx cGMP
manufacturing specifications and Phase 3 clinical study. With the
successful completion of this final study, Gene Bio plans submit a
biologics license application to the FDA and secure FDA approval to
market and sell Generx in the United States.
Proposed Financing: We are seeking to raise up to $6.0 million in
a short-term (24 month) debt financing to support our going
forward operations as a C-Round bridge financing which will be
followed (within 12-16 months) by a planned S-1 Registration
Statement initial public financing, that is anticipated to fully fund
the Generx clinical development program. The attached term sheet
provides the terms and conditions covering this proposed financing.
Investors will have a right to receive repayment of principal and
interest at maturity or participate in the planned IPO at a significant
discountto market. Nostrum has agreed to guarantee repayment of
principal at maturity.
Fact Sheet &
Proposed IPO
Bridge C-Round
Debt Financing
The Mechanism of Action: Generx has been designed to improve cardiac perfusion by promoting the formation of
functional coronary collateral blood vessels within the heart through the enlargement of existing arterioles
(arteriogenesis) and the formation on new capillary vessels (angiogenesis). This process, termed “medical
revascularization,” represents a fundamentally new mechanism of action that involves the stimulation and formation
of new biological structures in the heart, as opposed to currently available traditional symptomatic pharmacologic
therapies, which only address the symptoms of angina, or mechanical revascularization, through procedures involving
angioplasty and stent placement or coronary artery bypass graft surgery.
Clinical Findings: The Generx regulatory dossier represents one of the most extensive and advanced gene-based clinical
data platforms ever compiled. In multiple prior clinical studies, the Generx product candidate has been evaluated in
over 650 patients (450 receiving Generx) and appears safe and well-tolerated with findings of efficacy in men and
women, in measures of cardiac perfusion, exercise capacity, and angina status. Specifically, Generx has been evaluated
as a treatment for patients with refractory angina in four prior FDA-cleared, multi-center, randomized and placebocontrolled clinical studies (AGENT 1-4, covering Phase 1|2, Phase 2 and two Phase 2b/3 clinical studies), and one small
Phase 2 international study (ASPIRE). These studies have generated over 2,500 patient years of safety data. Generx has
now been cleared by the FDA for our final Phase 3 clinical study to further evaluate safety and definitive efficacy.
U.S. Market Strategy: To support our go to market strategy, we conducted a survey of U.S. interventional cardiologists to
gauge their experience-based assessment of the prevalence of refractory angina patients, and their openness to integrate
the use of the Generx angiogenic gene therapy product candidate, upon FDA approval, into their clinical practice. The
survey confirmed that all survey physician responders see patients with long-term refractory angina as an unmet medical
need, and all were strongly positive and without reservation about the adoption of Generx following FDA approval. All
cardiologists surveyed felt there is a current need for Generx to treat refractory angina and they would consider using
Generx in their daily practice.
Competitive Factors: We believe that we have a significant clinical lead over even our nearest competitor, and that our
knowledge base, technology platform, a $200 million investment research and development spend by larger pharma
players prior to Nostrum’s acquisition, our FDA cleared treatment algorithm and business model, all represent significant
barriers to entry. Following FDA approval, we believe that Generx will potentially be considered superior in the
competitive marketplace. We believe that Generx therapy will represent a better, faster, and cheaper solution than other
therapies now in development. Our FDA-cleared Ad5FGF-4 manufacturing process offers significant gross margin
opportunities, scalable campaign manufacturing, generates a ready to use plug-n-play product, and has a well-researched
and clinically supported MOA, and receptor-based, cardiac cell targeting. We see little or no direct competition in our
space until 2030.
Potential for Exceptional ROI: With public access to capital markets and sufficient financial resources, an accelerating
Phase 3 clinical study, a NASDAQ listing with stock trading liquidity, on a post-IPO basis, we believe, that there would be
support for an intermediate market capitalization ranging from $200 million to $500 million. Based on the Company’s
business model, market opportunity, overall economics and competitive exclusivity, with the successful completion of the
Phase 3 clinical study, Gene Bio believes that there would be ample evidence to support a Generx terminal value range
of $1.0 billion to $3.0 billion, that could potentially be offered by key strategic players from the pharmaceutical and
biotechnology companies focused in the gene therapy, cardiovascular drugs and biologics and vascular access sectors
operating in the U.S. and internationally.
For additional information, please reference our Annual Report on Form 10-K, dated April 21, 2022, as filed with the SEC,
the IPO Bridge C-Round Debt financing, dated June 22, 2022, and Gene Investor Presentation, dated July 27, 2021, that is
available on the Company’s website below. In addition, please also visit Gene Bio’s website
www.GeneBiotherapeutics.com and our Phase 3 patient recruitment website at www.MyRefractoryAngina.com


https://genebiotherapeutics.com/

For filings:https://genebiotherapeutics.com/investors/


Investment by Nostrum Pharmaceuticals LLC: https://www.otcmarkets.com/filing/html?id=14182106&guid=TmVFUWUD04P0tth

On August 2, 2021, the Audit Committee approved the appointment of RAM Associates, LLP (“RAM Associates”) as our new independent registered public accounting firm, effective immediately, to perform independent audit services for the fiscal years ending December 31, 2021 and 2020. RAM Associates has served as the auditor for Nostrum Laboratories, Inc. and its affiliates, which are subsidiaries of Nostrum Pharmaceuticals LLC, our largest shareholder, since 2008.


Clinicaltrials.com update:
https://clinicaltrials.gov/ct2/show/NCT02928094?term=generx&rank=1


Understanding refractory angina and the AFFIRM study:
https://www.myrefractoryangina.com/




Taxus Cardium Announces Name Change To Gene Biotherapeutics

January 10, 2018PR-M01-18-NI-021

SAN DIEGO, Jan. 8, 2018 /PRNewswire/— Taxus Cardium Pharmaceuticals Group (Trading Symbol: CRXM) today announced plans to affect a name change from Taxus Cardium Pharmaceuticals Group Inc. to Gene Biotherapeutics Inc. 

The name change reflects the Company's plan to exclusively focus on the late-stage clinical research and commercialization of gene-based biotherapeutics for niche markets in the oncology and cardiology spaces for patients with unmet medical needs.  Gene Biotherapeutics is actively pursuing the acquisition of clinical development and commercialization rights to new and innovative, late-stage, DNA-based product opportunities focused on multiple forms of cancer to leverage the company's established and validated adenovector-based technology platform and deep experience in the clinical advancement and commercialization of gene therapy product candidates.

Previously, the Company established Angionetics Inc., an 85% majority-owned subsidiary, to lead Gene Biotherapeutics' cardiovascular clinical research and commercialization activities.  Angionetics is currently focused on independent financings to support advancement of the FDA-cleared, Generx AFFIRM Phase 3 clinical study of patients with refractory angina (myocardial ischemia) due to advanced coronary artery disease. There are an estimated 1.0 million patients with refractory angina in the United States. Gene Biotherapeutics' plan to advance forward to establish Angionetics as an independent company remains unchanged.  As previously reported, Gene Biotherapeutics expects to retain a substantial long-term equity investment in Angionetics following completion of the planned external financings. For more information about the Generx AFFIRM Phase 3 clinical study visit www.MyRefractoryAngina.com.

Angionetics is also considering the initiation of multiple Phase 2 clinical studies to evaluate the Generx angiogenic gene therapy product candidate as a treatment for patients with Cardiac Syndrome X (microvascular dysfunction) and certain forms of congestive heart failure, including ischemic cardiomyopathy.

Angionetics' Generx [Ad5FGF-4] is a first in class, disease altering, one-time administered, late-stage, angiogenic gene therapy product candidate which has been biologically engineered to enhance blood flow (perfusion) in ischemic regions of the heart by leveraging cardiac plasticity to promote the natural formation and growth of microvascular coronary structures (collateral vessels). This is achieved by stimulating and augmenting the heart's innate natural capacity to modulate the enlargement of pre-existing collateral arterioles (arteriogenesis), and to form new capillary vessels (angiogenesis) in select ischemic regions downstream from large coronary arteries.

Angionetics is being uniquely positioned to become a leading molecular interventional cardiology company, and is seeking to develop a portfolio of new and innovative, single-treatment, gene-based, catheter-administered therapeutic products focused on the biologic modulation of cardiac conductivity, contraction and angiogenic revascularization to address the global unmet medical needs of millions of patients with multiple forms of heart disease. Consistent with Angionetics' business strategy, the company is currently considering the acquisition of several early-stage gene therapy product candidates.  To learn more about Angionetics visit www.angionetics.com.

As previously reported, Gene Biotherapeutics further plans to monetize its FDA-cleared, U.S.-patented, Excellagen, a highly-purified, aseptically-manufactured, fibrillar bovine collagen [2.6%] flowable dermal matrix for the treatment of diabetic neuropathic lower extremity ulcers, pressure and venous ulcers as well as other wound healing applications.  Excellagen has demonstrated its medical utility as a delivery platform for stem cells, and also carries the potential as a topical dermal delivery vehicle for small molecule drugs, peptides, proteins, and exosomes.   Excellagen® has been designated as a skin substitute (bearing a unique product Q Code), in accordance with the standards established by the U.S. Centers for Medicare and Medicaid Services (CMS). For more information about Excellagen, visit https://www.youtube.com/watch?v=D2GYCYc_8JE.

As of December 31, 2017, approximately 14.3 million shares of Gene Biotherapeutics Common Stock were issued and outstanding, and approximately 4.6 million additional shares of Common Stock have been reserved for future issuance upon the conversion of the Series A Convertible Preferred Stock.

 
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