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Good points.
I would like an official update. It is past time for a communication. Their lack of follow through on getting filings current raises my concern level. Although I also know should they IPO etc, these things will be taken care of in due course.
It is not uncommon for wealthy people to borrow $ even if they have the cash available.....I totally disagree with you.....Also if they do not get the funding deal they desire Nostrum can always $fund internally
While that is somewhat comforting, if Nostrum will guarantee the principal, why don't they just provide the financing and get on with it? I still think this thing is toast.
In terms of the proposed funding the fact that Nostrum will "guarantee repayment of principal at maturity" is significant.....Also Nostrum has real skin in the game which is probably $3,000,000 plus at this point.....One would think that they are serious about moving forward.....Remember Nostrum is a private company with $200 million plus in sales
Been saying this for longest time. No one listened when I warned everyone here. It was clear that some people were talking out of their ass with Insider Information. This is well deserved though.
Thanks for the response docj. Not exactly the ray of hope I was looking for, but thanks. In the current market environment, I seriously doubt they will have any takers and am more convinced these guys are toast. When a pinkie goes dark without a peep for a year, the writing is on the wall.
That is better than nothing! Lol!
...Expect a r/s (if) they move forward with an IPO. 1/5 or worse imo...
(Writing is on the wall in docj's post #5840.)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169727194
I appreciate the reply docj. However, I have been a long-term shareholder for quite some time.
I can't get a response...I am in the States now temporarily - work won't allow me to make a personal visit (no time). I WANT TO BAD.
Let's hope this all ends positive for the loyal.
Rarely, it does.
$CRXM
In a couple weeks we will have been shareholders for a year plus so IF CRXM DOEN"T SCREW US our future gains will be at the long term tax rate.
The plan was laid out back in the summer:
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
This company is a goner. Just accept it and move on... Not first or last scam you'll invest your hard earned money in.
I will believe it when I see it from this company?
CRXM, is the ticker about to be bought? That would be great!!! At least some company could use this and give us all a chance to at least breakeven with our individuals funds.
Everyone will be holding with long term capital gain status in about six weeks. A significant tax benefit if things go according to Gene Bio's plan.
Docj, do you care to elaborate on why there may be reason to be optimistic in the next week or so? I would like to join your enthusiasm but honestly, I see no reason to believe these guys will continue as a viable entity, for current shareholders anyway.
Total B.S. that we have ZEROOOOO NEWS OR UPDATES!!!
THIS IS WHY OTC Pinks can't be trusted!!
CRXM
docj.....We should get some updates soon
Idk, but they best file something before the Ticker purge going on gets them booted from OTC.
Is Chris still alive? When old geezers are running the show (in this case it’s no longer even running), you just gotta check up on them once in a while
Some sort of treatment will be needed for all the heart damage that has occurred from both covid infection and the vaccines...Too bad they can't get their shix together!
https://www.nature.com/articles/d41586-022-02074-3
No Doubt!
Total B.S.
Kind of Bait & Switch Scheme???
Meaning, get the money and then there is actually nothing instead of an actual study of some sort? Thus is most likely happening nonstop in Biotechnology Sector.
I wonder what a Securities Attorney would think of this deal??
CRXM??? Many quations and no good answers!! In my opinion
Bunch of BS what they did to shareholders. Unreal.
The only thing this company company will inform shareholders about one day is that their $$$ is gone. They’ll bankrupt the shell IMO and close the doors. None of these turfs care about retail investors - if they did it wouldn’t go dark to begin with.
Never mind I think I figured out the difference. But I would assume an increased blood flow efficiency created by Generx is likely to aide a malfunctioning heart in myocarditis sufferers. Just a thought.
Maybe one day this company will inform the shareholders what’s up.
Just curious, is Generx designed to treat myocarditis? Basically is Myocardial Ischemia the same thing? Been digging but I have been unsuccessful in finding a definitive difference?
https://clinicaltrials.gov/ct2/show/NCT02928094
Someone should check on CEO and see if he is alive or if our money is gone...
Is something about to happen in 6 weeks ??? fill us in ,
Everyone will be holding with long term capital gain status in about six weeks. A significant tax benefit if things go according to Gene Bio's plan.
JJ24......Agree Investors Will Prevail....Parabolic Gains Will Be Achieved Once They Get Rolling
This is pretty much the only other play I am heavily invested in that I am down big in. I predict that when the company finally gets their chit together it will be my biggest gain ever in OTC land ! Good luck to all longs here! $CRXM$
What is date of this document? Is this before we stopped trading or of recent months? Thanks in advance. I did not see a date on either page.
CRXM
I agree we have a broader range of potential indications. It would be great to have the reverse kept to a minimum. Many of us have been here for years and I would like to think our patience will be rewarded.
It will be interesting to see what the investment banks come up with.
Its really an apples and oranges comparison...CRXM is attempting to prevent what
Tenaya is servicing which is heart failure . CRXM mkt is clearly a much larger one Tenaya is attempting to relieve heart stress before failure thru heart muscle regenerative stimulation in MIce , yet fails to minimize the underlying causes one of which CRXM addresses that of narrowing arteries.I cant begin to understand or explain it all here . Great post underscoring the present value of CRXM My est possibly a 1 for 3 reverse if any .... should be a 200 -300 million market cap...IMHO
JJ24......Sounds Great.....Everything Is Heading In A Positive Direction.... Shareholders Will Prevail !!!!!
I assume the post IPO share structure and appetite for IPO shares will affect the reverse share split ratio.
How much does CRXM want to raise to support operations for how long?
What is an ideal number of shares to have after the IPO?
Will current shareholders be restricted from selling for a period after the IPO?
Bentley looking forward to NYC in December !
docj.....Nice.....Looking Great Moving Forward!
Nice! When this thing finally starts trading it will be up a gazillion %
This company should sale this ticker if not going to be used for any business. Then all of us might get a real deal going in here given low float. In my opinion.
CRXM??
It would appear that there is still a game to be played starting in January 2023 ...I believe we have seen this date rolled forward several times??? Is this one anticipated
to actually occur ?? Would like to see funding announcement ...that would be a game changer.
The clinical trial site was updated to show a start date of January 2023 for the generx AFFIRM study.
No problem and you are welcome. Sorry it looks the way it does. I'll try and improve it when time allows.
I reached out to Gene Bio about the oppurtunity but have not heard back from Chris.
docj.....Shareholders Appreciate Your Efforts In Managing This Board.....Thanks For Adding The New Investment Opportunity Document Sent By CEO Christopher J. Reinhard.....Better Days Ahead
One of my business partners was able to trade grey sheets with Schwab shortly after Exchange Act Rule 15c2-11 became effective. I'm unsure if Schwab still allows. Given that TD is restricting, Schwab probably will too.
I can ask Canadians if they can trade
Not Fidelity or TD. I've called a couple times. No bueno is all I hear.
Could be foreign accounts. I’m not sure if high value accounts are still able to trade. Some accounts (worth $1m+) were able to trade after restrictions were added.
I double checked with a few brokerages (awhile back). If you are a foreigner (as in living abroad with residency in that country)and buy it from a foreign brokerage that permits otc trading you can buy available shares.
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, 2018 PR-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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