Nice find Andy! Love seeing articles like this. The only thing that worries me about AEMD and CTSO is the market. If it crashes, people throw the babies out with the bathwater. Otherwise I see nothing but up for these companies. Keep up the good work.
Melbourne, Australia; Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow report for the period ended 31 December 2013.
The cash balance at 31 December 2013 was $27.8 million, a net cash burn of $3.7 million for the quarter. The cash balance excludes the Company’s anticipated R&D tax incentive refund of $4.7 million receivable this financial year.
The cash burn for the quarter includes expenditure relating to a number of clinical trials. This includes the recently commenced Phase 1 clinical trial of DEPTM Docetaxel, and also the advanced preparations for Phase 3 prevention of bacterial vaginosis (BV) clinical program for VivaGel®.
During the quarter and ahead of the clinical trial, Starpharma reported highly positive preclinical results for DEPTM Docetaxel compared to the commercial version of docetaxel (Taxotere®). Animals treated with Starpharma’s DEPTM Docetaxel formulation exhibited a lack of neutropenia (low white blood cells). In contrast, animals treated with Taxotere® exhibited severe neutropenia, a sign of bone marrow toxicity and the most important dose-limiting side effect of Taxotere® in humans.
'Keep this to yourself'?......I'm finally LOL, I mean noise actually left my throat in a giggly sort of way. Shhhhhh, don't tell anyone you just hit 'post' on an international bulletin board.....if we keep whispering reply's, maybe nobody will hear your initial post. Shhhhhhh......
I'm a paid member of the gumshoes. There is a wonderful ongoing discussion about SBOTF on the site. I do not recall seeing anything about failures. The only thing people are discussing is its potential, which most seem to think is unlimited.
Definition of 'SEC Form S-1'
The initial registration form for new securities required by the Securities and Exchange Commission (SEC) for public companies. Any security that meets the criteria must have an S-1 filing before shares can be listed on a national exchange.
Form S-1 requires companies to provide information on the planned use of capital proceeds, detail the current business model and competition, as well provide a a brief prospectus of the planned security itself, offering price methodology, and any dilution that will occur to other listed securities. The SEC also requires the disclosure of any material business dealings between the company and its directors and outside counsel.
Form S-1 is also known as the "Registration Statement Under the Securities Exchange Act of 1933".
Investopedia explains 'SEC Form S-1'
Investors can view S-1 filings online to perform due diligence on new offerings prior to their issue. The form is sometimes amended as material information changes or general market conditions cause a delay in the offering.
The Securities Exchange Act of 1933, often referred to as the "truth in securities" law, requires that these registration forms are filed to disclose important information upon registration of a company's securities. This helps the SEC achieve the objectives of this act, which is requiring investors to receive significant information regarding securities offered, and to prohibit fraud in the sale of the offered securities.
A less rigid registration form is the S-3, which is for companies that don't have the same ongoing reporting requirements.
Stellar Biotechnologies, Inc. ("Stellar" or “the Company”) (OTCQB: SBOTF) (TSX-V: KLH), announced today the presentation of a poster at Aquaculture America 2014 (Seattle, February 9-12, 2014), describing a new method for verifying authenticity of Keyhole Limpet Hemocyanin (KLH) product.
KLH is an important protein widely used in the pharmaceutical industry as a hapten carrier in active immune therapies and as an injectable product for immune function testing. KLH product is obtained only from the hemolymph of the Giant Keyhole Limpet (Megathura crenulata), a relatively scarce marine gastropod.
The poster titled “When Is A Keyhole Limpet a Giant?: A Rapid Assay to Verify Megathura Crenulata Hemocyanin” is the result of work conducted jointly by California State University, Fullerton and Stellar’s scientists. The study goal was to design a rapid, cost-effective test to distinguish Megathura crenulata KLH from hemocyanins of non-Megathura crenulata source.
The project involved development of a rapid, cost-effective method of verifying the source of a hemolymph product; specifically, a PCR-based test to positively identify if hemolymph is actually KLH (keyhole limpet hemocyanin), not from another gastropod species. The method relies on polymerase chain reaction (PCR), a molecular technique that amplifies DNA for analysis.
“Verification of starting material is the foundation for ensuring KLH authenticity and quality,” said Catherine Brisson, Ph.D., Stellar’s Chief Operating Officer. “At Stellar, we are continually assessing advanced analytical methods for use in KLH production; a hallmark of our leading position in KLH manufacture and quality control.”
Aquaculture America 2014 is the largest aquaculture conference in the Western hemisphere. It is hosted by the U.S. Aquaculture Society, a chapter of the World Aquaculture Society, dedicated to the exchange of information among the diverse aquaculture in the advancement of aquaculture industry.
Aethlon Medical (OTC BB:AEMD) filed their 10-Q for the fiscal third quarter 2014 ending 12/31/2013 on February 11th. Revenue of $76k was entirely from work under the subcontract agreement that the company has with Battelle related to the $22.8 million systems integrator contract with DARPA. Revenue missed our $496k estimate as AEMD did not book any DARPA related milestone revenue during the quarter but subsequent to quarter end billed DARPA $353k.
Through December AEMD had billed $3.4 million under the DAPRA awards, which represents $1.97 million under the initial year-1 contract and $1.42 million under the year-2 contract (worth $1.6 million and containing eight milestones), which was awarded to the company in August 2012. We forecasted the final $197k milestone under the year-2 contract and ~$300k under the year-3 contract (which was awarded to the company in September and, initially was to pay up to $1.53 million if all eight milestones were met) to be paid in Q3. We have now pushed back these forecasted receipts to fiscal Q4 and Q1 2015.
DARPA has the option of entering into the remainder of the proposed contract for years four and five. In the 10-Q AEMD notes that due to budget restrictions, DARPA plans to reduce the scope of AEMD's contract for years three through five. The three through five year contracts were initially worth ~$3.2M. Due to the budget change, this amount will now be ~$2.4M (the breakdown per contract-year was not disclosed). We have adjusted our model to account for the change.
We also model additional, although relatively minimal revenue from the Battelle contract throughout fiscal 2014 and into 2015. As a reminder, AEMD's subcontract is a time and materials contract so the total that AEMD will eventually bill will not be known until their work is completed. We do, however, think it's likely that there will be additional revenue contribution from this contract.
Q3 operating expenses were $1.3M, compared to our $1.1M estimate - the majority of the difference related to expenses of Exosome Sciences. Operating loss was $1.2M, compared to our $514k estimate - the difference mostly related to the delayed revenue relative to our forecast. Q3 net income and EPS were ($2.3) million and ($0.01) and included a $1.0M accrual related to a possible lawsuit settlement (if settled, it would be in the form of equity).
Aethlon continues to successfully raise operating capital on a regular basis and continues to make progress on cleaning up the balance sheet. During Q3 AEMD raised $3.2M from the sale of equity and repaid $200k of notes payable. We view the pricing, size and terms of the most recent equity raise as indicative of the continued and, potentially, growing interest in AEMD. Subsequent to quarter end another $17k in debt was repaid. Aethlon exited fiscal Q3 with $1.9M in cash and equivalents, compared to $9k at the end of fiscal Q2 2014 (9/30/2013). Cash used in operations was $839k in Q3.
We continue to expect cash generated from government and other contracts along with additional funds raised through the sale of securities to fund the company over the near-to-mid term.
Along with their ongoing ability to continue to raise operating capital, we have been encouraged, from the standpoint of strengthening their financial position and balance sheet, by the success of converting some of their outstanding debt to stock. While a substantial portion of debt remains in default, the company continues to make progress on cleaning up their balance sheet, which we view as meaningful from a de-risking perspective. We reiterate, however, as we have in the past, that Aethlon will need to raise a substantial amount of cash, enter into partnering arrangements or score additional valuable contracts/grants in order to complete the recently announced U.S. safety study and to be able to maintain operations for the longer-term. Nonetheless, we believe management's recent progress should not be marginalized.
On the operational side, AEMD now has another potentially significant iron in the fire with its Exosome Sciences business. In late 2013 Exosome Sciences was resumed and a lab opened in New Jersey where that business is working from. The recent relatively large capital raise provided initial funding to commence work at the lab. Initially this is expected to focus on exosomes' role in cancer diagnosis. We met with Jim Joyce at the JP Morgan healthcare conference in San Francisco in January and came away encouraged that the Exosome Sciences team has already made progress in advancing their lead diagnostic ELLSA assay. With research on exosomes still in its infancy, AEMD clearly sees a real opportunity with the potential to be at the cusp of research and a leading knowledge base in the role that exosomes play in the progression of cancer.
And while we do not currently model a contribution from the Exosome Sciences business, we do view this has possessing potential upside to AEMD's core business, particularly over the longer-term. We will update our model to incorporate a contribution from Exosome Sciences depending on its progression and when there's more insight into likelihood and timing of revenue generation.
Relative to Hemopurifier AEMD remains focused on not only the HCV opportunity but also sees real potential with cancer secreted exosomes and other areas, including for bioterror agents and pathogens. Aethlon also remains encouraged that there is a potential opportunity for use of Hemopurifier therapy for compassionate use.
We have updated our model for Q3 results and made minor changes as a result of the decrease in DARPA budget related to contract years 3,4 and 5.
Stellar Biotechnologies, Inc. ("Stellar" or “the Company”) (OTCQB: SBOTF) (TSX-V: KLH), announced today that the Company has been named to the 2014 TSX Venture 50®, an exclusive ranking of the top performing companies on the TSX Venture Exchange.
Stellar Biotechnologies is the top ranked company across all five industry sectors of the 2014 TSX Venture 50® list.
The TSX Venture 50® is an annual ranking conducted by the TMX Group of the fifty strongest-performing companies on the Canadian TSX Venture Exchange, categorized by industry sector. The list is chosen based on four equally weighted criteria; market capitalization growth, share price, trading volume, and analyst coverage. The TMX Group, which owns the Toronto Stock Exchange and Toronto Venture Exchange, describes the winning companies as those having “shown impressive results in key measures of market performance.”
“We are pleased to have this public market acknowledgement of Stellar’s accomplishments and growth potential,” said Frank Oakes, President and CEO. “We have a solid foundation and we continue to work diligently to deliver strong future returns to our shareholders and partners.”
Dendrimer-Docetaxel to enter human clinical trials
Starpharma’s internal drug delivery program is approaching a major milestone
and entering human clinical trials with its dendrimer-reformulated version of
A Phase 1 clinical trial of Dendrimer-Docetaxel – an enhanced version of the
off-patent blockbuster anti-cancer drug docetaxel (Taxotere®) – is due to begin
early in the New Year. The move into the clinic follows the successful results of a
number of pre-clinical studies. Docetaxel, which is now generic, has reported
annual sales of US$3.1 billion.
The latest of these studies compared Dendrimer-Docetaxel to Taxotere®
and demonstrated that Starpharma’s Dendrimer-Docetaxel did not cause
neutropenia (reduced circulating neutrophil numbers) and other important bone
marrow-related toxicities (refer below). Severe neutropenia occurs in more than
75% of patients treated
with Taxotere®. Dendrimer-Docetaxel treated rats were also free from thrombocytopenia
(low platelets) which, along with neutropenia, was observed in Taxotere®
treated animals. Bone marrow toxicities are the most important doselimiting
side effects of Taxotere®. Taxotere® carries a FDA “black box” warning
(refer right) in its Product Information regarding toxicities including neutropenia,
contraindications and management requirements for certain patients.
Another toxicity-reducing benefit attributed to Dendrimer-Docetaxel is the
removal of the detergent – Polysorbate 80 – from its formulation. Dendrimer-
Docetaxel has markedly improved solubility making the Dendrimer-Docetaxel
formulation water soluble so it is free of detergent (Polysorbate 80). Drugs
containing Polysorbate 80 (eg. Taxotere® and other docetaxel formulations) can
trigger hypersensitivity reactions, or fatal anaphylaxis, in patients and this is also
noted in the “black box” warning for all docetaxel formulations including
Apart from these reduced toxicities, earlier pre-clinical studies of
Starpharma’s Dendrimer-Docetaxel have also demonstrated its
significantly superior anti-cancer effectiveness – across a range of
important cancer types including breast, prostate, lung and ovarian
cancer – compared to Taxotere®. Starpharma’s dendrimers have also
shown broad applicability to the delivery of drugs outside of oncology.
It is estimated that dendrimers are applicable to more than 50% of
leading pharmaceuticals – this includes small molecule drug, proteins
(including insulin) and biologics such as antibodies.
VivaGel® Phase 3 trial for prevention of recurrent BV
Starpharma’s lead women’s health product VivaGel® will soon progress to
pivotal Phase 3 clinical trials to confirm its ability to prevent recurrence of
bacterial vaginosis (R-BV) infection. This trial will build on the positive
results of a Phase 2 efficacy study earlier this year, which demonstrated both
reduced overall risk of R-BV in patients using 1% VivaGel® and delayed time to
first recurrence, compared with placebo. “Positive Phase 2 data was observed
in April this year. We are now progressing VivaGel® to a phase 3 trial for a
prevention of R-BV indication, and our preparations for this pivotal trial program
are well advanced,” said Starpharma chief executive Dr Jackie Fairley.
Preparations for the Phase 3 studies including designing the trial with
regulatory input, as well as selection of trial sites and appointment of a leading
global Contract Research Organisation.
Existing treatments for BV are considered suboptimal. They do not offer
a long term solution and are associated with high rates of recurrence, unpleasant
side-effects, and high levels of bacterial resistance. There are currently no
approved products to prevent R-BV, so VivaGel® has the potential to be a 1st in
class therapeutic for prevention of R-BV.
BV is the most common cause of vaginal infection worldwide and BV
prevalence is known to vary by country and population group. A recent review of
almost 1,700 BV research papers, identified BV prevalence approaching
60% of women in some African nations.
In the US, overall BV prevalence was 29.2% and highest among non-Hispanic
blacks (51.4%) followed by Hispanics (31.9%) then non-Hispanic whites
(23.2%). In the UK, overall BV prevalence was 10.9%.
The VivaGel®-coated condom is currently
undergoing regulatory review and
significant prelaunch activities have
already been completed including
consumer research, product positioning,
packaging design and manufacturing
Consumer feedback on the VivaGel®-
coated condom collected via formal
market research this year shows positive
feedback and demand. The international
research demonstrated very positive
results in terms of product relevance and
benefits to consumers. 86% of
participants rated the VivaGel®-coated
condom as “very interesting” with 90%
saying they would buy it.
Actual consumer comments included:
“I would buy this product right now”;
“I think this product is amazing…This
product is very special and
“I have rated this product 5/5 as this is
a major breakthrough in the condom
market and for world health…”
Starpharma has licensed commercial
rights to Ansell and Okamoto for the
Impressive results for Dendrimer - Enhanced Oxaliplatin
Starpharma has recently released
impressive pre-clinical results showing
the superior performance of Dendrimer
Enhanced Oxaliplatin (DEO) compared
to oxaliplatin alone (Eloxatin®), a leading
bowel cancer drug.
The dendrimer-enhanced version of
the drug has been shown, in animal
models, to have:
• improved anti-tumour efficacy
• reduced toxicity for bone marrow,
• reduced toxicity for the nervous
The neurotoxicity improvement is
particularly important as this effect is
Eloxatin®’s major dose-limiting toxicity
and the cause of its most debilitating
side-effects. Around 85-95% of patients
who undergo Eloxatin® therapy will suffer
irreversible nerve damage to the hands
and feet (peripheral neuropathy). The
drug also triggers a short-term
heightened sensitivity to cold around
the time of treatment (see case study).
Starpharma’s novel, proprietary
DEO showed significantly reduced
neurotoxicity in validated animal models
for both peripheral neuropathy and cold
as measured by the von
“These findings are very significant
because this condition is a serious
clinical problem and the dendrimer
version of oxaliplatin clearly shows
a reduced level of neurotoxicity.
We are unaware of any other
examples of this effect reported
for other oxaliplatin formulations
in the literature.”
Professor Susan Dorsey
Director, Center for Pain Studies,
University of Maryland
sensitivity. In fact, DEO showed a
significant reduction in both
neurotoxicities even when DEO was
used at twice the dose of oxaliplatin.
Following treatment with DEO or
oxaliplatin, mice were assessed to check
for treatment-related neuropathy. The
DEO treated mice had a statistically
significant reduction in peripheral
neuropathy seen by a lower change from
baseline in the von Frey test (refer above)
and a lower cold sensitivity as measured
by the Cold Plate test, when compared
to mice treated with oxaliplatin.
Starpharma has also released the
results of a separate pre-clinical study
which demonstrated improved tumourinhibiting
effectiveness in a colon cancer
model and a reduction in bone
“The reduction in neurotoxicity alone
would represent a significant commercial
and clinical advantage for DEO but when
considered alongside the earlier
improvements in efficacy and reduced
bone marrow toxicity, this finding
demonstrates that Starpharma’s
dendrimer technology can deliver a
considerable overall enhancement to
this blockbuster drug,” said Starpharma
CEO Dr Jackie Fairley.
Oxaliplatin, sold as Eloxatin® by
Sanofi, is primarily used to treat colon
and colorectal cancer and the drug
achieved sales of approximately US$2B
OXALIPLATIN CASE STUDY
Sydney man Ben Bravery commenced
a regime of chemotherapy called
FOLFOX4 which includes oxaliplatin
after he was diagnosed
with stage 3 colorectal cancer in
2011, when he was 28 years old.
Mr Bravery’s cancer was surgically
removed prior to chemotherapy and
has not returned, however he has an
ongoing reminder of the toxicity of his
“I’m reminded on a daily basis of
the chemotherapy I had,” said Mr
Bravery, now aged 31.
“I still have nerve damage in my
fingers and feet, and this is something
I’ll probably have to live with for the
rest of my life. The nerve damage in my
feet is such that I have to check them
regularly for damage – because I won’t
feel small cuts or abrasions, and that
means they could go on to get infected
if I’m not careful.”
Mr Bravery also described the
short-term heightened sensitivity to
cold as like “drinking shattered glass”
if he consumed anything that was not
warm during the week after an infusion
“It was a very uncomfortable and
sharp feeling and can be really painful,”
“With me, it gradually worsened
during chemotherapy whereby I couldn’t
drink beverages at room temperature,
everything had to be heated up or it
would upset my mouth and throat.
“I went through chemo in spring and
summer, but still had to wear gloves
and shoes to keep my hands and feet
warm because they were so sensitive to
the cold. While touching or walking on
cold surfaces wasn’t that painful at the
time, the more you trigger this during
chemo the worse the side-effect
Mr Bravery said he would welcome
a form of oxaliplatin that had a reduced
side-effect profile as “chemotherapy is
already very tough”.
“Anything that reduces the sideeffects
is a good thing. Starpharma’s lab
results are really promising and may go
on to improve the lives of people having
treatment for colorectal cancer in the
Progress continues in agrochemical activities
Starpharma continues its agrochemical
activities with agreements now signed
with the majority of the top 10 agrochemical
companies, the most recent
being with Isagro for a partnership in
fungicides. This builds on our previously
announced agreements this year with
Gowan and Makteshim Agan.
Under the agreement, Isagro will test
Starpharma’s Priostar® dendrimer
technology with a number of its fungicides
to assess potential performance
gains over existing formulations. Isagro is
an agrochemical company with global
sales of approximately €150 million and
own complete formulations of
selected generic actives with enhanced
characteristics. A number of programs
including glyphosate are underway with
additional glyphosate field trials ongoing.
Dendrimers enhance existing
agrochemicals and create patentable
formulations by improving formulation
characteristics such as solubility and
stability which lead to improved
biological performance. New
formulations using Priostar® dendrimers
create superior agrochemical
formulations with a strong patent
position lifting the barrier to entry for
competing products and hence raising
value of the