To those that have studied the company and its prospects, its much closer to an investment than a gamble. A gamble would be a one trick pony, Stellar has its tentacles into many companies and trials. Only one has to hit to make people money. More than one hits and the sky is the limit.
PORT HUENEME, CA--(Marketwired - Nov 25, 2013) - Stellar Biotechnologies, Inc. ("Stellar" or "the Company") (OTCQB: SBOTF) (TSX VENTURE: KLH), the world leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), announced today that the Company's President and CEO Frank Oakes will present at the Sixth Annual LD Micro Conference to be held at the Luxe Sunset Boulevard Hotel in Los Angeles, on December 4, 2013 at 8:00 am PT.
Mr. Oakes will provide an update on the Company's Stellar KLH™ technology, recent accomplishments, and 2014 objectives. His presentation will be followed by a breakout Q&A session. Additional members of Stellar's executive team will attend and be available to discuss the Company's programs over the 3-day event.
It was great. Had John Pizzi doing comedy and magic. Big crowd, nice weather... lots of dancing. Crazy big fog machine pumping the low fog out, it was a blast. Too bad they don't let me post pictures. Ooops, I don't want to be accused of pumping my party.....
Wish I could take credit for it, just found it on Seeking Alpha, written by some guy named Smith on Stocks
I'm a stockholder, in at the ipo. I post info when I find it. Been on this board for years, been very quiet since this thing caught fire and lots of people suddenly came to this board. Hope your stock picks are better than your intuition.
To date, 31% of screened patients are EGFRvIII+. 47 patients (Group 1=22, Group 2=25) have been enrolled, and 23 (Group 1=12, Group 2=11) continue treatment. Primary treatment-related toxicity was Grade 1-2 injection site reaction. Rindopepimut-induced anti-EGFRvIII humoral responses are robust (median peak titer [range] = 1:12,800 [1:100-1:3,276,800]), similar or higher to those in rindopepimut studies of newly diagnosed GB, and greatest in BV-refractory patients. Of 17 Group 2 patients evaluable for response (investigator-assessed; RANO criteria), one Complete Response (32+ weeks duration; peak anti-EGFRvIII titer=1:3,276,800) and one Partial Response (at week 8; subsequent confirmation pending) have been observed. 5/17 (29%) had PFS 8 weeks. Preliminary data show that rindopepimut+BV can induce remarkably potent EGFRvIII-specific immune response and objective tumor response in immunosuppressed patients refractory to BV. Full response, PFS and OS data for both groups are expected to further define the potential clinical benefit of the combination in relapsed GB.
1Dana-Farber Cancer Institute, Boston, MA, USA, 2Stanford University School of Medicine, Stanford, CA, USA, 3Baylor Research Institute, Dallas, TX, USA, 4University of Alabama, Birmingham, AL, USA, 5Washington University, St. Louis, MO, USA, 6Duke University Medical Center, Durham, NC, USA, 7Utah Cancer Specialists, Salt Lake City, UT, USA, 8The Long Island Brain Tumor Center at Neurological Surgery, P.C, Lake Success, NY, USA, 9Texas Oncology, Austin, TX, USA, 10Celldex Therapeutics, Inc., Needham, MA, USA
EGFRvIII is a constitutively active tumorigenic deletion mutation of EGFR, expressed in ~30% of primary glioblastoma (GB) and linked to poor long-term survival. The investigational vaccine rindopepimut consists of the unique EGFRvIII peptide sequence conjugated to keyhole limpet hemocyanin (KLH), delivered intradermally with GM-CSF as an adjuvant. Three phase II studies of rindopepimut in newly diagnosed, resected, EGFRvIII+ GB have supported improvements in progression-free survival (PFS) and overall survival (OS), compared to contemporary cohorts matched for major eligibility criteria. Bevacizumab (BV), which inhibits VEGF and its immunosuppressive properties, may augment EGFRvIII-specific immune response and antitumor activity in patients with advanced GB. ReACT is a Phase II study of rindopepimut plus BV in patients with 1st or 2nd relapse of EGFRvIII+ GB. BV-naïve pts (Group 1; n=70) are randomized 1:1 to BV plus double-blinded injection of either rindopepimut or control (KLH). BV-refractory patients (Group 2, n=25) receive BV plus open-label rindopepimut.
Of the 600 recurrent glioblastoma patients, we don't know how many patients would be Avastin resistant. Hence, the addressable patient population is some fraction of 600. While this is a very small patient population, the approval for this narrow indication could be very important commercially. Once approved, it could lead to off-label use in newly diagnosed patients as well. And as previously noted, I am also expecting that rindopepimut could be priced at $100,000 per course of therapy so that 600 patients represents an addressable market of as much as $60 million in the U.S. and $120 million worldwide.
I have included a copy of the abstract that has already been released.
ReACT: a Phase II study of rindopepimut vaccine (CDX-110) plus bevacizumab in relapsed glioblastoma
David Reardon 1, Gordon Li2, Lawrence Recht2, Karen Fink3, Louis Nabors4, David Tran5, Annick Desjardins6, Nitin Chandramouli7, J. Paul Duic8, Morris Groves9, Anne Clarke10, Thomas Hawthorne10, Jennifer Green10, Michael Yellin10, John Sampson6
The data release relates to 25 patients enrolled in one arm of the Phase II ReACT trial in recurrent GBM. Patients with recurrent GBM have the expectation of six to nine months of median overall survival. They can be treated with Avastin, Gliadel Wafer as an adjunct to surgery (seldom used), surgery or just supportive care. These particular 25 patients were part of an arm of ReACT that enrolled patients who did not respond to Avastin. The August 12th announcement of the trial expansion obviously raised the expectation that rindopepimut had produced a clinically meaningful improvement.
The question is what constitutes a clinically meaningful improvement in recurrent GBM patients who are resistant to Avastin. I note that Avastin was approved in recurrent GBM on the basis that it produced tumor shrinkage in about 28% of patients, increased progression free survival by about 4.2 months but had no effect on median overall survival. Could it be the case that rindopepimut also might be approved on the basis of improvement only in progression free survival without an increase in median survival? Remember that these patients have very short survival expectations and have no viable drug option. Because of these factors, it is possible that this narrow indication could be a quick route to approval for rindopepimut.
This promises to be an important event for the stock. What is my prediction on the outcome? I think the data will be encouraging. However, this is based almost totally on the emphasis that Celldex has put on the data. Based purely on the science as I understand it, I would have been skeptical. I am extremely interested in seeing the data and hearing Celldex interprets it.
Background for Conference Call on Monday
Celldex announced on August 12, 2013, that it had completed enrollment in an initial cohort of 25 patients who were refractory to Avastin. Based on preliminary evidence of stable disease, tumor shrinkage and investigator-reported response, the company decided to add an expansion cohort of approximately 75 patients to better characterize the potential activity of rindopepimut in this refractory patient population.
The results in the 25 initial patients will be reported at the Society for Neuro-Oncology Annual Meeting of November 21 through 24 in San Francisco. The embargo on the abstract was lifted on Monday, November 11, and available on the SNO website. I have included a copy of the abstract in the appendix of this report. It has been accepted as an oral presentation and is entitled "ReACT: a Phase 2 Study of Rindopepimut Vaccine (CDX-110) Plus Bevacizumab in Relapsed Glioblastoma." The oral presentation will be made in a session lasting from 10:20 AM to 12:00 PM on Sunday, November 24. On Monday, November 25, at 8:30 am EST, management will also hold a conference call to review the data.
The conventional wisdom is that cancer vaccines/immunotherapy should be used as close as possible to initial diagnosis and surgery because it takes a long time to take effect. If so, rindopepimut would be expected to have little chance to work in the recurrence of an aggressive cancer like glioblastoma. Also, rindopepimut targets a single antigen, EGFRvIII, and many people believe that a cancer vaccine should target several antigens to be effective. Finally, some have suggested that there is less EGFRvIII expression in recurrent glioblastoma than newly diagnosed glioblastoma than recurrent. If so, rindopepimut would be expected to be more effective in newly diagnosed glioblastoma (for which Phase III data is some time off) than recurrent glioblastoma.
The conference call on Monday should be very interesting and may give us new insights into rindopepimut and perhaps cancer vaccines overall. There should be more data in the oral presentation than in the abstract that has already been published. The data in the abstract is several months old. In recurrent glioblastoma, this is a long time so that the data will be more mature and hopefully more meaningful.
Rindopepimut vaccine contains KLH:
Celldex (CLDX) has raised expectations for positive results for rindopepimut in recurrent glioblastoma. It will hold a conference call on Monday, November 25 at 8:30 AM to discuss results on the use of rindopepimut in recurrent glioblastoma. The actions of Celldex clearly indicate that the data will be positive. The recently published abstract of the paper on which this presentation partially will be based, indicated that there was an immune response to rindopepimut and that there was one complete response and one objective response out of 25 patients for an overall response rate of 8%.
I find the data interesting from this standpoint. There is widespread skepticism on Wall Street and in the medical community that any cancer vaccine will be effective. There has been one cancer vaccine approved and that was Dendreon's (DNDN) Provenge. However, there were a long string of failures before the Provenge approval and some after.
Even among people like me who are hopeful that cancer vaccines/immunotherapy can be the next great breakthrough in oncology, the data causes me to scratch my head.
Mr. McPartland's background includes guiding the development and execution of corporate strategy for private and public companies at all stages of their commercial evolution, including early- and mid-stage biopharmaceutical entities. His experience prior to MZ Group includes Vice President and Partner at Alliance Advisors, LLC where he specialized in the implementation of capital markets strategy, market positioning and financial communications; and Regional Vice President of Hayden Communications, Inc. where he led investor relations and corporate communications programs for micro and small cap companies. Mr. McPartland holds a B.S. in Business Administration and Marketing from Coastal Carolina University.
"Mark joins Stellar at an exciting growth phase for the Company," said Frank Oakes, Stellar's President and CEO. "We are poised to execute on multiple goals and Mark's experience is ideal for establishing the strong collaborations and broad exposure we will need in the capital markets, and among commercial partners and shareholders."
Mark McPartland said, "I've had the great pleasure to work closely with Stellar for the past year and seen first-hand how the Company's core KLH technology is a gateway to so many strategic opportunities. I am very keen to build on the foundation already established and help guide Stellar's future success. I am honored to be a part of such a dynamic and passionate team."
Stellar Biotechnologies, Inc. ("Stellar" or "the Company") (OTCQB: SBOTF) (TSX VENTURE: KLH), announced today the appointment of Mark A. McPartland as Vice President of Corporate Development and Communications. Mr. McPartland will report to Frank Oakes, President and CEO of Stellar Biotechnologies. Mr. McPartland will lead Stellar's corporate development and investor-related programs including management of stakeholder relationships, commercial collaborating, capital markets strategy, external communications, media relations, and public affairs. Additionally, he will collaborate in the development of corporate strategy and serve as primary point of contact to the investment community.
Mr. McPartland joins Stellar with over 16 years experience in business development, capital markets advisory, corporate communications and C-suite consulting. Prior to joining Stellar, he served as Senior Vice President at MZ Group, a subsidiary of @titude Global, the world's largest independent global investor relations ("IR") consulting firm. For the past year, MZ Group has served as Stellar's IR consulting agency and Mr. McPartland was the key liaison with senior management and the company's stakeholders.
We also note that we currently do not model a contribution from the recently launched Exosome Sciences business, which could potentially provide some upside to both the income statement as well as cash flow, potentially even in the near 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.
Aethlon exited fiscal Q2 with $9k in cash and equivalents, compared to $32k at the end of fiscal Q1 2013 (6/30/2013). However subsequent to fiscal Q2 quarter end the company shored up its cash position. Subsequent to quarter end and through November 13th AEMD collected an additional $233k from government contracts. In addition, in October they raised $230k (gross) from the sale of common stock with warrants. The company also continues to make progress with cleaning up its balance sheet with converting some outstanding and non-performing debt to equity.
Cash used in operations was $522k in Q2. 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. As we've noted in the past, AEMD has been very successful in raising operating capital on an ongoing basis.
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.
Milestone 126.96.36.199 – Cartridge construction with optimized affinity matrix design for each potential target. Complete the capture agent screening. The milestone payment was $208,781. Management considers this milestone to be substantive as it was not dependent on the passage of time nor was it based solely on another party's efforts. We completed the cartridge construction with optimized affinity matrix design for each potential target and completed the capture agent screening. The report was accepted by the contracting officer's representative and the invoice was submitted thereafter.
Milestone M5 – Target capture 90% in 24 hours for at least three targets in blood or blood components. The milestone payment was $208,781. Management considers this milestone to be substantive as it was not dependent on the passage of time nor was it based solely on another party's efforts. We demonstrated that we were able to capture 90% in 24 hours for at least three of the agreed targets in blood or blood components. The report was accepted by the contracting officer's representative and the invoice was submitted thereafter.
As a reminder, DARPA has the option of entering into the remainder of the proposed contract for years four and five, which would pay Aethlon up to an additional $1.7 million.
Q2 operating expenses were $875k, well below our $1.2 million estimate and the lowest since fiscal Q2 2012 (ending 9/30/2011). This is a result of management's focus on conserving resources and keeping op expenses to a minimum as well as lower litigation and investor relations expense. This is the second straight quarter that op expenses have come in well below our estimate. Operating loss was just $230k, significantly better than our $756k loss estimate. Q2 net income and EPS were ($3.4) million and ($0.02) and included a $3.0 million non-cash expense related to change in derivative liability - which is a result of the increase in the common stock price through Q3.
On the operational front, the last few months have been particularly productive. In addition to completing and receiving payment for DARPA milestones and commencing and being paid for work under the Battelle contract, AEMD officially launched their Exosome Sciences subsidiary and opened a lab in New Jersey where that business will work from. The company also announced that they expect to begin manufacturing the Hemopurifier to be used in the FDA approved study and further noted that they now have a processing technique that optimizes the ability of the affinity agent in the device to bind to blood borne viruses and pathogens. AEMD expects manufacturing to be completed by the current year-end. They expect patient treatment for the study to begin in Q1 2014.
Noteworthy is that among the DARPA milestones completed in Q2 was one related to the capture of at least 90% of three or more targeted substances from the blood in 24 hours. The milestone paid in Q2 related to the year-2 DARPA contract is (per AEMD's 10-Q);
Milestone 188.8.131.52 – Write and test software and conduct ergonomic research. Begin discussions with the systems integrator. The milestone payment was $195,581. Management considers this milestone to be substantive as it was not dependent on the passage of time nor was it based solely on another party's efforts. We obtained wrote and tested software and conducted ergonomic research and began discussions with the systems integrator. The report was accepted by the contracting officer's representative and the invoice was submitted thereafter.