Gdvmarch Thoughts On UBS-ENZO 10/12/01 Conference. Pt.1-4
FWIW. I felt the value of attending this year's UBS Warburg Third Global Life Sciences Conference was diminished for individual shareholders: I am cognizant the UBS target audience was client-institutional shareholders/analysts and not individual shareholders. Lower overall attendance didn't bother me much: I expected it given NYC's recent tragedies, the local, national and international fall-out; market-related price and industry personnel reductions; enactment of the S.E.C's Fair Disclosure Act this year, and UBS'resultant plans that facilitated no-travel, no-cost-to-listener telephone/replay access to the 430+ conference participants' oral presentations. But the absence of two things did bother me somewhat - i.e., company-related materials and extended post presentation Q & A sessions. IMO, this made it more difficult for individual shareholders to glean as much detailed information as became available in prior years.
First - Re: Company Materiel: In earlier years, long tables in the Conference Registration area were piled high with packets of detailed materiel put together by conference participants. They could be collected and taken home for later review. On 10/12/01 none existed. Other tables contained the usual UBS Warburg-produced manuals identifying participating companies and containing reduced-sized charts and thumbnail background sketches on each. However, on 10/12/01 I did not find laid out any UBS Warburg company research reports updated for the Life Sciences Conference. There were sets of shelves housing conference participants 'press releases - such as, e.g., those put out by Enzo on 10/12/01. Hence, there isn't an Enzo research report to re-print/excerpt on this Enzo board; but see comments in "THIRD" below.
Second - Re: Q & A: What I missed the most was UBS's decision not to provide a separate Breakout (Question and Answer) Session after each oral presentations this year. In prior years much information of greater interest to individual shareholders was gleaned at extended Q&A sessions housed in rooms adjacent to those where the 30-minute oral presentations were held. This year those former Q&A rooms were instead used to increase contemporaneously held oral presentation from 3 to 6. In addition, the 30-minute presentation rule was strictly enforced and next scheduled presenters introduced promptly.
As noted in my summation of last year's UBS Life Science Conference on Anthony's Unofficial Enzo Home Page at http://www.grq.net/enzo/index.html ("Notable Posts"), Barry Weiner's 30-minute oral presentation with slides was followed by an ~45-minute Q&A at which Dr. Dean Engelhardt gave input on Enzo's therapeutic progress and future forward looking plans. So, IMO, the non-provision this year of a realistic interactive Q & A session was a real loss to individual shareholders because, unlike institutional shareholders and analysts, the former may not have as easy work place access to much of the absent materiel and information as do the latter.
Third - Enzo's Oral Presentation: This year Enzo's ½-hour conference presentation is accessible to all for 4 weeks by dialing 1-877-710-5304 (domestic) and 1-402-220-0702 (international). Hence, a detailed report on the its oral presentation is not warranted. I did, however, peruse the post-conference messages on the 10/12/01 Enzo board and observed that no-one mentioned a few points I personally found of interest and will offer below, together with my two cents worth of personal layperson's opinion, interpretation and conjecture - which is all it is unless expressly stated to be otherwise.
1.The UBS Warburg/PaineWebber Research Report on Enzo Biochem, Inc.: One poster did query the status of the UBS person introducing Enzo's presentation. FWIW, I add the following: In the United States, UBS Warburg's Global Healthcare Research Team is divided into various Sections - to wit: Biotechnology; Facilities; Healthcare Information Technology & Outsourcing Bio-informatics; Life Sciences, including Services and Tools; Managed Care; Medical Technology & Supplies; and Pharmaceutical. Outside of the United States are other Healthcare-related divisions.
Geoffrey Harris, an M.B.A (under whose name Enzo's original research report was issued) heads the UBS Biotechnology Section now housed at UBS PaineWebber. That Section covers large (Geoff Harris), small and mid-cap (Andrew Gitkin, B.B.A) biotechs and includes Researchers with special skills in various sub-and-related topics, such as: immune systems, host deficiency, cardiology, cell therapy and gene therapy. Dr. Nessan Bermingham, who introduced Enzo's oral presentation on 10/12/01, has a Ph.D and a focus within the Biotechnology Section on Cell Therapy and Gene Therapy.
After Enzo's presentation I asked Dr. Bermingham: (1)Did UBS prepare a separate updated research report on Enzo for distribution at its Global Life Science Conference? (2) Has UBS finished preparing a "coverage" research report for Enzo -- noting it was mentioned as something forthcoming a year or so ago? (3) If UBS Warburg was still interested in Enzo? (4) Whether UBS had changed its mind about or still maintained its prior stock rating on Enzo? (5) Whether UBS still planned to produce a "coverage" research report on Enzo? (6) If so, when it would be available?
Answers: (1) NO. (2) NO. (3) YES. (4) NO CHANGE; SAME RATING.
(5) YES.
(6) NOT YET FIXED.
2. FINANCIAL GUIDANCE for Fiscal Year 2001 Ended 7/31/01: The playing field was definitely not a level one before enactment of the Fair Disclosure Act. In any event and as confirmed by the telephonic replay, Barry Weiner gave the same guidance to individual and institutional shareholders and the latter's analysts by giving charted and oral comparisons of nine-months published business financial data for FY-2001 against full 12-month figures for FY-2000. The FY-2001 nine-month totals were extremely close to the full annual results for FY-2000. Thus, unlike many other companies at this time -- and in the absence to date of indications of adverse financial news -- I feel it fair to tentatively infer therefrom that full FY-2001 figures due at/or about the last week of this month should at least equal or perhaps even exceed those reached at end of FY-2000. Noted, however, was the fact that unlike the tax-free totals for FY-2000, FY-2001 figures would be post-tax totals because tax credits were fully fully utilized by Enzo earlier this 2001 fiscal year.
3. COMMENTS ON HEP-B PHASE II (Arm or Group 1) Results; Plus GDV Forward-Looking Conjecture: The telephone replay contains the tentative early results found in some of Enzo's Arm/Group 1 of its Hep-B Phase II in Israel. Updated results on all 42 patients in this Group 1 are to be presented in a poster session at the American Association for the Study of Liver Disease ("AASLD") Annual Conference in Dallas, Texas, on November 11, 2001. Thus far, the safety, tolerance and efficacy statistics look very good in comparison with those achieved by existing treatment modalities.
Mention was made of progressing with other Arms of this Hep-B Phase II. In reviewing my abovementioned UBS Conference post on last year's Breakout (Q&A) Session I note forward-looking references therein which were made by Barry Weiner and Dr. Dean Engelhard and referred to the possibility that HBV Phase II may get expanded to include multi-center testing. Thus, if the same "ballpark" results of these early and incomplete Arm 1, Phase II results are reported at the 11/11/2001 AASLD poster session, it is my conjecture that one or more future Arms of this expanded HBV Phase II (currently there are another 3 to complete) will be carried out at trial sites elsewhere in addition to the Israeli site at Hadassah. I suspect enough work has been done in this first Arm of Phase II to warrant that one or more future Arms will recruit a substantial increase in the numbers of trial participants so that Enzo may include and evaluate the traditional control groups used in double-blind studies so as to ensure research results won't reflect bias on the part of the trial investigator(s).
Perhaps it will take at least another 1-1/2 years to complete athe dditional Phase II Arms, especially if the additional multicenter trial sites are not located in Israel. Approval to proceed will be required from other regulatory agencies as will that from out-of-Israel trial site(s)' Institutional Regulatory Boards, etc.
Barry Weiner made clear Enzo will need the collaborative input of entities skilled in manufacturing, marketing and distribution in the third world developing and other international regions in order to successfully disseminate its Hep-B form of oral (i.e., pills and/or liquid) tolerization medicine when it is approved. There are many domestic and foreign pharmaceutical companies having the requisite capacities and international reach. It is my personal opinion that Enzo's oral tolerization pipeline gives it a decided edge in dictating terms and control issues in any such deal(s). This advantage should also inure to Enzo's shareholders' long-term benefit.
FWIW, Barry Weiner's reference to 350-million persons infected by HBV referred to numbers of "chronic" HBV sufferers. World Health Organization statistics indicate that over 2-billion people worldwide are infected by some form of Hepatitis B. Those WHO statistics were issued before China's recent admission that 1-billion of its population have one form or another of Hepatitis B as a result of systemic shared needle practices (including acupuncture) and inappropriate re-infusion nationwide of mixed-shared blood to donor groups.
4. COMMENTS RE: HIV/AIDS TRIALS; Plus GDV Forward-Looking Conjecture: The allotted and strictly enforced 30-minute cut-off of oral presentations left Barry Weiner with limited time to cover many issues of importance to individual shareholders. Hence, there was only a hasty mention of a couple of HIV-related points I personally deem are important in evaluating time-frame, progress and potential viability of Enzo's HIV/AIDS stealth vector and oral tolerization treatments.
Somewhat heated contentions by some RAC members at the Enzo-RAC meeting on 3/8/01 centered on their misguided beliefs the initial part of HIV Phase I at UCSF had not shown an increase in new healthy CD4 cells. Even some RAC members appeared to have difficulty grasping the concept Enzo is using the body's natural means to effect control and, perhaps, eventual defeat of the HIV infection: To me, that at least means whatever is done by Enzo must proceed in partnership with NATURAL TIME. The birth, life, decay and death cycles of healthy and unhealthy cells are a function of predetermined natural time. Enzo is not using synthetic substances to effect an accelerated -- though incomplete and probably toxic or otherwise adverse -- cellular response. TIME WILL TAKE ITS NATURAL TIME to produce results with what the body then has.
In giving new updated HIV information that was not available on 3/8/01 but developed in the fullness of time, Barry Weiner made the following important statements on 10/12/01:
"WE ARE SEEING HIGHER AMOUNTS OF HIV ANTISENSE RNA IN THE CD4 POPULATION, WHICH IS THE NATURAL TARGET OF HIV."
I interpret this to mean further monitoring and testing of the 5 initial Phase I participants since 3/8/01 has not only shown bone marrow engraftment in all 5 patients, as B.W. reported, but has also produced evidence that the new progeny CD4 cells created via its HGTV-43 treatments are -- unlike the initial CD4 cells that HIV kills off and replaces with HIV-infected cells - surviving in a healthy manner AND continue to both increase in number and contain the HGTV-43 treatment. As Barry Weiner said: "THIS IS THE FIRST TIME IN NON-ABLATED ADULTS WE HAVE SEEN A TRANSGENE CONTINUE TO FUNCTION, LET ALONE INCREASE. IT IS A VERY ENCOURAGING DEVELOPMENT."
[COMMENT: A transgene is DNA integrated into the germ-line of transgenic organisms. I.e., Foreign genes introduced into an organism by injection. The animal (and now the person) receiving the injection carries the foreign genes in their genomes and transmits them to their progeny.]
Enzo has done it. To me, Enzo's plan to move forward to create a better way to re-infuse larger quantities of treated gene constructs into HIV-infected individuals, ab initio, so as to produce more HBTV-43 treated CD4 progeny that will outnumber and replace the imprisoned HIV-infected cells eventually dying and clearing without further replication from the infected person's system, is both a logical one and, for me, can't happen soon enough. Hence, as Barry Weiner also confirmed on 10/12/01, if two sites start expanded Phase I's and a third (soon to be named) Phase II site starts work also on ablation by low-level radiation and various types and levels of chemotherapy soon, my personal guestimate is that we will know in 12 to 14 months whether greater quantities of treated transgenes can be both successfully re-infused into HIV-infected individuals and made to work in a manner capable of producing the increasing numbers of treated progeny required to reconstitute the patients'HIV damaged immune systems. If so, Enzo shareholders may see HIV/AIDS and HEP-B revenues in the 2-1/2 to 4-year timeframe I posited 6 to 9 months ago.