Here is What I Hear
Things are looking up.
TOP TWO POINTS:
Company is increasingly confident that the long-awaited Duke/CHAVI publication in a prestigious journal will happen in March. It will feature multiple PPHM antibodies and constructs, not just Bavi. Through monkey SIV data and other pre-clinical studies, it is expected the publication will confirm to the world that American science is indeed on the doorstep of a huge breakthrough in immunotherapy for viral disease. The Company is expecting the article to present Bavi’s MOA as a centerpiece of that breakthrough.
Because Cotara GBM in India and Breast Cancer in Georgia are not “blinded” studies, Mgmt. can be, and will be, “opportunistic” (i.e. aggressive) in releasing multiple rounds of interim data. First Cotara update will be in February and first Georgia Ph II cancer data release could be as early as April or May. See below.
DETAILS BY TOPIC:
J.P. MORGAN CONFERENCE:
Mgmt. just returned yesterday from the large J.P. Morgan Health Care Conference in San Francisco. Prospective strategic BP partners, prospective analysts and prospective institutional investors were all in attendance. Several of these companies contacted PPHM before the conference to set up private meetings. Interest expressed was “very encouraging.”
Q: Do other analysts stay away now that R&R has locked up the IB relationship?
A: Just the opposite. It’s well known that the first report is always the hardest to get. Other analysts are much more likely to jump on board now, as new clinical data begins to flow over next several months.
COTARA UPDATE IN FEBRUARY:
The Cotara clinical update in February will cover (1) U.S. dosimetry data, (2) individual survival stories (like Phil at U.Penn) and (3) first 8-10 patients who completed Phase II dosing in India.
“Blinded” studies involving a control group are adversely affected by release of interim data, but in non-blinded studies like the Cotara Ph II study in India, interim data can be released at Company’s discretion. Given this latitude, and given the current pps, Mgmt. is going to release Cotara data “opportunistically.” First interim release will include data from 20-25% of India Ph II patients. Second interim release will include data from 50% of the study group, and final interim release will be on data from all 40 patients.
Note that these are first relapse patients for whom SOC median Time To Progression (TTP) is 9 weeks and SOC Median Survival Time (MST) from date of first relapse is six months. Thus meaningful TTP data is already available for the Indian Cotara patients treated in October, and meaningful MST data for patients treated in October will be available in February, i.e. six months after Sept. (note: a patient treated in October was probably diagnosed as a relapse in Sept. and six months is measured from date of relapse diagnosis).
The take-away point is that Cotara enrollment is now at full speed in India and Mgmt. intends to release interim data on this trial frequently starting in Feb. and continuing every 6-8 weeks as better and better TTP data and MST data keep rolling in.
GEORGIA PH II BREAST CANCER TRIAL
Start of enrollment will be PRed in late January (i.e. in next two weeks) and start of dosing should be PRed just a few weeks later. Like Cotara, this is not a “blinded” study so Company can release interim data aggressively.
In the PR announcing enrollment, Company will indicate the minimum number of responding patients that will be sufficient to trigger enlargement of the trial from 15 to 46 patients. For example, [5?] responding patients could be enough to enlarge the trial. Given that with chemo/SOC only 30% of first relapse patients respond, and given that in the India Ph I trial with extremely sick death-row patients Bavi achieved a 50% response rate in breast tumors (2 out of 4), Mgmt. is very hopeful they will be able to announce expansion of the trial to the full 46 patients after just a fraction of the first 15 patients have been treated. If enrollment stays on track, this PR (i.e., that trial is being expanded due to dramatic remission rate in early patients) could happen in April or May because the relatively healthy, 1st relapse patients in Georgia who are dosed in Feb. may not need 8 weeks to show tumor remission.
It was good to see that the Company is structuring the trial so as to be as aggressive as possible in getting results published quickly.
Some other good news from Georgia is that local doctors there are confident the Ph. II trial will enroll very quickly because this will be the first time Docetaxel has ever been available to cancer patients in Georgia (Wow!) and that alone, even without combo Bavi dosing, will be a huge advance over SOC in Georgia. Makes you think about the stuff we take for granted in America.
HCV/HIV CO-INFECTION TRIAL
With three centers now enrolling patients, Company expects enrollment to complete in 1H08. Interim data may be released in late 1H08 as well, but first data release could slip into July or August. Unfortunately, unlike straight HCV patients, in co-infected population many patients have a life-style which does not allow them to pass pre-trial screening process (e.g. it’s not realistic to expect they will show up for 8 consecutive weeks). This is why two additional centers had to be added to Stephen Smith cite in N.J. Enrollment is now on track at all three centers. Mgmt believes late spring is realistic time for completing enrollment, and early or mid summer is realistic for releasing results. Unlike Cotara in India and Bavi in Georgia where the Company volunteers info. on its “opportunistic” approach to data release, I heard nothing either way (and I forgot to ask) whether interim data from the early co-infection patients might be released this spring.
BAVI PH II LUNG and BREAST TRIALS IN INDIA
Tone of voice seems more confident that regulatory approval of these trials is now imminent, but Mgmt admits they’ve been expecting trial to start “any day now” for quite some time.
DUKE / CHAVI: I’ll repeat what I said at the top:
Company is increasingly confident that the long-awaited Duke/CHAVI publication in a prestigious journal will happen in March. It will feature multiple PPHM antibodies and constructs, not just Bavi. Through monkey SIV data and other pre-clinical studies, it is expected the publication will confirm to the world that American science is indeed on the doorstep of a huge breakthrough in immunotherapy for viral disease. The Company is expecting the article to present Bavi’s MOA as a centerpiece of that breakthrough.
SALE OF AVID: No sale of any interest will happen unless it’s absolutely clear PPHM has priority rights to fulfill all its clinical-trial needs first. Some analysts are encouraging Mgmt. to sell off a minority interest in Avid because it would make PPHM look more like other biotech companies and therefore make it easier to value.
LICENSE OF ONE OR MORE NON-CORE ASSETS (like VEA or 2C3) is on front-burner and could be announced soon. However, such a non-core license of a pre-clinical product will not, by itself, raise enough capital to fund another year of Ph II clinical trials. I heard the pps would have to be north of $2.50 in order for a sale of stock to be an alternative to a sale of a minority interest in Avid.
My personal guess (not something I heard) is that discussions are already underway to sell a piece of Avid but the transaction won’t close until May in order to see how the market reacts to the Duke / CHAVI publication and subsequent media coverage.
WHY NO INSIDER BUYING AT THESE PRICES. Mgmt. is very aware that their options have an average price of $1.49 and they could buy stock today in open market for much less. I heard the SEC window for such open market purchases by Mgmt. is not currently available because the near-term release of material clinical and pre-clinical data is now clearly visible to insiders.
REVERSE SPLIT. PPHM Board of Directors has not considered, and is not considering, a reverse stock split. It’s simply not on the table at this time.
NASDAQ LISTING EXTENSION from Jan 22 to July 22 is “in the bag.” Company has no concerns in this regard.
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