AI
Friday, March 17, 2017 12:15:20 PM
3-13-17/CC Re-Read – A few things popped out...
3-13-17/CC: STEPHEN WORSLEY (VP/Bus.Dev.)
“In the near-term, we are aggressively working to expand Avid’s client base, and in Q3 we signed another new client for a late-stage clinical product. We are currently in discussions with a number of prospective new clients, and we expect to sign addl. clients in the coming months.”
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Avid Revs FY17(fye 4-30-17) Guidance upped by +$10mm to $60-65mm. I went back 4 prior years – they’ve never failed to TOP the upper-ends of prior March Guidances. With Revs for 1st 3qtrs = (5.6 + 23.4 + 10.7) = $39.7mm, if they follow suit, Q4 Revs will be at least (65mm – 39.7) = $25mm. ...How close would that get us to Cash-Flow positive for Q4, should it happen? OP. CASH BURN for Q3(1-31-17) was: $6,274,000, and that's with Revs=$10.7mm at GM=26%.
CEO Steve King 3-13-17 AVID addendum: “We are currently on track to install 2 2,000-liter bioreactors in the facility within the next few months, with a book of business for the reactors already in place. We believe the total capacity potential of the facility, when operating in campaign mode, can exceed more than $75mm annually, bringing us to well over $100mm in total potential revenue between our 2 mfg. facilities, providing us with adequate capacity to continue Avid revenue growth through FY’18.”
= = = = = = = = = = =OF COURSE, NASDAQ...
3-13-17/CC: CFO PAUL LYTLE
“We have determined that it is not in the best interest of our stockholders to affect a reverse stock split prior to April 10, 2017. If our share price does not trade above $1 for 10 consecutive trading days by April 10th, we expect to receive a notice of delisting. If we received this notice, we will appeal this decision within the required 7 days and this appeal will stay any delisting actions by NASDAQ. At that point, NASDAQ will schedule a hearing, which is typically held within 45 days, and we will present our plan to regain compliance. We are considering several paths to regain compliance, including having addl. time to continue to allow the market to adjust, to reflect the current value of Avid as evidence with the recent movement in our share price. The hearing panel could afford us up to 180 addl. days to regain compliance, although this addl. time is not guaranteed and this decision is at the discretion of the NASDAQ’s hearing panel.”
= = = = = = = =”OTHER COLLABORATIONS FOR FUTURE CLINICAL STUDIES”
3-13-17/CC/S.King(Q&A): “While the initial Exosomes effort has been focused on ovarian cancer, we do have an interest in implementing this into all of our future clinical studies as a simple blood collection; so including potentially the NCCN studies, for instance, and other collaborations. But also there are sample sources of serum that we can obtain, as well as working with our collaborators at UTSW and Memorial Sloan Kettering to look at other tumor types.
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WHAT OTHER CLINICAL COLLABS MIGHT SURFACE? Only AZN, or somebody else? If MSKCC/Dr. Wolchok runs future Clinical Trial(s), they will have to be Sponsored by somebody – who? Peregrine, or AZN/Collab, or some other Collab??
= = = = = = = = =SUNRISE LONG-TERM SURVIVORS:
3-13-17/CC/JOE SHAN(Q&A): “There are SUNRISE patients still, as we mentioned, still receiving bavituximab, so that gives you an indication that there are patients that are not only, what we call long-term survivors but there are diseases that stabilized. That’s why it's was important that the trial is formally concluded that we allow the patients the opportunity to continue receiving bavituximab under COMPASSIONATE USE. The biomarker analysis is still ongoing, and we’re also hoping to wrap that up in the next few months. Those data will be presented as they’re become available, but the first observation that we’ve reported on already, we mentioned the correlation between beta-2glycoprotein-1 [B2GPI] levels, which is an important protein for bavituximab to bind, so that’s important confirmation of a biomarker for drug activity. And, like I mentioned, there will be a presentation on other cytokine biomarker, interferon gamma [IFN-y], in about 2 weeks time [4-3-17 AACR’17 http://tinyurl.com/zzldh9n ]. Regarding the COMPASSIONATE USE, the procedure varies from country-to-country, but basically, investigators that have patients still receiving bavituximab need to file an IND or expanded access...”
3-13-17/CC/S.King(Q&A):
“We’re obviously seeing a number of patients that are still on therapy who are then coming in for quite now very long extended period of time, we feel like they’re getting benefit… for us that’s one of the reasons we’re still very happy and actually excited about the collaborations at Sloan Kettering & UTSW, in particular, where there’s not just an interest in studying bavituximab in preclinical models, but actually taking some of that data and eventually turning that into clinical indications where the drug excels.”
= = = = = = = = =ASCO’17 A DEFINITE:
3-13-17/CC/S.King(Q&A): “We look forward to keeping everyone updated on those activities AACR, ASCO, and beyond.”
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We know all about AACR’17(April2-4, Jedd Wolchok’s “The Peregrine Show” - see below), but SK confirms something(s) coming at ASCO(June2-6). Possibilities include SUNRISE data on the long-term bavi survivors?, Bavi Biomarkers(a new one)?, and the Bavi+Capecitabine+RAD Rectal Cancer Ph1 IST (n=18) at UTSW, which shows “Final Results 2017” on the 1-17-17 updated Pipeline chart?
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Apr1-5: AACR 2017, WashDC http://tinyurl.com/zdsbds8 - SUMMARY of PPHM’s 5 AACR’17 ABSTRACTS:
1. MSKCC(Wolchok Lab)+PPHM: 4-2-17/1pm #574, “PSTargeting+RAD+AntiPD1 Promotes Anti-Tumor Activity, Melanoma” (same as SITC'16/11-14-16 http://tinyurl.com/js3fca4 )
2. MSKCC(Wolchok Lab)+PPHM: 4-3-17/8am #1651, “PSTargeting+Adoptive TCell Transfer (ACT) Eliminates Adv. Tumors w/o Off-Target Toxicities, Melanoma” <=NEW(2nd) Joint MemSloan(Wolchok Lab)/PPHM study, see: http://tinyurl.com/h3ylrku
3. PPHM: 4-4-17/8am #3652, “PSTargeting+LAG3+AntiPD1 Significantly Enhances Anti-Tumor Activity, Triple- MBC”
4. IMMUNOVACCINE+PPHM: 4-4-17/8am #3657, ”PSTargeting Enhances Anti-Tumor Activity of a Tumor Vaccine(DepoVax), HPV-Induced Tumor” https://www.imvaccine.com
5. PPHM+VANDERBILT+PRECISIONMEDICINE+PROVIDENCECC: 4-3-17/1pm #CT159/25 (Session: Ph2/3 Clinical Trials in Progress), “IFN-y Analysis In Blood & Tissue as a Potential Prognostic and/or Predictive Biomarker” (abstract embargoed, Sunrise Biomarker #3) – MORE on Biomarkers: http://tinyurl.com/jrenezs
Jun2-6: ASCO 2017, Chicago https://am.asco.org (Abstracts: Titles/MidAPR, Full=May17)
3-13-17 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/grhwjvy
...CEO SK: “We believe the recent improvement of stock price is a growing recognition of the value of Avid, and having the full value of the Avid business reflected in our stock price is a top priority.”
3-13-17/CC: STEPHEN WORSLEY (VP/Bus.Dev.)
“In the near-term, we are aggressively working to expand Avid’s client base, and in Q3 we signed another new client for a late-stage clinical product. We are currently in discussions with a number of prospective new clients, and we expect to sign addl. clients in the coming months.”
--------
Avid Revs FY17(fye 4-30-17) Guidance upped by +$10mm to $60-65mm. I went back 4 prior years – they’ve never failed to TOP the upper-ends of prior March Guidances. With Revs for 1st 3qtrs = (5.6 + 23.4 + 10.7) = $39.7mm, if they follow suit, Q4 Revs will be at least (65mm – 39.7) = $25mm. ...How close would that get us to Cash-Flow positive for Q4, should it happen? OP. CASH BURN for Q3(1-31-17) was: $6,274,000, and that's with Revs=$10.7mm at GM=26%.
Period Halozyme Cust-A Other-Custs
FYE 4-30-14 91% 1% 8%
FYE 4-30-15 79% 12% 9%
FYE 4-30-16 69% 26% 5%
Q/E 7-31-16 65% 29% 6%
Q/E 10-31-16 77% 10% 13%
Q/E 1-31-17 29% 56% 15%
CEO Steve King 3-13-17 AVID addendum: “We are currently on track to install 2 2,000-liter bioreactors in the facility within the next few months, with a book of business for the reactors already in place. We believe the total capacity potential of the facility, when operating in campaign mode, can exceed more than $75mm annually, bringing us to well over $100mm in total potential revenue between our 2 mfg. facilities, providing us with adequate capacity to continue Avid revenue growth through FY’18.”
= = = = = = = = = = =OF COURSE, NASDAQ...
3-13-17/CC: CFO PAUL LYTLE
“We have determined that it is not in the best interest of our stockholders to affect a reverse stock split prior to April 10, 2017. If our share price does not trade above $1 for 10 consecutive trading days by April 10th, we expect to receive a notice of delisting. If we received this notice, we will appeal this decision within the required 7 days and this appeal will stay any delisting actions by NASDAQ. At that point, NASDAQ will schedule a hearing, which is typically held within 45 days, and we will present our plan to regain compliance. We are considering several paths to regain compliance, including having addl. time to continue to allow the market to adjust, to reflect the current value of Avid as evidence with the recent movement in our share price. The hearing panel could afford us up to 180 addl. days to regain compliance, although this addl. time is not guaranteed and this decision is at the discretion of the NASDAQ’s hearing panel.”
= = = = = = = =”OTHER COLLABORATIONS FOR FUTURE CLINICAL STUDIES”
3-13-17/CC/S.King(Q&A): “While the initial Exosomes effort has been focused on ovarian cancer, we do have an interest in implementing this into all of our future clinical studies as a simple blood collection; so including potentially the NCCN studies, for instance, and other collaborations. But also there are sample sources of serum that we can obtain, as well as working with our collaborators at UTSW and Memorial Sloan Kettering to look at other tumor types.
–-----
WHAT OTHER CLINICAL COLLABS MIGHT SURFACE? Only AZN, or somebody else? If MSKCC/Dr. Wolchok runs future Clinical Trial(s), they will have to be Sponsored by somebody – who? Peregrine, or AZN/Collab, or some other Collab??
= = = = = = = = =SUNRISE LONG-TERM SURVIVORS:
3-13-17/CC/JOE SHAN(Q&A): “There are SUNRISE patients still, as we mentioned, still receiving bavituximab, so that gives you an indication that there are patients that are not only, what we call long-term survivors but there are diseases that stabilized. That’s why it's was important that the trial is formally concluded that we allow the patients the opportunity to continue receiving bavituximab under COMPASSIONATE USE. The biomarker analysis is still ongoing, and we’re also hoping to wrap that up in the next few months. Those data will be presented as they’re become available, but the first observation that we’ve reported on already, we mentioned the correlation between beta-2glycoprotein-1 [B2GPI] levels, which is an important protein for bavituximab to bind, so that’s important confirmation of a biomarker for drug activity. And, like I mentioned, there will be a presentation on other cytokine biomarker, interferon gamma [IFN-y], in about 2 weeks time [4-3-17 AACR’17 http://tinyurl.com/zzldh9n ]. Regarding the COMPASSIONATE USE, the procedure varies from country-to-country, but basically, investigators that have patients still receiving bavituximab need to file an IND or expanded access...”
3-13-17/CC/S.King(Q&A):
“We’re obviously seeing a number of patients that are still on therapy who are then coming in for quite now very long extended period of time, we feel like they’re getting benefit… for us that’s one of the reasons we’re still very happy and actually excited about the collaborations at Sloan Kettering & UTSW, in particular, where there’s not just an interest in studying bavituximab in preclinical models, but actually taking some of that data and eventually turning that into clinical indications where the drug excels.”
= = = = = = = = =ASCO’17 A DEFINITE:
3-13-17/CC/S.King(Q&A): “We look forward to keeping everyone updated on those activities AACR, ASCO, and beyond.”
---------
We know all about AACR’17(April2-4, Jedd Wolchok’s “The Peregrine Show” - see below), but SK confirms something(s) coming at ASCO(June2-6). Possibilities include SUNRISE data on the long-term bavi survivors?, Bavi Biomarkers(a new one)?, and the Bavi+Capecitabine+RAD Rectal Cancer Ph1 IST (n=18) at UTSW, which shows “Final Results 2017” on the 1-17-17 updated Pipeline chart?
----
Apr1-5: AACR 2017, WashDC http://tinyurl.com/zdsbds8 - SUMMARY of PPHM’s 5 AACR’17 ABSTRACTS:
1. MSKCC(Wolchok Lab)+PPHM: 4-2-17/1pm #574, “PSTargeting+RAD+AntiPD1 Promotes Anti-Tumor Activity, Melanoma” (same as SITC'16/11-14-16 http://tinyurl.com/js3fca4 )
2. MSKCC(Wolchok Lab)+PPHM: 4-3-17/8am #1651, “PSTargeting+Adoptive TCell Transfer (ACT) Eliminates Adv. Tumors w/o Off-Target Toxicities, Melanoma” <=NEW(2nd) Joint MemSloan(Wolchok Lab)/PPHM study, see: http://tinyurl.com/h3ylrku
3. PPHM: 4-4-17/8am #3652, “PSTargeting+LAG3+AntiPD1 Significantly Enhances Anti-Tumor Activity, Triple- MBC”
4. IMMUNOVACCINE+PPHM: 4-4-17/8am #3657, ”PSTargeting Enhances Anti-Tumor Activity of a Tumor Vaccine(DepoVax), HPV-Induced Tumor” https://www.imvaccine.com
5. PPHM+VANDERBILT+PRECISIONMEDICINE+PROVIDENCECC: 4-3-17/1pm #CT159/25 (Session: Ph2/3 Clinical Trials in Progress), “IFN-y Analysis In Blood & Tissue as a Potential Prognostic and/or Predictive Biomarker” (abstract embargoed, Sunrise Biomarker #3) – MORE on Biomarkers: http://tinyurl.com/jrenezs
Jun2-6: ASCO 2017, Chicago https://am.asco.org (Abstracts: Titles/MidAPR, Full=May17)
3-13-17 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/grhwjvy
...CEO SK: “We believe the recent improvement of stock price is a growing recognition of the value of Avid, and having the full value of the Avid business reflected in our stock price is a top priority.”
