Friday, September 12, 2014 2:51:36 PM
9-10-14: Piper-Jaffray, Roth, and MLV Updates on PPHM
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I. 9-10-14/P-JAFFRAY/C.Duncan: “Piper First Call Note: Cash & Phase III Enrollment Bode Well For 2016 News”
• In the coming months [MSTO/Oct30-Nov1, SITC/Nov6-9], Peregrine expects to announce results from Phase II studies of bavi in 1st-line NSCLC and in Hepatocellular (Liver) Carcinoma (+ sorafenib). Peregrine continues to take a broad approach in early studies of bavi. The company is interested in expanding clinical investigations of bavi in combination with checkpoint inhibitors, including PD-1 agents and other components.
• Bavi to the rescue? In addition to its known effects on leukocytes, management hinted about data concerning an even broader immunomodulatory role for bavi. This data, likely to be presented at SITC, could provide an avenue to augment the function of previously tested, underperforming vaccine candidates.
[Nov6-9: SITC 2014: 29th Annual Mtg, Natl-Harbor MD http://tinyurl.com/o3e498c ]
• Keep riding until SUNRISE: Peregrine's top clinical program, the Phase III SUNRISE program, currently has almost 140 sites globally, positioning the company to keep its recruitment efforts on schedule. The company's cash position is stable enough to ensure continued operations at least through the next 12mos, allowing them to enroll patients into the study. However, supplementary funding will be required to complete the SUNRISE program.
CONCLUSION
Peregrine reported F1Q15 earnings, ending the quarter with $73.3M in cash, bolstered by $9.5M in proceeds from the Series E preferred stock. At qtr-end, $20M (of $30M) of the Series E remained available to issue. Guidance for FY15 revenues was maintained at $19-23M. While we think this may prove conservative as the company had just over $22M in revenues for FY14, we are reducing our FY15 projections to the top-end of guidance. Lead Phase III study, SUNRISE, for bavi in 2nd-line NSCLC remains on track for completion of enrollment of approx. 600 patients by YE15. Additional early data is expected at the Society of Immunotherapy for Cancer (SITC) meeting Nov. 6-9 for melanoma & breast cancer (preclinical). Bavi has a mechanistic rationale that supports potential utility in oncology & infectious disease and we reiterate our Overweight rating and $4 price target on Peregrine.
*end*
Piper Jaffray/Charles Duncan - init. 3-5-13 OverWgt/PT=$4.00
…P.Jaffray Research: http://www.piperjaffray.com/3col.aspx?id=103
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II. 9-10-14/ROTH/J.Pantginis: “PPHM FY15Q1 Results; Broadening Bavituximab's Profile”
PPHM announced FY15/Q1 results, reporting EPS of ($.08), compared to our and the consensus estimate of ($.06). Total revenues for 1Q15 were $5.5mm vs. our est. of $5mm and consensus est. of $6mm. With IST data readouts in the upcoming months, we believe mgt. will be able to leverage that into expanding bavis profile and further drive partnership discussions. The company ended Q1 (7-31-14) with $73.3mm in cash, which mgt. believes is sufficient to fund operations for ~12 mos. PPHM reiterated guidance for contract mfg. revenue for FY2015 of $19-$23mm.
Reiterate Buy and $5 target.
IMPACT
Alongside the SUNRISE Phase III study ongoing in over 130 sites, there will be addl. focus on data readouts from other programs in the upcoming months:
1) The Phase I/II study of bavituximab in combination with sorafenib in Hepatocellular (Liver) Carcinoma will have data presented at the Annual Meeting of the Society for the Immunotherapy of Cancer in early November [Nov6-9: SITC 2014: 29th Annual Mtg, Natl-Harbor MD http://tinyurl.com/o3e498c ].
2) The Phase Ib of bavituximab in combination with carboplatin+pemetrexed in untreated stage IV NSCLC will have preliminary data presented at the Chicago Multidisciplinary Symposium in Thoracic Oncology [Oct 30-Nov1: MSTO/Chicago http://tinyurl.com/p2l43mt ] in late October.
Additionally, PPHM will present more data from the immuno-oncology program combining bavituximab with other immunotherapies, specifically, an anti-PD-1 checkpoint inhibitor, at SITC.
Data from the Liver Cancer study as well as from the immuno-oncology program should increase visibility, driving up potential partnering interest for bavituximab. Recall that PPHM also indicated that it is looking to expand bavituximab's profile into other indications, particularly in Breast Cancer. At ASCO 2014, PPHM presented data from an IST of bavituximab+paclitaxel in HER2-neg. metastatic breast cancer, showing that 85% of patients achieved ORR, with 15% achieving CR by RECIST.
ACTION
We reiterate our Buy rating and $5 target. With Peregrine being a pivotal stage company, we view the risk/reward profile as favorable, and we believe visibility from the broadening bavituximab profile and partnering potential should drive the stock in 2014.
*end*
Roth Capital/Joe Pantginis - init. 7-15-10 Buy/PT=$10, CURR: Buy/$5 http://www.roth.com
. . .Universe (click link bottom right): http://roth.bluematrix.com/docs/pdf/BLUE.pdf
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III. 9-10-14/MLV/G.Zavoico: “Peregrine Pharmaceuticals, Inc. Upcoming Trial Newsflow & Sound Financial Position Provides Light Before SUNRISE”
Yesterday, after markets closed, Peregrine Pharmaceuticals, Inc. reported its FY15Q1 results (ending 7-31-14) and provided updates on its ongoing clinical trials. Peregrine is in a favorable financial position, with cash to yr-end CY2015 (4-30-15), and it is maintaining full-year revenue guidance for its Avid Bioservices division. Moreover, we anticipate steadier news flow from several ongoing ISTs of bavituximab, culminating with completion of patient enrollment in its Phase III SUNRISE trial by yr-end CY2015, and interim & topline results about 6 & 12 mos later, respectively. We believe positive results from ongoing ISTs will generate investor & partnering interest and, together with results of preclinical studies, will establish bavituximab as an immune checkpoint inhibitor that is amenable to a variety of drug combinations and efficacious in multiple cancer types. We reiterate our BUY recommendation and $3.50 1-yr price target for Peregrine Pharmaceuticals, Inc.
• SUNRISE UPDATE: About 30 new clinical sites were activated during FY15Q1 for the Phase III SUNRISE trial of bavituximab in combination with docetaxel vs. docetaxel alone as 2nd-Line treatment of NSCLC. Nearly 140 sites are now recruiting patients. Peregrine has guided to full enrollment of almost 600 patients by end of CY2015 and the first interim data readout in mid-CY2016.
• NEWSFLOW:
• Interim results of a Phase Ib IST of bavituximab with carboplatin & pemetrexed in patients with previously untreated Stage IV NSCLC will be presented at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology in late October [Oct 30-Nov1: MSTO/Chicago http://tinyurl.com/p2l43mt ].
• Final results of a Phase I IST of bavituximab with paclitaxel in patients with HER2-negative Metastatic Breast Cancer was submitted for publication and should appear in press shortly.
• The Phase II portion of a Phase I/II IST of bavituximab with Sorafenib in patients with advanced Hepatocellular Carcinoma [Liver Cancer] completed enrollment and results are expected to be presented an upcoming medical conference [Nov6-9: SITC 2014: 29th Annual Mtg, Natl-Harbor MD http://tinyurl.com/o3e498c ].
• AVID REVENUE ON TARGET; at least 12 mos of cash. Peregrine's wholly-owned contract mfg. subsidiary continues to provide an important source of non-dilutive revenue, generating $5.5mm in revenue in FY15Q1. Peregrine reiterated its prior full-yr FY2015 revenue guidance of $19-23mm. Peregrine's net loss was $14.2mm, or $.08/sh in FY15Q1 (vs. $7.6mm $.05/sh in FY14Q1). The higher loss was attributable to expenses associated with ramping up of the SUNRISE trial. Peregrine said its $73.3mm in cash & cash equivalents on 7-31-14 will be sufficient to fund SUNRISE and preclinical studies to the end of CY2015 [4-30-14]. Currently, the budget does not include initiation of addl. trials in other indications. We project cash burn to increase throughout FY2015 as additional sites begin patient enrollment.
• VALUATION/RISKS. We use a discounted cash flow (DCF) analysis with projections to 2028 and a 20% discount rate and a 5% terminal growth rate. Risks include: slower than expected enrollment or negative results from SUNRISE, negative results from bavituximab trials in other indications, Avid revenue growth slower than projected, and potential dilutive financings.
*end*
MLV/George B. Zavoico - init. 2-8-10 Buy/PT=$10, CURR: Buy/$3.50 http://www.mlvco.com
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9-9-14 QTLY. CONF. CALL (King/Hutchins/Shan/Lytle) Transcript http://tinyurl.com/ktrfswj
...CEO S.King: “In addition to our clinical trials, many of which have also have translational data points built in to tie together pre-clin. data with the clinic, we have also continued to build momentum in our pre-clin. collaborations which now number in the dozens. We are evaluating new combinations & dosing strategies combining bavituximab with chemotherapy, radiation, and immune-oncology approaches, including those targeting CTLA-4, PD-1, as well as other downstream immune checkpoints."
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Sep26-30: ESMO 2014 (Eur. Society for Medical Oncology), Madrid http://www.esmo.org/Conferences/ESMO-2014-Congress (Industry Partner: Peregrine Pharm.)
Oct6: CRI’s 22nd Annual Intl. Cancer Immunotherapy Symposium - "Cancer Immunotherapy: Out of the Gate”, NYC http://tinyurl.com/kvcbggw
Oct 30-Nov1: Multidisciplinary Symposium on Thoracic Oncology (MSTO), Chicago http://tinyurl.com/p2l43mt Sponsors: ASTRO, ASCO, IASLC, Univ/Chicago
...Per VP Joe Shan 9-9-14: “Data from the Ph.Ib IST Univ-Pitt. Bavituximab+CP/1stLine/Stage4/NSCLC” (PI=Liza Villaruz, MD)
…Nov1 10-10:30: Speaker Scott J. Antonia (PPHM SAB/KOL/Moffitt), “Immune …Modulation of Lung Cancer”
Nov6-9: SITC 2014 – 29th Annual Meeting, Natl-Harbor MD http://tinyurl.com/o3e498c (per 9-9-14 C.Call/Jeff Hutchins/J.Shan & Qtly-Fins PR)
...SITC = The Society for Immunotherapy of Cancer http://www.sitcancer.org
...Bavi+Sorafenib/Liver Cancer IST data - "translational data showing immune changes" (5 sites: 3/UTSW, Parkland-Hosp, Dallas/VA, PI: Dr. Adam Yopp)
...Per Jeff Hutchins, 'followup data' from AntiPS+XXX/Melanoma preclin. studies
Nov22: ESMO/I-O: Symposium on Immuno-Oncology 2014, Geneva http://tinyurl.com/ofljfgs
…11:30-11:50am, David Carbone, MD/PhD (Ohio-ST, PPHM KOL/SRB), session=”Advances in Cancer Immunotherapy; from Vaccines to Antibodies & Cell Therapies”, talk=”Immune Checkpoint Inhibitors in Lung Cancer”
Jan29-30 2015: GTC’s 7th Immunotherapeutics & Immunomonitoring Conf., SanDiego http://tinyurl.com/lqnb3ou (GTC = Global Technolology Community http://www.gtcbio.com )
…Jan30 1:10-1:35pm, Dr. Bruce Freimark (PPHM’s Dir/PreClin.Res) speaks in session, “Combinatorial Immunotherapies”, title=TBD
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PPHM Fact Sheet updated 9-9-2014:
http://www.peregrineinc.com/images/stories/pdfs/sept-2014_corp_fact_sheet.pdf
PIPELINE from 9-9-14 Fact Sheet:
http://ir.peregrineinc.com/events.cfm
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I. 9-10-14/P-JAFFRAY/C.Duncan: “Piper First Call Note: Cash & Phase III Enrollment Bode Well For 2016 News”
• In the coming months [MSTO/Oct30-Nov1, SITC/Nov6-9], Peregrine expects to announce results from Phase II studies of bavi in 1st-line NSCLC and in Hepatocellular (Liver) Carcinoma (+ sorafenib). Peregrine continues to take a broad approach in early studies of bavi. The company is interested in expanding clinical investigations of bavi in combination with checkpoint inhibitors, including PD-1 agents and other components.
• Bavi to the rescue? In addition to its known effects on leukocytes, management hinted about data concerning an even broader immunomodulatory role for bavi. This data, likely to be presented at SITC, could provide an avenue to augment the function of previously tested, underperforming vaccine candidates.
[Nov6-9: SITC 2014: 29th Annual Mtg, Natl-Harbor MD http://tinyurl.com/o3e498c ]
• Keep riding until SUNRISE: Peregrine's top clinical program, the Phase III SUNRISE program, currently has almost 140 sites globally, positioning the company to keep its recruitment efforts on schedule. The company's cash position is stable enough to ensure continued operations at least through the next 12mos, allowing them to enroll patients into the study. However, supplementary funding will be required to complete the SUNRISE program.
CONCLUSION
Peregrine reported F1Q15 earnings, ending the quarter with $73.3M in cash, bolstered by $9.5M in proceeds from the Series E preferred stock. At qtr-end, $20M (of $30M) of the Series E remained available to issue. Guidance for FY15 revenues was maintained at $19-23M. While we think this may prove conservative as the company had just over $22M in revenues for FY14, we are reducing our FY15 projections to the top-end of guidance. Lead Phase III study, SUNRISE, for bavi in 2nd-line NSCLC remains on track for completion of enrollment of approx. 600 patients by YE15. Additional early data is expected at the Society of Immunotherapy for Cancer (SITC) meeting Nov. 6-9 for melanoma & breast cancer (preclinical). Bavi has a mechanistic rationale that supports potential utility in oncology & infectious disease and we reiterate our Overweight rating and $4 price target on Peregrine.
*end*
Piper Jaffray/Charles Duncan - init. 3-5-13 OverWgt/PT=$4.00
…P.Jaffray Research: http://www.piperjaffray.com/3col.aspx?id=103
= = = = = = = = = = = = == = = = = = =
II. 9-10-14/ROTH/J.Pantginis: “PPHM FY15Q1 Results; Broadening Bavituximab's Profile”
PPHM announced FY15/Q1 results, reporting EPS of ($.08), compared to our and the consensus estimate of ($.06). Total revenues for 1Q15 were $5.5mm vs. our est. of $5mm and consensus est. of $6mm. With IST data readouts in the upcoming months, we believe mgt. will be able to leverage that into expanding bavis profile and further drive partnership discussions. The company ended Q1 (7-31-14) with $73.3mm in cash, which mgt. believes is sufficient to fund operations for ~12 mos. PPHM reiterated guidance for contract mfg. revenue for FY2015 of $19-$23mm.
Reiterate Buy and $5 target.
IMPACT
Alongside the SUNRISE Phase III study ongoing in over 130 sites, there will be addl. focus on data readouts from other programs in the upcoming months:
1) The Phase I/II study of bavituximab in combination with sorafenib in Hepatocellular (Liver) Carcinoma will have data presented at the Annual Meeting of the Society for the Immunotherapy of Cancer in early November [Nov6-9: SITC 2014: 29th Annual Mtg, Natl-Harbor MD http://tinyurl.com/o3e498c ].
2) The Phase Ib of bavituximab in combination with carboplatin+pemetrexed in untreated stage IV NSCLC will have preliminary data presented at the Chicago Multidisciplinary Symposium in Thoracic Oncology [Oct 30-Nov1: MSTO/Chicago http://tinyurl.com/p2l43mt ] in late October.
Additionally, PPHM will present more data from the immuno-oncology program combining bavituximab with other immunotherapies, specifically, an anti-PD-1 checkpoint inhibitor, at SITC.
Data from the Liver Cancer study as well as from the immuno-oncology program should increase visibility, driving up potential partnering interest for bavituximab. Recall that PPHM also indicated that it is looking to expand bavituximab's profile into other indications, particularly in Breast Cancer. At ASCO 2014, PPHM presented data from an IST of bavituximab+paclitaxel in HER2-neg. metastatic breast cancer, showing that 85% of patients achieved ORR, with 15% achieving CR by RECIST.
ACTION
We reiterate our Buy rating and $5 target. With Peregrine being a pivotal stage company, we view the risk/reward profile as favorable, and we believe visibility from the broadening bavituximab profile and partnering potential should drive the stock in 2014.
*end*
Roth Capital/Joe Pantginis - init. 7-15-10 Buy/PT=$10, CURR: Buy/$5 http://www.roth.com
. . .Universe (click link bottom right): http://roth.bluematrix.com/docs/pdf/BLUE.pdf
= = = = = = = = = = = = =
III. 9-10-14/MLV/G.Zavoico: “Peregrine Pharmaceuticals, Inc. Upcoming Trial Newsflow & Sound Financial Position Provides Light Before SUNRISE”
Yesterday, after markets closed, Peregrine Pharmaceuticals, Inc. reported its FY15Q1 results (ending 7-31-14) and provided updates on its ongoing clinical trials. Peregrine is in a favorable financial position, with cash to yr-end CY2015 (4-30-15), and it is maintaining full-year revenue guidance for its Avid Bioservices division. Moreover, we anticipate steadier news flow from several ongoing ISTs of bavituximab, culminating with completion of patient enrollment in its Phase III SUNRISE trial by yr-end CY2015, and interim & topline results about 6 & 12 mos later, respectively. We believe positive results from ongoing ISTs will generate investor & partnering interest and, together with results of preclinical studies, will establish bavituximab as an immune checkpoint inhibitor that is amenable to a variety of drug combinations and efficacious in multiple cancer types. We reiterate our BUY recommendation and $3.50 1-yr price target for Peregrine Pharmaceuticals, Inc.
• SUNRISE UPDATE: About 30 new clinical sites were activated during FY15Q1 for the Phase III SUNRISE trial of bavituximab in combination with docetaxel vs. docetaxel alone as 2nd-Line treatment of NSCLC. Nearly 140 sites are now recruiting patients. Peregrine has guided to full enrollment of almost 600 patients by end of CY2015 and the first interim data readout in mid-CY2016.
• NEWSFLOW:
• Interim results of a Phase Ib IST of bavituximab with carboplatin & pemetrexed in patients with previously untreated Stage IV NSCLC will be presented at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology in late October [Oct 30-Nov1: MSTO/Chicago http://tinyurl.com/p2l43mt ].
• Final results of a Phase I IST of bavituximab with paclitaxel in patients with HER2-negative Metastatic Breast Cancer was submitted for publication and should appear in press shortly.
• The Phase II portion of a Phase I/II IST of bavituximab with Sorafenib in patients with advanced Hepatocellular Carcinoma [Liver Cancer] completed enrollment and results are expected to be presented an upcoming medical conference [Nov6-9: SITC 2014: 29th Annual Mtg, Natl-Harbor MD http://tinyurl.com/o3e498c ].
• AVID REVENUE ON TARGET; at least 12 mos of cash. Peregrine's wholly-owned contract mfg. subsidiary continues to provide an important source of non-dilutive revenue, generating $5.5mm in revenue in FY15Q1. Peregrine reiterated its prior full-yr FY2015 revenue guidance of $19-23mm. Peregrine's net loss was $14.2mm, or $.08/sh in FY15Q1 (vs. $7.6mm $.05/sh in FY14Q1). The higher loss was attributable to expenses associated with ramping up of the SUNRISE trial. Peregrine said its $73.3mm in cash & cash equivalents on 7-31-14 will be sufficient to fund SUNRISE and preclinical studies to the end of CY2015 [4-30-14]. Currently, the budget does not include initiation of addl. trials in other indications. We project cash burn to increase throughout FY2015 as additional sites begin patient enrollment.
• VALUATION/RISKS. We use a discounted cash flow (DCF) analysis with projections to 2028 and a 20% discount rate and a 5% terminal growth rate. Risks include: slower than expected enrollment or negative results from SUNRISE, negative results from bavituximab trials in other indications, Avid revenue growth slower than projected, and potential dilutive financings.
*end*
MLV/George B. Zavoico - init. 2-8-10 Buy/PT=$10, CURR: Buy/$3.50 http://www.mlvco.com
= = = = = = = = = = = = = = = = = = = =
9-9-14 QTLY. CONF. CALL (King/Hutchins/Shan/Lytle) Transcript http://tinyurl.com/ktrfswj
...CEO S.King: “In addition to our clinical trials, many of which have also have translational data points built in to tie together pre-clin. data with the clinic, we have also continued to build momentum in our pre-clin. collaborations which now number in the dozens. We are evaluating new combinations & dosing strategies combining bavituximab with chemotherapy, radiation, and immune-oncology approaches, including those targeting CTLA-4, PD-1, as well as other downstream immune checkpoints."
= = = = = = = = = = = = = = = = =
Sep26-30: ESMO 2014 (Eur. Society for Medical Oncology), Madrid http://www.esmo.org/Conferences/ESMO-2014-Congress (Industry Partner: Peregrine Pharm.)
Oct6: CRI’s 22nd Annual Intl. Cancer Immunotherapy Symposium - "Cancer Immunotherapy: Out of the Gate”, NYC http://tinyurl.com/kvcbggw
Oct 30-Nov1: Multidisciplinary Symposium on Thoracic Oncology (MSTO), Chicago http://tinyurl.com/p2l43mt Sponsors: ASTRO, ASCO, IASLC, Univ/Chicago
...Per VP Joe Shan 9-9-14: “Data from the Ph.Ib IST Univ-Pitt. Bavituximab+CP/1stLine/Stage4/NSCLC” (PI=Liza Villaruz, MD)
…Nov1 10-10:30: Speaker Scott J. Antonia (PPHM SAB/KOL/Moffitt), “Immune …Modulation of Lung Cancer”
Nov6-9: SITC 2014 – 29th Annual Meeting, Natl-Harbor MD http://tinyurl.com/o3e498c (per 9-9-14 C.Call/Jeff Hutchins/J.Shan & Qtly-Fins PR)
...SITC = The Society for Immunotherapy of Cancer http://www.sitcancer.org
...Bavi+Sorafenib/Liver Cancer IST data - "translational data showing immune changes" (5 sites: 3/UTSW, Parkland-Hosp, Dallas/VA, PI: Dr. Adam Yopp)
...Per Jeff Hutchins, 'followup data' from AntiPS+XXX/Melanoma preclin. studies
Nov22: ESMO/I-O: Symposium on Immuno-Oncology 2014, Geneva http://tinyurl.com/ofljfgs
…11:30-11:50am, David Carbone, MD/PhD (Ohio-ST, PPHM KOL/SRB), session=”Advances in Cancer Immunotherapy; from Vaccines to Antibodies & Cell Therapies”, talk=”Immune Checkpoint Inhibitors in Lung Cancer”
Jan29-30 2015: GTC’s 7th Immunotherapeutics & Immunomonitoring Conf., SanDiego http://tinyurl.com/lqnb3ou (GTC = Global Technolology Community http://www.gtcbio.com )
…Jan30 1:10-1:35pm, Dr. Bruce Freimark (PPHM’s Dir/PreClin.Res) speaks in session, “Combinatorial Immunotherapies”, title=TBD
= = = = = = = = = = = = = = = = = = = = = =
PPHM Fact Sheet updated 9-9-2014:
http://www.peregrineinc.com/images/stories/pdfs/sept-2014_corp_fact_sheet.pdf
PIPELINE from 9-9-14 Fact Sheet:
http://ir.peregrineinc.com/events.cfm
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