III. MLV 12-2010:“Dec’10 AMI Agreement”http://www.mlvco.com $75mm ATM/MLV 12-29-10 (commiss: max=5%) Form8K: http://tinyurl.com/2a6w76g (pursuant to $75mm S-3 Shelf Reg. filed 12-17-10: http://tinyurl.com/2469b2d ) • Sold 12/29/10-1/31/11: $6,460,000gr. / 2,385,862sh. = $2.71/sh. • Sold 2/1/11-2/28/11: $2,358,000gr. / 998,142sh. = $2.36/sh. • Sold 3/1/11-4/30/11: $4,470,000gr. / 1,840,487sh. = $2.43/sh. • Sold 5/1/11-7/31/11: $3,713,000gr. / 1,912,576sh. = $1.94/sh. • Sold 8/1/11-10/31/11: $5,582,000gr. / 4,727,840sh. = $1.18/sh. • Sold 9-2-12 Roth Direct: $6,940,000gr./ 6,252,252sh. = $1.11/sh. • Sold 11/1/11-1/31/12: $10,961,000gr. / 10,308,025sh. = $1.06/sh. • Sold 2/1/12-2/29/12: $5,871,000gr. / 5,726,946sh. = $1.03/sh. • Sold 3/1/12-4/30/12: $1,263,000gr. / 2,198,543sh. = $.57/sh. • Sold 5/1/12-6/30/12: $1,496,000gr. / 2,752,691sh. = $.54/sh. • Sold 7/1/12-9/26/12: none** • Sold 9/27/12-10/31/12: $16,719,000gr./ 18,557,928 = $.90/sh. • Sold 11/1/12-11/30/12: $7,296,000gr./ 9,220,313 = $.79 • Sold 12/1/12-1/31/13: $1,540,000gr./ 1,131,282 = $1.36 • Sold 2/1/13-3/12/13: $330,000gr./ 201,154 = $1.64 *Total Raised via MLV Dec’10 ATM Sales thru 3-12-2013: . . . . $75,000,000gr. / 68,214,041 = $1.10sh.
IV. MLV 12-2012:“Dec’12 AMI Agreement”http://www.mlvco.com $75mm ATM/MLV 12-29-12 (commiss: max=5%) Form8K: http://tinyurl.com/2a6w76g (pursuant to $75mm S-3 Shelf Reg. filed 3-9-12: http://tinyurl.com/7dl7pjm ) • Sold 2/1/13-3/12/13: $4,475,000gr. / 3,132,402sh. = $1.43/sh. • Sold 3/13/13-4/30/13: $8,897,000gr. / 6,188,273sh. = $1.44/sh. • Sold 5/1/13-7/11/13: $12,729,000gr. / 7,927,016sh. = $1.61/sh. *Total Raised via MLV Dec’12 ATM Sales thru 7-11-2013: . . . . $26,101,000gr. / 17,247,691 = $1.51sh.
TOTAL ALL A-T-M SALES – INCEPTION (3-2009) THRU 7-11-2013: ==> $148,600,000gr. / 104,396,178sh. = $1.42/sh.
- - - - - - - - - - 10-31-11 10Q: “During the 6mos. 10-31-11, we sold 6,440,416 shares of our common stock at mkt-prices for gross proceeds of $9,295,000 under the Dec’10 AMI Agreement before deducting commissions and other issuance costs of $260,000” 1-31-12 10Q: “During the 9mos. ended 1-31-12, we sold 16,948,441 shares of our common stock at mkt-prices for gross proceeds of $20,256,000 under the Dec’10 AMI Agreement before deducting commissions and other issuance costs of $482,000. …During Feb.2012, we sold an addl. 5,726,946 shares of common stock at market prices under the Dec’10 AMI Agreement in exchange for aggregate gross proceeds of $5,871,000. As of 2-29-12, gross proceeds of $38,644,000 remained available under our 2 effective shelf registration statements.” 4-30-12 10K: “Under the Dec. 2010 AMI Agreement with MLV …for aggregate gross proceeds of up to $75,000,000… During FY’s 2011 (5’10-4’11) and 2012 (5’11-4’12), we sold 30,098,421 shares of common stock at market prices under the Dec.2010 AMI for aggregate gross proceeds of $40,678,000 before deducting commissions & other issuance costs of $917,000. As of April 30, 2012, aggregate gross proceeds of up to $27,382,000 remained available under the Dec.2010 AMI… Subsequent to April 30, 2012 and through June 30, 2012, we sold 2,752,691 shares of common stock at mkt prices under the Dec.2010 AMI for aggregate gross proceeds of $1,496,000… Under the registered direct public offering dated Sept. 2, 2011, we entered into separate subscription agreements with 3 institutional investors, pursuant to which we sold an aggregate of 6,252,252 shares of our common stock at a purchase price of $1.11/sh. for gross proceeds of $6,940,000 before deducting placement agent fees and other offering expenses of $525,000.” 10-31-12 10Q: “During the 6mos. 10-31-12, we sold 21,310,619 shares… at varying mkt-prices under the Dec’10 AMI Agreement for gross proceeds of $18,215,000 before deducting commissions and other issuance costs of $620,000. From 11-1-12 thru 11-30-12, we sold 9,220,313 shares gross of $7,296,000. As of 11-30-12, aggregate gross proceeds of up to $1,871,000 remained available under the Dec’10 AMI Agreement. As of 11-30-12, gross proceeds of $151,871,000 remained available under 2 effective shelf registration statements.” 1-31-13 10Q/pg.11: “DEC’10-AMI(max=$75mm): During the 9 mos. ended 1-31-13, we sold 31,662,214 shares at varying mkt-prices for gross proceeds of $27,051,000 before deducting commissions/other-costs of $885,000. As of 1-31-13, gross proceeds of up to $330,000 remained available. From 2-1-13 – 3-12-13, we sold 201,154 shares at mkt prices for gross $330,000. As of 3-12-13, we had raised the full amt of gross proceeds available… DEC’12-AMI(max=$75mm): As of 1-31-13, we had not sold any shares. From 2-1-13 - 3-12-13, we sold 3,132,402 shares at mkt prices for gross proceeds of $4,475,000. As of 3-12-13, gross proceeds of up to $70,525,000 remained available.” 4-30-13 10K/pg.F26: Dec’12-AMI(max=$75mm)Agreement – During FY’13, we sold 9,320,675 shares gross proceeds of $13,372,000 before deducting commissions and other issuance costs of $337,000. As of April 30, 2013, gross proceeds of up to $61,628,000 remained available under the Dec’12-AMI. From 5/1/13 – 7/11/13, we sold 7,927,016 shares for gross proceeds of $12,729,000. As of 7-11-13, gross proceeds of $48,899,000 remained available under the Dec’12-AMI. http://tinyurl.com/p58jcbw
- - - - - - - - - - - - - - - - - - PPHM’S ATM PHILOSOPHY, CFO PAUL LYTLE, 12-9-10 CC: “Beyond these 2 sources of capital ([Avid & Gov’t], we have raised addl. capital through the equity markets and it’s important to note that over the past 3 years we have sold every share at market prices [“ATM”], without warrants, without discounts. We continue to be active in the investment community and we have had strong interest from institutional investors intrigued by our clinical data, by our multiple trials to evaluate Bavituximab’s broad therapeutic potential, and by the interim survival data we have seen from our novel brain cancer therapy Cotara. Our goal is to maintain a balanced financial approach with multiple sources of capital and to carefully manage our cash burn as we continue to advance these programs.” http://tinyurl.com/24xmcsn
Pipeline Chart updated at PeregrineInc.com ~7/18/13. The Ph2 1st-Line/NSCLC & Pancreatic trials have been removed, and the others’ status lines updated.
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS Lead Indication in Second-Line Non-Small Cell Lung Cancer: • Reached agreement with the U.S. FDA on a Phase III registration trial design of bavituximab in 2nd-Line NSCLC. • Recently announced final results from its 121 patient Phase IIb randomized, double-blind, placebo-controlled trial of bavituximab in second-line NSCLC at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting [6-3-13: http://tinyurl.com/my8qxw7 ]. ? Promising 60% improvement in median overall survival (OS) in the 3mg/kg bavituximab + docetaxel arm compared to the control arm and bavituximab was well-tolerated with no significant differences in adverse events between the trial arms. ? Subgroup analyses of OS by key patient characteristics including age, gender, ECOG status, ethnicity and prior treatment favored the bavituximab 3 mg/kg arm. • Planning for the initiation of a pivotal Phase III trial by calendar year-end.
OTHER ONCOLOGY INDICATIONS:
• A Phase I IST evaluating bavituximab in combination with paclitaxel in up to 14 patients with HER2-negative metastatic breast cancer. Interim data on 13 evaluable patients were presented at the 2013 ASCO Annual Meeting showed that 85% of patients achieved an objective tumor response, including 15% of patients achieving a complete response (CR) measured in accordance with RECIST criteria. All patients have been enrolled in this trial.
• A Phase I/II IST evaluating bavituximab in combination with sorafenib in up to 48 patients with advanced hepatocellular carcinoma (liver cancer). The Phase I portion of the trial has completed patient enrollment with enrollment in the Phase II portion of the trial ongoing.
• A Phase Ib IST evaluating bavituximab in combination with carboplatin and pemetrexed in up to 25 patients with previously untreated Stage IV NSCLC. This trial continues to enroll and dose patients.
• A Phase I IST evaluating bavituximab in combination with capecitabine and radiation therapy in up to 18 patients with Stage II or III rectal adenocarcinoma. This trial continues to enroll and dose patients.
IMAGING PROGRAM HIGHLIGHTS PS-Targeting Molecular Imaging Program Peregrine continues to enroll and dose patients in an open-label, single-center trial of its experimental PS-targeting molecular imaging candidate, 124I-PGN650, in patients with various solid tumor types. The primary goal of the trial is to estimate radiation dosimetry in critical and non-critical organs. Secondary objectives of the trial are tumor imaging and safety. Recently, data were presented from imaging studies demonstrating that the chemotherapeutic drug docetaxel, a commonly prescribed second-line treatment for patients with advanced NSCLC, increases the exposure of bavituximab's target molecule, PS, on tumor blood vessel cells and tumor cells. Results also showed that PS exposure in tumors is correlated with tumor burden and response to docetaxel treatment, supporting exposed PS as a promising biomarker of cancer and response to therapy. In the June 2013 issue of the journal Molecular Imaging, scientists from Peregrine published results from a study showing that PGN650 could be useful in imaging tumors and detect enhanced PS exposure in response to chemotherapy.
PPHM VP Dr. Jeff Hutchins presenting PS-Targeting Mabs in Immune Checkpoint Blockades session of CHI’s “Immunotherapies Congress” in Boston on Aug. 14th at 3pm…
Aug 13–15 2013: “CHI’s The Immunotherapies Congress”, Boston Co-located with the 8th Annual “ImVacS” (Immunotherapeutics & Vaccine Summit) http://www.imvacs.com 2 INAUGURAL SUB-CONFERENCES: • Aug13-14: Emerging Cancer Immunotherapies & Vaccines • Aug14-15: Immunomodulatory Therapeutic Antibodies for Cancer <=PPHM's Dr. Hutchins Presenting CHI = Cambridge Healthtech Inst. http://www.healthtech.com Conf. website: http://www.immunotherapiescongress.com http://www.immunotherapiescongress.com/Immunomodulatory-Antibodies-Cancer ”Recent advances in cancer immunotherapy have turned researcher's attentions to new therapeutic strategies focused on improved specificity, control of key checkpoints in immune response, the identification of new biomarkers and novel ways of combining therapies for maximum effect. The 2-conf. Immunotherapies Congress offers an exciting opportunity to learn how these strategies are being translated into the next generation of cancer immunotherapeutic drug products.” …“Immunomodulatory Therapeutic Antibodies for Cancer” showcases the exciting wave of checkpoint blockades such as anti-PD-1 & anti-CTLA-4 now in clinical development – and explores considerations of trial design, drug safety, and biomarker discovery that will influence their application in patients. - - - - - - OVERVIEW: ”The recent approval of BMS's Yervoy (ipilumumab) and a succession of related programs advancing through clinical trials has generated increased interest in the development of antibody-based immunomodulators for cancer. Immunomodulatory Therapeutic Antibodies for Cancer will provide updates of clinical stage programs, and examine how these novel therapeutics influence trial design and the selection of clinical endpoints. Strategies for immune modulation that are most appropriate for targeting with antibodies will be considered, along with where combination regimens and new therapeutic formats can be effectively applied.” - - - - - - - - - - - PEREGRINE – Aug. 14 3:00pm: Session: Immune Checkpoint Blockades Presentation: “Engagement of Phosphatidylserine (PS) by PS-targeting Antibodies Blocks an Upstream Immunosuppressive Checkpoint in the Tumor Microenvironment; Inducing Multiple Downstream Anti-tumor Response Mechanisms” Jeffrey T. Hutchins, PhD, VP, Preclinical Research ABSTRACT: The hallmark of apoptosis, phosphatidylserine (PS) exposure promotes non-inflammatory phagocytosis of dying native cells. This signaling pathway appears to be exploited by tumors resulting in the suppression of both innate and adaptive tumor immune responses. Administration of PS-targeting antibodies mediates pro-inflammatory cellular and cytokine responses that reverse this immunosuppressive checkpoint without the side-effects associated with systemic immune activation. Bavituximab is a late-stage clinical PS-targeting antibody that has demonstrated promising signs of anti-tumor activity and extended survival in patients with NSCLC and breast cancer. - - - - - - - - - Jeff T. Hutchins, VP, Preclinical Research - Dr. Hutchins was appointed VP of Preclinical Research in Sept. 2012. Prior to joining Peregrine, Jeff served for the last 5 of 11 years as VP, Pre-clinical Dev. at Inhibitex Inc, which was recently acquired by Bristol Meyers Squibb. . . http://www.peregrineinc.com/about-us/management-team.html
7-11-13 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/khpokw6 ...CEO S.King: “This [new bavi] moa insight has opened the door to completely new combinations not previously explored. Bavi acts on an upstream immune checkpoint, and thus, makes a potentially ideal combination with downstream-acting immune checkpoint inhibitors such as anti PD1 antibodies & CTLA-4 targeted approaches… Preclinical studies are well underway to explore these combinations, and we look forward to generating and reporting data later this year that could support moving these concepts into the clinic.”
6-27-13: Updates on Bavituximab Pgm. & Cash Position http://tinyurl.com/pmcgsgp …“primary focus remains on the init. of the PhIII trial in 2nd-Line NSCLC by y/e; recent data supporting an immunotherapy moa for bavituximab opens many new development opportunities including new combinations not previously planned and has created a lot of excitement around the potential of bavituximab in combination with other immunotherapeutic agents…"
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