|By Marketwired .||
|December 10, 2012 04:00 PM EST||
TUSTIN, CA -- (Marketwire) -- 12/10/12 -- Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a biopharmaceutical company developing first-in-class monoclonal antibodies focused on the treatment and diagnosis of cancer, today announced financial results for the second quarter ended October 31, 2012 of fiscal year (FY) 2013 and provided an update on its advancing clinical pipeline and other corporate developments.
"Certainly the recent highlight for Peregrine is the agreement reached with the FDA that provides a clear pathway for advancing our Cotara program into a pivotal registration trial in patients with brain cancer. This milestone is the result of a significant amount of work and collaboration with the FDA of which we are particularly proud given the potential for this novel treatment in this difficult to treat disease," said Steven W. King, president and chief executive officer of Peregrine. "This was also a very strong quarter for our manufacturing subsidiary, Avid Bioservices, as we are on track for another record year of manufacturing revenues. We are also making steady progress in advancing the bavituximab program on multiple clinical fronts with important clinical milestones anticipated to occur over the coming months. Upcoming clinical milestones for the program include key median overall survival endpoints in pancreatic and front-line non-small cell lung cancer and final results from our second-line non-small cell lung cancer study in which we discovered discrepancies and have subsequently been intensely reviewing. The goal of this review is to be able to generate a final data set that we believe could be used to support advancing the program into a pivotal trial."
COTARA PROGRAM HIGHLIGHTS
Peregrine announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the design of a single registration trial for Cotara in patients with recurrent glioblastoma multiforme (GBM) following an end-of-Phase II meeting. The FDA has agreed with the company's proposed randomized trial design evaluating two dose levels of Cotara in up to 300 patients. The trial design allows for multiple interim data analyses with the potential to stop patient accrual early based on predicted success or futility. The company plans to seek partners both in the U.S. and internationally to support the development of Cotara for this deadly form of brain cancer. Cotara has been granted orphan drug status and Fast Track designation for the treatment of GBM and anaplastic astrocytoma by the FDA and orphan drug designation by the European Medicines Agency (EMA).
BAVITUXIMAB CLINICAL TRIALS
Peregrine currently has eight ongoing clinical trials as follows:
- Peregrine continues to conduct a detailed internal review into the discrepancies tied to the randomized, double-blind placebo-controlled Phase II trial of bavituximab in second-line non-small cell lung cancer (NSCLC), that were discovered as part of the routine collection of data in advance of the company's end-of-Phase II meeting with regulatory authorities. The goal of this review is to gain a thorough understanding of the events leading up to, including and following the patient treatment group assignments and investigational drug coding and distribution. This review includes the testing of investigational product, patient samples, reviewing the operations of multiple vendors, among other activities. Investors are reminded not to rely on clinical data that the company disclosed on or before September 7, 2012 regarding this trial.
- Randomized Phase II clinical trial evaluating bavituximab plus carboplatin and paclitaxel versus carboplatin and paclitaxel alone in 83 evaluable patients with previously untreated Stage IIIb or Stage IV NSCLC. Patient enrollment was completed in September of 2011. A secondary endpoint in the trial, median overall survival (OS), is an event-driven endpoint and will be reported once mature.
- Randomized Phase II clinical trial evaluating bavituximab plus gemcitabine versus gemcitabine alone in 70 patients with previously untreated Stage IV pancreatic cancer. Patient enrollment was completed in June 2012. The primary endpoint in the trial, median OS, is an event-driven endpoint and will be reported once mature.
- Phase I/II Investigator Sponsored Trial (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.
- Phase I/II IST evaluating bavituximab in combination with cabazitaxel in up to 31 patients with second-line castration-resistant prostate cancer.
- Phase Ib IST evaluating bavituximab in combination with carboplatin and pemetrexed in up to 25 patients with previously untreated Stage IV NSCLC.
- Phase I IST evaluating bavituximab in combination with paclitaxel in up to 14 patients with HER2-negative metastatic breast cancer.
- Phase I IST evaluating bavituximab in combination with capecitabine and radiation therapy in up to 18 patients with Stage II or III rectal adenocarcinoma.
PS-TARGETING MOLECULAR IMAGING PROGRAM HIGHLIGHTS
Peregrine continues to enroll and dose up to 12 patients in an open-label, single-center trial of its experimental phosphatidylserine (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.
PRECLINICAL DEVELOPMENT HIGHLIGHTS
In October, at the 27th Annual Meeting of the Society for Immunotherapy of Cancer, data were presented demonstrating the ability of the company's PS-targeting antibodies to stimulate cancer fighting immune responses. Additionally, data were published in the peer-reviewed journal Nuclear Medicine and Biology highlighting results from a study investigating the company's fully human phosphatidylserine (PS)-targeting antibody PGN635 utilized as a radiolabeled tumor imaging probe. The results demonstrate the potential breadth of applicability of the company's PS-targeting antibodies to clearly image solid tumors regardless of cancer type, and provide a potential method to rapidly assess the anti-tumor efficacy of chemotherapies and other approved and experimental cancer treatments
Total revenues for the second quarter of FY 2013 were $6,139,000 compared to $4,232,000, for the same quarter of the prior fiscal year. This increase was primarily attributable to contract manufacturing revenue generated by Peregrine's biomanufacturing subsidiary Avid Bioservices, which generated contract manufacturing revenue of $6,061,000 for the second quarter of FY 2013, compared to $4,154,000 for the same quarter of the prior fiscal year. The increase in contract manufacturing revenue was primarily due to a greater number of completed manufacturing runs being released and shipped during the current quarter. Based on current manufacturing commitments from Avid's third-party clients for services to be provided during the remainder of FY 2013, we expect contract manufacturing revenue to be at least $18 million for FY 2013. In addition, Avid will continue to utilize available capacity and resources to continue its preparation for later stage clinical development and potential commercialization of bavituximab and Cotara, while also seeking to grow its services from third-party clients.
Total costs and expenses decreased $3,072,000 to $13,196,000 in the second quarter of FY 2013 from $16,268,000 in the second quarter of FY 2012. This decrease was primarily attributable to lower research and development expenses associated with a decrease in clinical trial costs. For the second quarter of FY 2013, cost of contract manufacturing and research and development expenses were $3,703,000 and $6,053,000, respectively, compared to $3,718,000 and $9,818,000, respectively, for the second quarter of FY 2012. Selling, general and administrative expenses for the second quarter of FY 2013 were $3,440,000 compared to $2,732,000 in the second quarter of FY 2012.
Peregrine's consolidated net loss was $8,753,000, or $0.08 per basic and diluted share, for the second quarter of FY 2013, compared to a net loss of $12,055,000, or $0.16 per basic and diluted share, for the same quarter of the prior year.
Peregrine reported $24,443,000 in cash and cash equivalents at October 31, 2012, compared to $18,991,000 at July 31, 2012. From the period of September 27, 2012 through October 31, 2012, the company raised $16.2 million in net proceeds in order to replace the initial funding it repaid on September 25, 2012 under a loan facility dated August 30, 2012. The funds were raised under an At Market Sales Issuance Agreement with McNicoll, Lewis & Vlak LLC at an average price per share of $0.90. The company issued no warrants in connection with the At Market Sales Issuance Agreement.
More detailed financial information and analysis may be found in Peregrine's Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.
Peregrine will host a conference call and webcast this afternoon, December 10, 2012, at 4:30 PM EST (1:30 PM PST).
To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Peregrine Pharmaceuticals conference call. A replay of the call will be available starting approximately two hours after the conclusion of the call through December 24, 2012 by calling (855) 859-2056, or (404) 537-3406 and using passcode 75630640.
To listen to the live webcast, or access the archived webcast, please visit: http://ir.peregrineinc.com/events.cfm
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. The company is pursuing multiple clinical programs in cancer with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that data from a Cotara pivotal trial may not support BLA submission or registration, the risk that the company does not have, or is unable to raise, sufficient capital to fund a pivotal trial and the risk that the company is unable to find a suitable partner to advance the Cotara program, the risk that final data from the randomized, double-blind, placebo-controlled Phase IIb may never support future development in second-line NSCLC, the risks associated with the recently filed class action lawsuits or potential regulatory investigations due to the uncertainty created by the above referenced discrepancies, the risk that results from the other randomized Phase II trial will not be consistent with results experienced in the earlier single-arm Phase II trial or support registration filings with the FDA, the risk that Avid's revenue growth may slow or decline, the risk that Avid may experience technical difficulties in processing customer orders which could delay delivery of products to customers and receipt of payment, and the risk that one or more existing Avid customers, including those with committed manufacturing or representing its backlog, terminates its contract prior to completion. It is important to note that the Company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the our SEC reports including, but not limited to, the annual report on Form 10-K for the fiscal year ended April 30, 2012 and quarterly report on Form 10-Q for the quarter ended October 31, 2012. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
PEREGRINE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS Three Months Ended Six Months Ended October 31, October 31, 2012 2011 2012 2011 ------------ ------------ ------------ ------------ Unaudited Unaudited Unaudited Unaudited REVENUES: Contract manufacturing revenue $ 6,061,000 $ 4,154,000 $ 10,196,000 $ 9,593,000 License revenue 78,000 78,000 194,000 294,000 ------------ ------------ ------------ ------------ Total revenues 6,139,000 4,232,000 10,390,000 9,887,000 COSTS AND EXPENSES: Cost of contract manufacturing 3,703,000 3,718,000 5,727,000 6,735,000 Research and development 6,053,000 9,818,000 13,034,000 17,578,000 Selling, general and administrative 3,440,000 2,732,000 6,357,000 5,661,000 ------------ ------------ ------------ ------------ Total costs and expenses 13,196,000 16,268,000 25,118,000 29,974,000 ------------ ------------ ------------ ------------ LOSS FROM OPERATIONS (7,057,000) (12,036,000) (14,728,000) (20,087,000) ------------ ------------ ------------ ------------ OTHER INCOME (EXPENSE): Interest and other income 44,000 9,000 52,000 22,000 Interest and other expense (44,000) (28,000) (45,000) (82,000) Loss on early extinguishment of debt (1,696,000) - (1,696,000) - ------------ ------------ ------------ ------------ NET LOSS $ (8,753,000) $(12,055,000) $(16,417,000) $(20,147,000) ============ ============ ============ ============ WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: Basic and Diluted 109,405,778 77,523,005 106,344,857 74,089,786 ============ ============ ============ ============ BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.08) $ (0.16) $ (0.15) $ (0.27) ============ ============ ============ ============ COMPREHENSIVE LOSS $ (8,753,000) $(12,055,000) $(16,417,000) $(20,147,000) ============ ============ ============ ============ PEREGRINE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS OCTOBER 31, APRIL 30, 2012 2012 ------------- ------------- Unaudited ASSETS CURRENT ASSETS: Cash and cash equivalents $ 24,443,000 $ 18,033,000 Trade and other receivables, net 2,320,000 2,353,000 Inventories, net 5,426,000 3,611,000 Prepaid expenses and other current assets, net 885,000 795,000 ------------- ------------- Total current assets 33,074,000 24,792,000 Property, net 2,683,000 2,900,000 Other assets 771,000 570,000 ------------- ------------- TOTAL ASSETS $ 36,528,000 $ 28,262,000 ============= ============= LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $ 3,176,000 $ 3,492,000 Accrued clinical trial and related fees 1,558,000 2,111,000 Accrued payroll and related costs 2,394,000 2,468,000 Deferred revenue 6,221,000 3,651,000 Customer deposits 8,500,000 4,865,000 Other current liabilities 1,083,000 1,052,000 ------------- ------------- Total current liabilities 22,932,000 17,639,000 Deferred revenue 205,000 361,000 Other long-term liabilities 721,000 779,000 Commitments and contingencies STOCKHOLDERS' EQUITY: Preferred stock-$0.001 par value; authorized 5,000,000 shares; non-voting; nil shares outstanding - - Common stock-$0.001 par value; authorized 325,000,000 shares; outstanding - 123,310,188 and 101,421,365, respectively 123,000 101,000 Additional paid-in capital 367,088,000 347,506,000 Accumulated deficit (354,541,000) (338,124,000) ------------- ------------- Total stockholders' equity 12,670,000 9,483,000 ------------- ------------- TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 36,528,000 $ 28,262,000 ============= =============
Christopher Keenan or Jay Carlson
Peregrine Pharmaceuticals, Inc.
SYS-CON Events announced today Telecom Reseller has been named “Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Aug. 31, 2016 09:30 AM EDT Reads: 1,084
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business in 2016. However, IoT is far more complex than most firms expected. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, a renowned visionary and thought leader, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology and business models to adopt and leverage IoT. He will drill down to the components in this fra...
Aug. 31, 2016 09:00 AM EDT Reads: 504
Pulzze Systems was happy to participate in such a premier event and thankful to be receiving the winning investment and global network support from G-Startup Worldwide. It is an exciting time for Pulzze to showcase the effectiveness of innovative technologies and enable them to make the world smarter and better. The reputable contest is held to identify promising startups around the globe that are assured to change the world through their innovative products and disruptive technologies. There w...
Aug. 31, 2016 08:45 AM EDT Reads: 922
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
Aug. 31, 2016 07:45 AM EDT Reads: 958
With so much going on in this space you could be forgiven for thinking you were always working with yesterday’s technologies. So much change, so quickly. What do you do if you have to build a solution from the ground up that is expected to live in the field for at least 5-10 years? This is the challenge we faced when we looked to refresh our existing 10-year-old custom hardware stack to measure the fullness of trash cans and compactors.
Aug. 31, 2016 02:45 AM EDT Reads: 1,898
The emerging Internet of Everything creates tremendous new opportunities for customer engagement and business model innovation. However, enterprises must overcome a number of critical challenges to bring these new solutions to market. In his session at @ThingsExpo, Michael Martin, CTO/CIO at nfrastructure, outlined these key challenges and recommended approaches for overcoming them to achieve speed and agility in the design, development and implementation of Internet of Everything solutions wi...
Aug. 31, 2016 02:15 AM EDT Reads: 2,295
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Aug. 31, 2016 02:00 AM EDT Reads: 2,029
Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is expected in the amount of information being processed, managed, analyzed, and acted upon by enterprise IT. This amazing is not part of some distant future - it is happening today. One report shows a 650% increase in enterprise data by 2020. Other estimates are even higher....
Aug. 31, 2016 01:45 AM EDT Reads: 3,113
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
Aug. 31, 2016 01:00 AM EDT Reads: 1,715
Identity is in everything and customers are looking to their providers to ensure the security of their identities, transactions and data. With the increased reliance on cloud-based services, service providers must build security and trust into their offerings, adding value to customers and improving the user experience. Making identity, security and privacy easy for customers provides a unique advantage over the competition.
Aug. 30, 2016 08:15 PM EDT Reads: 2,501
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Aug. 30, 2016 08:00 PM EDT Reads: 2,048
SYS-CON Events announced today that Pulzze Systems will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Pulzze Systems, Inc. provides infrastructure products for the Internet of Things to enable any connected device and system to carry out matched operations without programming. For more information, visit http://www.pulzzesystems.com.
Aug. 30, 2016 07:15 PM EDT Reads: 428
Data is an unusual currency; it is not restricted by the same transactional limitations as money or people. In fact, the more that you leverage your data across multiple business use cases, the more valuable it becomes to the organization. And the same can be said about the organization’s analytics. In his session at 19th Cloud Expo, Bill Schmarzo, CTO for the Big Data Practice at EMC, will introduce a methodology for capturing, enriching and sharing data (and analytics) across the organizati...
Aug. 30, 2016 06:15 PM EDT Reads: 441
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
Aug. 30, 2016 03:30 PM EDT Reads: 3,803
SYS-CON Events announced today that Adobe has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. Adobe is changing the world though digital experiences. Adobe helps customers develop and deliver high-impact experiences that differentiate brands, build loyalty, and drive revenue across every screen, including smartphones, computers, tablets and TVs. Adobe content solutions are used daily by millions of co...
Aug. 30, 2016 02:00 PM EDT Reads: 3,848
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Aug. 30, 2016 01:45 PM EDT Reads: 753
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Aug. 30, 2016 01:15 PM EDT Reads: 2,089
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Aug. 30, 2016 01:00 PM EDT Reads: 3,257
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long dev...
Aug. 29, 2016 10:00 PM EDT Reads: 2,537
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
Aug. 28, 2016 10:30 PM EDT Reads: 4,115