Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
The new CEO will not be able to do any of that. He will not be given that freedom to do such things. O'Connor will be controlled by Dr. Avtar Dhillon and Punit Dhillon the two co-founders.
OncoSec Announces Positive Updated Long-Term Follow-Up Data from Phase 2 Trial of ImmunoPulse® IL-12 in Combination with Pembrolizumab Demonstrating a Progression Free Survival Rate (PFS) of 57% at 15 months in Predicted Anti-PD-1 Non-Responder Melanoma PatientsUpdated Phase 2 Efficacy and Durability Findings to Be Presented at the 2017 Society for Immunotherapy of Cancer Annual MeetingOncoSec to Host Analyst and Investor Event During the 2017 Society for Immunotherapy of Cancer Annual Meeting in National Harbor, MD
PR NEWSWIRE 7:30 AM ET 11/8/2017
Symbol Last Price Change
ONCS 1.25down 0 (0%)
QUOTES AS OF 04:00:00 PM ET 11/07/2017
SAN DIEGO , Nov. 8, 2017 /PRNewswire/ -- OncoSec Medical Incorporated(ONCS) ("OncoSec" or "Company") , a company developing DNA-based intratumoral cancer immunotherapies, today announced positive updated long-term follow-up data from its Phase 2 OMS I-102 combination study of ImmunoPulse® IL-12 and pembrolizumab in patients unlikely to respond to anti-PD-1 therapy. The updated data will be presented in an oral poster presentation (P524) by Dr. Alain Alagzi at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in National Harbor, MD on November 10th, 2017 at 12:45 p.m. EST.
The updated clinical and correlative immune-focused biomarker data demonstrated a 57% progression free survival (PFS) rate at 15 months with 100% (11/11) duration of response and median PFS not yet reached. Building upon previously reported data of a best overall response rate (BORR) of 50% (41% complete response [CR] rate), the updated data further demonstrate that the combination of these therapies can prime a coordinated innate and adaptive immune response, and strongly suggests a synergistic relationship with anti-PD-1. The latest findings further demonstrate that this combination approach can reshape the tumor microenvironment, yielding a robust intratumoral and systemic anti-tumor response converting "cold" tumors to "hot," potentially improving clinical outcomes in patients predicted to not respond to anti-PD-1 therapy.
"Overall, the Phase 2 trial results, including progression free survival beyond two years in multiple patients, duration of response, best overall response rate, and tolerability of the combination, provide a strong and consistent theme across multiple endpoints, underscoring the promise of ImmunoPulse IL-12 plus pembrolizumab as a viable treatment option for patients diagnosed with metastatic melanoma," said Dr. Alain Algazi, Lead Trial Investigator, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.
Dan O'Connor , CEO of OncoSec noted: "The robust PFS benefit and tolerability observed with ImmunoPulse IL-12 plus pembrolizumab is the first demonstrating efficacy in a predicted PD-1 non-responder population and shows that the combination represents a potentially important addition to the treatment landscape for metastatic melanoma patients who have progressed or are progressing on anti-PD-1 therapy."
The full abstract is available and can be viewed on the STIC website at www.sitcancer.org. The poster is available in the Publications section of OncoSec's website.
Analyst Event in National Harbor, MD
OncoSec will host an analyst and investor event with clinical investigators on Friday, November 10, 2017 at 7:00 a.m. EST in National Harbor, MD during the 2017 Society of Immunotherapy for Cancer Annual Meeting. The event will include a presentation and discussion of updated clinical data for the company's ImmunoPulse IL-12 program, highlighting the global, registration-directed PISCES/KEYNOTE-695 trial. The event will be held in-person and via live webcast.
Investors and analysts are invited to listen to a live audio webcast of the presentation. To access the audio broadcast, please dial (877) 731-1960 and enter the conference ID number 4938639. To join via webcast, please use the following link: https://edge.media-server.com/m6/p/aj3vpts5. An archived version of the presentation will be available for 90 days on the "Investors" section of OncoSec's website: http://ir.oncosec.com/events-presentations.
For those interested in attending this event in person, please contact media@oncosec.com. Please RSVP in advance as seating is limited.
Peer-Reviewed Publication
The findings published in Immunotherapy provide an overview of OncoSec's preclinical and Phase 1 clinical data demonstrating that ImmunoPulse IL-12 plus electroporation is safe and well-tolerated by patients. Many patients do not respond to anti-PD-1 therapies alone, representing a significant unmet medical need. ImmunoPulse IL-12 has shown to increase intratumoral lymphocyte infiltration, pro-inflammatory cytokines and TH1 immune responses, potentially boosting the activity of PD-1 antibodies without significant systemic toxicity.
For the full-article please visit, https://www.ncbi.nlm.nih.gov/pubmed/29064334.
About the SITC Annual Meeting
The Society for Immunotherapy of Cancer (SITC) is a non-profit medical professional society of influential scientists, academicians, researchers, clinicians, government representatives, and industry leaders from around the world dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Currently, SITC has nearly 1,600 members representing 17 medical specialties and are engaged in research and treatment of at least a dozen types of cancer. The 32nd SITC Annual Meeting & Associated Programs will take place November 8-12, 2017 at the Gaylord National Hotel & Convention Center in National Harbor, MD. For more information, please go to http://www.sitcancer.org/2017.
About PISCES/KEYNOTE-695
PISCES/KEYNOTE-695 is a global, multicenter phase 2b, open-label trial of intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or "tavo") delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).
About OncoSec Medical Incorporated(ONCS)
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. ImmunoPulse is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12 (tavokinogene telseplasmid [pIL-12] or "tavo"). In Phase 1 and 2 clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile, evidence of anti-tumor activity in the treatment of various solid tumors, and the potential to reach beyond the site of local treatment to initiate a systemic immune response. OncoSec's lead program, ImmunoPulse IL-12, is currently in clinical development for metastatic melanoma and triple-negative breast cancer. The program's current focus is on the significant unmet medical need in patients with melanoma who are refractory or have relapsed on anti-PD-1 therapies. In addition to tavo, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse platform. For more information, please visit www.oncosec.com.
$ONCS PreMkt B/A $1.65/$1.70 with 365K vol
$ONCS new CEO Daniel O'Connor will not be able to do any of those unethical dealings with $ONCS as he will be harnessed closely by the BOD's two co-founder owners, Mr Avtar and Punit Dhillon.
Yes IMO.
Based on these additional revenues, approx $9.5 mil, being recorded in the 4th Qtr ending Dec 31, 2017, it could be expected along with the projected net revenues of $15 mil from MACI and Epicel, that $VCEL will have a net profit of approx $4 to 5 mil. Using O/S 35 mil (Basic and Diluted) then the net EPS is projected to be in the range of +$0.114 to $0.143
Thxs
Home › Investors › Press Releases
OncoSec Appoints Daniel J. O'Connor as Chief Executive Officer to Lead Next Stage of Growth as a Fully Integrated Late Stage Development and Commercial Company
DOWNLOAD AS PDF
NOVEMBER 07, 2017
Mr. O'Connor's appointment effective immediately; former President and CEO of Advaxis and Senior Vice President of ImClone Systems
Punit Dhillon to continue as President and Director of OncoSec
SAN DIEGO, Nov. 7, 2017 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec" or "Company") (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced the appointment of Daniel J. O'Connor as CEO of the Company. His appointment is effective immediately. Previously, on September 7, 2017, Mr. O'Connor joined the Company's Board of Directors. Mr. Punit Dhillon, co-founder of OncoSec, will continue to serve as the Company's President and a member of its Board of Directors.
"We are pleased to welcome Dan to OncoSec at this important time, and believe he is uniquely qualified to lead the company through the successful completion of its phase 2b registration directed trial, PISCES/KEYNOTE-695 in patients with unresectable metastatic melanoma who have progressed or are progressing on an anti-PD-1 therapy," said Avtar Dhillon, Chairman of OncoSec. "Dan is a proven leader with a strong track record of success and brings exceptional strategic and operational expertise in building thriving, successful biopharma companies."
"The Board and I want to thank Punit Dhillon for the contributions he made to OncoSec which positioned the Company for the next stage of growth and shareholder value creation."
"Dan's history commercializing and licensing cancer immunotherapy products is vital as we continue to progress our lead melanoma program through clinical trials and registration," said Punit Dhillon, President of OncoSec. "I am excited to welcome Dan as OncoSec's CEO and look forward to working with him to continue to advance the Company's intratumoral cancer immunotherapies."
Mr. O'Connor has 20 years of executive, legal, and regulatory experience in the biopharmaceutical industry, including CEO and other executive leadership positions at Advaxis, Inc., ImClone Systems, Bracco Diagnostics, Inc., and PharmaNet (today, inVentiv Health). Most recently, Mr. O'Connor was the President, Chief Executive Officer and Director of Advaxis, Inc., located in Princeton, NJ, from 2013 until 2017. As CEO of Advaxis, Mr. O'Connor uplisted Advaxis onto NASDAQ and, in five years raised more than $250 million in funding, transforming it into a patient-focused, fully-integrated, leading cancer immunotherapy company with collaboration partners including Amgen Inc., Merck & Co., Bristol Myers Squib and AstraZeneca.
At ImClone, Mr. O'Connor served as Senior Vice President, General Counsel, and Corporate Secretary where he supported the clinical development, launch, and commercialization of ERBITUX® and resolved several critical corporate issues, including extensive licensing negotiations, to facilitate ImClone's sale to Eli Lilly in 2008. While at PharmaNet (today, inVentiv Health), Mr. O'Connor served as General Counsel and was part of the senior leadership team that grew the company from a start-up contract research organization to a leader in clinical research.
Mr. O'Connor is a 1995 graduate of the Penn State University's Dickinson School of Law in Carlisle, Pennsylvania and currently serves as a Special Advisor to its Dean. Mr. O'Connor graduated from the United States Marines Corps Officer Candidate School in 1988 and was then commissioned as an officer in the U.S. Marines, attaining the rank of Captain and serving in Saudi Arabia during Operation Desert Shield. He received the National Service Metal and the Southwest Asia Service Medal. He is a former New Jersey criminal prosecutor. In 2017, Mr. O'Connor was appointed Vice Chairman of the Board of Trustees of BioNJ, leveraging his experience to guide and support the organization's mission of fostering the innovation of research-based life science companies in the New Jersey region. In October 2017, Mr. O'Connor was appointed to the New Jersey Biotechnology Task Force by Governor Chris Christie.
"I am delighted to join Punit and the Company at this important time and look forward to guiding the continued development of its strong, intratumoral pipeline," said Dan O'Connor. "I am eager to work with our Board, senior management and the entire organization to execute on our promising future, delivering on the Company's long-standing goal of positively impacting the lives of patients with cancer. I believe ImmunoPulse® IL-12 in late-stage melanoma, when used in combination with pembrolizumab, can reshape the tumor microenvironment and converting "cold" tumors to "hot," potentially improving clinical outcomes in patients predicted to not respond to anti-PD-1 therapy."
Trained more than 440 surgeons on the MACI surgical procedures to date,
$VCEL 8-K.
$VCEL spending the monies to train the surgeons!!!
"Money on the floor money at the door"
Yes and the warrants to ICT are now $4.30.
In Oct/Nov 2017 $VCEL Collected $4 mil of the $7 mil accounts receivable and rec'd $5.5 mil from ICT
Yes that is correct it is seasonal activity same Q/Q comparison for hospital operation procedures.
Yes almost always the case where Y/Y Qtrs are compared because of typical activity for the Y/Y Qtrs. Call it seasonal activity.
Also
Waiting now for $VCEL transcript for more info.
$VCEL +50% ownership of (1) Institutional + (2) Mutual Fds
https://www.cnbc.com/quotes/?symbol=VCEL&tab=ownership
Form 10-Q Vericel Corp For: Sep 30
10K WIZARD 9:13 AM ET 11/7/2017
http://archive.fast-edgar.com/20171107/APZ2Q22COC22D242222N22Z2QOOAU22HI292
Filed on: November 7, 2017
$VCEL
Weighted average number of common shares outstanding (Basic and Diluted) 33,667 Sept 30, 2017
Weighted average number of common shares outstanding (Basic and Diluted) 32,765 Jun 30, 2017
the operating loss for the quarter included $0.8 million of stock-based compensation expense and $0.4 million in depreciation expense
Would you link where shares were ATM to increase COH.
That is correct. $VCEL Q/Q Sept 2017 vs Jun 2017 Cash increased to $15.5 mil from $14.0 mil. COH is increasing as revenues increase from MACI and Epicel.
Elite Pharmaceuticals, Inc. to Host Conference Call to Discuss Second Quarter Financial Results on September 10, 2017Financials for Second Quarter Fiscal Year 2018 Ended September 30, 2017 will be released on November 9, 2017
GLOBENEWSWIRE 8:00 AM ET 11/7/2017
Symbol Last Price Change
ELTP 0.082up 0 (0%)
QUOTES AS OF 03:48:48 PM ET 11/06/2017
NORTHVALE, N.J., Nov. 07, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc.(ELTP) ("Elite" or the “Company") , a specialty pharmaceutical company developing a pipeline of abuse-deterrent opioids and niche generic products, announced today that the second quarter financial results of the 2018 fiscal year will be released on Thursday, November 9, 2017. Elite's management will host a live conference call on Friday, November 10th at 11:30 AM EST to discuss the company's financial and operating results and provide a general business update. Stockholder questions should be summited to the company in advance of the call.
Conference Call Information
Date: November 10, 2017
Time: 11:30 AM EST
Dial-in numbers: 1-800-346-7359 (domestic)
1-973-528-0008 (international)
Conference number: 98840
Questions: dianne@elitepharma.com by 9:00 AM EST on Friday,
November 10, 2017
Audio Replay: http://ir.elitepharma.com/events_presentations
Form 8-K Vericel Corp For: Nov 07
10K WIZARD 7:50 AM ET 11/7/2017
http://archive.fast-edgar.com/20171107/AMZZL22COC22N232222N22Z2QUOAZ22HI492
Filed on: November 7, 2017
Press Release: Vericel Reports Third-Quarter 2017 Financial Results
DOW JONES & COMPANY, INC. 7:00 AM ET 11/7/2017
Symbol Last Price Change
VCEL 4.3down 0 (0%)
QUOTES AS OF 04:00:00 PM ET 11/06/2017
Vericel Reports Third-Quarter 2017 Financial Results
Record Third Quarter Revenue of $14.3 Million Represents a 30% Increase Over Third Quarter 2016
Results Driven by Continued Momentum of MACI Uptake and Expanded Epicel Usage
Conference Call Today at 8:00am Eastern Time
CAMBRIDGE, Mass., Nov. 07, 2017 (GLOBE NEWSWIRE) -- Vericel Corporation(VCEL) , a leading developer of expanded autologous cell therapies for the treatment of patients with serious diseases and conditions, today reported financial results for the third quarter ended September 30, 2017.
Total net revenues for the quarter ended September 30, 2017 were $14.3 million, which included $9.9 million of MACI(R) (autologous cultured chondrocytes on porcine collage membrane) net revenues and $4.4 million of Epicel(R) (cultured epidermal autografts) net revenues, compared to $8.3 million of Carticel(R) (autologous cultured chondrocytes) net revenues and $2.6 million of Epicel net revenues, respectively, in the third quarter of 2016. Total net revenues increased 30% compared to the third quarter of 2016, with MACI revenues increasing 19% and Epicel revenues increasing 67%, respectively, compared to the same period in 2016.
Gross profit for the quarter ended September 30, 2017 was $7.1 million, or 50% of net revenues, compared to $4.1 million, or 37% of net revenues, for the third quarter of 2016.
Research and development expenses for the quarter ended September 30, 2017 were $2.9 million compared to $3.4 million in the third quarter of 2016. The reduction in third-quarter research and development expenses is primarily due to a reduction in clinical trial expenses.
Selling, general and administrative expenses for the quarter ended September 30, 2017 were $8.2 million compared to $ 7.0 million for the same period in 2016. The increase in selling, general and administrative expenses is primarily due to an increase in expenses for marketing initiatives related to the launch of MACI and an increase in personnel costs primarily related to an increase in the MACI sales force.
Loss from operations for the quarter ended September 30, 2017 was $4.0 million, compared to $6.4 million for the third quarter of 2016. Material non-cash items impacting the operating loss for the quarter included $0.8 million of stock- based compensation expense and $0.4 million in depreciation expense.
Other expense for the quarter ended September 30, 2017 was $1.4 million compared to $0.3 million for the same period in 2016. The change in other expense for the quarter is primarily due to the change in the fair value of warrants in the third quarter of 2017 compared to the same period in 2016 and interest expense on the company's outstanding revolving credit agreement and term loans.
Vericel's (VCEL) net loss for the quarter ended September 30, 2017 was $5.4 million, or $0.16 per share, compared to a net loss of $6.7 million, or $0.38 per share, for the same period in 2016.
As of September 30, 2017, the company had $15.5 million in cash compared to $23.0 million in cash at December 31, 2016.
"We had a very strong third quarter in which we achieved record third quarter revenues and the second straight quarter of 30% or higher revenue growth compared to the same quarter of the prior year," said Nick Colangelo, president and CEO of Vericel(VCEL). "Our significant revenue growth and gross margin expansion were driven by both the accelerating uptake of MACI as well as substantial growth for Epicel in the quarter."
Recent Business Highlights
During and since the third quarter of 2017, the company:
-- Achieved record third quarter revenues and the second straight quarter of
30% or greater revenue growth versus same quarter of the prior year;
-- Achieved 19% growth in MACI net revenues for the third quarter of 2017
compared to Carticel revenues for the same period in 2016;
-- Achieved 67% growth in Epicel net revenues for the third quarter of 2017
compared to the same period in 2016;
-- Achieved gross margins of 50% of net revenues in the third quarter of
2017 versus 37% of net revenues in the same period in 2016;
-- Trained more than 440 surgeons on the MACI surgical procedures to date,
with approximately 50% of trained surgeons coming from former Carticel
user and non-Carticel user segments;
-- Increased MACI biopsies 44% in the third quarter of 2017 compared to the
same period in 2016;
-- Announced that medical benefit policies have been updated to include MACI
at multiple commercial plans including UnitedHealthcare; at this time,
the number of covered lives for commercial plans providing access to MACI
is approximately equivalent to the number of covered lives for commercial
plans that previously covered Carticel; and
-- Announced plans to expand the MACI sales force from 28 to 40 sales
representatives.
"Based on the expanding surgeon customer base and the increasing volume of MACI biopsies and implants, we believe that demand for MACI will far exceed that for Carticel," added Mr. Colangelo. "Given the MACI launch momentum and expanded patient access, we have initiated another sales force expansion in order to drive continued strong revenue growth in 2018 and beyond."
Conference Call Information
Today's conference call will be available live at 8:00am Eastern time in the Investors section of the Vericel(VCEL) website at http://investors.vcel.com/events.cfm. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation's(VCEL) third-quarter 2017 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.
If you are unable to participate in the live call, the webcast will be available at http://investors.vcel.com/ events.cfm until November 7, 2018. A replay of the call will also be available until 11:00am (EST) on November 11, 2017 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 7097908.
Most definitely $VCEL Ixcell DCM costs winding down.
IMO Expecting $ONCS SITC BORR 50% poster on Fri Nov 10
$VCEL EPS IMO should be similar to last Qtr -$0.07 or better if they contained costs.
$ONCS SITC poster details should be tomorrow. In past was AHs approx 5PM EST.
SITC Presentation will be FRI Nov 10
$ONCS SITC poster presentation details are as follows:
Poster Number: P403
Lead Author: Shawna Shirley, Ph.D., Senior Scientist, OncoSec
Date and Time: Friday, November 10th, 12:30-2:00 p.m. and 6:30-8:00 p.m.
Location: Gaylord National Resort & Convention Center
Per SITC guidelines, abstracts are embargoed until 8:00 a.m. EST on November 7, 2017. To view abstracts, please visit the SITC website at https://www.sitcancer.org/2017/abstracts/info.
Thxs ash111
$VCEL releases Qtrly earnings tomorrow AM Tues Nov 7 before Mkt opens
Would you copy and paste what he is saying.
$VCEL is replacing Carticel with MACI procedure. USA military contract with $VCEL will now be for MACI procedures. New MACI contracts with new MACI procedure costs.
MACI becomes an authorized procedure for the military Brooke Army Medical CenterFort Sam Houston, TX 78234
Unlimited number of $VCEL MACI procedures allowed and all will be paid for by the USA gov't military.
Most likely the rest of the USA military will follow throughout the USA and Global USA Army base medical center.
It is huge revenue source for $VCEL that will grow for many years into the future.
IL-12B is P40
Thxs for the correction
IMO also 750 MACI procedures $32Mil
The USA Military is 100% endorsing $VCEL's MACI procedures.
In the past the Shorts would have been able to drive down the PPS. It now looks IMO that new buyers have stepped in and are buying all shares up to the offering price
$ONCS PPS at $1.32 is now very close to the offering/purchased PPS $1.34375
$ONCS PPS AHs Fri last $1.32 at 7:05 PM
Up from here?