Screw it, double down man.
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.
I think they have a good case, litigation investors are advantageous in their endeavors, but a $5 million bet gives some legit confidence behind this.
Decent warrant volume
Alert: Long-term trend change
·50-day moving average and support is now advancing
·More importantly the 200-day moving average is advancing for the first time @0.77
·A long 23-month base that qualifies as a multi-tested low
·EMA (20) histogram has given a BUY signal (crossing above the Zero centerline)
·PPO histogram (now above Zero) and crossing averages have just opened
So – big picture what we see here is a picture that has for the first time technically coalesced and is issuing a BUY alert as the long-term trend has been divined by the technical analysis Gods to be now pointed up. We have a solid low and long-term well-constructed base and the recent advance in ‘price’ above the ‘now advancing’ 50-day moving average. In addition ‘price’ is just a few ticks away from crossing above the ‘now advancing’ 200-day moving average.
A move above that ‘final’ moving average resistance at $0.77 would be the best technical news in many years for (CVM). Also key strategically here is that the $0.48 low on 8/24/2015 installs a ‘head’ in an ‘inverse head and shoulder’ bullish pattern that suggests an initial price objective near $1.10 once the moving average is pierced.
Larger than usual volume on warrants.
Clinic list...
21st Century Oncology Withdrawn
Scottsdale, Arizona, United States, 85251
United States, Illinois
Simmons Cancer Institute at Southern Illinois University Recruiting
Springfield, Illinois, United States, 62794
Principal Investigator: Krishna Rao, MD PhD
United States, Michigan
Henry Ford Health System Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Haythem Ali, MD
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Gautam G Jha, MBBS
United States, Mississippi
North Mississippi Health Services Withdrawn
Tupelo, Mississippi, United States, 38801
United States, North Carolina
21st Century Oncology Recruiting
Greenville, North Carolina, United States, 27834
Principal Investigator: Ron Allison, MD
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Principal Investigator: Keith Casper, MD
United States, Washington
VA Puget Sound Healthcare System & University of WA Recruiting
Seattle, Washington, United States, 98108
Principal Investigator: Tony S Quang, MD
Austria
HNO-Klinik der medizinischen Universitat Graz Recruiting
Graz, Austria, 8036
Principal Investigator: Sabine Reinisch, MD
Belarus
N.N. Alexandrov Research Istitute of Oncology and Medical Radiology Recruiting
Lesnoy 2, Minsk, Belarus, 223040
Principal Investigator: Alexander Zukhovets, MD, PhD
Vitebsk Regional Oncology Dispensary Recruiting
Vitebsk, Belarus, 210603
Principal Investigator: Evgenia Karchmit, MD
Bosnia and Herzegovina
University Clinical Centre Tuzla Recruiting
Trnovac, Tuzla, Bosnia and Herzegovina, 75 000
Principal Investigator: Fuad Brkic, MD
Clinical Center Banja Luka Recruiting
Banja Luka, Bosnia and Herzegovina, 78 000
Principal Investigator: Sanja Spiric, MD
University Clinical Hospital Mostar Recruiting
Mostar, Bosnia and Herzegovina, 88000
Principal Investigator: Miro Leventic, MD PhD
Clinical Centre University of Sarejevo Clinic for ENT Recruiting
Sarajevo, Bosnia and Herzegovina, 71000
Principal Investigator: Aida Volic, MD PhD
Canada, Ontario
St. Josephs Healthcare Department of Surgery Recruiting
Hamilton, Ontario, Canada, L8N4A6
Principal Investigator: J.E.M. Young, MD
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, JiH 5N4
Principal Investigator: Chang Shu Wang, MD
Canada
CHU de Quebec - L'Hotel Dieu de Quebec Recruiting
Quebec, Canada, G1R2J6
Principal Investigator: Andre Fortin, MD
Croatia
CHC Osijek Recruiting
Osijek, Croatia, 31000
Principal Investigator: Dinko Leovic, MD PhD
General Hospital Dr. Josip Bencevic Recruiting
Slavonski Brod, Croatia, 35000
Principal Investigator: Dvorin Djanic, MD PhD
KBC Zagreb Recruiting
Zagreb, Croatia, 10000
Principal Investigator: Vesna Bisof, MD
Clinical Hospital Center Zagreb Kispaticeva 12 Recruiting
Zagreb, Croatia, 10000
Principal Investigator: Miljenko Bura, MD PhD
KBC Sestre Milosrdnice Recruiting
Zagreb, Croatia, 10000
Principal Investigator: Hrvoje Sobat, MD
CH Dubrava Recruiting
Zagreb, Croatia, 10000
Principal Investigator: Vedran Uglesic, MD PhD
France
ICL 6 avenue Bourgogne CS30519 Recruiting
Vandoeuvre les Nancy, France, 54519
Principal Investigator: Gilles Dolivet, M.D., PhD.
Hungary
University of Debrecen Medical and Health Scioence Centre Recruiting
Debrecen, Hajdu Bihar, Hungary, krt. 98
Principal Investigator: Judit Kocsis, MD, PhD
National institute of Oncology Recruiting
Budapest, Rath Gyorgy, Hungary, H-1122
Principal Investigator: Eva Remanar, MD, Phd
Jasz-Nagykun-Szolnok Oncology Department Withdrawn
Szolnok, Toszegi, Hungary, H-5004
Uzsoki Hospital Withdrawn
Budapest, Uzsoki, Hungary, H-1145
Semmelweis University Recruiting
Budapest, Hungary, 1085
Principal Investigator: Zsolt Nemeth, MD
University of Pecs Institute of Oncotherapy Recruiting
Pecs, Hungary, 7628
Principal Investigator: Lazlo C Mangel, MD
University of Szeged Dept of Oral and Maxillofacial Surgery Recruiting
Szeged, Hungary, 6725
Principal Investigator: Josef Piffko, MD
Markusovsky Teaching Hospital Recruiting
Szombathely, Hungary, 9700
Principal Investigator: Mihaley Kisely, M.D.
India
Bibi General Hospital and Cancer Centre Active, not recruiting
Malkapet, Andhra Pradesh, India, 500024
Amrita Institute of Medical Sciences Active, not recruiting
Cochin, Kerala, India, 682041
Munakshi Mission Hospital and Research Centre Active, not recruiting
Lake Area, Melur Road, Madurai, India, 625107
Sujan Regional Cancer Hospital & Amravati Cancer Foundation Active, not recruiting
Amravati, Maharashtra, India, 444606
Government Medical College and Hospital Active, not recruiting
Aurangabad, Maharashtra, India, 431001
Tata Memorial Hospital Active, not recruiting
Mumbai, Maharashtra, India, 400012
Curie Manavata Cancer Center Active, not recruiting
Mumbai, Naka Nashik, India, 422004
Searoc Cancer Center Active, not recruiting
Jaipur, Rajashlan, India, 302013
V.N. Cancer Center G. Kuppuswamy Naidu Memorial Hospital Active, not recruiting
Coimbatore, Tamil Nadu, India, 641037
Regional Cancer Center Active, not recruiting
Kerala, Trivandrum, India, 695011
Galaxy Cancer Center Active, not recruiting
Ghaziabad, Uttar Pradesh, India, 210010
Israel
Rambam Health Care Campus Recruiting
Sha`ar Ha`Aliya, St Haifa, Israel, 31906
Principal Investigator: Yoav Leiser, MD
Rabin Medical Center Recruiting
Petah, Tikva, Israel, 49100
Principal Investigator: Raphael Feinmesser, MD
Soroka University Medical Center Recruiting
Beer Sheva, Israel, 84101
Principal Investigator: Joshua Benzion, M.D.
Malaysia
Dept of Head and Neck Surgery School of Medical Sciences Univ. Sains Recruiting
Kelantan, Malaysia, 16150
Principal Investigator: Baharudin Abdullah, MD
School of Medical Sciences University Sains Malaysia Recruiting
Kubang Kerian, Malaysia, 16150
Principal Investigator: Baharudin Abdullah, MD
Poland
Wojewodzki Szpital Specjalistyczny im Kopernika Recruiting
Lodz, ul Paderewskiego 4, Poland, 93-509
Principal Investigator: Jacek Fijuth, MD, PhD
Swietokrzyskie Centrum Onkologii Recruiting
Kielce, ul. Artwinskiego 3, Poland, 25-734
Principal Investigator: Slawomoir Okla, MD
Centrum Onkologii im. Prof. Lukaszcyka Recruiting
Warsaw, ul. Roentgena 5, Poland, 02-781
Principal Investigator: Ewa Ziolkowska, MD
Centrum Onkologi-Instytut im. Marie Sklodowskiej-Curie Recruiting
Warszawa, ul. Roentgena 5, Poland, 02-781
Principal Investigator: Andrzej Kawecki, MD
ul. M. Sklodowskiej-Curie 24A Recruiting
Bialystok, Poland, 15-276
Principal Investigator: Marek Ragowski, MD PhD
Szpital Specialistyczny im. Ludwika Rydgiera Recruiting
Krakow, Poland, 31826
Principal Investigator: Marci Hetnal, MD PHD
Samodzielny Publiczny Szpital Kliniczny Klinika Otolarryngologii I Onkologii Laryngologicznej Recruiting
Lublin, Poland, 20-954
Principal Investigator: Janusz S. Klatka, M.D., PhD.
Weilkopolskie Centrum Onkologii Klinika Chirurgii Glowy Szye Onkologii Laryngologiczne Recruiting
Poznan, Poland, 61-866
Principal Investigator: Wojciech J Golusinski, M.D., PhD.
Uniwersitecki Szpital Kliniczny Klinika Otolaryngologii Chirugii Glowy i Szxyi Recruiting
Wroclaw, Poland, 50-556
Principal Investigator: Tomaz Krecicki, MD
Romania
Spital Clinic Judetean Mures Recruiting
Targu Mures, Romania, 540072
Principal Investigator: Cornelia Toganel, MD
Russian Federation
Sverdlovsk Regional Cancer Center Recruiting
Sverdlovsk, Ekaterinberg, Russian Federation, 620905
Principal Investigator: Dmitry Bentsion, MD
Leningrad Regional Oncology Center Recruiting
St. Petersburg, Leningradskaya, Russian Federation, 188663
Principal Investigator: Andrey Karpenko, MD
Blokhin Cancer Research Center Recruiting
Moscow, Russian Federation, 115478
Principal Investigator: Ilya Romanov, MD
N.N. Blokhin Russian Cancer Research Center Recruiting
Moscow, Russian Federation, 115478
Principal Investigator: Mikhail Kropotov, MD
Budget Institution of Healthcare of Omsk Region Clincal Oncology Dispensary Recruiting
Omsk, Russian Federation, 644013
Principal Investigator: Mikhail Dvorkin, M.D.
Serbia
Serbia Clinic for ENT and Maxillofacial Surgery Recruiting
Belgrade, Pasterova 14, Serbia, 11000
Principal Investigator: Milovan Dimittrijevic, MD, PhD
Clincal Center Serbia Clinic for Oral and Maxillofacial Surgery Recruiting
Belgrade, Serbia, 11000
Principal Investigator: Jovica Milovanovic, M.D., PhD.
Faculty of Dental Medicine Clinic for Maxillofacial Surgery Recruiting
Belgrade, Serbia, 11000
Principal Investigator: Zivorad Nikolic, MD
Military Medical Academy Clinic for Maxillofacial Surgery Recruiting
Belgrade, Serbia, 11000
Principal Investigator: Srbljub Stosic, MD PhD
Clinic for Stomatology department for maxillofacial Surgery Recruiting
Nis, Serbia, 18000
Principal Investigator: Dragan Krasic, MD PhD
Clinical Center Nis center for Oncology Recruiting
Nis, Serbia, 18 000
Principal Investigator: Misko Zivic, DS
Clinical center Vojvodina Clinic for ORL Recruiting
Novi Sad, Serbia, 21000
Principal Investigator: Rajko Jovic, MD PhD
Clinical Centre Vojvodina Clinic for Maxillofacial Surgery Recruiting
Novi Sad, Serbia, 21000
Principal Investigator: Aleksandar Kiralj, MD PhD
Sri Lanka
National Cancer Institute Dept of Clinical Oncology & Radiotherapy Recruiting
Colombo, Sri Lanka, 10280
Principal Investigator: Mahendra Perera, MD
Oncology Unit Teaching Hospital Karapitya Recruiting
Galle, Sri Lanka
Principal Investigator: Horadugoda Priyanada, MD
Taiwan
Kaohsiung Branch Chang Gung Memorial Hospital Recruiting
Niaosong, Kaohsiung, Taiwan, 833
Principal Investigator: Chih-Yen Chien, MD
National Cheng Kung University Hospital Recruiting
Taipei, Tainan, Taiwan, 704
Principal Investigator: Sen-Tien Tsai, MD
National Taiwan Research Hospital Recruiting
Chengshan, Taipei, Taiwan, 100
Principal Investigator: Pei-Jen Lou, MD
Mackay memorial Hospital Withdrawn
Zhongshan, Taipei, Taiwan, 104
Linkou Branch Chang Gung Memorial Hospital Recruiting
Guishan, Taoyuan, Taiwan, 333
Principal Investigator: Ku-Hao Fang, MD
Changua Christian Hospital Recruiting
Changua, Taiwan, 500
Principal Investigator: Yu-Shih Lai, MD
Buddhist Tzu Chi General Hospital, Hualien Branch Recruiting
Hualien, Taiwan, 970
Principal Investigator: Peir-Rong Chen, MD
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Principal Investigator: Ming-Hsui Tsia, MD
Taichung Veterans General Hospital Recruiting
Taichung City, Taiwan, 40705
Principal Investigator: Chen Chi Wang, M.D.
Shin-Kong Wu Ho-Su Memorial Hospital Recruiting
Taipei, Taiwan, 111
Principal Investigator: Sheng-Po Hao, MD
Thailand
Khon Kaen University Dept of Otolaryngology Recruiting
Nai- Muang, Thailand, 40002
Principal Investigator: Patravoot Vatanasapt, MD
Turkey
Haceteppe University Dept of Otolaryngology - Head and Neck Surgery Recruiting
Ankara, Turkey, 06100
Principal Investigator: Nilda Suslu, MD
Acibadem University Maslak Hospital ENT Department Recruiting
Istanbul, Turkey
Principal Investigator: Omer F Unal, MD
Ukraine
Cherkasky Regional Oncological Dyspensary Dept. Head and Neck tumour Recruiting
Cherkasy, Ukraine, 18009
Principal Investigator: Viktor Paramonov, MD
Clinical Diagnostic Laboratory of Dnepropetrovsk Municipal Institution City Multidisciplinary Clinical Hospital No. 4 Recruiting
Dnepropetrovsk, Ukraine, 49102
Principal Investigator: Igor Bondarenko, M.D.
Donetsk Regional Antitumor Center Recruiting
Donetsk, Ukraine, 83092
Principal Investigator: Stanislave Zolotukhin, DD
Grigoriev Institute for Medical Radiology of National Academy of Medical Science of Ukraine Dept. of Remote, Combined Radiation and Complex Therapy Recruiting
Kharkiv, Ukraine, 61024
Principal Investigator: Olena Sukhina, M.D.
Kharkiv Regional Clinical Oncology Center Dept. Of Head and Neck Tumour Recruiting
Kharkiv, Ukraine
Principal Investigator: Yurii Vinnyk, Professor
Kiev City Clinical Oncology Center of the Main Health Care Dept. of the Kiev Day Hospital Not yet recruiting
Kiev, Ukraine
Principal Investigator: Olga Panomoreva, MD
Kiev City Clinical Oncology Center of the Main Health Care Dept of Kiev Day Hospital Radiotherapy Dept. Recruiting
Kiev, Ukraine
Principal Investigator: Larysa Synuskina
Kyiv Clinical Oncology Center of the Main Healthcare Dept. of Kyiv Recruiting
Kyiv, Ukraine
Principal Investigator: Olga Ponomareva, Professor
LVIV State OncologyRegional treatment and Diagnostic Ceneter Recruiting
Lviv, Ukraine, 79031
Principal Investigator: Yaroslav Shparyk, MD
Sumy Regional Clinical Oncology Dyspensary Recruiting
Sumy, Ukraine, 40004
Principal Investigator: Ihor Vynnychenko, MD
Zaporiz'ka Regional Clinical Oncology Dispensary Recruiting
Zaporiz'ka Oblast', Ukraine, 69040
Principal Investigator: Olexiy Kovalev, MD
United Kingdom
Aintree University Hospital Recruiting
Liverpool, United Kingdom, L9 7AL
Principal Investigator: Richard Shaw, MD
Sponsors and Collaborators
CEL-SCI Corporation
Teva Pharmaceutical Industries
Orient Europharma Co., Ltd.
CEL-SCI (NYSE:CVM) was the target of a significant growth in short interest in September. As of September 30th, there was short interest totalling 2,103,023 shares, a growth of 17.8% from the September 15th total of 1,784,957 shares, Market Beat.com reports. Currently, 2.2% of the company’s stock are sold short. Based on an average daily trading volume, of 545,949 shares, the days-to-cover ratio is presently 3.9 days.
CEL-SCI (NYSE:CVM) traded down 2.6362% during mid-day trading on Friday, hitting $0.7202. The stock had a trading volume of 170,006 shares. CEL-SCI has a 52 week low of $0.48 and a 52 week high of $1.23. The stock’s 50-day moving average is $0.63 and its 200 day moving average is $0.74. The company’s market capitalization is $80.72 million.
Some folks starting to bet against even with arbitration so close.
Warrants up 18%
Huge boost to zinc prices.
Things looking much more promising here.
DNR opens auction of mineral leases
The Minnesota Department of Natural Resources announced Wednesday that it is opening another auction of state mineral leases — plots of central and northern Minnesota land that mining companies can bid on to explore for copper, nickel, gold and other valuable metals.
The DNR is offering 88,572 acres in Aitkin, Carlton, Itasca, Kanabec, Koochiching and St. Louis counties where the state holds the mineral rights.
That's less acreage than was included when the DNR published a list of potential lease areas in June. The agency said that "based on public input, company interest and other factors," it removed 13,474 acres in St. Louis and Cass counties from the lease sale.
The largest concentration of sites proposed for minerals exploration is about 30 miles north of Duluth, between Island and Whiteface lakes in the Cloquet Valley State Forest. Maps of the leases and other information about the auction is available at dnr.state.mn.us/lands_minerals/leasesale/index.html.
The highest bidder gains exclusive rights to exploration, usually for five years, and can later negotiate mining rights for that parcel. Revenue from the mineral leases goes to public schools, local taxing districts and the state's general fund.
In most cases the state also owns the surface land in addition to the mineral rights below. But in some cases the state owns mineral rights under private land — and that's caused problems in recent years as landowners opposed mineral exploration on their property.
The issue boiled over between 2011 and 2013, when the state Executive Council at first delayed but ultimately approved mineral exploration contracts for several leases, especially in Lake County, where some landowners said they were unaware of the rights of mining companies to access their property.
Because of that public outcry, Minnesota Gov. Mark Dayton ordered the DNR to make its mineral lease process easier for the public to understand and access.
DNR officials said earlier this year that they incorporated a new process "designed to increase transparency, provide better access to information and afford an opportunity for public input."
This is the first mineral lease auction under the new system.
The DNR noted that acquiring a mineral lease is far from actual mining or even test drilling. Only about 2 percent of the mineral lease sites ever see actual test drilling, the agency said. So far, none have been mined. Before a state-owned parcel can be mined, the leaseholder must comply with all legal requirements for environmental review and permitting.
This is the DNR's 34th nonferrous mineral lease since the program began in 1966.
The deadline for bids is Nov. 13. After bids are opened on Nov. 16 and reviewed by the DNR, the state's Executive Council — the governor, lieutenant governor, attorney general, secretary of state and state auditor — will make a final decision about whether to approve the new state mineral leases.
The auction is for nonferrous minerals such as copper, nickel, platinum, palladium, gold, silver, cobalt, chromium, zinc, lead, bismuth, tin, tungsten, tantalum and niobium.
Agree on all points. They are directly involved in the study and must have some idea how it's going. If they saw completely bland results I don't think they would commit another few million dollars.
Going up faster than I wanted or thought...
Warrants up 100%
This also looks good for an arbitration case because the new company is enrolling way more patients than the last and also putting more skin in the game because they are seeing results first hand.
Yup, great news.
News!
Ergomed Increases Its Co-Development Contribution up to $12,000,000 in CEL-SCI’s Phase 3 Head and Neck Cancer Trial
Source: Business Wire
CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") and its Clinical Research Organization (CRO) Ergomed plc (AIM:ERGO) today announced that they have expanded their co-development agreement with increased activities to be undertaken by Ergomed. Pursuant to the expanded co-development agreement, Ergomed’s contribution to the Phase 3 study will increase from $10,000,000 to $12,000,000. The companies are undertaking the Phase 3 trial of CEL-SCI’s investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer.
Under the extended agreement, Ergomed will contribute up to $12,000,000 towards the cost of performing clinical services for the Phase 3 study in exchange for a single digit percentage of milestone and royalty payments, up to a specified maximum amount. Well over 500 patients have been enrolled in the world’s largest Phase 3 trial for head and neck cancer.
Ergomed CEO Miroslav Reljanovic stated, “At this point in the clinical trial we have decided to increase our investment in the development of Multikine, as we believe that it holds the potential to treat head and neck cancer in a new way. Our potential returns from this agreement will increase in line with our investment.”
CEL-SCI CEO Geert Kersten added, “Working with a skilled CRO, our Phase 3 trial is making significant progress towards completing study enrollment goals. We are pleased to enter into this expanded co-development agreement with Ergomed. It further aligns Ergomed’s goals with CEL-SCI’s as Ergomed will be rewarded for its $12,000,000 co-development investment from the commercialization of the drug.”
About the Multikine Phase 3 Study
The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.
Still think news is on the way this week? About what?
House vote..
Ecklund took about 43 percent of the vote with 3,083 votes with Bill Hansen of Sawbill Lake coming in second with about 37 percent of the vote with 2,637. Heidi Omerza, Ely City Council member, pulled 655 votes and Eric Johnson, International Falls resident and businessman, pulled 678 votes.
The DFL primary was cast by some as a regional referendum on proposed copper mining in northeastern Minnesota, with Ecklund a strong supporter of the proposed PolyMet copper mine project now under environmental review. Hansen, 62, in his third primary for the same regional House seat, was seen as a potential contender even though he strongly opposes copper mining.
Decent Friday trading.
Pretty big jump on low volume.
Rebound day.
Very well written.
Risks And Rewards For Cel-Sci: Phase III And Phase I Progress, And Arbitration
Oct. 1, 2015 4:15 PM • CVM
Summary
Phase III testing of Multikine on head and neck Cancer continues, with enrollment projected to be complete during the first quarter of 2016.
Phase I testing of Multikine as a treatment for HPV-related anal warts started in 2014 should be finishing up during October 2015, but maybe not?
A lawsuit that CVM has initiated against the CRO formerly running its Phase III testing is slated for the end of October 2015.
Absent an influx of cash from winning the lawsuit, CVM will need to do a capital raise during the next few quarters.
Cel-Sci Corporation (NYSEMKT:CVM), is a clinical stage bio-pharma company with a lead drug candidate (Multikine®) currently in the process of a long and slowly populated Phase III study for its effectiveness as a supplemental treatment for Head and Neck cancer. Multikine also is the subject of a Phase I test as a treatment for HPV (herpes virus) related perianal warts in HIV compromised patients.
The Multikine®drug (Leukocyte Interleukin, Injection) is an immunotherapy that CVM has developed that has shown promise in preclinical trials, and in Phase I & II clinical trials against certain types of cancers and against HPV-related warts in HIV-infected patients. The Multikine treatment for Head and Neck cancer is unique in that it is provided to cancer patients prior to their receiving the standard of care treatment of surgery, followed by radiation treatment alone, or radiation treatment concurrent with chemotherapy. The hypothesis here is that using the Multikine treatment to help shrink or arrest the growth of tumors prior to surgery, and prior to the immune system being impaired by follow-up radiation and/or chemotherapy can increase survivorship among patients by 10% or more.
Additionally, CVM possesses a validated manufacturing facility that is used to manufacture lots of its Multikine drug. This facility has been designed to meet US FDA and European quality standards for the manufacture of Multikine. CVM controls the facility it needs in order to go into production - once the drug has finally reached the stage where FDA review of results will allow CVM to go forward.
Financial Status and Concerns for CVM:
Cel-Sci does not have a revenue source other than through dilutive financing arrangements or stock-sales into the market. While CVM does not hold any significant quantities of long-term debt, the operating costs of the company while it has been ramping up Phase III testing have been high, and have increased significantly over the last few years. As of the most recent annual report, CVM reported a $27.57 MM operating loss for 2014, an increase in losses of ~$7.7 MM over what was reported for 2013. Most of this increased loss in 2014 can be explained by the increased spending on R&D functions due to the increased expenses of running the expanded Phase III trials as they were ramped during that year. Similar spending requirements during 2015 can be expected to continue on the Phase III trial and will continue to drive a large financial deficit again for the year. Direct assessments of the financial information from CVM's quarterly reports during 2015 indicates that a relatively high cash burn has indeed continued, and suggests that these high expenditures should be anticipated to continue at least until the Phase III study population has been filled sometime in early 2016.
CVM has raised operating capital during 2015 via private and public placements for $7 MM during the first quarter of 2015, and for $16 MM via public offerings of stock & warrants during the second quarter of 2015. Barring other sources of unanticipated revenue before the end of 2015, it is likely that CVM will have to undergo another similar round of dilutive financing in order to remain solvent and cover costs for their Phase III trial. The continued expectations for sales of stock and warrants have, understandably, had a net effect to help hold down share prices for CVM during 2015.
CVM is also involved in a lawsuit with the initial CRO for their Phase III trials in an attempt to reclaim damages to CVM caused by the mishandling of that Phase III trial by the Contract Research Organization (CRO) - a potentially positive factor I will discuss in detail a bit later in this article.
What we have here is a race between the needs for continued financing for CVM to continue moving forward with its Multikine drug, and the known risks for investors that dilutive financing would have on their bottom line for CVM and its shareholders in the short to medium term.
The R&D Factors for CVM during 2015 and into early 2016:
Phase III testing for Multikine in Head and Next Cancer:
The Phase III study for CVM's Multikine as a treatment for Head and Neck cancer has proceeded extremely slowly relative to expectations of investors when the trial was started. In part the slow pace of the study has been because of the large study population size required (880 patients enrolled to insure that at least 784 patients were retained in the final population) to ensure the statistical resolution needed to assess Multikine's effectiveness in treating this cancer was obtained. Adding to the sheer size of the study, the slow pace with which the Phase III trial has moved forward was negatively impacted because the CRO that was initially employed to run the study was ineffective and potentially negligent in getting their contracted work done.
During 2013, that CRO was fired by CVM, and new CRO's were brought in to rejuvenate the Phase III trial. Since that change in 2013, study enrollment has increased dramatically, numerous study locations have been added (currently over 20 locations worldwide are participating), and the Phase III study is on track to be fully populated during early 2016.
As of September 1, there were a total of 540 patients enrolled, and the number of patients added each month during 2015 has ranged between 19-34. The Phase III study is now projected for completion of enrollment during March 2016, but in this author's estimation may take a few months longer unless the rate of patients being enrolled increases over the next few months. This is about on Quarter after the previous estimated completion date of December 2015 for the endpoint for populating the Phase III study. This delay, while it may be understandable in light of the issues that CVM experienced with the initial CRO, is one of the many reasons that CVM share prices remain depressed relative to many other companies with drugs with a Phase III study ongoing testing. The risks in this delay are viewed as (justifiably) high by those that have been watching this company slog through clinical testing of Multikine.
Prior to the delays caused by the previous CRO, it was expected that the Study Completion date for assessing the primary outcome data would be in December 2017. The delay into 2016 for filling the study population could easily push that primary outcome assessment date into 2018. While some information on secondary outcome measures could be available prior to 2018, it is probably unrealistic to assert that CVM will have the data needed to apply for FDA approval of Multikine prior to sometime in late 2017, and the wait for shareholders could well continue into 2018.
Unless CVM can generate some other source of revenue to tide the company over through 2017 or 2018, that's a long time for investors to wait it out.
Phase I testing for Multikine against HPV Warts:
The Phase I clinical trial for Multikine against HPV warts in immunocompromised (HIV positive) patients was initiated as part of a Navy Cooperative Research And Development Agreement (CRADA) during 2013-2014. The original projected end date for that study for patient enrollment was during August 2015, and as of September 30, 2015, that study is listed as 'still enrolling patients' on the ClinicalTrials.gov website. The original study completion endpoint, for a total of 15 patients, for that set of trials was to be during October, 2015. However; to date there has been no indication that the study via the Navy CRADAS is being wrapped up in time to achieve this milestone. This is a source for concern and potential risk for CVM investors.
To complicate assessment of the success, or potential failure of this Phase I trial, there was an announcement during July of 2015 that a highly similar Phase I study was being initiated by (or expanded upon by) a different set of researchers. This second set of Phase I trials raises doubts in the minds of some investors, and begs the question as to whether any significant progress was made under the Navy CRADA that ran for more than a year. What aspects of that initial study under the CRADA either 1) merited the addition of this additional work to be conducted at UC San Francisco, or 2) indicated that the group slated to conduct the original Phase I work was not up to the task. This aspect of that Phase I study must be considered as (at best) unresolved, or (at worst) a negative sign for the future of CVM's Multikine as a treatment for HPV warts in these clinical situations.
When the Phase I study of Multikine against HPV perianal warts was initially announced for 2013-2014, one of the justifications made to take on the new potential use for Multikine was that the results needed to assess Multikine as a Cancer treatment would not be ready for 3-4 more years. Because of this long time-frame, pursuing Multikine as a treatment for perianal warts caused by HPV viruses in immunocompromised patients might bring Multikine to the market sooner, and thus bring in a revenue stream to CVM more quickly, and while CVM and its shareholders were waiting out the end results on Phase III testing for Head and Neck cancer.
Now there is at least the appearance that these Phase I trials are not moving forward quickly to fill that role. Justified or not - this potential delay plays into the existing narrative that CVM is a company that is not capable of bringing a treatment to market.
Absent some evidence that these anti-HPV wart studies for Multikine are moving forward, this makes the financial future of CVM appear even murkier, and with an added perceived risk that. Even if CVM can stay sufficiently financially together to allow it to finish out the Phase III testing of Multikine - can the company ride out the 2+ years it will need to see Multikine through to use as an anti-cancer treatment without more significant financial dilution to current shareholders?
A Wildcard for CVM - It's Lawsuit against its former CRO (inVentiv):
Barring further delays, the long-awaited trial for CVM against its previous Multikine Phase III CRO (inVentiv Clinical, LLC) for breach of contract and damages finally comes to a head at the end of October, 2015. CVM is suing inVentiv for up to $50 MM for the damages that they may have caused to CVM by not fulfilling their part of the contract in populating the large Phase III trial. When Inventive was fired in April of 2013, they had enrolled less than 120 patients in a year and a half, and the numbers of patients added to the trial was slowly dropping as months went on. Since April of 2013, over 450 patients have been enrolled in the study, and numerous study locations have been added world-wide. This dramatic change in trajectory at least superficially suggests that CVM has a viable case against the inVentiv when seeking damages. It also appears that the available appeals and delaying tactics for inVentiv have been exhausted at last, and the trial is going to go on as scheduled at the end of October.
There are three possible outcomes from this trial - two of which are extremely favorable for CVM's bottom line.
If there is a settlement prior to the trial, somewhat less than the $50 MM figure will be awarded to CVM. However, even 20-30% of that $50 MM figure would give CVM some of the operating capital that it needs to minimize the need for near-term dilution of current shareholders that the selling of more stocks or warrants into the market. At the least, an award of $10-15 MM would give CVM sufficient capital to complete the enrollment for Multikine for Head and Neck cancer treatments without having to do a capital raise.
If the case goes to trial and CVM wins the full $50 MM, then the concerns over needing to do a capital raise decrease for an even longer period of time - perhaps sufficient to tide CVM through the period it needs to get the Phase III primary outcome data for Multikine.
CVM loses the case. At which point shareholders are not really in a worse a financial situation than they are today and will continue to have to rely on dilutive financing to keep CVM a going concern.
As of September 30, CVM had a Market Capitalization of approximately $69.5 MM. Being awarded the full $50 MM in damages being sought would have an obvious positive effect on the perceived value of the company, on its short-term share prices, and on the outlook that CVM will have the financial resources to complete its Phase III testing, and to wait out the period before the primary and secondary outcome measures can be tabulated, and sent in for FDA review. In this case, it would not be a surprise to me to see share prices increase by 50% or more by November 2015.
Absent an award of damages resulting from this lawsuit - the immediate financial future for CVM will continue to be dependent on dilutive financing. More dilutive financing can be expected to continue to push down share prices for CVM and further crunch current shareholders. It would not be a surprise to see share prices decrease by another 25-30% from their current ~$0.60-0.70 trading range in immediate response to a failure to win damages.
October through the end of 2015 should bring a lot of clarity to CVM's ability to carry on with its Phase III testing of Multikine and maintain some financial stability for the company in the meantime.
Disclaimers:
Just One Lab Nerd has earned a Ph.D. in Genetics and possesses over 20 years working experience post-degree in genetics, biological chemistry, molecular genetics, population genetics, and in methods development and validation. The author has held a small long position in CVM since 2010, but has not added to or sold from his holdings since 2012 while waiting to see how CVM's Multikine Anti-Cancer drug has progressed through its Phase III trial, and how the lawsuit against inVentiv has progressed.
Disclosure: I am/we are long CVM, NNVC.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
3 parties.
1. Large institutions who want large, cheap blocks of shares.
2. Glencore: drive the price down, offer a very undervalued buyout price.
3. Predatory activist investors who are trying to kill the company.
That being said, it obvious this stock is under attack right at the pivotal moment in their company's history.
I'm loving these prices. More shares for me.
CEL-SCI Reports September Patient Enrollment for Its Phase 3 Head and Neck Cancer Trial
Source: Business Wire
CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") today announced that in the month of September it has enrolled 30 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer. Total patient enrollment is now 570 as of September 30, 2015 in the world’s largest Phase 3 study in head and neck cancer.
A total of 880 patients are expected to be enrolled in over 20 countries.
You don't need an inside source to know enrollment numbers are coming out.
4 directors acquired shares today.
1. Name and Address of Reporting Person *
ZIMMERMAN DANIEL H 2. Issuer Name and Ticker or Trading Symbol
CEL SCI CORP [ cvm ] 5. Relationship of Reporting Person(s) to Issuer (Check all applicable)
_____ Director _____ 10% Owner
__ X __ Officer (give title below) _____ Other (specify below)
Senior Vice President
(Last) (First) (Middle)
3. Date of Earliest Transaction (MM/DD/YYYY)
9/30/2015
(Street)
(City) (State) (Zip)
4. If Amendment, Date Original Filed (MM/DD/YYYY)
6. Individual or Joint/Group Filing (Check Applicable Line)
_ X _ Form filed by One Reporting Person
___ Form filed by More than One Reporting Person
Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
1.Title of Security
(Instr. 3) 2. Trans. Date 2A. Deemed Execution Date, if any 3. Trans. Code
(Instr. 8) 4. Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s)
(Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 7. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V Amount (A) or (D) Price
Common Stock 9/30/2015 A 5480 A $0.6 94324 D
1. Name and Address of Reporting Person *
TALOR EYAL 2. Issuer Name and Ticker or Trading Symbol
CEL SCI CORP [ cvm ] 5. Relationship of Reporting Person(s) to Issuer (Check all applicable)
_____ Director _____ 10% Owner
__ X __ Officer (give title below) _____ Other (specify below)
Chief Scientific Officer
(Last) (First) (Middle)
8229 BOONE BLVD, STE 802 3. Date of Earliest Transaction (MM/DD/YYYY)
9/30/2015
(Street)
VIENNA, VA 22182
(City) (State) (Zip)
4. If Amendment, Date Original Filed (MM/DD/YYYY)
6. Individual or Joint/Group Filing (Check Applicable Line)
_ X _ Form filed by One Reporting Person
___ Form filed by More than One Reporting Person
Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
1.Title of Security
(Instr. 3) 2. Trans. Date 2A. Deemed Execution Date, if any 3. Trans. Code
(Instr. 8) 4. Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s)
(Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 7. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V Amount (A) or (D) Price
Common Stock 9/30/2015 A 4000 A $0.6 3199055 D
Table II - Derivative Securities Beneficially Owned ( e.g. , puts, calls, warrants, options, convertible securities)
1. Name and Address of Reporting Person *
PRICHEP PATRICIA B 2. Issuer Name and Ticker or Trading Symbol
CEL SCI CORP [ cvm ] 5. Relationship of Reporting Person(s) to Issuer (Check all applicable)
_____ Director _____ 10% Owner
__ X __ Officer (give title below) _____ Other (specify below)
Senior Vice President
(Last) (First) (Middle)
3. Date of Earliest Transaction (MM/DD/YYYY)
9/30/2015
(Street)
(City) (State) (Zip)
4. If Amendment, Date Original Filed (MM/DD/YYYY)
6. Individual or Joint/Group Filing (Check Applicable Line)
_ X _ Form filed by One Reporting Person
___ Form filed by More than One Reporting Person
Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
1.Title of Security
(Instr. 3) 2. Trans. Date 2A. Deemed Execution Date, if any 3. Trans. Code
(Instr. 8) 4. Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s)
(Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 7. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V Amount (A) or (D) Price
Common Stock 9/30/2015 A 5886 A $0.6 3250466 D
1. Name and Address of Reporting Person *
KERSTEN GEERT R 2. Issuer Name and Ticker or Trading Symbol
CEL SCI CORP [ cvm ] 5. Relationship of Reporting Person(s) to Issuer (Check all applicable)
__ X __ Director _____ 10% Owner
__ X __ Officer (give title below) _____ Other (specify below)
Chief Executive Officer
(Last) (First) (Middle)
3. Date of Earliest Transaction (MM/DD/YYYY)
9/30/2015
(Street)
(City) (State) (Zip)
4. If Amendment, Date Original Filed (MM/DD/YYYY)
6. Individual or Joint/Group Filing (Check Applicable Line)
_ X _ Form filed by One Reporting Person
___ Form filed by More than One Reporting Person
Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
1.Title of Security
(Instr. 3) 2. Trans. Date 2A. Deemed Execution Date, if any 3. Trans. Code
(Instr. 8) 4. Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s)
(Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 7. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V Amount (A) or (D) Price
Common Stock 9/30/2015 A 6625 A $0.6 8845963 D
Or is this regarding the "INSIDE SCOOP"???....
Yeah I know. Sept. Enrollment numbers.
Yeah I would say anything under 23 and it would be time to start scratching the head a bit.
My guess is 27, hoping for more. Also hoping for other news by Friday.
Numbers out tomorrow.
Still waiting for that inside scoop.......
Hmmmmm?