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The "D" drops on Thursday , corresponding to the end of Q2 - any thoughts on how this will affect SP
The game is still on here
Phase 3 began in October. Does anyone read? http://ir.cytodyn.com/press-releases/detail/213/cytodyn-injects-first-patient-in-its-current-phase-3-study
I'm speaking out my ass here and I hate when other people do this on this board, but I thought that there was a, seven day hold on news from the conference . I can't cite the source off hand I don't remember where it was, perhaps the last conferemce call. But that's what I'm believe I heard. There will be news, unless they would not have been invited to speak today. This isn't a swap meet of biotechs, it's an invitational. By invite only after review of companies trials. Thays all. Hold out or sell Idgaf
Not seeing your conversion, call your brokerage they'll straighten it out fast. Just called TDA and it was corrected quickly.
Good luck
But Gilead has new hiv drugs, yes I know they're not the same, but any thoughts?
http://fortune.com/2016/04/05/gilead-next-gen-hiv/
Taimed is in Phase 1 not phase 3 for SC -TMB-355 (Ibalizumab)
TMB-355 (Ibalizumab is for EWND STAGE HIV / AIDS PATIENDS - not mainenance . END OF LIFE care LAST RESORT effort to save a patient
http://www.taimedbiologics.com/en/info/TMB355.aspx
Or maybe, or maybe or maybe. Stop making things up and focus on facts.
GILD is just fortifying the same old with new bells. Whether or not they buy CYDY remains to be seen, Its not going to take away 44% of its revenue stream. At the end of the day , PRO 140 isn't going to be for everyone and lets face it , not everyone wants to inject , as easy as Subcutaneous injections are. There is a market for it though , but there are also other therapies in the works from other companies. We need not forget that Pro 140 may also be used in people that DO NOT have HIV , as PreP. https://www.aids.gov/hiv-aids-basics/prevention/reduce-your-risk/pre-exposure-prophylaxis/
One of my big concerns about pro 140 was the attempt made using the gene editing software CRISPR to combat it , it seems that attempt has already been outdone by HIV itself mutating around the edits .
Im long here as well - lets see how this evolves over the next few weeks .
source : http://www.nature.com/news/hiv-overcomes-crispr-gene-editing-attack-1.19712
https://www.sciencedaily.com/releases/2016/04/160407132307.htm
https://www.newscientist.com/article/2083404-hiv-defies-attempt-to-edit-virus-out-of-human-cells-with-crispr/
7 presentations based on the same old HAART therapy. There are no other new therapies being featured. If you have nothing useful or new to say then go watch TV.
Qoute : "Anyone else catch the CEO saying ASM will be our coming out party with the data on the CC yesterday? Or was I just imagining it Lol?"
Absolutely, I don't know what twilight zone others were in yesterday with the selling, granted it's from the time line extension, but here comes the stream of news we all expected. CALM SEAS NEVER MADE GOOD CAPTAINS. Hold the wheel and stay long.
CYDY in Seeking Alpha : 5/11/16
Pursuant with today's CC
http://seekingalpha.com/news/3182425-cytodyn-completes-4_3m-capital-raise?dr=1&source=email_rt_mc_readmore&utoken=b3d0c29edd133a23075f8decfbd0d6db#/
CytoDyn completes $4.3M capital raise
May. 11, 2016 4:18 PM • SA Editor Douglas W. House
CytoDyn (OTCQB:CYDY) finalizes the private placement of 4,301,500 shares of common stock and accompanying five-year warrants to purchase up to 1,075,375 shares of common (one warrant to purchase 1/4 of a share of stock) at $1.35 at a combined price of $1.00.
Separately, the FDA has requested additional population data and scientific rationale to support the company's Orphan Drug request for PRO 140 for the treatment graft versus host disease. The company has until May to submit the additional information.
WHAT WE ARE MISSING WITH CYDY
It seems everyone has a lot of hopes on a Gilead buyout. there are other HIV medication makers , and like Gilead , their patents are going or have gone generic. Generic is just as much as a revenue killer imo as Pro 140 could be.
Here's a list of other HIV medication makers: Thoughts ?
http://www.aidsinfonet.org/fact_sheets/view/402
30 day timeline - expanded info -FDA Compassionate use
http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm#What_to_Expect
What to Expect After Submitting a Request for Expanded Access to an Investigational Drug (Including a Biologic) Under a Single Patient IND
Treatment may begin 30 days after FDA receives the IND, or earlier if FDA notifies the treating physician that the expanded access use may begin. The treating physician must ensure that IRB review is obtained in accordance with FDA’s regulations.
The treating physician may need to provide the IND application number to the medical product company prior to the company shipping the investigational drug.
The process is different if the request for expanded access is being submitted to an existing IND as a protocol submission.
No, the application is filed well before the end of the patients trial so that this lapse will not occur. If approved it hints at the efficacy of PRO 140 as well as its likelihood to be approved in the future imo
CytoDyn Files a Compassionate Use Protocol
SPECIAL NEED FOR PRO 140 FOR A PATIENT WHO IS REACHING THE END OF OUR PHASE 3 STUDY
VANCOUVER, Wash., April 14, 2016 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announced today that it filed with the FDA a protocol for a compassionate use of PRO 140 to allow a patient who is reaching the end of the Phase 3 combination study to continue treatment with PRO 140 for an extended period of time. This compassionate use protocol will enable the patient to remain on PRO 140 upon successful conclusion of their 25-week participation in the trial.
We believe this protocol is important for patients who were unable to achieve a completely suppressed viral load (<50 HIV RNA copies/mL) under a Highly Active Anti-Retroviral Therapy (HAART) regimen prior to enrolling in our Phase 3 combination study. Now that the patient is concluding 25 weeks in the trial, the patient and the treating physician requested continued access to PRO 140 beyond the completion of the patient's participation in the PR0140_CD02 study in order to maintain the suppressed viral load. Under the protocol, patients in this study would be taken off of PRO 140 after 25 weeks and would remain on their optimized HAART regimen, as prescribed by their treating physician.
Nader Pourhassan, Ph.D., CytoDyn President and CEO, commented: “CytoDyn’s first patient to complete the Phase 3 combination trial has demonstrated the medical need to remain on PRO 140 to maintain a suppressed viral load, which was not previously attainable by this patient under several years of a HAART regimen.” Dr. Pourhassan added: “It is important to note that only about 30% of all HIV patients in the U.S. have attained a complete suppressed viral load, which is the level at which HIV transmission is negligible. We believe that a compassionate use designation will allow patients who benefit from adding PRO 140 to their OBT regimen to maintain transmission-free maintenance after completing our Phase 3 trial.”
The compassionate use request to the Fda for the patient in clinical trials who is at the end of the testing and needs to continue using PRO 140 to survive , if approved, will tell us all we need to know before June.
I think the timeline for that request is about thirty days.
Pls post to Sticky
ANNOUNCEMENT : CLINICAL TRIALS CYTODYN'S FOR GVHD DRUG TO BEGIN SOON
https://clinicaltrials.gov/ct2/show/NCT02737306?term=cytodyn&rank=2
Study of PRO 140 for Prophylaxis of Acute GVHD in Patients With AML or MDS Undergoing Allogeneic Stem-Cell Transplant. (GVHD)
This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2016 by CytoDyn, Inc.
Sponsor:
CytoDyn, Inc.
Collaborator:
Amarex Clinical Research
Information provided by (Responsible Party):
CytoDyn, Inc.
ClinicalTrials.gov Identifier:
NCT02737306
First received: March 29, 2016
Last updated: April 12, 2016
Last verified: April 2016
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the feasibility of the use of PRO 140 as an add-on therapy to standard GVHD prophylaxis treatment for prevention of acute GVHD in adult patients with AML or MDS undergoing allogeneic stem-cell transplantation.
Condition Intervention Phase
Graft vs Host Disease
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Drug: PRO 140
Drug: Placebo
Phase 2
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease (GVHD) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) Undergoing Allogeneic Hematopoietic Cell Transplantation (HCT).
Resource links provided by NLM:
Genetics Home Reference related topics: core binding factor acute myeloid leukemia cytogenetically normal acute myeloid leukemia familial acute myeloid leukemia with mutated CEBPA
MedlinePlus related topics: Acute Myeloid Leukemia Leukemia Myelodysplastic Syndromes
Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Homologous Wasting Disease Myelodysplastic Syndromes Myeloid Leukemia
U.S. FDA Resources
Further study details as provided by CytoDyn, Inc.:
Primary Outcome Measures:
Incidence of Grade II , Grade III or Grade IV acute GVHD [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Incidence of severe and life-threatening (Grade III and Grade IV) acute GVHD [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: Yes ]
Incidence of organ-specific acute GVHD [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: Yes ]
Donor engraftment evaluated by T-cell in peripheral blood [ Time Frame: 365 days post-treatment (+/- 14 days) ] [ Designated as safety issue: No ]
Donor engraftment evaluated by myeloid chimerism in peripheral blood [ Time Frame: 365 days post-treatment (+/- 14 days) ] [ Designated as safety issue: No ]
Neutrophil count recovery [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: No ]
Platelet count recovery [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: No ]
Changes in ECOG performance score [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: No ]
GVHD-free survival (GFS) [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: Yes ]
Other Outcome Measures:
Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants (using Visual Analogue Scale). [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: Yes ]
Tolerability of repeated subcutaneous administration of PRO 140 as assessed by investigator-evaluation of injection site reactions. [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: Yes ]
Frequency of treatment emergent adverse events and serious adverse events [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: Yes ]
AML or MDS relapse rate [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: No ]
Changes and shifts in laboratory measurements over time [ Time Frame: 365 days post-treatment (+/- 14 days) ] [ Designated as safety issue: Yes ]
Changes in Electrocardiogram (ECG) parameters over time [ Time Frame: 365 days post-treatment (+/- 14 days) ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 60
Study Start Date: May 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRO 140
30 subjects
Drug: PRO 140
Two 1 mL injections, 175mg/ml each, of PRO 140 to opposite sides of the abdomen.
Other Name: Humanized monoclonal antibody to CCR5
Placebo Comparator: Placebo
30 subjects.
Drug: Placebo
Two 1 mL injections of the Placebo to opposite sides of the abdomen.
Other Name: Placebo Comparator
Detailed Description:
In this study, 60 subjects will be randomized to receive either PRO 140 or placebo in a 1:1 ratio (i.e. 30 subjects per arm). PRO 140 or placebo will be administered as a 350 mg subcutaneous injection on Day -3 or Day -2 prior to stem cell infusion, on the day of stem cell infusion (Day 0), and then weekly for 30 days (at Week 1, Week 2, Week 3 and Week 4) after which it will be administered every two weeks for up to 100±7 days (at Week 6, Week 8, Week 10, Week 12 and Week 14). Subjects will return to clinic for two Follow-up visits at 2 weeks after the last treatment visit, and one year after the first treatment visit.
Eligibility
Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Patients diagnosed with AML or MDS per below:
Patients with a history of histologically or pathologically confirmed diagnosis of AML and < 5% blasts in the peripheral blood or bone marrow (per bone marrow aspiration and/or biopsy within 6 weeks prior to screening) scheduled to undergo allogeneic stem cell transplantation
Patients with a histologically or pathologically confirmed diagnosis of MDS with < 10% blasts in the bone marrow (per bone marrow aspiration and/or biopsy within 6 weeks prior to screening) scheduled to undergo allogeneic stem-cell transplantation
Eastern Cooperative oncology Group (ECOG) performance status score ≤ 2
Patients must have normal organ function as defined below:
If undergoing myeloablative allogeneic HCT:
Males and females, age ≥18 and ≤ 65 years of age
Total bilirubin ≤ 2 mg/dL (except in patients with Gilbert's Syndrome)
Aspartate Transaminase (AST) / Alanine Transaminase (ALT) ≤ 3 times institutional upper limit of normal (except in patients with leukemic infiltration of liver)
Serum creatinine ≤ 2 mg/dL and creatinine clearance ≥ 60 ml/hr
Diffusing capacity of the lung for carbon monoxide (DLCO) > 50% predicted with no symptomatic pulmonary disease
Cardiac ejection fraction ≥ 50%. If between 40-49% a cardiology consult is required
Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the PI
If undergoing non-myeloablative allogeneic HCT:
Males and females, age ≥18 and ≤ 75 years of age
Total bilirubin ≤ 2 mg/dL (except in patients with Gilbert's Syndrome)
AST/ALT ≤ 3 times institutional upper limit of normal (except in patients with leukemic infiltration of liver)
Serum creatinine ≤ 2 mg/dL and creatinine clearance ≥ 40 ml/hr
DLCO ≥ 40% predicted with no symptomatic pulmonary disease. If DLCO is ≥35% and < 40% and the patient is asymptomatic, a pulmonary consult is required
Cardiac ejection fraction > 30%
Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the PI
Patients must have a reasonable expectation of ≥ 6 months survival
The donor-recipient Human Leukocyte Antigen (HLA) match criteria required for participation in this protocol are not research subjects in this study and they must meet criteria as National Marrow Donor Program (NMDP) donors. Procedures for selection of donors and stem cell dose will follow FDA Code of Federal Regulations requirements for Blood Products (21 CFR 640) and Human Cellular and Tissue Based Products (21 CFR 1271). The standard institutional practices for stem cell transplants also will be followed. The donors are:
HLA-Identical Sibling (6/6): Minimal typing necessary is serologic typing for class I (AB) and molecular typing for class II (DRB1)
Matched Unrelated Donor (8/8): Molecular identity at HLA A, B, C and DRB1 by high-resolution typing
Matched Related and Unrelated Donor (7/8): high-resolution molecular typing at the following loci is required: HLA A, B, C and DRB1
Both male and female patients and their partners of childbearing potential must agree to use appropriate birth control methods (birth control pills, barriers, or abstinence) throughout the study duration (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
Patients must understand and voluntarily sign an informed consent form
Exclusion Criteria:
Patients not expected to be available for follow-up for at least 114 days after transplant
Patients who have received prior allogeneic stem cell-transplantation
Patients who receive post-transplant high dose cyclophosphamide
Patients with active central nervous system (CNS) involvement by malignant cells
Patients receiving other investigational drugs for GVHD. Co-enrollment in other clinical trials that do not include experimental GVHD therapies is allowed
Prior use of any experimental or approved C-C chemokine receptor type 5 (CCR5) modulators including maraviroc and PRO 140
Patients with uncontrolled bacterial, viral or fungal infections including diagnosis of acute viral hepatitis (defined as any active infection with hepatitis A or a new diagnosis of hepatitis B or C within 24 weeks of transplant)
Currently active second malignancy other than non-melanoma skin cancers
Presence of fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated
Patients who are HIV positive
Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
Subjects on chronic steroid therapy > 5 mg/day within 2 weeks of screening except for inhaled, nasal, or topical steroids
Any other clinical condition that, in the Investigator's judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02737306
Contacts
Contact: Anand Balasubramanian, B. Pharm 301-956-2531 anandb@amarexcro.com
Sponsors and Collaborators
CytoDyn, Inc.
Amarex Clinical Research
More Information
Responsible Party: CytoDyn, Inc.
ClinicalTrials.gov Identifier: NCT02737306 History of Changes
Other Study ID Numbers: PRO 140_CD 03_GVHD
Study First Received: March 29, 2016
Last Updated: April 12, 2016
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board
United States: Institutional Review Board
Keywords provided by CytoDyn, Inc.:
Allogeneic Stem-Cell Transplantation
Additional relevant MeSH terms:
Graft vs Host Disease
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Immune System Diseases
Leukemia
Neoplasms
Neoplasms by Histologic Type
Precancerous Conditions
ClinicalTrials.gov processed this record on April 14, 2016
https://clinicaltrials.gov/ct2/show/NCT02737306?term=cytodyn&rank=2
FDA Clinical Trials fpr Cytodyn GVHD drug
https://clinicaltrials.gov/ct2/show/NCT02737306?term=CytoDyn&rank=2
CYTODYN 10-Q FILING APRIL 13,2016
https://biz.yahoo.com/e/160413/cydy10-q.html
Form 10-Q on 13-Apr-2016 All Recent SEC Filings
Show all filings for CYTODYN INC
Form 10-Q for CYTODYN INC
13-Apr-2016
Quarterly Report
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of the financial condition and results of operations of CytoDyn Inc., a Delaware corporation (the "Company") should be read in conjunction with the other sections of this Quarterly Report, including the Company's financial statements and related notes appearing elsewhere herein. This discussion and analysis contains forward-looking statements including information about possible or assumed results of the Company's financial condition, operations, plans, objectives and performance that involve risk, uncertainties and assumptions. The actual results may differ materially from those anticipated and set forth in such forward-looking statements.
Throughout this filing, we make forward-looking statements. The words "anticipate," "believe," "expect," "intend," "predict," "plan," "seek," "estimate," "project," "continue," "could," "may," and similar terms and expressions are intended to identify forward-looking statements. These statements include, among others, information regarding future operations, future capital expenditures, and future net cash flows. Such statements reflect the Company's current views with respect to future events and financial performance and involve risks and uncertainties, including, without limitation, regulatory initiatives and compliance with governmental regulations, the ability to raise additional capital, the results of clinical trials for the Company's drug candidates, and various other matters, many of which are beyond the Company's control. These and other that could materially affect such forward-looking statements can be found in the sections entitled "Risk Factors" in Part II, Item 1A. in this Quarterly Report on Form 10-Q, as well as Part I, Item 1A. in the Company's Annual Report on Form 10-K for the year ended May 31, 2015, filed with the SEC on July 10, 2015. Should one or more of these risks or uncertainties occur, or should underlying assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated. Consequently, all of the forward-looking statements made in this filing are qualified by these cautionary statements and there can be no assurance of the actual results or developments. The forward-looking statements made herein are only made as of the date hereof and we undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances except as required by law.
Results of Operations
Clinical Trials Update
Phase 2b Treatment Substitution - This monotherapy trial was initially completed in January 2015. Several patients are continuing in extension studies on this monotherapy of a weekly injection of PRO 140. Results from these extension studies thus far indicate patients are now reaching 18 to 20 months of suppressed viral load since their first date of enrollment. The trial's topline report was submitted to the FDA in February 2016.
Phase 3 Combination Therapy Trial - A pivotal trial for PRO 140 as a combination therapy to existing HAART drug regimens involving 300 patients. Enrollment of first patient was announced in October 2015. In early March, 2016, the Company submitted to the FDA an amendment to its pivotal combination PRO 140 protocol. The amendment is designed to broaden and expand enrollment criteria to try and reduce the time to enroll subjects in the study. The new protocol design has two arms each with 150 subjects. The first arm of the study addresses efficacy of PRO 140 for one week followed by 24 weeks of safety of PRO 140 with optimized background therapy ("OBT"). The second arm addresses safety only of PRO 140 for 25 weeks in combination with OBT. The standard 30-day comment period with the FDA for the amendment has passed and the protocol amendment has received Institutional Review Board ("IRB") approval. Management estimates the total cost of this trial to range from $13 million to $15 million.
Phase 3 Monotherapy Trial - A strategic trial including 300 patients to assess the treatment strategy of using PRO 140 subcutaneously as long-acting single-agent maintenance therapy for 48 weeks in virologically suppressed subjects with CCR5-tropic HIV-1 infection. Primary endpoint is length of time for complete suppressed viral load. Secondary endpoint is the number of weeks off of ART regimen. Enrollment of first patient has not been announced, pending current discussions with the FDA. Management estimates the total cost of this trial to range from $15 million to $20 million.
Graft versus Host Disease Trial - This Phase 2, randomized, double-blind, placebo-controlled, multi-center 100-day study with 60 patients is designed to evaluate the feasibility of the use of PRO 140 as an add-on therapy to standard GvHD prophylaxis treatment for prevention of acute GvHD in adult patients with acute myeloid leukemia ("AML") or myelodysplastic syndrome ("MDS") undergoing allogeneic hematopoietic stem cell transplantation ("HST"). Enrollment of the first patient has not been announced. Management estimates the cost of this trial to be approximately $3.5 million.
Table of Contents
Results of Operations for the three months ended February 29, 2016 and February 28, 2015 are as follows:
For the three months ended February 29, 2016, and February 28, 2015, the Company had no activities that produced revenues from operations.
For the three months ended February 29, 2016, the Company had a net loss of approximately $5.0 million compared to a net loss of approximately $2.7 million for the corresponding period in 2015. The increase in net loss of approximately $2.3 million over the comparable three-month period in 2015 was due primarily to an increase in general and administrative expenses of approximately $1.2 million and an increase in research and development of approximately $0.5 million, offset in part by a reduction of interest expense of approximately $0.7 million and a non-comparable benefit of $1.2 million from change in derivative liability in the comparable period a year ago. In addition, during the quarter ended February 29, 2016, the Company did not recognize a non-cash credit or benefit from a change in fair value of derivative liability, as compared to the comparable period a year ago.
For the three months ended February 29, 2016 and February 28, 2015, the Company incurred total operating expenses of approximately $5.0 million and $3.3 million, respectively, consisting primarily of salaries and benefits, stock-based compensation, amortization of patents, professional fees, legal fees, research and development and various other operating expenses.
The increase in operating expenses for the three-month period ended February 29, 2016 of approximately $1.8 compared to the three months ended February 28, 2015, related primarily to the increase in non-cash stock-based compensation, research and development, as well as general and administrative expenses. We expect the Company's research and development expenses to continue to increase in future periods as the activity within the Company's clinical trials expands and the Company's biologics manufacturing processes and related regulatory compliance activities increase. Stock-based compensation may also increase, as the Company continues to compensate consultants, directors, and employees with stock options.
There was no interest expense incurred during the three months ended February 29, 2016. All of our convertible notes converted or were paid during fiscal year 2016.
The future trends of all expenses will be driven, in part, by the future outcomes of the clinical trials and their correlative effect on general and administrative expenses, especially FDA regulatory requirements, in addition to the manufacturing of new commercial grade PRO 140, along with the necessary regulatory processes to confirm its qualification for future sale, if approved. The Company's ability to continue to fund operations will continue to depend on the Company's ability to raise additional capital. See, in particular, Item 1A (Risk Factors) in the Company's Annual Report on Form 10-K for the year ended May 31, 2015, as modified by Item 1A (Risk Factors) in this Form 10-Q.
Results of Operations for the nine months ended February 29, 2016 and February 28, 2015 are as follows:
For the nine months ended February 29, 2016 and February 28, 2015, the Company had no activities that produced revenues from operations.
For the nine months ended February 29, 2016, the Company incurred a net loss of approximately $19.2 million, as compared to a net loss of approximately $11.1 million for the similar 2015 period. The increased net loss for 2016 of approximately $8.1 million over 2015 was primarily attributable to an increase in operating expenses of approximately $5.4 million, coupled with an increase in interest expense of approximately $2.4 million, which was principally non-cash.
For the nine-month period ended February 29, 2016, operating expenses of approximately $14.6 million increased approximately $5.4 million over the comparable 2015 period due to a substantial increase of approximately $3.3 in research and development expenses, combined with an approximate increase of $1.6 million in general and administrative expenses and an increase in legal fees of approximately $0.4 million.
For the nine months ended February 29, 2016, the Company incurred a loss on the extinguishment of convertible notes of approximately $0.6 million (as more fully described in the accompanying financial statements in Note 3 - Convertible Instruments, AVCP Convertible Notes) and recognized a benefit from a change in fair value of derivative liability of approximately $0.6 million (as more fully described in the accompanying financial statements in Note 4 - Derivative Liability).
Interest expense for the nine months ended February 29, 2016, which totaled approximately $4.7 million, was comprised of (i) a non-cash charge related to the amortization of debt discount attributable to convertible notes, (ii) a non-cash charge related to the reduction in the exercise price of warrants to induce conversion of debt and warrant exercises, (iii) amortization of debt issuance costs and (iv) accrued interest payable on outstanding convertible notes. The amortization of debt discount of approximately $1.8 million for the nine months ended February 29, 2016 represents the amortization of the intrinsic value of the beneficial conversion feature of the convertible notes payable, fair value of the attached warrants and, to a lesser extent, an amount resulting from allocating a portion of the financing proceeds to the compound embedded derivative.
Table of Contents
Liquidity and Capital Resources
The Company's cash position at February 29, 2016, increased to approximately $10.2 million, as compared to approximately $1.1 million as of May 31, 2015, owing to private offerings of common stock and warrants.
On February 29, 2016, the Company had positive working capital of approximately $ 8.7 million, as compared to negative working capital of approximately $8.7 at May 31, 2015.
Cash Flows
Net cash used in operating activities totaled approximately $19.6 million during the nine months ended February 29, 2016, which reflects an increase of approximately $11.8 million of net cash used in operating activities over the comparable nine-month period a year ago. The $19.6 of net cash used in operating activities for the nine months ended February 29, 2016 represents the effect of approximately $19.3 million net loss and increases in prepaid expenses and decrease in current liabilities, offset by non-cash expenses primarily related to the various components of interest expense, along with stock-based compensation.
Net cash used in investing activities during the nine months ended February 29, 2016 and February 28, 2015 was nominal.
Net cash provided by financing activities of approximately $28.7 million for the nine months ended February 29, 2016 included net proceeds of approximately $29.4 million from private equity offerings and net proceeds of approximately $94,000 from the exercise of warrants, offset by the repayment of short-term convertible notes and accrued interest of approximately $0.8 million.
As reported in the accompanying financial statements, for the nine months ended February 29, 2016 and February 28, 2015, the Company incurred net losses of approximately $19.2 million and $11.1 million, respectively. The Company has no activities that produced revenue in the periods presented and have sustained operating losses since inception. The Company's ability to continue as a going concern is dependent upon its ability to raise additional capital, commence operations and achieve a level of profitability. Since inception, the Company has financed its activities principally from the sale of its equity securities and proceeds from the issuance of convertible notes. The Company intends to continue to finance its future operating activities and working capital needs largely from the sale of equity and perhaps debt securities, combined with additional funding from other traditional financing sources. The sale of equity and convertible debt securities may result in dilution to the Company's stockholders and those securities may have rights senior to those of the Company's common stock. If the Company raises additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these activities or other debt could contain covenants that would restrict the Company's operations. Any other third-party funding arrangements could require the Company to relinquish valuable rights. The Company may require additional capital beyond its currently anticipated needs. Additional capital, if available, may not be available on reasonable terms.
In connection with the Company's four ongoing clinical trials, it has entered into separate Project Work Orders for each trial with its clinical research organization ("CRO"). In the event the Company were to terminate any trial, it may incur certain financial penalties which would become payable to the CRO. Conditioned upon the form of termination of any one trial, the Company may incur financial penalties ranging from a low of $100,000 to a high of $400,000. In the remote circumstance that the Company would terminate all four clinical trials, the collective financial penalties may range from a low of $400,000 to a high of $1.2 million.
Under the Asset Purchase Agreement (the "Progenics Agreement"), dated July 25, 2012, which closed on October 16, 2012, between the Company and Progenics Pharmaceuticals, Inc. ("Progenics"), the Company acquired from Progenics its proprietary HIV viral-entry inhibitor drug candidate PRO 140 ("PRO 140"), a humanized anti-CCR5 monoclonal antibody, as well as certain other related assets, including the existing inventory of bulk PRO 140 drug product, intellectual property, certain related licenses and sublicenses, and U.S. Food and Drug administration ("FDA") regulatory filings. On October 16, 2012, the Company paid $3,500,000 in cash to Progenics to close the acquisition transaction. The Company is also required to pay Progenics the following milestone payments and royalties: (i) $1,500,000 at the time of the first dosing in a U.S. Phase 3 trial or non-U.S. equivalent, which was paid during the three months ended February 29, 2016; (ii) $5,000,000 at the time of the first U.S. new drug application approval by the FDA or other non-U.S. approval for the sale of PRO 140; and (iii) royalty payments of up to five percent (5%) on net sales during the period beginning on the date of the first commercial sale of PRO 140 until the later of (a) the expiration of the last to expire patent included in the acquired assets, and (b) 10 years, in each case determined on a country-by-country basis. Payments to Progenics are in addition to payments due under a Development and License Agreement, dated April 30, 1999 (the "PDL License"), between Protein Design Labs (now AbbVie Inc.) and Progenics, which was assigned to the Company in the PRO 140 transaction, pursuant to which the Company must pay additional milestone payments and royalties as follows:
(i) $1,000,000 upon initiation of a Phase 3 clinical trial, which was paid during the three months ended February 29,2016; (ii) $500,000 upon filing a Biologic License Application with the FDA or non-U.S. equivalent regulatory body; (iii) $500,000 upon FDA approval or approval by another non-U.S. equivalent regulatory body; and (iv) royalties of up to 7.5% of net sales for the longer of 10 years and the date of expiration of the last to expire licensed patent. Additionally, the PDL License provides for an annual maintenance fee of $150,000 until royalties paid exceed that amount.
As more fully described in Note 6 herein above, the Company is obligated, pursuant to a license agreement (the "Lonza Agreement") with a third-party licensor, Lonza Sales AG ("Lonza"), for the approximate one-time amount of $930,000 on June 30, 2016 in connection with the licensor's "system-know how" technology with respect to the Company's use of proprietary cell lines to manufacture new PRO 140 material. Ongoing annual license fees with the third-party licensor are approximately $450,000 payable in December of each year.
Table of Contents
As of the date of this filing, it is management's conclusion that the probability of achieving the subsequent future scientific research milestones is not reasonably determinable, thus the future milestone payments payable to Progenics and its sub-licensors are deemed contingent consideration and, therefore, are not currently accruable.
The future trends of all expenses will be driven, in part, by the future outcomes of the clinical trials and their correlative effect on general and administrative expenses, especially FDA regulatory requirements, in addition to the manufacturing of new commercial grade PRO 140, along with the necessary regulatory processes to confirm its qualification for future sale, if approved. The Company will require a significant amount of additional capital in the future to fulfill BLA requirements related to manufacturing PRO 140 for commercial use.
The Company has not generated revenue to date, and will not generate product revenue in the foreseeable future. The Company expects to continue to incur operating losses as it proceeds with clinical trials with respect to PRO 140 and continue to advance it through the product development and regulatory process. In addition to increasing research and development expenses, the Company expects general and administrative and manufacturing costs to increase, as the Company adds personnel and other administrative expenses associated with its current efforts.
The Company's ability to continue as a going concern will be contingent upon its ability to raise additional capital to fund its operations. If the Company is unsuccessful in raising additional capital in the future, it may be required to cease its operations. See, in particular, Item 1A (Risk Factors) in the Company's Annual Report on Form 10-K for the year ended May 31, 2015, as modified by Item 1A (Risk Factors) in this Form 10-Q.
Off-Balance Sheet Arrangements
The Company does not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on the Company's financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.
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The Orphan Drug Designation for GvHD
http://www.cytodyn.com/media/press-releases/detail/219/cytodyn-files-for-orphan-drug-designation-for-use-of-pro
CytoDyn Files for Orphan Drug Designation for Use of PRO 140 in Graft Versus Host Disease
PHASE 2 PROTOCOL HAS BEEN CLEARED BY THE FDA FOR ENROLLMENT
VANCOUVER, Wash., Dec. 22, 2015 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, today announced that it has filed for Orphan Drug Designation with the FDA for its first non-HIV indication, Graft versus Host Disease (GvHD). CytoDyn currently is conducting a Phase 3 pivotal trial with its lead product candidate, PRO 140, for the treatment of HIV infection.
The GvHD clinical trial is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study. It evaluates the safety and efficacy of PRO 140 for prophylaxis of acute GvHD in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing allogeneic stem-cell transplantation. The trial is a 100-day study with 60 patients.
Positive results from this study would allow the Company to file for a breakthrough designation to expedite the commercialization of PRO 140 for this clinical indication. As previously reported, PRO 140 is considered safe and well tolerated with negligible toxicities or side effects. The Company believes these attributes make it an ideal candidate for treatment of GvHD, a life-threatening disease for transplant recipients with compromised immune systems.
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Please reference: (https://rarediseases.info.nih.gov/files/fda%20orphan%20drugs.pdf)
The Company has selected a transplantation indication called GvHD as its first non-HIV clinical indication. The CCR5 receptor, the target for PRO 140, is an important mediator of GvHD, especially in the organ damage that is the usual cause of death. The only approved CCR5 inhibitor, Maraviroc, is currently in a Phase 2 study in GvHD. The Company believes that PRO 140 has significant advantages over Maraviroc in more favorable dosing and pharmacokinetics, less toxicity and side effects, and no direct stimulation (agonist activity) of the CCR5 receptor.
PRO 140 is a monoclonal antibody that targets the chemokine receptor, CCR5, expressed on a variety of cells that play a central role in inflammatory responses. PRO 140 binds to this receptor in a way that prevents HIV from using it as an entry gateway, while not activating the immune function of the receptor. The Company’s recent data indicate that PRO 140 interferes with (antagonist activity) activation of the receptor by its ligand, named CCL5. The CCL5 is a chemokine mediator which has been shown to be a central figure in many inflammatory disease processes, and blocking its interaction with CCR5 is believed to be of therapeutic benefit.
Dr. Nader Pourhassan, President and CEO, commented: “GvHD is our first expansion of PRO 140 into non-HIV clinical areas. We plan to explore further opportunities to expand the clinical applications of PRO 140 to those indications where CCR5 plays an important role, namely certain autoimmune diseases and cancer.”
About Graft versus Host Disease
Graft-versus-host disease (GvHD) is a complication that can occur after a stem cell or bone marrow transplant. With GvHD, the newly transplanted donor cells attack the transplant recipient's body. GvHD may occur after a bone marrow or stem cell transplant in which an individual receives bone marrow tissue or cells from a donor. This type of transplant is called allogeneic. The new, transplanted cells regard the recipient's body as foreign. When this happens, the newly transplanted cells attack the recipient's body. GvHD does not occur when an individual receives his or her own cells during a transplant. Before a transplant, tissue and cells from possible donors are tested to determine how closely they match the person having the transplant. GvHD is less likely to occur, or symptoms will be milder, when the match is close. The chance of GvHD, at varying degrees, can be approximately 30% to 40% when the donor and recipient are related and approximately 60% to 80% when the donor and recipient are not related. There are two types of GvHD: acute and chronic. Symptoms in both acute and chronic GvHD range from mild to severe. Acute GvHD usually happens within the first three months after a transplant. Chronic GvHD usually starts more than three months after a transplant, and can last a lifetime.
In the United States, in 2011, over 7,500 unrelated donor bone marrow transplants were performed and another 10,000 conducted outside the U.S. One-year survival is now approximately 60% with the most common causes of death being relapse or GvHD. The market in the U.S. is expected to reach $500 million in the next several years.
Not necessarily , In order to be able to present at ASM you must first submit an abstract of your work. I don't know how stringent they are with poring over the results but in order to make it to this echelon I would surmise it has to be pretty impressive.
hotw to apply to be in ASM http://www.asmmicrobe.org/index.php/submit-abstract/submit-an-abstract
Some sell off, but mostly hold.
On news it'll bounce and we know its right around the corner.
Coming up
-orphan status for fda designation drug
-phase 2b results report
-phase 3 continuation updates
-Gvhd (grant verse host disease) clinical trials
-announcements on advances for pro 140 use in individuals as PreP
- Pro 140 use as cancer therapy
- the possiblity of buyout by big PHARM Gilead
- Presentation at ASM conference in June.
This why we hold. In my opinion
Thanks
Off topic I use ameritrade , does anyoene else see under 6 k volume today so far , or is there something wrong with my network. this isnt a comment about the stock , i am wondering about the reporting .
Cytodyn claimed several times that PRO140 could be taken to market by 2017. Based on the clinical trial timeline however their testing wont be done for a long time . Phase 3 itself takes a very long time to complete , with many participants , who have to use the drug for many months on end in order to prove it qwork,. I think they may be misleading us. While PRO140 has shown to be effective so far , This isnt a slamdunk yet. Yesterday someone posted here about Gileads d HIV line is now the lesser part of their business . The fact is that that just because Pro140 is better , doesnt mean it will become the next standard in therapy . It was designed originally for people with HIV , who use injection drugs , who dont stick to their regimen. a very small percent of the population of those living with HIV. We need more information from CyDY abouttimelines. Thinking that Gilead will want this drug in their catalog may not be accurate.
Cytodyn Clinical Test Phase Timeline Calendar - 8 Studies - 4 Completed
4 In progress - Please note the end dates - June's presentation at ASM Microbe amondst Gilead and other leaders in the industry will present Phase IIB results - Phase III is currently in progress- Any insight how Cytodyn claims we may have product to market by 2017, given these dates ? The later dates at the end of the list indicate completed tests - including Phase IIb. SOURCE : https://clinicaltrials.gov/ct2/results?term=cytodyn&Search=Search
1 Recruiting Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection
Conditions: HIV; Human Immunodeficiency Virus
Intervention: Drug: PRO 140 350mg weekly SQ injection.
Estimated Enrollment:43
Study Start Date:May 2014
Estimated Study Completion Date:October 2016
Estimated Primary Completion Date:July 2016 (Final data collection date for primary outcome measure)
2 Recruiting A Randomized, Double-blind, Placebo-controlled Trial, Followed by Single-arm Treatment of PRO 140 in Combination w/ Optimized Background Therapy in Treatment-Experienced HIV Subjects
Condition: HIV
Interventions: Drug: PRO 140; Drug: Placebo; Drug: Optimized Background Regimen
Estimated Enrollment:300
Study Start Date:August 2015
Estimated Study Completion Date:August 2018
Estimated Primary Completion Date:August 2017 (Final data collection date for primary outcome measure)
3 Recruiting An Extension of Protocol PRO 140_CD01 TS Study
Conditions: HIV; Human Immunodeficiency Virus
Intervention: Drug: PRO 140 350mg weekly SQ injection.
Estimated Enrollment: 28
Study Start Date: November 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
4 Recruiting A Trial of Observed Long-acting, Anti-HIV Treatment With a Monoclonal CCR5 Antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-infected Injection Drug Users With Viral Rebound and Documented Poor Adherence
Condition: HIV
Interventions: Drug: PRO 140; Drug: Placebo
Estimated Enrollment: 79
Study Start Date: December 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
5 Completed Observational Study of Blood Treated With Cytolin
Condition: HIV Infections
Intervention:
6 Completed
Has Results Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection
Conditions: HIV -1 Infection; HIV Infections
Interventions: Drug: PRO 140 (humanized monoclonal antibody to CCR5); Drug: Placebo Comparator
7 Completed
Has Results PRO 140 by IV Administration in Adults With HIV-1 Infection
Condition: HIV Infections
Interventions: Drug: PRO 140; Drug: Placebo
8 Completed Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers
Condition: HIV Infections
Intervention: Drug: PRO 140
Cytodyns Current FDA CLinical Trials & Results
https://clinicaltrials.gov/ct2/results?term=cytodyn&Search=Search
News on horizon: As stated in the March 24th conference call :
Please keep in mind, our current combinational therapy Phase 3 and monotherapy Phase 3 trials are both in different populations than for which the Breakthrough Designation was applied. Again, this delay on Breakthrough Designation does not have any bearing in our two current trials, monotherapy and combinational therapy, and could be addressed if we do conduct a small trial in the specific patient population and submit to the agency the appropriate data.
In regards to Orphan Drug Designation, the normal waiting period is 60 days and this deadline has passed. As of today, we have not received a determination from the FDA on our Orphan Drug Designation application.
In regards to combinational therapy Phase 3 trial, we are working to determine firm timelines for when we will be able to enroll all patients and when we can un-blind the double-blinded efficacy section of our trial, and announce our primary endpoints results, and when the study will conclude and so forth. This we should have in the next four to six weeks.
FULL AUDIO of Cytodyn Conference call - March 24th 2016 -
Q&A session follows
For those who haven't listened yet.
https://www.youtube.com/watch?v=_6zywaDecKY
Operator
Greetings and welcome to the CytoDyn Investment Community Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.
I would now turn the conference over to Mr. Michael Mulholland, Chief Financial Officer for CytoDyn. Thank you, Mr. Mulholland. You may begin.
Michael Mulholland
Thank you. Hello, everyone, and thank you for joining us today. This is Michael Mulholland and I’m the Chief Financial Officer of CytoDyn. Before we begin, it is essential that we provide you with important cautionary language related to certain Federal Securities Laws. Our remarks during today’s conference call may include forward-looking statements.
Forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are difficult to predict. Actual results may be materially different from any future results expressed or implied by such forward-looking statements.
These risks and uncertainties include among other matters that clinical trials may not commence or proceed as planned, products that appear promising in early trials may not prove to be viable on safety or efficacy grounds, products may not receive regulatory approval or market acceptance, competition may reduce the commercial potential of our products, we may experience product recalls or product liability and our patents may be challenged or unenforceable.
Although forward-looking statements help to provide complete information about the company, forward-looking statements may be less reliable than historical information.
The company undertakes no obligation to update publically, forward-looking statements except as required by law. Please refereed to our recent quarterly and annual reports filed with the Securities and Exchange Commission, for more information about the risks and uncertainties that could cause actual results to differ.
I will now turn the call over to our President and CEO, Dr. Nader Pourhassan.
Nader Pourhassan
Thank you, Mike. Greetings, everyone. Thank you for participating on this investment community update conference call. As always we will begin the call with prepared comments and then we will open the call for your questions.
As of today, existing management of CytoDyn has been in place for about three-and-a-half years. In 2012, when CytoDyn purchased PRO 140, it was not highly regarded as a profitable potential therapy for HIV.
All of its valuable features were not recognized due to the fact its development timeline was dragging along at a very slow pace. While being developed by Progenics, it took about 12 years to get PRO 140 to a Phase 2a to conduct at three-week monotherapy trial. And as we know today, it probably would have taken another 15 more years to take this product to commercial level.
Even though PRO 140 always demonstrated strong anti-viral activity with a remarkable safety profile that impressed the FDA and received Fast Track designation, and even though the NIH had granted PRO 140 $28 million during its first 12-years of development, yet PRO 140 did not have a great path to approval.
We believe CytoDyn has overcome this huge challenge by conducting a non-traditional clinical trial and generating a data that was anything but expected. Today, as all of our investors are aware, there is much focus on our Phase 3 monotherapy trial that could change the HIV paradigm for many of the HIV patients.
And there is even more focus on a publication of Phase 2b monotherapy results in a peer-reviewed journal that would give a new credibility to PRO 140 in the scientific community. I will address this issue later on this call.
Our very impressive Phase 2b monotherapy trial has provided new opportunities for the future of PRO 140 and its outlook is getting better with each day. Patients in the extension on as we previously reported are passing one-and-a-half years of complete viral suppression and our making history. And their weakly results are continuing to amaze us.
This is an incredible achievement unlike anything seen in the world of HIV treatment since the recognition of HAART, which saves millions from this deadly disease. However, HAART, Highly Active Antiretroviral Therapy, has its own challenges, which is mainly toxicity issues.
In the world of HIV, it is unheard of going without HAART, even for one-month, nonetheless for 18 months as our HIV patients have in the extension arm. These patients have only received a simple weekly subcutaneous injection of an antibody that is proven to have hardly any toxicity or side effect. If PRO 140 is ultimately approved as a monotherapy, then the eligible HIV patients could soon enjoy a life without all the toxicities that ranges from diarrhea, abdominal pain, nausea, to vomiting, rash, numbness, tingling, burning sensation, upset stomach, fatigue, chills, dizziness, headache, insomnia, fever and the list of drug toxicity goes on and on.
And if PRO 140 is approved for combinational therapy, then patients perhaps could replace the most toxic portion of their HAART regimen with PRO 140, and more importantly, the major issue with adherence, which is taking daily pills day in and day out in an exact same time could be mitigated.
CytoDyn’s strategy is to gain FDA approval for PRO 140 as a combination therapy, which we believe represents the quickest path to market followed by an approval for PRO 140 monotherapy back-to-back. As we have mentioned in our previous releases, our planned development of PRO 140 has not been limited to HIV, as we are taking this even further and exploring our first of potential several non-HIV indications mainly GvHD graft versus host disease transplant patient indication.
Our newly named Chief Science Officer, Dr. Denis Burger is leading all of our non-HIV indications for PRO 140. Because of all we have accomplished prior to 2016, we believe 2016 will be a remarkable year for CytoDyn and its shareholders.
Now in regards to recent progress, we understand that all of our investor would like to have everything happen quickly. But the reality in our business is exactly as it is listed on the FDA website, which is that drug development is a very lengthy process and it could take about 20 years from initial development to final FDA approval. However, to show how fast CytoDyn is moving in this tough field, allow me to list the last three months’ activities and update everyone in regards to each one.
In December of 2016 - I’m sorry, in December 2015, just about three months ago, the FDA cleared PRO 140 for a Phase 2 clinical trial in GvHD. Just about a week later CytoDyn filed for Orphan Drug Designation for GvHD. 30 days later after that we filed for Breakthrough Therapy Designation for PRO 140 for treatment experienced patients will have developed resistance against prior HIV regimen. Just a week later, CytoDyn announce that its Phase 2b monotherapy extension arm is still moving for with 11 patients still continuing and were passing 14 to 17 months of complete viral suppression.
Few days after this last announcement, which was just about a month ago, we announced that we submitted and initiated our much anticipated Phase 3 monotherapy trial with PRO 140 and are awaiting FDA comments before injecting the first patient. In my opinion are very productive and fulfilling three months.
So with that, allow me to update everyone about the following activities: Phase 3 monotherapy, Breakthrough Designation for HIV, Orphan Drug Designation for GvHD, Phase 3 Combination Therapy timeline, GvHD Phase 2 trial status, abstract submission to ASM Microbe Conference.
In regard to the Phase 3 monotherapy trial, we have received comments from the FDA and we are working with the KOL, Key Opinion Leader, to respond to these comments in the next few days. The comments did not have any clinical hold and the companies allowed to initiate this trial, but we will first finish responding to the FDA before we inject the first patient. However, initiation of hospitals and clinical sites are already well underway.
In regards to our application for Breakthrough Therapy Designation for PRO 140 for HIV, we received a response from FDA. The FDA indicated that the agency concurs with CytoDyn that treatment experience for patients who have developed resistance against prior HIV regimen meet the criteria for a serious or life-threatening disease or condition, which would warrant a Breakthrough Designation.
However, the FDA indicated that CytoDyn’s previous studies were not in the specific patient population that the Breakthrough Designation for PRO 140 was applied for. Therefore, CytoDyn needs data from that specific population that the Breakthrough Designation was applied for in order to be granted that Breakthrough Designation.
The company now could plan and to initiate a small study in HIV resistant patients to specifically address FDA’s comments.
Please keep in mind, our current combinational therapy Phase 3 and monotherapy Phase 3 trials are both in different populations than for which the Breakthrough Designation was applied. Again, this delay on Breakthrough Designation does not have any bearing in our two current trials, monotherapy and combinational therapy, and could be addressed if we do conduct a small trial in the specific patient population and submit to the agency the appropriate data.
In regards to Orphan Drug Designation, the normal waiting period is 60 days and this deadline has passed. As of today, we have not received a determination from the FDA on our Orphan Drug Designation application.
In regards to combinational therapy Phase 3 trial, we are working to determine firm timelines for when we will be able to enroll all patients and when we can un-blind the double-blinded efficacy section of our trial, and announce our primary endpoints results, and when the study will conclude and so forth. This we should have in the next four to six weeks.
In regard to Phase 2 GvHD, we are progressing forward without any delay.
Now in regards to ASM Microbe Conference, they had many investors and a few reporters request information in regards to our publication of the Phase 2 monotherapy data. Some suggested that maybe the data was not good enough to publish.
Please allow me to state here on record that our Phase 2b monotherapy data has surprised us, surprised our Key Opinion Leaders and surprised the inventor PRO 140. Furthermore, we continue to believe if our Phase 3 monotherapy is successful and replicate the result of the Phase 2b trial it could potentially change the HIV paradigm. However, we have not published our data from the Phase 2b monotherapy trial yet, because we have submitted an abstract to ASM Microbe Conference held around June 20.
And if we are accepted then the publication has to be delayed until after a possible presentation at that conference. Obviously, we have not announced whether we have been accepted to this conference or not, but the result have been out. Those who were granted a spot for presentation were notified as of February 29 about a month ago by ASM organizers.
Please feel free to go to ASM Microbe Conference website to read more about this very important conference. So not publishing the data from Phase 2b monotherapy had nothing to do with the caliber of our data, which we have said all along, we believe has been remarkable. Furthermore, this trial did not have data lock date at the end of the trial, due to many patients wanting to continue in that extension arm.
Our data lock date was picked about 10 months after the main portion of the study, even though many patients are still on the trial. So in conclusion, as we said before, our data has been ready for submission to a peer-reviewed journal.
So with all that, allow me to summarize the six important activities that everyone should note. Our current Phase 3 combinational therapy is underway. Our current Phase 3 monotherapy is going forward. Our current Phase 2b trial in graft versus host disease is underway. A Breakthrough Designation application that is on hold and will need more data from a small trial that CytoDyn could initiate. An Orphan Drug Designation application that has been filed with FDA about 93 days ago and we still have no results from the FDA in this regard. Last and not least is a publication of our Phase 2b data in a peer-reviewed journal, which has been delayed due to the submission of an abstract to ASM Microbe Conference.
So again, our Phase 3 monotherapy along with our Phase 3 combinational therapy for HIV is going forward and the FDA has not held us back from conducting a Phase 3 monotherapy.
And finally, all of our CMC manufacturing requirements for PRO 140 are going forward to assure we meet all the standards of the FDA and have promotional product ready once we have the FDA approval to launch PRO 140. Overall, we are very pleased and very proud of our continuing extensive progress in taking PRO 140 to new horizons and exploring all its capabilities.
Operator, we would now like to open the call for questions, please.
Question-and-Answer Session
Operator
Thank you. [Operator Instructions] Our first question from Francis Russo, a private investor. Please go ahead.
Francis Russo
Good afternoon, Nader. It’s Francis. Hope you are doing well. And I have a few questions for you. The first one is, now that you and Dr. Berger have approximately 17 other possible indications around cancer and autoimmune indications, three that you’ve publicly mentioned, will CytoDyn just reach out to few companies to get some type of non-dilutive equity? One easy target may be, could be Paul Maddon reaching out to Progenics. And I’d like to hear your thoughts on that.
Nader Pourhassan
Thank you, Francis, and good afternoon to you. As we mentioned before when we did our in vitro studies, we believe that we have indication in graft versus host disease. We did say that we would explore other indication, for example, cancer and other autoimmune diseases. But our strategy has not been revealed yet and we cannot talk about that at all.
Francis Russo
Understood. My other question, you were just recently in an article that you were speaking about CytoDyn as being a hot-hot story and you called the stock to get in the path. Do you or any board members have plans to buy shares in the open market at a premium over the current share price if you believe the stock is severely undervalued?
Nader Pourhassan
I cannot speak for our board members and I cannot tell you, when I said the stock is a gift I believe that our value is very undervalued obviously, but that’s all I can say at this time.
Francis Russo
All right. Thank you.
Nader Pourhassan
You’re welcome.
Operator
Thank you. Our next question is from Michael Langsdorf, a private investor. Please go ahead.
Michael Langsdorf
Doctor, it seems to be that it is pretty expensive to continue to develop more than one drug, especially when we’re selling stock at $0.75. Have you ever considered just sticking with the HIV until we get that done and stay away from the graft to host diseases, because it takes over $100 million I think to develop these things and therefore spreading ourselves too thin we’ve already had problems raising money?
Nader Pourhassan
Thank you, Michael. First of all, I did not know we had problems raising money. I was not aware of that, but having said that…
Michael Langsdorf
At $0.75 a share you are.
Nader Pourhassan
And as far as the graft versus host disease trial, as we indicated, the cost to do a Phase 2b trial in a different indication is less than $4 million, which could take the company to the position where we would have data that would be impressive. And since GvHD, the deadly disease, we thought we could do a Breakthrough Designation at that time. We thought that’s a great asset for us to have.
Now, having said that, we haven’t really spent a lot of money on GvHD. As you know, we have not even announced the first person being injected. So funding for something like that in our opinion is crucial.
Michael Langsdorf
Maybe I didn’t say it quite right. It seems to me that we have one primary drug which hopefully we get to market sometime in the next 24 months. Are we not diluting our efforts when we got more than one drug that we’re trying to get to market? That’s number one. And number two, when I say expensive money or you pay Paulson 10% to sell stock at $0.75, that’s a hard way to get money without diluting the stock.
Nader Pourhassan
So answer to your first question is no. Answer to your second question is we have indicated the market size out there for us when if we get approval, and we believe dilution, whether we go from 200 or 250 million shares at the end of the day if you’re successful is not going to impact us that much.
Michael Langsdorf
How much…
Michael Mulholland
Yes, let me just add…
Michael Langsdorf
…to develop the second drug, I guess, maybe that’s what I’m saying. How much do you think more is going to be necessary to develop our HIV and how much for the second one?
Nader Pourhassan
Mike?
Michael Mulholland
Well, as Nader just indicated, the graft versus host disease trial has an estimated cost of approximately $4 million. Earlier in your comment you indicated that we’ve got one drug and then you inferred that we were developing another costly drug for graft versus host disease. We don’t have multiple drugs. We have one antibody. And the one antibody is been evaluated in a non-HIV trial and that is the graft versus host disease. So it’s really not dilutive to all of management’s efforts and our capital resources by simply pursuing another clinical indication in a Phase 2b trial.
Nader Pourhassan
Next question, please.
Operator
Thank you. The next question is from Paul Rosenbaum with SWR Corporation. Please go ahead.
Paul Rosenbaum
Hi, doctor, I have a couple of different questions. One, you talked about a breakthrough designation that’s put on hold, because you didn’t target the specific patient population. Did you know what the specific patient population was and why didn’t you target it?
Nader Pourhassan
Thank you for this question. So the breakthrough designation was for resistance patients and we believe that when we had shown our product, PRO 140, working on patients who had viral load of more than 5,000 even. And it showed that it dropped the viral load for more than 2 log that indicated that we have a product that could work on that population.
But, obviously, our people who we consulted with disagree with FDA on that. But we will definitely respect the FDA decision and if we want to go forward with a Breakthrough Designation we will have to do a small trial. But having said that, we have a so strong two Phase 3 that we have to have an internal discussion and decide what we want to do.
Paul Rosenbaum
But how long does a small scale trial take? And, basically, if we do it, it doesn’t make that much of a difference as long as you’re already starting your Phase 3, correct?
Nader Pourhassan
That’s correct. But if we do a small trial and go forward, perhaps our timeline of getting our efficacy for Phase 3 is already met. And if that happens then, we believe that might not work for us. But having said that, the timelines are very, very quick and we don’t know that timeline. We have to explore that. Then we will make a decision and let everybody know.
Okay. Well, listen, this is an observation. It’s not a criticism. But the previous speaker, I couldn’t - I think what he was getting at, and if he wasn’t, I’ll get at it, is that you’re a small company, I’m a large investor in your company and I’m confused sometimes with the scope of what you’re trying to do. I’m an investor. I’m not a scientist. For me it seems to be all over the place in terms of what you’re trying to accomplish. I do understand there’s one antibody that has different applications. But why call this conference today when there is really nothing new as far as I’m concerned.
I’m assuming that you’re going forward on all these phases. What I’m concerned about is the reverse split. Can you talk about that now? Do you have any plans on doing it or is that something that’s on hold to see whether you develop all this in the future?
Nader Pourhassan
Yeah. Before Michael Mulholland comment on the reverse splits, if we’re talking - if we’re splitting hair over $3 million or so that we’re going to spend on GvHD that’s about as a price that we sold $0.75, that’s 4 million shares. So I don’t think for such a huge indication we should be, that’s our decision that we made. But as far as reverse split - I’m sorry.
Paul Rosenbaum
I’m not splitting hairs on the $3 million. I understand what you’re doing. It’s the presentation in terms of what you’re trying to do. It’s confusing sometimes to me and I’m not a stupid guy.
Nader Pourhassan
Well, I understand what you say. Let me have Mike comment on the reverse split. Go ahead.
Michael Mulholland
Yes. Let me just add that, again confirming, yes, the board has approval to affect the reverse split. And when in their judgment that it’s appropriate to do so and that authorization is effective through August 26, 2016, to reaffirm again, we do aspire to uplift to a national exchange for all the reasons we’ve previously cited: broader access to capital, expended shareholder base, improved visibility among many others.
But right now, our number one priority is capital and we need to keep funding the fundamental drivers of enterprise value and that’s our clinical trials. As I said before, we have mapped out the myriad of activities necessary to affect an uplifting. But we’re going to differ those efforts until it’s most appropriate for our shareholders.
The uplifting - the primary threshold for us with respect to quantitative listing requirements to uplift is a $2 stock price on the MKT tier of NYSC and a $4 stock price for NASDAQ. Based upon what we believe we have progressing in the months ahead, we hope to achieve at least one of those thresholds organically. And thus reversing - affecting to reverse stock split is not our highest priority right now.
Paul Rosenbaum
Good. Good. Thank you.
Nader Pourhassan
Thank you. Next question?
Operator
Thank you. The next question is from Jared Cohen of JM Cohen & Co. Please go ahead.
Jared Cohen
Yes, given what you have going on, I’m still - given your financing needs, I still haven’t understood why you haven’t gone out to a strategic partner like many of your companies be your size and where you are in Phase 3 trials have done. Can you answer that?
Nader Pourhassan
We cannot talk about any discussions with any big pharma or any other person that we’re talking in regards to partnering. So with that…
Jared Cohen
I know you can’t, I know you can’t, but have you at least tried to do that. I mean it seems that you should - I mean, given where you are, I mean, theoretically you should have a higher market cap. And companies your size seemed to be able to get that type of partnership.
Nader Pourhassan
So we have a very experienced - capital market experience in our Chief Scientific Officer and he, Dr. Burger, had explained many times to shareholders that we are on OTCB, we have to get to the next exchange in order to get the respect that we deserve because of our accomplishments, having said that, all of our focus is on that. Strategic partnering, we have never said we are closing the door to any one of those. We actually have our door wide open. But I cannot just comment on any of that.
But as far as going forward plan with capital market, those we are - this is in great hands of Dr. Denis Burger, me and Mike Mulholland, and we are working very closely with bankers and other institutes to accommodate us for that.
Jared Cohen
All right, secondly, you’ve never released any statistics going back to really to your Phase 2 trials, in terms of true statics of P value or anything else. Can you go into that a little bit?
Nader Pourhassan
Well, when you talk about P value, it doesn’t apply to when you’re talking about viral load of some patients.
Jared Cohen
Yes. I understand…
Nader Pourhassan
Yes, we are talking about the result has impressed the Key Opinion Leaders, thought-leaders, and we need to get that in peer-reviewed journal. We are working on that. That will be our key to get to the scientific community for the first time after Progenics has sold this product.
Jared Cohen
Okay. But you were supposed to be one at that conference to release something in February and that seemed to never happen and CROI where I think it. And why didn’t that happen?
Nader Pourhassan
CROI indicated they did not have slots available for Breakthrough Designation - I’m sorry, for the late breakers. So the fact that we didn’t get into it was explained also to us that there was many people trying to get there and therefore HIV didn’t have late breakers, so…
Jared Cohen
All right, thank you very much.
Nader Pourhassan
Thank you. Next?
Operator
Thank you. The next question is from Gil Solomon, a private investor. Please go ahead.
Gil Solomon
Hi, it’s great to have this discussion from everybody’s point of view. I’m a Medical Director at a health plan and I review all of the requests for new drugs. And I am very well aware of the FDA process and the cost of these drugs, and so, but not so much on the investment part, so I’m very interested to hear those questions.
But I’m very encouraged and I’m glad that you did have this update to find out what the FDA is doing, because that is a very arduous process to get through, so compared to the other drugs that I’ve followed I think that’s a very positive thing.
And I’m also gratified that you’re doing the graft versus host symptoms, Orphan Drug Designation, and there’s a very limited drugs to treat that. So that it would become an indication where, if it’s positive, there will be a lot of shift to treating this on an ongoing basis. So at least from my point of view, at least from the scientific point of view it’s sounds very encouraging.
Nader Pourhassan
Thank you so much, Doctor, for very useful comments. Next?
Operator
Yes, the next question is from Tom Parigian of Paulson Investment Company. Please go ahead.
Thomas Parigian
Hi, good afternoon, Nader.
Nader Pourhassan
Good afternoon, Tom.
Thomas Parigian
Okay. So, a few questions in response to a couple of investor questions, two for you, and then one for Mike. So did you in the board make a decision to spend relatively small money on the GvHD and the cancer opportunities as a result of having an anti-dilutive opportunity, meaning that if these two relatively small expenditures resulting in positive outcomes, could it and would it have an anti-dilutive effect by virtue of giving you an opportunity to sign a strategic?
Nader Pourhassan
That’s excellent of the version of question, Tom, definitely I wish more people would think in that way, because that is the correct way and that would open up huge opportunities for very small amount to spend.
Thomas Parigian
Thank you. So regarding ASM Microbe, you indicated or you suggested to the listeners on today’s call to go to the ASM Microbe site. And I suspect you did that because you can’t make an announcement regarding that conference, but it should be available on their site for us to review as to whether or not you will be included in June 20 conference. Is that accurate?
Nader Pourhassan
I believe you are accurate. I have not checked the website myself, but I encourage everybody who wanted to know more information about it to go to that site.
Thomas Parigian
Okay, thank you. And my last question, this one would be mainly for Mike Mulholland, one of the investors earlier indicated, in my opinion, that there were some negative aspects of the financing that CytoDyn has been successfully doing for the last several years. Because these financing have included a commission to an investment bank and that they have been done at $0.75, is it not true, Mike, that these $0.75 financings have been at higher valuations at each capital raise?
Michael Mulholland
Most definitely, over the course of the company’s relationship with your firm going back to the second half of 2013, our valuation in the market has been quite variable. As I’ve explained to many people our stock price in our view trades on investor sentiment and not on objective intrinsic valuation metrics. And on an unsolicited basis, I think your firm has done a good job of delivering capital every single time.
Thomas Parigian
Well, thank you. And that wasn’t the reason for the question, but I just want to make sure that I wasn’t under a misconception and that you as the CFO agree that each and every capital raise done at $0.75 was at a higher valuation than the one prior to it.
Michael Mulholland
Yes. I think on balance that’s true.
Thomas Parigian
Right, because there is more shares outstanding at each interval and I just wanted to make sure that the listeners understood that. Thank you.
Michael Mulholland
Yes. Thank you.
Nader Pourhassan
Thank you. Next?
Operator
Thank you. The next question is from Richard Giannotti [ph], a private investor. Please go ahead.
Unidentified Analyst
Nader, good afternoon.
Nader Pourhassan
Good afternoon.
Unidentified Analyst
I just - like my comment dovetails on the gentleman from Paulson. And I’m a pretty simple guy, so, I guess, yes, I understand where he’s saying that the more shares that are out there in $0.75 it places to a higher value. And so, I guess my question is, where in the world with all that you have going on, which in my opinion is fabulous, and I’ve been with this company for more years than I would like to admit to my wife, is where is the selling coming from, because I can’t piece it together?
And again, I’m a simple person. So as I follow the sales that go on and sometimes the huge blocks that are sold, and then it seems to be wobbles now at $0.80, I’m wondering if the board ever has a discussion about that and whether you could answer that, and maybe the gentlemen from Paulson like to get back on the line and explain to me and keep it out of the people aren’t selling shares and holding onto their warrants, because that’s a great arbitrage and I comment them for doing that.
And I guess, another part of the question might be is how long is our relationship with Paulson are we obligated to.
Nader Pourhassan
In regards to who is selling, we do not keep track of people with stock, whether they’re going to be selling or not. That’s not our…
Unidentified Analyst
Right.
Nader Pourhassan
We cannot get in…
Unidentified Analyst
No, I get that, I get that. Your job is to run the company and keep PRO 140. And you are doing a marvelous job. I just want…
Nader Pourhassan
I appreciate that.
Unidentified Analyst
Yes. I’m just…
Nader Pourhassan
No, I appreciate that. And I just want to bring it to everybody’s attention that Gilead, just 1997 or so, if you look at their chart they were trading very, very low numbers less than $1. And Warren Buffett and an analyst pass on that company, they had huge success. The fact that people don’t recognize soon enough is not something that we are concerned with, because we believe we are having tremendous amount of success getting ourselves to Phase 3 and doing remarkable job. Our clinical clinicians are doing remarkable job getting us to the next stage. But as far as the selling and the relationship with Paulson, I’ll let Mike answer that.
Michael Mulholland
Well, I really can’t speak to why certain shareholders sell their stock, or I can’t speak to what their investment horizon is and what their holding periods are. Also I can do is refer to as a finance guy is to what’s the true valuation of our company. And that’s not yet known or hasn’t been identified. I think if one does some - their own independent due diligence and reflects on market sizes or market opportunities of some of our clinical indications, which we have updated on our website late last month, and investor can come to their own conclusion with respect to whether or not $0.80 makes any sense or not. But we certainly can’t comment.
Nader Pourhassan
Yes. And one thing I should add is Paulson has very tremendous amount of funds for us in the last two-and-a-half years. But then I’d like to thank all the brokers. I said to them, you guys have helped the company to bring a very important product to the patients of the world and you should be very proud of what you’ve done. All of our success would have never been accomplished, even an inch of it without Paulson.
And the first time we raised money with Paulson, we had a lot of shareholder disgruntled. But after they saw that we got to Phase 2b with that money and we were able to generate the data with that money, they all had a whole new respect for Paulson.
Michael Mulholland
Let me just add in direct response to your question, our placement agent agreement with Paulson came to a natural expiration at the end of January in connection with the final closing of our private offering, which was announced shortly after in an 8-K. And we have no agreements going forward.
Unidentified Analyst
Okay. I’m just - I know nobody can pinpoint who would be selling. But the thing is that - and again I’m just rambling here, is - if you could find out who is selling, it would - the price of the stock would obviously reach a much higher level, because in my mind it should be $2 right now, if not, even more given the potential that you have, even though speculation in America seems to have gone by the wayside. Either that has to stop or I would like you to stop, or the other thing is eventually if we are going to reach the high watermark, because you’re going to come out with a fantastic announcement and that will propel the company stock price to go up, because then everybody will see your true value.
So keep up the good work. If those on the line are sellers, do me a favor, stop, please. Happy Easter.
Nader Pourhassan
Thank you. Happy Easter to you. Thank you. Next?
Operator
Thank you. Our next question comes from [Doug Hibberd of NTB] [ph]. Please go ahead.
Unidentified Analyst
Good afternoon.
Michael Mulholland
Good afternoon, Doug.
Unidentified Analyst
Just a couple of quick questions, on the Phase 3 for the adjunct treatment, I’ve noticed you’ve got 26 sites set up. And some of them are enrolling, some of them aren’t. They’re all active. Can you give us any indication on how are you going as far as enrollment. And the other thing is…
Michael Mulholland
Go ahead.
Nader Pourhassan
Go ahead.
Michael Mulholland
No, go ahead.
Unidentified Analyst
Well, I was going to say, on top of that I’m a firm believer that third-party validation is what we need. And you’re working towards that with the ASM Microbe concert. And I was hoping that the breakthrough therapy in essence would be a third-party validation by the FDA. I mean, this is then basically saying there isn’t anything out here like this.
If the data is going to be revealed and you’re really making headway with the Phase 3 treatment adjunct trial, then it would seem a moot point, whether the breakthrough is even really needed.
Nader Pourhassan
So thank you, Doug, for that. The number of sites, you are correct, it’s close to 24, 26. We have a policy. We announced first patient and last patient. However, in my speech I indicated that in four to six weeks we will give a very firm timeline. In regards to the breakthrough that we mentioned, I have to tell you that when we met FDA, they said, look guys, we’re giving you very, very short study. And that breakthrough is very close to this.
So even though that, they have now just told us give us a data in this population, we’ll give you that also. So we’re very pleased with everything going forward and breakthrough designation. I know everybody wants to start right now, right now. But we have a one small study we will conduct, if we wanted pursue it, and not, concentrate on the Phase 3, two of them.
Unidentified Analyst
Okay. So I missed that. You said you’d have a clinical trial update in a few weeks?
Nader Pourhassan
That’s correct. We want to give in four to six weeks, we will give firm timelines for when we believe we will be able to announce our un-blind or for example un-blinded, double-blinded side and talk about the efficacy. And we will have those timelines out for everybody.
Unidentified Analyst
Okay. I’m sorry for missing that. I appreciate it. Thank you, guys.
Nader Pourhassan
No problem. Thank you, Doug. Next?
Operator
Thank you. The next question is from Robert Sawyer, a private investor. Please go ahead.
Robert Sawyer
Nader, how are you?
Nader Pourhassan
Very good…
Robert Sawyer
Congratulations. Everything looks good. On the conference, could you explain if we’re invited to this conference how important that is to PRO 140 to our stocks, CytoDyn? Can you explain how important that is?
Nader Pourhassan
Yes, so, Bob, we cannot really talk too much about that. But if you go to their website, it’s I think about 4,000 scientists in the world. This is the first time it’s called ASM. It used to be ICAAC. And it’s really, really gigantic. I wouldn’t say it’s less than the CROI by any way, shape or form. And I would allow people to just go to their website and draw their own conclusion.
Robert Sawyer
All right, and one thing I noticed today that Orphan Drug status, and maybe I was wrong on this, thinking, but when I was looking at the FDA website, I noticed that Orphan Drug status is 100 days. And I’ve been told that it was 90 days. So you’d said that we had not heard from them yet. Maybe, we just haven’t - maybe we’ve got another 10 days to go. Am I correct or wrong on that?
Nader Pourhassan
What was told to me by our CRO was it’s at 60 days, but FDA was running behind perhaps 30 days or so. But being at 93 days, it is 90 days, 100 days or anything, we shouldn’t be more than a few days away.
Robert Sawyer
Yes, because you did, I believe you applied the December 22 if I’m correct for Orphan Drug status. So that’s…
Nader Pourhassan
That’s...
Robert Sawyer
No, I think we’ve got just probably - if I’m correct, hopefully, we’ll have a nice Easter basket at the end.
Nader Pourhassan
Okay.
Robert Sawyer
And I appreciate all you’re doing. And keep up the great work.
Nader Pourhassan
Thank you. I appreciate your support. Next?
Robert Sawyer
Thanks.
Operator
Thank you. Actually, gentlemen, at this time, we have no further questions in queue. I’d like to turn it back over to you for any additional closing comments.
Nader Pourhassan
So thank you, everybody, for being on the call. We believe we summarized everything that we are doing and updates. I hope to hear from anybody via our e-mail, at website, or a letter. Thank you so much.
Operator
Thank you, ladies and gentlemen. This does conclude today’s teleconference. You may disconnect your lines at this. And thank you for your participation.
Does anyone know why Progenics PRO 140 wasnt approved back in 2006 ?
February 22, 2006 05:00 AM Eastern Standard Time
TARRYTOWN, N.Y.--(BUSINESS WIRE)--Feb. 22, 2006--Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that PRO 140 has been designated a fast track product by the U.S. Food and Drug Administration (FDA) for the treatment of human immunodeficiency virus (HIV) infection. The FDA Fast Track Development Program facilitates development and expedites regulatory review of drugs intended to address an unmet medical need for serious or life-threatening conditions. PRO 140 belongs to a new class of HIV/AIDS therapeutics -- viral-entry inhibitors -- that are intended to protect healthy cells from viral infection. PRO 140, currently in phase 1b clinical trials in HIV-infected individuals, is a humanized monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter cells.
http://www.businesswire.com/news/home/20060222005325/en/Progenics-Pharmaceuticals-HIV-Drug-PRO-140-Receives
INJECTABLE long acting HIV meds under development by Johnson & Johnson - again not the same tech as we have at CYDY but the competition is definetly on the trail. Heres to hope for a successful phase 3
Johnson & Johnson's ($JNJ) Janssen announced that a Phase IIb study of a combination regimen of two investigational long-acting injectable HIV drugs found that the therapy performed similarly to a regimen consisting of three oral medications. The oral medications are given daily, while the injectables are administered once every 4 to 8 weeks, meaning the results have implications for improving medication adherence.
http://www.fiercedrugdelivery.com/story/injectable-hiv-regimen-being-developed-jj-and-viiv-healthcare-shows-promise/2015-11-10
FDA Approves new GILEAD safer once a day pill for HIV treatment. Any ideas how this plays for CYDY ?
Somewhat same old bio-tech in new pill form
http://www.sfgate.com/technology/businessinsider/article/A-safer-alternative-to-a-once-daily-HIV-pill-just-7227797.php
http://fortune.com/2016/04/05/gilead-next-gen-hiv/
The FDA just approved a new treatment for HIV.
Descovy, a combination drug that only has to be taken once a day, is the third in a series of HIV medicine updates to get the FDA's green light.
Developed by Gilead Sciences Inc., it works by interfering with a special protein necessary for the virus to multiply.
Keeping the amount of HIV in the blood low is key for suppressing symptoms of the virus, but it isn't a cure.
HERE'S WHAT YOU NEED TO KNOW:
Descovy is a combo of the drugs emtricitabine, and tenofovir alafenamide, or TAF. Only TAF is new, and it's been used in other new HIV medications such as Genvoya and Odefsey. It's an update to Truvada, which has emtricitabine and tenofovir disoproxil fumarate.
The goal with the update from tenofovir disproxil fumarate to TAF is so that the medications are less harsh on the body, and can be used in smaller doses.
In a late-stage trial, a combination using TAF called Genvoya proved just as effective as Stribild, one of Gilead's combination pills that was approved in 2012 and that contained tenofovir disoproxil fumarate.
Compared with Stribild, Genvoya had better long-term safety in trials. It is also less toxic to kidneys and has less of a negative impact on bone density.
In the case of Genvoya, that includes possible lactic acid buildup in the blood and severe liver problems, which can both be life-threatening.
Analysts forecast Descovy to make $2 billion by 2020.
Essentially, the new-and-improved drugs ares set up to be a safer alternatives for HIV treatment. Having new once-daily pills with lessened effects to bones and kidneys could be good news for the estimated 1.2 million people in the US living with HIV.
The drug they're developing is similar only in that its injectable , it not the same technology, CYDY is nano tech molecular, Gilead is a viral suppressant with side effects. Hopeful for Phase 3 results.
does anyone know when Phase 3 concludes ?
Only Apple products run Apple ios, The Turing phone runs android.
Patents aren't contracts, you can score a patent by sketching an idea on a napkin and registering it. Contracts for production are the only thing that will make the stock have any value moving forward.
When will the shareholder vote for LI's inclusion begin ?
When compared to the speculation of what this brand LQMT can do , here are companies that are not bound to one single consumer electronic manufacturer rather than the entire industry, furthermore by the time drilling is to be conducted on mars there will be new alloys. the clock is ticking, LQMT may have shot itself in the foot before getting into the race by binding itself solely to Apple for consumer electronics.
Lets talk about drill bits on mars when its relevant in 12 years.
Manufacturers are already making phones with Liquid Metal alternatives, How do you think this will affect LQMT and the industry. Does this minimize the importance of Apple licensing ?
http://neurogadget.com/2015/08/06/the-turing-phone-the-strongest-phone-so-far-designed-with-a-liquidmorphium-material/11665