KTRA's next reporting date is February 10, 2023.
1.62 million outstanding unchanged. Show your proof or it didn’t happen.
What Is Orphan Drug Status?
Orphan drug status, a status designated by the FDA, gives companies researching cures for rare diseases a seven-year window of exclusive marketing rights post-approval, reductions in certain application fees, and tax incentives (50% tax credits for cost award). Orphan drug status can be granted for new drugs, already approved drugs, or drugs that are already on the market.
Dec. 15, 2022 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for VAL-083 for the treatment of diffuse intrinsic pontine glioma (DIPG), a rare and highly-aggressive childhood brain cancer.
The FDA's ODD program provides orphan status to drugs defined as those intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people. ODD provides the sponsor of the drug with development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.
"This is another important step for us in evaluating VAL-083 as a treatment for brain tumors in addition to our lead indication of glioblastoma," said Robert E. Hoffman, Kintara's President and CEO. "We will continue with our clinical advancement of the drug candidate with our objective of delivering a much-needed new treatment that can benefit patients."
Starting to suspect DILUTION. With no news this is typically how dilution works. Management dilutes while investors wait for news, WHICH MIGHT OR MIGHT NOT COME. Since no news as to the presentation results I am thinking they HAD NO LUCK because of economic times being what they are,
This is the time in the cycle when investors start suspecting that ALL is not as it seems. Very common in the OTC. Management LIES.
I hope they get funding also. If they do not get funding, In my experience, it will be because management is way too technical for
investors to understand the product. I am thinking that is the case here. They changed CEO's this year. They should at least let investors know what is going on.
If that much. I hope the company gets funding soon
I am going to sell today on a double. I bought at $4.80. I think the 3 principles are looking for the BIG payout. Like you, I will be watching.
I already sold with a double from 7.20. I am waiting to see how low will it go. The one thing that turned me off, was on Proactive Investors, that is the reason I pulled the plug. I am currently neither bullish or bearish, but I have a feeling these guys are looking for a major partnership or completely sell the company. Good luck.
Their priority IS NOT the PPS. It is to SELL THE COMPANY.
Insider Own 1.20% of a Shares Outstanding 1.62M. What does that tell you?
Yes they’re priority is not the PPS.
I do not "fear" the dip. I have been doing this long enough to know that Bio management KNOWS NOTHING about the stock market and typically once a run starts they just let it die out.
Don’t fear this little dip we’re holding a diamond news will come CEO was very positive about it last conference.
IF management lets this stock sit with NO news for very long traders will think that they are having a HARD TIME getting financing for the final trials phase. That is what I am starting to think. The MM's are having
somewhat a difficult time keeping this in a loop but that will not last very long. Currently they are watching how low the PPS goes because if they let it go too low and news breaks they are in major money trouble.
This week the PPS will drift lower and lower. Think I sell out by Wednesday, Thursday at the latest is no news.
Yes, we will get there regardless. I am extremely bullish on this.
FINVIZ says Target Price $150.00
Undeniably one of the lowest market cap biotech out there that has 80% efficacy for breast cancer. Say hello to 50-60 million dollar market cap fairly soon for starters, by end of next year we will be sitting pretty at triple dollars.
I think most traders are expecting funding for the last trial.
Hugely bullish on this one. The pattern is similar to SAV*A, not saying it would peak around where SAV*A was a year or two years ago, but something tells me they want to push this 25-30 area and let it sit that range until further data comes out, or better yet, a partnership for funding.
Yea this mofo moving nicely
Kintara Therapeutics is focused on developing unique anti-cancer compounds, supported by a strong scientific rationale for development in indications with established biomarkers, and where patients are failing, or are unable to tolerate, current therapies.
VAL-083 is a "first-in-class" small molecule chemotherapeutic. Its unique structure provides many valuable benefits, including the targeting of DNA for its therapeutic effect and its ability to cross the blood brain barrier, critical for activity against central nervous system (CNS) tumors.
VAL-083 has completed Pre-Clinical, Phase I and II trials for the treatment of bevacizumab-refractory glioblastoma multiforme (GBM) and is currently being studied in two Phase II biomarker-driven clinical trials for unmethylated-MGMT GBM.
We are also pursuing the development of VAL-083 in the treatment of ovarian cancer.
REM-001 has broad utility for the treatment of serious cutaneous oncology indications. REM-001 has been previously studied in four Phase 2 and/or Phase 3 clinical trials in patients with cutaneous metastatic breast cancer (“CMBC”), who had previously received chemotherapy and/or failed radiation therapy.
Zacks Small-Cap Research
Based on our DCF model and a 15% discount rate, Kintara Therapeutics is valued at approximately $5.25 per share. Our model applies a 60% probability for VAL-083 in unmethylated GBM, a 50% probability in methylated GBM and a 50% probability of approval and commercialization in REM-001 for CMBC. The model includes contributions from the United States and Europe. Other regions will be included upon further clarity.
Shares Outstanding (mil) 43.2
Current Price (10/8/2021) $0.77
Thanks to its promising pipeline and $0.88 share price, 5-star analyst Michael King, of
H.C. Wainwright, sees an attractive entry point for investors.
“We are bullish about KTRA shares for the following five reasons
: (1) The GBM AGILE trial tests VAL-083 in
all three subtypes of GBM, allowing for multiple opportunities for VAL-083 to prove its
efficacy against phenotypically distinct types of the disease.
(2) VAL-083 is a bifunctional
alkylating agent that crosses the blood brain barrier and exhibits very favorable pharmacologic
properties relative TMZ; fulfilling the need for systemic availability in the brain.
has an established favorable safety record, both from initial trials and prior clinical use in
(4) Dire unmet need in GBM may present relatively low bar for approval.
(5) Phase 3 ready REM-001 is an additional bonus which is not factored into our valuation
assumptions and could potentially deliver value to shareholders while providing a backstop
against downside,” King explained.