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There is so much here. Cant believe this isnt 3.00
$VSTM Chart waking up here..on watch this week..
https://stockcharts.com/c-sc/sc?s=VSTM&p=D&b=5&g=0&i=0&r=1647091922529
VSTM - 103 million in CASH and no debt. Phase 2 trials...won't be under $3 long. Recent partnership with AMGEN tells you all you need to know about their validity.
Serious Buyout candidate here.
VSTM MOVING News on TOS and Benzinga 08:02 AM EDT, 09/22/2021 (MT Newswires) -- Verastem Oncology (VSTM) on Wednesday appointed Louis Denis chief medical officer.
Denis, who has more than 25 years of experience, previously served as chief medical officer of Asana BioSciences.
Finviz Rated
https://finviz.com/quote.ashx?t=VSTM
TradeView Buy Rated
https://www.tradingview.com/symbols/NASDAQ-VSTM/technicals/
$VSTM UP and maybe Up Up and Away !!
Verastem Oncology (NASDAQ:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced the appointment of Louis J. Denis, M.D., as Chief Medical Officer. Dr. Denis brings more than 25 years of clinical development and oncology expertise to Verastem.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005333/en/
$VSTM
Love news like we have today. VSTM Partnership with Amgen.
ITRM FDA SUNDAY
* * $VSTM Video Chart 05-24-2021 * *
Link to Video - click here to watch the technical chart video
you are quite welcome. I do not have a position in this stock but wish i did. no powder at the moment. but i was in a stock the baker bros owned and it went from $2.50 to $30+ dollars several years ago. it was ACAD. good luck and send me any tickers you think will pop glty
thanks in advance :)
Thanks for posting!
Baker bros opened a position here...keep an eye on this ticker they have an eye for undervalued bio stocks!!!
they own 5.9% of this company VSTM
that is 10,144,039 shares.
http://www.j3sg.com/Reports/Stock-Insider/Generate-Institution-Portfolio.php?DV=yes&institutionid=4698
Hello. Yes, this is a quiet board. I’ve been holding a relatively small position for about 6 months. Glad to see an upward trend without noise on the board. Hopefully a good sign of things to come.
I just opened a position today...wow this is a pretty quiet board hope its not cuz the company sucks.
Dude was there for 2 weeks and left, he was a CFO not anything more...probably got a better job offer for more money. Good buying op here.
I was responding thinking that was someone saying good add opp on a different board. I’m holding here cuz of the cash VSTM good value imo
bad news today IMO. chief scientist leaving? how can that be good?
I’m not adding any more here until I see next pr, mil is enough for me with marks actions
Looks like great buying opp here today
Great company. 100 mil+ cash. They diluted the sharehold at 10.00. 2 years ago. Now royalties and stage 2 Drugs. Love it ALL
Gonna be a good Monday then continue I think
Sell?? Buy buy buy. You see this chart. Something is UP. News coming and its gonna be big. These are funds loading on the ask
This stock is a Long. A lot of cash. A few drugs moving forward. No dilution. They could even buy a new phase 1 IMO soon
It is not over yet.
not sure it can go that high though. unless something great happens with their cancer drug. vSTM
maybe to 10 which is the 5 year high? VSTM
Vstm is over on the 4hr
$VSTM hod 2.13 added $ITRM
Called 2.00. Next news 3.50. So exciting here. I been around this company 4ever. Drugs in pipeline. Tons of cash. And more cash to come with royalties. Money for trials. No dilution in site. And based on volume... Funds accumulating
$VSTM looking good here
* * $VSTM Video Chart 11-27-2020 * *
Link to Video - click here to watch the technical chart video
Hello VOLUME. 2.00 next week. Goodnite
Hmmmm. Ok. Nice movement here. I bet we see good results phase 2 of something. This stock always pops
its right. i talked to ir
Someone responded 90 mil debt. I don’t see that. Thoughts?
$VSTM that was a monster 10-Q little nuggets buried in the 10-Q...... company paid off Hercules debt due 2022 in full .... two years early paying a 0.5m early repayment penalty...renegotiated 2018 bonds conversion now $3.25
$VSTM Still Grinding & Churning away!
nope. they have debt at least more than 50% of the cash. smh
1.52 Hit. Monday news I bet then over 2.00. Do you know how much damn cash we got. We could buy a drug besides our phase 1 & 2
$VSTM Grinding & Churning Upward
nah the 1.49 resistance keeps failing. IMO going back to 1.20 or less
Alot of buying at this level tic tok
Verastem Sees FY 2020 Operating Expenses Between $80M And $90M, Has Cash Runway Until At Least 2024
4:25 pm ET November 9, 2020 (Benzinga) Print
Announced Positive Updated Data from Ongoing Investigator-Initiated Phase 1/2 FRAME Study Evaluating VS-6766 and Defactinib Combination in Patients with Low-Grade Serous Ovarian Cancer
On Track to Commence Company-Sponsored Phase 2 Registration-Directed Trials by Year-End 2020 in Both Low-Grade Serous Ovarian Cancer and KRAS Mutant Non-Small Cell Lung Cancer
Strong Balance Sheet with Cash, Cash Equivalents and Investments Totaling $205.7 Million; Strategic Sale of COPIKTRA® (duvelisib) Provides Cash Runway Until at Least 2024
Verastem, Inc. (NASDAQ:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, today reported financial results for the three months ending September 30, 2020, and provided an overview of recent corporate highlights.
"The third quarter of 2020 was marked most notably by the sale of the COPIKTRA (duvelisib) franchise to Secura Bio in a deal valued at up to $311 million, plus royalties. This strategic transaction allows us to focus our resources and efforts on advancing the VS-6766 and defactinib combination program in KRAS mutant solid tumors and provides us with a cash runway until at least 2024," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "Looking ahead to the remainder of the year, we remain on track to commence two new company-sponsored, registration-directed Phase 2 clinical trials by year end, one in low-grade serous ovarian cancer (LGSOC) and one in KRAS mutant non-small cell lung cancer (NSCLC)."
Third Quarter 2020 and Recent Highlights
Presented Updated Data from the Phase 1/2 FRAME Study in Patients with LGSOC. In mid-September, Verastem reported positive updated results from the ongoing investigator-initiated Phase 1/2 FRAME study coinciding with a virtual oral presentation by Dr. Udai Banerji, Institute of Cancer Research and The Royal Marsden, at the 2nd Annual RAS-Targeted Drug Development (RTDD) Summit. The FRAME study is evaluating VS-6766, Verastem's RAF/MEK inhibitor, in combination with defactinib, its FAK inhibitor, in patients with LGSOC. The results demonstrated that the novel, intermittent, combination dosing schedule used in the FRAME study continues to show encouraging clinical activity, durability and a favorable safety profile in patients with KRAS mutant LGSOC, including patients who had previously progressed following treatment with a MEK inhibitor.
New Data Published in The Lancet Oncology Supports Potential of VS-6766. An investigator-initiated Phase 1 study evaluating the intermittent dosing schedule of VS-6766 was published in the November issue of The Lancet Oncology. Tolerability and antitumor activity were observed across various cancers with RAS/RAF/MEK pathway mutations. The dose escalation study was the first to evaluate a dual RAF/MEK inhibitor using innovative intermittent dosing schedules in patients harboring RAS/RAF pathway mutations.
On Track to Commence Phase 2 Registration-Directed Trials in Lead Indications This Year. Following a meeting with the U.S. Food and Drug Administration (FDA), Verastem reported that the FDA is supportive of its adaptive study design for the planned Phase 2 registration-directed trial evaluating VS-6766 and defactinib in patients with recurrent LGSOC. Verastem expects to commence registration-directed clinical trials in both recurrent LGSOC and KRAS mutant non-small cell lung cancer by the end of 2020. Assuming a positive outcome from these registration-directed trials, Verastem expects to submit New Drug Applications to the FDA requesting accelerated approval for VS-6766 alone or in combination with defactinib in both LGSOC and KRAS mutant NSCLC.
Closed COPIKTRA Sale to Secura Bio in a Deal Totaling $311 Million, Plus Royalties. Verastem recently announced the closing of a strategic transaction selling global commercial and development rights to COPIKTRA in all oncology indications to Secura Bio, Inc. The transaction, which carries a total deal value of up to $311 million, plus royalties, provides Verastem with a cash runway until at least 2024 and will allow the Company to focus its resources and efforts on the clinical development of VS-6766 and defactinib in KRAS mutant solid tumors.
Presented New Preclinical Research Demonstrating Synergy and Tumor Regression with VS-6766 in Combination with G12C Inhibitors. In a virtual poster presentation, also at the RTDD Summit, Verastem highlighted new preclinical researchwhere VS-6766 showed synergy with KRAS-G12C inhibitors in reducing cancer cell viability across a panel of KRAS-G12C mutant NSCLC and colorectal cancer (CRC) cell lines. This enhanced cellular anti-cancer activity of the combination correlated with deeper and more durable inhibition of ERK pathway signaling compared to G12C inhibition alone. The anti-tumor effects of VS-6766 were stronger than the effects of trametinib at a comparable dose.
Third Quarter 2020 Financial Results
Total Revenue for the three months ending September 30, 2020 (2020 Quarter) was $78.6 million, compared to $9.0 million for the three months ending September 30, 2019 (2019 Quarter).
Sale of COPIKTRA license and related assets revenue for the 2020 Quarter was $70.0 million, compared to $0.0 for the 2019 Quarter. The 2020 Quarter was comprised of a $70.0 million upfront payment recognized as part of the COPIKTRA sale to Secura Bio Inc.
License and collaboration revenue for the 2020 Quarter was $2.8 million, compared to $5.0 million for the 2019 Quarter. The 2019 Quarter included a $5.0 million upfront payment received pursuant to a license and collaboration agreement executed between Verastem Oncology and Sanofi in July 2019. The 2020 Quarter was primarily comprised of $2.5 million for Sanofi achieving two development milestones under the license and collaboration agreement.
Net product revenue for the 2020 Quarter was $5.8 million, compared to $4.0 million for the 2019 Quarter.
Cost of sales as a result of the sale of COPIKTRA license and related assets for the 2020 Quarter was $31.2 million, compared to $0.0 million for the 2019 Quarter. The 2020 Quarter comprised of the intangible asset, certain duvelisib inventory, net duvelisib contract prepaid balances and certain manufacturing equipment for the amounts of $19.2 million, $6.0 million, $5.8 million, and $0.2 million, respectively, delivered to Secura Bio Inc. as part of the COPIKTRA sale.
Total research and development (R&D) and selling, general and administrative (SG&A) expenses for the 2020 Quarter were $31.6 million, compared to $34.4 million for the 2019 Quarter.
R&D expense for the 2020 Quarter was $11.0 million, compared to $12.2 million for the 2019 Quarter. The decrease of $1.2 million, or 10%, was primarily related to a decrease in contract research organization costs and lower employee related expense.
SG&A expense for the 2020 Quarter was $20.6 million, compared to $22.2 million for the 2019 Quarter. The decrease of $1.6 million, or 7%, primarily resulted from the company's shift in strategic direction which led to lower commercial program and employee related expense. The 2020 Quarter includes $3.5 million of nonrecurring transaction expenses directly attributable to the COPIKTRA sale to Secura Bio Inc.
Net income (loss) for the 2020 Quarter was $13.1 million, or $0.08 per share (basic and diluted), compared to $(30.1) million, or $(0.41) per share (basic and diluted), for the 2019 Quarter.
For the 2020 Quarter, non-GAAP adjusted net income was $18.8 million, or $0.11 per share (diluted), compared to non-GAAP adjusted net loss of $26.2 million, or $0.35 per share (diluted), for the 2019 Quarter. Please refer to the GAAP to Non-GAAP Reconciliation attached to this press release.
Verastem Oncology ended the third quarter of 2020 with cash, cash equivalents and short-term investments of $205.7 million.
Financial Guidance and Outlook
With the proceeds from the sale of COPIKTRA, Verastem has a cash runway until at least 2024 to deliver on the current programs for VS-6766 and defactinib, including clinical and regulatory milestones and development in LGSOC and KRAS mutant NSCLC. Verastem expects its 2020 operating expenses to be approximately 40% lower than its 2019 operating expenses. As a result of its new strategic direction and operating plans, along with the sale of the COPIKTRA franchise during the third quarter 2020 and associated transition activities, the Company expects total operating expenses for the full year 2020 to be in the range of $80 million to $90 million. Beginning in 2021 Verastem expects its annual operating expenses to be approximately $50 million.
Use of Non-GAAP Financial Measures
Beat consensus by .177
Fiscal Quarter
Q3 2020
Report Date
11/09/2020
Consensus/Actual EPS
$0.043/
$0.22
$VSTM
Verastem Oncology Q3 EPS $0.11 Up From $(0.35) YoY, Sales $78.60M Up From $9.03M YoY
VSTM earnings at after market central time according to TDA...
Beat earnings last quarter.
$VSTM
Verastem Oncology Announces New Data Published in The Lancet Oncology Supports Potential of VS-6766 as Treatment for RAS Muta...
October 28 2020 - 08:01PM
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Investigator-Initiated Phase 1 Study is First to Evaluate a Dual RAF/MEK Inhibitor Using Innovative Intermittent Dosing Schedules in Patients Harboring RAS/RAF Pathway Mutations
Study Finds VS-6766 Regimen is Tolerable and Shows Antitumor Activity in Recommended Phase 2 Single Agent Dose
Phase 2 Registration-Directed Trials with VS-6766 Alone and in Combination with Defactinib in Low-Grade Serous Ovarian Cancer and KRAS Mutant Non-Small Cell Lung Cancer Expected to Commence by Year-End 2020
Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, today announced new data have been published today in The Lancet Oncology. The study evaluated the intermittent dosing schedule of VS-6766 (formerly known as CH5126766) to inform further testing of VS-6766 as both a single agent in RAS/RAF-mutant cancers such as KRAS mutant non-small cell lung cancer (NSCLC) or in combination with small molecules including the FAK inhibitor defactinib in KRAS mutant solid tumors (NCT03875820). In this dose-escalation study, tolerability and antitumor activity were observed across various cancers with RAS/RAF/MEK pathway mutations.
“The positive results observed with this innovative intermittent dosing regimen of VS-6766 demonstrate its significant potential across various cancers with RAS/RAF/MEK pathway mutations,” stated Udai Banerji, Professor of Molecular Cancer Pharmacology at The Institute of Cancer Research, London, and Honorary Consultant in Medical Oncology, MBBS, MD, DNB, PhD, FRCP at The Royal Marsden NHS Foundation Trust, London, and lead investigator of the clinical study. “We were encouraged by the data, demonstrating both antitumor activity and tolerability of VS-6766, and this intermittent schedule can be used alone or for combination therapy schedules with other anticancer agents for a variety of difficult-to-treat cancers.”
The full manuscript, titled “Intermittent schedules of the oral RAF–MEK inhibitor CH5126766/VS-6766 in patients with RAS/RAF-mutant solid tumours and multiple myeloma: a single-centre, open-label, phase 1 dose-escalation and basket dose-expansion study,” can be accessed here.
“These results support the potential of VS-6766 as a treatment for a variety of cancers where conventional approaches have been sub-optimal and there is significant unmet need. We believe VS-6766 has the potential to be the backbone of RAS therapy by addressing the multiple points of resistance and toxicity issues that have made advancing new options difficult,” said Brian Stuglik, Chief Executive Officer of Verastem Oncology. “Our Phase 2 registration-directed trials with VS-6766 in low grade serous ovarian cancer and KRAS mutant NSCLC are scheduled to begin by the end of this year. These adaptive design trials are a capital efficient approach to rapidly evaluate VS-6766 alone or in combination with defactinib to determine which regimen to take forward into the expansion phase of the trial.”
Results from the Phase 1 Study Investigating Intermittent Dosing of VS-6766 in Patients with RAS/RAF-mutated Solid Tumors and Multiple Myeloma
Between June 2013 to January 2019, 58 patients, including 51 patients with solid tumors and seven patients with multiple myeloma, were enrolled in a study conducted at The Institute of Cancer Research (ICR) and The Royal Marsden Hospital in the U.K. The study consisted of two parts; 1) dose escalation part to determine the recommended dosage (29 patients) and 2) basket expansion part to investigate efficacy and safety of the recommended dosage determined in the dose escalation part (29 patients).
Four mg twice weekly was established as the recommended Phase 2 dose for VS-6766 monotherapy and was deemed tolerable based on clinician’s assessment with several patients remaining on study for more than six months.
In the subsequent basket expansion part, seven (26.9%) of 26 response-evaluable patients with RAS mutations in the basket expansion achieved objective responses, with response rates in patients with NSCLC, gynecological malignancies, colorectal cancer (CRC), melanoma, and multiple myeloma being 3/10 (30%), 3/5 (60%), 0/4 (0%), 0/1 (0%), and 1/6 (16.7%), respectively. In all six responders with solid tumors, tumor shrinkage was observed at the time of the first restaging scan after two cycles of treatment, with partial responses confirmed after two to four cycles. Five of the six responses lasted more than six months.
Among the 57 safety-evaluable patients, the most common Grade 3/4 treatment related adverse events (TRAEs) were rash (19%), CPK elevation (11%), hypoalbuminemia (11%), and fatigue (7%). Five (9%) patients experienced treatment-related serious adverse events. In the study, TRAEs were manageable, resolved spontaneously or reversed with dose modification. There were no treatment-related deaths. The study also confirmed a long half-life of 55 hours and target engagement in the form of reduction of both p-ERK and p-MEK in three patients who underwent paired biopsies, supporting intermittent dosing schedules.
This study was supported by Chugai Pharmaceutical Co., Ltd. Verastem in-licensed VS-6766 from Chugai in January 2020.
About VS-6766
VS-6766 (formerly known as CH5126766 and CKI27) is a unique inhibitor of the RAF/MEK signaling pathway. In contrast to other MEK inhibitors in development, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors.
About Defactinib
Defactinib (VS-6063) is an oral small molecule inhibitor of FAK and PYK2 that is currently being evaluated as a potential combination therapy for various solid tumors. The Company has received Orphan Drug designation for defactinib in ovarian cancer and mesothelioma in the US, EU and Australia. Preclinical research by Verastem Oncology scientists and collaborators at world-renowned research institutions has described the effect of FAK inhibition to enhance immune response by decreasing immuno-suppressive cells, increasing cytotoxic T cells, and reducing stromal density, which allows tumor-killing immune cells to enter the tumor.1,2
About the VS-6766/Defactinib Combination
RAS mutant tumors are present in 30% of all human cancers and have historically presented a difficult treatment challenge and are often associated with significantly worse prognosis. Challenges associated with identifying new treatment options for these types of cancers include resistance to single agents, identifying tolerable combination regimens with MEK inhibitors and new RAS inhibitors in development addressing only a minority of all RAS mutated cancers.
The combination of VS-6766 and defactinib has been found to be clinically active in patients with KRAS mutant tumors. In an ongoing investigator-initiated Phase 1/2 FRAME study, the combination of VS-6766 and defactinib is being evaluated in patients with LGSOC, KRAS mutant NSCLC and colorectal cancer (CRC). Updated interim data from this study presented at the 2nd Annual RAS-Targeted Drug Development Summit in September 2020 demonstrated a 56% overall response rate and long duration of therapy among patients with KRAS-G12 mutant LGSOC. Based on an observation of higher response rates seen in NSCLC patients with KRAS-G12V mutations in the study, Verastem will also be further exploring the role of VS-6766 and defactinib in KRAS-G12V NSCLC. The FRAME study was expanded in August 2020 to include new cohorts in pancreatic cancer, KRAS mutant endometrial cancer and KRAS-G12V NSCLC.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a development-stage biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with cancer. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition and focal adhesion kinase (FAK) inhibition. For more information, please visit www.verastem.com.
Woooah. $30? Really
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