COVID-19 cases are receiving continued focus as the US hit another record, seeing the highest number of weekly cases thus far. Adding to the increasingly grim outlook, Russia and France were also reported to have set new daily records for infections with the number of hospitalized Americans jumping to a two month high. Many investors appear to be sitting on the sidelines, a thesis which was confirmed by today’s volume being significantly lower than Octobers average. Ultimately it appears that many investors have become apprehensive as Wall Street’s fear gauge has hit its highest mark in the past 7 weeks. Many are pointing towards the November 3rd election, continued inaction from politicians in passing economic relief and the ever present growing number of cases as being reason to sit on a cash position and monitor for a bottom. Currently the futures are relatively flat as investors place their bets, or many cases don’t with the upcoming election and pandemic induced volatility.
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High risk, most speculative play.
Generally companies with market caps under
$100M and weak cash positions (under $20M)
Medium risk. Decent cash position (over $20M),
present a decent trade-setup, and ideally have catalysts
Lower risk relative to yellow and red rated trades.
These trades are supported by strong underlying
fundamentals and have upcoming catalysts. Ideally,
there is a nice technical setup too.
- Late clinical-stage specialized biopharma company developing therapies for rare diseases with high unmet medical needs. Its most advanced assets SGX301 and SGX942 are in Phase 3 trials in patients with cutaneous T-cell lymphoma (CTCL) and oral mucositis, respectively.
- In March 2020 SNGX reported positive top-line Phase 3 data in its FLASH study in patients with CTCL.
- More recently on 10/22, SGNX announced that over half of the patients in the FLASH trial elected to remain in the study through week 18 and continued to notice clinical benefits
- The company’s “Public-Health Solutions” business segment is developing vaccines for Ricin and COVID-19 among other infectious diseases
- Both programs (SGX301 and SGX942) have received government funding and have been awarded Orphan Drug and/or Fast Track Designation.
- On 6/22 SNGX was added to the Russel Micro Cap Index
- On 6/24 SNGX finished enrollment into its Phase 3 DOM-INNATE study in patients with oral mucositis. Final top-line data is due 4Q20
- The company’s “heat stable” COVID-19 vaccine program (CiVax) in the early stages of development. Positive pre-clinical data was published in a peer-reviewed Journal in July written by SNGX’s collaborators at the University of Hawaiʻi at Mānoa (UHM)
- Another publication in Sept 2020 by SNGX’s collaborators demonstrated thermostabilization of its vaccine antigens
- Following an interim analysis of efficacy in the Phase 3 DOM-INNATE study by an independent data monitoring committee, it was recommended that the study proceed. Top-line data from this study is due this quarter
- The company stated that between its cash position ($11.2M), stock purchase agreement with B. Riley FBR, Inc., and non-dilutive funding from the gov its financial runway is sufficient through Phase 3 data readouts this year.
- The stock appears to have started a trend-reversal last week. Of note, there is a high warrant overhang
- Support to watch = $1.68
- Risk-estimate. Red (due to low cash and warrant overhang)
- PT= $2.0-2.50+
- A commercial-stage specialty pharma company that utilizes the 505(b)(2) regulatory pathway to bring products to market. Its focus is primarily on hospital injectable and pediatric rare disease areas.
- ETON currently has one FDA approved product (Biophren) and six assets in the marketing application submission process (see product pipeline below 👇)
- Its application for EM-100 had a GDUFA date of 9/15. However, the FDA is yet to make a decision.
- Investors anticipate that the FDA will inform the company of its decision imminently.
- Sales of its commercial product Biophren were negatively impacted due to COVID-19 restrictions preventing sales reps from meeting with pharmacy directors. The company stated in its 2Q20 earnings report that it adapted its sales approach which should drive stronger sales revenue in 2H20.
- Following a $22M public offering at $7/share that closed on 10/16/20, ETON has ~$30M in cash plus a $15M credit facility
- On 9/29/20 the FDA granted approval of ETON’s ALKINDI® SPRINKLE as replacement therapy for AI in kids under 17
- On 10/6/20 ETON submitted an NDA for ET-101 for treating partial-onset seizures and migraine
- On 10/8 its NDA for dehydrated alcohol injection was accepted by the FDA and assigned a PDUFA date of 5/27/21
- Anticipating further upside ahead of multiple PDUFA/GDUFA catalysts and 3Q20 earnings in November
- Support to watch = $7.56
- Risk-estimate: Yellow
- PT= $9.00-10.00 (0-3 weeks)
- Entry alert on Friday $1.18-1.22. Trade thesis is still intact
- A biotech company focused on developing drugs that inhibit pathways involved in cancer cell growth and survival.
- In August VSTM entered into an agreement to sell the rights to its commercial drug Copiktra to Secura Bio in a deal worth $311M plus double-digit royalties on sales.
- This left the company in a strong financial position with a cash runway into at least 2024. However, it is also left without a significant source of revenue and thus highly dependent on its clinical programs.
- The company has two Phase 1/2 registrations directed trials underway. On 9/16/20 VSTM had a conference call to discuss updated phase 1/2 data in low-grade serious ovarian cancer patients. A second Phase 1/2 study in non-small cell lung cancer (NSCLC) is expected to commence in 4Q20
- Presenting updated Phase 2 data at the 2020 American Society of Hematology (ASH) (Dec 5-8)
- Presenting updated Phase 1/2 data at the Study of Lung Cancer (IASLC) World Lung Cancer Conference (January 2021)
- Anticipating a pump into ASH
- $1.15-1.20 = buy zone
- Support to watch = $1.07
- Risk estimate: Green
- PT= $1.50-2.0 (0-6 weeks)
- Neutral on the trade. We need to see support at $4.95 hold and for the stock to set a higher low. The risk estimate level was increased to yellow.
- A clinical-stage biotech company developing first-in-class targeted therapies for patients with certain types of blood cancer (i.e. chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkin’s Lymphomas)).
- Its most advanced assets (CG-806 and APTO-253) are in proof of concept studies for CLL/NHL/AML and MDS/AML, respectively.
- As first-in-class drugs, CG-806 and APTO-253 would have competitive advantages if they prove to be safe and efficacious in clinical trials.
- Essentially, the drugs precisely suppress cancer genes involved in tumor resistance yet with minimal off-target activity
- On 10/19/20 APTO initiated dosing at the highest dose (450 mg) in cohort 5 of its ongoing Phase 1a/1b clinical study of CG-806 in patients with AML. In patients with CLL, the 450 mg dose separated itself from the other does in terms of efficacy.
- In the study of CG-806 in CLL/NHL, an even higher dose (750 mg) is being tested in cohort 5
- Preclinical data showed dose-dependent responses to treatment and favorable safety profiles
- Several catalysts in 4Q20 for CG-806 and APTO-253 including seeking clinical activity in AML, CLL, exploring new cancer types, and presenting clinical data at ASH in December.
- Following a $55M offering on 7/15/20 at $5.25/share the company had $138M in cash providing a long runway into 2023
- Support to watch = $4.95
- Risk estimate: Yellow
- PT= $7-9.50 (1-8 weeks)
- Alerted last week @ $4.50-4.58 entry. The trade thesis is still intact
- Commercial-stage specialty pharmaceutical company. On 6/19/20 the company had its first product (Gimoti) approved by the FDA.
- On 1/23/20 EVOK entered into a commercialization agreement with Eversana. Per the terms of the 5-year deal, Eversana would handle the commercialization activities of gimoti.
- EVOK maintains the rights to gimoti and keeps 80% of the profits. Additionally, upon approval, a $5M revolving credit facility became available to EVOK.
- As a nasal spray, gimoti is the first non-oral treatment outpatient treatment for diabetic gastroparesis
- On 7/15/20 EVOK entered a commercial manufacturing agreement with Patheon (a division of Thermo Fisher Scientific)
- As of 6/30/20, EVOK had $8M in cash providing a runway into 2Q21 (without consideration of gimoti revenue or the $5M credit)
- Gimoti was launched in 4Q20 (Oct 1 thru Dec 31). Investors anticipate that management might share some insights into the strength of the launch at the upcoming 3Q20 earnings report/conference call (~11/11/20)
- Support to watch = $4.30
- Risk estimate: Yellow
- PT= $5-7 (0-3 weeks)
- Trade thesis is still intact
- CANF “has an advanced pipeline of proprietary compounds in phase 2 and 3 clinical development stage, which address autoimmune-inflammatory and liver diseases.”
- Recently announced positive phase 3 Psoriasis interim data analysis and hosted a conference call last Thursday (October 15th)
- Shares took a tumble after this conference call, creating a potential swing opportunity
- Has been presenting at NASH, investor conferences, and partnering conferences recently
- The company had roughly $9million cash as per their latest earnings, raising concern in our view for further dilution before the year is over. Due to this cash level, we anticipate a run-up into the upcoming presentation in November but will be paying close attention to lock in gains if/when they come as to avoid further dilution
- Presenting phase 2 NASH data at AASLD on November 13th
- FDA recently cleared them for a phase 2 study on COVID-19
- We are anticipating a run-up and recovery from the recent tumble going into the data being presented in November with potential COVID-19 updates fueling further share price appreciation
- Monitoring for optimal entry
- Risk estimate: Red
- Keeping a close eye on support at $1.70 and $1.67
- PT = $2-2.20+ (before November 13th)
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