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Ticker: CGEM | Â Risk Est | Â Support | Â Resistance | Â Price Target |
$11.40 | Yellow | $11.12, 10.30 | $ 11.54, 12.33 | $13-15+ (0-21 wks) |
Background:Â
Clinical stage biopharma company dedicated to creating new standards of care for patients with cancer
- The company takes a modality-agnostic approach to developing the most effective cancer therapies
- Specifically, CGEM researchers identify high-impact cancer targets and then pursue the best modality to address each identified target
- Focus on molecules that activate the immune system OR inhibit key cancer drivers.
- Most advanced program Zipalertinib (CLN-081/TAS6417)= in pivotal study in non-small cell lung cancer (NSCLC) patients with the EFGR mutation
- Partnered with Taiho Pharmaceuticals
Relevant Developments:
- Increased its ownership in its Cullinan MICAÂ from 54% to 92%; 10/25/22
- MICA holds the worldwide rights to CLN-619, an antibody that restores the MICA/MICB pathway to promote tumor cell lysis from both cytotoxic innate and adaptive immune cells
- The P1 study of CLN-619 = on track for data in mid-2023
- Appointed David P. Ryan, M.D to the company’s BOD; 11/2/22
- Received IND clearance for CLN-978 in a P1 study in relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL); 1/24/23
- Entered into an exclusive license with Harbour BioMed for the development/commercial US rights of HBM7008 (CLN-418); 2/13/23
- Paid Harbour BioMed $25M upfront
- Harbour BioMed is eligible for $148M in milestones + $415M in sales-based milestones + tiered royalties up to high teens
- Announced that posters of preclinical data highlighting the therapeutic potential of CLN-619 and CLN-617 will be presented at AACR in April; 3/14/23
Highlights from preliminary 4Q/FY22 earnings reported 3/9/23
- Expanded clinical stage portfolio through licensing of U.S. rights to CLN-418
- Received FDA clearance of IND application for CLN-978; submitted IND application for CLN-617
- Initial clinical data updates for CLN-049 and CLN-619 on track for mid-2023
- Potential for 6 clinical stage programs by year end and cash runway into 2026
Next CatalystsÂ
- Poster presentations at AACR (4/17/23)
- Initial P1 data for CLN-049 and CLN-619 (mid 2023)
- Initial P1 data for CLN-418 (2024)
- Initiate P1 study for CLN-978 (YE23)
- Initiate P1 study for CLN-617 (YE23)
Technicals/Notes
- Liking the setup here for a swing into the initial clinical P1 data updates for CLN-049 and CLN-619 slated for mid-2023
- The stock is currently trading in the middle of its 52-wk range ($7.30-15.89)
- Interestingly, the stock set its 52-wk low on 5/11/22 the day before announcing a strategic agreement through which Taiho will acquire Cullinan Pearl and co-develop/commercialize it’s lead program (CLN-081/TAS6417)
- Something that stands out is that there was a surge in volume and CGEM’s stock price with 14M shares traded on 5/12/22 (367K 10-day avg presently)
- Furthermore, the stock continue to trend up from there before setting a 52-wk high at $15.89 on 7/20/22
- This indicates, in our view, that investors were likely aligned with management on this decision and agreed it was in the best interest of shareholders
- Since then the stock has not traded lower than $9.68 making this a critical level of support for us
Ticker: AURA | Â Risk Est | Â Support | Â Resistance | Â Price Target |
$10.0 | Yellow | $10.0, 9.43 | $10.61, 11.46 | Â $14-18+ (0-21 wks) |
Background:
Clinical-stage biotech company developing virus-like drug conjugates (VDCs) (a novel class of therapies) for the treatment of multiple cancer indications.
- Initial development of AURA’s VDC tech platform is to treat tumors of high unmet need in ocular and urologic cancersÂ
- Lead asset Bel-sar = In a P3 study in early-stage choroidal melanoma (a vision- and life-threatening form of eye cancer where standard of care with radiotherapy leaves patients with severe comorbidities, including major vision loss)
- Bel-sar is designed to selectively target and destroy cancer cells and activate the immune system with the potential to create long-lasting anti-tumor immunity
Relevant Developments:Â
- Presented interim data from the P2 study of Bel-sar as a 1L therapy for patients with early-stage choroidal melanoma; 10/3/22
- Hosted a virtual investors day as wellÂ
- Preliminary analysis of the data supported tolerability up to three cycles of therapy and showed a dose-dependent anti-tumor response
- Announced the global P3 trial design with suprachoroidal route of administration following the positive P2 interim data; 11/10/22
- Raised over $92M in an oversubscribed equity offer at $12/share (no warrants); 11/30/22
- Click here to listen to the latest investor conference at Cowen on 3/8/23Â
Highlights from record 4Q/FY22 earnings reported 3/15/23
- U.S. Food and Drug Administration (FDA) Grants Fast Track Designation for bel-sar for the treatment of choroidal metastasis
- Bel-sar’s second ocular oncology indication to receive this designation as well
- Global P3 trial in primary choroidal melanoma on track to begin dosing in 1H23
- Strong financial position with over $188M in cash as of 12/31/22 paving a runway into 2025
Catalysts
- Start dosing in the global P3 study (1H23)
- Initial P1 data for Bel-sar in bladder cancer (2H23)
Technicals/Notes:
- Liking the setup here for a swing trade into 2Q23 with dosing expected to being in the global randomized P3 trial in Primary Choroidal Melanoma
- The stock is presently trading at the lower end of its 52-wk range ($9.43-24.83) with no discernible red flags, in our view, since AURA set its 52-wk high on 8/17/22
- Of note this coincided with 2Q22 earnings which the company reported on 8/11/22
- We are particular eager to see initial results from the company’s P1 study of Bel-sar in bladder cancer given its an area of unmet need
- As we saw with SESN which appreciated from $1 to $5+ as it approached its expected FDA approval of Vinicum for Bladder cancer
- Initial P1 data for Bel-sar in this indication is expected in 2H23 and we expect this to be a meaningful catalyst
- Support: The share price we monitor to remain bullish on a position, this serves as our mental stop loss
- Resistance: The share price we monitor to indicate a potential breakout zone
- Time Frame: A rough estimate on the amount of time a stock will take to reach our price target
- Core Positions: For this evenings copy of our core position updates, click here
- Trade Updates: For stocks on previous emails or SMS alerts that aren’t on this evenings email, click here
- *Risk estimates are rough estimates we use to gauge the potential volatility of a stock
- Red: High risk, most speculative play.
Generally companies with market caps under
$100M and weak cash positions (under $20M) - Yellow: Medium risk. Decent cash position (over $20M),
present a decent trade-setup, and ideally have catalysts - Green:Â 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.
“Trade Insights” are updated weekly and include a market update and two tickers with relevant developments and items on the horizon which may impact share price. If you have questions, please navigate to the key and or contact us or pop into the group chat.
Disclaimer
Trading stocks is risky. Part or all of an investment may be lost. Our daily “Trade Insights” emails are meant to give you ideas for swing and day trades but do not serve as investment advice. We recommend users conduct their own independent research before making investment decisions and consult with a financial advisor.
Price targets, risk estimates and all other assumptions outlined in all of our content housed in our website, emails and SMS alerts are estimates designed to help you with your research efforts and are not exact predictions. These are not to be perceived as investment advice, independent research should always be conducted and consulting with a registered financial advisor is traditionally good practice. We may trade some of these companies based on the thesis outlined by the existing data, but are not compensated by these companies in any form.Â
For a full copy of our disclaimer please click here to read
We like to consider taking profits on stocks we are up on and buying puts/using a stop loss to mitigate risk, this is not advice but merely our personal strategy in many of the trades we execute.Â