TCRT-PGEN Fundamental & Technical Discussion Board - TCRT 2Q22: The Initial SB TCR-T in Solid Tumor Phase I/II Trial Readout is Around the Corner in 3Q - TCRT-PGEN Fundamental & Technical Discussion Board - InvestorVillage


TCRT-PGEN Fundamental & Technical Discussion Board
This is a semi-private group. You are free to browse messages, but you must be a member of this group to post messages. Join This Group

Group: TCRT-PGEN Fundamental & Technical Discussion Board   /  Message Board  /  Read Message

 
 






Keyword
Subject
Between
and
Rec'd By
Authored By
Minimum Recs
  
Previous Message  Next Message    Post Message    Post a Reply return to message boardtop of board
Msg  29123 of 30613  at  8/15/2022 3:07:15 PM  by

Rob Cos

The following message was updated on 8/15/2022 4:06:32 PM.

TCRT 2Q22: The Initial SB TCR-T in Solid Tumor Phase I/II Trial Readout is Around the Corner in 3Q22 - Buy Price Target: $7.50

August 15, 2022
 
Alaunos Therapeutics, Inc. (TCRT - $1.99)
 
Healthcare/Biotechnology
 
Ticker:TCRT
Rating:Buy
Price Target: $7.50
 
2Q22: The Initial SB TCR-T in Solid Tumor Phase I/II Trial Readout is Around the Corner in 3Q22
 

This morning, TCRT reported 2Q22 financial results with a net loss of ($9.9MM) vs. Laidlaw ($9.5MM) and the Street ($10.3MM) estimates. Net loss/share was ($0.05), vs. ($0.04) of Laidlaw and ($0.05) of the Street estimates. TCRT ended 2Q22 with ~$60MM cash. We believe this could support its operations into 2Q23.

· SB TCR-T clinical development update. After announcing dosing of the first patient (KRASG12D-targeted NSCLC) at 5 bn cells in May, TCRT today confirmed that the next patient will be dosed at the higher next dose (40 bn cells). Preparation is underway and the company expects to provide more details in the near future. As a reminder, the two next doses are 40 bn and 100 bn cells. TCRT also reiterated that the initial clinical data from the first few patients could be available in 3Q22 at a scientific/medical conference, an important catalyst for TCRT shares, in our opinion. Data might possibly be presented at the ESMO (9/9-13) or CRI-ENCI-AACR (9/28-10/1). The primary endpoint is safety, MTD, and RP2D. The first safety check is scheduled ~one month post dosing. Another recent positive development is that the CRADA collaboration has been extended through 1/2025 with research and clinical trials to be conducted at Dr. Steven A. Rosenberg’s laboratory at the NCI. The focus is on individualized TCR-T development. TCRT continues to optimize its cGMP manufacturing capability/capacity with a new senior management hire. Improvements also include establishment of cryopreserved cell products and simultaneous production of multiple products, potentially reducing the rate to two vs. the current one patient per month. TCRT also indicated that of the ~500 lung or CRC patients interested in participating the trial, ~5% are a match for the study. Even certain patients who are currently ineligible, could become eligible in the future if their near-term therapies fail. TCRT is developing the next gen membrane bound IL-15 TCRTs with an IND application planned in 2H23.

· Others. Partner Solasia Pharma recently (6/19) gained an approval for Darvias, an organo-arsenic compound, in r/r PTCL in Japan. Hence, TCRT can expect rather minor milestone and royalty (low single digit) payments going forward.

Action. We are reiterating our Buy rating and our target price of $7.50 to reflect our bullish view on the two clinical products advancing. Our valuation is based on probability adjusted DCF, peer comparable, and sum-of-the-parts analyses.
 
 
Anticipated milestones in 2022 and beyond
 
Program...Indication...Event...Timing...impacts
 
SB neoantigen TCR-T cell therapy Solid tumors:
 
Potentially report initial clinical data3Q22****
IND filing of mbIL-15 TCR-T2H23***
Potentially enroll the first patient at NCI2023***
 
Ad-RTS-hIL-12 + veledimex
 
Recurrent glioblastoma (rGBM) Potential partnering 2022/2023***
 
3rd gen.autologous SB CD-19CAR-T cell therapy
 
CD19+ B cell malignanciesPotential partnering 2022/2023***
 
 
Major risks
 
Clinical study failure could have a major impact on TCRT share value. Although the preclinical results of SB neoantigen TCR-T cell therapy in solid tumors and Phase I results of Ad-RTS-hIL-12 plus veledimex in recurrent glioblastoma (rGBM) are rather robust, it remains difficult to fully handicap the outcome of clinical studies in the future. Given SB neoantigen TCR-T cell therapy is a novel IO treatment modality and without precedent, potential risk could be higher until clinical validation has been established. As such, if clinical studies fail to successfully meet the primary endpoint in future clinical studies, ZIOP share value could be substantially impacted.
 
Failure or substantial delay of regulatory approval could have a major negative impact on TCRT share value. Even if TCRT’s pipeline products complete clinical studies successfully, risks remain as whether the regulatory agencies could approve the regulatory filing. If unsuccessful or with substantial delaying due to various factors, such as requirement for additional studies, the TCRT shareholder value could also be significantly impaired.
 
Commercial risks, including competitions, remain difficult to handicap. Even if TCRT’s drugs could be approved, it may be difficult to forecast the commercial value of the drug due more precisely to various reasons. Multiple factors that could affect the future sales of a drug include: 1) change of competitive landscape, possibly due to entrance of new and better drugs especially given the different disease-modifying modalities in development. Specifically, for r/r solid tumors, the increased developments of novel IO and non-IO therapy modalities could relegate cellular therapy, like TCR-T only to very severe patient and therefore, limit the market potential of these medications. 2) the pace of physician adoption for the use of novel drugs, like SB neoantigen TCR-T cell therapy and Ad-RTS-hIL-12 plus veledimex; 3) pricing flexibility; 4) level or acceptance of reimbursement by third party insurers, and 5) potential change of the treatment paradigm and render some drug obsolete. In short, if the company’s sales substantially fall short, we believe shareholder disappointment could negatively impact the company’s valuation.
 
Additional financings could dilute shareholder value. Based on the SEC filing, the company has ~$60MM total cash as of the end of last quarter. Although the balance sheet, we believe, could support near-term corporate development operation entering 2Q23, TCRT will most likely need more financial resources going forward if they want to complete the current and other upcoming clinical studies and potentially participate in the commercialization of approved drug.
 
 Anticipated milestones in 2022 and beyond
 
 Program...Indication...Event...Timing...impacts
 
 SB neoantigen TCR-T cell therapy Solid tumors:
 
Potentially report initial clinical data3Q22****
IND filing of mbIL-15 TCR-T2H23***
Potentially enroll the first patient at NCI2023***
 
Ad-RTS-hIL-12 + veledimex
 
Recurrent glioblastoma (rGBM) Potential partnering 2022/2023***
 
3rd gen.autologous SB CD-19CAR-T cell therapy
 
CD19+ B cell malignanciesPotential partnering 2022/2023***
 
 
 


     e-mail to a friend      printer-friendly     add to library      
|  
Recs: 38  
   Views: 0 []
Previous Message  Next Message    Post Message    Post a Reply return to message boardtop of board




Financial Market Data provided by
.
Loading...