Theralase is a high risk/high reward play, says Mackie Research

Calling Theralase Technologies (Theralase Technologies Stock Quote, Chart, News TSXV:TLT) a high-risk, high-reward investment opportunity, Mackie Research analyst André Uddin delivered an update to clients on Monday where he reiterated his “Speculative Buy” rating and $0.70 per share target.

Toronto-based Theralase is a drug and device development company focused on developing a photodynamic therapy for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The company also has a legacy business segment which is marketing its proprietary cool laser therapy devices for pain and inflammation management.

Theralase reported its second quarter 2020 finances on August 28, posting total revenue for the six-month period ended June 30, 2020, at $293,453, down 21 per cent from the same period for 2019.

The company said the decrease is related to the COVID-19 pandemic which caused a majority of health care practitioners to temporarily close their practices and place any purchasing decisions on temporary or permanent hold.

The company reported net research and development expenses up 70 per cent year-over-year to $2.2 million, primarily due to increased expenses related to operating its Phase II NMIBC study featured lead asset TLD-1433. At the end of the Q2, the company had $9.6 million in cash and zero debt.

In its operational highlights, Theralase noted the launch of four Canadian study sites with one more in advanced negotiation for the Phase II study, along with advanced discussions to launch four US-based study sites later in the year.

The company also noted a Sponsored Research Agreement (SRA) with the University of Manitoba to start development on a coronavirus vaccine and therapy using Theralase’s TLD-1433 and its patented light-activated Photo Dynamic Compounds (PDCs), with the plan being to advance to human trials by 2021.

In his report, Uddin said Theralase’s financials over the quarter and half-year are less important at this stage, with the company’s future wrapped in TLD-1433 and its current Phase II study, although the analyst had forecasted Q2 revenue of $0.0 million compared to the resultant $0.2 million. Uddin said he has increased his Q3 R&D expense estimate from $0.2 million to $1 million.

On the company and stock, Uddin wrote, “Besides TLD-1433, TLT plans to commence pre-clinical toxicology studies with an i.v. formulation of TLD-1433 combined with transferrin (termed Rutherrin), which could potentially be activated by radiation to treat other types of tumors (glioblastoma and NSCLC). We are maintaining our SPECULATIVE BUY rating.”

On the treatment of BCG-unresponsive NMIBC, Uddin spoke of the competitive landscape, saying, “Sesen is in the middle of a rolling BLA submission for Vicinium, which is expected to complete in Q4 2020. In May 2020, FerGene received a complete response letter to its BLA for Adstiladrin, which is due to manufacturing issues. Cold Genesys’ CG0070 and Roche’s Tecentriq could enter into pivotal trials in the future.”

At press time, Uddin’s $0.70 target represented a projected 12-month return of 268 per cent.