Theratechnologies Inc. Common - THTX STOCK NEWS

Theratechnologies Inc. (THTX) unveiled promising preclinical data for its investigational peptide drug conjugate, sudocetaxel zendusortide (TH1902), during the 2023 AACR meeting. The data suggest that this candidate can enhance immune cell infiltration in 'cold' tumors and boost efficacy alongside PD-L1 checkpoint inhibitors. In melanoma models, the combination of sudocetaxel zendusortide and PD-L1 therapy showed improved tumor inhibition and survival rates. In breast cancer models, it achieved complete tumor regression, outperforming docetaxel and Herceptin combinations. The expression of SORT1, targeted by TH1902, was noted in 60-75% of TNBC and HER2+ cases, supporting its development. The FDA has granted fast track designation for TH1902, although a Phase 1 trial is currently on hold pending protocol amendments.

Theratechnologies announced its Q1 2023 results, reporting a consolidated revenue increase of 7.3% to $19.9 million, driven by a 9% rise in EGRIFTA SV sales and a 5% increase in Trogarzo revenue. The company confirmed its FY2023 revenue guidance of $90 million to $95 million, reflecting a growth range of 13% to 19%. Theratechnologies plans to file an amended protocol for the TH1902 Phase 1 trial by the end of April 2023, following a voluntary enrollment pause. However, the company faced a net loss of $10.4 million and reported increased R&D expenses of $9.4 million. Adjusted EBITDA was $(3.9 million), showing improvement from the previous year. The company is focused on improving operational efficiency and controlling costs.

MONTREAL, April 3, 2023 – Theratechnologies (NASDAQ: THTX) will release its financial results for Q1 2023, ending February 28, on April 12, 2023. The conference call will begin at 8:30 AM ET, hosted by CEO Paul Lévesque along with key management team members. Investors can join the call 10 minutes prior for access. The North America dial-in is 1-877-513-4119, international dial-in 1-412-902-6615, with access code 4314981. Replay options are available until April 19, 2023. For additional details, visit the company’s website.

Theratechnologies (THTX) announced new findings on sudocetaxel zendusortide (TH1902), showcasing its potential to enhance anti-PD-L1 immunotherapy and induce tumor infiltrating lymphocytes in melanoma models. The studies also reveal TH1902's activity in SORT1+ triple-negative and HER2+ breast cancers. Presentations at the upcoming AACR meeting will highlight its efficacy in various tumor types and the connection to high SORT1 expression. The FDA has granted fast track designation for TH1902 targeting sortilin-positive tumors. However, a Phase 1 trial is currently on partial clinical hold as patient recruitment was paused in December 2022.

Theratechnologies has received a notification from Nasdaq dated March 3, 2023, indicating non-compliance with the Minimum Bid Price Requirement as its shares closed below $1.00 for over 30 days. The company has until August 30, 2023, to regain compliance. If the share price reaches $1.00 for at least ten consecutive business days, compliance will be restored. Should compliance not be achieved, the company may qualify for a further 180-day extension, requiring adherence to market value standards. The Nasdaq notification does not affect trading or compliance on the Toronto Stock Exchange.

Theratechnologies reported a Q4 2022 revenue of $21.4 million, a 14.2% increase, with FY2022 revenue at $80.1 million, up 15%. The FY2023 revenue guidance is between $90 million and $95 million, projecting 13% to 19% growth. The company aims to achieve positive Adjusted EBITDA by year-end, focusing on commercial growth and budget control. Key products, EGRIFTA SV® and Trogarzo®, showed significant sales increase, contributing to the positive outlook. However, challenges exist with the voluntary pause of the TH1902 clinical trial due to concerns over efficacy and adverse events.

Theratechnologies Inc. (THTX) announced a significant amendment to its credit agreement with Marathon Asset Management, allowing access to a US$20 million second tranche without the need to file a human factors validation study (HFS) to the FDA. This modification permits the inclusion of a going concern note in the auditor’s report without triggering an event of default. The amendment involved issuing 5 million common share purchase warrants to Marathon, each at an exercise price of US$1.45 until February 20230. The company must still comply with other conditions, including achieving net revenues of at least US$75 million before accessing the funds.

On February 22, 2023, Theratechnologies (NASDAQ: THTX) presented data at the CROI conference indicating that tesamorelin may reduce excess visceral abdominal fat (EVAF) in people with HIV, potentially improving metabolic syndrome outcomes. A post-hoc analysis from two Phase III trials showed that 26 weeks of tesamorelin treatment significantly decreased metabolic syndrome prevalence from 48.5% to 30.8% among responders. These findings suggest tesamorelin's utility in treating metabolic conditions related to HIV and may open avenues for addressing nonalcoholic fatty liver disease (NASH). The results bolster confidence in further research for tesamorelin's adoption in broader populations.