Theratechnologies Inc - THTX STOCK NEWS

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.

Theratechnologies (THTX) announced a plan to amend its Phase 1 oncology clinical trial protocol for TH1902, aiming for a timely re-submission to the FDA. Following a pause in enrollment on December 1, 2022, the company formed a Scientific Advisory Committee (SAC) consisting of U.S. oncology experts to guide protocol optimization. The company is preparing responses to FDA inquiries, with a SAC meeting set for late March to discuss findings. Theratechnologies also plans to evaluate potential partnerships for TH1902 post-resumption. The goal for 2023 is to achieve positive adjusted EBITDA by year-end, making new investments contingent upon trial advancements.

Theratechnologies has announced its financial results for the fourth quarter and full year of fiscal 2022, which ended on November 30. The report is scheduled for release on February 28, 2023, at 8:30 AM ET. The call will include insights from CEO Paul Lévesque and other key executives, who will provide updates on business development. Investors should prepare to join the call at least ten minutes early to secure access. Details for the conference call, including dial-in numbers and access codes, are provided in the release. For continued updates, stakeholders can access information on the company's website.

Theratechnologies has announced its fiscal year 2023 guidance, projecting revenues between $90 million and $95 million, which reflects a growth of 13% to 19% over FY2022's estimated $80 million. The company's operating plan aims for positive EBITDA by year-end, supported by a dedicated U.S. salesforce and growth in commercial operations. A Scientific Advisory Committee is formed for the Phase 1 trial of TH1902, with FDA review of the protocol amendment expected within thirty days. The focus remains on sustainable double-digit sales growth and optimizing existing product administration methods.

Theratechnologies Inc. announces a pause in patient enrollment for its Phase 1 clinical trial of TH1902, an investigational peptide drug conjugate targeting sortilin-expressing cancers. Following consultation with investigators, the decision was made due to unconvincing efficacy results and observed adverse events, primarily neuropathy and eye toxicity. The company intends to amend its protocol to modify dosing regimens for TH1902. Despite disappointment, Theratechnologies remains committed to advancing its SORT1+ Technology platform for treating advanced cancers.

Theratechnologies (THTX) presented new data at the 34th EORTC-NCI-AACR Symposium showcasing high expression of SORT1 in various solid tumors, indicating its potential as a novel anticancer therapeutic target. The study involved 1,446 cancer samples, revealing significant SORT1 expression in cancers like breast, ovarian, and endometrial, while showing minimal expression in normal tissues. These findings support ongoing clinical trials of TH1902, a SORT1-targeted peptide-drug conjugate, aiming to improve cancer treatment.