Theratechnologies Inc Stock Price, News & Analysis

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.

Theratechnologies (THTX) reported a strong Q3 2022, with consolidated revenue growth of 17% to $20.8 million and North American revenue growth of 19%. The company is on track to meet its FY2022 revenue guidance of $79-$82 million. Sales of EGRIFTA SV® and Trogarzo® increased by 14.7% and 19.7%, respectively. Notably, the TH1902 Phase 1 trial is proceeding as planned, showing signs of efficacy in specific cancer patients. Additionally, a $100 million credit agreement has extended the company's financial runway, enabling the retirement of convertible notes.

Theratechnologies (THTX) announced the upcoming presentation of data on SORT1 expression in various cancers at the EORTC-NCI-AACR symposium from October 26-28, 2022. This data supports SORT1 as a target for anticancer therapies. The study involves the peptide-drug conjugate TH1902, currently being evaluated in a first-in-human trial across eight solid tumor types. The presentation will be led by Dr. Guylaine Roy, highlighting the significance of SORT1 in oncology and potential impacts on treatment innovation.

Theratechnologies announced FDA approval for Trogarzo® (ibalizumab-uiyk) to be administered via a 30-second undiluted IV push every two weeks, simplifying treatment for patients with multidrug-resistant HIV-1. This new method enhances convenience for clinics, facilitating wider administration. The safety profile of Trogarzo® administered via IV push is comparable to traditional IV infusion. This decision is backed by Phase 3 trials that confirmed safety and pharmacokinetics. Trogarzo® previously received FDA approval in March 2018 for intravenous infusion.

Theratechnologies announced it will release its third quarter financial results for fiscal 2022, ending on August 31, on October 13, 2022. A conference call will take place at 8:30 AM ET to discuss these results and other business updates, featuring CEO Paul Lévesque and other management team members.

Participants should dial in at least ten minutes early. The call can also be accessed via webcast.