Theratechnologies Inc. Common - THTX STOCK NEWS

Theratechnologies (NASDAQ: THTX) announced that the FDA has set a PDUFA goal date of March 25, 2025 for its supplemental Biologics License Application for the F8 formulation of tesamorelin. If approved, the F8 formulation will replace the current F4 formulation (EGRIFTA SV®) in the U.S. market. The new formulation is protected by patent until 2033.

Theratechnologies announced preliminary data from Part 3 of its Phase 1b trial of sudocetaxel zendusortide in advanced ovarian cancer patients. The trial, involving 13 heavily pre-treated patients, tested two weekly doses: 1.75-mg/kg/week (Arm A, 7 patients) and 2.5-mg/kg/week (Arm B, 6 patients).

Key findings include no dose-limiting toxicities in either arm and encouraging activity in Arm B, where three patients showed significant tumor shrinkage, including one with complete liver lesion resolution. Arm B patients received longer treatment duration (mean 10.25 weeks) compared to Arm A (mean 7.6 weeks).

The Medical Review Committee unanimously recommended continued evaluation at higher doses. The company plans to accelerate its search for a partner to advance its oncology program.

Theratechnologies (THTX) has entered into an exclusive licensing agreement with Ionis Pharmaceuticals to commercialize two investigational RNA-targeted medicines in Canada: olezarsen and donidalorsen. Olezarsen is being evaluated for familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (sHTG), while donidalorsen targets hereditary angioedema (HAE).

Under the agreement, Theratechnologies will pay Ionis a $10 million upfront payment and up to $12.75 million in milestone payments. Ionis will receive tiered double-digit royalties on annual net sales. Both drugs are pending FDA approval, with submissions to Health Canada planned for 2025. The agreement expands Theratechnologies' portfolio beyond its HIV business in the U.S.

Theratechnologies announced the resumption of EGRIFTA SV® production following a voluntary shutdown at their contract manufacturer's facility due to FDA inspection observations. One new batch has completed quality control and awaits FDA approval through a Prior Approval Supplement, expected to be filed mid-December 2024. Two additional batches are in production.

The company has managed existing inventory to meet patient demand until mid-January 2025 and is working with FDA divisions to prevent potential shortages in 2025. EGRIFTA SV® is exclusively distributed in the United States.

Theratechnologies has secured up to $75 million in new credit facilities through agreements with TD Bank and Investissement Québec (IQ). The financing includes a $40 million three-year senior secured syndicated financing from TD Bank, with a $20 million accordion feature, and a $15 million subordinated loan from IQ. The new financing, featuring more favorable interest rates, replaces the existing Marathon Asset Management facility. The TD Bank financing includes a $25 million secured term loan and $15 million revolving facility at SOFR plus 2.75%, while the IQ loan carries an 11.45% interest rate. This restructuring is expected to free up approximately $19 million in cash in 2025 for business development initiatives.

Theratechnologies has resubmitted its supplemental Biologics License Application (sBLA) to the FDA for the F8 formulation of tesamorelin, addressing concerns raised in January 2024's Complete Response Letter. The F8 formulation aims to replace EGRIFTA SV® with simplified dosing for treating excess abdominal fat in HIV patients with lipodystrophy. The FDA's previous concerns focused on chemistry, manufacturing and controls, and immunogenicity risk information. The FDA will review the updated application within four months, with a decision expected around March 2025. The new formulation is patent protected until 2033.

Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) presented data at IDWeek 2024 highlighting the impact of excess visceral abdominal fat (EVAF) on cardiovascular disease (CVD) risk in people with HIV (PWH). Two studies were presented:

1. The VAMOS study showed that EVAF is prevalent (58%) in PWH on modern anti-retroviral therapy (ART) and is associated with higher CVD risk factors and 10-year ASCVD risk.

2. An analysis of tesamorelin phase 3 studies demonstrated that tesamorelin-induced EVAF reduction may lower CVD risk in PWH, particularly in those with higher baseline risk.

These findings suggest that EVAF is an overlooked CVD risk factor in PWH, and tesamorelin may help reduce this risk by lowering EVAF.

Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) unveiled the study design and baseline characteristics of the PROMISE-US trial, focusing on ibalizumab in heavily treatment-experienced (HTE) people with HIV and multidrug resistance. The study aims to assess long-term clinical outcomes and factors contributing to virologic control. Key findings include:

1. Ibalizumab was more frequently selected for patients with lower CD4 counts and higher viral loads.
2. Most subjects on ibalizumab remained on therapy for over 24 months.
3. The study enrolled 114 participants: 70 in Cohort 1 (non-ibalizumab), 42 on ibalizumab (Cohort 2), and 2 screen failures.
4. Ibalizumab use was associated with higher viral loads (p = 0.0629) and declining CD4 T cells (p = 0.001).
5. 80% of Cohort 2 participants remained on ibalizumab for over 12 months.
6. No infusion reactions were reported, indicating good tolerability.

Theratechnologies reported strong Q3 2024 financial results with revenue of $22.6 million, up 8% year-over-year. The company achieved positive net income of $3.1 million or 6 cents per share, and Adjusted EBITDA of $7.2 million. EGRIFTA SV® sales grew 26.6% to $16.7 million, while Trogarzo® sales declined 22.9% to $5.9 million. The company revised its fiscal 2024 revenue guidance to $83-$85 million due to potential EGRIFTA SV® supply constraints, but increased Adjusted EBITDA guidance to $17-$19 million. Theratechnologies ended Q3 with $34.7 million in cash and $4.2 million in bonds/money market funds. The company faces some uncertainty around EGRIFTA SV® manufacturing and FDA approval timelines but expects to resume distribution in early 2025.