Anuncio • Sep 05
Theratechnologies Inc. Announces Availability of EGRIFTA WR (tesamorelin) for Injection to Reduce Excess Abdominal Fat in Adults with HIV and Lipodystrophy Theratechnologies Inc. announced the availability of EGRIFTA WR™ (tesamorelin) for injection for the reduction of excess abdominal fat in adult patients with HIV and lipodystrophy. The announcement follows the approval of EGRIFTA WR™ by the U.S. Food and Drug Administration (FDA) earlier this year. The new, improved formulation of tesamorelin for injection – the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy – will gradually replace EGRIFTA SV®, the current formulation. Specialty pharmacies are now ordering EGRIFTA WR™ to fill prescriptions for the new formulation. EGRIFTA SV® will continue to be available during a transitional period as managed care plans increasingly provide coverage for EGRIFTA WR™. EGRIFTA WR™ only needs weekly reconstitution and requires less than half the injection volume as EGRIFTA SV®, which is reconstituted daily. The product is supplied as four single-patient-use vials, each containing 11.6 mg of tesamorelin, sufficient for seven daily injections. The daily dose is 1.28 mg (0.16 mL of the reconstituted solution) injected subcutaneously. EGRIFTA WR™ can be stored at room temperature (20° to 25° C [68° to 77° F]) before and after reconstitution. The EGRIFTA WR™ formulation is patent protected in the U.S. until 2033. Pharmacokinetic studies have shown bioequivalence of EGRIFTA WR™ to the original F1 formulation of tesamorelin for injection (previously sold under the trade name EGRIFTA®). The most commonly reported adverse reactions of tesamorelin for injection include arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia. Individuals with HIV and lipodystrophy who are currently using EGRIFTA SV® can enroll in the Thera Patient Support® program to help them transition to EGRIFTA WR™ as insurance coverage becomes available. The program, which is offered free of charge, includes a dedicated team of Thera Nurse Navigators who are available to train enrolled patients on the use of EGRIFTA WR™. EGRIFTA WR™ (tesamorelin) for injection is approved in the U.S. for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. EGRIFTA WR™ is a growth hormone- releasing factor (GHRF) analog that acts on pituitary cells in the brain to stimulate the production and release of endogenous growth hormone. Limitations of Use: Long-term cardiovascular safety of EGRIFTA WR™ has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. EGRIFTA WR™ is not indicated for weight loss management as it has a weight- neutral effect. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA WR™. Contraindications: Do not use EGRIFTA WR™ if a patient: Has disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma. Has active cancer. Is allergic to tesamorelin or any of the ingredients in EGRIFTA WR™. Is pregnant or planning to become pregnant. The most commonly reported adverse reactions of EGRIFTA WR™ include: arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia. Reported Earnings • Jul 10
Second quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Second quarter 2025 results: US$0.09 loss per share (down from US$0.02 profit in 2Q 2024). Revenue: US$17.7m (down 20% from 2Q 2024). Net loss: US$4.46m (down US$5.45m from profit in 2Q 2024). Revenue exceeded analyst estimates by 1.9%. Earnings per share (EPS) missed analyst estimates. Revenue is forecast to grow 7.7% p.a. on average during the next 3 years, compared to a 64% growth forecast for the Biotechs industry in Canada. Over the last 3 years on average, earnings per share has increased by 83% per year but the company’s share price has fallen by 28% per year, which means it is significantly lagging earnings. Breakeven Date Change • Jul 09 The 3 analysts covering Theratechnologies previously expected the company to break even in 2025. New consensus forecast suggests the company will make a profit of US$416.5k in 2025. Earnings growth of 42% is required to achieve expected profit on schedule.
Anuncio • Jul 04
Theratechnologies Inc. to Report Q2, 2025 Results on Jul 09, 2025 Theratechnologies Inc. announced that they will report Q2, 2025 results on Jul 09, 2025 Breakeven Date Change • Jul 03
Forecast to breakeven in 2025 The 3 analysts covering Theratechnologies expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$417.2k in 2025. Earnings growth of 49% is required to achieve expected profit on schedule. Anuncio • Apr 18
Theratechnologies Provides Update on Sale Process Theratechnologies Inc. (TSX:TH) (“Theratechnologies” or the “Company”) announced that following careful consideration of the current circumstances, including the publicly announced proposal from Future Pak, LLC, the Board of Directors of the Company (the “Board”) has decided to further evaluate the potential sale of the Company through an open and non-exclusive process. In connection with this determination, the Board has authorized the special committee, consisting of independent and disinterested directors (the “Special Committee”), to oversee the process and make a recommendation to the full Board. To support this process, in addition to Barclays as financial advisor and Fasken as legal advisor, the Special Committee has also engaged Raymond James as independent financial advisor and Norton Rose Fulbright as independent legal advisor. There is no assurance that discussions with Future Pak or any other interested party will result in a transaction. The Company would like to reassure its clients, employees and partners that while these discussions may be ongoing, operations continue in the normal course. The Company does not intend to provide further updates or comments with respect to the foregoing, other than as required pursuant to applicable securities laws. Price Target Changed • Apr 14
Price target decreased by 20% to CA$6.41 Down from CA$8.00, the current price target is an average from 2 analysts. New target price is 79% above last closing price of CA$3.59. The company is forecast to post earnings per share of US$0.007 next year compared to a net loss per share of US$0.17 last year. Anuncio • Apr 13
Future Pak, Ltd. made a proposal to acquire Theratechnologies Inc. (TSX:TH) for approximately $260 million. Future Pak, Ltd. made a proposal to acquire Theratechnologies Inc. (TSX:TH) for approximately $260 million on April 11, 2025. Future Pak submitted the proposal to acquire all outstanding shares of common stock of Theratechnologies Inc. in a cash consideration of $4.50 per share. The proposal represents a total enterprise value of up to $255 million, comprising: $205 million in cash at closing, and Up to $50 million in contingent value right (CVR) payments, including: 50% of the annual EGRIFTA® franchise gross profit above $30 million annually for three years post-closing. A $10 million one-time milestone payment if cumulative EGRIFTA gross profit exceeds $125 million over the same three-year period. Future Pak confirms that the transaction would not be subject to a financing contingency and has the full support of its strategic financial partner, Colbeck Capital Management. Future Pak has engaged Bourne Partners Securities LLC as financial advisor and Honigman LLP as legal advisor. New Risk • Apr 11
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Canadian stocks, typically moving 18% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$17m free cash flow). Share price has been highly volatile over the past 3 months (18% average weekly change). Negative equity (-US$24m). Minor Risk Market cap is less than US$100m (CA$85.1m market cap, or US$61.2m). Reported Earnings • Apr 09
First quarter 2025 earnings released First quarter 2025 results: Revenue: US$19.0m (up 17% from 1Q 2024). Net income: US$117.0k (up US$4.60m from 1Q 2024). Profit margin: 0.6% (up from net loss in 1Q 2024). Revenue is forecast to grow 6.2% p.a. on average during the next 3 years, compared to a 65% growth forecast for the Biotechs industry in Canada. Over the last 3 years on average, earnings per share has increased by 67% per year but the company’s share price has fallen by 47% per year, which means it is significantly lagging earnings. Anuncio • Apr 09
Theratechnologies Inc. Provides Earnings Guidance for the Year 2025 Theratechnologies Inc. provided earnings guidance for the year 2025. As a result of the supply disruption of EGRIFTA SV® during the first quarter of 2025 resulting in a one-time loss of 6 to 7 weeks of sales ($10 to $12 million), and taking into account the approval of EGRIFTA WR™, the company estimate full year 2025 revenue to be in the range of $80 million to $83 million. Anuncio • Apr 08
Theratechnologies Receives FDA Approval of Prior Approval Supplement (PAS) for Egrifta SV sBLA Theratechnologies Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Prior Approval Supplement (PAS) to the supplemental biologics license application (sBLA) for EGRIFTA SV® (tesamorelin for injection). Tesamorelin for injection is the only treatment approved in the U.S. to reduce excess abdominal fat in adults with HIV and lipodystrophy. Approval of the PAS removes any regulatory requirement for discretionary product release, thereby allowing Theratechnologies to resume regular distribution of EGRIFTA SV. The FDA also recently approved the new F8 formulation of tesamorelin for injection, which is set to replace EGRIFTA SV and will be marketed in the US as EGRIFTA WR. Important Safety Information for EGRIFTA SV/EGRIFTA WR (tesamorelin for injection) Tesamorelin for injection is approved in the U.S. for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Tesamorelin for injection is a growth hormone- releasing factor (GHRF) analog that acts on pituitary cells in the brain to stimulate the production and release of endogenous growth hormone. Limitations of Use: Long-term cardiovascular safety of tesamorelin for injection has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. Tesamorelin for injection is not indicated for weight loss management as it has a weight- neutral effect. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking tesamorelin for injection. Contraindications: Do not use tesamorelin for injection if a patient: Has disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma. Has active cancer. Is allergic to tesamorelin or any of the ingredients in tesamorelin for injection. Is pregnant or planning to become pregnant. The most commonly reported adverse reactions of tesamorelin for injection include: arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia. Anuncio • Apr 04
Theratechnologies Inc. to Report Q1, 2025 Results on Apr 09, 2025 Theratechnologies Inc. announced that they will report Q1, 2025 results at 8:30 AM, US Eastern Standard Time on Apr 09, 2025 Anuncio • Mar 26
Theratechnologies Inc. Receives FDA Approval for EGRIFTA WR (Tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy Theratechnologies Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection. The Company will commercialize the new formulation under the tradename EGRIFTA WR™. Tesamorelin for injection is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. The new formulation, EGRIFTA WR™, is a daily injectable but only needs weekly reconstitution. It requires less than half the administration volume as the current F4 formulation, sold in the U.S. as EGRIFTA SV®, which is reconstituted daily. Pharmacokinetic studies have shown bioequivalence of EGRIFTA WR™ to the original F1 formulation of tesamorelin for injection (previously sold under the trade name EGRIFTA®). The most commonly reported adverse reactions of EGRIFTA WR™ include arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia. EGRIFTA WR™ will be supplied as four single-patient-use vials, each containing 11.6 mg of tesamorelin, sufficient for seven doses. The daily dose is 1.28 mg (0.16 mL of the reconstituted solution) injected subcutaneously. The product can be stored at room temperature (20° to 25° C [68° to 77° F]) before and after reconstitution. EGRIFTA WR™ will be manufactured at a new, U.S.-based contract drug manufacturing organization (CDMO). The new formulation, which is patent protected in the U.S. until 2033, is set to replace EGRIFTA SV®. Anuncio • Mar 12
Theratechnologies Inc. Presents Encouraging Virologic Suppression Data from the PROMISE-US Trial of Ibalizumab at CROI Theratechnologies Inc. presented data from a real-world, observational, registry study demonstrating the efficacy and safety of ibalizumab in reducing HIV RNA to undetectable levels in heavily treatment-experienced (HTE) patients with multidrug resistant HIV. In a poster session at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, Calif., investigators from the Prospective Observational Study of Multidrug-Resistant Patient Outcomes with and without Ibalizumab in a Real-World Setting: United States (PROMISE-US) reported that patients treated with regimens containing ibalizumab achieved undetectable HIV viral load levels at similar rates as those receiving non-ibalizumab-containing regimens, despite displaying characteristics indicative of more severe HIV disease at baseline. Theratechnologies previously announced the study design and baseline characteristics of participants in PROMISE-US (ClinicalTrials.gov identifier: NCT05388474), a phase 4, multicenter, retrospective and prospective, observational, non-interventional registry study. The trial is designed to assess risk factors and predictors of virologic and immunologic response in HTE people with HIV (PWH) and specific sub-populations. Three-quarters (74%) of participants in Cohort 1 who had baseline viremia had more than 200 CD4 T-cells/mm3 at baseline, compared to only 44% of those in Cohort 2 who were viremic at baseline (p=0.0376). Among those with baseline viremia, 50% of Cohort 1 participants and 47% in Cohort 2 achieved undetectable viral load (50 RNA copies/mL) after six months of treatment (p=0.873). At 12 months, viral load was undetectable in 53% of Cohort 1 participants, and in 42% of those in Cohort2 (p=0.0.524). Ibalizumab was well-tolerated with no infusion reactions reported and no discontinuation of treatment by participants in Cohort 2 due to a treatment emergent adverse event. Anuncio • Mar 11
Theratechnologies Inc., Annual General Meeting, May 07, 2025 Theratechnologies Inc., Annual General Meeting, May 07, 2025. Board Change • Mar 03
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 11 experienced directors. 1 highly experienced director. Independent Chairman Frank Holler was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Anuncio • Mar 01
Theratechnologies Inc. Announces Impairment Charges for the Fourth Quarter Ended November 30, 2024 Theratechnologies Inc. announced impairment charges for the fourth quarter ended November 30, 2024. For the period, the company reported impairment loss on intangible assets of USD 3,488,000. Anuncio • Jan 10
Theratechnologies Provides Update on EGRIFTA SV® Supply Theratechnologies Inc. announced that a shortage of EGRIFTA SV® (tesamorelin for injection) will occur at the patient level in mid-January 2025, following a voluntary shutdown of the contract manufacturing facility in 2024. While the Company is aware of remaining inventory of EGRIFTA SV® in certain pharmacies throughout the United States, several pharmacies have reported stockouts. Theratechnologies filed a required Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) on December 18, 2024. The Company subsequently submitted questions as part of a Type D meeting request concerning the status of two recently manufactured batches of EGRIFTA SV®, which are waiting to be released to pharmacies. The FDA confirmed that it would respond to the Company’s questions in writing no later than February 8, 2025. The Company will update the market on any further material developments. EGRIFTA SV® is distributed in the United States only. Anuncio • Dec 11
Theratechnologies Inc. Receives March 2025 PDUFA Goal Date for Updated Tesamorelin F8 Formulation sBLA Theratechnologies Inc. announced that the United States Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2025 to the Company's recently submitted supplemental Biologics License Application for the F8 formulation of tesamorelin. If approved by the FDA, the F8 formulation is intended to replace the F4 formulation, which is sold in the U.S. under the trade name EGRIFTA SV®?. The new formulation is patent protected in the U.S. until 2033. Anuncio • Dec 10
Theratechnologies Announces Preliminary Tolerability and Efficacy Data from Phase 1B, Dose-Ranging Trial of Sudocetaxel Zendusortide in Patients with Advanced Ovarian Cancer Theratechnologies Inc. announced data from Part 3 (dose optimization, weekly dosing schedule) of its ongoing Phase 1b trial of sudocetaxel zendusortide (TH1902) – the company’s lead investigational peptide drug conjugate in patients with advanced ovarian cancer. Based on results demonstrating favorable tolerability and signals of efficacy, the Medical Review Committee, which includes study investigators and external experts, has unanimously recommended continued evaluation and exploration of higher doses. A total of 13 patients with advanced ovarian cancer who progressed despite prior platinum-based and taxane chemotherapy were enrolled in two Arms in Part 3 of the Phase 1b trial. Seven patients were enrolled in Arm A and received a 1.75-mg/kg/week dose of sudocetaxel zendusortide on a weekly infusion, three-weeks-on/one-week-off schedule every 28 days. The six patients enrolled in Arm B received a 2.5-mg/kg/week dose on the same schedule. Investigators observed no dose-limiting toxicities in either arm. Although there were no responses observed in the five Arm A participants that comprised the per-protocol set, there was encouraging evidence of activity observed in three of the six patients enrolled in the Arm B PP set, including one patient with a complete resolution of a liver lesion. Those three Arm B patients also experienced significant reductions in the CA-125 ovarian tumor marker as well as significant tumor shrinkage, including two patients with more than a 25% reduction in tumor size. Additionally, Arm B participants in the PP set received a mean of 10.25 weeks of treatment compared to a mean of 7.6 weeks of treatment in patients treated on Arm A. All patients in Arm B received at least two cycles of treatment, with some completing up to four cycles (on-treatment range: 4-18 weeks). The Company received permission from the U.S. Food and Drug Administration in 2023 to amend the initial Phase 1b clinical trial protocol based on results from Parts 1 and 2, which utilized every-3-week dosing. For Part 3, the protocol was amended to explore dosing weekly for three weeks, followed by a one-week break and shifted the focus to patients with ovarian cancer. At the 2024 American Society of Clinical Oncology annual meeting earlier this year, Theratechnologies presented an updated analysis from Parts 1 and 2 of the study, in which sudocetaxel zendusortide induced durable disease stabilization (up to 45 weeks) lasting beyond treatment completion in several patients with a variety of solid tumors. The ASCO presentation also highlighted early signals of efficacy observed in female cancers (ovarian cancer, endometrial cancer, triple-negative breast cancer [TNBC]), as well as a manageable safety profile when sudocetaxel zendusortide was dosed at 300mg/m2 given once every 3 weeks with few Grade 3 adverse events. In addition to the Phase 1b clinical trial results, there is also an extensive body of preclinical data demonstrating the flexibility of the Company’s SORT1+ Technology platform when conjugated with different toxic payloads. With a significant portion of the clinical trial data to date now available, Theratechnologies will accelerate its search for a partner to advance its oncology program. Anuncio • Dec 04
Theratechnologies Inc. Announces Resume Production of EGRIFTA SV Theratechnologies Inc. announced that the production of EGRIFTA SV has resumed following a voluntary shutdown of the Company's contract manufacturer's facility to address observations from an inspection by the US Food and Drug Administration (FDA). One newly manufactured batch of EGRIFTA SV has completed standard quality control and will be available for release to the market upon approval from the FDA of a Prior Approval Supplement, which the Company is expected to file around mid-December 2024. The manufacturing of two additional batches of EGRIFTA SV is currently underway. The Company implemented measures to carefully manage existing inventory levels of EGRIFTA SV to meet patient demand until mid-January 2025. Theratechnologies continues to collaborate closely with the relevant divisions of the FDA and other key stakeholders to avoid a shortage at the patient level in 2025. The Company will update the market on any further material developments. Breakeven Date Change • Nov 30
Forecast breakeven date pushed back to 2025 The 4 analysts covering Theratechnologies previously expected the company to break even in 2024. New consensus forecast suggests the company will make a profit of US$9.28m in 2025. Average annual earnings growth of 55% is required to achieve expected profit on schedule. Anuncio • Nov 26
Theratechnologies Submits Updated Tesamorelin F8 Formulation sBLA for FDA Review Theratechnologies Inc. announced the resubmission of its supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the F8 formulation of tesamorelin, the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. Theratechnologies has filed the resubmission to address concerns raised in the FDA’s Complete Response Letter (CRL) to the initial F8 formulation sBLA filing. In the CRL, which was issued in January 2024, the FDA requested clarifications largely related to chemistry, manufacturing and controls (CMC), as well as further information on immunogenicity risk. The FDA will review the updated sBLA within four months of submission. Theratechnologies therefore expects a decision around the end of March 2025. The new formulation is patent protected in the U.S. until 2033. Anuncio • Oct 18
Theratechnologies Presents Data on Tesamorelin's Role in Reducing Cardiovascular Risk in People with Hiv At Idweek 2024 Theratechnologies Inc. announced data from two poster presentations, focusing on the association between excess visceral abdominal fat (EVAF) and cardiovascular disease (CVD) risk in people with HIV (PWH), and on the use of tesamorelin to reduce such risk. In a poster presentation at IDWeek 2024 in Los Angeles, Calif., investigators from the Visceral Adiposity Measurement and Observations Study (VAMOS) reported that EVAF is one of several risk factors that contribute to heightened CVD risk in PWH who are on modern anti-retroviral therapy (ART) regimens. In a separate poster presentation, researchers demonstrated that the EVAF-lowering properties of tesamorelin, a growth hormone-releasing factor (GHRF), enable a reduction in CVD risk in PWH. VAMOS, a cross-sectional, multicenter observational study, is the first trial designed to improve the understanding of the impact of EVAF on CVD, steatotic liver disease, insulin resistance, and other metabolic parameters in PWH who are on modern ART regimens. The investigators examined the impact of EVAF (defined as visceral fat surface area =130 cm2 by CT scan) on traditional CVD risk factors and overall cardiovascular (CV) risk in 170 participants with HIV. The prevalence of EVAF in the study was 58%, and the mean visceral fat area was 148 cm2. Among participants with EVAF, values for the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR; p=0.0001) and triglyceride:high-density lipoprotein (TG:HDL) ratios (p=0.0013) were higher than in those without EVAF. Investigators noted a positive correlation between EVAF and HOMA-IR (?=0.43, p=0.0001) and TG:HDL ratios (?=0.33, p=0.0001). Importantly, greater EVAF was associated with a higher 10-year atherosclerotic cardiovascular disease (ASCVD) risk (p=0.0001). The investigators also found that increasing visceral fat surface area was inversely associated with growth hormone (GH) levels (?=-0.17, p=0.03), and that participants with EVAF had lower GH levels overall (p=0.05). Researchers examined data from two phase 3 randomized studies to assess the impact of tesamorelin-induced reduction of EVAF on CVD outcomes in 543 PWH. They calculated 10-year ASCVD risk scores for participants at baseline and at 26 weeks of tesamorelin treatment. The percentages of participants on lipid-lowering therapies, antihypertensive treatment, or diabetes medications were 44%, 37%, and 18%, respectively. Although most participants had low CVD risk at baseline, 44% had borderline to high CVD risk. Participants on tesamorelin tended toward a modest reduction in 10-year ASCVD risk scores, with an estimated change of -0.4% (95% confidence interval [CI] -0.89%, 0.05%). The reduction in CVD risk was relatively larger among subjects with higher CVD risk at baseline (p=0.038 for the overall trend among all participants). These reductions in ASCVD risk scores were driven primarily by reductions in total cholesterol, independent of lipid-lowering therapies. IDWeek 2024, taking place October 16-19, is the joint annual meeting of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, the Pediatric Infectious Diseases Society and the Society of Infectious Diseases Pharmacists. Anuncio • Oct 11
Theratechnologies Inc. Revises Earnings Guidance for the Fiscal Year 2024 Theratechnologies Inc. revised earnings guidance for the fiscal year 2024. For the year, the company expects revenue guidance range is revised to between $83 and $85 million from $87 to $90 million. The revised revenue guidance takes into consideration the revenue shortfall due to the potential supply constraint of EGRIFTA SV® in late November and the year-to-date trend of Trogarzo sales. Reported Earnings • Oct 10
Third quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2024 results: EPS: US$0.06 (up from US$0.031 loss in 3Q 2023). Revenue: US$22.6m (up 8.4% from 3Q 2023). Net income: US$3.09m (up US$3.84m from 3Q 2023). Profit margin: 14% (up from net loss in 3Q 2023). Revenue missed analyst estimates by 5.2%. Earnings per share (EPS) exceeded analyst estimates by 102%. Revenue is forecast to grow 9.9% p.a. on average during the next 3 years, compared to a 61% growth forecast for the Biotechs industry in Canada. Over the last 3 years on average, earnings per share has increased by 39% per year but the company’s share price has fallen by 53% per year, which means it is significantly lagging earnings. Breakeven Date Change • Sep 18
Forecast breakeven date pushed back to 2025 The 4 analysts covering Theratechnologies previously expected the company to break even in 2024. New consensus forecast suggests losses will reduce by 92% to 2024. The company is expected to make a profit of US$7.31m in 2025. Average annual earnings growth of 67% is required to achieve expected profit on schedule. Reported Earnings • Jul 11
Second quarter 2024 earnings: EPS and revenues exceed analyst expectations Second quarter 2024 results: EPS: US$0.02 (up from US$0.41 loss in 2Q 2023). Revenue: US$22.0m (up 26% from 2Q 2023). Net income: US$987.0k (up US$11.0m from 2Q 2023). Profit margin: 4.5% (up from net loss in 2Q 2023). Revenue exceeded analyst estimates by 1.5%. Earnings per share (EPS) also surpassed analyst estimates. Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 81% growth forecast for the Biotechs industry in Canada. Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings. Anuncio • Jul 10
Theratechnologies Inc. Provides Earnings Guidance for the Year 2024 Theratechnologies Inc. provided earnings guidance for the year 2024. For the year, the company expects revenue to be in the range of $87 million to $90 million, or growth of the commercial portfolio in the range of 6.4% to 10.0%, as compared to the 2023 fiscal year results. Board Change • Jul 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 11 experienced directors. 1 highly experienced director. Independent Chairman Frank Holler was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Anuncio • Jun 27
Theratechnologies Inc. to Report Q2, 2024 Results on Jul 10, 2024 Theratechnologies Inc. announced that they will report Q2, 2024 results on Jul 10, 2024 Breakeven Date Change • Jun 02
Forecast to breakeven in 2024 The 4 analysts covering Theratechnologies expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$152.8k in 2024. Earnings growth of 66% is required to achieve expected profit on schedule. Major Estimate Revision • May 21
Consensus EPS estimates upgraded to US$0.085 loss The consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -US$0.154 to -US$0.085 per share. Revenue forecast steady at US$87.9m. Biotechs industry in Canada expected to see average net income decline 13% next year. Consensus price target broadly unchanged at CA$6.04. Share price was steady at CA$1.77 over the past week. Anuncio • May 11
Theratechnologies Inc. Announces Frank Holler as Chair of the Board of Directors Theratechnologies Inc. announced that Frank Holler will now act as Chair of the Board of Directors of the Company. Major Estimate Revision • Apr 17
Consensus estimates of losses per share improve by 70% The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from US$86.6m to US$87.6m. EPS estimate increased from -US$0.382 per share to -US$0.115 per share. Biotechs industry in Canada expected to see average net income decline 25% next year. Consensus price target of CA$8.00 unchanged from last update. Share price fell 10% to CA$1.80 over the past week. Reported Earnings • Apr 11
First quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2024 results: US$0.10 loss per share (improved from US$0.43 loss in 1Q 2023). Revenue: US$16.2m (down 18% from 1Q 2023). Net loss: US$4.48m (loss narrowed 57% from 1Q 2023). Revenue missed analyst estimates by 16%. Earnings per share (EPS) exceeded analyst estimates by 28%. Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 69% growth forecast for the Biotechs industry in Canada. Over the last 3 years on average, earnings per share has increased by 6% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings. Anuncio • Apr 10
Theratechnologies Inc. Provides Earnings Guidance for the Fiscal Year 2024 Theratechnologies Inc. provided earnings guidance for the fiscal year 2024. For the year, the company expects revenue guidance range is confirmed between $87 million and $90 million as compared to the 2023 fiscal year results. Anuncio • Apr 10
Theratechnologies Inc. Preclinical Data Presentation At AACR 2024 Highlights Versatility and Flexibility of SORT1+ Technology™ Oncology Platform Theratechnologies Inc. presented preclinical data that highlight the versatility and flexibility of the Company's SORT1+ Technology™? platform. In a poster session at the 2024 annual meeting of the American Association for Cancer Research (AACR) in San Diego, Calif., researchers reported that Theratechnologies' investigational camptothecin-peptide conjugates are well tolerated and associated with significant tumor regression in colorectal cancer (CRC) and triple-negative breast cancer (TNBC) xenograft models. The study also demonstrated synergistic anti-tumor efficacy and good tolerability with the combination of two peptide drug conjugates with different payloads. A copy of the AACR poster, as well as a second poster presented at the conference, which reinforces existing data for the Company's lead investigational PDC sudocetaxel zendusortide (TH1902) in activating anti-PD-L1 immunotherapy tumor cell-killing in SORT+1 cancers, can be found at the Theratechnologies website. Sudocetaxel zendusortside is a first-of-its-kind sortilin receptor (SORT1)-targeting PDC, and the first compound to emerge from the Company's broader licensed oncology platform. A new chemical entity, sudocetaxel z endusortide employs a cleavable linker to conjugate (attach) a proprietary peptide to docetaxel, a well-established cytotoxic chemotherapeutic agent used to treat many cancers. The FDA granted Fast Track designation to sudocetaxel z Endusortide as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. Sudocetaxel Zendusortide is currently being evaluated in a Phase 1 clinical trial. Theratechnologies has established the SORT1+ TechnologyTM platform as an engine for the development of PDCs that target SORT1, which is expressed in multiple tumor types. These assumptions include, without limitation, that the Company's Phase 1 clinical trial using sudocetaxel zENDusortide will be successful, that signs of efficacy will be observed in such Phase 1 clinical trial and no toward side effects will be reported, and that the findings observed from the preclinical work conducted on new PDCs will be replicated into human subjects. These risks and uncertainties include, but are not limited to, the lack of observation of strong efficacy results from the Phase 1 clinical trial. Therateschnologies has established the Sort1+ TechnologyTM platform as a engine for the development of P DCs that target SORT1. Anuncio • Apr 06
Theratechnologies Inc. Appoints Elina Tea to its Board of Directors and as Member of the Company's Audit Committee Theratechnologies Inc. announced the appointment of Elina Tea, Chief Financial Officer at GLS North America, to its Board of Directors and as a member of the Company’s Audit Committee. Ms. Tea will be Investissement Québec’s designee pursuant to its investor rights agreement with the company. In her current role as Chief Financial Officer at GLS North America, Elina Tea oversees all operational and strategic matters with the finance, M&A, legal, and human resources departments of the GLS Canada and GLS US businesses. She previously served as Chief Financial Officer at Vosker Corp. and Vice-President, Corporate Development at Cogeco Communications, and has amassed considerable financial and business development experience at a range of companies including SNC-Lavalin (Office of the President), Desjardins Group, RBC Capital Markets, and Ernst & Young Corporate Finance. She holds a Bachelor of Commerce degree, with a double concentration in Accounting and Finance from McGill University and is a Chartered Financial Analyst. With the appointment of Elina Tea, the Company’s Audit Committee will now comprise four independent members including the recently appointed Jordan Zwick, Gerald Lacoste, and Frank Holler as Chair. Anuncio • Apr 04
Theratechnologies Inc. to Report Q1, 2024 Results on Apr 10, 2024 Theratechnologies Inc. announced that they will report Q1, 2024 results on Apr 10, 2024 Anuncio • Mar 09
Theratechnologies Inc., Annual General Meeting, May 09, 2024 Theratechnologies Inc., Annual General Meeting, May 09, 2024. Major Estimate Revision • Feb 28
Consensus EPS estimates fall by 12% The consensus outlook for earnings per share (EPS) in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$92.6m to US$87.8m. Losses expected to increase from US$0.35 per share to US$0.39. Biotechs industry in Canada expected to see average net income decline 19% next year. Consensus price target up from CA$2.00 to CA$8.00. Share price fell 8.7% to CA$2.09 over the past week. Price Target Changed • Feb 23
Price target increased by 300% to CA$8.00 Up from CA$2.00, the current price target is provided by 1 analyst. New target price is 264% above last closing price of CA$2.20. Stock is down 61% over the past year. The company is forecast to post a net loss per share of US$0.39 next year compared to a net loss per share of US$0.91 last year. Reported Earnings • Feb 22
Full year 2023 earnings: EPS and revenues miss analyst expectations Full year 2023 results: US$0.91 loss per share (improved from US$1.98 loss in FY 2022). Revenue: US$81.8m (up 2.1% from FY 2022). Net loss: US$24.0m (loss narrowed 49% from FY 2022). Revenue missed analyst estimates by 1.8%. Earnings per share (EPS) also missed analyst estimates by 2.1%. Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 59% growth forecast for the Biotechs industry in Canada. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has fallen by 48% per year, which means it is performing significantly worse than earnings. Anuncio • Feb 16
Theratechnologies Completes Enrollment of First Six Patients in Updated Phase 1 Clinical Trial of Sudocetaxel Zendusortide in Advanced Ovarian Cancer Theratechnologies Inc. announced completion of enrollment of the first six participants in Part 3 of its Phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer. Sudocetaxel zendusortide, also known as TH1902, is an investigational, first-in-class peptide-drug conjugate (PDC) that targets the sortilin receptor (SORT1) and aims to expedite the internalization and delivery of the cytotoxic payload (docetaxel) directly into cancer cells. Theratechnologies announced dosing of the first patient in Part 3 of the Phase 1 trial in October 2023. In June 2023, the U.S. Food and Drug Administration (FDA) accepted the Company’s amended protocol for the Phase 1 trial, which is designed to optimize the dosing, improve the therapeutic window and extend the duration of therapy of sudocetaxel zendusortide. The amendment, which the Company submitted in May 2023, also narrows the patient population to focus on individuals with high-grade serous ovarian cancer, including high-grade peritoneal or fallopian tube cancer, or high-grade endometrioid cancer -- a population in which sudocetaxel zendusortide has demonstrated preliminary efficacy. After establishing the safety of the initial dose in the first six patients for a period of three months, the enrollment of the next cohort of six patients at a higher dose will be initiated. Sudocetaxel zendusortide is a first-of-its-kind sortilin receptor (SORT1)-targeting PDC, and the first compound to emerge from the Company’s broader licensed oncology platform. A new chemical entity, sudocetaxel zendusortide employs a cleavable linker to conjugate (attach) a proprietary peptide to docetaxel, a well-established cytotoxic chemotherapeutic agent used to treat many cancers. The FDA granted Fast Track designation to sudocetaxel zendusortide as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. Sudocetaxel zendusortide is currently being evaluated in a Phase 1 clinical trial. Theratechnologies has established the SORT1+ Technology™ platform as an engine for the development of PDCs that target SORT1, which is expressed in multiple tumor types. SORT1 is a “scavenger” receptor that plays a significant role in protein internalization, sorting, and trafficking. Expression of SORT1 is associated with aggressive disease, poor prognosis, and decreased survival. It is estimated that SORT1 is expressed in 40% to 90% of endometrial, ovarian, colorectal, triple-negative breast (TNBC), and pancreatic cancers, making this receptor an attractive target for anticancer drug development. Anuncio • Feb 07
Theratechnologies Inc. to Report Q4, 2023 Results on Feb 21, 2024 Theratechnologies Inc. announced that they will report Q4, 2023 results Pre-Market on Feb 21, 2024 Anuncio • Dec 13
Theratechnologies Inc. Announces FDA Approval of Trogarzo® 90-Second Intravenous (IV) Push Loading Dose Theratechnologies Inc. announced that the United States Food and Drug Administration (FDA) has approved the company’s Labelling Prior Approval Supplement to include a 2,000-mg intravenous (IV) push loading dose for Trogarzo® (ibalizumab-uiyk). IV push is a method by which the undiluted medication is “pushed” by syringe for faster administration into the body’s circulation and is designed to make Trogarzo® administration easier and more convenient for people with HIV and their health care providers. As a result, more clinics will be able to initiate new patients and provide ongoing treatment. In the U.S., Trogarzo®, in combination with other antiretrovirals (ARVs), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant virus failing their current ARV regimen. The label update follows FDA approval of the IV push maintenance dose in October 2022. With the new label, Trogarzo® administration can now take only 90 seconds for the loading dose, as opposed to a 30-minute infusion, and 30 seconds for a maintenance dose every two weeks. Theratechnologies is currently finalizing its application to the FDA for an intramuscular (IM) method of administration of the Trogarzo® maintenance dose. Anuncio • Nov 29
Soleus Capital Management Engages in Discussions with Theratechnologies On November 28, 2023, Soleus Capital Management, L.P. announced that it has engaged, and intends to continue to engage, in communications with Theratechnologies Inc.’s Board of Directors and management team regarding Soleus Capital Management’s investment in the Company and opportunities to enhance stockholder value, including the potential appointment to the Board of a candidate designated by Soleus Capital Management and the engagement of an investment bank to help the Company explore strategic transactions that may involve the sale by the Company of some or all of its assets and/or a change of control of the Company. Anuncio • Nov 01
Theratechnologies Inc. announced that it has received $12.5 million in funding from Investissement Québec On October 31, 2023, Theratechnologies Inc., closed the transaction. The company has raised $12,500,000 in the transaction. Anuncio • Oct 28
Theratechnologies Inc. has completed a Follow-on Equity Offering in the amount of $12.5 million. Theratechnologies Inc. has completed a Follow-on Equity Offering in the amount of $12.5 million.
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 12,500,000
Price\Range: $1
Discount Per Security: $0.08 New Risk • Oct 27
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 93% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (25% average weekly change). Negative equity (-US$42m). Earnings are forecast to decline by an average of 8.7% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (93% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$34m net loss in 3 years). Market cap is less than US$100m (CA$58.3m market cap, or US$42.0m). Anuncio • Oct 27
Theratechnologies Inc. announced that it expects to receive $12.5 million in funding from Investissement Québec Theratechnologies Inc. announced that it has entered into a subscription agreement with new investor Investissement Québec to issue 9,118,184 Common Shares and 3,381,816 fully-funded, non-voting subscription receipts, exchangeable into Common Shares on a one-for-one basis for the gross proceeds of $12,500,000 on October 25, 2023. The consummation of the Concurrent Private Placement will be contingent upon the closing of the Public Offering. Completion of the Concurrent Private Placement will be subject to customary closing conditions of Common Shares underlying the Exchangeable Subscription Receipts on the Toronto Stock Exchange and the submission of notice to the Nasdaq Global Market. Investissement Québec will beneficially own approximately 19.9% (25.4% if the Exchangeable Subscription Receipts were to be exchanged into Common Shares) of the issued and outstanding Common Shares as of the date of closing. If the Option is exercised in full, Investissement Québec will beneficially own approximately 19.1% of the issued and outstanding Common Shares as of the date of closing. Anuncio • Oct 20
Theratechnologies Inc. Ibalizumab Demonstrates Cost-Effectiveness as an Addition to Routine Clinical Care in Heavily Treatment-Experienced People with HIV Theratechnologies Inc. shared data demonstrating the cost-effectiveness of ibalizumab, a monoclonal antibody antiretroviral therapy (ART) commercialized in the U.S. under the trade name Trogarzo®?, as an addition to optimized background regimens (OBR) in heavily treatment-experienced (HTE) people with HIV. The analysis, which was presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 conference in Orlando, Fla., suggests that adding ibalizumab to routine clinical care may provide payers with a cost-effective treatment option that can substantially improve outcomes for HTE individuals with HIV. Researchers employed a Markov model to estimate the cost per quality-adjusted life-year (QALY) gained following the addition of ibalizumab to OBR from a U.S. payer perspective. They derived estimates of comparative mortality rate (SMR)-weighting comparison of data from two ibalizumab clinical trials to those from a real-world, non-ibalizumab control group in the Observational Pharmaco-Epidemiology Research & Analysis (OPERA®?) database. Developed by epidemiologists at Epividian®?, OPERA®? is a large electronic health record (EHR) database containing patient-level data for about 14% of the total U.S.IV population. The analysis encompassed numerous costs, including those for treatment acquisition and administration, monitoring, adverse events, opportunistic infections, and terminal care. mortality assumptions and health-state utility values were based on disease-specific published literature and clinical trial data. Over a lifetime horizon, the addition of ibalizUMab to OBR increased the time patients' HIV remained undetectable (less than 50 copies/ml) or suppressed (between 50 and 200 copies/ml). The addition of ibalizum AB also extended patients' QALYs compared to OBR alone. Researchers calculated a base-case incremental cost-effectiveness ratio (ICER) of $169,103 for ibalizumab versus OBR, a ratio that fell within an acceptable cost-effectiveness range for the population size. Deterministic and probabilistic scenario analyses indicated that the result was robust to changes to structural or parameter uncertainty. In the United States, Trogarzo, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen. Trogarzo®? is not approved in Canada. Trogarzo®? are administered by intravenous infusion as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every two weeks after dilution in 250 mL of 0.9% Sodium Chloride Injection, USP. In October 2022, the Trogarzo®? maintenance dose was approved by the FDA to also be administered as an undiluted IV push over 30 seconds. Anuncio • Oct 13
Theratechnologies Announces Dosing of First Patient in Updated Clinical Trial of Sudocetaxel Zendusortide in Advanced Ovarian Cancer Theratechnologies Inc. announced dosing of the first participant in Part 3 of its Phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer. Sudocetaxel zendusortide is an investigational, first-in-class peptide-drug conjugate (PDC) that targets the sortilin (SORT1) receptor and expedites the internalization and delivery of a cytotoxic payload directly into cancer cells. The announcement follows U.S. Food and Drug Administration (FDA) acceptance on June 2, 2023 of the Company’s amended protocol for the Phase 1 trial. The revised protocol is designed to improve the therapeutic window of sudocetaxel zendusortide and extend its duration of therapy. It includes weekly administration and also narrows the patient population to focus on individuals with high-grade serous ovarian cancer, including high-grade peritoneal or fallopian tube cancer, or high-grade endometrioid cancer - a population in which sudocetaxel zendusortide has demonstrated preliminary efficacy. After establishing the safety of the initial dose in the first six patients, the study aims to enroll a total of 16 patients in Part 3. Enrollment of the first patient in Part 3 of the trial follows closely upon demonstration of antitumor activity in Parts 1 and 2, as presented at the 2023 annual meeting of the American Society of Clinical Oncology. Sudocetaxel zendusortide is a first-of-its-kind sortilin- (SORT1) targeting PDC, and the first compound to emerge from the SORT1+ TechnologyTM platform. A new chemical entity, sudocetaxel zendusortide employs a cleavable linker to conjugate (attach) a proprietary peptide to docetaxel, a well-established cytotoxic chemotherapeutic agent used to treat many cancers. The FDA granted Fast Track designation to sudocetaxel zendusortide as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. Sudocetaxel zendusortide is currently being evaluated in a Phase 1 clinical trial. Theratechnologies has established its SORT1+ TechnologyTM platform as an engine for the development of proprietary PDCs that target SORT1 receptor, which is expressed in multiple tumor types. SORT1 is a “scavenger” receptor that plays a significant role in protein internalization, sorting, and trafficking. Expression of SORT1 is associated with aggressive disease, poor prognosis, and decreased survival. It is estimated that SORT1 is expressed in 40% to 90% of endometrial, ovarian, colorectal, triple-negative breast (TNBC), and pancreatic cancers, making this receptor an attractive target for anticancer drug development. Anuncio • Oct 06
Theratechnologies Inc. Receives January 2024 PDUFA Goal Date for Tesamorelin F8 Formulation sBLA Theratechnologies Inc. announced that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 22, 2024 to the Company's supplemental Biologics License Application (sBLA) of the F8 formulation of tesamorelin. Tesamorelin is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. Once approved, the F8 formulation is set to replace the current F4 formulation, which is sold in the U.S. under the trade name EGRIFTA SV. The proposed proprietary name for the F8 formulation of tESamorelin, EGRIFTA MDV, is already under review by the FDA. In accordance with the FDA's standard review practices, unless the Company is notified before November 21, 2023, that the application is not sufficiently complete to permit a substantive review, the FDA will file the sBLA for the F8 formulation of Tesamorelin. EGRIFTA SV is approved in the U.S., for the reduction of excess abdominal Fat in HIV-infected adult patients with lipodystrophy. EGRIFTA SV is a growth hormone releasing factor (GHRF) analog that acts on pituitary cells in the brain to stimulate the production and release of endogenous growth hormone. Limitations of Use: Long-term cardiovascular safety of EGRIFTA SV has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. EGRIFTA SV is not indicated for weight loss management as it has a weight neutral effect. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA SV. Do not use EGRIFTA SV if a patient: Has a pituitary gland tumor, has had pituitary gland surgery, has other problems related to their pituitary gland, or has had radiation treatment to their head or head trauma. Has active cancer. Is allergic to tesamorelin or any of the ingredients in EGRIFTA SV. Is pregnant or planning to become pregnant. The most commonly reported adverse reactions of EGRIFTA SV include: hypersensitivity reactions, hyperglycemia, injection site reactions, arthralgia, pain in extremity, myalgia and peripheral edema. Anuncio • Sep 26
Theratechnologies Submits Tesamorelin F8 Formulation Sbla for Fda Review Theratechnologies Inc. announced that the Company has filed a supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin to the U.S. Food and Drug Administration (FDA) for review. Tesamorelin is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. Pharmacokinetic studies have shown bioequivalence of the F8 formulation to the original F1 formulation of tesamoreline (pre previously sold under the trade name EGRIFTA®). The F8 formulation is eight times more concentrated than EGRIFTA® and two times more concentrated than the F4 formulation sold in the U.S. under the trade name EGRifTA SV®, enabling a smaller volume of administration as well as a new product presentation in a multiple-dose vial (MDV) that is reconstituted only once per week. The new formulation is patent protected in the U.S. until 2033. In accordance with the FDA's filing review period, Theratechnologies expects to receive an acknowledgment letter of the sBLA application within 30 days along with a Prescription Drug User Fee Act (PDUFA) goal date. The proposed proprietary name for the F8 formulation, EGRIFTA MDVTM, is already under review by the FDA. Anuncio • Sep 19
Theratechnologies Inc. to Report Q3, 2023 Results on Sep 26, 2023 Theratechnologies Inc. announced that they will report Q3, 2023 results on Sep 26, 2023 Anuncio • Aug 31
Theratechnologies Inc. Announces All U.S. Oncology Clinical Sites Now Enrolling for Phase 1 Trial of Sudocetaxel Zendusortide Theratechnologies Inc. announced that all five of the U.S.-based clinical sites participating in the conduct of the Phase 1 clinical trial of the Company's lead investigational peptide drug conjugate, sudocetaxel zendusortide, are now activated to screen, enroll and dose advanced ovarian cancer patients. A sixth site based in Canada is finalizing its start-up activity. Sudocetaxel zendusortide is currently Theratechnologies’ lead investigational peptide drug conjugate candidate for the treatment of cancer derived from its SORT1+ Technology™. It is the Company’s proprietary peptide linked to docetaxel – a commonly used cytotoxic agent used to treat many cancers. The FDA granted fast track designation to sudocetaxel zendusortide as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. Sudocetaxel zendusortide is currently being evaluated in a phase 1 clinical trial. Theratechnologies is currently developing a platform of proprietary peptides called SORT1+ Technology™ for cancer drug development targeting SORT1 receptors. The SORT1 receptor plays a significant role in protein internalization, sorting and trafficking. It is highly expressed in cancer cells compared to healthy tissue, which makes SORT1 an attractive target for cancer drug development. Expression of SORT1 is associated with aggressive disease, poor prognosis and decreased survival. It is estimated that the SORT1 receptor is expressed in 40% to 90% of cases of endometrial, ovarian, colorectal, triple-negative breast and pancreatic cancers. Anuncio • Aug 01
Theratechnologies Completes 1-For-4 Reverse Stock Split to Regain Compliance with Nasdaq Listing Requirements Theratechnologies Inc. (“Theratechnologies”, the “Company”, or “we”) announced that it has completed the previously announced consolidation of the issued and outstanding common shares of the Company’s share capital on the basis of one (1) post- consolidation share for each four (4) pre-consolidation shares issued and outstanding (the “Consolidation”). The Consolidation received the applicable regulatory approvals, including from the Toronto Stock Exchange (the “TSX”) and the Nasdaq Stock Market (“NASDAQ”). No shareholder approval was required for the Consolidation to come into effect. The Company’s common shares began trading on the TSX and the NASDAQ on a consolidated basis on July 31, 2023. Issued and outstanding common shares were consolidated on the basis of 1 post-consolidation share for each 4 pre-consolidation shares issued and outstanding, to regain compliance with NASDAQ listing requirements. Anuncio • Jul 23
Theratechnologies Inc. Announces Resignation of Gary Littlejohn as Board of Directors and Member of Its Audit Committee Theratechnologies Inc. announced that Mr. Gary Littlejohn has resigned from the board of directors of the company and as a member of its audit committee, effective immediately.