Summary of Jaguar Health FY Conference Call Company Overview - **Company Name**: Jaguar Health (NasdaqCM: JAGX) - **Subsidiary**: Napo Pharmaceuticals - **Key Product**: Crofelemer (brand name Mytesi), FDA-approved for chronic diarrhea in HIV/AIDS patients and chemotherapy-induced diarrhea in dogs under the brand name Canalevia-CA1 [4][5] Core Points and Arguments - **Product Development**: Jaguar Health focuses on drug development from plants traditionally used in tropical areas, with crofelemer being a first-in-class FDA-approved anti-secretory agent [4][5] - **Exclusivity**: The company holds over 150 patents and has exclusivity due to the FDA's botanical guidance, which prevents generics from entering the market [5] - **Recent Licensing Agreement**: An exclusive license agreement with FuturePak could be worth up to $38 million, including an upfront payment of $16 million and potential milestone payments [6] - **Sales Strategy**: Jaguar has transitioned its commercial responsibilities for Mytesi and Canalevia to FuturePak, allowing it to focus on its pipeline, particularly in rare diseases [11][12] Pipeline Focus - **Rare Disease Programs**: Jaguar is concentrating on ultra-rare diseases, specifically microvillus inclusion disease (MVID) and short bowel syndrome (SBS), with potential FDA filings by the end of 2026 [8][11] - **Market Potential**: The SBS market is estimated to be over $5 billion, with some estimates as high as $12 billion [12] - **Clinical Trials**: Ongoing trials for MVID and SBS are showing promising results, with significant reductions in parenteral nutrition for patients [16][25] Regulatory Pathways - **Breakthrough Designation**: The company is pursuing breakthrough therapy designation from the FDA, which could expedite the approval process for its rare disease treatments [28][29] - **Prime Designation in Europe**: This designation would facilitate communication and speed up the regulatory process across the EU [29] Canalevia-CA1 Update - **FDA Approval**: Canalevia-CA1 received conditional approval for chemotherapy-induced diarrhea in dogs, with ongoing studies required for full approval [32][33] - **Clinical Trial Funding**: Funds from the licensing agreement and grants will support the clinical trial for Canalevia-CA1 [34] Key Milestones for 2026 - **Clinical Trials**: Completion of MVID and SBS trials, with expectations for breakthrough and prime designations [38] - **Business Development**: Focus on securing business development deals independent of Mytesi and Canalevia, targeting rare disease indications [38] Additional Insights - **Patient Impact**: The company emphasizes the importance of supportive care in treating chronic conditions, particularly in the HIV community [10][11] - **Manufacturing as Profit Center**: Jaguar continues to manufacture crofelemer, which has become a profit center due to its commercialization by FuturePak [8] This summary encapsulates the key points discussed during the Jaguar Health FY Conference Call, highlighting the company's strategic focus, product pipeline, and market opportunities.

MONTREAL, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, announced today the completion of the previously-announced plan of arrangement under Chapter XVI – Division II of the Business Corporations Act (Québec) involving CB Biotechnology, LLC (the “Purchaser”), an affiliate of Future Pak, LLC (“Future Pak”), pursuant to which the Purchaser has acquired all the issued and outstanding commo ...

Group 1 - The Special Meeting of Shareholders of Theratechnologies is being recorded, and participants consent to the recording and use of personal information disclosed during the meeting [1] - Mr. Frank Holler, Chair of the Board of Directors of Theratechnologies, is leading the meeting [2]

Core Viewpoint - Theratechnologies Inc. has announced the availability of EGRIFTA WR™ (tesamorelin) for injection, aimed at reducing excess abdominal fat in adult patients with HIV and lipodystrophy, following its approval by the U.S. FDA earlier this year [1][2]. Product Details - EGRIFTA WR™ offers a more convenient weekly reconstitution and requires less than half the injection volume compared to the previous formulation, EGRIFTA SV®, which required daily reconstitution [3]. - The new formulation is supplied as four single-patient-use vials, each containing 11.6 mg of tesamorelin, sufficient for seven daily injections, with a daily dose of 1.28 mg [3]. - EGRIFTA WR™ can be stored at room temperature (20° to 25° C [68° to 77° F]) before and after reconstitution, and its formulation is patent protected in the U.S. until 2033 [3]. Clinical Significance - The new formulation is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy, and it aims to simplify management and enhance user experience [2][4]. - Pharmacokinetic studies have shown bioequivalence of EGRIFTA WR™ to the original formulation of tesamorelin [4]. Transition Support - Individuals currently using EGRIFTA SV® can enroll in the Thera Patient Support® program to assist in transitioning to EGRIFTA WR™ as insurance coverage becomes available [5]. - The program includes a dedicated team of Thera Nurse Navigators to train enrolled patients on the use of EGRIFTA WR™ [5][6]. Company Overview - Theratechnologies is a specialty biopharmaceutical company focused on the commercialization of innovative therapies that aim to redefine standards of care [10].

Core Viewpoint - Theratechnologies Inc. is in the process of a special meeting to discuss its acquisition by CB Biotechnology, LLC, with a proposed cash consideration of US$3.01 per share plus contingent value rights [1][3][5] Group 1: Meeting and Arrangement Details - The special meeting of shareholders is scheduled for September 12, 2025, to consider the Arrangement Resolution for the acquisition [1][11] - The Arrangement involves the Purchaser acquiring all issued and outstanding common shares of the Company for US$3.01 per share in cash, plus contingent value rights [3][4] - An interim order has been granted by the Superior Court of Québec to authorize the meeting and related materials [4] Group 2: Board and Special Committee Recommendations - The Board and the Special Committee unanimously recommend that shareholders vote in favor of the Arrangement, citing it as fair and in the best interests of the Company [5][6] - Fairness opinions from Barclays and Raymond James support the conclusion that the Arrangement is fair from a financial perspective [11] Group 3: Financial Considerations and Premium - The proposed cash consideration represents a significant premium of 216% over the closing price on April 10, 2025, prior to the announcement of the initial proposal [7][11] - The contingent value rights could provide additional cash payments of up to US$1.19 per share, depending on the achievement of certain milestones [3][11] Group 4: Shareholder Support and Voting - Senior officers and directors, owning approximately 1.14% of the outstanding shares, have entered into voting agreements to support the Arrangement [9] - Soleus Capital Master Fund, holding 10.4% of the outstanding shares, has expressed support for the Arrangement [10] Group 5: Background and Strategic Process - The Company undertook a targeted market check and engaged with multiple potential acquirers before entering into the Arrangement Agreement with Future Pak [11] - The process included extensive negotiations and consideration of various offers, ultimately leading to the current Arrangement [11]

Core Insights - Theratechnologies Inc. presented two significant studies at the 19th Annual American Conference for the Treatment of HIV, focusing on excess visceral abdominal fat (EVAF) in people with HIV (PWH) [1][2][3] VAMOS Analysis - The VAMOS study revealed that EVAF is linked to reduced muscle quality in aging PWH, with a prevalence of 58% among 170 participants [5] - Muscle quality declines with age (r= -0.465; p<0.0001) but is not significantly correlated with body mass index (BMI) (r= -0.118; p=0.124) [5] - Increased visceral fat correlates strongly with lower skeletal muscle quality (r= -0.445; p<0.0001), suggesting it may exacerbate age-related functional decline [5] Tesamorelin/GLP-1 RA Case Series - A case series demonstrated the effectiveness of combining tesamorelin and GLP-1 receptor agonists (RAs) in treating EVAF in PWH, with a mean waist circumference reduction of 1.3 inches [7] - After at least six months of combination therapy, patients experienced mean reductions in weight (-13 pounds), BMI (-2.2 kg/m²), and waist circumference (-3.4 inches), with six out of seven patients meeting their metabolic and body composition goals [7] - This is the first report of dual use of tesamorelin and GLP-1 RAs in PWH, highlighting their complementary mechanisms [7][8]

Financial Performance - Revenue for the three-month period ended February 28, 2025, was $19,047,000, representing a 17.4% increase from $16,247,000 in the same period of 2024[4] - The net profit for the period was $117,000, a significant improvement compared to a net loss of $4,481,000 in the prior year[4] - For the three-month period ended February 28, 2025, the Company generated a net profit of $117, compared to a net loss of $4,481 in the same period of 2024[17] - Revenue from the primary customer, RxCrossroads, was $19,047 for the three-month period ended February 28, 2025, up from $16,169 in 2024[70] Operating Expenses - Operating expenses decreased to $17,152,000 in Q1 2025 from $18,493,000 in Q1 2024, a reduction of approximately 7.2%[4] - Research and development expenses were $2,969,000, a decrease from $3,752,000 in the previous year, reflecting a reduction of 20.8%[4] - The company recorded share-based compensation expense of $646 for the three-month period ended February 28, 2025, down from $689 in 2024[56] - Non-refundable tax credits of $185 were recorded against research and development expenses for the three months ended February 28, 2025, compared to $0 in 2024[59] - Total refundable and non-refundable research and development tax credits recorded for the three months ended February 28, 2025 were $194, an increase from $32 in 2024[60] Assets and Liabilities - Total assets increased to $56,451,000 as of February 28, 2025, up from $53,340,000 as of November 30, 2024, reflecting a growth of 3.95%[3] - Current liabilities decreased to $35,149,000 from $36,861,000, a decline of approximately 4.6%[3] - The company reported a total equity of $(24,467,000) as of February 28, 2025, an improvement from $(25,272,000) as of November 30, 2024[3] - As of February 28, 2025, the Company had cash of $3,905 and working capital of $2,668, with an accumulated deficit of $416,770[17] Cash Flow - The company generated cash flows from operating activities of $2,457,000, compared to cash outflows of $3,129,000 in the prior year[8] - The Company experienced negative cash flows from operating activities of $9,744 for the three-month period ended February 28, 2025, compared to $1,708 in 2024[17] - The Company expects its existing cash and cash equivalents, along with cash generated from operations, to be sufficient to fund operating expenses for at least the next 12 months[16] Debt and Financing - The company issued long-term debt amounting to $5,000,000 during the period, contributing to financing activities[8] - Total long-term debt as of February 28, 2025, is $45,089,000, compared to $40,939,000 as of February 29, 2024, representing an increase of 10.5%[40] - The TD Term Loan has a face value of $25,000,000 with an interest rate of 7.17%, maturing on November 27, 2027, and includes a $20,000,000 accordion feature[40] - The IQ Term Loan has a face value of $15,000,000 with an interest rate of 11.45%, maturing on May 27, 2028[45] - As of February 28, 2025, the Company drew $5,000,000 from the TD Revolver to fund working capital[40] Regulatory and Product Development - The FDA approved the supplemental Biologics License Application for the F8 formulation of tesamorelin, which will be commercialized as EGRIFTA WR™, expected to launch in Q3 2025[20] - The Company filed a Prior Approval Supplement with the FDA on December 18, 2024, to resume distribution of EGRIFTA SV® after a temporary supply disruption[18] - The Company has entered into an agreement with Ionis Pharmaceuticals to license two investigational RNA-targeted medicines, with an initial payment of $10,000 and potential milestone payments up to $12,750[35] - The Company plans to transition from EGRIFTA SV® to EGRIFTA WR™, which is critical for meeting Adjusted EBITDA covenants[21] Stock and Options - As of February 28, 2025, the Company has 5,026,208 stock options outstanding, with a weighted average exercise price of CAD 4.98[53] - The Company has a total of 2,128,406 options available for grant under the stock option plan as of February 28, 2025[52] - The company expects to grant stock options with a fair value of $1,781 in 2025, with a planned issuance price of CA$2.40 and US$1.65[56] Compliance and Covenants - The Company was in compliance with all financial covenants as of February 28, 2025[46] - The TD Credit Agreement restricts the ability to incur additional debt and make acquisitions, except in limited circumstances[42] Fair Value and Tax - The company has determined that the carrying values of its short-term financial assets and liabilities approximate their fair value due to their short maturity[65] - The effective tax rate may differ from management's estimate due to expectations of generating taxable income in fiscal 2025[58]

Core Insights - Theratechnologies Inc. presented data indicating the limitations of using body mass index (BMI) alone for assessing cardiovascular (CV) risk in people with HIV (PWH), emphasizing the need for screening excess visceral abdominal fat (EVAF) to better identify at-risk individuals [1][2][3] Group 1: Study Findings - The VAMOS study characterized BMI as a poor independent surrogate for excess visceral adiposity and CV risk in PWH, particularly highlighting high CV risk in participants with normal or overweight BMI but high levels of EVAF [2][3] - The study involved 170 PWH who had achieved virological suppression on antiretroviral therapy (ART) for at least one year, comparing 10-year atherosclerotic cardiovascular disease (ASCVD) risk scores across different BMI categories [3][4] - Obese individuals (BMI 30-34.9 kg/m2) had the highest prevalence of EVAF at 88%, while 43% of PWH with normal BMI (20-25 kg/m2) and 47% of those classified as overweight (BMI 25-29.9 kg/m2) also exhibited EVAF [3][4] Group 2: Clinical Implications - PWH with EVAF had significantly higher 10-year ASCVD risk scores compared to those without EVAF, regardless of BMI, indicating the importance of considering EVAF in risk assessments [4][5] - The findings suggest that healthcare providers focusing solely on BMI may overlook a significant population of normal-weight and overweight individuals with HIV who are at risk due to EVAF [5] - The study advocates for the use of simple and more precise tools, such as waist circumference measurement, to identify PWH at risk of cardiovascular disease [5]

Exhibit 99.1 Theratechnologies Reports Financial Results for the Fourth Quarter and Full Year of Fiscal 2024 Montreal – February 26, 2025 – Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care, today reported business highlights and financial results for the fourth quarter and full year of fiscal year 2024, ended November 30, ...

Three- and nine-month periods ended August 31, 2024 and 2023 (Unaudited) THERATECHNOLOGIES INC. Table of Contents (In thousands of United States dollars) (Unaudited) Exhibit 99.1 | | Page | | --- | --- | | Interim Consolidated Statements of Financial Position | 1 | | Interim Consolidated Statements of Comprehensive Income (Loss) | 2 | | Interim Consolidated Statements of Changes in Equity | 3 | | Interim Consolidated Statements of Cash Flows | 4 | | Notes to Interim Consolidated Financial Statements | 5 - 2 ...