On December 2, 2024 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has closed on a $40 million three-year non-dilutive, senior secured syndicated financing with TD Bank, as agent (TD Bank Financing) (Press release, Theratechnologies, DEC 2, 2024, View Source [SID1234648728]). The new credit facilities include a $20 million accordion feature, which could expand total commitments up to $60 million. Investissement Québec (IQ), the Company’s largest shareholder, has also agreed to provide a $15 million second ranking secured subordinated term loan (IQ Subordinated Loan). Net proceeds from the new loans together with cash on hand will be used to repay all obligations including prepayment penalties under the Company’s existing facility with affiliates of Marathon Asset Management, L.P. (Marathon) pursuant to the credit agreement entered into with Marathon in July 2022, and to fund business development activities. All amounts are in US dollars unless otherwise stated.

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"This transaction represents a critical milestone for the Company’s strategic focus on the commercialization of innovative therapies through business development deals and partnerships," said Philippe Dubuc, Senior Vice President and Chief Financial Officer at Theratechnologies. "The new facility’s favorable rates and terms provide us with meaningful financial flexibility to execute on our acquisition strategy at substantially lower costs. The flexible structure fully aligns with our strategic objectives of continuing to enhance profitability and strengthen our balance sheet to fuel long-term growth and sustainability."

Key highlights of the TD Bank Financing include:

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$25 million senior secured term loan and a $15 million senior secured revolving facility; each with interest on a floating rate (SOFR) plus a margin based on the Company’s total net debt-to-Adjusted EBITDA ratio.

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At closing, the interest rate will be SOFR plus 2.75%. This rate compares favorably to the Company’s previous credit facility, which carried an interest rate of SOFR + 9.50%.

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The TD Bank term loan will be amortized over a seven-year period, and will mature on November 27, 2027.

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The Company has drawn $5 million on the revolving facility.

Key highlights of the IQ Subordinated Loan include:

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A $15 million second ranking secured subordinated term loan with interest based on US Government rates plus a margin based on the Company’s total net debt-to-Adjusted EBITDA ratio.

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The interest rate is currently set at US Government rates plus 7.23%, or 11.45%.

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The loan will be interest-only and be subject to full repayment after 42 months.

After giving effect to the financing, the Company will have $45 million in debt, with an estimated cash balance as at November 30, 2024 of approximately $20 million, for a net debt position of approximately $25 million.

On December 2, 2024 Amgen (NASDAQ:AMGN) reported that it will present at Citi’s 2024 Global Healthcare Conference at 9:30 a.m. ET on Thursday, Dec. 5, 2024 (Press release, Amgen, DEC 2, 2024, View Source [SID1234648712]). Peter Griffith, executive vice president and chief financial officer at Amgen, Jay Bradner, executive vice president of Research and Development and chief scientific officer at Amgen, and Susan Sweeney, executive vice president of Obesity and Related Conditions at Amgen, will participate in a fireside chat at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On December 2, 2024 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that new data on UGN-102 (mitomycin) for intravesical solution, JELMYTO (mitomycin) for pyelocalyceal solution, and UGN-301(zalifrelimab intravesical solution) will be presented at the Society of Urologic Oncology (SUO) 2024 annual meeting being held in Dallas, Texas from December 4 – 6 (Press release, UroGen Pharma, DEC 2, 2024, View Source [SID1234648729]).

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"We are excited that the SUO has accepted data highlighting the potential of our investigational treatment, UGN-102, in development for patients with low-grade, intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC), as well as the ongoing clinical value of JELMYTO for treating low-grade upper tract urothelial carcinoma (LG-UTUC)," said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. "These presentations underscore our ongoing commitment to addressing the critical unmet needs of patients with urothelial cancers, as well as our mission to provide innovative treatment options that seek to improve both outcomes and quality of life for those battling these challenging conditions."

Key details of UGN-102, JELMYTO and UGN-301 abstracts accepted by SUO:

Abstract Title

Schedule

Presenter

PRIMARY CHEMOABLATION OF RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE-INVASIVE BLADDER CANCER WITH UGN-102: A SINGLE-ARM, OPEN-LABEL, PHASE 3 TRIAL (ENVISION)

Poster 121

Date: 12/5

Time: 2:15-3:15 pm CT

Dr. Max Kates

LONG-TERM OUTCOMES OF PRIMARY CHEMOABLATION OF LOW-GRADE UPPER TRACT UROTHELIAL CARCINOMA (LG-UTUC) WITH UGN-101, A MITOMYCIN REVERSE THERMAL GEL

Poster 122

Date: 12/5

Time: 2:15-3:15 pm CT

Dr. Brian Hu

HOME INSTILLATION OF UGN-102 FOR PRIMARY CHEMOABLATION OF RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE-INVASIVE BLADDER CANCER: A SINGLE-ARM, OPEN-LABEL, PHASE 3B TRIAL

Poster 124

Date: 12/5

Time: 2:15 – 3:15 pm CT

Dr. Vincent Michael Bivins

A PHASE 1 DOSE-ESCALATION STUDY OF UGN-301 (ZALIFRELIMAB) IN PATIENTS WITH RECURRENT NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)

Poster 133

Date: 12/5

Time: 2:15 – 3:15 pm CT

Caretha L. Creasy

A PHASE 1 DOSE-ESCALATION STUDY OF UGN-301 (ZALIFRELIMAB) AS MONOTHERAPY AND IN COMBINATION WITH OTHER AGENTS IN PATIENTS WITH RECURRENT NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)

Poster 206

Date: 12/6

Time: 10:00 – 11:00 am CT

Caretha L. Creasy

For further information about UroGen’s ongoing clinical trials and programs, please visit our website at urogen.com to learn more or follow us on X (Twitter), @UroGenPharma.

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting by a trained healthcare professional. UroGen completed the NDA submission in August, ahead of schedule. The FDA accepted the NDA for UGN-102 and assigned a PDUFA goal date of June 13, 2025.

About JELMYTO

JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with LG-UTUC. It is recommended for primary treatment of biopsy-proven LG-UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.

UGN-301

UGN-301 is our investigational, in-licensed, anti-CTLA-4 monoclonal antibody (zalifrelimab), prepared with reverse-thermal hydrogel for intravesical administration into the bladder. Intravesical administration of UGN-301 is designed to increase drug concentrations in the bladder without significant systemic exposure, potentially diminishing the systemic toxicity associated with CTLA-4 blockade. UroGen is evaluating UGN-301 as combination therapy for the intravesical treatment of high-grade NMIBC.

On December 2, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported that it will present preclinical Proof-of-Concept for its precision cancer vaccine concept, targeting non-conventional ERV (endogenous retrovirus) tumor antigens shared across patients at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress, taking place from December 11-13, 2024, in Geneva, Switzerland (Press release, Evaxion Biotech, DEC 2, 2024, View Source [SID1234648746]).

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The data to be presented stems from studies in human cells and mouse tumor models. The studies investigated human T-cell responses and mouse tumor growth inhibition induced by precision ERV vaccine targets identified using Evaxion’s AI-Immunology platform.

AI-Immunology can select ERV antigens for precision therapeutic cancer vaccines, offering therapeutic options for multiple specific cancer types and potentially enabling treatment for patients who are unresponsive to conventional cancer immunotherapy.

The new concept of deploying ERVs as vaccine targets allows for designing precision cancer vaccines that could be effective across diverse immune system characteristics, making them suitable for a wide range of patients. Evaxion plans to utilize this now preclinically validated concept to design new precision vaccine candidates to complement our existing pipeline of personalized cancer vaccines.

Conference presentation details:

Abstract title: AI-designed cancer vaccines: antigens from the dark genome are promising cancer vaccine targets
Poster#: 124P
Location: Foyer Mezzanine
Date/Time: December 12, 2024, at 12.30 CET/06.30 EST
Presenter: Daniela Kleine-Kohlbrecher, Senior Project Manager at Evaxion

On December 2, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., reported it will host an investor webcast on December 16, 2024 at 8:30 am EST (Press release, BeiGene, DEC 2, 2024, View Source [SID1234648713]). The Company’s R&D leadership team will provide an update on BeiGene’s innovative portfolio and pipeline, focusing on key presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting (ASH) (Free ASH Whitepaper) and the San Antonio Breast Cancer Symposium.

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The live webcast of this event can be accessed from the investors section of BeiGene’s website at View Source, View Source, View Source An archived replay will be available for 90 days following the event.