Core Insights - Viking Therapeutics (VKTX) reported a Q3 2025 loss of $0.81 per share, which was wider than the Zacks Consensus Estimate of a loss of $0.70 per share, and a significant increase from a loss of $0.22 per share in the same quarter last year [1][6] Financial Performance - Research and development (R&D) expenses surged to $90 million in Q3 2025, compared to $22.8 million in the same period last year, primarily due to increased costs related to clinical studies and manufacturing for drug candidates, as well as higher employee-related expenses [2][6] - General and administrative expenses decreased to $8.6 million, down nearly 38% year over year, attributed to lower legal and patent service costs and reduced stock-related compensation expenses [3] - Year-to-date, VKTX shares have declined by 22%, while the industry has seen nearly 11% growth [3] Pipeline Developments - Viking Therapeutics is advancing VK2735, a dual GLP-1 and GIP receptor agonist, in clinical studies for obesity treatment, with both oral and subcutaneous formulations being evaluated [4][6] - The company initiated a late-stage program for the subcutaneous formulation of VK2735, consisting of two Phase III studies: VANQUISH-1 and VANQUISH-2, targeting completion of enrollment in VANQUISH-1 by year-end and VANQUISH-2 by Q1 2026 [7] - Recent results from a mid-stage study of the oral version of VK2735 showed that patients on the highest dose lost up to 12.2% of body weight after 13 weeks, although there were significant dropouts due to adverse effects [8] - A new maintenance dosing study for VK2735 has begun, exploring various regimens to sustain initial weight loss, with results expected in mid-2026 [9] - The company plans to file an investigational new drug (IND) application for an internally developed amylin agonist program in Q1 2026, delayed from the previous target of late 2025 [10] Cash Position - As of September 30, 2025, Viking Therapeutics had cash, cash equivalents, and short-term investments totaling $715 million, down from $808 million as of June 30, 2025 [5]

Core Insights - iBio Inc. (NASDAQ:IBIO) has seen a significant increase in stock price, trading up 11.51% to $1.55 in pre-market sessions, following a 25.23% rise to $1.39 in the previous day's regular session [1][2] Company Announcements - iBio announced that its executives will present data on its obesity treatment candidate, IBIO-610, at two industry conferences in November [2] - Dr. Cory Schwartz will present on November 4 in Atlanta, focusing on a first-in-class Activin E antagonist antibody for obesity treatment, including data from nonhuman primate studies [3] - CEO Martin Brenner will present on November 12 in Lisbon, discussing the fat-selective weight loss effects of the anti-Activin E antibody in diet-induced obese mice [3] Stock Performance - Year-to-date, iBio's stock is down 43.27%, but it has gained 82.89% over the past six months [4] - The stock has a 52-week range of $0.56 to $6.89, with a market capitalization of $28.15 million and an average daily trading volume of 2.64 million shares [4] - Current analysis indicates that IBIO is experiencing long-term consolidation in its stock performance [4]

Financial Data and Key Metrics Changes - Research and development expenses for Q3 2025 were $90 million, up from $22.8 million in Q3 2024, primarily due to increased clinical study costs and salaries [9] - General and administrative expenses decreased to $8.6 million in Q3 2025 from $13.8 million in Q3 2024, mainly due to reduced legal and patent service costs [9] - The net loss for Q3 2025 was $90.8 million or $0.81 per share, compared to a net loss of $24.9 million or $0.22 per share in Q3 2024 [10] - For the first nine months of 2025, research and development expenses totaled $191.5 million, up from $70.7 million in the same period of 2024 [11] - The net loss for the first nine months of 2025 was $202 million or $1.80 per share, compared to a net loss of $74.5 million or $0.69 per share in the same period of 2024 [11] - Cash, cash equivalents, and short-term investments were $715 million as of September 30, 2025, down from $903 million at the end of 2024 [12] Business Line Data and Key Metrics Changes - The company is advancing VK2735, a dual agonist for obesity treatment, with both subcutaneous and oral formulations [13] - The phase two clinical trial of VK2735's oral tablet formulation achieved significant weight loss results, with reductions up to 12.2% from baseline after 13 weeks [20][21] - The subcutaneous formulation demonstrated up to 8% weight loss after 28 days in prior studies, indicating strong efficacy [14] Market Data and Key Metrics Changes - The Vanquish Registration Program for VK2735 is targeting enrollment of approximately 4,500 patients for one trial and 1,100 patients for another, with enrollment proceeding well [17][18] - The company plans to submit an end-of-phase two meeting request to the FDA to discuss next steps for the oral formulation of VK2735 [24] Company Strategy and Development Direction - The company is focused on advancing its obesity treatment programs and exploring maintenance dosing strategies for VK2735 [26] - Viking Therapeutics is also developing novel agonists targeting the amyloid receptor, with an IND filing expected in Q1 2026 [27] - The company aims to manage its balance sheet effectively to support multiple value inflection points [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the enrollment progress in the Vanquish studies and noted no early signs of patient persistence issues [33] - The company is exploring various maintenance dosing regimens to enhance patient adherence and long-term outcomes [65] - Management remains open to partnerships for commercialization but is also prepared to proceed independently [117] Other Important Information - The company highlighted the importance of maintaining weight loss and preventing regain through effective dosing strategies [110] - Management discussed the potential impact of recent developments in the oral GLP-1 space on their program, emphasizing their strong safety and tolerability profile [76] Q&A Session Summary Question: Early signs of patient persistence in the Vanquish studies - Management noted that enrollment is ahead of schedule and there are no notable persistence issues at this early stage [33] Question: Details on the maintenance study's induction phase - The induction phase will involve titration to doses of 17.5 mg, 20 mg, and 22.5 mg over 19 weeks [34] Question: Doses for the maintenance study - Monthly doses will range from 15 mg to 22.5 mg, with daily doses at 17.5 mg and 27.5 mg [41] Question: Impact of government shutdown on enrollment and timing - Management reported no significant impact from the government shutdown on enrollment or timing of the amyloid program [51] Question: Future clinical steps for maintenance regimens - Management indicated that a longer study may be needed to validate maintenance regimens, potentially a phase two B or phase three [50] Question: Considerations for the end-of-phase two meeting with the FDA - The meeting will focus on study design, duration, and leveraging the safety package from the subcutaneous formulation [83] Question: Expectations for operating expenses moving forward - Operating expenses are expected to remain elevated due to ongoing phase three activities [90] Question: Strategic interest in the metabolic disease space - Management acknowledged increased interest in the MASH space and noted ongoing discussions regarding VK2809 [91]

Financial Data and Key Metrics Changes - Research and development expenses for Q3 2025 were $90 million, up from $22.8 million in Q3 2024, primarily due to increased clinical study expenses and salaries [8][10] - General and administrative expenses decreased to $8.6 million in Q3 2025 from $13.8 million in Q3 2024, mainly due to reduced legal and patent service costs [9] - The net loss for Q3 2025 was $90.8 million or $0.81 per share, compared to a net loss of $24.9 million or $0.22 per share in Q3 2024 [9][10] - For the first nine months of 2025, research and development expenses totaled $191.5 million, up from $70.7 million in the same period in 2024 [10] - The net loss for the nine months ended September 30, 2025, was $200 million or $1.80 per share, compared to a net loss of $74.5 million or $0.69 per share in the same period in 2024 [10][11] - Cash, cash equivalents, and short-term investments stood at $715 million as of September 30, 2025, compared to $93 million at the end of 2024 [11] Business Line Data and Key Metrics Changes - The company is advancing VK2735, a dual agonist for obesity, with both subcutaneous and oral formulations being developed [12][14] - The Phase II VENTURE oral dosing trial showed statistically significant weight loss reductions of up to 12.2% from baseline after 13 weeks [19][20] - The VANQUISH Phase III program is ongoing, targeting approximately 4,500 patients in one trial and 1,100 in another [15][16] Market Data and Key Metrics Changes - The obesity treatment market is seeing increased interest, with Viking's VK2735 positioned to compete effectively [27][28] - The company is exploring various dosing regimens for VK2735, including monthly subcutaneous and daily oral options [26][29] Company Strategy and Development Direction - Viking is focused on completing its Phase III trials for VK2735 while also pursuing additional programs targeting the amylin receptor [27][28] - The company plans to submit an end of Phase II meeting request to the FDA to discuss next steps for the oral formulation of VK2735 [24][29] - Viking is managing its balance sheet to ensure financial stability for ongoing and future development programs [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing enrollment in the VANQUISH studies and the positive results from the VENTURE oral dosing study [28][29] - The company is prepared to engage with potential partners for commercialization but is also ready to proceed independently if necessary [126] Other Important Information - Viking has seen a significant increase in interest in its NASH asset, reflecting a broader market trend [97] - The company is preparing for potential regulatory discussions regarding its oral formulation and its implications for future studies [88] Q&A Session Summary Question: Early signs of patient persistence in Phase III trials - Management noted that enrollment is ahead of schedule and there are no early signs of persistence issues [34][35] Question: Details on the maintenance study titration - The company is titrating patients up to target doses before transitioning to monthly dosing [36] Question: Monthly doses for maintenance study - Monthly doses will range from 15 mg to 22.5 mg, with daily oral doses at 17.5 mg and 27.5 mg [44] Question: Impact of government shutdown on enrollment - Management reported no significant impact from the government shutdown on enrollment or timelines [54] Question: Future clinical steps for maintenance regimen - Depending on data, the next step could involve a Phase 2b or Phase 3 study to validate the maintenance regimen [51] Question: Expectations for OpEx moving forward - R&D expenses are expected to remain elevated due to ongoing Phase III activities [96] Question: Considerations for the end of Phase II meeting - The focus will be on study design, duration, and leveraging existing safety data for the oral formulation [88] Question: Transitioning from subcutaneous to oral dosing - Management indicated that the oral study would follow a traditional titration approach [103] Question: Strategic interest in metabolic disease space - The company remains open to partnerships but is also prepared to proceed independently [126]

Core Insights - Terns Pharmaceuticals Inc. announced topline results from its FALCON Phase 2 trial of TERN-601, an oral GLP-1 receptor agonist aimed at treating obesity in adults without diabetes [1][2]. Weight Loss Results - At a 250 mg dose, the placebo-adjusted weight loss was 1.8%, which was not statistically significant (p=0.056) [3]. - At a 500 mg slow titration, weight loss was approximately 3.6%, and at a 500 mg dose, it was around 4.6% [3]. - Weight loss at a 750 mg dose was about 3% [3]. Safety and Tolerability - Among the 134 participants who received TERN-601, 11.9% discontinued treatment and 8.2% had dose modifications due to adverse events (AEs), primarily gastrointestinal [4]. - The most common gastrointestinal AEs included nausea (56%), vomiting (26.9%), constipation (11.9%), and diarrhea (9.7%), with a dose-related occurrence [4]. - Liver function tests (LFTs) remained stable during the treatment period, although three participants experienced grade 3 LFT elevations, with two cases consistent with drug-induced liver injury (DILI) [5][6]. Market Reaction - Following the announcement, Terns Pharmaceuticals shares fell by 3.33%, trading at $7.85 [6].

Summary of Skye Bioscience Conference Call on Phase IIa Clinical Trial Results Company Overview - **Company**: Skye Bioscience (NasdaqGM:SKYE) - **Focus**: Development of Nimasumab for obesity treatment Key Industry Insights - **Clinical Trial**: Phase IIa CBON clinical trial results for Nimasumab - **Primary Endpoint**: Weight loss compared to placebo Core Findings 1. **Monotherapy Results**: - The 200 mg monotherapy arm did not meet the primary endpoint compared to placebo - Weight loss: -1.5% for Nimasumab vs -0.3% for placebo in the modified intent to treat population [8][34] - Lower than expected drug exposure was identified as a reason for this outcome [8][9] 2. **Combination Therapy Results**: - Combination of Nimasumab and Semaglutide showed a clinically meaningful weight loss of approximately -14.3% at 26 weeks compared to -10.8% for Semaglutide alone [13][35] - 100% of participants in the combination arm achieved at least 5% weight loss, and two-thirds achieved at least 10% [14][35] 3. **Safety Profile**: - Nimasumab demonstrated a favorable safety and tolerability profile, with adverse events similar to placebo [16][52] - No neuropsychiatric adverse events were reported, which is a significant differentiator from previous CB1 approaches [17][19] 4. **Pharmacokinetics (PK) Insights**: - Preliminary PK analysis indicated that many participants had lower than predicted drug exposure [41][43] - Higher dosing is suggested as a logical next step to improve efficacy [11][12] 5. **Future Directions**: - Plans to test higher doses (600 mg to 1000 mg) in future trials to explore efficacy further [72][73] - Ongoing extension study evaluating a 300 mg dose to gather additional PK and efficacy data [62][64] Additional Considerations - **Mechanistic Insights**: The combination of Nimasumab and Semaglutide works through complementary mechanisms, enhancing weight loss without increasing gastrointestinal side effects [15][60] - **Body Composition**: The combination therapy showed a favorable lean to fat mass ratio improvement compared to Semaglutide alone [39][61] - **Market Positioning**: Nimasumab is positioned as a complementary treatment in the obesity landscape, particularly against GLP-1s, which have GI burden challenges [21][60] Conclusion - The results from the Phase IIa trial provide valuable insights into the efficacy and safety of Nimasumab, highlighting the need for further exploration of dosing strategies to optimize therapeutic outcomes in obesity treatment. The combination therapy shows promise in enhancing weight loss while maintaining a favorable safety profile.

Core Insights - Pfizer is acquiring weight loss drugmaker Metsera in a deal valued at up to $7.3 billion, which is expected to close by the end of the year [2] - Metsera's lead obesity drug candidate, MET-097i, is progressing to phase three studies following promising mid-stage trial results [2][4] Company Overview - Metsera, founded in 2022, has developed a pipeline of oral and injectable obesity treatments through licensing and acquisition [3] - The focus is on MET-097i, an injection designed for once-a-month administration, potentially offering a competitive advantage over existing weekly injections [4] Clinical Trial Results - In the VESPER-1 trial, the highest dose of MET-097i resulted in an average weight loss of 14.1% after 28 weekly doses, with some participants losing up to 26.5% [6] - An extension study of VESPER-1 indicated continued weight loss without plateauing at 36 weeks [7] - Comparatively, other drugs like Wegovy and Zepbound have shown weight loss results of around 15% and above 20%, respectively [8] Drug Tolerability - Patients tolerated MET-097i well, with a low discontinuation rate of 2.9% due to side effects, which is favorable compared to other obesity drugs [10][13] - At a starting dose of 0.4 milligrams, tolerability was comparable to a placebo, and gradual dose increases showed minimal side effects [11][12] Market Potential - Analysts estimate that Metsera's obesity drug candidates could generate over $5 billion in combined peak annual sales [14]

Core Insights - Novo Nordisk has experienced significant commercial success with its semaglutide products, Wegovy and Ozempic, but its growth has recently slowed due to increased competition [1] - The company revised its sales and profit outlook for 2025, citing slower uptake of Wegovy and Ozempic amid competition from Eli Lilly's tirzepatide-based drugs [2] - Novo Nordisk is developing next-generation obesity candidates to maintain its leadership position in the U.S. market [3] Product Development - The most advanced candidate in Novo Nordisk's pipeline is CagriSema, which combines cagrilintide and Wegovy, having met primary endpoints in late-stage studies but showing lower-than-expected weight loss [4] - Novo Nordisk reported superior weight loss results from a sub-analysis of its phase III study on cagrilintide, supporting its obesity pipeline expansion strategy [5] - The company is also developing oral and subcutaneous formulations of amycretin, which outperformed Wegovy in early-stage studies [5] Strategic Moves - Novo Nordisk is pursuing licensing deals and acquisitions to enhance its obesity pipeline, including the acquisition of Inversago Pharmaceuticals and a $2.2 billion deal with Septerna [6] - The strategic focus on next-generation obesity candidates and targeted acquisitions reflects a calculated approach to sustain market leadership [7] Competitive Landscape - Eli Lilly is a major competitor, marketing its tirzepatide medicines and investing in new obesity treatments, including late-stage candidates [8] - Other companies, such as Viking Therapeutics, are also advancing GLP-1-based candidates, indicating a competitive environment in the obesity treatment space [9]

Revita Program - The durable weight maintenance market represents an untapped opportunity of approximately $175 billion[7] - 85% of patients regain weight after stopping GLP-1 drugs, highlighting a significant unmet clinical and economic need[10] - The REMAIN-1 Pivotal Cohort is on track to complete randomization in early 2026, with potential PMA filing in H2 2026[10] - In the REMAIN-1 Midpoint Cohort study, Revita patients experienced a further 2.5% weight loss after stopping GLP-1s, compared to a 10% weight regain in sham-treated patients (p=0.014) at 3 months[54] Rejuva Program - The company submitted the first CTA module in the EU for RJVA-001, with anticipated preliminary data in 2026[10] - Rejuva aims for a cost of goods (COGs) of less than $10,000 per patient, targeting a price benchmark of approximately $10,000 per year based on ICER pricing[92] - Preclinical data showed that Rejuva's RJVA-001 demonstrated glucose-lowering activity and improved weight compared to daily semaglutide in a db/db murine model[101] - In a DIO mouse model, RJVA-001 prototype showed sustained weight loss while preserving lean mass, outperforming semaglutide[104] Intellectual Property - The company has a robust intellectual property estate with 100+ patents issued globally, including 33 U S patents, and 70+ pending patent applications as of June 2025[135]

Lilly halts a study of an experimental drug designed to prevent obesity patients from losing too much muscle, citing strategic business reasons https://t.co/isjH65RANR ...