High Impact Presentations Taking Place Next Week At Obesity Week

Lickety-Split Analytics

Good morning. This week we are discussing high impact presentations at next week’s Obesity Week conference. We will also update you on press release from the last week, including key news such as an explanation of Coya’s Phase 2 Alzheimer’s data, Viking’s earnings results, and Journey Medical’s PDUFA next week.

-Ashley Adams

High Impact Presentations At Obesity Week

Obesity Week is taking place in San Antonio next week from November 3rd to 6th. We wanted to highlight high impact posters and presentations expected to take place.

Poster Presentations

Excitement Surrounding Novel Mechanism and Efficacy:

• Bioage (BIOA)- APJ Agonist

  • The APJ Agonist Azelaprag Improves Weight Loss and Body Composition in DIO Mice on a CB1 Antagonist

• Corbus Pharmaceuticals (CRBP)- CB1 Inverse Agonist

  • Seventeen Years Since Rimonabant's Downfall: Reassessing Its Suicidality  Risk Profile

  • Induction and Maintenance Regimens With CB1 Inverse Agonist CRB‐913 and Semaglutide in DIO Mice

• Scholar Rock (SRRK)- Myostatin Inhibitor

  • SRK- 439  Selectively  Inhibits Myostatin to Promote Healthy Body Composition During Metformin Therapy

• Structure Therapeutics (GPCR)- Amylin and Calcitonin Receptor Agonists, GLP-1 RA

  • Novel Oral Small Molecule Dual Amylin and Calcitonin Receptor Agonists for Obesity Treatment

  • Drug Design Principles and Pharmacokinetics/Pharmacodynamics of GSBR‐1290, a Small Molecule GLP‐1RA

  • Significant and Clinically Relevant Weight Changes at 12 Weeks With Small Molecule GLP‐1RA,GSBR‐1290

Excitement Surrounding High Efficacy Probability, First Oral Delivery:

• Viking Therapeutics (VKTX)- GLP‐1/GIP RA

  • First‐in‐Human Study of an Oral Formulation of the GLP‐1/GIP Co‐Agonist VK2735 in Healthy Adults

  • Results From the 13‐Week VENTURE Phase 2a Study of the GLP‐1/GIP Co‐Agonist VK2735 in Obese Subjects

Excitement Surrounding Company Stronghold, Efficacy, and Expansion:

• Eli Lilly (LLY)- GLP-1 RA

  • Estimated Impact of Tirzepatide on Medical Costs in Moderate‐to‐Severe OSA with Obesity

  • Likelihood of Obstructive Sleep Apnea Among Patients With Obesity and Anti‐Obesity Medication Use

• Novo Nordisk (NVO)- GLP-1 RA

  • Effects of Semaglutide 2.4 mg on Healthcare Costs in Patients With Obesity and ASCVD (SHINE‐ASCVD)

• Novo & Lilly- GLP-1 RA

  • Head‐to-Head Comparison of Healthcare Costs and Utilization Among Patients With Semaglutide vs Tirzepatide Use

• AstraZeneca (AZN)- GLP‐1, Glucagon, Amylin RA

  • AZD5004/ECC5004 a Small Molecule GLP1-RA May Be Administered Once Daily Under Fed/Fasted Conditions

  • Safety, Tolerability, and Pharmacokinetics of ECC5004, an Oral Small Molecule GLP‐1R Agonist

  • Safety and Pharmacokinetics of AZD9550, a GLP‐1R/GCGR Dual Agonist, in a First‐in‐Human Study

  • Treatment With a Long‐acting Amylin, AZD6234, Leads Body Weight Loss With Preservation of Lean Mass

  • Safety, Tolerability, and Pharmacokinetics of AZD6234, a Long‐Acting Agonist of the Amylin Receptor

  • Amylin Receptor Agonist AZD6234 Shows Advantages Over GLP‐1R Activation for Leptin Re‐Sensitization

Oral Presentations

• Novo Nordisk (NVO)

  • Life After GLP-1s: A Real-World Population Snapshot

  • The Safety and Efficacy of a Slow Flexible Titration Regimen of Semaglutide

• Zealand Pharma (ZEAL.CO)- Further Phase 1b Clinical Data Presentation

  • Safety, Tolerability, and Clinical Effects of Petrelintide (ZP8396), A Long-acting Amylin Analog

Press Release Updates

• Lumos Pharma (LUMO) entered into a definitive merger agreement with Double Point Ventures to go private via tender offer of $4.25 cash per share plus CVRs on 10/23/24.

• Coya Therapeutics (COYA) hosted a call yesterday morning discussing the results of their phase 2 Alzheimer’s trial. Despite meeting both primary and secondary endpoints for safety and Treg population enhancement with no off-target effects, Coya’s share price dropped 27.67%. We largely attribute this to the a dose response plateau between dose groups. The trial tested two groups for 21 weeks, with one group of 22 participants randomized in 1:1 ratio of a 5 day therapy every 4 weeks (q4wks) vs placebo and an additional 16 patients randomized in a 2:1 ratio of a 5 day therapy every 2 weeks (q2wks) vs placebo. Receiving the therapy every 2 weeks, effectively the high dose group, did not exhibit benefit over therapy every 4 weeks in exploratory endpoints. We would expect the company to advance the 4 week therapy methodology.

• CalciMedica (CALC) plans to host a call to review the full data set from the phase 2b CARPO trial of Auxora in Acute Pancreatitis. The call is expected to take place today 10/30/24 at Noon ET. Analysis is expected to include win ratio analysis Here is the Webinar Registration Link.

• Journey Medical (DERM) has a PDUFA action date coming up next week on 11/4/24 for the approval of their potentially best-in-class rosacea drug DFD-29. This approval decision also affects large stakeholder Fortress Biotech (FBIO). Journey published data this week highlighting higher dermal concentration and the pharmacokinetics of oral DFD-29 vs current market leader Oracea.

• Viking Therapeutics (VKTX) released third quarter financial results. Their subcutaneous obesity drug VK2735 has an end-of-phase 2 meeting planned in Q4 2024 and a trial for the oral version is expected to initiate in Q4 2024. VOYAGE Phase 2b NASH/MASH results were selected for oral presentation at AASLD on 11/19/2024. Viking ended the quarter with a strong $930M cash position. Additionally, CNBC featured Viking in a segment last week.

Third-quarter financial results are expected to be presented by:

• Achieve Life Sciences (ACHV) on 11/7/2024 at 4:30pm ET

• Grail (GRAL) on 11/12/2024 at 4:30pm ET

• X4 Pharmaceuticals (XFOR) on 11/13/2024 at 8am ET and will include study results of the phase 2 chronic neutropenia trial.

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Lickety-Split Analytics is not a licensed investment advisor and we do not provide investment recommendations or advice. We strive to deliver accurate information and analysis, but cannot guarantee accuracy. Our goal is to share insights and perspectives to empower you to make informed investment decisions. Conducting your own due diligence and potentially consulting with a financial advisor is crucial before making any investment decisions. This helps to ensure the investment aligns with your individual risk tolerance and financial goals.

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