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| This study also demonstrated VK2735's encouraging impact on liver fat and plasma lipids |
| In conclusion, 2023 was an exciting and productive year for Viking, with the company achieving significant progress with each of our clinical programs |
| Finally, we completed 2023 with a strong balance sheet and a cash position that will support our objectives for 2024 and beyond |
| In particular, VK2809 demonstrated excellent gastrointestinal tolerability |
| Viking made good progress with other pipeline programs during the year as well |
| The initial VOYAGE data also served to further establish VK2809's promising safety and tolerability profile |
| On the financial side, we completed 2023 with a strong balance sheet, thanks to our continued diligence in managing expenses, along with a successful public offering of common stock, which resulted in gross proceeds of approximately $288 million |
| We believe these results indicate that VK2809 has the potential to provide long-term cardiovascular benefits |
| In the hip fracture study, we saw very significant increases in lean body mass at all doses and a beautiful dose response |
| The initial data from this study successfully achieved the primary endpoint and affirmed VK2809's best-in-class effect on liver fat along with its favorable tolerability and safety profile |
| VK2735 demonstrated a half-life of approximately 170 hours to 250 hours and excellent therapeutic exposures |
| As in the single ascending dose date, the multiple ascending dose study demonstrated encouraging safety and tolerability and positive signs of clinical activity |
| I think that's exciting |
| In May, we announced positive topline results from the Phase 2b VOYAGE study of our thyroid hormone receptor beta agonist, VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis and fibrosis |
| The single ascending dose portion of the study enrolled healthy men and women and demonstrated that, single subcutaneous doses of VK2735 were safe and well tolerated and displayed favorable pharmacokinetics |
| 2023 was an exciting year for Viking, highlighted by important data releases from two of our four clinical programs |
| As I mentioned in my opening comments, in 2023, Viking made significant progress with each of our 4 clinical programs, positioning the company for an exciting year ahead |
| VK0214 also demonstrated an encouraging safety and tolerability profile with no serious adverse events reported and no treatment or dose-related signals observed for GI side effects, vital signs or cardiovascular measures |
| With respect to our obesity program, during the year, we announced positive results from a first-in-human Phase 1 clinical trial of VK2735, a dual agonist of the GLP-1 and GIP receptors |
| In the first quarter of 2023, we announced positive results from a Phase 1 single ascending dose and multiple ascending dose study of VK2735 |
| During the year, we reported the results from the first Phase 1 trial of VK2735, which demonstrated early signals of efficacy as well as promising safety and tolerability |
| Last May, we announced positive top line results from the ongoing Phase 2b VOYAGE study of VK2809 |
| As steatosis and lipotoxicity are believed to be underlying drivers in NASH, these results suggest important long-term benefits across key subgroups |
| I do think it's encouraging to see that the dual agonist mechanism appears to be effective at NASH resolution |
| But we still see there's nice opportunity for a targeted agent |
| We see the subcu as the meat of the market, but we see the oral opportunity is a really important incremental opportunity |
| All of us at Viking are optimistic about the year ahead and would like to extend our thanks to our shareholders, partners, investigators and importantly, the patients participating in our clinical trials for their continued support |
| In this study, subjects dosed with VK2735 demonstrated statistically significant weight loss with favorable safety and tolerability |
| These results indicate VK2735's potential benefit in patients with various forms of fatty liver disease |
| We also initiated the Phase 1 clinical evaluation of a novel oral formulation of VK2735, which we believe may expand the market opportunity for this compound |
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| That's a very, very difficult challenge that the industry faces |
| You have an event coming up in 6 months or whatever, and you want to lose some weight ahead of that |
| Plasma levels of apolipoprotein B were also reduced by up to 21% |
| For the year ended December 31, 2023, Viking reported a net loss of $85.9 million or $0.91 per share compared to a net loss of $68.9 million or $0.90 per share in the corresponding period in 2022 |
| And it's -- to the extent, a loss of muscle from these agents is clinically relevant than maybe adding muscle building agents could be a reasonable approach |
| For the three months ended December 31, 2023, Viking reported a net loss of $24.6 million, or $0.25 per share, compared to a net loss of $19.6 million, or $0.26 per share, in the corresponding period in 2022 |
| The quarter is not very long |
| It was just the trial was enrolled more quickly than expected and were no hiccups during the course of the study |
| So the biopsies are the slower element there |
| As a result, patients are unable to efficiently metabolize very long chain fatty acids and the accumulation of these compounds is believed to contribute to the onset and progression of X-ALD |
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