バイキング・セラピューティクス 2026年第3四半期決算説明会：VK2735が進展、手元資金は9億6000万ドルに達する

要点

• バイキング・セラピューティクスが発表した2026年第3四半期の純損失は1億8,320万ドル（1株当たり1.55ドル）となり、前年同期の9,080万ドル（同0.81ドル）から拡大しました。治験関連費用、製造費用および人件費の増加が主な要因です。
• VK2735の4つの第III相試験の進展に伴い、第3四半期の研究開発費は前年同期比85.3%増の1億6,680万ドルに増加しました。
• 2026年9月30日時点の現金、現金同等物および短期投資の合計は9億6,000万ドルとなり、これには最近の普通株式および転換社債の発行による手取金純額約5億5,000万ドルが含まれています。
• 皮下投与型VK2735の第III相試験「VANQUISH-1」および「VANQUISH-2」は全被験者の登録を完了し、計画通りに進展しています。バイキングは、2027年初頭に最初の被験者が延長期間に移行すると見込んでいます。
• バイキングは経口投与型VK2735の第III相「SUNRISE」プログラムを開始しました。経営陣は、成功すれば同プログラムにより、VK2735が市場に投入される初の経口二重GLP-1/GIP受容体作動薬となる可能性があると述べています。
• 維持療法試験において、週1回投与のVK2735から隔週投与に切り替えた被験者は、33週時点でそれまでの体重減少効果の83%〜97%を維持しました。月1回投与では82%〜90%が維持されたのに対し、プラセボへ移行した群では61%でした。

主な財務実績

研究開発費の増加は、主に臨床試験費用、製造費、株式報酬費用、給与およびコンサルティング費用の増加を反映しています。第3四半期の一般管理費の増加は、法務および特許関連サービス費用、コンサルタント費用、株式報酬費用、給与ならびに福利厚生費によるものです。

現金、現金同等物および短期投資は、2025年12月31日時点の7億600万ドルから9億6,000万ドルに増加しました。バイキングは普通株式と転換社債の同時公募を通じて、発行総額で約5億7,500万ドル（手取金純額で約5億5,000万ドル）を調達しました。

事業および業績ハイライト

皮下投与型VK2735

VANQUISH-1は肥満の成人患者を対象とし、VANQUISH-2は肥満および2型糖尿病の成人患者を対象としています。両ランダム化第III相試験では、7.5 mg、12.5 mg、17.5 mgの週1回投与群とプラセボ群を78週間にわたり比較します。

主要評価項目はベースラインからの体重変化率です。副次および探索的評価項目には、5%、10%、15%、20%以上の体重減少を達成した被験者の割合が含まれます。

以前の第II相VENTURE試験において、VK2735の週1回投与は13回投与後に最大14.7%の平均体重減少をもたらし、減量の頭打ちは見られませんでした。治療に起因する有害事象の大部分は軽度または中等度でした。

経口投与型VK2735

SUNRISE第III相承認申請プログラムは、2つの68週間の試験で構成されています。SUNRISE-1は肥満かつ少なくとも1つの体重関連併存疾患を有する成人を対象とし、SUNRISE-2は肥満かつ2型糖尿病の成人を対象としています。

被験者は27.5 mg、35 mg、55 mgのいずれかの経口用量を1日1回投与、またはプラセボを投与されます。先行する第II相試験において、経口VK2735は13週後に頭打ちを伴わず最大12.2%の平均体重減少を示しました。

経営陣は、用量選定は有効性、服薬負担（錠剤数）、商用における経済性を反映したものであると説明しました。用量漸増は4週間単位で行われます。27.5 mg群に割り当てられた被験者は目標用量で60週間、55 mg群は52週間過ごします。

維持投与

VK2735の週1回投与を21週間行った後、実薬投与群では平均約16%〜19%の体重減少を達成したのに対し、プラセボ群では約0%でした。投与を受けた被験者の約90%が少なくとも10%の体重減少を達成し、およそ3分の1が少なくとも20%の減少を達成しました。

17.5 mgを週1回、33週間投与された探索的コホートでは平均約22%の体重減少を達成し、頭打ちは見られませんでした。その後、隔週投与または月1回投与に切り替えた被験者は、当初の体重減少効果の大部分を維持しました。経営陣によると、維持期間中の消化器系有害事象の発現率はプラセボと比べて意味のある差はありませんでした。

本試験のパート2では、21週間の皮下投与導入期間の後、1日1回の経口維持用量、追加の皮下隔週および月1回投与法、ならびにプラセボを検証する予定です。

VK3019

VK3019は肥満治療薬として開発中のアミリン/カルシトニン二重受容体作動薬です。バイキングは現在、安全性、忍容性、薬物動態を評価するため、健康な成人を対象とした第I相単回用量漸増試験を実施しています。

経営陣は、肥満霊長類を用いた前臨床データからVK3019はVK2735よりも強力である可能性が示唆されたものの、これが臨床的に再現されるかどうかは不確実であると強調しました。潜在的な開発ルートには、単剤療法およびVK2735との併用療法が含まれます。

経営陣の見通し・ガイダンス

• バイキングは、VANQUISH試験の最初の被験者が2027年初頭に延長試験に入ると予想しています。これらの延長試験には、皮下投与の隔週および月1回維持コホートが含まれます。
• VK2735維持試験のパート2の結果は2027年に判明する見込みです。
• VK3019の単回用量漸増試験は2026年末までに完了する見込みであり、続いて2027年第1四半期に複数回用量漸増試験が開始される予定です。
• グレゴリー・ザンテ最高財務責任者（CFO）は、四半期ごとの金額には変動があるものの、全社的な現金使用額は1四半期当たり平均約1億ドルになる見込みであると示しました。
• 経営陣は、一般管理費が短期的にはほぼ横ばいで推移し、その後の商用化の準備が進むにつれて増加する可能性があると予想しています。

リスクおよび注視すべき点

• バイキングは、VK2735と競合する肥満治療薬との直接的な試験間比較を行わないよう警告しました。経営陣は、より短期間の試験に基づいてVANQUISHの78週時点での体重減少効果を予測することは控えました。
• VANQUISHの治験脱落率は試験設計時の想定通りに推移していますが、データはブラインド（盲検）状態が維持されているため、解釈には限界があります。
• VK2735の初回規制承認申請に低頻度の維持投与を含めるかどうかは未定です。経営陣は、現時点ではその後の追加承認申請で行う可能性が高いと述べています。
• 週1回の皮下投与型VK2735から、より曝露量の少ない1日1回の経口投与へ切り替えた場合の影響は、特に維持期間の初期において予測が困難です。
• VK3019はまだ複数回投与の臨床データを得ていません。経営陣は、後期の開発段階を決定する前に、忍容性、薬物動態、週1回投与の実現可能性、体重減少の推移、および併用療法の可能性を評価する予定です。
• 臨床試験の拡大および商用化に向けた準備により、営業費用および純損失が大幅に増加しています。

アナリスト質疑応答の要点

経営陣は、製剤および投与スケジュールの柔軟性がVK2735の商業上の主要な差別化要因になり得ると指摘しました。バイキングは、同一分子の経口剤および注射剤の開発とともに、週1回、隔週、月1回の投与戦略を進めています。

同社は将来の上市を見据えて商業化体制の構築を進めています。現在の体制には、コマーシャル・リーダーシップ、マーケット・アクセス、メディカル・アフェアーズ、医療経済・アウトカム研究（HEOR）、メディカル・サイエンス・リエゾン（MSL）支援、テクニカル・オペレーションズ、サプライチェーン、品質保証、コンプライアンスが含まれています。

経口維持療法について、バイキングは約17 mgから55 mgまでの幅広い範囲で1日1回投与を検証しています。経営陣は収益性および服薬負担（錠剤数）の観点から、SUNRISE登録試験の最大用量である55 mgを超える計画は現在ありません。

経営陣は、VANQUISH延長試験のデータはより大規模かつ長期的なデータセットを提供するものであるため、初期の維持試験データよりも将来の規制文書を裏付ける可能性が高いと述べました。

VK3019について、バイキングは28日間の複数回投与試験を通じて、週1回投与に適したプロファイル、許容可能な忍容性、および有意な体重減少の推移を目指しています。経営陣はVK2735との併用療法を最も直接的な機会と捉えている一方、GLP-1受容体作動薬に耐えられない患者や十分な効果が得られない患者向けの単剤療法も検討しています。

決算説明会トランスクリプト全文

決算説明会の完全なトランスクリプト

経営陣による説明

Operator

Welcome to the Viking Therapeutics Third Quarter 2026 Financial Results Conference Call.

[Operator Instructions]

As a reminder, this conference call is being recorded today, October 28, 2026. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Stephanie Diaz

Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO; Greg Zante, Viking's CFO; and Hubert Chen, Viking's Chief Medical Officer. Before we begin, I'd like to caution that comments made during this conference call today, October 28, 2026, will contain forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines and milestones. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These forward-looking statements to speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Lian for his initial comments.

Brian Lian

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the third quarter and 9 months ended September 30, 2026, and review recent updates across our pipeline programs and organization. During the third quarter, we made important progress across multiple pipeline programs and announced positive results from an innovative maintenance dosing study in our obesity program. With respect to our lead compound, VK2735, a dual agonist of the GLP-1 and GIP receptors, Viking's Phase III VANQUISH clinical program continued to proceed according to plan. The VANQUISH program is evaluating the subcutaneous formulation of VK2735 in 2 studies, VANQUISH-1 in adults with obesity and VANQUISH-2 in adults with obesity and type 2 diabetes. Both trials are fully enrolled and during the third quarter, both continued to advance towards completion.

In addition, during the third quarter, the company made significant progress with its oral VK2735 program and earlier this month, we announced the initiation of the Sunrise Phase III registration program. As with the VANQUISH program for subcutaneous VK2735, the Sunrise Phase III program consists of 2 studies: one, evaluating the treatment of adults with obesity and the other evaluating adults with obesity and type 2 diabetes. We are very happy to have these important studies underway, and I'll provide more details on them in a few minutes.

During the quarter, we also announced positive data from our novel VK2735 maintenance dosing study. Part 1 of this study was focused on our subcutaneous formulation and demonstrated an exciting signal that indicates the potential for novel dosing strategies to manage weight loss long term with lower and less frequent dosing regimens.

In this study, participants receiving VK2735 successfully maintained the majority of their initial weight loss following the transition to every other week or monthly dosing schedules. As a follow-up, we recently announced the initiation of a second part to this study to evaluate the maintenance potential of our oral formulation along with additional subcutaneous regimens. Beyond VK2735, during the third quarter, Viking continued to advance its amylin receptor agonist, VK3019 in a Phase I single ascending dose study. We expect to complete this study by year-end and plan to proceed to a multiple ascending dose study in the first quarter of 2027.

Finally, during the third quarter, Viking successfully closed concurrent upsized offerings of common stock and convertible notes, raising gross proceeds of approximately $575 million. These funds substantially increase our financial runway and will support the ongoing development of all programs as well as the company's growing commercial operations and launch plans. I'll have additional comments following a review of our financial results for the third quarter and 9 months ended September 30.

With that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

Gregory Zante

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file shortly. I'll now go over our results for the third quarter and 9 months ended September 30, 2026, beginning with the quarter. Research and development expenses were $166.8 million for the 3 months ended September 30, 2026, compared to $90 million for the same period in 2025. The increase was primarily due to increased expenses related to clinical studies, manufacturing for the company's drug candidates, stock-based compensation, salaries and benefits and third-party consultants partially offset by decreased expenses related to preclinical studies.

General and administrative expenses were $20.3 million for the 3 months ended September 30, 2026, compared to $8.6 million for the same period in 2025. The increase was primarily due to increased expenses related to legal and patent services, third-party consultants, stock-based compensation and salaries and benefits. For the 3 months ended September 30, 2026, Viking reported a net loss of $183.2 million or $1.55 per share compared to a net loss of $90.8 million or $0.81 per share in the corresponding period in 2025. The increase in net loss for the 3 months ended September 30, 2026, was primarily due to increased research and development expenses and general and administrative expenses noted previously compared to the same period of 2025.

I'll now go over our results for the 9 months ended September 30, 2026. Research and development expenses were $432.7 million for the 9 months ended September 30, 2026, compared to $191.5 million for the same period in 2025. The increase was primarily due to increased expenses related to clinical studies, stock-based compensation, manufacturing for the company's drug candidates, salaries and benefits and third-party consultants, partially offset by decreased expenses related to preclinical studies. General and administrative expenses were $51.1 million for the 9 months ended September 30, 2026 compared to $37.1 million for the same period in 2025.

The increase was primarily due to increased expenses related to third-party consultants, legal and patent services and salaries and benefits, partially offset by decreased expenses related to stock-based compensation. For the 9 months ended September 30, 2026, Viking reported a net loss of $469.5 million or $4.03 per share compared to a net loss of $202 million or $1.80 per share in the corresponding period in 2025. The increase in net loss for the 9 months ended September 30, 2026, was primarily due to increased research and development expenses and general and administrative expenses noted previously compared to the same period in 2025.

Turning to the balance sheet. At September 30, 2026, Viking held cash, cash equivalents and short-term investments of $960 million compared to $706 million as of December 31, 2025. This balance includes the aggregate net proceeds of approximately $550 million from our recent financing. This concludes my financial review, and I'll now turn the call back over to Brian.

Brian Lian

Thanks, Greg. I'll now provide an update on Viking's clinical programs, beginning with our lead obesity program, VK2735. VK2735 is a dual agonist of the glucagon like-peptide 1, or GLP1 receptor, and the glucose-dependent insulin entropic polypeptide, or GIP receptor. Viking is currently advancing both an injectable and an oral formulation of this compound for the treatment of obesity. In prior clinical studies, VK2735 has demonstrated promising efficacy, safety and tolerability and we are excited to be advancing this compound in multiple studies, 4 of which are Phase III studies. With respect to the subcutaneous formulation, Viking's prior Phase II trial successfully achieved its primary and secondary end points demonstrating significant weight loss compared with placebo as well as an impressive safety, tolerability and pharmacokinetic profile.

In the Phase II VENTURE study, patients receiving weekly VK2735 doses demonstrated statistically significant reductions in mean body weight from baseline ranging up to 14.7% after 13 weekly doses with no signs of plateau. The VENTURE study also showed VK2735 to be safe and well tolerated through 13 weeks of dosing with the majority of treatment-emergent adverse events characterized as mild or moderate.

Following this study and with subsequent feedback from the FDA, the company advanced subcutaneous VK2735 into Phase III development, initiating the VANQUISH registration program in June of last year. The VANQUISH program consists of 2 clinical studies: VANQUISH-1 in adults with obesity and VANQUISH-2 in adults with obesity and type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks.

Participants in each trial have been randomized to weekly doses of 7.5 milligrams, 12.5 milligrams, 17.5 milligrams or placebo. The primary endpoint of the VANQUISH trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients who achieve at least 5%, 10%, 15% and 20% weight loss.

Each study will include an extension allowing participants the opportunity to continue receiving treatment following the primary dosing period, including patients who were randomized to placebo. During the third quarter, both VANQUISH studies continued on track, and we expect the first patients to enter the extension periods in early 2027. In addition to the subcutaneous registration program, we also made good progress with the oral tablet formulation of VK2735. As with the subcutaneous formulation, the prior Phase II study of the tablet formulation successfully achieved its primary and secondary endpoints. Top line results from the Phase II VENTURE oral dosing study demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 12.2% from baseline.

The tablet formulation also demonstrated encouraging safety and tolerability through 13 weeks of daily dosing with the vast majority of drug-related treatment and merchant adverse events characterized as mild or moderate. Given these positive results, along with feedback from an end of Phase II meeting with the FDA, the company advanced oral VK2735 into Phase III development for the treatment of obesity.

During the third quarter, our team made great progress toward this goal. And earlier this month, we announced the initiation of our Phase III Sunrise registration program. The Sunrise Phase III program includes 2 studies evaluating oral VK2735, one in adult obesity and one in adults with obesity and type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled multicenter trial designed to assess the efficacy and safety of oral VK2735 dosed once daily for 68 weeks. Sunrise I is evaluating treatment of adults with obesity who have at least 1 weight-related co-morbidity. Sunrise II is enrolling adults with obesity and type 2 diabetes. Participants in each trial will be randomized to receive once daily oral VK2735 doses of 27.5 milligrams, 35 milligrams, 55 milligrams or placebo. The primary endpoint of both SUNRISE trials is a percent change in body weight from baseline for participants receiving oral VK2735 as compared to placebo after 68 weeks of treatment.

Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy metrics, including the percentage of patients who achieve various weight loss thresholds from baseline. We're happy to have these important trials underway. If successful, we believe these studies will position VK2735 as the first oral formulation of a dual GLP-1 GIP agonist to reach the market.

As clinicians and patients continue to seek flexibility in formulations and dosing, we believe oral VK2735 may represent another differentiated and high-value tool in their treatment toolbox. I'll now provide an update on Viking's novel maintenance studies, including the positive results we announced last month. As we have discussed previously, VK2735 has a unique and differentiated profile that we believe may accommodate less frequent dosing compared to standard weekly dosing, making it uniquely suited for the maintenance setting. Through our ongoing engagement with obesity KOLs and clinicians, we consistently hear that less frequent dosing regimens may represent attractive options for patients who have achieved their weight loss goals and are seeking to maintain that weight loss moving forward.

Importantly, by using the same therapeutic agent for both the initial weight loss and for the long-term maintenance phase weight management, we believe patients may experience reduced side effects compared with options that require switching between different therapeutic agents. By reducing side effects, adherence to treatment may be improved allowing patients to ultimately realize the long-term benefits of weight loss, such as improved cardiovascular health, enhanced physical function and increased quality of life. Last month, we reported positive results from an innovative 2-part range finding study. This study was designed to explore a variety of maintenance dosing regimens and the results demonstrate for VK2735's ability not only to achieve significant weight loss during an induction phase, but to also maintain a high percentage of that weight loss during the maintenance space.

The innovative design included several components, a 21-week induction period, a 12-week maintenance period evaluating both monthly and every other week dosing regimens and a sustained weekly dosing period where subjects received 33 weeks of weekly dosing that was titrated to a 17.5 milligram dose.

Through the initial 21 weeks of weekly dosing, subjects receiving VK2735 demonstrated steep and progressive weight loss at all dose levels with no signs of plateau. Week 21 weight loss among active treatment groups ranged from approximately 16% to approximately 19% compared with approximately 0% for placebo. Among treated subjects, at 21 weeks, 90% achieved at least 10% weight loss and approximately 1/3 achieved 20% weight loss. This compares well with the placebo cohort for which no subjects achieved 10% or greater weight loss. Trajectories among all VK2735 cohorts through 21 weeks suggested further weight loss might be achieved with longer-term dosing.

This was indeed observed in the exploratory cohort of subjects who were maintained on a 17.5 milligram weekly dose for the entire 33-week study period. These subjects achieved mean weight loss of approximately 22% from baseline. No plateau was observed, suggesting further weight loss might be expected with continued dosing.

In the maintenance phase of the study, following the 21-week induction period, subjects were transitioned from weekly dosing to every other week or monthly dosing. Among subjects dosed every other week, the mean weight loss retained at week 33 ranged from 83% to 97% compared with 61% among subjects transitioned from 17.5 milligrams weekly to placebo. As expected, subjects were transitioned to placebo during the maintenance phase experienced progressive weight gain compared with the every other week regimens. Similar results were also observed in subjects transition to monthly maintenance dosing at week 21. Among VK2735-treated subjects, the mean weight loss retained at week 33 ranged from 82% to 90% compared with 61% for placebo.

As with the every other week regimens, the fact that dosing was effectively reduced by up to 85% in these cohorts demonstrates a compelling maintenance signal and supports the concept of less frequent dosing as a viable approach to long-term weight management. The top line results also demonstrated a favorable tolerability profile. During the 21-week induction period, rates of nausea, vomiting, diarrhea and constipation were consistent with what was observed in our prior Phase II VENTURE study. This is impressive as these subjects were titrated every 2 weeks which was faster than the 3-week titration schedule used in the VENTURE study.

During the 12-week maintenance space, both every other week and monthly dosing regimens demonstrated promising tolerability. Treatment-emergent adverse events and overall rates of nausea, vomiting, diarrhea and constipation were not meaningfully different from placebo, suggesting excellent tolerability under these less frequent dosing regimens. In addition to the impressive weight maintenance effects just discussed, we believe this is an equally exciting results from this study. The tolerability data suggests that despite gaps of up to 4 weeks between doses, treated individuals in this study did not resensitize the GI adverse events such as nausea or vomiting.

These results support our view that VK2735's differentiated PK profile with an extended half-life and excellent long-term exposures may provide for greater flexibility in dosing compared with existing options. As a follow-up to this promising study, earlier this month, we announced the initiation of Part 2 of the study designed to evaluate a range of oral maintenance regimens along with additional subcutaneous maintenance regimens. As in part 1 of the study, all participants will receive initial weekly subcutaneous doses of VK2735 for 21 weeks. At week 21, participants will transition to a range of maintenance dosing options, including daily oral doses, every other week subcutaneous doses, monthly subcutaneous doses or placebo.

Study objectives are to evaluate the safety, tolerability and pharmacokinetic profile of VK2735 under these various regimens. Exploratory endpoints will again assess changes in body weight from baseline and from week 21 to the end of the study at week 33. We expect the results of this study to be available in 2027.

I'll now provide a brief update on Viking's newest program, VK3019, a novel dual agonist of the amylin and calcitonin receptors in development for the potential treatment of obesity. Preclinical data for this program showed impressive effects on body weight, food intake and metabolism in healthy rats, diet-induced obese mice and obese primates compared to control-treated animals.

Earlier this year, the company initiated a Phase I single ascending dose clinical trial of VK3019. This trial is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy adults. The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of single subcutaneous doses of VK3019. Exploratory pharmacodynamic assessments include evaluations of changes in body weight after a single dose administration. We expect to complete the single ascending dose study later this quarter and plan to initiate a multiple ascending dose study in the first quarter of 2027. We're excited to have the Amylin program in the clinic as we believe it may represent yet another option for patients seeking flexibility in their weight management journey.

Finally, as reported last month, in the third quarter, Viking successfully closed concurrent public offerings of common stock and convertible notes, resulting in gross proceeds of approximately $575 million. Following the offering, the company held $960 million in cash at the end of the third quarter. In addition to providing the runway to reach important clinical milestones, including completion of our ongoing Phase III trials, these funds will help support the company's preparation and plans as we prepare for the potential launch of VK2735. In conclusion, during the third quarter, the company continued to advance each of the programs in its obesity franchise. Our Phase III VANQUISH studies of the subcutaneous formulation are both fully enrolled and advancing according to plan. During the quarter, we made significant progress preparing for our oral Phase III trials and recently announced the initiation of the Sunrise registration program.

The Sunrise Phase III program will closely mirror the VANQUISH program. though at a smaller scale and will enroll patients with obesity and obesity with type 2 diabetes. In the maintenance setting, Viking recently achieved 2 key milestones. Late in the third quarter, we announced positive results from our dose-ranging maintenance study, successfully demonstrating a credible maintenance effect, which was a key objective of the study.

Importantly, in the maintenance portion of this study, we observed tolerability that was not meaningfully different from placebo. We also saw a highly competitive weight loss of 22% among subjects titrated to 17.5 milligrams weekly for 33 weeks with no evidence of a plateau suggesting the potential for additional weight loss. Earlier this month, we announced the initiation of the second part of the maintenance dosing study designed to evaluate a range of daily oral doses, monthly subcutaneous doses and every other week subcutaneous doses or placebo. We look forward to reporting the results of this trial in 2027. To support our clinical and development activities during the quarter, the company successfully closed public offerings of common stock and convertible notes providing a cash balance of $960 million at quarter end. Viking is now well positioned to advance its ongoing clinical programs and to continue working to deliver a broad portfolio of therapeutic formulation and dosing options to best support a personalized, convenient and sustainable weight loss program for people living with obesity.

We're proud of the progress made during the third quarter and look forward to reporting the results from our ongoing trials in the quarters ahead. This concludes our prepared comments for today. Thanks for joining us, and we'll now open the call for questions. Operator?

Operator

[Operator Instructions]

The first question comes from Jon Lee with UBS.

質疑応答

Unknown Analyst

Congrats on all the progress and great to be following you guys again. Where do I start? When you guys actually present the results of the Phase III VANQUISH-1 and 2 next year. Would it be fair for us to make cross-trial comparison with tirzepatide? And how much of the Phase II results do you think will be recapitulated in Phase III? And just a quick follow-up. What's your [indiscernible] What do you think will be the key differentiator of 2735 from a commercial standpoint?

Brian Lian

Thanks a lot, June and welcome back. Good to talk to you. So I think multiple elements of differentiation in the program. I guess from the highest level, we have 2 formulations of subcutaneous in an oral formulation of the same molecule and it would represent if the oral is approved, the first approved dual agonist of GLP-1 and GIP having the ability to switch between agents, we think, as we said in the prepared comments, probably reduces the risk of unexpected adverse events. Having the ability to dose weekly every other week or monthly, I think in part flexibility that others cannot offer at this point, and we don't see in the market today.

So I think that's another very important point of differentiation. So offering that flexibility and optionality would be, I think, key differentiators for us. As far as cross trial comparisons, always, we always caution against doing something like that. I'm sure everybody will do it. But we think the data will stand on their own and happy to compare between studies, but we're pretty confident in the overall profile and what we've seen thus far.

Operator

The next question comes from Gregory Renza with Truist Securities.

Gregory Renza

Brian and team, congrats on the progress in the quarter. Brian, you certainly alluded to the criticality of the commercial build and the launch plan execution. Just wondering if you can give us an update on where that build is, what the gap is when it comes to what needs to be done on the infrastructure and the capabilities and where you see the leadership taking shape from a commercial standpoint from here. Congrats again on the progress.

Brian Lian

Yes, we have a pretty solid commercial team, especially given that we're 2.5 years out from potential launch. But we have an SVP of Commercial, who has been involved in multiple obesity drug launches. We've got VP of Market Access underneath him. We've got a VP of Medical Affairs and we have health economics and outcomes research. We've got a Director of Medical Science Liaison, so pretty solid core group of people, and we'll continue building from here. And it's a lot of that stuff, as you prepare for commercialization is less visible. But we've added staff just in the last quarter or so in tech ops, in CMC, supply chain and quality and compliance. So those are not is invisible to everybody, but really, really important roles that are being filled as we grow and prepare for commercialization.

Operator

The next question comes from Annabel Samimy with Stifel.

Jack Padovano

This is Jack on for Annabel. Congrats on the progress so far. So two for us. So for the Phase III trials for the oral. What was the rationale for selecting a much more narrow dose range there? In the Phase II, it was pretty wide all the way out to 120 mg, Phase III dose is obviously a lot tighter. So maybe some color there on kind of what went into that decision and what the cadence of the up-titration to get to those doses would be helpful.

And then on the [indiscernible]. Will you be planning on reporting out the SAD data separately? Or will you wait until you have the full study results first? And from that, is there a specific target profile you're looking for there from the full study that you would be happy with at this stage relative to the dual agonist? Would you be hoping for like a similar efficacy and better safety, better efficacy and safety or something else entirely?

Brian Lian

Yes, I'll start with the second group of questions there first. So with the amylin agonist, we're in a single-ascending dose study now that's nearing completion. We'll see what it tells us. It's just a single dose. So hard to read a lot into it. But if there's something interesting there, we would certainly intend to disclose it. Probably the more interesting data would be from a 4-week study, the multiple ascending dose study that we plan to initiate in the first quarter.

But the SAD [indiscernible] it will give us a lot of information on, obviously, single-dose tolerability, pharmacokinetics, that sort of thing. And so we'll report -- if there's something interesting to report, we'll certainly do that. When we look at the profile, it's a different profile. Amylin receptor is a different mechanism than modulating the GLP and GIP receptors. When we look at the in vivo data, especially in the obese primate model, the 3019 compound looks to be little more potent than the 2735 compound.

We don't know if that's going to translate or not, but I think it was an exciting signal that we saw in the early primate studies. And going to the Sunrise dose selection, yes, a lot went into the dose selection there. So we heard from the Phase II experience, we want to lower the tablet burden, number of tablets and the size of the tablets for patients. We also want to make sure that the program makes economic sense.

And so we need to have sufficient gross margins to allow us to run a highly profitable enterprise. And we think those doses chosen in the Sunrise program reflect both of those. And I think give us a very nice potency range there. Keep in mind, the 13-week data, none of the cohorts were yet plateauing. So we feel there's a little room to run there at all doses that were studied in the Phase II study. So anyway, long answer to your question, but that's what went into the dose selection there.

Operator

The next question comes from Tom Smith with Leerink Partners.

Nathanael Charoensook

This is Nat Charoensook on for Tom Smith. Congrats on the progress this quarter. Maybe a couple clarification questions from us. Sort of first one, what is the planned titration schedule in Sunrise? And how much time will patients spend at the 27.5, 35 and 55-milligram doses.

Brian Lian

Yes. Yes. Sorry, that was the last question, so I forgot to answer that. But there are 4-week titration blocks. So the 27.5 starts at 10 for 4 weeks. 17.5 for 4 weeks, and then that spends 60 weeks at 27.5. And then we look at the highest dose, the 55 mg, that goes up in 4-week blocks as well and you end up at 55 milligrams for 52 weeks. And so there are 4 steps there because those 4 steps take 4 weeks each. That's what leads to a 68-week study duration.

Nathanael Charoensook

Got it. And what are the -- are those levels are being evaluated in part II of the [indiscernible] study? Or like are they expected to be much lower than the doses used for induction?

Brian Lian

No. We'll look at a range of doses there, ranging from around 17 to 55. We have 5 arms there. We haven't disclosed those doses yet. But that's the range we'll look at in the oral part of the study, and that's week 21 to 33. And then we have 6 subcu arms, 3 every other week and 3 monthly as well in that study, and we'll talk about that dose selection, I guess, as we get a little bit closer to that transition to the maintenance phase.

Operator

The next question comes from Hardik Parikh with JPMorgan.

Hardik Parikh

I was just wondering, could you talk about how you plan to leverage the subcu maintenance data you published in the third quarter. I was just wondering how do you think you could potentially differentiate on an eventual FDA label? Do you think that with that Phase I data set, this Part 2 initiation in the VANQUISH Phase III trial extension, could you get some sort of a maintenance label.

Brian Lian

Yes. Great question, Hardik. We think so. But we're not going to get into details of the regulatory dialogue. But I think that based on the extension studies that we're going to be conducting, we think they would support potential language in the label. All of these items are obviously review issues, but we think that that's certainly a possibility. At a minimum, we would have a pretty robust data set to share with people KOLs, clinicians and discuss it at scientific conferences. So I think both options are very attractive, but I think label would be our preference for sure.

Hardik Parikh

Okay. Got it. And then with this recent public offering you had, I was just wondering, when you look at kind of the broader development pipeline in obesity across the industry, including in China, do you guys consider or do you have any views on opportunities to in-license additional assets to kind of further broaden out your portfolio? Or are you kind of, at this point, just focused on what you have in now at the moment?

Brian Lian

Yes, it's a good question. And we don't really disclose a lot of the strategic discussions that we have internally. But there are some interesting programs out there that might be worth learning more about. But that said, we have a fair amount of internal activity as well that's, I think, very exciting. And so how do you balance the resources in pursuing both of them. I think doing as much diligence as possible and following up on the things that really rise to the top as far as opportunity would be our practice. But I guess the preference would be to maintain the focus on the internal pipeline because of what we see today. But we are aware of other pretty interesting opportunities that are available right now externally.

Operator

The next question comes from William Wood with B.Riley Securities.

William Wood

Congrats on the continued progress this quarter. Maybe just thinking about the anguish extension study, that looks to get underway in first quarter 2027. This obviously read out before Part 2 maintenance trial readout. So I'm just curious how you're seeing some of the extension dosing. Will you go up to a 22.5 dose possibly how those schedules? And are you going to only sort of be looking at 1 or 2 or is there -- doses? Or is there potential to really expand that based on what you saw? And then also sort of the same thought for the oral maintenance for Sunrise, how are you sort of thinking should the expectation be that you have sort of this maintenance dosing schedule incorporated there also?

Brian Lian

Yes. So with the subcu extension, we will be putting in both every other week and monthly cohorts. We're not going to disclose the dose levels there until we get that extension underway. But -- and so we discuss what that range looks like. But I think, pretty interesting dose ranges. With the oral extension, we do plan to incorporate extensions to the sunrise studies. But it's premature really to talk about what those doses might look like.

Operator

The next question comes from Mike Ulz with Morgan Stanley.

Michael Ulz

Congrats on all the progress as well. Maybe just a follow-up question related to the oral dosing part 2 of the maintenance study. Just given you saw some pretty positive maintenance in your subcu part 1 of greater than 90%, just -- is there a particular target you have for the oral maintenance portion or any particular bar there you're thinking about?

Brian Lian

No, that one's a little bit of hard one to predict because the exposures when you go from 17.5 mg weekly down to a lower daily oral dose are just going to be. It's such a jump in exposures. It's offset by the fact that you're dosing daily. But hard to know how those will play out longer term. I think as you get through the 12-week window there with the oral, you should see a very nice sustained plasma level, but how that step-down manifest early on in that study, I'd be really interesting to see. But really hard to prognosticate on it.

Operator

The next question comes from Steve Seedhouse with Cantor Fitzgerald.

Timur Ivannikov

This is Timur Ivannikov on for Steve. So we also had a question about Part 2 of the maintenance study. Could you clarify why you're not including a weekly oral maintenance regimen? Is it a matter of API cost or the number of tablets required? Or is there another factor?

Brian Lian

It's a good question. We thought that because the single dose variability is quite high, with the oral route of administration that it might be better to look at multiple different dose levels on the daily basis. So -- and then we also added more cohorts on the subcu side as well. But really, it's that volatility and exposures that led us to think the time and resources were better invested in straight daily and additional subcu doses.

Operator

The next question comes from Jay Olson with Oppenheimer.

Jay Olson

Congrats on all the progress. As the VANQUISH Phase III program advances, can you comment qualitatively on overall trial retention and blinded discontinuation trends relative to your expectations based on Phase 2. And then we had a question about the timing of filing your Vanquish maintenance data and specifically for the VANQUISH extension studies evaluating every other week and monthly subcu maintenance. Will these less frequent dosing arms be included in the initial regulatory submission package, so you could reference that data at launch.

Brian Lian

Yes. It's a great question. And I would say it's TBD. I'd say it's probably more likely that it would be a supplement later, but we don't know that for sure. at this point, it's possible we might be able to incorporate something in the initial -- in the initial filing. And I'm sorry, I forgot the first question.

Jay Olson

I was asking about...

Brian Lian

Oh, the discontinuation, yes. The discontinuation rate is tracking our expectations. So -- and it's blinded data. So it's really difficult to interpret why someone discontinues. But the overall rate is within what we expected when we designed the study.

Operator

The next question comes from Edward Nash with Canaccord Genuity.

Unknown Analyst

This is [indiscernible] on the call for Edward. Congrats on the progress, I guess two from us, one is on the part 2 of the maintenance study. Just curious about what are the key answered questions from part 1 that you would look to address in Part 2? And then another one on the oral formulation positioning. So do you believe the oral formulation would primarily target treatment-naive patients or do you think switching from an injectable would represent a meaningful enough opportunity?

Brian Lian

Yes. So the -- what we're seeing right now with the oral therapies is sort of a market expansion. And we expect a lot of those initial users to likely transition to the subcu route administration to achieve even greater weight loss than they've experienced with the initial oral experience. When we look at the -- and so we would expect that to continue as the market continues to mature. With the second part of the maintenance study, we're very interested in seeing how you -- how a person's weight change response when you go from this weekly subcutaneous injection to a daily oral dose administration. So that's -- we haven't seen that really with any dual agonist just yet. So that will be a very key takeaway from this study as well as the additional transitions from weekly to every other week and weekly to monthly. So pretty large things. It's actually a larger study and probably a little more complicated than the one we just read out, but it should be very data rich.

Operator

The next question comes from Ryan Deschner with Raymond James.

Ryan Deschner

Congrats on the progress. I know it's early for both studies, but curious if you could comment generally on the rate of enrollment of Sunrise versus VANQUISH and how much overlap with the VANQUISH clinical trial sites you have with the expected sites for Sunrise.

Brian Lian

Yes. It's a fair amount of overlap, [indiscernible] here. I don't know that SP-2 Exact number, but...

Unknown Executive

Yes, it's -- there's still an overlap, especially for the sites that have performed well for us. We certainly want to retain them. But as you would also expect, obesity is still prevalent that we can -- we have no problems to identify these sites. So overall, we don't think there will be a heavy competition or worry about enrollment because we have too many overlapping sites.

Brian Lian

And then the rate -- sorry. Sorry, Ryan, on your rate of enrollment. Pretty early days there, but I think we're satisfied with what we see at this point. But again, very, very early in the trajectory there.

Operator

The next question comes from Roger Song with Jefferies.

Jiale Song

Great. Maybe just adding one more question on the Part 2 maintenance study. Just curious on the oral side, given you test a broader range in the Phase II versus the Phase III, how likely you will incorporate some of the higher doses or broader range like you tested in Phase II in the maintenance, given you have a higher exposure from the subcu? And then another question related to the amylin since no question asked about that. So given you're moving to the mutidose next year. So what kind of profile do you think in the current landscape, you will make you feel confident to move forward into later-stage development. And then particularly as monotherapy or the combination with your current GLP-1, GIP.

Brian Lian

Yes. Thanks, Roger. With the oral in the maintenance, we're looking at a daily dose. So we probably wouldn't exceed the registration doses that are going up to 5 milligrams in the SUNRISE study. And that's because to my earlier comments, you just want to have something that's highly profitable. And so 55 will be the highest we would go at this point in the maintenance setting there in that second part of the study. With respect to the amylin agonist, we'll see. It's hard to know before doing a study, what would be attractive.

But obviously, we want to see something that's reasonably well tolerated that shows something that could dose once weekly. That's -- since that's the most common dosing regimen, reasonable weight loss after a 28-day regimen and that's not only the magnitude, which I think sometimes is over interpreted, but the trajectory is, what do they look like at 28 days and then what might you expect after 12 weeks when you look at the PK profile of the different arms selected.

So those would be the kinds of things that we would look at. And when we look at the opportunities for the amylin agonist, I mean, the most obvious one is the combo on top of the 2735 compound because you then have multiple sort of nonoverlapping mechanisms that might contribute to a person's overall weight change. But we also see as a single agent, the opportunity to treat people who can't tolerate GLP-1 or who just don't respond well to a GLP-1. So -- and maybe those are relatively low percentages, but the market is so large that they're actually a multibillion-dollar opportunities. So all of them would be open to a novel amylin agonist.

Operator

The next question comes from Andy Hsieh with William Blair.

Tsan-Yu Hsieh

Just a quick one on the Phase III Sunrise titration, I guess, velocity. So as you go from 10 to 55, the step-up based on our calculations, it's about 75 for the first step, 57 for the second step, 27 for the third step, but then increasing to 57 for the last -- for the 55 per day dosing. And I'm just curious about your rationale in incorporating that to reach 55?

Brian Lian

Yes. Well, I think it's probably not -- since you're slowly accumulating plasma levels, it's probably not going to result in any sort of change in tolerability, if that's sort of the underlying question. The tablet strengths are 27.5 and 17.5. And so that's what leads to the multiples of those numbers as the final dosing numbers.

Tsan-Yu Hsieh

I see. Okay. That's helpful. So it's more of a practical thing. Okay. That's helpful.

Operator

The next question comes from Jeet Mukherjee with U.S. Bank BTIG.

Jeet Mukherjee

Maybe just to start off, how should we be thinking about the GI tolerability profile for the oral maintenance portion of the study relative to what you saw with the subcu maintenance portion and maybe just the other question was your thoughts on the ZEP [indiscernible] and combo data that was recently released and where your potential for a 27, 35 plus amylin combo could perhaps differentiate.

Brian Lian

Yes. Thanks, Jeet. So when we think about the GI tolerability, a lot of that is tied to the initial exposures and then the overall exposure as well. I mean, what is the dose level, which is one of the reasons we started at 1.25 mg in the VANQUISH studies. So if that's the case that the initial exposure and slowly ramping up mitigates GI adverse events. You would think that transitioning from 17.5 mg weekly to a daily oral dose would not represent any risk of increased GI adverse events. So we haven't done that part of the study yet, but that would be the the initial thought that, that risk would be somewhat low because of the length of time you've been exposed to the mechanism. And as far as the competitor data, I think probably a better question for the competitors, but look to be very attractive on the efficacy side.

We don't know I think the full tolerability profile there. But what's really attractive on the efficacy side. And I think it bodes well for a potential combination that we might explore with our 3019 and 2735 compounds.

Operator

The next question comes from Yale Jen with Laidlaw & Co.

Yale Jen

Congrats on the progress. My question here is that since VANQUISH will have the extension study for the different sort of less [indiscernible] dosing as well as your part 1 of the maintenance study reported recently. So in terms of when you ultimately file for the approval, whether that will be a supplement or the initial one, would you mainly use the data from the maintenance part 1 study? Or are you more likely to use the data of the extension study of the VANQUISH.

Brian Lian

Yes. It's more likely that we would use the VANQUISH extension studies because that will be a longer and larger data set versus the first maintenance study. So that's the data set we plan to incorporate.

Yale Jen

And maybe just to add on one question here. In terms of the timing, that if you will have the VANQUISH top line in the second half or maybe the later about second half to report whereas the extension study of the VANQUISH has been conducted for a while. Would that be sufficient time or duration for that data to be included into the initial filing? Or you still feel that it might be better for us supplement later?

Brian Lian

Yes. No, it's a great question. And it's TBD at this point. If we can put together something that might be suitable for submission with the initial NDA, we would do that. But it seems more likely that this would -- that the VANQUISH extension data would be sort of a stand-alone package that would be a supplement later. But again, too early to say definitively.

Operator

The next question comes from Biren Amin with Piper Sandler.

Biren Amin

What's the expected weight loss that you project for the 17.5 milligram weekly dose in VANQUISH-1 at week 78 given the data from the 17.5 milligram weekly dose at week 21 and week 33 from the maintenance trial. So that's the first question.

And then the second question, for the combination potential of the amylin agonist and 2735. Would you project weekly dosing for the amylin agonist, which would make for potentially more convenient combination with 2735? And if so, what's the half-life that you'd like to see from the Phase I SAD study?

Brian Lian

Yes. So ideally, yes, those half-life would match sufficiently well to allow you to dose on the same cadence. So what that number is, I think you've got probably some wine room around those numbers, but we don't have the yet from the SAD. So it's hard to say. But I think you'd want those to be, I think, plausible, within a plausible range of each other to allow for the weekly dosing frequency. As far as the projected vanquish efficacy, really, really hard to make those sorts of predictions. So I don't know. It looks pretty good right now at 21 weeks. And in the small number of people who went out 33 weeks, it looks really good as well. So those are good signs, but too early to make those kinds of predictions from the VANQUISH Phase IIIs.

Operator

As we are nearing the conclusion of today's call, our final question will come from Daniel Brims with Lake Street.

Daniel Brims

Thank you for fitting me in. Just have a housekeeping question. We saw a large step-up with R&D and you're starting to build out the sales force, so how should we think of R&D and SG&A moving forward?

Gregory Zante

I think SG&A would be pretty consistent moving forward. This quarter, overall operating expense wise and cash usage-wise, was a little higher, excluding the financing than it might be going forward. But I think as we think about cash, just company-wide, I think we'd see a usage of average of around $100 million per quarter but some quarters will be higher, some will be lower moving forward. But on the G&A side, I think we probably see maybe a pickup later more toward the commercialization. But in the near term, I would see it being fairly flat.

Daniel Brims

All right. Congrats good on the quarter.

Operator

That will conclude today's call. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.

Stephanie Diaz

Thank you all for participating today, and thank you for your continued support of Viking Therapeutics. We look forward to reporting again in the near term. Bye-bye.

Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.