On August 9, 2023 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported its financial results and provides an update on operational progress for the second quarter and six months ended June 30, 2023 (Press release, Summit Therapeutics, AUG 9, 2023, View Source [SID1234634115]).
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Operational & Corporate Updates
Our operational progress with ivonescimab (SMT112), an innovative, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule:
Summit is actively engaged in development activities for SMT112. In just over six months since we closed our in-licensing transaction for ivonescimab, Summit has:
Held multiple meetings with the US Food & Drug Administration (FDA) regarding its planned Phase III clinical program and incorporated this feedback accordingly, and
Begun its clinical development in non-small cell lung cancer (NSCLC) in the following indications:
Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) ("HARMONi" trial)
Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients ("HARMONi-3" trial)
In May 2023, the first patient in Summit’s license territories was treated in the Phase III HARMONi clinical trial.
Summit intends to dose patients in the HARMONi-3 trial during the second half of 2023.
In June 2023, promising Phase II data from AK112-201, a study of Chinese subjects conducted and analyzed by our partners, Akeso, was presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In addition to encouraging data in multiple indications within NSCLC, a portion of the updated data presented at ASCO (Free ASCO Whitepaper) supports Summit’s HARMONi-3 clinical trial in first-line metastatic squamous NSCLC: Phase II data in 63 treatment-naive, squamous NSCLC patients treated with ivonescimab plus chemotherapy with a median follow-up time of 13.3 months experienced:
Median progression-free survival (PFS) of 11.0 months (95% CI: 9.5 to 16.8 months)
Overall response rate (ORR) of 67% (95% CI: 53% to 78%) with a median duration of response of 15 months
Median overall survival (OS) was not reached; although estimated 9-month OS was 93.2%
Grade >3 treatment-related adverse events (TRAEs) was 41%; the most frequent TRAEs were anemia, decreased neutrophil counts, and alopecia
Recapping our Collaboration and License Agreement with Akeso Inc. (Akeso) for ivonescimab (SMT112):
On December 5, 2022, Summit and Akeso entered into a Collaboration and License Agreement for ivonescimab.
The Collaboration and License Agreement with Akeso closed on January 17, 2023 after going effective following customary waiting periods.
Summit received the rights to develop and commercialize ivonescimab (SMT112) in the United States, Canada, Europe, and Japan. Akeso retained development and commercialization rights for the rest of the world, including China.
In exchange for these rights, Summit committed to an upfront payment of $500 million, which was paid in two installments.
The first installment worth $300 million was paid in January in conjunction with the closing of the transaction. Of the $300 million paid to Akeso by Summit, Akeso opted, in accordance with the Collaboration and License Agreement, to receive 10 million shares in lieu of a cash payment of $25.1 million; the remaining $274.9 million was paid by Summit to Akeso in cash.
The second installment of $200 million was paid on March 6, 2023 in cash.
Going forward, Akeso will be eligible to receive regulatory and commercial milestones of up to $4.5 billion. In addition, Akeso will receive low double-digit royalties on net sales in the Summit territories.
Akeso has a rich and diversified antibody drug pipeline with over 30 internally discovered drug candidates in various stages of development, including six bispecific antibodies. Akeso has taken part in over 80 clinical trials for 17 drug candidates, including 14 pivotal trials. Akeso has two drugs approved for oncology indications in China: a PD-1 inhibitor and a novel PD-1 / CTLA-4 bispecific antibody. Akeso has over 2,400 employees.
Financial Highlights
Aggregate cash, cash-equivalents, short-term investments, and receivables on June 30, 2023 totaled $220.1 million as compared to $654.7 million on December 31, 2022.
Our cash, cash-equivalents and short-term investments on June 30, 2023 was $215.0 million as compared to $648.6 million on December 31, 2022. Accounts receivable and research and development tax credits receivable on June 30, 2023 were $5.1 million as compared to $6.1 million on December 31, 2022.
Our short-term investments consist of U.S. treasury securities.
Our notes payable balance at June 30, 2023 was $100.0 million, which is due in September 2024.
Based on our current cash and investments position, we believe that we have sufficient capital resources to fund our operating costs and working capital needs, including our planned clinical trials for ivonescimab, for at least twelve months following the issuance of our Q2 financial statements filed on Form 10-Q.
Net loss for the three and six months ended June 30, 2023 was $14.7 million and $557.1 million, respectively. Net loss for the three and six months ended June 30, 2022 was $16.8 million and $38.2 million, respectively.
The net loss for the six months ended June 30, 2023 includes one-time in-process research and development expenses associated with the in-licensing of ivonescimab from Akeso of $520.9 million.
Operating cash outflow for the six months ended June 30, 2023 and 2022 was $42.4 million and $38.2 million, respectively.
Second Quarter 2023 Earnings Call
Summit will host an earnings call this morning, Wednesday, August 9, 2023, at 9:00am ET. A live webcast and instructions for joining the call are accessible through Summit’s website www.smmttx.com. An archived edition of the webcast will be available on our website after the call.