Based on the results of HARMONi-2, Summit announced
its intention to initiate HARMONi-7 in early 2025. HARMONi-7 is currently planned as a multi-regional Phase III clinical trial that will compare ivonescimab monotherapy
to pembrolizumab monotherapy in patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 TPS > 50%).
In addition to the HARMONi-2 data, on September 8, 2024, Akeso announced the results from AK112-205, a single-region (China), multi-center, open-label Phase II study, conducted by Akeso, of patients with Stage II or III resectable NSCLC, with data generated and analyzed by Akeso. Further, data for
ivonescimab was presented as a part of the 2024 European Society for Medical Oncology Annual Meeting (ESMO 2024) featuring updated ivonescimab data in advanced triple-negative breast cancer (TNBC), recurrent / metastatic head and neck squamous cell
carcinoma (HNSCC), and metastatic microsatellite-stable (MSS) colorectal cancer (CRC). Each trial from which the data was generated was a Phase II study conducted in China sponsored by Akeso, with data generated and analyzed by Akeso.
Based on the results of these recent Phase II data sets as well as previously presented data, we intend to explore further clinical
development of ivonescimab in solid tumor settings outside of metastatic non-small cell lung cancer, our current area of focus in its Phase III clinical trials.
Private Placement
On
September 11, 2024, we entered into the Purchase Agreements with multiple leading biotech institutional and individual accredited investors (the Investors), for the sale by us in a private placement (the Private
Placement) of an aggregate of 10,352,418 shares (the Shares) of our common stock, at purchase price of $22.70 per Share, which was the closing price of the common stock on September 11, 2024, for aggregate gross proceeds to us
of approximately $235.0 million (the Private Placement). The closing of the Private Placement occurred on September 13, 2024. The proceeds of the Private Placement are expected to be used for working capital and general
corporate purposes, including, without limitation, the repayment of principal in the amount of approximately $75.5 million of the $100 million promissory note issued by the Company to Robert W. Duggan, due April 1, 2025.
Our Chief Executive Officer, Executive Chairman and majority stockholder, Robert W. Duggan, Chief Executive Officer, President and member of
our Board of Directors (the Board), Dr. Mahkam Zanganeh, Chief Operating Officer, Chief Financial Officer and member of the Board, Manmeet Soni, Chief Accounting Officer, Bhaskar Anand, and member of the Board, Jeff Huber, through
his controlled entity Caspian Capital LLC, each participated as Investors in the Private Placement, purchasing an aggregate of 3,480,173 shares of common stock.
The offer and sale of shares of common stock issued to the Investors were not initially registered under the Securities Act or any state
securities laws. We relied on the exemption from the registration requirements afforded by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder for the Private Placement. In connection with their execution of the
respective Purchase Agreements, each of the Investors represented to us that such Investor is either (i) an accredited investor as defined in Regulation D of the Securities Act, or (ii) a qualified institutional buyer (as
defined in Rule 144A of the Securities Act), and that the securities purchased by such Investor were being acquired solely for its own account and for investment purposes and not with a present view to its future public sale or distribution.
On September 11, 2024, in connection with the Purchase Agreements, we entered into Registration Rights Agreements with the Investors (the
Registration Rights Agreements). The Registration Rights Agreements provide, among other things, that we will as soon as reasonably practicable file with the Securities and Exchange Commission (the SEC) a registration
statement registering the resale of the Shares. We agreed to use our