Shelf Registration Statement and ATM Offering

During the period from July 1, 2021 through September 30, 2022, we did not sell ADSs pursuant to the Sales Agreement.

Research and development expenses consist primarily of costs incurred in connection with the development of our product candidates. These expenses include:

• expenses incurred under agreements with contract research organizations or

contract manufacturing organizations, as well as investigative sites and

consultants that conduct our clinical trials, preclinical studies and other

• manufacturing scale-up expenses and the cost of acquiring and manufacturing

• employee-related expenses, including salaries, related benefits, travel and

share-based compensation expenses for employees engaged in research and

development functions, as well as external costs, such as fees paid to outside

• license maintenance fees and milestone fees incurred in connection with

General and administrative expenses consist primarily of salaries, related benefits and share-based compensation expenses for personnel in executive and administrative functions. General and administrative expenses also include professional fees for legal, consulting, accounting and audit services.

Three and Nine Months Ended September 30, 2022 Compared to the Three and Nine Months Ended September 30, 2021

Below is a summary of our results of operations for the periods indicated:

Research and development expenses increased by approximately $7.1 million, or 180%, for the nine months ended September 30, 2022, as compared to the same period in 2021 also due primarily to increased clinical and preclinical activities.

Financing expense, net decreased by approximately $72 thousand for the nine months ended September 30, 2022 as compared to the same period in 2021. The increase was primarily due to foreign currency exchange rate loss partially offset by interest income from bank deposits,

• the progress and costs of our preclinical studies, clinical trials and other

• the scope, prioritization and number of our clinical trials and other research

• the amount of revenues and contributions we receive under future licensing,

development and commercialization arrangements with respect to our product

• the costs of the development and expansion of our operational infrastructure;

• the costs of filing, prosecuting, enforcing and defending patent claims and

• the costs and timing of securing manufacturing arrangements for clinical or

• the costs of contracting with third parties to provide sales and marketing

• the costs of acquiring or undertaking development and commercialization

• any cost that we may incur under future in- and out-licensing arrangements

relating to our product candidates.

Net cash used in operating activities $ (14,667 ) $ (9,480 ) $

Financing activities for the nine months ended September 30, 2021 reflect proceeds received from a private placement transaction that closed on March 22, 2021, pursuant to which the Company sold ADSs in an amount equal to $45.5 million, as well as sales of the Company's ADSs sold under the Sales Agreement.

We recognize compensation expenses for the fair value of non-employee awards over the requisite service period of each award.

Certain recently-issued accounting pronouncements are discussed in Note 2, Summary of Significant Accounting Policies, to the audited consolidated financial statements in our 2021 Annual Report.

© Edgar Online, source Glimpses