IKENA ONCOLOGY, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q) – Marketscreener.com

Our discovery efforts are focused on additional targeted oncology programs, following our philosophy of designing treatments for patients’ populations identified through the genetic make-up of their tumors. Our pre-clinical pipeline is growing to include additional Hippo pathway and RAS pathway-targeting programs, including our program against the novel target extracellular signal related kinase 5 (“ERK5”). We are generating mechanistic and translational data to identify underserved RAS-mutated cancer patient populations and assess approaches that could benefit them.
We were incorporated as a Delaware corporation on March 2, 2016, and our headquarters is located in Boston, Massachusetts. Since our inception, we devoted our efforts to organizing and staffing our company, acquiring intellectual property, business planning,
To date, we have not had any products approved for sale and have not generated any revenue from product sales.

advance the development of our product candidate pipeline;

initiate and continue research and preclinical and clinical development of potential new product candidates;

maintain, expand and protect our intellectual property portfolio;

acquire or in-license additional product candidates and technologies;

expand our infrastructure and facilities to accommodate our growing employee base and ongoing development activities;

require the manufacture of larger quantities of our product candidates for clinical development and potential commercialization;

seek marketing approvals for our product candidates that successfully complete clinical trials, if any;

establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval; and

See “Risk Factors” for a discussion of the potential adverse impact of the COVID-19 pandemic on our business, financial condition, and results of operations.
Components of our Results of Operations
All of our revenue has been derived from research and development revenue under our BMS Collaboration Agreement.
Collaboration Agreement and Stock Purchase Agreement with BMS
As previously announced, in part due to a component shortage relating to COVID-19 vaccine manufacturing, we paused the development IK-412 for the remainder of the BMS contract term once the ongoing committed CMC work has been completed.
Our operating expenses since inception consist solely of research and development costs and general and administrative costs.
Research and Development Expenses

employee-related expenses, including salaries, related benefits and stock-based compensation expense, for employees engaged in research and development functions;

expenses incurred under agreements with CROs which are primarily engaged to support our clinical trials;

the cost of acquiring and manufacturing preclinical study materials, including manufacturing registration and validation batches;

facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities and insurance;

acquisition of in-process research and development assets that have no alternative future use;

costs related to compliance with quality and regulatory requirements; and

payments made under third-party licensing agreements.

our ability to add and retain key research and development personnel;

our ability to successfully develop, obtain regulatory approval for, and then successfully commercialize our product candidates;

our successful enrollment in and completion of clinical trials, including our ability to generate positive data from any such trials;

the size and cost of any future clinical trials for existing or future product candidates in our pipeline;

the costs associated with the development of any additional programs we identify in-house or acquire through collaborations and other arrangements and the success of such collaborations;

the terms and timing of any additional collaborations, license or other arrangement, including the timing of any payments thereunder;

our ability to establish and maintain agreements and operate with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if any of our product candidates are approved;

costs related to manufacturing of our product candidates or to account for any future changes in our manufacturing plans;

our ability to obtain and maintain third-party insurance coverage and adequate reimbursement for our product candidates, if and when approved;

the acceptance of our product candidates, if approved, by patients, the medical community and third-party payors;

effectively competing with other products if our product candidates are approved;

our ability to maintain a continued acceptable safety profile for our therapies following approval.
General and Administrative Expenses
Results of Operations
Comparison of the three months ended March 31, 2022 and 2021
The following table summarizes our results of operations (in thousands):
Research and Development Expenses
Total research and development expenses $ 14,343 $ 10,021 $
General and Administrative Expenses
Sources of Liquidity
Cash Flows
The following table summarizes our sources and uses of cash (in thousands):
Ended March 31,
Net cash provided (used in) by operating activities $ (19,784 )
132,528Net Cash Used in Operating ActivitiesNet Cash Used in Investing Activities
The increase in cash used investing activities of $165.2 million was primarily attributable the purchases of marketable securities of $166.0 million in connection with the Company investing its excess cash.
Net Cash Provided by Financing Activities
The decrease in cash provided by financing activities of $132.0 million primarily reflects cash proceeds received in connection with the IPO in March of 2021.

the costs, timing and outcome of regulatory review of our product candidates;

our ability to establish and maintain collaborations on favorable terms, if at all;

the achievement of milestones or occurrence of other developments that trigger payments under any collaboration agreements we might have at such time;

the costs and timing of future commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;

the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval;

the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

the in-licensing or acquisition of assets in line with our strategy;

our headcount growth and associated costs as we expand our business operations and our research and development activities; and

the costs of operating as a public company.
Contractual Obligations
Critical Accounting Policies and Use of Estimates
Recently Issued Accounting Pronouncements
© Edgar Online, source Glimpses


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