Company: SCYX
Filing Date: 2025-03-12
Form Type: 10-K
Source: 0000950170-25-038044
Chunk: 51

Company: SCYNEXIS INC
Filing Date: 2025-03-12
Form: 10-K
Item: Item 1A
Chunk 51
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 fluctuate significantly from quarter to quarter. We anticipate that our expenses will increase substantially as we:

•conduct ongoing and initiate new clinical trials;

•maintain, expand and protect our intellectual property portfolio;

•hire additional clinical, quality control and scientific personnel; 

•maintain and create additional infrastructure to support our operations as a public company; and

•develop in-house product candidates or seek to in-license product candidates from third-parties.

In addition, our expenses could increase if we are required by the U.S. Food and Drug Administration, or the FDA, to perform studies in addition to, or that are larger than, those that we currently expect.

As a result of the foregoing, we expect to experience net losses and negative cash flows from operations for the foreseeable future, and we are unable to predict when, or if, we will be able to achieve profitability. Our losses and negative cash flows have had, and will continue to have a material adverse effect on our stockholders’ equity, financial position and statement of operations.

We expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance.

Our financial condition and operating results have varied significantly in the past and will continue to fluctuate from quarter to quarter or year to year due to a variety of factors, many of which are beyond our control. The following factors relating to our business, as well as factors described elsewhere in this report, may contribute to these fluctuations:

•the costs associated with completing the ongoing and anticipated clinical studies for ibrexafungerp and SCY-247, which are difficult for us to predict, including the potential costs associated with the anticipated resumption of the Phase 3 MARIO study if the clinical hold is lifted;

•any delays in regulatory review and approval of ibrexafungerp;

•delays in the timing of submission of any new drug application, or NDA, or supplement thereto, as well as commencement, enrollment and the timing of clinical testing, of any product candidates we may seek to develop;

•market acceptance of BREXAFEMME and any future product candidates for which we obtain FDA approval;

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•changes in regulations and regulatory policies;

•competition from existing products or new products that may emerge;

•the ability of patients or healthcare providers to obtain coverage of, or sufficient reimbursement for, any products we are able to develop;

•our ability to establish or maintain collaborations, licensing or other arrangements;

•costs related to, and