SKYE — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-11

• In October 2025, we announced topline results from our CBeyond Phase 2a proof-of-concept clinical trial of nimacimab administered as a subcutaneous injectable for the treatment of obesity and overweight in the United States. We reported the following 26 week data from the CBeyond Phase 2a study:

• consistent with previously reported data (Wilding et al., 2022, STEP-1 Trial Extension), which demonstrated that patients will gain a majority of weight back within 1-year of stopping treatment with semaglutide.

• Topline data from our CBeyond Phase 2a study was presented at ObesityWeek medical conference in November 2025.

• Patients who completed 26 weeks of treatment in the Phase 2a study were eligible to enroll in a 26-week extension for a potential full treatment duration of 52 weeks with a 13-week follow-up period. A total of 43 patients were enrolled, with 19 and 24 patients in the combination and monotherapy coho…

• In February 2026, we reported the following interim results from the combination cohort of our Phase 2a extension study:

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• In October 2025, we reported the following 26 week topline data from our ongoing CBeyond study:

• Patients who completed 26 weeks of treatment in the primary phase of the study were eligible to enroll in a 26-week extension for a potential full treatment duration of 52 weeks with a 13-week follow-up period. In September 2025, we completed the enrollment in the extension study. A total of 43 pati…

• We were incorporated under the laws of the State of Nevada on March 16, 2011. Our headquarters are based in San Diego, CA, and we also maintain administrative office space in San Francisco, CA. Since our incorporation, we have devoted substantially all of our efforts to building our product portfoli…

• Our general and administrative expenses have fluctuated year-over-year as we have entered into various strategic acquisitions to restructure and reposition our company. Additionally, as a business in the early stages of drug development we are in the process of scaling our operations by hiring addit…

• investor relations activities, legal and other administration and professional services to comply with the rules and regulations of the SEC, the Financial Industry Regulatory Authority ("FINRA") and Nasdaq. Other significant costs are expected to include legal fees relating to patent and corporate m…

Text added vs the prior filing · source: 10-Q · 2026-05-11

• Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock, which could negatively impact the market price and liquidity of our common stock and our ability to access the capital markets.

• Our common stock is listed on the Nasdaq Global Market, or Nasdaq. In order to maintain this listing, we must satisfy the continued listing requirements and standards of Nasdaq, including a minimum closing bid price requirement for our common stock of $1.00 per share. On March 17, 2026, we received …

• If the closing bid price of our common stock continues to trade below $1.00 per share, we intend to implement a reverse stock split to attempt to regain compliance, as disclosed in our Current Report on Form 8-K filed with the SEC on March 19, 2026. However, a reverse stock split requires stockholde…

• If we are unable to regain compliance within the applicable cure period, including any available extension, our common stock would be subject to delisting from Nasdaq. Further, even if we regain compliance, we may not be able to sustain compliance with Rule 5450(a)(1) in the long term. A delisting c…

Text added vs the prior filing · source: 10-Q · 2026-05-11

• No officers or directors, as defined in Rule 16a-1(f) under the Exchange Act, adopted and/or terminated a "Rule 10b5-1 trading arrangement" or a "non-Rule 10b5-1 trading arrangement," as defined in Regulation S-K Item 408, during the last fiscal quarter.

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• On August 25, 2025, Chris Twitty, the Company’s Chief Scientific Officer, adopted a Rule 10b5-1 trading plan. Dr. Twitty's Rule 10b5-1 trading plan is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c ) under the Exchange Act ("Rule 10b5-1(c)") and provides for the potential sa…

• No other officers or directors, as defined in Rule 16a‐1 (f) under the Exchange Act, adopted and/or terminated a "Rule 10b5‐1 trading arrangement" or a "non‐Rule 10b5‐1 trading arrangement," as defined in Regulation S‐K Item 408, during the last fiscal quarter.