SPRUCE BIOSCIENCES, INC. Item 1.01 Entry into a Material Definitive Agreement.
On
The Company has also granted to Kaken a right of first negotiation with respect
to the development, manufacturing and commercialization of tildacerfont for CAH
in
Pursuant to the Agreement, Kaken will make an upfront payment to the Company of
The Company has agreed to supply Kaken's clinical drug supply requirements of tildacerfont pursuant to a clinical supply agreement that the parties will enter into within ninety days of the effective date of the Agreement. During the Royalty Term, the Company has agreed to supply Kaken's requirements of tildacerfont pursuant to the Agreement and a commercial supply agreement to be entered into by the parties, though Kaken may procure alternate suppliers. Following the Royalty Term, Kaken at its option may continue to purchase Company-manufactured tildacerfont at a purchase price equal to the Company's manufacturing cost plus a low double-digit administrative fee.
Either party may terminate the Agreement (i) in the event the other party shall have materially breached its obligations thereunder and such default shall have continued for a specified period after written notice thereof or (ii) upon the bankruptcy or insolvency of the other party. In addition, the Company may terminate the Agreement upon prior written notice if Kaken ceases all development or commercialization activities for a specified period of time, subject to certain exceptions, or (ii) challenges the validity, enforceability or scope of any of the patents licensed by the Company to Kaken under the Agreement, subject to certain conditions. Kaken may terminate the Agreement at any time for convenience upon prior written notice provided within a specified period of time to the Company.
Item 2.02 Results of Operations and Financial Condition.
On
All of the information furnished in this Item 2.02 shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended ("Exchange Act"), and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
As noted in Item 2.02, on
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Increasing the Study Length, Lowering Age Eligibility, and Adding an Open-Label Extension to Make the Trial More Accessible to Patients and Families
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The Company amended the study length from a two-week PK and exploratory PD study to a 12-week study. The Company plans to also offer a two-year open-label extension to the 12-week study. These changes are designed to enable patients to retain access to the study drug for up to two years following completion of the study, and provide for observation of clinical outcomes, such as bone age and predicted adult height.
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The Company is lowering the minimum age requirement from six years to two years of age. Given the significant growth and development that occurs in children between the ages of two years and five years of age, this change is designed to provide important data on the impact of reductions in androgen levels and glucocorticoids ("GC") in younger children.
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Increasing the Amount of Data That Can Be Extrapolated from Program
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The following additional data will be collected to inform a potential Phase 3 registrational clinical trial, while allowing for observation of key clinical outcomes:
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two weeks of pediatric tildacerfont PK exposure data at two weight adjusted doses (50mg and 200mg) to inform a dose for the Phase 3 registrational program;
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four weeks of PD data to potentially show reduction in androstenedione (A4) and establish dose-response (day 1-28);
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A4 reduction data and GC reduction based on a protocol-specified algorithm (day 28-90); and
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sub-chronic safety data at 12 weeks.
Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995, including, but not limited to, the Company's expectations
regarding a Phase 3 registrational clinical trial of tildacerfont in patients
with CAH. These forward-looking statements involve risks and uncertainties, as
well as assumptions, which, if they prove incorrect or do not fully materialize,
could cause the Company's results to differ materially from those expressed or
implied by such forward-looking statements, including, but not limited to, risks
and uncertainties related to: topline data may not reflect the complete or final
results of a particular study or trial, and are subject to change; the Company's
ability to advance, obtain regulatory approval of and ultimately commercialize
its product candidates; the timing and results of preclinical and clinical
trials; the risk that positive results in a clinical trial may not be replicated
in subsequent trials or successes in early stage clinical trials may not be
predictive of results in later stage trials and preliminary interim data
readouts of ongoing trials may show results that change when such trials are
completed; the Company's ability to fund development activities and achieve
development goals; the Company's ability to protect its intellectual property;
the direct and indirect impacts of geopolitical and macroeconomic events on the
Company's business; and other risks and uncertainties described under the
heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year
ended
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number Description 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
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