ITEM 2.02 Results of Operations and Financial Condition.
On
The information in Item 2.02 of this Current Report on Form 8-K shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it 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 any such filing, regardless of any general incorporation language in such filing.
ITEM 2.05 Costs Associated with Exit or Disposal Activities.
On
In connection with the Plan, the Company estimates that it will incur expenses
of approximately
ITEM 8.01 Other Events.
On
Key highlights of the Company's strategic growth plan include:
Prioritizing pipeline expansion through in-licensing and acquisition
• Active diligence process to identify and evaluate actionable clinical-stage assets for in-licensing and acquisition. • Primarily seeking clinical-stage assets targeting debilitating and rare disease therapeutic areas. • Potential asset targets must have compelling data, a well-defined commercial opportunity, and efficient clinical and regulatory development pathway. • Ability to leverage management team's collective prior experience in developing and commercializing more than 25 approved therapeutics.
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Out-licensing of bone-targeting drug platform and precision bone growth molecule NOV004 • Seeking to out-license bone-targeting drug platform and precision bone growth molecule NOV004. • Precision bone growth molecule NOV004 is an anabolic peptide engineered to precisely target and concentrate at the bone fracture site, resulting in rapid increases in bone density, strength, and expedited healing as demonstrated in extensive preclinical studies. • NOV004 has completed all IND-enabling studies, in addition to completion of a successful pre-IND meeting with theU.S. Food and Drug Administration . • Out-licensing effort to commence immediately with goal of identifying a partner and concluding the process by the end of 2023.
Forward-Looking Statements
Certain Statements in this Current Report on Form 8-K contain "forward-looking
statements" that are subject to substantial risks and uncertainties.
Forward-looking statements contained herein may be identified by the use of
words such as "anticipate," "expect," "believe," "plan," "intend," "will,"
"may," "should," "estimate," "project," "outlook," "runway," "forecast,"
"potential" or other similar words. Examples of forward-looking statements
include, among others, statements relating to the Company's cash position;
anticipated cost reductions, estimated restructuring costs, and cash
expenditures to be paid by the Company in connection with the Plan; its
expectations regarding its plan to out-license its bone-targeting drug platform
and NOV004, and related timing, and ability to find different partnership
opportunities to expand its development pipeline through in-licensing and
acquisition of clinical stage assets, and cost savings and expenses associated
therewith. Forward-looking statements are based on the Company's current
expectations and are subject to inherent uncertainties, risks, and assumptions
that are difficult to predict and could cause actual results to differ
materially from what the Company expects. Further, certain forward-looking
statements are based on assumptions as to future events that may not prove to be
accurate. Factors that could cause actual results to differ include, but are not
limited to, the risks and uncertainties described the section titled "Risk
Factors" in the Company's Quarterly Report on Form 10-Q filed with the
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