Item 7.01. Regulation FD Disclosure.
On January 25, 2022, Spero Therapeutics, Inc. (the "Company") updated its
investor presentation (the "Investor Presentation"), which the Company expects
to use in connection with general corporate presentations and will be made
available on the Company's website or distributed by the Company in hardcopy or
electronic form.
A copy of the Investor Presentation is attached as Exhibit 99.1 to this Current
Report on Form 8-K (this "Current Report"). The Investor Presentation is current
as of January 25, 2022, and the Company disclaims any obligation to update the
Investor Presentation after such date.
In accordance with General Instruction B.2 on Form 8-K, except as set forth
under Item 8.01 below, the information set forth in this Item 7.01 and the
Investor Presentation is "furnished" and shall not be deemed to be "filed" for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or
otherwise subject to the liabilities of that Section, nor shall such information
be deemed incorporated by reference in any filing under the Securities Exchange
Act of 1934, as amended, or the Securities Act of 1933, as amended.
Item 8.01. Other Events.
Certain portions of the Investor Presentation are attached as Exhibit 99.2 to
this Current Report and are filed with this Current Report.
Forward-looking Statements
This report, including the exhibits hereto, contains forward-looking statements.
These statements include, but are not limited to, statements about the potential
approval by the U.S. Food and Drug Administration ("FDA") of a New Drug
Application ("NDA") for tebipenem HBr; the timing of launch of tebipenem HBr;
future commercialization of tebipenem HBr; the potential number of patients who
could be treated by tebipenem HBr and market demand for tebipenem HBr generally;
the effectiveness of tebipenem HBr and its potential impact on healthcare
resource utilizations; expected broad access across payer channels for tebipenem
HBr; the expected pricing of tebipenem HBr and the anticipated shift in treating
patients from intravenous to oral administration; the initiation, timing,
progress and results of the Company's preclinical studies and clinical trials
and its research and development programs, including management's assessment of
such results; the direct and indirect impact of the pandemic caused by an
outbreak of a strain of coronavirus (COVID-19) on the Company's business and
operations; the timing of the availability of data from the Company's clinical
trials; the timing of the Company's filings with regulatory agencies; and the
Company's cash forecast and anticipated expenses and the availability of
additional non-dilutive funding from governmental agencies beyond any initially
funded awards. In some cases, forward-looking statements can be identified by
terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate,"
"could," "intent," "target," "project," "contemplate," "believe," "estimate,"
"predict," "potential" or "continue" or the negative of these terms or other
similar expressions. Actual results may differ materially from those indicated
by such forward-looking statements as a result of various important factors,
including any delays in review of the NDA submission by the FDA for any reason
or that the Physician Drug User Fee Act date for the NDA review may be revised;
the timing and content of advice given and decisions made by regulators,
including the FDA; the Company's need for additional funding; the lengthy,
expensive, and uncertain process of clinical drug development; whether results
obtained in preclinical studies and clinical trials will be indicative of
results obtained in future clinical trials; whether the Company's product
candidates will advance through the preclinical development and clinical trial
process on a timely basis, or at all, taking into account such factors as the
effects of possible regulatory delays, slower than anticipated patient
enrollment, manufacturing challenges, clinical trial design, clinical data
requirements and clinical outcomes; whether the results of such clinical trials
will warrant submission for approval from the FDA or equivalent foreign
regulatory agencies; whether the Company will satisfy all of the pre-conditions
to receipt of the development milestone payments under its agreements with
Everest Medicines and certain entities managed by HealthCare Royalty Management,
LLC (HCR); whether BARDA elects to exercise its second option under the
Company's agreement with BARDA; the Company's reliance on third parties to
manufacture, develop, and commercialize its product candidates, if approved; the
ability to develop and commercialize the Company's product candidates, if
approved; the Company's ability to re-initiate the Phase 2a clinical trial of
SPR720 for nontuberculous mycobacterial (NTM) pulmonary disease; the potential
impact of the COVID-19 pandemic; the Company's ability to retain key personnel
and to manage its growth; whether the Company's cash resources will be
sufficient to fund its continuing operations for the periods and/or trials
anticipated; and other factors discussed in the "Risk Factors"
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set forth in filings that the Company periodically makes with the U.S.
Securities and Exchange Commission. The forward-looking statements included in
this report, including the exhibits hereto, represent the Company's views as of
the date of this report. The Company anticipates that subsequent events and
developments will cause its views to change. However, while the Company may
elect to update these forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so. These forward-looking statements
should not be relied upon as representing the Company's views as of any date
subsequent to the date of this report.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit 99.1 Investor Presentation of Spero Therapeutics, Inc. dated
January 25, 2022.
Exhibit 99.2 Excerpts from Investor Presentation of Spero Therapeutics, Inc.
dated January 25, 2022.
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document).
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