Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset
clinical-stage biopharmaceutical company focused on identifying,
developing and commercializing treatments in high unmet need areas
involving multi-drug resistant (MDR) bacterial infections and rare
diseases, today announced that it has entered into a definitive
agreement to sell up to $10,000,000 of Spero’s common stock in a
registered direct offering with Novo Holdings A/S to be issued in
two tranches. The first tranche of the offering consists of
465,983 shares sold at a price of $10.73 per share, for aggregate
gross proceeds to the Company of approximately $5,000,000, and is
expected to close on or about June 14, 2019, subject to the
satisfaction of customary closing conditions. The closing of the
second tranche of $5,000,000 is triggered upon the earlier of (i)
Spero’s public announcement of pharmacokinetic data from the
lead-in cohort in its Phase 3 clinical trial of SPR994 and (ii)
June 30, 2020. The number of shares to be sold in the second
tranche will be determined by the volume weighted average trading
price (VWAP) of Spero’s common stock around the trigger date.
Because the shares of common stock are being sold directly to Novo
Holdings A/S and not through a placement agent, underwriter or
securities broker or dealer, Spero is not paying any underwriting
discounts, commissions, concessions or similar compensation with
respect to the sale.
Spero intends to use the net proceeds to advance
its SPR720 program. SPR720 is Spero’s oral antibiotic being
developed for the treatment of non-tuberculous mycobacterial (NTM)
infections. In February 2019, SPR720 was granted Qualified
Infectious Disease Product (QIDP) designation by the U.S. Food and
Drug Administration for both the treatment of NTM infections and
lung infections caused by non-tuberculous mycobacteria (NTM) and
Mycobacterium tuberculosis (TB). The Novo REPAIR Fund focuses on
priority pathogens as defined by the World Health Organization and
the United States Centers for Disease Control, including TB. SPR720
is currently in a Phase 1 clinical trial in healthy volunteers, and
Spero expects top-line data from the trial in the second half of
2019.
“Spero and Novo Holdings are both committed to
addressing the growing, global problem of antibiotic resistance,
and funding from this offering will provide additional capital to
advance SPR720 and our robust pipeline of product candidates
designed to combat antibiotic resistance,” said Ankit
Mahadevia, M.D., Spero’s Chief Executive Officer.
Aleks Engel, Director of the REPAIR Impact Fund,
commented: “We are delighted to be able to support a novel program
targeting mycobacterial infections, one of the world’s greatest
killers, and the highly capable team at Spero developing it.”
The securities described above are being offered
pursuant to Spero’s shelf registration statement on Form S-3 (File
No. 333-228661) filed with the Securities and Exchange Commission
(SEC), which was declared effective on December 11, 2018. One
or more prospectus supplements relating to the offering will be
filed with the SEC and will be available on the SEC’s website at
www.sec.gov. Copies of such prospectus supplements and
accompanying prospectus may also be obtained directly from Spero by
contacting Spero Pharmaceuticals, Inc., Attn: Investor Relations,
3675 Massachusetts Avenue, 14th Floor, Cambridge, Massachusetts
02139, or by telephone at 857-242-1547.
This press release shall not constitute an offer
to sell or a solicitation of an offer to buy these securities, nor
shall there be any sale of these securities in any state or
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such state or jurisdiction. This offering
may only be made by means of a prospectus supplement and related
base prospectus.
About Spero
Spero Therapeutics, Inc. is a multi-asset,
clinical-stage biopharmaceutical company focused on identifying,
developing and commercializing novel treatments for
multidrug-resistant (MDR) bacterial infections and rare
diseases.
About The Novo Holdings REPAIR Impact
Fund
Novo Holdings founded in February 2018 the
REPAIR Impact Fund on behalf of Novo Nordisk Foundation to invest
in companies that are involved in the discovery and early
development of therapies against resistant microorganisms. The aim
of the REPAIR Impact Fund is to expand the therapeutic arsenal of
mankind in the fight against antibiotic resistance. Read more
at https://www.repair-impact-fund.com/
REPAIR is an acronym: Replenishing and Enabling
the Pipeline for Anti-Infective Resistance.
Novo Holdings A/S is a Danish private limited
liability company wholly owned by the Novo Nordisk Foundation. It
is the holding company of the Novo Group, comprising Novo Nordisk
A/S, Novozymes A/S and NNIT A/S, and manages the Foundation’s
assets. In addition to being the major shareholder in the
Novo Group companies, Novo Holdings provides seed and venture
capital to development-stage companies, takes significant ownership
positions in well-established companies within life science and
manages a broad portfolio of financial assets.
Forward Looking Statements
This press release may contain forward-looking
statements. These statements include, but are not limited to,
statements about Spero’s expectation that positive results from a
single pivotal Phase 3 clinical trial of SPR994 and ancillary
supportive studies to be conducted in parallel with the Phase 3
trial will support the approval of SPR994; the initiation, timing,
progress and results of Spero’s preclinical studies and clinical
trials and its research and development programs; statements
regarding management’s assessment of the results of such
preclinical studies and clinical trials; the timing of clinical
data, including the availability of pharmacokinetic data from the
lead-in cohort in the Phase 3 clinical trial of SPR994 and top-line
data from the Phase 1 clinical trial of SPR206 and the Phase 1
clinical trial of SPR720; statements regarding the completion of
the offering, including the satisfaction of the applicable closing
conditions and the issuance of the first and second tranches of
shares; and Spero’s cash forecast and anticipated expenses, the
sufficiency of its cash resources 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 whether
the FDA will accept a single pivotal study for approval
of SPR994; whether results obtained in preclinical studies and
clinical trials will be indicative of results obtained in future
clinical trials; whether Spero’s product candidates will advance
through the preclinical development and clinical trial process on a
timely basis, or at all, taking into account the effects of
possible regulatory delays, slower than anticipated patient
enrollment, manufacturing challenges, clinical trial design and
clinical outcomes; whether the results of such trials will warrant
submission for approval from the U.S. Food and Drug
Administration or equivalent foreign regulatory agencies;
whether Spero’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” set forth in
filings that Spero periodically makes with the U.S. Securities
Exchange Commission. The forward-looking statements included in
this press release represent Spero’s views as of the date of this
press release. Spero anticipates that subsequent events and
developments will cause its views to change. However, while Spero
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 Spero’s views as of any date subsequent to the date of
this press release.
Spero Investor and Media
Contact: Sharon Klahre Director, Investor Relations +1
857-242-1547 IR@sperotherapeutics.com
For more information on Novo Holdings or the
REPAIR Impact Fund contact:Aleks Engel, Director, REPAIR Impact
Fund +45 3527 6500 repair@novo.dk
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