Graybug Vision, Inc. (Nasdaq: GRAY) (Graybug) and CalciMedica Inc.
(CalciMedica) today announced that they have entered into a
definitive merger agreement to combine the companies in an
all-stock transaction. The combined company will focus on further
developing CalciMedica’s lead product candidate Auxora™, a
proprietary, intravenous-formulated, small molecule calcium-release
activated calcium (CRAC) channel inhibitor, to treat
life-threatening inflammatory diseases, such as acute pancreatitis
(AP), asparaginase-associated pancreatitis (AAP), acute kidney
injury (AKI), and acute hypoxemic respiratory failure (AHRF), for
which there are no currently approved therapies. Auxora, which
modulates the immune response and protects against tissue cell
injury, has been studied in four completed efficacy clinical
trials, demonstrating positive and consistent clinical results, as
well as a favorable safety profile. Subject to each company’s
stockholder approval, the combined company is expected to trade on
the Nasdaq Global Market.
With approximately $35 million in cash and cash
equivalents anticipated from the combined company, including a
private placement financing expected to occur immediately prior to
the merger closing, the combined company is expected to have a cash
runway into the second half of 2024, funding the advancement of
Auxora in AP and AAP through clinical milestones in 2023. The
proposed merger is expected to close in the first quarter of
2023.
“After completing a comprehensive strategic
review, we determined that the proposed merger with CalciMedica
would provide the best return for Graybug stockholders moving
forward,” said Frederic Guerard, Pharm.D., Chief Executive Officer
of Graybug. “The decision by our management and board of directors
to select CalciMedica to be our merger partner will allow our
stockholders to participate in a company with a strong
clinical-stage pipeline poised to revolutionize treatment for
large, underserved patient populations suffering from
life-threatening inflammatory diseases worldwide.”
The combined company plans to advance the
development of Auxora through multiple clinical trials and
anticipates the following milestones in 2023:
- Results
from an ongoing Phase 2b clinical trial (CARPO) in AP patients with
systemic inflammatory response syndrome (SIRS) in second half of
2023 — CARPO is a randomized, double-blind,
placebo-controlled, dose-ranging trial intended to establish
efficacy in AP. It is expected to enroll 216 patients. AP can be a
life-threatening condition where the pancreas becomes inflamed,
sometimes leading to pancreatic cell death or necrosis, systemic
inflammation, and organ failure. There are an estimated 275,000
hospitalizations for AP annually in the United States, of which
approximately 40% present with SIRS, which can compromise the
function of other tissues or organs, including the lungs, and is
responsible for much of the mortality seen in AP. Details of the
CARPO trial are available on clinicaltrials.gov (NCT04681066).
- Results from an ongoing
investigator-sponsored Phase 1/2 clinical trial (CRSPA) in
pediatric patients who develop AAP as a result of treatment with
asparaginase for their underlying acute lymphoblastic leukemia
(ALL) in first half of 2023 — CRSPA is a Phase 1/2 trial
being conducted in pediatric patients with AAP, which is acute
pancreatitis resulting from the administration of asparaginase.
Treatment with asparaginase triggers the development of AAP in
7-10% of patients with ALL, with more than half of those patients
developing pancreatic necrosis. CalciMedica believes that the CRSPA
trial has defined an optimal pediatric dose and plans to meet with
the U.S. Food and Drug Administration in the first half of 2023 to
determine the path forward for a potential accelerated approval of
Auxora. Details of the CRSPA trial are available on
clinicaltrials.gov (NCT04195347).
“I’m extremely pleased to announce this proposed
merger with Graybug, which comes at a pivotal time for our
company,” said Rachel Leheny, Ph.D., Chief Executive Officer of
CalciMedica. “This transaction will provide us with the financial
strength to advance the development of our lead candidate, Auxora,
in life-threatening inflammatory illnesses. We have multiple
value-driving milestones expected over the next 12 months,
including data from our Phase 2b CARPO clinical trial in patients
with AP and a potential path to accelerated approval for Auxora in
AAP. At CalciMedica, we are focused on delivering novel therapies
that target CRAC channel inhibition to underserved patients with
life-threatening inflammatory diseases for which no approved
therapies exist. This transaction serves as a significant next step
in the advancement of our important mission.”
About the Proposed Transaction,
Management and OrganizationGraybug equity holders are
expected to collectively own approximately 29% of the combined
company, and pre-merger CalciMedica equity holders are expected to
collectively own approximately 71% of the combined company, in each
case, on a fully diluted basis using the treasury stock method. The
percentage of the combined company that Graybug’s equity holders
will own as of the close of the transaction is subject to certain
adjustments as described in the merger agreement, including an
adjustment based on the amount of Graybug’s net cash at
closing.
Following the merger, the combined company will
be headquartered in La Jolla, California and Rachel Leheny, Ph.D.,
will serve as Chief Executive Officer of the combined company. The
merger agreement provides that the board of directors of the
combined company will be composed of seven members, five selected
by CalciMedica and two selected by Graybug.
The merger agreement has been unanimously
approved by the boards of directors of both companies and is
subject to the approvals by the stockholders of each company and
other customary closing conditions.
Piper Sandler is serving as financial advisor
and Fenwick & West LLP is serving as legal counsel to Graybug.
Oppenheimer & Co. Inc. is serving as financial advisor and
Cooley LLP is serving as legal counsel to CalciMedica.
Investor Conference Call
InformationThe companies will host a conference call and
webcast presentation to discuss the proposed transaction as well as
CalciMedica’s technology and pipeline on Tuesday, November 22,
2022, at 8:00 a.m. ET. The live webcast and associated presentation
can be accessed on the Investors and Media section of Graybug’s
website at
https://investors.graybug.vision/news-events/events-presentations
and CalciMedica’s website at https://calcimedica.com/events, along
with an archived replay following the live event.
About GraybugGraybug is a
clinical-stage biopharmaceutical company focused on developing
transformative medicines for ocular diseases. Founded in 2011 based
on technology licensed from the Johns Hopkins University School of
Medicine, Graybug has offices in Redwood City, CA, and Baltimore,
MD. For more information, please visit www.graybug.vision.
About CalciMedicaCalciMedica is
a clinical-stage biopharmaceutical company focused on developing
first-in-class therapies for life-threatening inflammatory diseases
with high unmet need. CalciMedica’s proprietary technology targets
the inhibition of CRAC channels designed to modulate the immune
response and protect against tissue cell injury, with the potential
to provide therapeutic benefits in life-threatening inflammatory
diseases for which there are currently no approved therapies.
CalciMedica’s lead product candidate Auxora, a proprietary,
intravenous-formulated CRAC channel inhibitor, has demonstrated
positive and consistent clinical results and a favorable safety
profile in four completed efficacy clinical trials. Auxora is in
development for acute pancreatitis and asparaginase-associated
pancreatitis. CalciMedica was founded by scientists from
TorreyPines Therapeutics and the Harvard CBR Institute for
Biomedical Research, and is headquartered in La Jolla, CA. For more
information, please visit www.calcimedica.com.
Forward-Looking
Statements This
communication contains forward-looking statements which include,
but are not limited to, statements regarding expected timing,
approval, completion, effects and potential benefits of the
proposed merger and transactions contemplated by the merger
agreement, including the private placement; the expected cash and
cash equivalents of the combined company at closing; including the
expected cash runway and ability of such capital to provide
sufficient funding for the advancement of Auxora in AP and AAP
through clinical milestones in 2023; the expected ownership
percentages in the combined company; the expected management team
and board of directors of the combined company; the design and
potential benefits of Auxora; CalciMedica’s plans and expected
timing for developing its product candidates and potential benefits
of its product candidates, including its plans to approach the FDA
regarding accelerated approval for Auxora, the timing thereof and
optimism regarding the support therefor; and the development and
outcomes of CARPO and CRSPA trial programs, including the
milestones, data announcements, and any other potential results
related thereto. These forward-looking statements are subject to
the safe harbor provisions under the Private Securities Litigation
Reform Act of 1995. Graybug’s and CalciMedica’s expectations and
beliefs regarding these matters may not materialize. Actual
outcomes and results may differ materially from those contemplated
by these forward-looking statements as a result of uncertainties,
risks, and changes in circumstances, including but not limited to
risks and uncertainties related to: the ability of the parties to
consummate the merger and the transactions contemplated by the
merger agreement in a timely manner or at all; the satisfaction (or
waiver) of closing conditions to the consummation of the merger,
including but not limited to those with respect to: the approval of
Graybug’s stockholders; potential delays in consummating the
merger, and the ability of the combined company to timely and
successfully achieve the anticipated benefits of the merger; the
impact of health epidemics, including the COVID-19 pandemic, or
fluctuations in global financial markets on the parties’ respective
businesses and the actions the parties may take in response
thereto; the occurrence of any event, change or other circumstance
or condition that could give rise to the termination of the merger
agreement; the effect of the announcement or pendency of the merger
on Graybug’s or CalciMedica’s business relationships, operating
results and business generally; costs related to the merger; the
outcome of any legal proceedings that may be instituted against
Graybug, CalciMedica or any of their respective directors or
officers related to the merger agreement or the transactions
contemplated thereby; CalciMedica’s ability to execute its plans
and strategies; the ability to obtain and maintain regulatory
approval for Auxora; results from clinical trials may not be
indicative of results that may be observed in the future; potential
safety and other complications from Auxora; the scope progress and
expansion of developing and commercializing Auxora; the size and
growth of the market therefor and the rate and degree of market
acceptance thereof; and economic, business, competitive, and/or
regulatory factors affecting the businesses of Graybug and
CalciMedica generally. Additional risks and uncertainties that
could cause actual outcomes and results to differ materially from
those contemplated by the forward-looking statements are included
under the caption “Risk Factors” and elsewhere in Graybug’s most
recent filings with the Securities and exchange commission (“SEC”),
including its Quarterly Report on Form 10-Q for the quarter ended
June 30, 2022 and any subsequent reports on Form 10-K, Form 10-Q or
Form 8-K filed with the SEC from time to time and available at
www.sec.gov. These documents can be accessed on Graybug’s web page
at https://investors.graybug.vision/ by clicking on the link
“Financials and Filings.”
Important Additional
Information In
connection with the merger, Graybug intends to file with the SEC
preliminary and definitive proxy statements relating to the
proposed merger and any other relevant documents. The definitive
proxy statement will be mailed to Graybug’s stockholders determined
as of a record date, which is to be established for voting on the
proposed merger and any other matters to be voted on at the special
meeting. Before making any voting decision, investors and security
holders are urged to read the preliminary and definitive proxy
statements, any amendments, or supplements thereto, and any other
documents to be filed with the SEC in connection with the proposed
merger or incorporated by reference in the proxy statements when
they become available because they will contain important
information about Graybug, CalciMedica and the proposed merger.
Investors and security holders may obtain free copies of these
documents (when they are available) on the SEC’s web site at
www.sec.gov, on Graybug’s website at
https://investors.graybug.vision/ or by contacting Graybug’s
Investor Relations via email at IR@graybug.vision or by telephone
at (650) 487-2409.
No Offer or
Solicitation This
communication will not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor will there be any sale of securities in any
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction.
Participants in the
Solicitation Graybug
and its directors and certain of its executive officers may be
deemed participants in the solicitation of proxies from the
stockholders of Graybug in connection with the proposed merger and
any other matters to be voted on at the special meeting.
Information regarding the names, affiliations and interests of such
directors and executive officers will be included in the
preliminary and definitive proxy statements (when available).
Additional information regarding such directors and executive
officers is included in Graybug’s definitive proxy statement on
Schedule 14A for the 2022 Annual Meeting of Stockholders, which was
filed with the SEC on April 22,
2022. Information
regarding the persons who may, under SEC rules, be deemed
participants in the solicitation of proxies of Graybug’s
stockholders in connection with the proposed merger and any other
matters to be voted upon at the special meeting will be set forth
in the preliminary and definitive proxy statements (when available)
for the
merger. These
documents are available free of charge as described in the
preceding paragraph.
Graybug Contacts: |
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Investor
ContactIR@graybug.vision(650) 487-2409 |
Media
Contactmedia@graybug.vision(404) 384-0067 |
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CalciMedica
Contacts: |
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Investors and
MediaArgot Partners Sarah Sutton/Kevin
Murphycalcimedica@argotpartners.com(212) 600-1902 |
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