$20.4
million in upfront financing with the potential to receive up
to an additional approximately $34.2
million for an aggregate of up to approximately $55 million
Upfront net proceeds to provide funds to
expand Auxora™ clinical development to include planned Phase
2 acute kidney injury (AKI) trial expected to begin in 1H
2024
Aggregate net proceeds (assuming exercise of
all accompanying warrants) expected to be sufficient to fund
CalciMedica through subsequent, potentially pivotal, clinical
trials and other work in CalciMedica's acute pancreatitis (AP) and
AKI programs
LA
JOLLA, Calif., Jan. 22,
2024 /PRNewswire/ -- CalciMedica, Inc.
(CalciMedica or the Company) (Nasdaq: CALC), a clinical-stage
biopharmaceutical company focused on developing novel calcium
release-activated calcium (CRAC) channel inhibition therapies for
acute and chronic inflammatory and immunologic diseases, today
announced that it has entered into a securities purchase agreement
with new and existing investors to raise up to approximately
$55 million in gross proceeds that
includes initial upfront funding of $20.4
million and up to an additional approximately $34.2 million upon exercise of accompanying
warrants.
The financing includes participation from new
healthcare-dedicated investors, including an affiliate of Deerfield
Management, Soleus Capital, Stonepine Capital Management and
Aisling Capital, as well as existing investors Sanderling
Ventures and Bering Capital.
"We are excited about this vote of confidence from leading life
science investors, which validates the progress we are making in
the clinic with Auxora™ targeting acute inflammatory and
immunologic diseases," said Rachel
Leheny, Ph.D., Chief Executive Officer of CalciMedica. "This
financing allows us to initiate clinical trials in AKI, a condition
with significant unmet medical need, and brings us closer to our
goal of making a meaningful difference in the lives of critically
ill patients."
JonesTrading Institutional Services LLC acted as the sole
placement agent for the private placement. H.C. Wainwright &
Co. acted as financial advisor to the Company.
Pursuant to terms of the securities purchase agreement,
CalciMedica will issue an aggregate of 5,113,812 shares of its
common stock (and, in lieu thereof, pre-funded warrants to purchase
351,352 shares of common stock) and accompanying warrants to
purchase up to an aggregate of 5,465,164 shares of its common stock
(or pre-funded warrants in lieu thereof) at a combined purchase
price of $3.70 per share and
accompanying warrants (or $4.3915 per
share and accompanying warrants for directors, employees or
consultants participating in the private placement), in accordance
with the "Minimum Price" requirement as defined in the Nasdaq
rules. The accompanying warrants consist of two tranches:
- Tranche A warrants to purchase up to 2,732,582 shares of common
stock at an exercise price of $5.36
per share for an aggregate of up to approximately $14.7 million are required to be exercised by the
earlier of 30 days following the announcement of topline data
(expected 1H 2024) from the CalciMedica's Phase 2b CARPO trial of Auxora in AP patients with
accompanying systemic inflammatory response syndrome (SIRS) and
December 31, 2024.
- Tranche B warrants to purchase up to 2,732,582 shares of common
stock at an exercise price of $7.15
per share for an aggregate of up to approximately $19.5 million are required to be exercised by the
earlier of 30 days following the announcement of topline data from
the planned Phase 2 clinical trial of Auxora in AKI (expected to
start in 1H 2024) and December 31,
2026.
The accompanying warrants are only exercisable in cash, except
in limited circumstances. In lieu of shares of common stock,
certain investors are purchasing pre-funded warrants at a combined
purchase price of $3.6999 per pre-funded warrant and
accompanying warrants, which equals the purchase price per share of
common stock and accompanying warrant, less
the $0.0001 per share exercise price of each pre-funded
warrant. The private placement is expected to close in two
closings with the initial closing on or about January 23, 2024 and the second closing expected
on or about February 5, 2024, in each
case, subject to satisfaction of customary closing conditions.
CalciMedica intends to use the upfront net proceeds from the
private placement to fund the Company's ongoing and planned Phase 2
clinical trials for Auxora in AP and AKI, respectively. The
aggregate net proceeds (assuming exercise of all accompanying
warrants) are expected to be sufficient to fund subsequent,
potentially pivotal, clinical trials and other work in
CalciMedica's AP and AKI programs.
The offer and sale of the foregoing securities are being made in
a transaction not involving a public offering, and the securities
have not been registered under the Securities Act of 1933, as
amended (the "Securities Act"), or applicable state securities
laws. Accordingly, the securities may not be reoffered or resold in
the United States except pursuant
to an effective registration statement or an applicable exemption
from the registration requirements of the Securities Act and such
applicable state securities laws. CalciMedica has agreed to file a
registration statement with the Securities and Exchange Commission
registering the resale of the shares of common stock purchased in
the private placement and shares of common
stock underlying the warrants.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy the securities, nor shall there be
any sale of the securities in any state in which such offer,
solicitation or sale would be unlawful prior to the registration or
qualification under the securities laws of such state. Any offering
of the securities under the resale registration statement will only
be made by means of a prospectus.
About CalciMedica
CalciMedica is a clinical-stage
biopharmaceutical company focused on developing novel CRAC channel
inhibition therapies for inflammatory and immunologic diseases.
CalciMedica's proprietary technology targets the inhibition of CRAC
channels to modulate the immune response and protect against tissue
cell injury, with the potential to provide therapeutic benefits in
life-threatening inflammatory and immunologic 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 in multiple completed efficacy clinical trials.
CalciMedica is currently conducting a Phase 2b trial for a planned 216 patients (called CARPO
– NCT04681066) for acute pancreatitis (AP) with systemic
inflammatory response syndrome (SIRS), with topline data expected
in the first half of 2024, as well as supporting the ongoing Phase
1/2 CRSPA asparaginase-induced pancreatic toxicity (AIPT)
study (called CRSPA – NCT04195347), with additional data expected
by 2H 2024. CalciMedica plans to initiate a Phase 2 study in acute
kidney injury (AKI) in 1H 2024. CalciMedica was founded by
scientists from Torrey Pines 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 the timing, terms and completion of the
proposed private placement; expected gross proceeds from the
proposed private placement and any additional gross proceeds that
may be received by CalciMedica upon exercise, if any, of the
accompanying warrants issued in the private placement; the expected
use of proceeds from the proposed private placement; expectations
that the aggregate net proceeds (if received) would be sufficient
to fund subsequent, potentially pivotal, clinical trials and other
work in CalciMedica's AP and AKI programs; the proposed private
placement bringing CalciMedica closer to its goal of making a
meaningful difference in the lives of critically ill patients; the
design and potential benefits of Auxora, including its potential to
reduce the severity of AP and AKI; CalciMedica's plans and expected
timing for developing its product candidates and potential benefits
of its product candidates; CalciMedica's plans and expected timing
with respect to its ongoing and planned clinical trials, including
the milestones, data announcements, expected enrollment, potential
benefits of 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. 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 impact of fluctuations in global financial markets
on CalciMedica's business and the actions it may take in response
thereto; 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; economic, business, competitive, and/or regulatory factors
affecting the business of CalciMedica generally; CalciMedica's
ability to protect its intellectual property position; and the
impact of government laws and regulations. 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" in
CalciMedica's Quarterly Report on Form 10-Q for the quarter ended
September 30, 2023 and elsewhere in
CalciMedica's 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 CalciMedica's web
page at ir.calcimedica.com/financials-filings/sec-filings.
CalciMedica Contact:
Investors and Media
Argot Partners
Sarah Sutton/Kevin Murphy
calcimedica@argotpartners.com
(212) 600-1902
View original content to download
multimedia:https://www.prnewswire.com/news-releases/calcimedica-announces-private-placement-of-up-to-approximately-55-million-302040624.html
SOURCE CalciMedica, Inc.
