FORT COLLINS, Colo.,
Aug. 16, 2021 /PRNewswire/
-- Cytocom, Inc. (Nasdaq: CBLI), a leading
biopharmaceutical company creating next-generation immune therapies
for serious medical conditions that induce immune restoration and
homeostasis, today reported recent corporate updates and financial
results for the Company for the second quarter ended June 30, 2021, a period of time prior to the
completion of the merger between legacy Cleveland BioLabs and
the formerly private Cytocom Inc. Following the completion of the
merger on July 27, 2021, Cytocom,
Inc. emerged as a publicly traded entity.
"The first half of 2021 and recent weeks
have demonstrated management's commitment to driving
shareholder value by executing transactions that
have been transformative for Cytocom," stated
Michael K. Handley, President and
CEO of Cytocom.
"Following the successful merger between legacy
Cleveland BioLabs and the formerly private Cytocom Inc., we
believe we are well financed and positioned to become
a dominant player in the field of immune-modulation, with
one of the largest platforms of toll-like receptors in the
biopharmaceuticals industry."
Mr. Handley commented, "Our clinical- and development-stage
pipeline has never been stronger and showcases greatly enhanced
drug development capabilities that should drive future growth.
A research alliance with the La Jolla Institute of
Immunology will harness Cytocom's pipeline
of next-generation immunotherapies to advance discovery
work that could add new assets to a pipeline already exploring
eight drug candidates across 21 indications. By mid-2022, we expect
to be enrolling patients in several clinical
trials, including a Phase 3 trial for our lead drug
candidate, CYTO-201, in pediatric Crohn's disease, Phase
1b/2 trials for CYTO-205 as a
treatment for acute and 'long-haul' COVID-19 and
a Phase 1b/2 clinical trial for CYTO-401 in
pancreatic cancer."
Mr. Handley continued, "Beyond our clinical-stage
assets, we are exploring opportunities for the
immune-stimulatory toll-like receptor 5 agonist, entolimod,
and its next-generation molecule, GP532. These were the core
assets inherited from Cleveland BioLabs and our team is
already at work devising a plan to
develop entolimod/GP532 for the
multibillion-dollar hematologic market,
specifically as a treatment for chronic or
acute neutropenia and anemia in cancer patients.
We anticipate a clinical
trial could initiate later this
year."
Recent Corporate Updates:
- The Company's common stock began trading on Nasdaq under the
post-merger name, Cytocom, Inc., with the current ticker symbol
"CBLI" at the opening bell on July 28,
2021.
- Secured commitments for capital with agreements providing for
$90 million in debt and equity
financing to continue advancing the Company's product
pipeline.
-
- Financing led by $75
million equity commitment from GEM Global Yield LLC SCS and joined
by $17 million debt and equity
financing from Avenue Capital and Adit Ventures.
- The merger created an immunotherapy company with 21
development- and clinical-stage programs across eight different
assets.
-
- The merger joined two companies, each harnessing a different
and promising technology focused on delivering immune therapies for
oncology, emerging viruses and other indications. With Cytocom's
TLR4 and TLR9 antagonists, and the TLR5 agonists, entolimod and
GP532, Cytocom now has one of the largest platforms of toll-like
receptors (TLR) in the biopharmaceutical industry.
- Research alliance with La Jolla Institute for Immunology to
leverage world-class research infrastructure and Cytocom's
proprietary AIMS™ discovery platform to research potential new
immune-modulating agents for the treatment of cancer, emerging
viruses, autoimmune disorders, and hematological diseases.
- Advance clinical programs for Crohn's disease,
anemia/neutropenia, COVID-19 and pancreatic cancer.
-
- Productive end-of-Phase 2 meeting completed for CYTO-201 in
pediatric Crohn's disease; Patient enrollment in Phase 3 trial
expected to begin by year-end 2021.
- Reviewing the research and development pipeline inherited from
Cleveland BioLabs. The Company plans to evaluate ongoing
development requirements and medical needs of the toll-like
receptor 5 agonist, entolimod, in radiation emergencies.
- Exploring new indications for entolimod and we are excited
about the potential for toll-like receptor 5 agonists in treating
neutropenia and anemia in cancer patients.
- Completed Type C meeting for clinical trial exploring CYTO-401
in late-stage, non-resectable pancreatic cancer patients expected
in the first half of 2022.
- Phase 1b/2 trials for CYTO-205 in
acute and post-acute COVID-19 expected to enroll patients by
year-end 2021.
Mr. Handley concluded, "In terms of our financial and cash
position, Cytocom is well capitalized. The commitments
for $90 million in debt and equity
financing from GEM Global Yield LLC SCS, Avenue Capital,
and Adit Ventures should provide capital to advance
growth initiatives, further development of the company's internal
pipeline, and allow us to build on the momentum of recent weeks.
Our listing on Nasdaq should raise our visibility among the
investment community and public markets, enhance trading liquidity
and drive long-term shareholder value."
Second Quarter Financial Results:
- The Company did not generate revenue during the second quarter
of 2021, compared to $0.06 million in
revenue for the second quarter of 2020. The decrease was
attributable to the cessation of revenue from the Company's Joint
Warfighter Medical Research Program contract from the Department of
Defense (DoD) for the continued development of entolimod as a
medical radiation countermeasure, the cessation of revenue from the
Company's Peer Reviewed Medical Research Program from the DoD for
clinical development of entolimod as a medical radiation
countermeasure, and the cessation of revenue from its service
contract with Incuron.
- Research and development costs for the second quarter of 2021
decreased to $0.05 million compared
to $0.17 million for the second
quarter of 2020. The reduction in research and development costs
was due to a $0.12 million decrease
in expenses related to the biodefense applications of
entolimod.
- General and administrative costs for the second quarter of 2021
increased to $0.6 million compared to
$0.5 million for the second quarter
of 2020. This increase was primarily attributable to a $0.1 million increase in legal and professional
fees arising from the merger.
- Net loss for the quarter ended June 30,
2021, increased to $(0.7)
million, excluding minority interests, for the second
quarter of 2021, or $(0.04) per
share, compared to a net loss, excluding minority interests, of
$(0.4) million, or $(0.03) per share, for the same period in 2020.
The increase in net loss was primarily due to a reduction in other
income attributable to a one-time event experienced in 2020, an
increase in general and administrative costs, and reduced revenue,
partially offset by a reduction in research and development
expenses, and a decrease in the non-cash adjustment to the
Company's warrant liabilities.
- The Company has approximately $23
million in cash on hand and expects its cash position to
increase to $30 million by the end of
August 2021 with commitments to an
additional $60 million under the
Company's debt and equity arrangements with GEM Global Yield LLC
SCS and Avenue Venture Opportunities Fund, L.P. The Company
believes this, and other capital sources are sufficient to fund the
continued advancement of the Company's clinical-stage pipeline and
drive Cytocom toward multiple value infection points.
Conference Call and Webcast Details
Cytocom will host a conference call and live audio webcast
Monday, August 16, at 8:30 a.m. ET to discuss these financial results
and provide a business update.
Date:
|
Monday, August 16,
2021
|
Time:
|
8:30 a.m.
ET
|
Telephone Access
(US):
|
833-317-6003
|
Telephone Access
(International):
|
412-317-6061
|
Access Code for
All Callers:
|
3735775
|
A live webcast and audio archive for the event may be accessed
from the "Investors" section of the Cytocom website at
https://www.cytocom.com/investors/. A replay of the webcast
will be archived on the website for 90
days beginning at approximately 10:00 a.m. ET,
on August 16, 2021.
About Cytocom
Cytocom, Inc. is a clinical-stage biopharmaceutical company
developing novel immunotherapies targeting autoimmune,
neutropenia/anemia, emerging viruses and cancers based on a
proprietary platform designed to rebalance the body's immune system
and restore homeostasis. The company also has one of the largest
platforms of toll-like receptors (TLR4, TLR5, and TLR9) in the
biopharmaceutical industry, addressing conditions such as radiation
sickness and cancer treatment side
effects. Cytocom is developing therapies designed to
elicit directly within patients a robust and durable response of
antigen-specific killer T-cells and antibodies, thereby activating
essential immune defenses against autoimmune, inflammatory,
infectious diseases, and cancers.
Specifically, Cytocom has several clinical-stage
development programs for Crohn's disease, hematology, pancreatic
cancer, and COVID-19 in addition to expansion to fibromyalgia and
multiple sclerosis. To learn more about Cytocom, Inc.,
please visit www.cytocom.com.
Forward Looking Statements:
This press release contains forward-looking statements that
involve risks and uncertainties. All statements other than
statements of current or historical fact contained in this press
release, including statements regarding the Company's expected
clinical development timeline for the Company's product
candidates, future financial position, business strategy,
new products, budgets, liquidity, cash flows, projected costs,
regulatory approvals, the impact of any laws or regulations
applicable to the company, and plans and objectives of management
for future operations, are forward-looking statements. The
words "anticipate," "believe," "continue," "should," "estimate,"
"expect," "intend," "may," "plan," "project," "will," and similar
expressions, as they relate to us, are intended to identify
forward-looking statements. We have based these forward-looking
statements on the current expectations about future events held by
management. While we believe these expectations are reasonable,
such forward-looking statements are inherently subject to risks and
uncertainties, many of which are beyond the Company's control. The
company's actual future results may differ materially from those
discussed here for various reasons. The company discusses many of
these risks under the heading "Risk Factors" in the proxy
statement/prospectus filed with the SEC on June 10, 2021, as updated by the company's other
filings with the SEC. Factors that may cause such differences
include, but are not limited to, the outcome of any legal
proceedings that have been or may be instituted against the company
related to the merger between Cleveland BioLabs and Cytocom;
unexpected costs, charges or expenses resulting from the merger;
the Company's need for additional financing to meet the Company's
business objectives; the Company's history of operating losses; the
Company's ability to successfully develop, obtain regulatory
approval for, and commercialize the Company's products in a timely
manner; the Company's plans to research, develop and commercialize
the Company's product candidates; the Company's ability to attract
collaborators with development, regulatory and commercialization
expertise; the Company's plans and expectations with respect to
future clinical trials and commercial scale-up activities; the
Company's reliance on third-party manufacturers of the Company's
product candidates; the size and growth potential of the markets
for the Company's product candidates, and the Company's ability to
serve those markets; the rate and degree of market acceptance of
the Company's product candidates; regulatory requirements and
developments in the United States,
the European Union and foreign countries; the performance of the
Company's third-party suppliers and manufacturers; the success of
competing therapies that are or may become available; the Company's
ability to attract and retain key scientific or management
personnel; the Company's historical reliance on government funding
for a significant portion of the Company's operating costs and
expenses; government contracting processes and requirements; the
exercise of significant influence over the Company's company by the
Company's largest individual stockholder; the impact of the novel
coronavirus ("COVID-19") pandemic on the Company's business,
operations and clinical development; the geopolitical
relationship between the United
States and the Russian
Federation as well as general business, legal, financial and
other conditions within the Russian
Federation; the Company's ability to obtain and maintain
intellectual property protection for the Company's product
candidates; the Company's potential vulnerability to cybersecurity
breaches; and other factors discussed in the Company's SEC filings,
including the Company's Annual Report on Form 10-K for the year
ended December 31, 2020 and the risk
factors discussed under the heading "Risk Factors" in the proxy
statement/prospectus the company filed in connection with the
merger on June 10,
2021.
Given these uncertainties, you should not place undue
reliance on these forward-looking statements. The forward-looking
statements included in this press release are made only as of the
date hereof. We do not undertake any obligation to update any such
statements or to publicly announce the results of any revisions to
any of such statements to reflect future events or
developments.
Contacts:
Cytocom, Inc.
Nichol Ochsner
Senior V.P. Investor Relations and Corporate
Communications
(732) 754-2545
nichol.ochsner@cytocom.com
Tiberend Strategic Advisors,
Inc.
Maureen
McEnroe, CFA (Investors)
(212) 375-2664
mmcenroe@tiberend.com
Johanna Bennett (Media)
(212) 375-2686
jbennett@tiberend.com
CYTOCOM, INC. AND
SUBSIDIARIES
|
CONSOLIDATED
CONDENSED BALANCE SHEETS
|
|
|
June 30,
2021
|
|
December
31,
2020
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
13,776,955
|
|
|
$
|
1,946,418
|
|
Short-term
investments
|
—
|
|
|
324,870
|
|
Accounts
receivable
|
—
|
|
|
11,512
|
|
Other current
assets
|
46,825
|
|
|
31,506
|
|
Total current
assets
|
3,046,733
|
|
|
2,314,306
|
|
Equipment,
net
|
4,954
|
|
|
3,715
|
|
Other long-term
assets
|
—
|
|
|
—
|
|
Total
assets
|
$
|
13,828,734
|
|
|
$
|
2,318,021
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
|
60,503
|
|
|
$
|
167,773
|
|
Accrued
expenses
|
240,120
|
|
|
136,838
|
|
Total current
liabilities
|
300,623
|
|
|
304,611
|
|
Stockholders'
deficit:
|
|
|
|
Total Cytocom, Inc.
stockholders' equity (deficit)
|
8,569,489
|
|
|
(2,960,055)
|
|
Noncontrolling
interest in stockholders' equity
|
4,958,622
|
|
|
4,973,465
|
|
Total stockholders'
equity
|
13,528,111
|
|
|
2,013,410
|
|
Total liabilities and
stockholders' equity
|
$
|
13,828,734
|
|
|
$
|
$2,318,021
|
|
|
See Notes to
Consolidated Financial Statements
|
CYTOCOM, INC. AND
SUBSIDIARIES
|
CONSOLIDATED
CONDENSED STATEMENTS OF OPERATIONS
|
(UNAUDITED)
|
|
|
For the Three
Months
Ended June 30,
|
|
For the For the
Six Months
Ended June 30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenues:
|
|
|
|
|
|
|
|
Grants and
contracts
|
$
|
—
|
|
|
$
|
63,255
|
|
|
$
|
—
|
|
|
$
|
219,297
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
51,515
|
|
|
170,007
|
|
|
169,773
|
|
|
388,215
|
|
|
General and
administrative
|
617,722
|
|
|
485,439
|
|
|
1,050,726
|
|
|
867,605
|
|
|
Total operating
expenses
|
669,237
|
|
|
655,446
|
|
|
1,220,499
|
|
|
1,255,820
|
|
|
Loss from
operations
|
(669,237)
|
|
|
(592,191)
|
|
|
(1,220,499)
|
|
|
(1,036,523)
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest and other
income
|
2,295
|
|
|
508, 811
|
|
|
6,210
|
|
|
511,711
|
|
|
Foreign exchange gain
(loss)
|
(152)
|
|
|
(780)
|
|
|
(10)
|
|
|
(387)
|
|
|
Change in value of
warrant liability
|
—
|
|
|
(292,385)
|
|
|
—
|
|
|
(453,074)
|
|
|
Total other
income
|
2,143
|
|
|
215,646
|
|
|
6,200
|
|
|
58,250
|
|
|
Net loss
|
(667,094)
|
|
|
(376,544)
|
|
|
(1,214,299)
|
|
|
(978,272)
|
|
|
Net loss attributable
to noncontrolling interests
|
7,588
|
|
|
6,707
|
|
|
16,695
|
|
|
19,903
|
|
|
Net loss attributable
to Cytocom, Inc.
|
$
|
(659,506)
|
|
|
$
|
$(369,838)
|
|
|
$
|
(1,197,604)
|
|
|
$
|
(958,370)
|
|
|
Net loss attributable
to common stockholders
per share of common stock, basic and diluted
|
$
|
(0.04)
|
|
|
$
|
(0.03)
|
|
|
$
|
(0.08)
|
|
|
$
|
(0.08)
|
|
|
Weighted average
number of shares used in
calculating net loss per share, basic and diluted
|
15,468,945
|
|
|
11,947,364
|
|
|
14,847,980
|
|
|
11,651,761
|
|
|
|
See Notes to
Consolidated Financial Statements
|
CYTOCOM, INC. AND
SUBSIDIARIES
|
CONSOLIDATED
CONDENSED STATEMENTS OF CASH FLOWS
|
(UNAUDITED)
|
|
|
For the Six Months
Ended June 30,
|
|
2021
|
|
2020
|
Net cash used in
operating activities
|
$
|
(1,223,547)
|
|
|
$
|
(902,004)
|
|
Net cash provided by
investing activities
|
323,111
|
|
|
43,245
|
|
Net cash provided by
financing activities
|
12,723,288
|
|
|
3,165,640
|
|
Effect of exchange
rate change on cash and equivalents
|
7,685
|
|
|
(23,695)
|
|
Increase in cash and
cash equivalents
|
11,830,537
|
|
|
2,283,186
|
|
Cash and cash
equivalents at beginning of period
|
1,946,418
|
|
|
1,126,124
|
|
Cash and cash
equivalents at end of period
|
$
|
13,776,955
|
|
|
$
|
3,409,310
|
|
|
|
|
|
See Notes to
Consolidated Financial Statements
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/cytocom-inc-reports-second-quarter-2021-financial-results-301355490.html
SOURCE Cytocom Inc.