REG - NetScientific PLC - PDS Provides Business Update & Full-Year Results
31/03/2022 13:30
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RNS Number : 8002G NetScientific PLC 31 March 2022
NetScientific plc
("NetScientific" or the "Group")
PDS Biotech Provides Business Update and Reports Fourth-Quarter and Full-Year 2021 Financial Results
London, UK - 31 March 2022 - NetScientific plc (AIM: NSCI), the
international life sciences and sustainability technology investment and
commercialisation Group, announces that its portfolio company, PDS
Biotechnology Corporation (Nasdaq: PDSB), today provided a business update and
announced its financial results for the year ended December 31, 2021.
PDS Highlights for the Period
· Achieved several milestones in the VERSATILE-002 Phase 2
combination trial of PDS0101-KEYTRUDA(®) (pembrolizumab) for recurrent
and/or metastatic human papillomavirus (HPV)16-associated head and neck
cancer. These milestones include:
o Presented preliminary safety data on a total of 18 checkpoint inhibitor
naïve patients at the 2022 Multidisciplinary Head and Neck Cancers Symposium.
Highlights from the presentation include the absence of dose-limiting
toxicities, drug discontinuation related to toxicity, or any significant
immune-related adverse events. Subjects received a median of 4 doses of
PDS0101 (range 1-5) and a median of 6 doses of KEYTRUDA(®) (range 1-13).
o Achieved preliminary objective response benchmarks that enabled us to
advance towards full enrolment of 54 patients in the checkpoint inhibitor
naïve patient cohort.
o Initiated enrolment in the checkpoint inhibitor-refractory cohort.
· Announced initiation of an investigator-initiated trial with Mayo
Clinic for patients with HPV-associated oropharyngeal cancer at high risk of
recurrence. The trial will evaluate PDS0101 as monotherapy and in combination
with KEYTRUDA(®).
· Announced encouraging preclinical data for the universal flu
vaccine that demonstrated a potent neutralization response against multiple
strains of the influenza virus and provided protection against infection after
challenge with a live H1N1 pandemic strain of influenza in preclinical animal
subjects.
· Granted U.S. Patent Application by the United States Patent and
Trademark Office for composition of matter and use of PDS0101, extending its
U.S. patent protection into 2037.
· Achieved enrolment objective of 30 patients in the checkpoint
inhibitor refractory arm of the NCI-led triple combination trial in March
2022.
· Achieved median overall survival at December 31, 2021 of 12
months for 30 HPV16-positive patients who had received at least one evaluation
in the NCI-led triple combination trial. Approximately 73% of the patients had
failed 3 prior treatment regimens including checkpoint inhibitor therapy.
Full-Year 2021 Financial Results
For the year ended December 31, 2021, the net loss was approximately $16.9
million, or $0.66 per basic share and diluted share, compared to a net loss of
approximately $14.8 million, or $0.89 per basic share and diluted share for
the year ended December 31, 2020.
For the year ended December 31, 2021, research and development expenses
increased to approximately $11.3 million compared to approximately $7.9
million for the year ended December 31, 2020. The increase of $3.4 million was
primarily attributable to an increase in regulatory and clinical costs of $2.6
million, non-cash stock-based compensation of $1.1 million and personnel costs
of $0.4 million, partially offset by an overall decrease in manufacturing and
facility costs of $0.7 million.
For the year ended December 31, 2021, general and administrative expenses
increased to approximately $10.2 million compared to approximately $7.0
million for the year ended December 31, 2020. The $3.2 million increase was
primarily attributable to an increase in personnel costs of $1.0 million,
non-cash stock-based compensation of $2.5 million, and facilities costs of
$0.1 million, partially offset by a decrease in professional fees of $0.4
million.
Total operating expenses for the year ended December 31, 2021 were
approximately $21.4 million, an increase of approximately 44% compared to
total operating expenses of approximately $14.9 million for the year ended
December 31, 2020.
The Company's cash balance as of December 31, 2021 was $65.2 million. Based on
the Company's available cash resources and cash flow projections, the Company
believes this balance is sufficient to fund Company operations and research
and development programs through the end of 2023.
Dr. Frank Bedu-Addo, President and CEO of PDS Biotech commented: "I'm very
pleased to report that we have undergone a 12-month period of incredible
productivity here at PDS Biotech. We've made significant clinical progress on
our lead oncology candidate, PDS0101, and presented at leading oncology
conferences on the promising efficacy and safety results of PDS0101 from two
of our ongoing Phase 2 clinical trials. Another phase 2 clinical study of
PDS0101 to be led by Mayo Clinic was initiated this month, to evaluate PDS0101
as a potential first-line neo-adjuvant treatment for patients with
oropharyngeal cancer prior to transoral robotic surgery. We also recently
announced encouraging pre-clinical data from our NIAID-funded universal flu
vaccine program. We continue to leverage our unique T-cell activating
platforms to advance additional pre-clinical oncology and infectious disease
candidates.
"Over the past year, we completed two licensing transactions and secured
additional intellectual property for our expanding pipeline. We also received
approval of a US composition of matter and use patent for PDS0101. We
strengthened our scientific advisory and leadership teams by adding
distinguished immuno-oncology experts to our scientific advisory board and
welcomed Matthew Hill as our Chief Financial Officer. We also added more than
$52 million to our balance sheet in 2021, significantly extending our cash
runway and ability to continue to advance our clinical and pre-clinical
programs. We look forward to an equally productive 2022, during which we
expect to announce additional data from our ongoing Phase 2 oncology trials
for PDS0101, as well as plan to progress at least one of our preclinical
programs, PDS0103 into the clinic."
Dr. Ilian Iliev, CEO of NetScientific, commented: "PDS has continued the
steady progress and build-out of the business, progressing multiple clinical
applications of the Versamune platform in immuno-oncology and infectious
disease vaccines. The company's careful planning and successful fund-raise in
2021 - in which NetScientific participated - has positioned PDS well to
weather market volatility, and continue to progress its clinical trials
pipeline."
The full text of the announcement from PDS Biotechnology is reproduced below
and is available online here:
https://www.pdsbiotech.com/investors/news-center/press-releases/press-releases1/118-2022-news/601-iotechrovidesusinesspdateandeportsourthua20220331
(https://www.pdsbiotech.com/investors/news-center/press-releases/press-releases1/118-2022-news/601-iotechrovidesusinesspdateandeportsourthua20220331)
###
FLORHAM PARK, N.J., March 31, 2022 (GLOBE NEWSWIRE) -- PDS Biotechnology
Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing
a growing pipeline of molecularly targeted cancer immunotherapies and
infectious disease vaccines based on the Company's proprietary
Versamune(®) and Infectimune™ T-cell activating technologies, today
provided a business update and announced its financial results for the year
ended December 31, 2021.
"I'm very pleased to report that we have undergone a 12-month period of
incredible productivity here at PDS Biotech," commented Dr. Frank Bedu-Addo,
President and Chief Executive Officer of the Company. "We've made significant
clinical progress on our lead oncology candidate, PDS0101, and presented at
leading oncology conferences on the promising efficacy and safety results of
PDS0101 from two of our ongoing Phase 2 clinical trials. Another phase 2
clinical study of PDS0101 to be led by Mayo Clinic was initiated this month,
to evaluate PDS0101 as a potential first-line neo-adjuvant treatment for
patients with oropharyngeal cancer prior to transoral robotic surgery. We also
recently announced encouraging pre-clinical data from our NIAID-funded
universal flu vaccine program. We continue to leverage our unique T-cell
activating platforms to advance additional pre-clinical oncology and
infectious disease candidates."
Dr. Bedu-Addo continued: "Over the past year, we completed two licensing
transactions and secured additional intellectual property for our expanding
pipeline. We also received approval of a US composition of matter and use
patent for PDS0101. We strengthened our scientific advisory and leadership
teams by adding distinguished immuno-oncology experts to our scientific
advisory board and welcomed Matthew Hill as our Chief Financial Officer. We
also added more than $52 million to our balance sheet in 2021, significantly
extending our cash runway and ability to continue to advance our clinical and
pre-clinical programs. We look forward to an equally productive 2022, during
which we expect to announce additional data from our ongoing Phase 2 oncology
trials for PDS0101, as well as plan to progress at least one of our
preclinical programs, PDS0103 into the clinic."
Fourth Quarter 2021 and Recent Business Highlights:
· Achieved several milestones in the VERSATILE-002 Phase 2
combination trial of PDS0101-KEYTRUDA(®) (pembrolizumab) for recurrent
and/or metastatic human papillomavirus (HPV)16-associated head and neck
cancer. These milestones include:
o Presented preliminary safety data on a total of 18 checkpoint inhibitor
naïve patients at the 2022 Multidisciplinary Head and Neck Cancers Symposium.
Highlights from the presentation include the absence of dose-limiting
toxicities, drug discontinuation related to toxicity, or any significant
immune-related adverse events. Subjects received a median of 4 doses of
PDS0101 (range 1-5) and a median of 6 doses of KEYTRUDA(®) (range 1-13).
o Achieved preliminary objective response benchmarks that enabled us to
advance towards full enrollment of 54 patients in the checkpoint inhibitor
naïve patient cohort.
o Initiated enrollment in the checkpoint inhibitor-refractory cohort.
· Announced initiation of an investigator-initiated trial with Mayo
Clinic for patients with HPV-associated oropharyngeal cancer at high risk of
recurrence. The trial will evaluate PDS0101 as monotherapy and in combination
with KEYTRUDA(®).
· Announced encouraging preclinical data for the universal flu
vaccine that demonstrated a potent neutralization response against multiple
strains of the influenza virus and provided protection against infection after
challenge with a live H1N1 pandemic strain of influenza in preclinical animal
subjects.
· Granted U.S. Patent Application by the United States Patent and
Trademark Office for composition of matter and use of PDS0101, extending its
U.S. patent protection into 2037.
· Achieved enrollment objective of 30 patients in the checkpoint
inhibitor refractory arm of the NCI-led triple combination trial in March
2022.
· Achieved median overall survival at December 31, 2021 of 12
months for 30 HPV16-positive patients who had received at least one evaluation
in the NCI-led triple combination trial. Approximately 73% of the patients had
failed 3 prior treatment regimens including checkpoint inhibitor therapy.
Full-Year 2021 Financial Results
For the year ended December 31, 2021, the net loss was approximately $16.9
million, or $0.66 per basic share and diluted share, compared to a net loss of
approximately $14.8 million, or $0.89 per basic share and diluted share for
the year ended December 31, 2020.
For the year ended December 31, 2021, research and development expenses
increased to approximately $11.3 million compared to approximately $7.9
million for the year ended December 31, 2020. The increase of $3.4 million was
primarily attributable to an increase in regulatory and clinical costs of $2.6
million, non-cash stock-based compensation of $1.1 million and personnel costs
of $0.4 million, partially offset by an overall decrease in manufacturing and
facility costs of $0.7 million.
For the year ended December 31, 2021, general and administrative expenses
increased to approximately $10.2 million compared to approximately $7.0
million for the year ended December 31, 2020. The $3.2 million increase was
primarily attributable to an increase in personnel costs of $1.0 million,
non-cash stock-based compensation of $2.5 million, and facilities costs of
$0.1 million, partially offset by a decrease in professional fees of $0.4
million.
Total operating expenses for the year ended December 31, 2021 were
approximately $21.4 million, an increase of approximately 44% compared to
total operating expenses of approximately $14.9 million for the year ended
December 31, 2020.
The Company's cash balance as of December 31, 2021 was $65.2 million. Based on
the Company's available cash resources and cash flow projections, the Company
believes this balance is sufficient to fund Company operations and research
and development programs through the end of 2023.
Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM EDT on Thursday, March
31, 2022. Participants should dial 877-407-3088 (United States) or
201-389-0927 (International) and mention PDS Biotechnology. A live webcast of
the conference call will also be available on the investor relations page of
the Company's corporate website
at https://pdsbiotech.com/investors/news-center/events
(https://www.globenewswire.com/Tracker?data=FwzD2XpsO3jEGQiWMm35WDqx9IUc_eE8Yoi-XAxmZ5RqtqFoP-Dyda3xgY3fIAziM0ZZvJ1UhfhaknN9ddUN9BY0h9Z1gANHUPaeDGWJZKMiRuouR9lCA7tElc7x4EbPMdVUetBpe5rpl1RljItPdxrRY3VncmuA1QGaDuptSvY=)
. After the live webcast, the event will be archived on PDS Biotech's website
for six months.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing
pipeline of molecularly targeted cancer and infectious disease immunotherapies
based on the Company's proprietary Versamune(®) and Infectimune™ T-cell
activating technology platforms. Our Versamune(®)-based products have
demonstrated the potential to overcome the limitations of current
immunotherapy by inducing in vivo, large quantities of high-quality, highly
potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS
Biotech has developed multiple therapies, based on combinations of
Versamune(®) and disease-specific antigens, designed to train the immune
system to better recognize diseased cells and effectively attack and destroy
them. The Company's pipeline products address various cancers including
HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal,
vulvar) and breast, colon, lung, prostate and ovarian cancers.
Our Infectimune™ -based vaccines have demonstrated the potential to induce
not only robust and durable neutralizing antibody responses, but also powerful
T-cell responses including long-lasting memory T-cell responses. To learn
more, please visit www.pdsbiotech.com
(https://www.globenewswire.com/Tracker?data=5dWy6SP-Pf0d5YWTvgK0QW1on5X7DC7K5zIihBA-4xVBTdYuwhmpUfgSH9bOGW4pTb8XuDe4u68gQVAZ7VkMCWYhPCMMsEvl2u93g1GCODsdKWE1DUcvE8ziCiz4SirgQ_OkMI1-7gRCAoN49FC_KUK9SgNvc5pDTWvJot6EsOv7FgGxRoiuUDkMfsAlmyglr63zN5knExgqjxd6zbbAd7OkjmudszTozaaXtUTqmWy6BoL7Hl8RWi5dmT0It-oN)
or follow us on Twitter at @PDSBiotech.
Forward Looking Statements
This communication contains forward-looking statements (including within the
meaning of Section 21E of the United States Securities Exchange Act of 1934,
as amended, and Section 27A of the United States Securities Act of 1933, as
amended) concerning PDS Biotechnology Corporation (the "Company") and other
matters. These statements may discuss goals, intentions and expectations as to
future plans, trends, events, results of operations or financial condition, or
otherwise, based on current beliefs of the Company's management, as well as
assumptions made by, and information currently available to, management.
Forward-looking statements generally include statements that are predictive in
nature and depend upon or refer to future events or conditions, and include
words such as "may," "will," "should," "would," "expect," "anticipate,"
"plan," "likely," "believe," "estimate," "project," "intend," "forecast,"
"guidance", "outlook" and other similar expressions among others.
Forward-looking statements are based on current beliefs and assumptions that
are subject to risks and uncertainties and are not guarantees of future
performance. Actual results could differ materially from those contained in
any forward-looking statement as a result of various factors, including,
without limitation: the Company's ability to protect its intellectual property
rights; the Company's anticipated capital requirements, including the
Company's anticipated cash runway and the Company's current expectations
regarding its plans for future equity financings; the Company's dependence on
additional financing to fund its operations and complete the development and
commercialization of its product candidates, and the risks that raising such
additional capital may restrict the Company's operations or require the
Company to relinquish rights to the Company's technologies or product
candidates; the Company's limited operating history in the Company's current
line of business, which makes it difficult to evaluate the Company's
prospects, the Company's business plan or the likelihood of the Company's
successful implementation of such business plan; the timing for the Company or
its partners to initiate the planned clinical trials for PDS0101, PDS0203 and
other Versamune and Infectimune-based product candidates; the future success
of such trials; the successful implementation of the Company's research and
development programs and collaborations, including any collaboration studies
concerning PDS0101, PDS0203 and other Versamune and Infectimune-based product
candidates and the Company's interpretation of the results and findings of
such programs and collaborations and whether such results are sufficient to
support the future success of the Company's product candidates; the success,
timing and cost of the Company's ongoing clinical trials and anticipated
clinical trials for the Company's current product candidates, including
statements regarding the timing of initiation, pace of enrollment and
completion of the trials (including the Company's ability to fully fund its
disclosed clinical trials, which assumes no material changes to our currently
projected expenses), futility analyses, presentations at conferences and data
reported in an abstract, and receipt of interim results (including, without
limitation, any preclinical results or data), which are not necessarily
indicative of the final results of the Company's ongoing clinical trials; any
Company statements about its understanding of product candidates mechanisms of
action and interpretation of preclinical and early clinical results from its
clinical development programs and any collaboration studies; and other
factors, including legislative, regulatory, political and economic
developments not within the Company's control, including unforeseen
circumstances or other disruptions to normal business operations arising from
or related to COVID-19. The foregoing review of important factors that could
cause actual events to differ from expectations should not be construed as
exhaustive and should be read in conjunction with statements that are included
herein and elsewhere, including the risk factors included in the Company's
annual and periodic reports filed with the SEC. The forward-looking statements
are made only as of the date of this press release and, except as required by
applicable law, the Company undertakes no obligation to revise or update any
forward-looking statement, or to make any other forward-looking statements,
whether as a result of new information, future events or otherwise.
Versamune(®) is a registered trademark and Infectimune is a trademark of PDS
Biotechnology. KEYTRUDA(®) is a registered trademark of Merck Sharp &
Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Consolidated Balance Sheets
December 31, December 31,
2021
2020
ASSETS
Current assets:
Cash and cash equivalents $ 65,242,622 $ 28,839,565
Prepaid expenses and other 1,597,569 1,497,665
Total current assets 66,840,191 30,337,230
Property and equipment, net 86 5,443
Operating lease right-to-use asset 357,611 547,706
Total assets $ 67,197,888 $ 30,890,379
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,309,403 $ 1,415,224
Accrued expenses 2,187,704 1,735,322
Operating lease obligation - short term 258,924 119,904
Total current liabilities 3,756,031 3,270,450
Noncurrent liability:
Operating lease obligation - long term 231,430 490,353
Total liabilities 3,987,461 3,760,803
STOCKHOLDERS' EQUITY
Common stock, $0.00033 par value, 75,000,000 shares authorized at December 31, 9,387 7,346
2021 and December 31, 2020, 28,448,612 shares and 22,261,619 shares issued and
outstanding at
December 31, 2021 and December 31, 2020, respectively
Additional paid-in capital 123,904,602 70,907,315
Accumulated deficit (60,703,562 ) (43,785,085 )
Total stockholders' equity 63,210,427 27,129,576
Total liabilities and stockholders' equity $ 67,197,888 $ 30,890,379
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Consolidated Statements of Operations and Comprehensive Loss
Year Ended December 31,
2021 2020
Operating expenses:
Research and development expenses $ 11,254,538 $ 7,924,450
General and administrative expenses 10,184,773 6,977,936
Total operating expenses 21,439,311 14,902,386
Loss from operations (21,439,311 ) (14,902,386 )
Other income
Interest income 4,346 55,006
Loss before income taxes (21,434,965 ) (14,847,380 )
Benefit from income taxes 4,516,488 -
Net loss and comprehensive loss $ (16,918,477 ) $ (14,847,380 )
Per share information:
Net loss per share, basic and diluted $ (0.66 ) $ (0.89 )
Weighted average common shares outstanding basic and diluted 25,597,125 16,745,044
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Consolidated Statements of Cash Flows
Year Ended December 31,
2021 2020
Cash flows from operating activities:
Net loss $ (16,918,477 ) $ (14,847,380 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense 4,074,458 432,321
Stock-based 401K company common match 35,747 19,967
Depreciation expense 5,357 15,608
Operating lease expense 241,031 160,684
Changes in operating assets and liabilities:
Prepaid expenses and other assets (99,904 ) 810,797
Accounts payable (105,821 ) 217,504
Accrued expenses 452,382 637,682
Restructuring reserve - (498,185 )
Operating lease liabilities (170,839 ) (98,133 )
Net cash used in operating activities (12,486,066 ) (13,149,135 )
Cash flows from financing activities:
Proceeds from exercise of warrants - 70,459
Proceeds from exercise of stock options 344,125 -
Proceeds from issuances of common stock, net of issuance costs 48,544,998 29,756,502
Net cash provided by financing activities 48,889,123 29,826,961
Net increase in cash and cash equivalents 36,403,057 16,677,826
Cash and cash equivalents at beginning of period 28,839,565 12,161,739
Cash and cash equivalents at end of period $ 65,242,622 $ 28,839,565
###
This announcement contains inside information for the purposes of Article 7 of
the UK version of Regulation (EU) No 596/2014 which is part of UK law by
virtue of the European Union (Withdrawal) Act 2018, as amended ("MAR"). Upon
the publication of this announcement via a Regulatory Information Service,
this inside information is now considered to be in the public domain.
For more information, please contact:
NetScientific Via Walbrook PR
Ilian Iliev, CEO
WH Ireland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel +44 (0)20 7220 1666
Walbrook PR +44 (0)20 7933 8780 or netscientific@walbrookpr.com
Nick Rome / Nicholas Johnson / Paul McManus 07748 325 236 / 07884 664 686 / 07980 541 893
About NetScientific
NetScientific plc (AIM: NSCI) is a holding company, that invests in, develops,
commercialises and realises shareholder value in life sciences/healthcare,
sustainability and technology companies, which offer significant growth
potential predominately in the UK and USA, as well as globally.
With the acquisition of EMV Capital in August 2020, the Group doubled its
portfolio from 8 to 17 companies, either through direct subsidiary, balance
sheet investment or capital under advisory, varying from start-up private
companies to publicly listed equities.
NetScientific delivers shareholder returns through a proactive and hands-on
management approach to their portfolio companies; identifying, investing in,
and helping to build game-changing companies. The Group targets value
inflection points and the release of value through partial or full exits from
trade sales, public listings, or equity sales. The Company has a strong
transatlantic and growing international presence, providing attractive
expansion prospects.
NSCI can deploy a capital-light investment structure; utilising the power of
the PLC Brand, and the NetScientific balance sheet to anchor future
investments and achieve a multiplier effect by attracting 3rd party investment
for the portfolio companies.
NetScientific is headquartered in London, United Kingdom, and was admitted to
trading on AIM, a market operated by the London Stock Exchange, in 2013
(website: netscientific.net (https://netscientific.net/) ).
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