4D pharma Reports Full Year 2021 Financial Results, Operational Highlights, and Guidance for Key Milestones in 2022
March 31 2022 - 5:27PM
Business Wire
4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical
company leading the development of Live Biotherapeutic products
(LBPs), a novel class of drug derived from the microbiome, today
reported financial results for the full year ending December 31,
2021 and highlighted its key corporate objectives for 2022.
“2021 was a productive year for 4D pharma. We reported promising
signals in the clinic from our lead candidates in immuno-oncology
and inflammatory disease, and entered into our second clinical
collaboration in oncology, further validating the potential for
single strain Live Biotherapeutics to treat systemic disease and
the MicroRx platform. Additionally, we completed the merger with
Longevity Acquisition Corporation which led to 4D pharma being
listed on the NASDAQ exchange, providing us access and visibility
across the US capital markets,” said Duncan Peyton, Chief Executive
Officer of 4D pharma. “Already in 2022 we have continued this
progress, and look forward to updating shareholders as we execute
on our corporate objectives throughout the year.”
Full Year 2021 Financial Highlights
- Cash and cash equivalents of $21.0 million as of December 31,
2021
- Net assets of $32.4 million as of December 31, 2021
- Loss and total comprehensive income for the full year 2021 was
$32.1 million
- Research and Development Expenses was $21.6 million; General
and Administrative Expense was $15.9 million
- Listed on the NASDAQ Global Market under ticker symbol ‘LBPS’
after completing the merger with Longevity Acquisition Corporation,
a special purpose acquisition company (SPAC) on March 22, 2021
Full Year 2021 Operational Highlights
- Provided an update on the ongoing clinical trial portfolio for
lead oncology candidate MRx0518. This included the first
announcement of signals of anti-tumor activity for the combination
of MRx0518 with Keytruda® in bladder cancer, adding to the
previously reported activity in renal cell carcinoma and non-small
cell lung cancer.
- Announced a clinical trial collaboration and supply agreement
with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., under which
4D pharma will conduct a clinical trial to evaluate MRx0518 in
combination with Bavencio® (avelumab), an anti-PD-L1 immune
checkpoint inhibitor, as a first-line maintenance therapy for
patients with locally advanced or metastatic urothelial carcinoma
that has not progressed with first-line platinum-containing
chemotherapy. This study is expected to commence in 2022.
- Presented additional clinical mechanistic data for MRx0518 at
the European Society for Medical Oncology (ESMO) Congress, as both
a monotherapy and in combination with Keytruda® (pembrolizumab).
The results identified baseline biomarkers associated with clinical
benefit in patients with solid tumors resistant to immune
checkpoint inhibitors (ICIs) treated with MRx0518 in combination
with pembrolizumab; and gene and metagene signature changes in
solid tumors following treatment with MRx0518 monotherapy.
- Presented further analyses of the completed Phase II clinical
trial of Blautix® in patients with irritable bowel syndrome with
constipation (IBS-C) or with diarrhea (IBS-D) at Digestive Disease
Week (DDW) 2021. The post-hoc analyses revealed strong and
statistically significant activity on the key symptom of bowel
habit, a potential FDA-approvable primary endpoint. In addition,
analysis of the data by geographical region shows that earlier
topline results were impacted by an unusually high placebo response
in patients in the UK and Ireland, and enhanced positive signals
were seen in the larger US population.
- Subsequently, the company presented additional mechanistic
clinical data for Blautix® at Gastro 2021. The results show
treatment with Blautix® led to structural changes in the gut
microbiota and greater increases in interconnectivity between taxa
than placebo, in patients with both IBS-C and/or IBS-D.
- Reported topline results from Part A of our Phase I/II
randomized, double-blind, placebo-controlled clinical trial of
MRx-4DP0004 as a treatment for asthma. Part A met the primary
endpoint showing MRx-4DP0004 was safe and well tolerated. In
addition, MRx-4DP0004 generated promising signals of clinical
activity which support progression into Part B of the study.
- Published preclinical research relating to second-generation
immuno-oncology LBP MRx1299 improving the activity of CAR-T in
animal models of cancer, in collaboration with Philipps-University
Marburg, Germany, and Universitätsklinikum Würzburg, Germany.
- Completed the merger with special purpose acquisition company
(SPAC) Longevity Acquisition Corporation and concurrent private
placement, raising total gross proceeds of approximately $39.8
million.
- Entered into a senior secured credit facility for up to $30
million with Oxford Finance LLC, including the initial drawdown of
the first tranche for $12.5 million, with the remaining $7.5
million and $10 million tranches dependent on the achievement of
certain milestones.
- Announced the appointments of Paul Maier as Non-Executive
Director and John Beck as Chief Financial Officer (CFO). Later in
the year the Company was saddened to announce the passing of John
Beck.
Subsequent Events Since the 2021 Period End
- On January 3, 2022 announced the appointment of John Doyle as
Chief Financial Officer (CFO)
- On February 22, 2022, the Company announced that the U.S. Food
and Drug Administration (FDA) has cleared investigational new drug
(IND) applications for MRx0005 and MRx0029 for the treatment of
Parkinson’s disease. The Company expects to initiate a
first-in-human Phase I clinical trial in people with Parkinson’s
disease in mid-2022.
- On March 23, 2022, the company announced that in Part B of the
ongoing Phase I/II study of MRx0518 and Keytruda® in patients with
solid tumors that have progressed on a prior immune checkpoint
inhibitor (ICI), the renal cell carcinoma (RCC) group met its
primary efficacy endpoint ahead of enrolment completion.
Anticipated Development Milestones and Key Objectives for
2022
- First patient dosing in our Phase II study of MRx0518 &
Bavencio® as a first-line maintenance therapy for urothelial
carcinoma expected in Q2 2022
- Complete enrollment of Phase I study of MRx0518 in pancreatic
cancer expected to be Q2 2022
- Presentation of data from the Phase I/II Part A Study in Asthma
at The American Thoracic Society conference in May 2022
- Part B of ongoing Phase I/II trial of MRx-4DP0004 in asthma,
expected to commence in 2H 2022
- Phase I trial of MRx0005 and MRx0029 in people with Parkinson’s
disease expected to commence in 2H 2022
- Provide update and guidance on Phase II study of Blautix® in
patients with irritable bowel syndrome (IBS)
- Provide update on next steps in Phase I/II study of MRx0518 and
Keytruda® in the Renal Cell Carcinoma (RCC) group
About 4D pharma
4D pharma is a world leader in the development of Live
Biotherapeutics, a novel and emerging class of drugs, defined by
the FDA as biological products that contain a live organism, such
as a bacterium, that is applicable to the prevention, treatment or
cure of a disease. 4D pharma has developed a proprietary platform,
MicroRx®, that rationally identifies Live Biotherapeutics based on
a deep understanding of function and mechanism.
4D pharma's Live Biotherapeutic products (LBPs) are orally
delivered single strains of bacteria that are naturally found in
the healthy human gut. The Company has five clinical programs,
namely a Phase I/II study of MRx0518 in combination with KEYTRUDA®
(pembrolizumab) in solid tumors, a Phase I study of MRx0518 in a
neoadjuvant setting for patients with solid tumors, a Phase I study
of MRx0518 in patients with pancreatic cancer, a Phase I/II study
of MRx-4DP0004 in asthma, and Blautix® in irritable bowel syndrome
(IBS) which has completed a successful Phase II trial. A Phase I
study of MRx0005 and MRx0029 in patients with Parkinson’s disease
is expected to commence in 2022. Additional preclinical-stage
programs include candidates for CNS disease, immune-inflammatory
conditions and cancer. The Company has a research collaboration
with MSD (Merck & Co., Inc., Kenilworth, NJ, USA), to discover
and develop Live Biotherapeutics for vaccines.
For more information, refer to https://www.4dpharmaplc.com.
Forward-Looking Statements
This announcement contains "forward-looking statements." All
statements other than statements of historical fact contained in
this announcement, including without limitation statements
regarding the Company’s anticipated development milestones and key
objectives for 2022, the anticipated timing of a first-in-human
Phase I clinical trial in people with Parkinson’s disease and the
anticipated timing of a clinical trial to evaluate, are
forward-looking statements within the meaning of Section 27A of the
United States Securities Act of 1933, as amended (the "Securities
Act"), and Section 21E of the United States Securities Exchange Act
of 1934, as amended (the "Exchange Act"). Forward-looking
statements are often identified by the words "believe," "expect,"
"anticipate," "plan," "intend," "foresee," "should," "would,"
"could," "may," "estimate," "outlook" and similar expressions,
including the negative thereof. The absence of these words,
however, does not mean that the statements are not forward-looking.
These forward-looking statements are based on the Company's current
expectations, beliefs and assumptions concerning future
developments and business conditions and their potential effect on
the Company. While management believes that these forward-looking
statements are reasonable as and when made, there can be no
assurance that future developments affecting the Company will be
those that it anticipates.
All of the Company's forward-looking statements involve known
and unknown risks and uncertainties, some of which are significant
or beyond its control, and assumptions that could cause actual
results to differ materially from the Company's present
expectations or projections. The foregoing factors and the other
risks that could cause actual results to differ materially include
the risk that the Company changes its expected strategy and plans,
risk related to safety of investigational therapeutics, clinical
development risk, and those additional risks and uncertainties
described in the documents filed by the Company with the US
Securities and Exchange Commission ("SEC"). The Company wishes to
caution you not to place undue reliance on any forward-looking
statements, which speak only as of the date hereof. The Company
undertakes no obligation to publicly update or revise any of its
forward-looking statements after the date they are made, whether as
a result of new information, future events or otherwise, except to
the extent required by law.
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