LGND Ligand Pharmaceuticals Incorporated

125.17
-4.35  -3%
Previous Close 129.52
Open 128.49
52 Week Low 78.26
52 Week High 219.75
Market Cap $2,084,340,854
Shares 16,652,080
Float 11,846,390
Enterprise Value $2,183,574,401
Volume 129,133
Av. Daily Volume 179,261
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Upcoming Catalysts

Drug Stage Catalyst Date
SB206 - B-SIMPLE4
Molluscum
Phase 3
Phase 3
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V114
Pneumococcal disease
PDUFA priority review
PDUFA priority review
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APVO436
Acute myeloid leukemia (AML)
Phase 1
Phase 1
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Ganaxolone (RAISE)
Refractory status epilepticus (RSE)
Phase 3
Phase 3
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Ensifentrine (RPL554) - (ENHANCE-1 and ENHANCE-2)
Chronic obstructive pulmonary disease (COPD)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
VK2809 VOYAGE
Non-alcoholic steatohepatitis (NASH) and fibrosis
Phase 2b
Phase 2b
Phase 2b enrolment to be completed 2H 2021.
KYPROLIS (ARROW)
Multiple Myeloma
Approved
Approved
FDA approval announced October 1, 2018.
PF743 (JZP-458)
Acute lymphoblastic leukemia (ALL)
BLA Filing
BLA Filing
BLA filing announced December 21, 2020.
Ensifentrine (RPL554) - Metered Dose Inhaler
Chronic obstructive pulmonary disease (COPD)
Phase 2
Phase 2
Phase 2 MDI data met primary endpoint - February 2, 2021.
PF708
Osteoporosis
Approved
Approved
FDA approval announced October 7, 2019 - additional comparative use human factors (CUHF) data required before Therapeutic Equivalence (TE) can be determined.
Ganaxolone - Magnolia
Postpartum depression
Phase 2
Phase 2
Phase 2 negative data released July 23, 2019.
RPL554 DPI formulation
Maintenance treatment of COPD
Phase 2
Phase 2
Phase 2 data met primary endpoint - August 5, 2019.
CS1001
Gastric adenocarcinoma or gastro-esophageal junction adenocarcinoma.
Phase 3
Phase 3
Phase 3 trial has been initiated by partner CStone Pharmaceuticals.
Captisol-enabled (CE) Iohexol program
Contrast-induced Nephropathy
Phase 1
Phase 1
Phase 1 top-line data met primary endpoint - July 10, 2019.
Brexanolone - SAGE-547 (202C)
Postpartum Depression - moderate
Approved
Approved
FDA approval announced March 19, 2018.
KYPROLIS (ASPIRE)
Relapsed Multiple Myeloma
Approved
Approved
sNDA approval announced June 11, 2018.
KYPROLIS (ENDEAVOR)
Relapsed Multiple Myeloma
Approved
Approved
sNDA approved January 17, 2018.
Ganaxolone
Fragile X Syndrome
Phase 2
Phase 2
Phase 2 data released June 2016. Primary endpoint not met but intends to advance development

Latest News

  1. Conference Call Begins at 4:30 p.m. Eastern Time Today

    Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today reported financial results for the three months ended March 31, 2021 and provided an operating forecast and program updates. Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time to discuss this announcement and answer questions.

    "This year has opened strong for Ligand with solid financial performance and great results from all of our core technology platforms," said John Higgins, Chief Executive Officer. "We are very pleased to report a smooth and efficient integration of the four acquisitions we closed last year. Our R&D team has expanded considerably and we are reaping the benefits of these transactions…

    Conference Call Begins at 4:30 p.m. Eastern Time Today

    Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today reported financial results for the three months ended March 31, 2021 and provided an operating forecast and program updates. Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time to discuss this announcement and answer questions.

    "This year has opened strong for Ligand with solid financial performance and great results from all of our core technology platforms," said John Higgins, Chief Executive Officer. "We are very pleased to report a smooth and efficient integration of the four acquisitions we closed last year. Our R&D team has expanded considerably and we are reaping the benefits of these transactions with more licensing deals and contract revenue. Working within a highly dynamic and unpredictable COVID-19 landscape, we continue to play a key role supporting the manufacture of remdesivir through the supply of Captisol® to numerous partners around the globe. We anticipate 2021 will be the highest year of total revenues in Ligand's history, and we look forward to multiple regulatory approvals later this year of drugs based on our technologies."

    First Quarter 2021 Financial Results

    Total revenues for the first quarter of 2021 were $55.2 million, compared with $33.2 million for the same period in 2020. Royalties for the first quarter of 2021 were $7.1 million, compared with $6.6 million for the same period in 2020. Captisol sales were $31.3 million for the first quarter of 2021, compared with $21.1 million for the same period in 2020, with the increase primarily due to higher sales of Captisol for use with remdesivir. Contract revenue was $16.8 million for the first quarter of 2021, compared with $5.5 million for the same period in 2020, with the increase primarily due to the timing of partner milestone events and the acquisitions of Icagen in April 2020 and Pfenex in October 2020.

    Cost of Captisol was $8.2 million for the first quarter of 2021, compared with $4.7 million for the same period in 2020, with the increase primarily due to higher sales of Captisol. Amortization of intangibles was $11.8 million for the first quarter of 2021, compared with $3.5 million for the same period in 2020, with the increase primarily due to amortization of contractual relationships and technologies acquired from Icagen and Pfenex. Research and development expense was $17.9 million for the first quarter of 2021, compared with $11.9 million for the same period of 2020, with the increase primarily due to additional expenses following the Icagen and Pfenex acquisitions. General and administrative expense was $12.6 million for the first quarter of 2021, compared with $9.3 million for the same period in 2020, with the increase primarily due to additional expenses following the Icagen and Pfenex acquisitions.

    Net income for the first quarter of 2021 was $18.1 million, or $1.05 per diluted share, compared with net loss of $(24.1) million, or $(1.46) per share, for the same period in 2020. Net income for the first quarter of 2021 included a $9.1 million net non-cash gain from the value of Ligand's short-term investments, while net loss for the first quarter of 2020 included a $(29.7) million net non-cash loss from the value of Ligand's short-term investments. Adjusted net income for the first quarter of 2021 was $24.3 million, or $1.41 per diluted share, compared with $15.3 million, or $0.89 per diluted share, for the same period in 2020. Please see the table below for a reconciliation of net income/(loss) to adjusted net income.

    As of March 31, 2021, Ligand had cash, cash equivalents and short-term investments of $339.2 million.

    2021 Financial Guidance

    Ligand today affirms its guidance for 2021 total revenues to be approximately $291 million and 2021 adjusted earnings per diluted share to be approximately $6.15. Ligand's revenue guidance is subject to unexpected changes in demand for Captisol related to remdesivir and the timing and amount of contract payments from milestone events. Ligand may update total revenue guidance at any time during the year, in particular as the COVID-19 pandemic and demand for Captisol related to remdesivir continue to evolve.

    First Quarter 2021 and Recent Business Highlights

    In February, Travere announced that sparsentan achieved its pre-specified interim focal segmental glomerulosclerosis (FSGS) partial remission of proteinuria endpoint (FPRE) in the DUPLEX Phase 3 study after 36 weeks of treatment. Sparsentan demonstrated a statistically significant response on FPRE compared with the active control, irbesartan (p=0.0094). Preliminary results from the interim analysis suggest that sparsentan was generally well-tolerated and showed a comparable safety profile to irbesartan. Based on the data from the interim analysis, Travere intends to pursue submissions for accelerated approval of sparsentan for FSGS in the second half of 2021. Additionally, in February the European Commission granted orphan designation to sparsentan for the treatment of IgA nephropathy (IgAN), a rare kidney disorder and a leading cause of end-stage kidney disease. Travere is conducting an ongoing, global pivotal Phase 3 clinical trial (PROTECT) to evaluate the long-term nephroprotective potential of sparsentan for the treatment of IgAN. Travere anticipates topline interim efficacy data in the third quarter of 2021.

    OmniAb® Platform Updates

    OmniAb is Ligand's industry-leading, AI- and BI- (Biological Intelligence™) powered multi-species antibody platform for the discovery of mono- and bispecific therapeutic human antibodies. 2020 was a year of major investment with the acquisition and development of multiple technologies that enhance the offering for OmniAb partners, including the addition of antigen-generation services as well as deep-sequence analysis of functional antibody repertoires. As of March 31, 2021, 17 different OmniAb-derived antibodies have been studied in approximately 73 active or completed clinical trials. Progress by multiple OmniAb partners during the first quarter resulted in more than $4 million in milestone payments being earned by Ligand. Ligand expects the first regulatory approvals for OmniAb-derived antibodies in 2021.

    On January 11, Aptevo Therapeutics provided an update on their ongoing Phase 1/1b trial of APVO436 in AML/HR-MDS, noting that patient dosing in cohorts 1 through 9 has completed and enrollment in cohort 10 is ongoing. APVO436 is an OmniAb-derived bispecific antibody targeting CD123 and CD3 for the potential treatment of hematological malignancies.

    On February 8, CStone Pharmaceuticals announced that the OmniAb-derived anti-PD-L1 antibody sugemalimab was granted Breakthrough Therapy Designation (BTD) in China for the treatment of patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL). In October 2020, sugemalimab was granted Orphan Drug Designation in the U.S. for the treatment of T-cell lymphoma and BTD for the treatment of R/R ENKTL. A New Drug Application (NDA) for sugemalimab is under review in China for Stage IV squamous/non-squamous non-small cell lung cancer, and CStone expects a determination in the second half of 2021.

    On January 27, Harbour BioMed announced that Batoclimab (HBM9161), a novel investigational anti-FcRn antibody, was granted BTD in China for treatment of adult patients with myasthenia gravis.

    Pelican Platform Updates

    The Pelican Expression Technology™ is Ligand's proprietary Pseudomonas fluorescens protein expression technology that has major collaborations with Jazz Pharmaceuticals, Merck, Serum Institute of India and Alvogen, each of which has potential to contribute meaningfully to Ligand's royalty revenue.

    On January 12, Merck announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for V114, Merck's investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults 18 years of age and older. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of July 18, 2021. The European Medicines Agency is also reviewing an application for licensure of V114 in adults.

    On January 18, Alvogen's partner Thermarex announced the launch of Livogiva® in the EU. Livogiva is a biosimilar of the reference medicine Forsteo® (teriparatide) and therapeutic equivalence has been demonstrated in a Phase 3 clinical study in patients with severe osteoporosis who were treated for 6 months.

    On April 6, Arcellx announced FDA clearance of their Investigational New Drug application for ACLX-001, an engineered cell therapy for the treatment of multiple myeloma. Arcellx presented preclinical data supporting Arcellx's ARC-SparX platform cell therapy ACLX-001, a novel BCMA-targeted CAR-T, at the AACR annual meeting in April of 2021.

    Captisol® Business Updates

    Captisol is utilized in the formulation of Gilead Sciences' Veklury® (remdesivir). The product has been approved or authorized for temporary use as a treatment for COVID-19 in approximately 50 countries worldwide and is included in more than 40 ongoing interventional or observational clinical studies. In addition to supplying Gilead, Ligand is also supplying Captisol to Gilead's voluntary licensing generic partners who are manufacturing remdesivir for 127 other countries. Gilead announced the decision to stop its Phase 3 study with intravenous Veklury in high-risk non-hospitalized patients with COVID-19 due to the evolution of the COVID-19 landscape. Gilead stated they continue to develop an investigational inhaled dosage form of remdesivir and expect results from the ongoing proof-of-concept study later this year.

    On March 31, the FDA approved the addition of the anti-CD38 monoclonal antibody (mAb) Sarclisa (isatuximab) to the combination of Kyprolis® (carfilzomib) and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. Kyprolis is also approved in combination with the anti-CD38 mAb Darzalex (daratumumab) plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received a maximum of three prior lines of therapy.

    On April 27, Aldeyra announced positive topline results from the Phase 3 INVIGORATE trial of 0.25% reproxalap ophthalmic solution (reproxalap), an investigational, novel small-molecule covalent inhibitor of RASP (reactive aldehyde species), in patients with allergic conjunctivitis. The clinical trial achieved statistical significance (p<0.0001) for the primary endpoint of change from baseline in subject-reported ocular itching score, and all secondary endpoints including investigator-assessed ocular redness, patient-reported ocular tearing score and total ocular severity score. Aldeyra plans to meet with the FDA in the second half of 2021 to discuss the INVIGORATE results and the potential submission of an NDA.

    Other Business Updates

    On April 21, Sermonix Pharmaceuticals announced a preclinical collaboration with Jay Gertz, Ph.D., a researcher at the Huntsman Cancer Institute and associate professor of oncological sciences at the University of Utah, to examine the potential effects of lasofoxifene on unique models of endometrial cancer that carry ESR1 mutations. Lasofoxifene has shown novel activity in ESR1 mutations, and Sermonix is currently enrolling patients in two Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) studies in metastatic breast cancer.

    Ligand provides regular updates on individual partner events through its Twitter account, @Ligand_LGND.

    Adjusted Financial Measures

    The Company reports adjusted net income and adjusted net income per diluted share in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company's financial measures under GAAP include share-based compensation expense, amortization of debt-related costs, amortization related to acquisitions and intangible assets, changes in contingent liabilities, mark-to-market adjustments for amounts relating to its equity investments in public companies, excess tax benefit from share-based compensation and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included at the end of this press release. However, other than with respect to total revenues, the Company only provides financial guidance on an adjusted basis and does not provide reconciliations of such forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in contingent liabilities, changes in the market value of its investments in public companies, stock-based compensation expense and effects of any discrete income tax items. Management has excluded the effects of these items in its adjusted measures to assist investors in analyzing and assessing the Company's past and future core operating performance. Additionally, adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company's board of directors to measure, in part, management's performance and determine significant elements of management's compensation.

    Conference Call

    Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (833) 540-1167 from the U.S. or (929) 517-0358 from outside the U.S., using the conference ID 7398698. To participate via live or replay webcast, a link is available at www.ligand.com.

    About OmniAb®

    The OmniAb antibody discovery platform provides Ligand's biopharmaceutical industry partners access to the world's most advanced antibody repertoires and screening technologies to enable unparalleled discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence™ (BI) of our proprietary transgenic animals, including OmniRat, OmniChicken and OmniMouse, each capable of generating high quality fully human antibodies that have been optimized naturally through in vivo affinity maturation. OmniFlic (transgenic rat) and OmniClic (transgenic chicken) address industry needs for bispecific antibody applications though a common light chain approach, and OmniTaur features unique structural attributes of cow antibodies for complex targets. OmniAb animals comprise the most diverse host systems available in the industry and they are optimally leveraged through AI-enhanced antigen design and immunization methods, paired with high-throughput microfluidic-based single B cell screening and deep computational analysis of next-generation sequencing datasets to identify fully human antibodies with superior performance and developability characteristics. The OmniAb suite of technologies and differentiating AI and BI features are combined to offer a highly efficient and customizable end-to-end solution for the growing antibody discovery needs of the global biopharmaceutical industry.

    About the Pelican Expression Technology™

    Pelican is a robust, validated, cost-effective and scalable platform for recombinant protein production, and is especially well-suited for complex, large-scale protein production where traditional systems are not suitable. Multiple global manufacturers have demonstrated consistent success with the platform and the technology is currently out-licensed for numerous commercial and development-stage programs. The versatility of the platform has been demonstrated in the production of enzymes, peptides, antibody derivatives and engineered non-natural proteins. Partners seek the platform as it can contribute significant value to biopharmaceutical development programs by reducing development timelines and costs for manufacturing therapeutics and vaccines. Given pharmaceutical industry trends toward large molecules with increasing structural complexities, Pelican is well positioned to meet these growing needs as the most comprehensive broadly available protein production platform in the industry.

    About Captisol®

    Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas' Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Gilead's VEKLURY®, Amgen's KYPROLIS®, Baxter International's NEXTERONE®, Acrotech Biopharma L.L.C.'s and CASI Pharmaceuticals' EVOMELA®, Melinta Therapeutics' BAXDELA™ and Sage Therapeutics' ZULRESSO™. There are many Captisol-enabled products currently in various stages of development. Ligand maintains a broad global patent portfolio for Captisol with more than 400 issued patents worldwide relating to the technology (including over 40 in the U.S.) and with the latest expiration date in 2033. Other patent applications covering methods of making Captisol, if issued, extend to 2040.

    About Ligand Pharmaceuticals

    Ligand is a revenue-generating biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) to ultimately generate our revenue. Ligand's OmniAb® technology platform is a patent-protected transgenic animal platform used in the discovery of fully human mono- and bispecific therapeutic antibodies. The Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand's Protein Expression Technology is a robust, validated, cost-effective and scalable platform for recombinant protein production, and is especially well-suited for complex, large-scale protein production where traditional systems are not suitable. Ab Initio™ technology and services for the design and preparation of customized antigens enable the successful discovery of therapeutic antibodies against difficult-to-access cellular targets. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Amgen, Merck, Pfizer, Sanofi, Janssen, Takeda, Servier, Gilead Sciences and Baxter International. For more information, please visit www.ligand.com.

    Forward-Looking Statements

    This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as "plans," "believes," "expects," "anticipates," and "will," and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding: Ligand's ability to supply Captisol to Gilead and other partners; the potential opportunities for Ligand and its partners related to development of COVID-19 treatments; the timing of product launches by Ligand or its partners; the potential for regulatory approvals of our partners' product candidates including the first potential approvals for an OmniAb-derived antibody; and guidance regarding 2021 financial results. Actual events or results may differ from Ligand's expectations due to risks and uncertainties inherent in Ligand's business, including, without limitation: Ligand may not receive expected revenue from royalties, Captisol sales or contract revenue; the COVID-19 pandemic has disrupted and may continue to disrupt Ligand's and its partners' business, including delaying manufacturing, preclinical studies and clinical trials and product sales, and impairing global economic activity, all of which could materially and adversely impact Ligand's results of operations and financial condition; Ligand may not achieve its guidance for 2021; the FDA may revise or revoke approval for remdesivir for the treatment of patients with COVID-19 requiring hospitalization based on later information regarding the safety or efficacy of remdesivir; the commercial opportunity for remdesivir could be materially and adversely affected as a result of approved vaccines and alternative approved and investigational therapies; Gilead may develop an alternative formulation of remdesivir that does not incorporate Captisol or uses less Captisol in such formulation; there may not be a market for the product(s) even if successfully developed and approved; Ligand is currently dependent on single source sole supplier for Captisol and failures by such supplier may result in delays or inability to meet the Captisol demands of its partners; Amgen, Acrotech Biopharma or other Ligand partners, may not execute on their sales and marketing plans for marketed products for which Ligand has an economic interest; Ligand or its partners may not be able to protect their intellectual property and patents covering certain products and technologies may be challenged or invalidated; Ligand's partners may terminate any of its agreements or development or commercialization of any of its products; Ligand may not generate expected revenues under its existing license agreements and may experience significant costs as the result of potential delays under its supply agreements; Ligand and its partners may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit Ligand's ability to obtain regulatory approval; unexpected adverse side effects or inadequate therapeutic efficacy of Ligand's product(s) could delay or prevent regulatory approval or commercialization; challenges, costs and charges associated with integrating recently completed acquisitions with Ligand's existing businesses; and ongoing or future litigation could expose Ligand to significant liabilities and have a material adverse effect on the company. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release, including the possibility of additional contract revenue we may receive. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    Other Disclaimers and Trademarks

    The information in this press release regarding certain third-party products and programs, including Kyprolis, an Amgen product and EVOMELA, an Acrotech Biopharma product, comes from information publicly released by the owners of such products and programs. Ligand is not responsible for, and has no role in, the development of such products or programs.

    Ligand owns or has rights to trademarks and copyrights that it uses in connection with the operation of its business including its corporate name, logos and websites. Other trademarks and copyrights appearing in this press release are the property of their respective owners. The trademarks Ligand owns include Ligand®, Pelican®, Captisol® and OmniAb®. Solely for convenience, some of the trademarks and copyrights referred to in this press release are listed without the ®, © and ™ symbols, but Ligand will assert, to the fullest extent under applicable law, its rights to its trademarks and copyrights.

    LIGAND PHARMACEUTICALS INCORPORATED

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited, in thousands, except per share amounts)

     

    Three Months Ended March 31,

     

    2021

     

    2020 (1)

    Revenues:

     

     

     

    Royalties

    $

    7,112

     

     

    $

    6,565

     

    Captisol

    31,272

     

     

    21,109

     

    Contract

    16,766

     

     

    5,487

     

    Total revenues

    55,150

     

     

    33,161

     

    Operating costs and expenses:

     

     

     

    Cost of Captisol

    8,153

     

     

    4,683

     

    Amortization of intangibles

    11,786

     

     

    3,535

     

    Research and development

    17,879

     

     

    11,891

     

    General and administrative

    12,617

     

     

    9,264

     

    Total operating costs and expenses

    50,435

     

     

    29,373

     

    Income from operations

    4,715

     

     

    3,788

     

    Gain (loss) from short-term investments

    13,061

     

     

    (30,741

    )

    Interest expense, net

    (5,535

    )

     

    (3,818

    )

    Other income (expense), net

    (6,477

    )

     

    356

     

    Total other income (loss), net

    1,049

     

     

    (34,203

    )

    Income (loss) before income taxes

    5,764

     

     

    (30,415

    )

    Income tax benefit

    12,342

     

     

    6,284

     

    Net income (loss):

    $

    18,106

     

     

    $

    (24,131

    )

     

     

     

     

    Basic net income (loss) per share

    $

    1.10

     

     

    $

    (1.46

    )

    Shares used in basic per share calculation

    16,435

     

     

    16,529

     

     

     

     

     

    Diluted net income (loss) per share

    $

    1.05

     

     

    $

    (1.46

    )

    Shares used in diluted per share calculations

    17,248

     

     

    16,529

     

     

    (1) Certain reclassifications have been made to the prior period data to conform with the current period presentation.

    LIGAND PHARMACEUTICALS INCORPORATED

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited, in thousands)

     

    March 31, 2021

     

    December 31, 2020

    ASSETS

     

     

     

    Current assets:

     

     

     

    Cash, cash equivalents and short-term investments

    $

    339,207

     

     

    $

    411,186

     

    Accounts receivable, net

    54,436

     

     

    56,847

     

    Inventory

    36,932

     

     

    26,487

     

    Income taxes receivable

    1,145

     

     

    2,217

     

    Other current assets

    5,708

     

     

    3,822

     

    Total current assets

    437,428

     

     

    500,559

     

    Deferred income taxes, net

    27,432

     

     

    24,320

     

    Goodwill and other identifiable intangible assets, net

    774,300

     

     

    784,992

     

    Commercial license and other economic rights, net

    10,451

     

     

    10,979

     

    Operating lease right-of-use assets

    7,611

     

     

    6,892

     

    Finance lease right-of-use assets

    17,950

     

     

    15,842

     

    Other assets

    19,949

     

     

    18,701

     

    Total assets

    $

    1,295,121

     

     

    $

    1,362,285

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

    Current liabilities:

     

     

     

    Accounts payable and accrued liabilities

    $

    21,579

     

     

    $

    22,314

     

    Current contingent liabilities

    41,509

     

     

    39,884

     

    Current operating lease liabilities

    2,173

     

     

    1,885

     

    Current finance lease liabilities

    5,437

     

     

    6,593

     

    Deferred revenue

    25,107

     

     

    29,435

     

    Total current liabilities

    95,805

     

     

    100,111

     

    2023 convertible senior notes, net

    352,313

     

     

    442,293

     

    Long-term contingent liabilities

    9,548

     

     

    9,249

     

    Deferred income taxes, net

    56,812

     

     

    64,598

     

    Other long-term liabilities

    34,803

     

     

    36,509

     

    Total liabilities

    549,281

     

     

    652,760

     

    Total stockholders' equity

    745,840

     

     

    709,525

     

    Total liabilities and stockholders' equity

    $

    1,295,121

     

     

    $

    1,362,285

     

    LIGAND PHARMACEUTICALS INCORPORATED

    ADJUSTED FINANCIAL MEASURES

    (Unaudited, in thousands, except per share amounts)

     

    Three months ended March 31,

     

    2021

     

    2020(7)

     

     

     

     

     

     

     

     

    Net income (loss)

    $

    18,106

     

     

    $

    (24,131

    )

    Share-based compensation expense

    8,405

     

     

    5,653

     

    Non-cash interest expense(1)

    4,916

     

     

    7,203

     

    Amortization related to acquisitions and intangible assets

    11,786

     

     

    3,535

     

    Amortization of commercial license and other economic rights(2)

    528

     

     

    3,730

     

    Change in contingent liabilities(3)

    1,684

     

     

    (367

    )

    Acquisition and integration costs(4)

    422

     

     

     

    Loss (gain) from short-term investments

    (13,061

    )

     

    30,741

     

    Realized gain (loss) from short-term investments

    3,912

     

     

    (1,055

    )

    Other(5)

    6,089

     

     

    263

     

    Income tax effect of adjusted reconciling items above

    (6,357

    )

     

    (9,411

    )

    Excess tax benefit from share-based compensation(6)

    (12,120

    )

     

    (886

    )

    Adjusted net income

    24,310

     

     

    15,275

     

    Diluted per-share amounts attributable to common shareholders:

     

     

     

    Net income (loss)

    $

    1.05

     

     

    $

    (1.46

    )

    Share-based compensation expense

    0.49

     

     

    0.34

     

    Non-cash interest expense(1)

    0.29

     

     

    0.44

     

    Amortization related to acquisitions and intangible assets

    0.68

     

     

    0.21

     

    Amortization of commercial license and other economic rights(2)

    0.03

     

     

    0.23

     

    Change in contingent liabilities(3)

    0.10

     

     

    (0.02

    )

    Acquisition and integration costs(4)

    0.02

     

     

     

    Loss from short-term investments

    (0.76

    )

     

    1.85

     

    Realized gain from short-term investments

    0.23

     

     

    (0.06

    )

    Other(5)

    0.35

     

     

    0.01

     

    Income tax effect of adjusted reconciling items above

    (0.37

    )

     

    (0.57

    )

    Excess tax benefit from share-based compensation(6)

    (0.70

    )

     

    (0.05

    )

    Adjustment for shares excluded due to anti-dilution effect on GAAP net loss

     

     

    (0.04

    )

    Adjusted net income

    1.41

     

     

    0.89

     

     

     

     

     

    GAAP - Weighted average number of common shares-diluted

    17,248

     

     

    16,529

     

    Add: Shares excluded due to anti-dilutive effect on GAAP net loss

     

     

    611

     

    Adjusted weighted average number of common shares-diluted

    17,248

     

     

    17,140

     

    (1) Amounts represent non-cash debt related costs that are calculated in accordance with the authoritative accounting guidance for convertible debt instruments that may be settled in cash.

    (2) For the three months ended March 31, 2021, the amount represents the amortization of commercial license and other economic rights to revenue. For the three months ended March 31, 2020, the amounts represent the amortization of commercial license and other economic rights to revenue and research and development expenses in the amounts of $1,222 and $2,508, respectively.

    (3) Amounts represent changes in fair value of contingent consideration related to Icagen, Pfenex, Crystal, CyDex, and Metabasis transactions.

    (4) Amounts represent severance costs, legal fees and certain contract termination costs in connection with the acquisitions.

    (5) Amounts primarily relate to loss on debt extinguishment.

    (6) Excess tax benefits from share-based compensation are recorded as a discrete item within the provision for income taxes on the consolidated statement of operations as a result of the adoption of an accounting pronouncement (ASU 2016-09) on January 1, 2017. Prior to the adoption, the amount was recognized in additional paid-in capital on the consolidated statement of stockholders' equity.

    (7) Certain reclassifications have been made to the prior period data to conform with the current period presentation.

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  2. Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) will report financial results for the three months ended March 31, 2021 after the close of the U.S. financial markets on Monday, May 3, 2021 and will hold a conference call that same day beginning at 4:30 p.m. Eastern time. Speakers on the call will include Ligand's CEO John Higgins, President and COO Matt Foehr and Executive Vice President and CFO Matt Korenberg.

    Conference Call and Webcast Information

    What:

    Ligand conference call to discuss first quarter 2021 financial results and provide general business updates

     

    Date:

    Monday, May 3, 2021

     

    Time:

    4:30 p.m. Eastern time (1:30 p.m. Pacific time)

     

    Conference Call:

    Dial (833) 540-1167 within the U.S…

    Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) will report financial results for the three months ended March 31, 2021 after the close of the U.S. financial markets on Monday, May 3, 2021 and will hold a conference call that same day beginning at 4:30 p.m. Eastern time. Speakers on the call will include Ligand's CEO John Higgins, President and COO Matt Foehr and Executive Vice President and CFO Matt Korenberg.

    Conference Call and Webcast Information

    What:

    Ligand conference call to discuss first quarter 2021 financial results and provide general business updates

     

    Date:

    Monday, May 3, 2021

     

    Time:

    4:30 p.m. Eastern time (1:30 p.m. Pacific time)

     

    Conference Call:

    Dial (833) 540-1167 within the U.S.

    Dial (929) 517-0358 outside the U.S.

    Conference ID is 7398698

     

    Webcast:

    Live conference call webcast and replay available here.

    About Ligand Pharmaceuticals

    Ligand is a revenue-generating biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Ligand's business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Ligand's goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Ligand's business model is based on doing what Ligand does best (drug discovery, early-stage drug development, product reformulation and partnering). Ligand partners with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) to ultimately generate our revenue. Ligand's OmniAb® technology platform is a patent-protected transgenic animal platform used in the discovery of fully human mono- and bispecific therapeutic antibodies. The Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand's Protein Expression Technology® platform is a robust, validated, cost-effective and scalable approach to recombinant protein production, and is especially well-suited for complex, large-scale protein production that cannot be made by more traditional systems. Ab Initio technology and services for the design and preparation of customized antigens enable the successful discovery of therapeutic antibodies against difficult-to-access cellular targets. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Amgen, Merck, Pfizer, Roche, Sanofi, Janssen, Takeda, Gilead Sciences, GSK and Baxter International. For more information, please visit www.ligand.com.

    Follow Ligand on Twitter @Ligand_LGND.

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  3. COLUMBUS, Ohio, April 21, 2021 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to treat ESR1-mutated metastatic breast and gynecological cancers, today announced a preclinical collaboration with researcher Jay Gertz, Ph.D., to examine the potential effects of lasofoxifene, Sermonix's lead investigational drug, on endometrial cancer.

    The project will investigate the effects of lasofoxifene on unique models of endometrial cancer that carry ESR1 mutations. Lasofoxifene has shown novel activity in ESR1 mutations, and Sermonix is currently enrolling patients in two Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) studies within the breast cancer arena…

    COLUMBUS, Ohio, April 21, 2021 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to treat ESR1-mutated metastatic breast and gynecological cancers, today announced a preclinical collaboration with researcher Jay Gertz, Ph.D., to examine the potential effects of lasofoxifene, Sermonix's lead investigational drug, on endometrial cancer.

    The project will investigate the effects of lasofoxifene on unique models of endometrial cancer that carry ESR1 mutations. Lasofoxifene has shown novel activity in ESR1 mutations, and Sermonix is currently enrolling patients in two Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) studies within the breast cancer arena.

    "Sermonix is committed to exploring ESR1 mutations across gynecological tumor types and examining lasofoxifene's potential to serve the unmet medical needs of more women fighting cancer," said Barry Komm, Ph.D., chief scientific officer of Sermonix. "The unique ESR1 model system is state-of-the-art for this exploration and Dr. Gertz is an esteemed partner with whom it is an honor for Sermonix to collaborate."

    Dr. Gertz is a cancer researcher at Huntsman Cancer Institute and associate professor of oncological sciences at the University of Utah. His lab studies how transcription regulation is altered in cancer with a particular focus on the roles of steroid hormone signaling in endometrial and breast cancers.

    "The Gertz Lab has a major emphasis in advancing the study of new drugs for endometrial cancer, an aggressive disease with limited treatment options," said Dr. Gertz. "We look forward to learning more about the efficacy of lasofoxifene in the context of ESR1-mutated endometrial cancer."

    About Lasofoxifene

    Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene's bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene's novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

    About Sermonix

    Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking two Phase 2 clinical studies of lasofoxifene, its lead investigational drug. Sermonix Pharmaceuticals was founded in 2014 by David Portman, M.D., a leading clinical researcher and expert in women's health, menopause and selective estrogen receptor modulator (SERM) therapy. The Sermonix management team, led by Dr. Portman, has significant experience in all stages of the drug development and regulatory process. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience in the oncology drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in SERM biology. Miriam Portman, M.D., is chief operating officer. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development officer, has extensive experience in pharmaceutical drug commercialization. Simon Jenkins, Ph.D. vice president of operations, has over 30 years of experience in global drug development leadership. Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert's Pharmaceutical Division. Learn more at https://sermonixpharma.com/.

    Contact information:

    David Portman, MD

    CEO and Founder, Sermonix Pharmaceuticals



    614-582-6849



    Primary Logo

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  4. Leeds, UK, April 01, 2021 (GLOBE NEWSWIRE) -- 4D pharma plc ((AIM: DDDD, NASDAQ:LBPS) ("4D", the "Company" or, together with its subsidiaries, the "Group"), a pharmaceutical company leading the development of Live Biotherapeutics, is pleased to announce the final results for the Group for the year ended 31 December 2020.

    All details stated hereafter relate to the UK IFRS accounts; the Group also produces US GAAP accounts, the details of which are included in the Form 20-F to be filed with the U.S. Securities and Exchange Commission.

    Financial highlights for the year:

    Total equity of £28.0 million (2019: £22.3 million)
    Cash and cash equivalents (including cash on deposit) of £8.8 million (2019: £3.8 million)
    Loss for the year and total

    Leeds, UK, April 01, 2021 (GLOBE NEWSWIRE) -- 4D pharma plc ((AIM: DDDD, NASDAQ:LBPS) ("4D", the "Company" or, together with its subsidiaries, the "Group"), a pharmaceutical company leading the development of Live Biotherapeutics, is pleased to announce the final results for the Group for the year ended 31 December 2020.

    All details stated hereafter relate to the UK IFRS accounts; the Group also produces US GAAP accounts, the details of which are included in the Form 20-F to be filed with the U.S. Securities and Exchange Commission.

    Financial highlights for the year:

    Total equity of £28.0 million (2019: £22.3 million)
    Cash and cash equivalents (including cash on deposit) of £8.8 million (2019: £3.8 million)
    Loss for the year and total comprehensive income for the year of £25.9 million (2019: £23.7 million)
    Adjusted loss per share of 22.80 pence (2019: 40.81pence)
    Basic and diluted loss per share of 22.80 pence (2019: 36.75 pence)

    Operational highlights

    Announced safety and proof-of-concept clinical efficacy data for lead Live Biotherapeutic MRx0518 in combination with checkpoint inhibitor (ICI) Keytruda® in heavily pre-treated patients with non-small cell lung cancer and renal cell carcinoma refractory to prior ICIs
    Presented the first clinical monotherapy data for a Live Biotherapeutic in oncology with data from Part A of our clinical trial of MRx0518 in the neoadjuvant setting
    Launched a third clinical trial of MRx0518, in pancreatic cancer in combination with stereotactic radiotherapy
    Commencement and expansion of Part B of Phase I/II clinical trial of MRx0518 in combination with Keytruda®, with inclusion of additional tumor type cohorts and additional US sites added
    Phase II data for Blautix® showing clinical activity in irritable bowel syndrome with constipation (IBS-C) or with diarrhoea (IBS-D)
    Launch of a Phase II clinical trial of oral immuno-modulatory Live Biotherapeutic MRx-4DP0004 for the treatment of patients hospitalised with COVID-19
    Completed two fundraises by way of a Placing and Subscription raising gross proceeds of approximately £30 million
    Entered into a proposed merger agreement with Longevity Acquisition Corporation (Longevity), a NASDAQ-listed Special Purpose Acquisition Company (SPAC), and announced intention to seek NASDAQ listing
    Appointment of Prof. Axel Glasmacher as Non-Executive Chairperson
    Appointment of Dr. Katrin Rupalla as an independent Non-Executive Director
    Appointment of Glenn Dourado as Chief Business Officer

    Since the period end

    On 22 March 2021 the Company completed its previously announced merger with Longevity and the listing of its ADSs on NASDAQ became effective under the ticker ‘LBPS'; the following day 4D's warrants began trading on NASDAQ under the ticker ‘LBPSW'
    On 22 March 2021, the Company completed a £18.01 million ($25.03) million gross fundraise by way of a private placement of ordinary shares, with Directors intending to subscribe for a further £1.44 million ($2.0 million) following release of the year end results
    On 1 March 2021 we announced the appointment of Paul Maier as an independent Non-Executive Director, and appointment of John Beck as Chief Financial Officer
    On 8 February 2021 we announced our second oncology clinical collaboration and drug supply agreement, with Merck KGaA and Pfizer, Inc. to evaluate MRx0518 in combination with ICI Bavencio® as a first-line maintenance therapy for urothelial carcinoma

    Prof. Axel Glasmacher, Chairman of 4D pharma, commented: "2020 was a transformational year for 4D: We were able to publish first proof-of-concept data for MRx0518 in last-line cancers and to initiate our NASDAQ listing. This creates a solid foundation for the next steps towards bringing live biotherapeutics to patients suffering from severe diseases. On behalf of the Board I would like to thank everyone at 4D for an exceptional performance under difficult circumstances."

    Duncan Peyton, Chief Executive Officer, commented: "4D has made significant progress leading the field in the development of Live Biotherapeutics, and made great strides from a corporate perspective. In addition to the data we have generated in the field of oncology, we completed our merger with Longevity and obtained a NASDAQ listing which, together with a concurrent fundraise, provides 4D with approximately $40 million of additional capital and a solid financial footing moving forward. This puts 4D pharma in a strong position to capitalise on multiple data readouts from our ongoing trials in asthma and oncology as well as facilitating the move into the clinic with our Parkinson's disease programme."

    The Annual Report, together with a notice of the Company's Annual General Meeting ("AGM"), will be posted to shareholders and made available on the Company's website, www.4dpharmaplc.com, by 16 April 2021. The Annual General Meeting will be held at 10 a.m (BST) on Monday 24th May 2021 at 9 Bond Court, Leeds, LS1 2JZ. We continue to follow guidance from the UK Government which limits public gatherings. To prevent issues and remain compliant with the rules in force, persons, shareholders, advisers and other guests will not be allowed to attend the AGM and anyone seeking to attend the meeting in person will be refused entry. We therefore encourage shareholders to submit any questions they would like to pose to the Board to so as to be received no later than Wednesday 19th May 2021 . All emails should be marked "AGM Question" in the subject line, and will require a shareholder number. If the UK Government's guidance changes before the AGM and allows significant gatherings of people, we will notify you via the Company's website at 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 future results form our clinical trials including our move to the clinic with our Parkinsons and Bavencio trial, the effect of our recent capital raise on the financial footing of the Company, the timing for our shareholder mailing and meeting and the intent of certain of our Directors to invest in our ordinary shares 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 historical experience and its present expectations or projections. The foregoing factors and the other risks and uncertainties that could cause actual results to differ materially include delays or changes to the nature and scope of our clinical trials, patient response rates, the effect of current and future pandemics, the timing and nature of future cash needs and those additional risks and uncertainties described 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.

    For further information please contact:

    4D Pharma plc

    Duncan Peyton, Chief Executive Officer + 44 (0)113 895 0130

    Investor Relations 

    N+1 Singer - Nominated Adviser and Joint Broker +44 (0) 20 7496 3000

    Phil Davies / Iqra Amin / James Fischer (Corporate Finance) / Tom Salvesen (Corporate Broking)

    Bryan Garnier & Co. Limited - Joint Broker +44 (0)20 7332 2500

    Dominic Wilson / Phil Walker

    Image Box PR

    Neil Hunter / Michelle Boxall

    Tel +44 (0)20 8943 4685

     / 

    www.4dpharmaplc.com]

    Chairman and CEO's statement

    Introduction

    4D pharma's strategy continues to be to pioneer a novel class of safe and effective therapeutic derived from the gut microbiome – Live Biotherapeutic Products – and to selectively partner or potentially develop these through regulatory approval and subsequent commercialisation.

    During the year, we made significant progress across our LBP clinical development programs. In April we announced the successful completion of the Part A safety phase of our Phase I/II clinical trial of lead immuno-oncology LBP candidate MRx0518 in combination with immune checkpoint inhibitor (ICI) Keytruda® (pembrolizumab) in patients with solid tumors refractory to prior ICI therapy. During Part A of this clinical trial, MRx0518 showed no treatment-related serious adverse effects or drug discontinuations and, importantly, no increase of immune-related adverse events that are often associated with ICI therapy. The safety review committee duly recommended to proceed to Part B of the study, which is ongoing.

    In August, we announced comprehensive clinical benefit data from the 12 patients enrolled into Part A of the trial. Five patients (42%) demonstrated clinical benefit (defined as a complete response, partial response or stable disease for six months or longer) on treatment with MRx0518 and Keytruda®, including three patients achieving partial responses, an objective response rate of 25%. To the best of our knowledge, we have delivered the first ever proof-of-concept data in the treatment of cancer using LBPs.

    At the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2020 in November we announced the expansion of the Part B of this study, with the inclusion of three additional tumor type cohorts of triple-negative breast cancer, squamous cell carcinoma of the head and neck, and microsatellite instability high/mismatch repair deficient solid tumors, in addition to the previously enrolling cohorts of renal cell carcinoma, non-small cell lung cancer and bladder cancer.

    In October 2020 we completed a Phase II clinical trial investigating the efficacy of Blautix® in the treatment of irritable bowel syndrome (IBS) which showed: (i) a statistically significant increase in overall response in pre-planned analysis of the combined IBS-C/D group compared to placebo; and (ii) a positive, though non-significant increase in overall response in both IBS-C and IBS-D cohorts, individually. The primary efficacy endpoint of the trial was based on whether or not a subject, from either the IBS-C or IBS-D cohorts, was considered an overall responder. For a subject to be classed as an ‘overall responder' they must have reported an improvement in their weekly (cohort specific) symptoms (abdominal pain intensity and stool frequency or consistency) for ≥50% of the treatment period.

    In April 2020 we received MHRA acceptance for a UK Phase II clinical trial of our immuno-modulatory LBP MRx-4DP0004 in patients hospitalised with COVID-19. MRx-4DP0004 is in an ongoing Phase I/II clinical trial in asthma patients as an add-on therapy to existing long-term maintenance therapy.

    In support of our efforts to advance LBP candidates into the clinic for the treatment of neurodegenerative diseases such as Parkinson's disease, in December 2020 we became an industry partner of the Parkinson's Progression Markers Initiative (PPMI), a longitudinal study sponsored by The Michael J. Fox Foundation for Parkinson's Research to better understand Parkinson's disease and accelerate the development of new treatments. 4D pharma representatives will join the Partner Scientific Advisory Board closely involved in the design and execution of the study, as well as a variety of PPMI Working Groups.

    In the year we made good progress in our research collaboration with Merck Sharp & Dohme to discover and develop vaccines in up to three indications. To date, we have screened and characterised hundreds of LBPs with immuno-modulatory potential and selected from this group lead LBPs with desirable immuno-modulatory properties for further evaluation and development.

    In addition to continued progress in advancing multiple development programs and therapeutic candidates, in October 2020 the Company entered a definitive merger agreement with Longevity Acquisition Corporation a publicly-traded special purpose acquisition company (SPAC) and announced our intention to seek a NASDAQ listing of 4D pharma American Depositary Shares (ADSs). After the period end, on 22 March 2021, the merger was completed and the listing of 4D pharma ADSs on NASDAQ became effective under the ticker symbol ‘LBPS'; the associated warrants began trading on NASDAQ on 23 March 2021 under the ticker ‘LBPSW'.

    Update on the impact of COVID-19

    In 2020, the global COVID-19 pandemic affected almost all aspects of the global economy and the pharmaceutical industry, the Group included. In response to this unexpected and unprecedented event, the Group took the situation very seriously and heeded the advice of the UK, Spanish, Irish and US governments and other authorities, utilising technology effectively to mitigate this unprecedented disruption where possible. To protect the safety of patients, the Group's staff and the staff of the Company's collaborators, the Group limited non-essential activity at clinical sites which in turn had an impact on patient recruitment for some studies, resulting in some potential delays to expected clinical readouts.

    The likely duration of the disruption caused by COVID-19 still remains uncertain, making it difficult to accurately predict the impact on the Group's operations and clinical timelines. However, in light of this unprecedented situation the Board of Directors carefully re-evaluated the Group's strategic priorities and near-to-mid-term objectives and took measures to streamline the business and to prioritise allocation of capital and resources to key programs set to deliver key clinical value drivers for our shareholders.

    The Group remains committed to reviewing the rapidly evolving global situation and adapting its strategy and operations accordingly.

    Organisational changes, Board and governance

    In 2020 4D pharma welcomed decades of biopharma experience to our Board and leadership team, providing invaluable expertise to help guide the Company's ongoing growth and development.

    In April, Prof. Axel Glasmacher was appointed Chairperson from his previous role as Non-Executive Director. We expect Prof. Glasmacher to be able to contribute his experience as an oncology physician, Senior Vice President Global Clinical R&D at Celgene and Board member of the Cancer Drug Development Forum, to guide the clinical strategy of 4D's LBPs including, but not limited to, lead oncology candidate MRx0518.

    In August the Board was pleased to welcome Dr. Katrin Rupalla. Dr Rupalla's appointment as a Non-Executive Director was ratified in September. Dr. Rupalla is currently Senior Vice President Regulatory Affairs, Medical Documentation and R&D Quality at Lundbeck A/S (CPH: LUN), a CNS specialist biotech, and before this spent several years in senior roles overseeing the global development of blockbuster oncology products at Merck & Co., Roche, Celgene and Bristol-Myers Squibb (BMS).

    In addition to expanding our Board of Directors, we have also made important additions to our Executive management team. In April we welcomed Glenn Dourado as our new Chief Business Officer, bringing a wealth of expertise in biopharma business development and strategy, with extensive experience particularly with NASDAQ-listed biotechs and in the field of oncology, expanding both our Business Development activities and also our US footprint.

    After the period end, in March 2021, we further expanded our Board and management team, appointing John Beck as Chief Financial Officer and Paul Maier as Non-Executive Director; Mr Maier was also appointed Chair of 4D's Audit and Risk Committee and will serve as the Company's ‘audit committee financial expert' under QCA, SEC and NASDAQ rules. Mr. Beck brings over 30 years of experience in financial and biopharmaceutical industry management experience. This includes three previous positions as Chief Financial Officer of publicly traded life sciences companies where he achieved notable results in areas including finance, business and corporate development, strategy, and commercialisation.

    Mr. Maier has over 25 years of investor and public relations, operational, regulatory, and finance expertise in the healthcare industry. Mr. Maier was previously the Chief Financial Officer of Sequenom Inc., where he was responsible for raising over $360 million in equity and debt financings, expanding institutional sell-side research analyst coverage, as well as establishing and overseeing internal financial infrastructure. Previously, he was Senior Vice President and Chief Financial Officer of Ligand Pharmaceuticals (NASDAQ:LGND). He has also acted as an independent financial consultant to life sciences companies. Mr. Maier is currently a Board member of Eton Pharmaceuticals, Inc, Biological Dynamics and International Stem Cell Corporation (OTCQB:ISCO).

    The Board is committed to maintaining high standards of governance, both at Board level and operationally throughout the business.

    Group statement of total comprehensive income

    For the year ended 31 December 2020

         31 December  31 December 
         2020  2019 
      Notes  £000  £000 
    Revenue      534   211 
    Research and development costs      (22,041)  (26,512)
    Administrative expenses      (9,079)  (4,359)
    Foreign currency gains / (losses)      363   (1,006)
    Other income      45   34 
    Operating loss before non-recurring items      (30,178)  (31,632)
    Non-recurring items         2,659 
    Operating loss after non-recurring items      (30,178)  (28,973)
    Finance income      5   61 
    Finance expense      (173)  (514)
    Loss before taxation      (30,346)  (29,426)
    Taxation  3   4,383   5,360 
    Loss for the year      (25,963)  (24,066)
    Other comprehensive income:            
    Exchange differences on translating foreign operations      110   379 
    Loss for the year and total comprehensive income for the year      (25,853)  (23,687)
    Loss per share            
    Basic and diluted for the year  4   (22.80)p  (36.75)p

    The basic and diluted loss per share are the same as the effect of share options is anti-dilutive.

    Group statement of financial position

    At 31 December 2020

         At  At 
         31 December  31 December 
         2020  2019 
      Notes  £000  £000 
    Assets            
    Non-current assets            
    Property, plant and equipment            
    - Owned assets      3,659   4,196 
    - Right-of-use assets      835   964 
    Intangible assets      14,025   13,988 
    Taxation receivables      177   188 
           18,696   19,336 
    Current assets            
    Inventories      291   198 
    Trade and other receivables      3,223   1,118 
    Taxation receivables      4,436   6,122 
    Cash and cash equivalents      8,775   3,836 
           16,725   11,274 
    Total assets      35,421   30,610 
    Liabilities            
    Current liabilities            
    Trade and other payables      6,379   6,192 
    Lease liabilities      73   68 
           6,452   6,260 
    Non-current liabilities            
    Lease liabilities      986   1,043 
    Deferred tax  3   13   964 
           999   2,007 
    Total liabilities      7,451   8,267 
    Net assets      27,970   22,343 
    Capital and reserves            
    Share capital  5   329   164 
    Share premium account  5   136,278   108,296 
    Merger reserve      958   958 
    Translation reserve      555   446 
    Other reserve      (864)  (864)
    Share-based payments reserve      3,497   367 
    Retained earnings      (112,783)  (87,024)
    Total equity      27,970   22,343 

    Group statement of changes in equity

    For the year ended 31 December 2020

                     Share-based       
      Share  Share  Merger  Translation  Other  payment  Retained  Total 
      capital  premium  reserve  reserve  reserve  reserve  earnings  equity 
      £000  £000  £000  £000  £000  £000  £000  £000 
    At 1 January 2019  164   108,296   958   67   (864)  708   (63,566)  45,763 
    Issue of share capital (net of expenses)                        
    Total transactions with owners recognised in equity for the year                        
    Loss and total comprehensive income for the year           379         (24,066)  (23,687)
    Lapsed options                 (608)  608    
    Issue of share-based compensation                 267      267 
    At 31 December 2019  164   108,296   958   446   (864)  367   (87,024)  22,343 
    Issue of share capital (net of expenses)  165   27,906                  28,071 
    Issue of Warrants (net of expenses)                 3,110      3,110 
    Exercise of Warrants     76            (11)     65 
    Total transactions with owners recognised in equity for the year  165   27,982            3,099      31,246 
    Loss and total comprehensive income for the year           109         (25,963)  (25,854)
    Lapsed options                 (204)  204    
    Issue of share-based compensation                 235      235 
    At 31 December 2020  329   136,278   958   555   (864)  3,497   (112,783)  27,970 

    Group cash flow statement

    For the year ended 31 December 2020

         Year to  Year to 
         31 December  31 December 
         2020  2019 
      Notes  £000  £000 
    Loss after taxation      (25,963)  (24,066)
    Adjustments for:            
    Depreciation of property, plant and equipment      1,003   1,065 
    Amortisation of intangible assets      203   216 
    Profit on disposal of property, plant and equipment         (17)
    Loss on disposal of intangible assets         29 
    Lease liabilities included in the Income statement      135   159 
    Finance income      (5)  (61)
    Finance expense      173   514 
    Release of contingent consideration         (2,659)
    Share-based compensation      3,334   267 
    Cash flows from operations before movements in working capital      (21,120)  (24,553)
    Changes in working capital:            
    (Increase)/decrease in inventories      (93)  92 
    (Increase)/decrease in trade and other receivables      (2,105)  130 
    Decrease/(increase) in taxation receivables      1,697   (780)
    (Decrease)/increase in trade and other payables      (1,052)  3,555 
    Cash outflow from operating activities      (22,673)  (21,556)
    Cash flows from investing activities            
    Purchases of property, plant and equipment      (163)  (538)
    Purchase of software and other intangibles      (15)  (57)
    Cash received on disposal of assets         43 
    Monies drawn from deposit         10,174 
    Net cash (outflow)/inflow from investing activities      (178)  9,622 
    Cash flows from financing activities            
    Proceeds from issues of ordinary share capital  5   29,740    
    Expenses on issue of shares  5   (1,594)   
    Lease liability payments      (188)  (197)
    Interest received      5   94 
    Interest paid      (173)  (180)
    Net cash inflow/(outflow) from financing activities      27,790   (283)
    Increase/(decrease) in cash and cash equivalents      4,939   (12,217)
    Cash and cash equivalents at the start of the year      3,836   16,053 
    Cash and cash equivalents at the end of the year      8,775   3,836 

    Notes

    For the year ended 31 December 2020

    1. Basis of preparation

    The financial information set out herein does not constitute statutory accounts as defined in Section 434 of the Companies Act 2006. The financial information for the year ended 31 December 2020 has been extracted from the Company's audited financial statements which were approved by the Board of Directors on 31 March 2021 and which, if adopted by the members at the Annual General Meeting, will be delivered to the Registrar of Companies for England and Wales.

    The financial information for the year ended 31 December 2019 has been extracted from the Company's audited financial statements which were approved by the Board of Directors on 22 May 2020 and which drew attention to the material uncertainty over the going concern basis of preparation but received an unqualified audit opinion, did not contain a statement under section 498(2) or (3) of the Companies Act 2006 and have been delivered to the Registrar of Companies.The information in this preliminary statement has been extracted from the audited financial statements for the year ended 31 December 2020 and as such, does not contain all the information required to be disclosed in the financial statements prepared in accordance with the International Financial Reporting Standards as adopted by the European Union (‘IFRS').

    The Company is a public limited company incorporated and domiciled in England & Wales and whose shares are quoted on AIM, a market operated by The London Stock Exchange and through American Depository Shares (ADS's) listed on NASDAQ . The Company is incorporated in England and Wales. The registered office is 9 Bond Court, Leeds LS1 2JZ.

    2. Going concern

    The Group and parent company are subject to a number of risks similar to those of other development stage pharmaceutical companies. These risks include, amongst others, generation of revenues in due course from the development portfolio and risks associated with research, development and obtaining regulatory approvals of its products. Ultimately, the attainment of profitable operations is dependent on future uncertain events which include obtaining adequate financing to fulfil the Group's commercial and development activities and generating a level of revenue to support the Group's cost structure.

    The Directors have prepared detailed financial forecasts and cash flows looking beyond twelve months from the date of the approval of these financial statements. In developing these forecasts, the Directors have made assumptions based upon their view of the current and future economic conditions that are expected to prevail over the forecast period. Shortly after the year-end the Company completed the Merger with Longevity Acquisition Corporation (Longevity) through the issue of new ordinary shares. On completion cash in hand for Longevity was $14.8 million which is expected to add approximately £8.3 million ($11.6 million) in cash to the Company after the payment of costs and settlement of liabilities. A further 4,320,000 warrants convertible to Ordinary shares were also issued as part of the transaction which, if exercised in full, would add approximately $29.0 million in cash to the Company. Concurrently with the completion of the Longevity transaction the Company issued new Ordinary shares in a private placement which raised £18.0 million ($25.0 million) in gross proceeds, with certain Directors intending to subscribe for a further £1.44 million ($2.0 million) following release of the Company's results for the year ended 31 December 2020. Also, in March 2021 our Spanish Subsidiary received a €1.0 million (£0.86 million) overdraft facility as part of the Spanish COVID-19 relief package. The overdraft is unsecured, incurs annual interest at a rate of 2.35% and is repayable at the end of the three-year term. Given the additional funding from the items above, but excluding both the possible redemption the Company warrants issued during the February 2020 share issue (currently worth around £21.9 million) and the warrants issued as part of the Longevity transaction, the Directors estimate that the Group will have sufficient cash to fund its operations into Q2 of 2022 and have prepared the financial statements accordingly using a going concern basis.

    3. Taxation

    The tax credit is made up as follows:

      Year to  Year to 
      31 December  31 December 
      2020  2019 
      £000  £000 
    Current income tax        
    Total current income tax  (3,473)  (5,351)
    Adjustment in respect of prior years  42   (9)
    Total income tax credit recognised in the year  (3,431)  (5,360)
    Current deferred tax        
    Previously recognised deferred tax gains offset against losses  (940)   
    Current year charge  (12)   
    Total deferred tax  (952)   
    Total income tax credit recognised in the year  (4,383)  (5,360)

    The enacted UK corporation tax rate of 19% forms the basis for the UK element of the deferred tax calculation noted below, the equivalent rates used for Ireland and Spain were 12.5% and 25% respectively. However, following the UK budget in 2021 the chancellor announced an increase to the main rate of corporation tax rate in the UK to 25% from April 2023, if applied this would significantly increase the value of the unrecognised deferred tax asset.

    At 31 December 2020, the Group had tax losses available for carry forward of approximately £66.6 million (31 December 2019: £48.3 million). The Group has not recognised deferred tax assets relating to such earned forward losses of approximately £12.6 million (31 December 2019: £6.8 million).

    Group management considers that there is insufficient evidence of future taxable income, taxable temporary differences and feasible tax-planning strategies to utilise all of the cumulative losses and therefore it is not considered certain that the deferred tax assets will be realised in full. If future income differs from current projections, this could significantly impact the tax charge or benefit in future years.

    4. Loss per share

    (a) Basic and diluted

      Year to  Year to 
      31 December  31 December 
      2020  2019 
      £000  £000 
    Loss for the year attributable to equity shareholders  (25,963)  (24,066)
    Weighted average number of shares        
    Ordinary shares in issue  113,851,960   65,493,842 
    Basic loss per share (pence)  (22.80)p  (36.75)p

    The basic and diluted loss per share are the same as the effect of share options and warrants is anti-dilutive.

    (b) Adjusted

    Adjusted loss per share is calculated after adjusting for the effect of non-recurring income and expenses in relation to the reassessment of the contingent liability.

    Reconciliation of adjusted loss after tax:

      Year to  Year to 
      31 December  31 December 
      2020  2019 
      £000  £000 
    Reported loss after tax  (25,963)  (24,066)
    Non-recurring income     (2,659)
    Adjusted loss after tax  (25,963)  (26,725)
    Adjusted basic loss per share (pence)  (22.80)p  (40.81)p

    5. Share capital

      Ordinary  Share  Share    
      shares  capital  premium  Total 
    Group and Company Number  £000  £000  £000 
    Allotted, called up and fully paid ordinary shares of 0.25p                
    Ordinary shares as at 1 January 2019 & 31 December 2019  65,493,842   164   108,296   108,460 
    Placing and subscription 18 February 2020  44,000,000   110   21,890   22,000 
    Expenses of placing and subscription on 18 February 2020        (1,065)  (1,065)
    Warrants exercised (issued 18 February 2020)  75,693      76   76 
    Placing and subscription 13 July 2020  21,898,400   55   7,610   7,665 
    Expenses of placing and subscription on 13 July 2020        (529)  (529)
    Ordinary shares as at 31 December 2020  131,467,935   329   136,334   136,663 

    The balances classified as share capital and share premium include the total net proceeds (nominal value and share premium respectively) on issue of the Company's equity share capital. The entire share capital consists of 0.25 pence ordinary shares.

    Each ordinary 0.25 pence share is entitled to:

     one vote in any circumstances;
     Pari passu to dividend payments or any other distribution; and,
     Pari passu to participate in a distribution arising from a winding up of the Company.

    The Company raised £22.0 million in gross proceeds (£20.9 million net) on 18 February 2020 from a placing of 16,820,080 new ordinary shares and a subscription of 27,179,920 new ordinary shares at an issue price of 50 pence per share. In addition, each placee and subscriber was allotted one warrant for every two ordinary shares subscribed in the fundraising. As a result, a total of 22,000,000 warrants were allotted. Each warrant entitles the holder to subscribe for one ordinary share at an exercise price of 100p at any time up to the fifth anniversary of admission.

    The Company raised £7.7 million in gross proceeds (£7.1 million net) on 13 July 2020 from a placing of 16,807,616 new ordinary shares and a subscription of 5,090,784 new ordinary shares at an issue price of 35 pence per share.

    6. Related party transactions

    Interest in Shares and Warrants

    During the year the Company undertook two capital raises through the issue of shares and warrants. Details of the Directors' participation in these raises and other share acquisitions is as follows:

    Executive Directors Duncan Peyton

    CEO
      Dr Alex Stevenson

    CSO
     
    Shares and Warrants Number of

    shares
      Number of

    warrants
      £  Number of

    shares
      Number of

    warrants
      £ 
    At 1 January 2020  6,455,075          6,413,136        
    Subscription on 18 February 2020 at £0.50 per share  1,333,332   666,666   666,666   1,333,332   666,666   666,666 
    Total at 18 February 2020  7,788,407   666,666   666,666   7,746,468   666,666   666,666 
    Subscription on 13 July 2020 at £0.35 per share  571,428      200,000   571,428      200,000 
    Total at 13 July 2020  8,359,835   666,666   866,666   8,317,896   666,666   866,666 
    Percentage of enlarged share capital at 13 July 2020  6.36%          6.33%        



    Non-Executive Directors David Norwood*

    NED
      Prof. Axel Glasmacher

    NED
     
    Shares and Warrants Number of shares  Number of

    warrants
      £  Number of shares  Number of

    warrants
      £ 
    At 1 January 2020  7,123,725                  
    Subscription on 18 February 2020 at £0.50 per share  1,333,336   666,668   666,668          
    Total at 18 February 2020  8,457,061   666,668   666,668          
    Market based purchase 17 March 2020 at £0.28 per share  100,000      28,000          
    Subscription on 13 July 2020 at £0.35 per share  285,714      100,000   30,000      10,500 
    Total at 13 July 2020  8,842,775   666,668   794,668   30,000      10,500 
    Percentage of enlarged share capital at 13 July 2020  6.73%          0.02%        



    *David Norwood resigned as a Director on 30 September 2020. As his shareholding was not sufficient for him to qualify as a substantial shareholder, transactions after this date have been excluded.

    No warrants had been exercised by the existing Directors at 31 December 2020.

    Further details of shares issued and proceeds from their issue can be found in note 21 to the full accounts.

    Merger with Longevity Acquisition Corporation

    On 22 October 2020 the Company announced its intention to merge with Longevity Acquisition Corporation (Longevity), a Special Purpose Acquisition Company, and its intention to seek a NASDAQ listing.

    To secure the merger a backstop agreement was put in place involving certain of the Directors and significant shareholders (the "Backstop Investors"). The details of the agreement at 31 December 2020 were as follows:

    Backstop Arrangements and Related Party Transactions

    The current Longevity shareholders have the right to redeem their shareholding in Longevity, even if the requisite majority of Longevity shareholders approve the merger. $14.6 million is currently held in a trust account by Longevity to fund redemptions. Any redemptions by Longevity shareholders would reduce the capital available to the enlarged group. Backstop agreements have therefore been executed by Longevity, the Company and Whale Management Corporation ("SPAC Sponsor") with certain investors, including Duncan Peyton and Alex Stevenson, (together the "Backstop Investors").

    The Backstop Investors have committed to subscribe for Longevity shares prior to completion so as to raise up to $14.6 million in the event of redemptions by Longevity shareholders. To secure the Backstop Arrangements, Longevity has agreed to allot 700,000 Longevity shares to the Backstop Investors, Whale has agreed to transfer 200,000 Longevity Shares to the Backstop Investors, and the Company has agreed to allot up to 7,530,000 4D ordinary shares to the Backstop investors if and to the extent outstanding warrants issued by Longevity are exercised.

    The Backstop arrangements also provide that, subject to certain conditions, 4D may be required to file, within thirty days after completion, a registration statement under the US Securities Act registering the resale of the 4D ordinary shares received by the Backstop Investors pursuant to the merger and the Backstop arrangements. The Backstop Investors have agreed to loan Longevity US$1.86 million, the proceeds of which will be used to repay Whale for loans previously made by Whale to Longevity to fund its launch costs. On completion, the enlarged group will repay this sum to the Backstop Investors.

    Related Party Transactions

    The participation by Duncan Peyton (in the amount of $1,075,862) and Alex Stevenson (in the amount of $827,856) in the Backstop arrangements constitutes a related party transaction for the purposes of the AIM Rules. In addition, Steve Oliveira and connected parties, a substantial shareholder of the Company (as defined by the AIM Rules) is participating in the Backstop arrangements in the amount of $5 million (in aggregate). The participation by Steve Oliveira and connected parties in the Backstop Arrangements also constitutes a related party transaction for the purposes of the AIM Rules.

    The 4D Independent Directors, having consulted with the Company's nominated adviser, N+1 Singer, consider that the terms of the related party transactions are fair and reasonable insofar as Shareholders are concerned. In providing their advice to the 4D Independent Directors, N+1 Singer have taken into account the commercial assessments of the 4D Independent Directors.

    Lock-up Agreements

    Duncan Peyton and Alex Stevenson, being the Chief Executive Officer and Chief Scientific Officer respectively, will enter into lock-up agreements at completion. Under the terms of the lock-up agreement, each of Mr Peyton and Dr Stevenson will agree that, subject to certain limited exceptions, they will not sell any consideration shares due to them under the terms of the merger for a period of twelve months.

    7. Subsequent events

    Merger with Longevity Acquisition Corporation

    On 18 March 2021 (the "Closing Date"), the transaction (the "Closing") contemplated by the previously announced Merger Agreement and BVI Plan of Merger (the "Merger"), dated as of 21 October 2020 (the "Merger Agreement"), by and among Longevity Acquisition Company ("Longevity"), 4D Pharma plc ("4D Pharma"), and Dolphin Merger Sub Limited, a British Virgin Islands company and a wholly-owned subsidiary of 4D Pharma (the "Merger Sub") was approved and the transaction was completed on 22 March 2021. The Merger Sub is the surviving entity (the "Surviving Corporation"). As a result of the Merger, each Longevity share issued and outstanding immediately prior to the completion of the Merger was converted into the right to receive 7.5315 ordinary shares of 4D Pharma payable in 4D Pharma ADSs ("American Depositary Shares") at a rate equal to one 4D Pharma ADS for every eight 4D Pharma ordinary shares. 4D Pharma issued no fractional 4D Pharma Shares or 4D Pharma ADSs in the Merger. Each warrant to purchase Longevity Shares and right to receive Longevity Shares that was outstanding immediately prior to the Closing was assumed by 4D Pharma and automatically converted into a warrant to purchase ordinary shares of 4D Pharma and a right to receive ordinary shares of 4D Pharma, payable in 4D Pharma ADSs, respectively.

    In connection with the Closing, certain holders of Longevity common shares exercised their right to redeem those shares in accordance with the Company's organisational documents, as amended, for cash at a price of approximately $11 per Ordinary Share, for an aggregate of approximately $3,000. Pursuant to a Backstop Agreement previously entered into between Longevity, 4D Pharma, Longevity's sponsor (Whale Capital Management the "Sponsor") and certain current shareholders of 4D Pharma and new investors (such current shareholders of 4D Pharma and new investors, collectively, the "Buyers"), the Buyers provided financial backing of approximately $14.7 million to Longevity immediately prior to the Closing, to cover against redemptions by Longevity Shareholders. In view of the de minimis redemptions, the backstop was not called upon. The consideration paid to the Buyers pursuant to the Backstop Agreements consisted of 700,000 newly issued Ordinary Longevity Shares, the transfer by Longevity's sponsor of 200,000 outstanding Longevity Shares, the grant of an option to acquire up to an additional 400,000 outstanding Longevity Shares from the Sponsor, and the commitment by 4D Pharma to grant to the Buyers following the closing of the Merger warrants to acquire up to 1,000,000 Longevity shares (equivalent to 7,530,000 shares in 4D Pharma) for 0.25 pence per ordinary share. In connection with the Closing, and pursuant to the Merger Agreement, (a) an aggregate of 28,298,192 Ordinary shares were issued in 4D Pharma to Longevity shareholders and the Buyers, (b) 4D Pharma assumed Longevity warrants to acquire and rights to receive an aggregate of 16,268,040 ordinary shares in 4D Pharma, and (c) 2,750,000 shares of 4D Pharma were issued to a bank as an advisor fee.

    At the Closing, 4D Pharma entered into a Lock-up Agreement with the Sponsor and certain shareholders of 4D. Pursuant to the Lock-Up Agreement, each holder agreed that, subject to certain exceptions, during the period ending twelve months after the Closing, it will not (i) lend, offer, pledge, hypothecate, encumber, donate, assign, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any shares received as consideration in the Merger (the "Restricted Securities"), (ii) enter into any swap, short sale, hedge or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the Restricted Securities, or (iii) publicly disclose the intention to effect any transaction specified in clause (i) or (ii), or (iv) make any demand for or exercise any right with respect to the registration of any Longevity Shares.

    As Longevity has no ongoing trade or business, the Merger does not constitute a business combination under IFRS 3. As such the transaction will be treated as a financing through the issue of ordinary shares in 4D Pharma. At Closing, Longevity had approximately $14.8 million of cash in hand on completion equating to $11.6 million net of costs and will form part of the share capital and share premium accounts in 4D Pharma.

    NASDAQ Listing

    On 22 March 2021, with the completion of the Longevity transaction, the Company completed its NASDAQ Global Market listing using American Depositary Shares (ADSs) under the ticker ‘LBPS' and the following day the warrants began trading under the ‘LBPSW' ticker. Ordinary shares can be converted at any time to ADSs at a ratio of eight ordinary shares for one ADS. J.P Morgan Chase bank, N.A. is acting as depositary bank for the ADSs and the Company's ordinary shares will continue to be admitted to trading on AIM under the ticker ‘DDDD'

    Private Placement Financing

    On 17 March 2021, the Company announced that it had entered into securities purchase agreements with certain US and UK institutional and accredited investors to raise approximately £17.29 million ($24.03 million) in gross proceeds through a private placement of 15,713,309 new ordinary shares of £0.0025 at a price of £1.10 ($1.53) per share. A further subscription for 654,023 ordinary shares was also made by Merck Sharpe & Dohme Corp. before admission to AIM on 23 March 2021 bringing the total subscription to 16,367,332 ordinary shares and gross proceeds of the placement to approximately £18.01 million ($25.03 million) gross or £16.87 million ($23.45 million) net of fees. In addition to the placement Duncan Peyton (Chief Executive Officer) and Alex Stevenson (Chief ScientificOfficer) intend to subscribe for, in aggregate, £1.44 million ($2.0 million) of new ordinary shares at the issue price of £1.10 following the release of these financial results.

    Overdraft Facility

    In March 2021 4D Pharma Leon S.L.U. agreed a €1.0 million (£0.86 million) overdraft facility supported by the Spanish government as part of its COVID-19 relief package. The overdraft is unsecured, incurs annual interest at a rate of 2.35% and is repayable in full at the end of three years, further adding to the Group's available funding.

    8. Report and accounts

    A copy of the Annual Report and Accounts will be sent to all shareholders with notice of the Annual General Meeting, and will be made available on the Company's website, www.4dpharmaplc.com, by 14 April 2021.





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  5. 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs) - a novel class of drug derived from the microbiome, today announces the appointment of Paul Maier as Non-Executive Director of the Board. Mr Maier will also be a member of 4D's Audit and Risk Committee and will serve as the Company's "audit committee financial expert" under SEC and Nasdaq rules.

    "With over 25 years of extensive senior operational, international and financial management experience in the pharmaceutical and biotechnology industry, Paul will be able to provide 4D pharma with invaluable insights as we continue to execute across our business both clinically and operationally," said Duncan Peyton, Chief Executive Officer…

    4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs) - a novel class of drug derived from the microbiome, today announces the appointment of Paul Maier as Non-Executive Director of the Board. Mr Maier will also be a member of 4D's Audit and Risk Committee and will serve as the Company's "audit committee financial expert" under SEC and Nasdaq rules.

    "With over 25 years of extensive senior operational, international and financial management experience in the pharmaceutical and biotechnology industry, Paul will be able to provide 4D pharma with invaluable insights as we continue to execute across our business both clinically and operationally," said Duncan Peyton, Chief Executive Officer of 4D pharma. "Paul's strong track record will support our Board with additional perspective and expertise."

    "I am excited to join 4D pharma's Board and support its goals to establish a larger global presence while working to bring its differentiated approach and pipeline of Live Biotherapeutics to patients in need," said Paul Maier, Non-Executive Director of 4D pharma. "I look forward to working with 4D and offering my experiences in transactional and operational strategy as the company continues to grow, catalyzed by 4D's upcoming NASDAQ listing."

    Mr. Maier has over 25 years of investor and public relations, operational, regulatory, and finance expertise in the healthcare industry. Mr. Maier was previously the Chief Financial Officer of Sequenom Inc., where he was responsible for raising over $360 million in equity and debt financings, expanding institutional sell side research analyst coverage, as well as overseeing and establishing internal financial infrastructure. Previously, he was Senior Vice President and Chief Financial Officer of Ligand Pharmaceuticals (NASDAQ:LGND) where he helped build Ligand from a venture stage company to a commercial, integrated biopharmaceutical organization, raising over $1 billion in equity and debt financings including a successful IPO, and helped negotiate multiple R&D and commercial partnerships and transactions. He has also acted as an independent financial consultant to life sciences companies. Mr. Maier is currently a Board member of Eton Pharmaceuticals, Inc, Biological Dynamics and International Stem Cell Corporation (OTCQB:ISCO). He holds an MBA from Harvard University and a BS in Business Logistics from the Pennsylvania State University.

    Additional Disclosures Required under the AIM Rules for Companies

    In accordance with Schedule 2(g) of the AIM Rules, Paul Victor Maier (aged 73) currently holds the following directorships:

    Eton Pharmaceuticals, Inc

    Biological Dynamics, Inc

    International Stem Cell Corp.

    Previous directorships held in the past five years:

    Ritter Pharmaceuticals, Inc (Mar 2015 – May 2020)

    Apricus Biosciences, Inc (May 2012 – Jan 2019)

    Mabvax, Inc (June 2014 – July 2018)

    Paul Maier does not currently hold any ordinary shares in the Company.

    Save as set out above there are no further disclosures pursuant to Rule 17 or Schedule Two paragraph (g) of the AIM Rules for Companies in respect of the appointment of Paul Maier.

    About 4D pharma

    Founded in February 2014, 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 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 six 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 (NCT03851250), a Phase II study of MRx-4DP0004 in patients hospitalized with COVID-19 (NCT04363372), and Blautix® in Irritable Bowel Syndrome (IBS) (NCT03721107) which has completed a successful Phase II trial. Preclinical-stage programs include candidates for CNS disease such as Parkinson's disease and other neurodegenerative conditions. The Company has a research collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to discover and develop Live Biotherapeutics for vaccines.

    For more information, refer to www.4dpharmaplc.com.

    Forward-Looking Statements

    This press release contains "forward-looking statements." All statements other than statements of historical fact contained in this announcement, including without limitation statements regarding timing of the clinical trial 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 historical experience and its present expectations or projections. The foregoing factors and the other risks and uncertainties that affect the Company's business, including the risks of delays in the commencement of the clinical trial and those additional risks and uncertainties described the documents filed by the Company with the US Securities and Exchange Commission ("SEC"), should be carefully considered. 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.

    Additional Information about the Transaction and Where to Find it

    This press release is being made in respect of a proposed business combination involving 4D and Longevity. Following the announcement of the proposed business combination, 4D filed a registration statement on Form F-4 (the "Registration Statement") with the SEC which was declared effective on February 25, 2021. This press release does not constitute an offer to sell or the solicitation of an offer to buy or subscribe for any securities or a solicitation of any vote or approval nor shall there be any sale, issuance or transfer 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. The Registration Statement includes a prospectus with respect to 4D's ordinary shares and ADSs to be issued in the proposed transaction and a proxy statement of Longevity in connection with the merger. The proxy statement/prospectus has been mailed to the Longevity shareholders on or about February 26, 2021. 4D and Longevity also plan to file other documents with the SEC regarding the proposed transaction.

    This press release is not a substitute for any prospectus, proxy statement or any other document that 4D or Longevity may file with the SEC in connection with the proposed transaction. Investors and security holders are urged to read the Registration Statement and, when they become available, any other relevant documents that will be filed with the SEC carefully and in their entirety because they will contain important information about the proposed transaction.

    You may obtain copies of all documents filed with the SEC regarding this transaction, free of charge, at the SEC's website (www.sec.gov). In addition, investors and security holders will be able to obtain free copies of the Registration Statement and other documents filed with the SEC without charge, at the SEC's website (www.sec.gov) or by calling +1-800-SEC-0330.

    Participants in the Solicitation

    Longevity and its directors and executive officers and other persons may be deemed to be participants in the solicitation of proxies from Longevity's shareholders with respect to the proposed transaction. Information regarding Longevity's directors and executive officers is available in its annual report on Form 10-K for the fiscal year ended February 29, 2020, filed with the SEC on April 30, 2020. Additional information regarding the participants in the proxy solicitation relating to the proposed transaction and a description of their direct and indirect interests is contained in the Registration Statement.

    4D and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the shareholders of Longevity in connection with the proposed transaction. A list of the names of such directors and executive officers and information regarding their interests in the proposed transaction is included in the Registration Statement.

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