4D pharma Reports Full Year 2021 Financial Results, Operational Highlights, and Guidance for Key Milestones in 2022

LEEDS, England–(BUSINESS WIRE)–4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, today reported financial results for the full year ending December 31, 2021 and highlighted its key corporate objectives for 2022.

“2021 was a productive year for 4D pharma. We reported promising signals in the clinic from our lead candidates in immuno-oncology and inflammatory disease, and entered into our second clinical collaboration in oncology, further validating the potential for single strain Live Biotherapeutics to treat systemic disease and the MicroRx platform. Additionally, we completed the merger with Longevity Acquisition Corporation which led to 4D pharma being listed on the NASDAQ exchange, providing us access and visibility across the US capital markets,” said Duncan Peyton, Chief Executive Officer of 4D pharma. “Already in 2022 we have continued this progress, and look forward to updating shareholders as we execute on our corporate objectives throughout the year.”

Full Year 2021 Financial Highlights

• Cash and cash equivalents of $21.0 million as of December 31, 2021
• Net assets of $32.4 million as of December 31, 2021
• Loss and total comprehensive income for the full year 2021 was $32.1 million
• Research and Development Expenses was $21.6 million; General and Administrative Expense was $15.9 million
• Listed on the NASDAQ Global Market under ticker symbol ‘LBPS’ after completing the merger with Longevity Acquisition Corporation, a special purpose acquisition company (SPAC) on March 22, 2021

Full Year 2021 Operational Highlights

• Provided an update on the ongoing clinical trial portfolio for lead oncology candidate MRx0518. This included the first announcement of signals of anti-tumor activity for the combination of MRx0518 with Keytruda® in bladder cancer, adding to the previously reported activity in renal cell carcinoma and non-small cell lung cancer.
• Announced a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., under which 4D pharma will conduct a clinical trial to evaluate MRx0518 in combination with Bavencio® (avelumab), an anti-PD-L1 immune checkpoint inhibitor, as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. This study is expected to commence in 2022.
• Presented additional clinical mechanistic data for MRx0518 at the European Society for Medical Oncology (ESMO) Congress, as both a monotherapy and in combination with Keytruda® (pembrolizumab). The results identified baseline biomarkers associated with clinical benefit in patients with solid tumors resistant to immune checkpoint inhibitors (ICIs) treated with MRx0518 in combination with pembrolizumab; and gene and metagene signature changes in solid tumors following treatment with MRx0518 monotherapy.
• Presented further analyses of the completed Phase II clinical trial of Blautix® in patients with irritable bowel syndrome with constipation (IBS-C) or with diarrhea (IBS-D) at Digestive Disease Week (DDW) 2021. The post-hoc analyses revealed strong and statistically significant activity on the key symptom of bowel habit, a potential FDA-approvable primary endpoint. In addition, analysis of the data by geographical region shows that earlier topline results were impacted by an unusually high placebo response in patients in the UK and Ireland, and enhanced positive signals were seen in the larger US population.
• Subsequently, the company presented additional mechanistic clinical data for Blautix® at Gastro 2021. The results show treatment with Blautix® led to structural changes in the gut microbiota and greater increases in interconnectivity between taxa than placebo, in patients with both IBS-C and/or IBS-D.
• Reported topline results from Part A of our Phase I/II randomized, double-blind, placebo-controlled clinical trial of MRx-4DP0004 as a treatment for asthma. Part A met the primary endpoint showing MRx-4DP0004 was safe and well tolerated. In addition, MRx-4DP0004 generated promising signals of clinical activity which support progression into Part B of the study.
• Published preclinical research relating to second-generation immuno-oncology LBP MRx1299 improving the activity of CAR-T in animal models of cancer, in collaboration with Philipps-University Marburg, Germany, and Universitätsklinikum Würzburg, Germany.
• Completed the merger with special purpose acquisition company (SPAC) Longevity Acquisition Corporation and concurrent private placement, raising total gross proceeds of approximately $39.8 million.
• Entered into a senior secured credit facility for up to $30 million with Oxford Finance LLC, including the initial drawdown of the first tranche for $12.5 million, with the remaining $7.5 million and $10 million tranches dependent on the achievement of certain milestones.
• Announced the appointments of Paul Maier as Non-Executive Director and John Beck as Chief Financial Officer (CFO). Later in the year the Company was saddened to announce the passing of John Beck.

Subsequent Events Since the 2021 Period End

• On January 3, 2022 announced the appointment of John Doyle as Chief Financial Officer (CFO)
• On February 22, 2022, the Company announced that the U.S. Food and Drug Administration (FDA) has cleared investigational new drug (IND) applications for MRx0005 and MRx0029 for the treatment of Parkinson’s disease. The Company expects to initiate a first-in-human Phase I clinical trial in people with Parkinson’s disease in mid-2022.
• On March 23, 2022, the company announced that in Part B of the ongoing Phase I/II study of MRx0518 and Keytruda® in patients with solid tumors that have progressed on a prior immune checkpoint inhibitor (ICI), the renal cell carcinoma (RCC) group met its primary efficacy endpoint ahead of enrolment completion.

Anticipated Development Milestones and Key Objectives for 2022

• First patient dosing in our Phase II study of MRx0518 & Bavencio® as a first-line maintenance therapy for urothelial carcinoma expected in Q2 2022
• Complete enrollment of Phase I study of MRx0518 in pancreatic cancer expected to be Q2 2022
• Presentation of data from the Phase I/II Part A Study in Asthma at The American Thoracic Society conference in May 2022
• Part B of ongoing Phase I/II trial of MRx-4DP0004 in asthma, expected to commence in 2H 2022
• Phase I trial of MRx0005 and MRx0029 in people with Parkinson’s disease expected to commence in 2H 2022
• Provide update and guidance on Phase II study of Blautix® in patients with irritable bowel syndrome (IBS)
• Provide update on next steps in Phase I/II study of MRx0518 and Keytruda® in the Renal Cell Carcinoma (RCC) group