On September 30, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported that management will present at the following investment conferences in October (Press release, Celsion, SEP 30, 2021, https://investor.celsion.com/news-releases/news-release-details/celsion-present-three-investment-conferences-october [SID1234590548]):

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Chardan’s 5th Annual Genetic Medicines Conference. Michael H. Tardugno, Celsion’s chairman, president and chief executive officer, and Khursheed Anwer, Ph.D., Celsion’s chief scientific officer, will participate in a presentation and fireside chat on October 5, 2021 at 4:30 p.m. ET. Management will be available for 1×1 meetings on October 4 and 5, and investors should contact their Chardan representative to arrange a virtual meeting.
LD Micro Main Event. Jeffrey W. Church, chief financial officer, will present virtually at 9:00 a.m. ET on October 12, 2021.
Alliance Global Partners’ Virtual Healthcare Conference. Mr. Tardugno will participate in an oncology focused panel discussion moderated by James Molloy on October 13, 2021 at 9:00 a.m. ET.

On September 30, 2021 Edison Oncology Holding Corp. ("Edison Oncology"), a company established to develop new therapies targeting the fight against cancer, and Apollomics Inc. ("Apollomics"), an innovative biopharmaceutical company committed to the discovery and development of mono- and combination oncology therapies, reported that the first patient was dosed with EO1001 (APL-122) in a Phase I/IIa clinical trial in patients with advanced solid tumors (Press release, Apollomics, SEP 30, 2021, View Source [SID1234590534]). EO1001 is a potent irreversible tyrosine kinase inhibitor (TKI) that has demonstrated inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent in laboratory studies.

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"We are thrilled to see our first patient treated with EO1001 and hope that the potential safety and efficacy suggested by our preclinical data has the potential to translate into clinical benefits for patients suffering from cancer," said Jeffrey Bacha, B.Sc., MBA, Co-Founder and Chief Executive Officer of Edison Oncology. "Our preclinical studies have shown that EO1001 is potent against multiple activating mutations in the intracellular domain of EGFR. We look forward to the results from this first clinical trial as we believe EO1001 has the potential to address unmet medical needs in many types of cancer including non-small cell lung cancer, breast cancer and glioblastoma."

The Phase I/IIa clinical trial will enroll up to 50 patients and is being conducted in Australia under contract service provided by Senz Oncology Pty Ltd. The objective of this first-in-human clinical trial is to examine the safety and tolerability of EO1001 in patients with metastatic or advanced stage ErbB-1(EGFR), ErbB-2(HER2) and/or ERbB-4 (HER4) positive cancer. Patients with relapsed ErbB-positive cancers in solid tumors, including patients with central nervous system (CNS) involvement, will be enrolled at several clinical sites in Australia.

Sanjeev Redkar, PhD, Co-Founder and President of Apollomics, added, "We are pleased to achieve this important milestone in the development of EO1001 which we refer to as APL-122. In preclinical models, APL-122 demonstrated activity in ErbB positive tumors and the ability to penetrate and treat cancers in the CNS. Therefore, this Phase I/IIa study is inclusive of patients with brain metastases. Advancing into human clinical trials marks a pivotal step in our development of this promising cancer therapy."

Dr. Sophia Frentzas, medical oncologist and clinical researcher at Monash Cancer Center in Melbourne, Australia and Principal Investigator for the clinical trial said, "ErbB positive tumors represent a significant patient population with unmet clinical needs. These include patients with HER2 (ErbB2) positive breast cancer and EGFR (ErbB1) mutant lung cancer who have acquired resistance, or are refractory, to frontline targeted therapy. They also include those patients with other tumour types where the ErbB pathway has been increasingly shown to be a clinically significant oncogenic driver (e.g. GBM, endometrial, ovarian, bladder cancer and others). Cross-talk between ErbB family members is implicated in resistance to treatment and the growing incidence of central nervous system metastases plays a significant role in patient morbidity and mortality. In particular, the latter presents a significant limitation with currently available targeted therapies. EO1001 is an oral, brain-penetrating, uniquely potent, pan-ErbB inhibitor. We look forward to exploring its safety and efficacy in this first-in-human trial."

On February 9, 2021, Edison Oncology and Apollomics announced an exclusive licensing agreement whereby Apollomics will develop and commercialize EO1001 (APL-122) globally, except in Mainland China, Hong Kong and Taiwan.

About EO1001

EO1001 is an irreversible tyrosine kinase inhibitor (TKI) that has demonstrated inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent in laboratory studies. EO1001 is potent against mutations in the intracellular domain of EGFR that are typically found in diseases such as Non-Small Cell Lung Cancer (NSCLC) including T790M, L858R and d746-750, HER2 (ErbB2) which is prominent in breast cancer, and against the EGFR-variant III (EGFRvIII) that is characteristic of glioblastoma. In preclinical trials, EO1001 has been well-tolerated and demonstrated the ability to enter the central nervous system (CNS) following oral dosing and activity against treatment-resistant EGFRvIII-driven tumors, including malignancies in CNS, in vivo. EO1001 is referred to as APL-122 by Apollomics.

On September 30, 2021 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), an Australian-based clinical stage radiopharmaceutical company developing next-generation products to address the growing need in oncology, and Evergreen Theragnostics, Inc. ("Evergreen"), a radiopharmaceutical contract manufacturer, reported that the companies have entered into a Targeted Copper Theranostics (TCTs) manufacturing agreement for Clarity’s US clinical trials (Press release, Clarity Pharmaceuticals, SEP 30, 2021, View Source [SID1234590524]).

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Evergreen will centrally manufacture and distribute a range of ready-to-use cGMP TCTs for Clarity’s expanding clinical programs across the US from its new state-of-the-art facility in Springfield, New Jersey, USA. These include:

Cu-67 SARTATE for Clarity’s theranostic neuroblastoma study which is currently underway at multiple sites across the US (NCT04023331); and
Cu-64 SAR-Bombesin for Clarity’s upcoming clinical trials for this pan-cancer product in the US.
The proximity of the manufacturing facility to major transportation hubs and the optimal half-lives of Cu-64 and Cu-67 will enable Evergreen to efficiently distribute TCTs to hospitals across North America as well as reach European markets.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We look forward to working together with Evergreen on Clarity’s products for our ongoing US-based clinical trial in neuroblastoma, an aggressive childhood cancer, and our highly anticipated clinical trial of our diagnostic pan-cancer product SAR-Bombesin in the US. Clarity’s TCT products hold great promise in the field of radiopharmaceuticals, including manufacturing, logistical and clinical benefits, underlying the key advantage of getting ready-to-use products to patients wherever they are located. The manufacturing agreement with Evergreen in the Springfield facility enables Clarity to take advantage of those benefits and strengthens our existing TCT manufacturing footprint in North America to ensure seamless clinical trial supply, reinforcing our focus on the US regulatory pathway for our TCT products as we head towards our ultimate goal of better treating children and adults with cancer."

Evergreen’s CEO, James Cook, commented, "We are pleased to be working together with Clarity on the manufacturing and supply of the TCT platform of products, helping Clarity to pave the way for the broader use of copper-64 and copper-67 based products. This pairing of isotopes is ideally suited for central manufacturing with optimal half-lives for distribution across North America. We look forward to working closely with Clarity and enhancing patient access to these innovative radiopharmaceuticals."

This announcement has been authorised for release by the Executive Chairman.

About CORAR
Evergreen Theragnostics was established in 2019 to be a leading US-based radiopharmaceutical Contract Development and Manufacturing Organization (CDMO). With a state-of-the-art global GMP facility opened in 2021, Evergreen provides highly reliable manufacturing services for therapeutic and centrally distributed diagnostic radiopharmaceuticals, from early development through commercialization. The company was founded by a team that brings a strong track record in theragnostic radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management.

On September 30, 2021 Acacia Pharma Group plc ("Acacia Pharma", the "Group" or the "Company") (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures or cancer chemotherapy, reported its results for the six month period ended 30 June 2021 and provides an update on the commercial progress of Barhemsys and Byfavo in the United States (Press release, Acacia Pharma, SEP 30, 2021, View Source [SID1234590521]).

A presentation of interim results by Acacia Pharma’s senior management team will be webcast (listen only) live later today 30 September at 14.00 CEST (08.00 EST) and participants can register by clicking here or from www.acaciapharma.com. A replay will be available after the event at the same link.

International conference call dial-in details are noted below with callers able to participate in a Q&A.

The results report will be available at www.acaciapharma.com in the Investors section from 07.00 CEST today and the presentation will be made available before the start of the call.

As previously announced, Acacia will also hold a KOL webinar later today at 18.00 CEST/12.00 EDT to discuss the hospital user experience with Barhemsys and Byfavo. Advanced registration is required, and details can be found on our website under the Media/Events section.

Commenting on the results, Mike Bolinder, Chief Executive Officer, said: "We continue to make significant progress towards becoming a leading US hospital pharmaceutical company. During the first half, our team has done an exceptional job executing on our corporate objectives, despite the challenging operating environment posed by the global pandemic. The commercial launches of both Barhemsys and Byfavo are making excellent progress in terms of formulary access, the most important measure of success in this early phase of their commercialization. Given this strong performance, we remain on track to meet our annual formulary goals for both products.

"One key early indicator of the sales potential of both products is the overwhelmingly positive feedback we have received from customers about their initial experiences. They have been very impressed at how rapidly both drugs have been able to improve their care for patients.

"We continue to experience high levels of engagement and support from Key Opinion Leaders and many of the largest academic institutions across the country. We have already begun the pediatric study for Byfavo at study sites in some of the most well-known and respected pediatric centers in the U.S.

"With Barhemsys, we are planning to initiate our Phase 4 PROMPT study, which is designed to gather real-world evidence on the benefits of using the drug. We believe this study can help quantify and document the difference Barhemsys makes in the real-world setting which will provide further important data to support our marketing efforts. We are also very pleased to report that the Marketing Authorization Application (MAA) for Barhemsys has been submitted, validated and is now under formal review in major European markets and we are working diligently to progress international licensing agreements ahead of the product’s anticipated European approval in 2022.

"Lastly, we have continued to make strong progress at the corporate level. We raised €27m (c$33m) in February, made an early repayment of the outstanding Hercules loan facility thereby lowering our borrowing costs and continue to tightly manage our cash burn. Additionally, we were very excited to have appointed Deb Hussain as our new Chief Commercial Officer who brings tremendous knowledge and experience to the organization."

Operating Highlights for First Half 2021

Barhemsys and Byfavo launches continue to track well despite the challenging operating environment caused by the global pandemic
Barhemsys (amisulpride injection)
Sales team began customer engagement in October 2020
To date, 260 accounts on formulary with >80% win rate
Well on track to meet our formulary goal (300 accounts) by year end despite continued COVID-19 related access restrictions
Partnering with key institutions to begin the Barhemsys PROMPT study to gather real-world evidence
MAA submitted, validated and now under formal review in major European markets
Byfavo (remimazolam injection)
Launched in the U.S. at the end of January 2021
To date, 95 accounts on formulary with >90% win rate
On track to meet our formulary goal (150 accounts) by year end
Byfavo pediatric study initiated
Commercial traction for both products continues to be strong
Positive feedback from customers on initial experience with Byfavo and Barhemsys
Engagement with KOLs and key institutions remains high
Phase 4 studies being initiated to expand usage
Significant addressable markets for both products
Appointment of new Chief Commercial Officer
Deb Hussain joined as Chief Commercial Officer in May 2021 after having spent over 20 years at Eli Lilly and Company, where she led some of the largest and most successful brands in the industry and had profit and loss responsibility for over $2 billion of revenue.
Financial Highlights

Results are presented in US$, reflecting the currency of the majority of expected costs and revenues

Equity financing of €27m (c$33m) completed in February 2021. Early repayment of Hercules loan completed in May 2021
Cash and cash equivalents were $47.1m at 30 June 2021 (30 June 2020: $24.6m, 31 December 2020: $46.7m)
Net revenue for the first half of 2021 was $0.4m (1H 2020: $0.0m)
Operating loss for the period was $24.9m (1H 2020: $12.8m) as the Group has invested in the launch and commercialization of Barhemsys and Byfavo
G&A costs increased $4.1m in 1H 2021 to $8.5m (1H 2020: $4.4m) mainly as a result of the amortization of the Byfavo license ($4.1m)
R&D activities have been focused on meeting FDA post-marketing commitments for both Barhemsys and Byfavo. R&D costs in the first half of 2021 increased to $2.1m (1H 2020: $0.6m) as the development activities in relation to our post-marketing commitments were initiated
Basic loss per share for the first half of 2021 was $0.31 (H1 2020: $0.24) reflecting greater commercial spend and incorporating an increase of 24.8 million shares following the equity raises in August 2020 and February 2021 (1H 2021: 88.7 million average shares outstanding; 1H 2020: 63.9 million average shares outstsanding).
Summary and Outlook for 2021

Acacia Pharma is on track to meet its formulary goals for both Barhemsys and Byfavo for the full year 2021 and the Company has been very encouraged by the positive user feedback received for both products.

The markets being addressed initially are large and the Company is confident that these products will successfully address the current unmet needs in PONV and procedural sedation. A series of Phase 4 studies is now being initiated to provide further impetus and data to expand into additional market segments for both Barhemsys and Byfavo over the longer term.

Furthermore, with the highly experienced team put in place and the strong early foundation being built for Barhemsys and Byfavo through formulary access, we believe Acacia Pharma is well positioned to deliver significant commercial success in the future.

Conference call dial-in details

To join the conference call by telephone, please dial-in 5-10 minutes prior to the start using the password Acacia Pharma and any of the phone numbers provided below.

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On September 30, 2021 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, reported the interim results for the Company and its subsidiaries (together "the Group") for the six months ended 30 June 2021 (Press release, 4d Pharma, SEP 30, 2021, View Source [SID1234590515]).

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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 6-K to be filed with the U.S. Securities and Exchange Commission.

Financial highlights

●Net assets at 30 June 2021 of £39.7 million (30 June 2020: £31.5 million and 31 December 2020: £28.0 million).

●Cash and cash equivalents and short-term deposits at 30 June 2021 of £20.7 million (30 June 2020: £10.0 million and 31 December 2020: £8.8 million).

●Loss and total comprehensive income for the six months ended 30 June 2021 of £56.1 million (30 June 2020: £13.6 million and 31 December 2020: £25.9 million).

●Research and development expenditure for the six months ended 30 June 2021 of £9.9 million (30 June 2020: £12.4 million and 31 December 2020: £22.0 million).

Operational highlights

●Completed the acquisition of Longevity Acquisition Corporation (Longevity), a special purpose acquisition company (SPAC), and the listing on NASDAQ of 4D pharma American Depository Shares (ADSs) under the ticker symbol ‘LBPS’. As a result of the business combination, cash of $14.8 million held by Longevity became available to 4D pharma.

●In conjunction with the merger and NASDAQ listing, 4D pharma completed a private placement raising gross proceeds of approximately $25.0 million (£18.0 million), including participation of existing investor Merck Sharp & Dohme Corp.

●Presented additional supportive data from the completed Phase II trial of Blautix in subjects with irritable bowel syndrome with constipation (IBS-C) or with diarrhea (IBS-D) at Digestive Disease Week (DDW). The DDW 2021 poster can be accessed via the Posters & Publications page of our website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

●Announced the completion of target enrollment of 30 patients in Part A of the Phase I/II first-in-human clinical trial of MRx-4DP0004 for the treatment of asthma.

●Announced a clinical trial collaboration and drug supply agreement with Merck KGaA, Darmstadt, Germany, and Pfizer Inc. for BAVENCIO (avelumab). Under the collaboration, 4D pharma intends to commence a clinical trial to evaluate BAVENCIO in combination with MRx0518 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 is the second clinical collaboration combining MRx0518 with an immune checkpoint inhibitor.

●Also provided a clinical update on the MRx0518 clinical program, with updates on patient recruitment and study status across the three ongoing MRx0518 clinical trials.

●Entered into a collaboration with Parkinson’s UK, a non-profit organization, to establish a Patient Advisory Board to present patient-centric perspectives as the Company advances novel Live Biotherapeutics for the treatment of neurodegenerative conditions such as Parkinson’s disease.

●Announced the appointment of John Beck as Chief Financial Officer.

●Announced the appointment of Paul Maier as Non-Executive Director.

Since the period end

●Announced the passing of John Beck, Chief Financial Officer.

●Published pre-clinical research relating to its second-generation immuno-oncology LBP MRx1299 improving the activity of CAR-T.

●Announced the acceptance of two e-Poster presentations of MRx0518 clinical biomarker data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, held from 16–21 September 2021. The ESMO (Free ESMO Whitepaper) 2021 posters can be accessed via the Posters & Publications page of our website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

●Closed a senior secured credit facility for up to $30 million with Oxford Finance SARL, in three tranches: an initial tranche of $12.5 million at closing which extends 4D pharma’s cash runway into Q4 2022, with the remaining $7.5 million and $10 million tranches dependent on the achievement of certain milestones.

For further information please contact:

As we move into the second half of 2021, we look forward to capitalizing on the efforts of the team throughout the first six months of 2021. We have generated more data expanding our unique understanding of mechanisms of host-microbe interactions and are seeing the benefits in our clinical programs while we continue to drive research through our proprietary MicroRx platform. This work has allowed us to discover new therapeutic possibilities in disease such as Parkinson’s, and demonstrate potential of our Live Biotherapeutics alongside new modalities such as CAR-T. Alongside the continued push to bring our Live Biotherapeutics to an approval in oncology, 4D pharma achieved a significant milestone at the beginning of the year following our listing on NASDAQ.

Building the oncology franchise

We continue our commitment to oncology, building a strong understanding of the utility of our Live Biotherapeutics in this field. In particular recognizing the value of a therapeutic which has little or no side effects to combination with existing therapies in the fight against cancer while many other combination treatments currently evaluated in immune-oncology increase toxicity.

With our lead oncology candidate MRx0518, we have built on our ongoing work with MSD (Merck & Co.) and its anti-PD-1 immune checkpoint inhibitor (ICI) Keytruda (pembrolizumab), announcing a new clinical collaboration and drug supply agreement with Merck KGaA and Pfizer and their anti-PD-L1 ICI Bavencio (avelumab). In contrast to the ongoing study with Keytruda in ICI-refractory patients, the new Bavencio collaboration takes MRx0518 into earlier lines of treatment, and expands our clinical portfolio targeting the PD-1 axis.

Under the collaboration we will conduct a clinical study to evaluate MRx0518 in combination with Bavencio as a first-line maintenance therapy for urothelial carcinoma, a common form of bladder cancer. Bavencio is the first and only ICI approved in this setting, and we are excited to commence this fourth clinical study of MRx0518 before the end of 2021.

In addition, we announced progress updates for the three ongoing clinical studies of MRx0518 – in combination with Keytruda in patients with solid tumors refractory to prior ICI therapy; as a neoadjuvant monotherapy; and in combination with radiation prior to surgery for pancreatic cancer. These studies continue to progress well, giving more insights into the biological mechanisms of MRx0518 and its activity on the patient immune system, potentially allowing us to understand which patients may benefit most from MRx0518 in combination with ICIs like Keytruda and Bavencio.

After the period end, in September, 4D pharma presented new data from the Keytruda combination and neoadjuvant monotherapy studies at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The ESMO (Free ESMO Whitepaper) 2021 posters can be accessed via the Posters & Publications page of our website at View Source." target="_blank" title="View Source." rel="nofollow">View Source The new data includes tumor immune biomarkers associated with response to the combination with MRx0518 and Keytruda, which is an exciting proposition we look forward to investigating further as we continue to progress MRx0518. This is supported by additional data for MRx0518 as a monotherapy, providing further evidence of immune activation by our oral Live Biotherapeutic, including positive changes in prognostic indicators predictive of response to immunotherapy. These data continue to deepen our understanding of the activity of MRx0518 on patients, and will help inform engagement with regulatory authorities and clinicians as we continue to develop this leading immuno-oncology Live Biotherapeutic.

The main focus of our work in oncology at this time is the preparation of a pivotal development program for MRx0518 in an oncologic indication.

Through our clinical programs and research, our work in oncology illustrates the potential of the MicroRx platform to expand 4D pharma’s leadership in oncology.

Alongside our work in solid tumors, 4D also continues to push forward in identifying new LBP candidates in additional oncology settings, such as CAR-T. 4D pharma recently published pre-clinical research relating to second-generation oncology LBP MRx1299 in the respected peer-reviewed journal Nature Communications. The research demonstrates the ability of the bacterium Megasphaera massiliensis and its short chain fatty acid (SCFA) metabolite pentanoate to enhance the anti-tumor activity of cytotoxic T lymphocytes (CTL) and Chimeric antigen receptor T cell (CAR-T) therapies in animal models of cancer.

Blautix – a leading late-stage LBP candidate

IBS remains a misunderstood disease and not easily characterized. In the US, as many as 35 million people report IBS symptoms, with 60-70% being women. IBS remains a disease with significant unmet need. Current treatments target sub-type specific symptoms (diarrhea or constipation) but, due to side effects and sub-optimal efficacy, patient satisfaction and compliance remains an issue. Further, there currently is no therapeutics approved for patients with fluctuating or mixed symptoms, known as IBS-M.

Following publication of topline efficacy and safety results from our Phase II study of Blautix in irritable bowel syndrome with constipation (IBS-C) and with diarrhea (IBS-D) in October 2020, important additional data was presented at Digestive Disease Week (DDW) in May 2021. The DDW 2021 posters can be accessed via the Posters & Publications page of our website at View Source . A key finding from sub-group analyses was an unusually high placebo response rate in patients in the UK and Ireland which negatively impacted the topline results. Conversely, we saw an enhanced effect in the US population in both IBS-C and IBS-D.

In agreement with regulatory guidelines and key opinion leader feedback, the positive Phase II data provides a clear path forward for the development of Blautix as a novel treatment for IBS with the potential to be a single, safe, effective therapeutic able to address multiple subtypes of IBS. We have engaged with the US FDA regarding plans for pivotal development, and discussions are ongoing with multiple potential partners for the program.

MRx-4DP0004 – Systemic immune activity via the gut

MRx-4DP0004 is in an ongoing Phase I/II first-in-human clinical trial in patients with partly controlled asthma, as an add-on therapy to their long-term maintenance asthma medication.

In June we announced the completion of target enrolment of 30 patients in Part A of our Phase I/II randomized, placebo-controlled study of asthma candidate MRx-4DP0004. Part A of the trial primarily assesses the safety and tolerability of MRx-4DP0004, as well as biomarker signals of activity relevant to asthma. We expect to announce top line results later in 2021.

Leveraging the gut-brain axis

As accumulating evidence points towards the gut-brain axis and the role of the microbiome in conditions of the central nervous system (CNS), we are excited to continue to push forward in this field. In April, the company announced our collaboration with Parkinson’s UK, to establish a Patient Advisory Board (PAB) of people living with Parkinson’s disease. The PAB provides valuable patient perspectives as we continue to advance candidates MRx0029 and MRx0005 towards a first-in-man study in patients with Parkinson’s disease expected to begin in 2022.

Corporate activity

The NASDAQ is the premier exchange for biotechnology companies worldwide, giving companies global reach and visibility within the healthcare investment ecosystem. Achieving a listing on NASDAQ has been a strategic objective for 4D pharma’s continued growth and success moving forward.

In March 2021 we met this transformational milestone, as we listed 4D pharma American Depository Shares (ADSs) on the NASDAQ exchange in the United States following the completion of our merger with special purpose acquisition company (SPAC) Longevity Acquisition Corporation.

In conjunction with the SPAC merger and NASDAQ listing we conducted a fundraise which together provided the company with approximately $42 million of additional capital. In doing so we began to strengthen our international investor base and put 4D pharma in a strong financial position to execute across our pipeline.

Further, after the period end in July, we also announced a credit facility with Oxford Finance LLC, that provides 4D pharma with up to $30 million of capital across three tranches, of which the first tranche of $12.5 million was received upon closing. The facility diversifies and strengthens the company’s capital structure with a well-respected specialty finance firm in the life sciences field. The additional funds further extend our cash runway beyond additional potentially transformative development milestones.

In addition to strengthening our financial position, we also strengthened our leadership team. In March we welcomed Paul Maier as a Non-Executive Director who will also serve as a financial expert under SEC and NASDAQ rules. Paul brings over 25 years of operational and financial management experience in the life sciences industry, and his experience has been a valuable addition to our Board of Directors.

It was with great sadness that we announced the passing of John Beck in July of this year, who had served as Chief Financial Officer with the company since March. John was greatly respected within the life sciences industry and brought 30 years of finance experience to our team. His significant contributions to the company during his time with us have been highly valuable, and we hope to carry his legacy forward by building upon the strong foundations he helped to lay as 4D pharma entered a new era as a US-listed entity.

Conclusion

The first half of 2021 has been a significant period for 4D pharma. Our dual listing on NASDAQ raised our international profile and, using this as a platform along with new funds at our disposal, we look ahead to a period rich in clinical catalysts across our pipeline of Live Biotherapeutic Products taking the microbiome beyond the gut, including clinical readouts and the commencement of new studies across multiple programs. Highs and lows in the broader microbiome space have created mixed feelings towards microbiome therapeutic approaches – we are confident 4D pharma’s differentiated, mechanism-driven approach is poised to deliver.