On July 29, 2021 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported an update on its recent corporate progress and reported financial results for the quarter ended June 30, 2021 (Press release, MacroGenics, JUL 29, 2021, View Source [SID1234585360]).

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"In June, we presented encouraging data from a Phase 1 study of MGC018 at ASCO (Free ASCO Whitepaper). We look forward to providing further updates on this compound and margetuximab in gastric cancer at ESMO (Free ESMO Whitepaper) in September. Beyond these two programs, we continue to progress our growing pipeline of investigational therapeutics for the potential treatment of cancer as well as to execute on the recent launch and commercialization of MARGENZA with our partner, EVERSANA," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Also in June, we announced our broad strategic collaboration with Zai Lab to develop and commercialize preclinical bispecific antibodies in oncology. We’re very pleased to have entered this second collaboration with Zai Lab."

Key Updates on Proprietary Programs

Recent progress and anticipated events in 2021 related to MacroGenics’ approved product, MARGENZA, and its investigational product candidates in clinical development are highlighted below.

Margetuximab is an Fc-engineered, monoclonal antibody (mAb) that targets the HER2 oncoprotein, which is expressed by certain breast, gastroesophageal and other solid tumor cells.
MARGENZA (margetuximab-cmkb) commercial launch. In March 2021, MacroGenics and its commercial partner, EVERSANA, launched MARGENZA for the treatment of adult patients with metastatic HER2-positive breast cancer, in combination with chemotherapy, who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Based on the accrued overall survival (OS) events in the SOPHIA metastatic breast cancer Phase 3 study, the Company expects to complete and share top-line results from the final analysis of OS data, based on 385 OS events by the end of the third quarter of 2021.
Phase 2/3 MAHOGANY study in advanced gastric and gastroesophageal junction cancer. All 40 patients have been enrolled in the first part of Module A of the MAHOGANY study, which is evaluating margetuximab in combination with retifanlimab, an anti-PD-1 molecule the Company licensed to Incyte Corporation in 2017. The Company plans to report interim safety and efficacy data on these patients at ESMO (Free ESMO Whitepaper) in September 2021.
Flotetuzumab is a bispecific CD123 × CD3 DART molecule being evaluated in patients with primary induction failure (PIF) and early relapsed (less than six months, or ER6) acute myeloid leukemia (AML). MacroGenics is conducting a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with PIF/ER6 AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the composite primary endpoint. The Company anticipates providing further updates on the clinical development of flotetuzumab in late 2021.
MGC018 is an antibody-drug conjugate (ADC) that targets B7-H3. In June 2021, MacroGenics presented updated clinical data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating anti-tumor activity in patients with melanoma and metastatic castration-resistant prostate cancer (mCRPC). Preliminary results in the mCRPC cohort expansion showed 11 of 22 patients (50%) had a PSA reduction of 50% or greater, with anti-tumor activity observed in four of seven patients with measurable disease who had their first 9-week imaging results available, including one unconfirmed partial response. Anti-tumor activity was also reported in all three melanoma patients who received 4 mg/kg in dose escalation, with one patient achieving a confirmed partial response. MGC018 trial cohorts are ongoing for mCRPC, melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN) and triple negative breast cancer (TNBC). MacroGenics will provide an update of clinical data at ESMO (Free ESMO Whitepaper) in September.
Enoblituzumab is an Fc‐engineered, anti‐B7‐H3 mAb. MacroGenics continues to recruit its Phase 2 study of enoblituzumab in a chemotherapy-free regimen in combination with retifanlimab in front-line patients with SCCHN who are PD-L1 positive and with tebotelimab in SCCHN patients who are PD-L1 negative. The Company has recently activated clinical trial sites in Europe to advance enrollment of the study.
Tebotelimab is a bispecific, tetravalent DART molecule targeting PD-1 and LAG-3. MacroGenics is evaluating the molecule in patients as both monotherapy as well as in combination with other agents. The Company’s partner in Greater China, Zai Lab, is evaluating tebotelimab as monotherapy in patients with hepatocellular carcinoma and melanoma as well as in combination with niraparib in a variety of advanced or metastatic solid tumors. MacroGenics expects to provide an update on the next stage of development for tebotelimab later this year.
MGD019 is a bispecific, tetravalent DART molecule targeting PD-1 and CTLA-4. The Company is conducting a Phase 1 dose expansion study in cohorts of patients with microsatellite stable colorectal cancer (MSS CRC), checkpoint-naïve NSCLC, mCRPC and melanoma.
IMGC936 is an ADC that targets ADAM9, a cell surface protein over-expressed in several solid tumor types, and is being developed jointly under a 50/50 collaboration with ImmunoGen, Inc. Under the collaboration, ImmunoGen is leading clinical development of IMGC936 in a Phase 1 clinical trial evaluating safety and pharmacokinetics in patients with select cancers and have indicated they anticipate disclosing initial data in early 2022.
MGD024 is a next-generation, bispecific CD123 × CD3 DART molecule in preclinical development. The molecule incorporates a CD3 component designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, along with an Fc domain to permit intermittent dosing through a longer half-life. The Company expects to submit an Investigational New Drug (IND) application to the FDA in the fourth quarter of 2021.
Second Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2021 were $297.3 million, compared to $272.5 million as of December 31, 2020. This does not include $55 million in consideration (consisting of a $25 million upfront payment and a $30 million equity investment) received from Zai Lab in July 2021, which related to the execution of the collaboration agreement that was announced on June 16, 2021.

Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $30.8 million for the quarter ended June 30, 2021, including $3.2 million net sales of MARGENZA, compared to total revenue of $20.3 million for the quarter ended June 30, 2020. This increase was primarily due to the recognition of $14.4 million of revenue from Zai Lab related to the recent June 2021 collaboration announcement and recognition of a $5 million milestone from Incyte Corporation.

R&D Expenses: Research and development expenses were $55.8 million for the quarter ended June 30, 2021, compared to $57.4 million for the quarter ended June 30, 2020.

SG&A Expenses: Selling, general and administrative expenses were $15.2 million for the quarter ended June 30, 2021, compared to $10.2 million for the quarter ended June 30, 2020. This increase was primarily related to MARGENZA launch costs.
Net Loss: Net loss was $39.9 million for the quarter ended June 30, 2021, compared to net loss of $46.9 million for the quarter ended June 30, 2020.

Shares Outstanding: Shares outstanding as of June 30, 2021 were 60,133,447, which excluded 958,467 shares issued to Zai Lab in July as part of the recently announced collaboration.

Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of June 30, 2021, plus consideration received from Zai Lab in July 2021, as well as anticipated and potential collaboration payments, should enable it to fund its operations through 2023, assuming the Company’s programs and collaborations advance as currently contemplated.
Conference Call Information
MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the quarter ended June 30, 2021 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 7983402.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On July 29, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update and financial results for the second quarter ending June 30, 2021 (Press release, PTC Therapeutics, JUL 29, 2021, View Source [SID1234585359]).

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"I am delighted to say all facets of our business made substantial progress this quarter and we anticipate having four registration-directed trials ongoing by next quarter," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "I am also proud of the execution of the global commercial team, which is driving the continued robust growth of the DMD franchise and has led us to raise our 2021 revenue guidance despite ongoing challenges from the pandemic."

Key Second Quarter and Other Corporate Updates:

The Duchenne muscular dystrophy (DMD) franchise had a total quarterly net product revenue of $102 million in the second quarter of 2021. This represents a 36% growth over the second quarter of 2020, continuing PTC’s trend of strong quarterly commercial revenues.
Translarna (ataluren) revenue growth was driven by expansion of the patient base, continued high compliance and broader access in existing geographies as well as continued geographic expansion including Russia, Central and Eastern Europe, Middle East and North Africa.
Emflaza (deflazacort) revenue growth was primarily due to new patient starts, continued high adherence and fewer discontinuations.
Evrysdi (risdiplam) received approval from the Ministry of Health Labor and Welfare in Japan in June 2021. Evrysdi is a product of a collaboration between PTC, Roche and the SMA Foundation.
Evrysdi is now approved in 54 countries.
In the U.S., more than 1800 patients are currently treated with Evrysdi, approaching 20% total market share.
Second Quarter Clinical Updates:

The registration-directed Phase 3 PTC923 phenylketonuria (PKU) trial, APHENITY, is expected to initiate in the third quarter of 2021.
PTC has multiple ongoing clinical trials, three of which are registration-directed clinical studies:
The MIT-E Phase 2/3 vatiquinone trial for mitochondrial epilepsy with data anticipated in the third quarter of 2022.
The MOVE-FA Phase 3 vatiquinone trial for Friedreich ataxia with data anticipated in 2023.
The FITE19 Phase 2/3 emvododstat trial in patients with COVID-19 is expected to be completed by year end 2021.
A Phase 1 healthy volunteer trial of the second Bio-e compound, PTC857, was recently completed and results demonstrated predictable pharmacology and no reported tolerability findings. This allows dose selection necessary to move forward to Phase 2, which we plan to initiate for amyotrophic lateral sclerosis (ALS) in the first quarter of 2022.
Results from additional cohorts are expected from the Phase 1 healthy volunteer trial of PTC518 for Huntington’s disease in the third quarter of this year. Phase 2 planning is already underway and is expected to be initiated by the end of 2021.
The Committee for Medicinal Products for Human Use (CHMP) imposed a clock stop in the aromatic L-amino acid decarboxylase deficiency (AADC-d) review process to allow for completion of its pre-approval inspections. This process is still ongoing and therefore the CHMP opinion is now expected in the fourth quarter of 2021.
For the Biologics License Application (BLA) for AADC-d, the third cannula surgery has been completed, and PTC will align with the FDA and expects to submit the BLA by the end of this year.
Second Quarter 2021 Financial Highlights:

Total revenues were $116.7 million for the second quarter of 2021, compared to total revenues of $75.2 million for the second quarter of 2020.
Total revenue includes net product revenue across the commercial portfolio of $103.1 million and royalty revenue of $13.6 million for the second quarter of 2021.
Translarna net product revenues were $52.6 million for the second quarter of 2021, compared to $38.6 million for the second quarter of 2020. These results reflect an increase in net product sales in existing markets as well as continued geographic expansion.
Emflaza net product revenues were $49.1 million for the second quarter of 2021, compared to $36.2 million for the second quarter of 2020. These results reflect new patient prescriptions, high compliance, and fewer discontinuations.
Roche reported first half of 2021 Evrysdi sales of approximately CHF 243 million, resulting in year-to-date royalty revenue of $20.2 million. Evrysdi is a product of a collaboration between PTC, Roche and the SMA Foundation.
U.S. GAAP (generally accepted accounting principles) research and development (R&D) expenses were $125.5 million for the second quarter of 2021, compared to $176.5 million for the second quarter of 2020. The decrease in research and development expenses is primarily related to one-time charges in the second quarter of 2020 of $53.6 million for our Censa merger, as well as $41.2 million for our commercial manufacturing service agreement with MassBiologics of the University of Massachusetts Medical School, or MassBio, related to dedicated manufacturing space for our lead gene therapy program, AADC deficiency. This was partially offset by increased investment in research programs and advancement of the clinical pipeline in the second quarter of 2021.
Non-GAAP R&D expenses were $112.0 million for the second quarter of 2021, excluding $13.4 million in non-cash stock-based compensation expense, compared to $168.0 million for the second quarter of 2020, excluding $8.6 million in non-cash stock-based compensation expense.
GAAP selling, general and administrative (SG&A) expenses were $68.9 million for the second quarter of 2021, compared to $53.7 million for the second quarter of 2020. The increase reflects our continued investment to support commercial activities including expanding our commercial portfolio, including an increase in rent and related expenses associated with entering into a long-term lease for our facility located in Hopewell Township.
Non-GAAP SG&A expenses were $56.6 million for the second quarter of 2021, excluding $12.3 million in non-cash stock-based compensation expense, compared to $45.3 million for the second quarter of 2020, excluding $8.3 million in non-cash stock-based compensation expense.
Change in the fair value of deferred and contingent consideration was $0.7 million for the second quarter of 2021, compared to $7.7 million for the second quarter of 2020. The change in fair value of deferred and contingent consideration is related to the fair valuation of potential future consideration to be paid to former equity holders of Agilis Biotherapeutics, Inc. (Agilis) in connection with PTC’s acquisition of Agilis, which closed in August 2018.
Net loss was $118.4 million for the second quarter of 2021, compared to net loss of $181.4 million for the second quarter of 2020.
Cash, cash equivalents and marketable securities was $947.1 million at June 30, 2021, compared to $1.1 billion at December 31, 2020.
Shares issued and outstanding as of June 30, 2021 were 70,559,330.
PTC Updates Full Year 2021 Guidance as Follows:

PTC now anticipates net product revenues for the DMD franchise for the full year 2021 to be between $370 and $390 million.
PTC continues to anticipate GAAP R&D and SG&A expense for the full year 2021 to be between $825 and $855 million.
PTC continues to anticipate Non-GAAP R&D and SG&A expense for the full year 2021 to be between $725 and $755 million, excluding estimated non-cash, stock-based compensation expense of $100 million.
Non-GAAP Financial Measures:
In this press release, the financial results and financial guidance of PTC are provided in accordance with GAAP and using certain non-GAAP financial measures. In particular, the non-GAAP financial measures exclude non-cash, stock-based compensation expense. These non-GAAP financial measures are provided as a complement to financial measures reported in GAAP because management uses these non-GAAP financial measures when assessing and identifying operational trends. In management’s opinion, these non-GAAP financial measures are useful to investors and other users of PTC’s financial statements by providing greater transparency into the historical and projected operating performance of PTC and the Company’s future outlook. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. Quantitative reconciliations of the non-GAAP financial measures to their respective closest equivalent GAAP financial measures are included in the table below.

Today’s Conference Call and Webcast Reminder:

PTC will host a conference call to discuss the second quarter of 2021 corporate updates and financial results today at 4:30 pm ET and can be access by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 7064479. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for 30 days following the call.

On July 29, 2021 Amgen (NASDAQ:AMGN) reported that it will report its second quarter financial results on Tuesday, August 3, 2021, after the close of the U.S. financial markets (Press release, Amgen, JUL 29, 2021, View Source [SID1234585358]). The announcement will be followed by a conference call with the investment community at 2:00 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

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Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On July 29, 2021 Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, reported financial results and business highlights for the second quarter 2021 (Press release, Evelo Biosciences, JUL 29, 2021, View Source [SID1234585357]).

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"We have demonstrated in multiple cohorts in a Phase 1b clinical trial the potential of our platform to create medicines that control systemic inflammation and immunity that are well-tolerated and easily administered. Over the next 6-12 months, we have a series of catalysts that will bring us closer to our mission of delivering on this promise to patients, beginning with data from our EDP1815 Phase 2 trial in psoriasis and the start of our EDP1815 Phase 2 trial in atopic dermatitis, both expected in 3Q 2021," said Simba Gill, Ph.D., Chief Executive Officer of Evelo. "Importantly, our efforts with EDP1815 and dermatological diseases are only the beginning. Consistent with our strategy and understanding of the breadth of our platform, we continue to explore ways to enhance and extend the applications of SINTAX-based medicines. We are progressing our next-generation extracellular vesicle (EV) candidates into the clinic next year. And, as we look ahead to later-stage development, we strengthened our team with the addition of Mark Plinio as Chief Commercial Officer. We have the resources and leadership in place to advance and expand our broad portfolio of product candidates that have the potential to be safe, well-tolerated, and affordable therapies for hundreds of millions of people around the world."

Second Quarter 2021 Highlights and Recent Progress

EDP1815 Phase 2 Trial in Atopic Dermatitis

Evelo announced that it has finalized the design of the EDP1815 Phase 2 clinical trial in atopic dermatitis.
The trial will be a 12-week, double-blind, placebo-controlled, multiple cohort trial in patients with mild, moderate, and severe atopic dermatitis.
Approximately 198 patients will be randomized to receive EDP1815, and 66 patients will be randomized to receive placebo. Patients will receive either 1 capsule once daily, 2 capsules once daily, or 1 capsule twice daily.
The primary endpoint will be the mean difference between EDP1815 and placebo in the percentage change from baseline in Eczema Area and Severity Index (EASI) score at week 12.
Secondary endpoints will include a number of physician-reported outcomes, such as Investigators Global Assessment (IGA), Body Surface Area (BSA), along with numerous patient-reported outcomes, such as Dermatology Life Quality Index (DLQI), itch using the daily peak pruritus numerical rating scale, and Patient Oriented Eczema Measure (POEM).
All trial participants who complete the 12-week trial will be eligible to enroll into an open-label extension trial where they will receive EDP1815.
EDP2939 in Inflammatory Diseases

In May 2021, Evelo presented preclinical data for its extracellular vesicle (EV) product candidate, EDP2939, for the treatment of inflammatory diseases, at Virtual IMMUNOLOGY2021, the 104th Annual Meeting of the American Association of Immunologists (AAI).
In the preclinical study, mice undergoing a delayed-type hypersensitivity (DTH) reaction against keyhole limpet hemagglutinin (KLH) were treated with EDP2939, EDP2939 in combination with different antibodies, or with placebo.
These data suggest that EDP2939 requires the stimulation of both the TLR2 receptor and the IL-10 receptor, in addition to lymphocyte homing to the intestinal lymphoid tissue.
Also, in-vitro, EDP2939 induces TLR2-dependent release of IL-10. Fluorescent biodistribution analysis showed that EDP2939 was not detected outside the gastrointestinal tract.
The data suggest that treatment with EDP2939 resulted in broad-based resolution of inflammation and the establishment of immune homeostasis, with no apparent adverse safety or tolerability effects preclinically, providing key insights into the pharmacologic effects, mechanism of action, and biodistribution of EDP2939.
Business Highlights

In June 2021, Evelo announced the appointment of Mark Plinio as Chief Commercial Officer and a member of the Evelo Leadership Team.
Upcoming Key Milestones
EDP1815 – Psoriasis; data anticipated to be reported in 3Q 2021

Data from Phase 2b dose-ranging trial
Data from Phase 1b cohorts with tablets and capsules
EDP1815 – Atopic Dermatitis

Start of Phase 2 trial in 3Q 2021
Data from Phase 2 trial anticipated in 3Q 2022
EDP1867 – Atopic Dermatitis

Interim data from Phase 1b trial anticipated in 4Q 2021
EDP2939 – Inflammation

Initiation of clinical development in 2022
EDP1908 – Oncology

Initiation of clinical development in 2022
Second Quarter 2021 Financial Results

Cash Position: As of June 30, 2021, cash and cash equivalents were $123.3 million, as compared to cash and cash equivalents of $68.9 million as of December 31, 2020.
Research and Development Expenses: R&D expenses were $20.7 million for the three months ended June 30, 2021, compared to $15.2 million for the three months ended June 30, 2020. The $5.5 million increase was primarily due to increased costs related to Evelo’s inflammation clinical development programs, personnel and R&D platform costs, partially offset by decrease in oncology program costs.
General and Administrative Expenses: G&A expenses were $7.0 million for the three months ended June 30, 2021, compared to $5.1 million for the three months ended June 30, 2020. The $1.9 million increase was primarily due to increased personnel, facility, and other costs.
Net Loss: Net loss was $31.6 million for the three months ended June 30, 2021, or $0.59 per basic and diluted share, as compared to a net loss of $20.7 million for the three months ended June 30, 2020, or $0.63 per basic and diluted share.
Conference Call
Evelo will host a conference call and webcast at 8:30 a.m. ET today. To access the call please dial (866) 795-3242 (domestic) or (409) 937-8909 (international) and refer to conference ID 1658301. A live webcast of the event will also be available under "News and Events" in the Investors section of Evelo’s website at View Source The archived webcast will be available on Evelo’s website approximately two hours after the completion of the event and will be available for 30 days following the call.

On July 29, 2021 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, reported the closing of a senior secured credit facility for up to $30m with Oxford Finance LLC, a specialty finance firm that provides senior debt to life sciences and healthcare services companies (Press release, 4d Pharma, JUL 29, 2021, View Source [SID1234585356]).

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"The credit facility from Oxford Finance provides access to additional capital strengthening our financial position and increasing our financial flexibility as we continue to advance our programs to bring first-in-class Live Biotherapeutics to market," said Duncan Peyton, CEO of 4D pharma. "The initial $12.5 million tranche of this financing extends our cash runway into Q4 2022, with multiple clinical catalysts throughout 2021 and 2022."

"4D pharma have made remarkable progress in advancing their portfolio of novel drug candidates across multiple therapeutic areas, demonstrating their leadership in the microbiome field," said Christopher A. Herr, senior managing director at Oxford Finance. "Oxford Finance is pleased to support 4D pharma as it continues to progress its pipeline of innovative Live Biotherapeutics."

This financing provides 4D pharma with up to $30 million of cash in three tranches: an initial tranche of $12.5 million at closing, with the remaining $7.5 million and $10 million tranches dependent on the achievement of certain milestones. The facility will require 4D pharma to make monthly interest-only payments through to September 1, 2023, or, subject to the achievement of development milestones, September 1, 2024.

4D pharma has also granted Oxford Finance a warrant, exercisable for five years from today, to subscribe for 212,568 new ordinary shares in the Company at $1.18 per share. Further warrants will be granted to Oxford Finance as further tranches are drawn down.