On March 17, 2022 Silence Therapeutics plc, Nasdaq: SLN ("Silence" or "the Company"), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, reported its financial results for the fourth quarter and full year ended December 31, 2021 and reviewed recent business highlights (Press release, FierceBiotech, MAR 17, 2022, View Source [SID1234610257]).

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"2021 was a remarkable year for Silence," said Craig Tooman, President and Chief Executive Officer at Silence. "We successfully delivered the first clinical data from our proprietary mRNAi GOLD platform, advanced two wholly owned programs in the clinic and made excellent progress across both our proprietary and partnered pipelines. This momentum has continued into 2022 with the positive SLN360 data and we look forward to the late breaking presentation at ACC on April 3rd. With clinical data now demonstrated in two separate programs, we are optimistic about what we can deliver from our platform and look forward to a very exciting year ahead."

Rhonda Hellums, Chief Financial Officer at Silence commented, "We continued to benefit from our hybrid business model in 2021, receiving around $58 million in non-dilutive capital from our collaborations. We moved exclusively to the Nasdaq and significantly expanded our global shareholder base. We ended the year with £73.5 million in cash, cash equivalents and term deposits and we will continue to prioritize non-dilutive financing solutions."

Fourth Quarter 2021 Business Highlights

mRNAi GOLD Proprietary Program Updates

SLN360 Lp(a) Lowering Program

Extended follow-up period in the single-ascending dose cohorts up to 365 days to further assess the duration of action.
Established therapeutic dose range based on single-ascending dose cohorts 1-4 to proceed to the multiple-ascending dose portion.
SLN124 Hepcidin Regulation Program

Presented clinical data from the SLN124 healthy volunteer study at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Key data included:
All 3 dose levels were well tolerated with no serious or severe treatment emergent adverse events (TEAEs) or TEAEs leading to withdrawal.
Average hepcidin, a key endogenous regulator of iron balance and distribution, increased up to ~4-fold after a single dose with effect sustained for at least 2 months.
Serum iron reduced by ~50% after a single dose with effect sustained for at least 2 months.
mRNAi GOLD Partnered Program Updates

Secured new collaboration with Hansoh Pharma to develop therapeutics leveraging the Silence mRNAi GOLD platform, providing the Company with exclusive rights to two undisclosed targets in all territories except the China region (Greater China, Hong Kong, Macau and Taiwan). Hansoh received an exclusive option to license rights to those two targets in the China region and global rights to a third undisclosed target.
Post Year-end Highlights

Announced positive topline data in the SLN360 phase 1 single-ascending dose study in 32 healthy adults with high Lp(a) (≥ 60 mg/dL or 150 nmol/L). Topline data included:
SLN360 was well tolerated with no clinically important safety concerns identified.
SLN360 reduced Lp(a) in a dose dependent manner from 46% up to a maximum of 98% with up to an 81% reduction persisting at 150 days.
Detailed results from the SLN360 phase 1 single-ascending dose study will be presented in a late-breaker at the American College of Cardiology (ACC) Annual Meeting on April 3, 2022.
Started dosing in the SLN360 phase 1 multiple-ascending dose study in adults with high Lp(a) that have a confirmed history of stable atherosclerotic cardiovascular disease ("ASCVD").
Completed enrollment in the SLN124 phase 1 single-ascending dose study in thalassemia patients and remain on-track to report topline data in the third quarter of 2022.
SLN124 granted FDA orphan drug designation in polycythemia vera (PV) and the Company remains on-track to start a phase 1 study in PV in the second half of 2022.
Discontinued further enrollment in the myelodysplastic syndrome (MDS) arm of the SLN124 phase 1 program due to recruitment challenges in this population and the decision to prioritize spend in thalassemia and PV indications where the Company believes it can derive the most value in the near term.
2021 Financial Results

For the twelve-month period ending December 31, 2021, the net loss after tax was £39.4 million, or weighted average loss per share 44.3 pence compared to the same period in 2020 of £32.5 million, or weighted average loss per share 39.8 pence. The increase in net loss was primarily related to increase in R&D expenditures as the Company continues to further advance and expand its pipeline of novel medicines.

Revenue

Revenue recognized for the year ending December 31, 2021 was £12.4 million, compared to £5.5 million for the year ending December 31, 2020. The Company records revenue from collaborations based on percentage of contract completion and the increase was driven by the advancement of current collaboration programs, as well as the execution of new collaboration agreements in 2021. Therefore, as the Company’s current collaboration programs progress and additional programs are initiated revenues are also expected to increase over time.

Cost of sales

The cost of sales increased for the twelve months ending December 31, 2021 to £7.5 million from £3.8 million in the period ending December 31, 2020. Cost of sales includes research and development expenditure that is directly related to work carried out on revenue generating contracts. The increase was largely due to the further advancement and initiation of new collaboration programs.

Research and Development

During the year ending December 31, 2021, research and development expenditures increased by £10.6 million to £30.8 million from £20.2 million in the year ending December 31, 2020. The increase is a result of additional clinical studies and an increase in contract manufacturing activities for Silence’s proprietary programs, as well as an increase in personnel costs to expand the internal capabilities and expertise to further advance the Company’s siRNA platform.

General and Administrative

General and administrative expenses increased by £6.0 million to £20.0 million for the year ending December 31, 2021 from £14.0 million for the same corresponding period in 2020. This increase was predominantly related to requirements for public company compliance and support of the R&D portfolio including personnel.

Liquidity, cash and cash equivalents

As of December 31, 2021, the Company had £73.5 million of cash and cash equivalents. During 2021, the Company received $40.0 million or £30.8 million from its partner AstraZeneca, and milestones totaling $4.0 million or £2.9 million from its partner Mallinckrodt. The Company also received a $16.0 million upfront payment, or £10.7 million net of taxes, from the execution of a collaboration agreement with Hansoh in the fourth quarter of 2021. Since 2019, Silence has received over $100 million in upfront and milestone payments from its collaboration partners. These proceeds provide non-dilutive capital for the continued development and advancement of the Company’s proprietary and partnered product candidates. The Company believes that its cash and cash equivalents of £73.5 million as of the end of December 2021 is sufficient to fund its operations through early 2023.

On March 17, 2022 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, reported financial results for the fourth quarter and full year ending December 31, 2021 and provided an update on pipeline programs (Press release, Synlogic, MAR 17, 2022, View Source [SID1234610274]).

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"2021 was a transformational year for Synlogic highlighted by proof of concept for our lead program in phenylketonuria (PKU)," said Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer. "Despite the devastating burden of this disease, a large majority of people living with PKU remain in need of an efficacious, safe, oral medication. We look forward to sharing Phase 2 data in the first half of this year as we continue plans to initiate Phase 3 later this year. We are also excited for clinical data readouts from our homocystinuria (HCU) and enteric hyperoxaluria programs, as well as research progress including our ongoing collaborations with Ginkgo Bioworks and Roche."

Recent Portfolio Highlights

SYNB1618 and SYNB1934: In Development for the Treatment of PKU

PKU is a rare metabolic disease that can result in irreversible cognitive and neurological damage. Approximately 75% of people with PKU remain untreated, reflecting limitations of current therapies. SYNB1618 and SYNB1934 are non-systemically absorbed, oral drug candidates being studied for both adjunctive and monotherapy treatment of PKU.
In September 2021, Synlogic reported positive interim results from the Phase 2 SynPheny-1 study for SYNB1618, with clinically meaningful and statistically significant reduction of plasma Phe levels in patients with PKU. Based on this achieved proof of concept, the Company began preparations for Phase 3 development.
In parallel, Synlogic added an arm to the Phase 2 Synpheny-1 study for SYNB1934, a next-generation drug candidate for PKU designed for greater potency in Phe reduction. This additional arm in Synpheny-1 followed positive results with SYNB1934 in healthy volunteer studies.
In H1 2022, Synlogic expects to announce additional data from the Synpheny-1 study and, based on those findings, which of the two candidates will proceed to Phase 3 and potential commercialization.
SYNB1353: In Development for the Treatment of HCU

In November 2021, Synlogic and Ginkgo Bioworks announced the nomination of SYNB1353, a drug candidate designed to consume methionine for the treatment of HCU. Like PKU, HCU is an inherited rare metabolic disease caused by an inborn error of metabolism that results in significant disease burden, including intellectual disability and thromboembolism.
During 2022, the Company plans to submit an investigational new drug application (IND), initiate clinical trials and, in H2 2022, report Phase 1 healthy volunteer data for SYNB1353.
SYNB8802: In Development for the Treatment of Enteric Hyperoxaluria

Enteric hyperoxaluria, a leading cause of recurrent kidney stones, is a chronic, progressive disease that can lead to chronic kidney disease (CKD) and end-stage renal disease (ESRD), and for which there is currently no FDA-approved treatment.
Synlogic demonstrated proof of mechanism for SYNB8802 in enteric hyperoxaluria in 2021, and it is currently being evaluated in patients who have undergone Roux-en-Y gastric bypass surgery, with proof-of-concept data from this study expected in 2022.
Preclinical Pipeline

Synlogic plans to advance research programs to address metabolic and immunologic diseases, including wholly owned programs targeting inflammatory bowel disease and hyperuricemia (gout), diseases for which the Synthetic Biotic clinical profile of orally-administered, non-systemically absorbed biotherapeutics is particularly compelling.
The Company’s research collaboration with Roche to develop a Synthetic Biotic for the treatment of inflammatory bowel disease continues to progress.
Synlogic and Ginkgo continue to advance their long-term strategic platform collaboration with multiple undisclosed metabolic and immunology programs now in preclinical development.

Corporate Updates

Earlier this month, the company announced the appointment of Michael Jensen as Chief Financial Officer. Mr. Jensen brings extensive and diversified experience within global pharmaceutical and medical device companies to Synlogic, spanning analytics, financial management, information systems, and operations. Mr. Jensen was formerly the CFO of Intrinsic Therapeutics.

Fourth Quarter 2021 Financial Results

As of December 31, 2021, Synlogic had cash, cash equivalents, and marketable securities of $136.6 million.

Revenue was $0.6 million for the three months ended December 31, 2021. Revenue in 2021 was associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic medicine for the treatment of IBD. There was no revenue for the three months ended December 31, 2020.

Research and development expenses were $11.9 million for the three months ended December 31, 2021, compared to $11.4 million for the corresponding period in 2020.

General and administrative expenses for the three months ended December 31, 2021 were $3.9 million compared to $3.3 million for the corresponding period in 2020.

For the three months ended December 31, 2021, Synlogic reported a consolidated net loss of $15.1 million, or $0.21 per share, compared to a consolidated net loss of $14.6 million, or $0.39 per share, for the corresponding period in 2020.

Full Year 2021 Financial Results

Revenues were $1.8 million for the year ended December 31, 2021, compared to $0.5 million for the same period in 2020. Revenue in 2021 was associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic medicine for the treatment of IBD. Revenue in 2020 was due to the prior collaboration with AbbVie, which was terminated in May 2020. Operating expenses were $62.5 million for the year ended December 31, 2021, compared to $61.0 million for the same period in 2020. For the year ended December 31, 2021, consolidated net loss was $60.6 million, or $1.09 per share, compared to a consolidated net loss of $59.2 million, or $1.65 per share, for the year ended December 31, 2020.

Financial Outlook

Based upon its current operating plan and balance sheet as of December 31, 2021, Synlogic expects to have sufficient cash to be able to fund operations into 2024.

Investor Conference Presentation

Today, Synlogic will participate in Oppenheimer’s 32nd Annual Healthcare Conference. Dr. Brennan will present virtually at 10:40 am ET.

A live webcast of the presentation will be accessible under the "Event Calendar" in the Investors & Media section of the Company’s website. An archived version will also be available after the presentation on the Synlogic website.

Conference Call & Webcast Information

Synlogic will host a conference call and live webcast at 8:30 a.m. ET today, March 17, 2022. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 1719849. A replay will be available for 30 days on the Investors and Media section of the Synlogic website.

On March 17, 2022 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company"), reported that it has entered into an agreement with Millipore-Sigma ("Millipore") a global Contract Development and Manufacturing Research Organization ("CDMO"), to manufacture a supply of GLP-grade BVX-1021, the Company’s newly developed vaccine ("BVX-1021") for the strain of coronavirus that causes Severe Acute Respiratory Syndrome ("SARS1"), the respiratory illness responsible for the deadly 2002–2004 pandemic. There are no vaccines approved for SARS1 (Press release, BioVaxys Technology, MAR 17, 2022, View Source [SID1234610291]).

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BVX-1021 is the subject of an ongoing research collaboration between The Ohio State University ("Ohio State") and BioVaxys, announced in December 2021, that is evaluating the Company’s novel approach for a "universal vaccine" that can treat a broad range of sarbecoviruses ("pan-sarbecovirus vaccine"). Sarbecoviruses are a family of viruses that include SARS-CoV-2 and all current ‘Variants of Concern’ such as Delta and Omicron (as well as at least ten additional variants that are currently being monitored), SARS1, and a broad range of other potentially dangerous zoonotic viruses.

The collaboration between BioVaxys and Ohio State, which has been underway since early January 2022, is evaluating the combination of BVX-0320 and BVX-1021 in a guinea pig model. The major endpoints of the study are the development of virus-neutralizing antibodies to live virus SARS-CoV-2 and other sarbecoviruses, including bat and pangolin SARS-related coronaviruses. Bats are a major reservoir of many strains of SARS, with several strains have been identified in palm civets, which were likely ancestors of SARS-CoV-1. (Journal of Virology. 84 (6): 2808–19, 2010). The presence of neutralizing antibodies in the animal model would strongly suggest that BVX-1021 would confer an additional immune response across all sarbecoviruses in those people fully vaccinated for Covid-19 as well as those with natural immunity.

Dr. David Berd, Chief Medical Officer of Biovaxys, explained, "Scientists have observed that people who survived the 2002-03 SARS pandemic and then were administered a Covid-19 vaccine developed antibodies that cross-reacted with all of the sarbecoviruses that they tested. That observation suggested to us that a similar pan-sarbecovirus immune response could be generated by immunizing with haptenized spike protein from SARS1 and SARS-Cov-2, i.e., our BVX-0320 and BVX-1021 products."

BVX-1021 is a hapten-modified recombinant S-protein from SARS-CoV-1, whereas BVX-0320, BioVaxys’ Covid-19 vaccine, is a hapten-modified recombinant S-spike protein from SARS-CoV-2, the virus which causes Covid-19. A hapten is a small molecule that stimulates an immune response when conjugated with a protein such as a virus surface antigen, but lacks antigenicity of its own. Previous studies conducted by BioVaxys in mice have shown that haptenized SARS-CoV-2 spike protein elicits both, robust T cell and antibody response.

BioVaxys recently announced results of a study that demonstrated that BVX-0320, its haptenized SARS-CoV-2 s-spike protein vaccine, does not bind to the Angiotensin Converting Enzyme-2 (ACE2) receptor. The finding suggests that Company’s haptenized SARS-CoV-2 spike protein vaccine may not lead to the unusual but serious myocarditis observed with mRNA vaccines.

Kenneth Kovan, President & Chief Operating Officer of BioVaxys stated, "The Covid-19 market is shifting to vaccines that will not only protect against emerging variants of SARS-CoV-2, but also for any related coronaviruses that likely may arise in the future. BVX-1021 demonstrates that we can leverage our technology platform to create novel hapten-viral antigen vaccines to target additional markets."

BioVaxys intends to develop BVX-1021 as a standalone "booster" targeting anyone who has been immunized with a World Health Organization-recognized Covid-19 vaccine or convalesced from a Covid-19 infection. To date, approximately 389 million people worldwide have recovered from Covid-19 (Worldometer, March 11, 2022), and 57% of the global population (Our World in Data, March 2022), or 4.4 billion people, have received a full course of SARS-CoV-2 vaccine.

Millipore is a subsidiary of Merck KGaA (Deutsche Bourse: MRCG), one of the largest pharmaceutical companies in the world, with a market capitalization of US$81 billion.

For greater certainty, BioVaxys is not making any express or implied claims that the Company can currently treat COVID-19.

On March 17, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that it will release fourth quarter and full year 2021 financial results before the market opens on Thursday, March 24, 2022 (Press release, Hookipa Pharma, MAR 17, 2022, View Source [SID1234610224]). The Company will host a live conference call and webcast at 8:30 AM ET to discuss its financial results and provide a corporate update.

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Conference Call & Webcast:

The webcast and the presentation will also be available within the Investors & Media section of HOOKIPA’s website at View Source

On March 17, 2022 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the fourth quarter ended December 31, 2021 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, MAR 17, 2022, View Source [SID1234610258]).

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Chief Executive Officer John Valliant, Ph.D. commented, "In 2021, we made progress leveraging our platform technology and research engine to build a diverse pipeline of targeted alpha therapies (TATs) from different classes of targeting molecules to pursue validated cancer targets in areas of high unmet medical need."

Dr. Valliant continued, "We continue to execute on our Phase 1 trial of FPI-1434 in patients with solid tumors, and look forward to reporting data from this trial in the second half of this year. Our subsequent programs are progressing, with the investigational new drug application (IND) for FPI-1966 cleared in 2021, and the submission of an IND for FPI-2059, our first small molecule program, expected in the first half of this year. In addition, under our collaboration, we have agreed with AstraZeneca to progress to IND-enabling studies a new bispecific antibody-based TAT. We also recently entered two strategic partnerships to discover novel, peptide-based radiopharmaceuticals, both demonstrating the versatility and potential applicability of the Fusion platform. In parallel, we have expanded our leadership team, deepening our radiopharmaceutical and oncology expertise, and progressed our manufacturing and actinium supply initiatives, supporting our pipeline growth and clinical plans. Amid a resurgence of excitement about the potential for radiopharmaceuticals becoming a pillar of cancer therapy, Fusion is well-positioned as a leader in the space."

Clinical Update

FPI-1434

In the Phase 1 study, Fusion is exploring various dosing levels of FPI-1434 as well as two dosing regimens: one with FPI-1434 alone, and another in which a small dose of cold antibody (naked IGF-1R antibody without the isotope) is administered prior to each dose of FPI-1434. The Company continues to anticipate reporting Phase 1 safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, and details on the dosing paradigm, in the second half of 2022. Fusion continues to anticipate the initiation of a Phase 1 combination study with FPI-1434 and KEYTRUDA (pembrolizumab) to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.

FPI-1966

The Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3, intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose, has been initiated with the first study site open to recruitment. Fusion now expects to dose the first patient in the second quarter of 2022 rather than the first quarter and expects preliminary pharmacokinetic and imaging data from the first patient cohort in the second quarter of 2023. The shift is a result of delays in study site initiations related to the COVID-19 pandemic.

FPI-2059

FPI-2059 is a small molecule radioconjugate in development as a targeted alpha therapy for various solid tumors. The molecule targets neurotensin receptor 1 (NTSR1), a promising target for cancer treatment, that is overexpressed in solid tumors. FPI-2059 combines Ipsen’s IPN-1087 (previously studied as a beta-emitting radiopharmaceutical), which Fusion acquired in 2021, with actinium-225. Fusion continues to anticipate submitting an IND application for FPI-2059 in the first half of 2022.

Recent News and Highlights

In January, Fusion announced the nomination of the first TAT candidate under the Company’s collaboration agreement with AstraZeneca. Both companies will jointly develop through a Phase 1 study the novel TAT which utilizes Fusion’s Fast-Clear linker technology to radiolabel an AstraZeneca-owned bispecific antibody with the alpha-emitting isotope, actinium-225. Fusion and AstraZeneca are continuing to progress up to two additional TATs and up to five combination therapies with Fusion’s TATs.
Also in January, Fusion announced the company entered into a strategic research collaboration with 48 Hour Discovery Inc. and Pepscan Therapeutics B.V. to discover novel, peptide-based radiopharmaceuticals for the treatment of various solid tumors.
Fourth Quarter 2021 Financial Results

Cash and Investments: As of December 31, 2021, Fusion held cash, cash equivalents and investments of $220.8 million, compared to cash, cash equivalents and investments of $299.5 million as of December 31, 2020. Fusion expects its cash, cash equivalents and investments as of December 31, 2021 will enable the Company to fund its operations through the end of 2023.
Collaboration Revenue: For the fourth quarter of 2021, Fusion recorded $0.6 million of revenue under the AstraZeneca collaboration agreement.
R&D Expenses: Research and development expenses for the fourth quarter of 2021 were $11.8 million, compared to $5.0 million for the same period in 2020. The increase was primarily related to costs associated with manufacturing for the Company’s clinical and preclinical programs, as well as increased clinical costs associated with FPI-1966.
G&A Expenses: General and administrative expenses for the fourth quarter of 2021 were $6.3 million, compared to $6.6 million for the same period in 2020. The decrease was primarily related to a reduction in professional fees and other costs associated with the Company’s 2020 initial public offering, partially offset by increases in personnel-related expenses.
Net Loss: For the fourth quarter of 2021, Fusion reported a net loss of $17.2 million, or $0.40 per share, compared with a net loss of $13.4 million, or $0.32 per share, for the same period in 2020.
Impact of COVID-19

Fusion is experiencing material delays in patient recruitment, enrollment and study site initiations as a result of continued resourcing issues related to COVID-19 at trial sites.

There also remains uncertainty relating to the trajectory of the pandemic, hospital staffing and resource issues, and whether they may cause further delays in patient study recruitment. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in further difficulties or delays in initiating, enrolling, conducting or completing the planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The continued impact of COVID-19 on results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.