On May 10, 2022 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," "our," "us," or "we"), a clinical-stage biopharmaceutical company, reported financial results for the first quarter of 2022 and provided an update on the Company’s business operations and clinical development programs (Press release, Reata Pharmaceuticals, MAY 10, 2022, View Sourcenews/news-details/2022/Reata-Pharmaceuticals-Inc.-Announces-First-Quarter-2022-Financial-Results-and-Provides-an-Update-on-Clinical-Development-Programs/default.aspx" target="_blank" title="View Sourcenews/news-details/2022/Reata-Pharmaceuticals-Inc.-Announces-First-Quarter-2022-Financial-Results-and-Provides-an-Update-on-Clinical-Development-Programs/default.aspx" rel="nofollow">View Source [SID1234614117]).

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"We are pleased to have recently completed rolling submission of a New Drug Application ("NDA") for omaveloxolone for the treatment of patients with Friedreich’s ataxia in the United States," said Warren Huff, Reata’s Chief Executive Officer. "Friedreich’s ataxia is a rare, genetic, debilitating, and degenerative neuromuscular disorder with no approved therapies, and we are looking forward to working with the U.S. Food and Drug Administration ("FDA") on its review of our NDA throughout this year. If approved, we are preparing to be in a position to launch this important drug by early 2023."

Recent Company Highlights

Neurology

Omaveloxolone in Patients with Friedreich’s Ataxia

The FDA has granted Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation to omaveloxolone for the treatment of Friedreich’s ataxia. In March 2022, we completed the rolling submission of an NDA to the FDA for omaveloxolone for the treatment of patients with Friedreich’s ataxia. This NDA is supported by the efficacy and safety data from the MOXIe Part 2 trial and additional supporting data from the MOXIe Part 1 and MOXIe Extension trials.

We have secured an agreement on our Pediatric Investigation Plan with the European Medicines Agency ("EMA") Pediatric Committee, and we are continuing to complete the regulatory procedures and submissions required prior to filing a Marketing Authorization Application ("MAA") in Europe for approval of omaveloxolone for the treatment of patients with Friedreich’s ataxia. We plan to submit an MAA to the EMA in the fourth quarter of 2022.

Chronic Kidney Disease

Bardoxolone Methyl in Autosomal Dominant Polycystic Kidney Disease

We are currently enrolling patients in FALCON, a Phase 3, international, multi-center, randomized, double-blind, placebo-controlled trial studying the safety and efficacy of bardoxolone methyl ("bardoxolone") in patients with autosomal dominant polycystic kidney disease ("ADPKD") randomized one-to-one to active drug or placebo. FALCON is enrolling patients in a broad range of ages with an estimated glomerular filtration rate ("eGFR") between 30 and 90 mL/min/1.73 m2. More than 550 patients are currently enrolled in the trial.

In the first quarter of 2022, we submitted a protocol amendment to the FALCON Phase 3 trial of bardoxolone in patients with ADPKD with the FDA and other relevant health authorities. We recently met with the FDA in a Type A meeting to discuss our protocol amendment. Based on the discussion during the meeting and the meeting minutes, the Division stated that the proposed primary endpoint of eGFR change from baseline at Week 108 (8 weeks after planned drug discontinuation at Week 100) was reasonable since the available data suggest that bardoxolone’s acute pharmacodynamic effect on eGFR should be largely resolved. The FDA also confirmed that, if the FALCON trial is positive, it could support registration of bardoxolone in ADPKD.

First Quarter Financial Highlights

Cash and Cash Equivalents

On March 31, 2022, we had cash and cash equivalents of $532.0 million, as compared to $590.3 million on December 31, 2021.

GAAP and Non-GAAP Research and Development ("R&D") Expenses

R&D expenses according to generally accepted accounting principles in the U.S. ("GAAP") were $39.8 million for the first quarter of 2022, as compared to $34.9 million for the same period of the year prior. The increase is primarily due to personnel and personnel-related costs to support the product development activities.

Non-GAAP R&D expenses were $32.2 million for the first quarter of 2022, as compared to $28.1 million for the same period of the year prior.1

GAAP and Non-GAAP General and Administrative ("G&A") Expenses

GAAP G&A expenses were $24.8 million for the first quarter of 2022, as compared to $20.7 million for the same period of the year prior. The increase is primarily due to rent expense related to the new headquarters building lease that commenced in December 2021.

Non-GAAP G&A expenses were $17.0 million for the first quarter of 2022, as compared to $12.8 million for the same period of the year prior.1

GAAP and Non-GAAP Net Loss

The GAAP net loss for the first quarter of 2022 was $73.8 million, or $2.03 per share, on both a basic and diluted basis, as compared to a GAAP net loss of $67.5 million, or $1.86 per share, on both a basic and diluted basis, for the same period of the year prior.

The non-GAAP net loss for first quarter of 2022 was $48.5 million, or $1.33 per share on both a basic and diluted basis, as compared to a non-GAAP net loss of $41.9 million, or $1.16 per share, on both a basic and diluted basis, for the same period of the year prior.1

Updated Cash Guidance

The Company reaffirms its existing cash and cash equivalents will be sufficient to enable it to fund operations through the end of 2024.

___________________________

1 See "Non-GAAP Financial Measures" below for a description of non-GAAP financial measures and a reconciliation between GAAP and non-GAAP R&D expenses, GAAP and non-GAAP G&A expenses, and GAAP and non-GAAP net loss, respectively, appearing later in the press release.

Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, including non-GAAP R&D expenses, non-GAAP G&A expenses, non-GAAP operating expenses, non-GAAP net loss and non-GAAP net loss per common share – basic and diluted. These measures are not in accordance with, or an alternative to, GAAP, and may be different from non-GAAP financial measures used by other companies.

The Company defines non-GAAP R&D expenses as GAAP R&D expenses, which exclude stock-based compensation expense; non-GAAP G&A expenses as GAAP G&A expenses, which exclude stock-based compensation expense; non-GAAP operating expenses as GAAP operating expenses, which exclude stock-based compensation expense; non-GAAP net loss as GAAP net loss, which excludes stock-based compensation expense and non-cash interest expense from liability related to sale of future royalties; and non-GAAP net loss per common share – basic and diluted as GAAP net loss per common share – basic and diluted, which excludes stock-based compensation expense and non-cash interest expense from liability related to sale of future royalties. The Company has excluded the impact of stock-based compensation expense, which may fluctuate from period to period based on factors including the variability associated with performance-based grants for stock options and restricted stock units and changes in the Company’s stock price, which impacts the fair value of these awards. The Company has excluded the impact of accreted non-cash interest expense from liability related to sale of future royalties as it may be calculated differently from, and therefore may not be comparable to, peer companies who also provide non-GAAP disclosures. The Company has excluded the impact of stock-based compensation expense and non-cash interest expense from liability related to sale of future royalties because the Company believes its impact makes it difficult to compare its results to prior periods and anticipated future periods.

Because management believes certain items, such as stock-based compensation expense and non-cash interest expense from liability related to sales of future royalties, can distort the trends associated with the Company’s ongoing performance, the following measures are often provided, excluding special items, and utilized by the Company’s management, analysts, and investors to enhance consistency and comparability of year-over-year results, as well as to industry trends, and to provide a basis for evaluating operating results in future periods: non-GAAP net loss; non-GAAP net loss per common share – basic and diluted; non-GAAP R&D expenses; non-GAAP G&A expenses; and non-GAAP operating expenses.

The Company believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with these non-GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating performance, allocating resources, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this press release.

Conference Call Information

Reata’s management will host a conference call on May 10, 2022, at 8:30 a.m. ET. The conference call will be accessible by dialing (844) 200-6205 (toll-free domestic) or (929) 526-1599 (international) using the access code 488160. The webcast link is View Source

First quarter 2022 financial results to be discussed during the call will be included in an earnings press release that will be available on the Company’s website shortly before the call at View Source and will be available for 12 months after the call. The audio recording and webcast of the conference call will be accessible for at least 90 days after the event at View Source.

On May 10, 2022 Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, reported that members of management will present at the Guggenheim Radiopharmaceuticals Day on Tuesday, May 17, 2022 in New York, NY (Press release, Oncoinvent, MAY 10, 2022, View Source [SID1234614133]).

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Details are as follows:

Company panel discussion together with Point Biopharma, Fusion Pharmaceuticals, Aktis Oncology and Curie Therapeutics on Tuesday, May 17, 2022 at 1:30 p.m. ET.
Fireside chat with Charles Zhu, Vice President Guggenheim Securities LLC on Tuesday, May 17, 2022 at 4:30 p.m. ET.

On May 10, 2022 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), an immunology company, reported financial results for the first quarter of 2022 (Press release, Corbus Pharmaceuticals, MAY 10, 2022, View Source [SID1234614150]).

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Key Corporate and Program Updates:

Anti-integrin monoclonal antibodies (mAb) program targeting the inhibition of TGFβ is progressing on schedule.
CRB-601, an anti-αvβ8 mAb, is being developed as a potential treatment for solid tumors. Corbus presented the first preclinical data for CRB-601 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2022. The poster can be viewed at: www.corbuspharma.com/AACRposter.
The most recent data from CRB-601 will be presented on May 11, 2022 at the New York Academy of Sciences Frontiers in Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper). This new data demonstrates effects of CRB-601 in additional syngeneic animal models with increasing levels of resistance to check point inhibitors.
Across models explored to date, CRB-601 demonstrates an enhancement of anti-tumor activity when combined with anti PD-1 therapy compared to either single agent alone. This enhancement of efficacy is associated with tumor infiltration of proliferating CD4+ and CD8+ T cells in addition to NK cells and M1 macrophages.
Collectively, this data supports the hypothesis that blockade of local TGFb production by CRB-601 can lead to changes in immune cell infiltration in the tumor microenvironment, potentially enhancing the benefit of PD-1 blockade.
IND-enabling activities for CRB-601 are ongoing and the program is on-schedule for an IND submission in the first half of 2023.

A lead candidate, CRB-913, has been selected for the CB1 inverse agonist program. In animal models of diet-induced obesity, CRB-913 induced weight loss and impacted multiple metabolic parameters, both as monotherapy and in combination with semaglutide and tirzepatide. Corbus is seeking partnerships to advance CRB-913 into clinical studies.

The National Institutes of Health sponsored Phase 2 study of lenabasum in systemic lupus erythematosus has completed its last patient visit and the clinical database has been locked. The Company is awaiting topline results. Corbus is pursuing potential partnerships to fund further development of lenabasum.

A detailed update on the Corbus pipeline can be found in the most recent Corporate Presentation available at: ir.corbuspharma.com/presentations
"We are executing our plan to transform Corbus into a company with a novel and diversified immuno-oncology pipeline. We’re excited about the first data to come out of our integrin program and for the opportunity to present it at scientific conferences. We look forward to entering the clinic in 2023," commented Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "We are actively engaging in business development activities with the goal of expanding our immuno-oncology pipeline while monetizing our ECS assets through new partnerships."

Financial Results for First Quarter Ended March 31, 2022:

The Company reported a net loss of approximately $9.4 million, or a net loss per diluted share of $0.08, for the three months ended March 31, 2022, compared to a net loss of approximately $16 million, or a net loss per diluted share of $0.14, for the same period in 2021.

Operating expenses decreased by $7.5 million to approximately $8.5 million for the three months ended March 31, 2022, compared to $16 million in the comparable period in the prior year. The decrease was primarily attributable to decreased clinical trial and drug manufacturing costs, and an overall reduction in compensation expense.

As of March 31, 2022, the company has $86.8 million of cash and investments on hand which is expected to fund operations into the first quarter of 2024, based on the current planned expenditures.

On May 10, 2022 The Bayer Group reported a very successful start to 2022 (Press release, Bayer, MAY 10, 2022, View Source [SID1234614020]). "We achieved outstanding sales and earnings growth, with particularly substantial gains for our agriculture business," said Werner Baumann, Chairman of the Board of Management, on Tuesday as he presented the quarterly statement for the first quarter of 2022. "Our forecast going forward this year remains confident despite the great uncertainties, including the stability of supply chains and energy supplies, and we confirm the currency-adjusted outlook for the full year published in March."

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Group sales in the first quarter increased by 14.3 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.) to 14.639 billion euros. EBITDA before special items increased by 27.5 percent to 5.251 billion euros. Positive currency effects benefited sales by 529 million euros (Q1 2021: minus 938 million euros) and EBITDA before special items by 67 million euros (Q1 2021: minus 337 million euros). EBIT increased by 36.6 percent to 4.212 billion euros. This figure included net special gains of 40 million euros (Q1 2021: 15 million euros). These primarily related to provisions in connection with the glyphosate litigations. Net income rose by 57.5 percent to 3.291 billion euros. Core earnings per share from continuing operations advanced by 36.3 percent to 3.53 euros.

Group sales and earnings were not negatively impacted by Russia’s invasion of Ukraine in the first quarter. In business terms, Russia and Ukraine do not rank among the company’s top ten key countries; in total, the two countries account for around 3 percent of sales.

Free cash flow improved by 63.2 percent to minus 1.187 billion euros. Net financial debt as of March 31, 2022, at 34.527 billion euros, was 4.2 percent higher than at year-end 2021, mainly as a result of cash outflows from operating activities and negative currency effects.

Crop Science increases earnings by around 50 percent

In the agricultural business (Crop Science), sales rose by 21.6 percent (Fx & portfolio adj.) to 8.447 billion euros thanks to substantial price and volume growth. Bayer’s sales grew by double-digit percentages in all regions and achieved particularly strong growth at Herbicides (Fx & portfolio adj. 59.8 percent) and Fungicides (Fx & portfolio adj. 18.6 percent). While there was particularly strong growth for Herbicides in North America, Fungicides generated double-digit percentage sales growth in all regions. Corn Seed & Traits posted sales gains, primarily due to price increases in all regions. Here, Bayer also benefited from volume gains in the Europe/Middle East/Africa, Latin America, and Asia/Pacific regions. Sales at Soybean Seed & Traits were level with the prior-year period (Fx & portfolio adj. up 0.8 percent), and were higher in North America due to price increases but lower in Latin America due to lower volumes.

EBITDA before special items at Crop Science advanced by 49.9 percent to 3.669 billion euros, driven mainly by higher prices. Bayer also benefited from higher volumes and ongoing efficiency programs. By contrast, earnings were diminished by an increase in costs, particularly in the cost of goods sold, that was mainly due to high inflation. There was a positive currency effect of 98 million euros (Q1 2021: minus 252 million euros). The EBITDA margin before special items increased significantly by 6.6 percentage points to an all-time high of 43.4 percent; currency effects had a dilutive effect of 0.8 percentage points.

Pharmaceuticals: sales up thanks to Eylea, Nubeqa and radiology business

Sales of prescription medicines (Pharmaceuticals) rose by 2.6 percent (Fx & portfolio adj.) to 4.624 billion euros, climbing substantially in the Europe/Middle East/Africa region. The division was more than able to offset price-related declines in sales due to tender procedures in China, especially for the oral anticoagulant Xarelto (Fx & portfolio adj. minus 5.0 percent) and the cancer drug Nexavar (Fx & portfolio adj. minus 34.7 percent) through higher volumes for other products. This was possible in part by continuing to expand business with the ophthalmology drug Eylea (Fx & portfolio adj. 13.9 percent), which boosted market share in a growing market, particularly in Europe and China. Moreover, Bayer achieved gains in the Radiology category, particularly with Ultravist (Fx & portfolio adj. 26.4 percent), against a weaker prior-year quarter driven by the pandemic. Due to encouraging growth in volumes in the United States, Europe and Japan, the cancer drug Nubeqa recorded a sales gain of 61.5 percent (Fx & portfolio adj.). In addition, the market launch of Kerendia for the treatment of patients with chronic kidney disease and type 2 diabetes in the third quarter of 2021 had a positive impact.

EBITDA before special items at Pharmaceuticals declined by 7.3 percent to 1.389 billion euros. The main factors for this development were increased investments in future growth, primarily in the marketing and distribution of new products such as Kerendia, Nubeqa and Verquvo. The division also incurred higher research and development expenses compared to the prior-year quarter which had benefited from the proportionate recognition of 52 million euros in proceeds from the sale of a priority review voucher in the United States. Negative currency effects of 34 million euros (Q1 2021: 57 million euros) were an additional burden. The EBITDA margin before special items was 30.0 percent; currency effects had a dilutive effect of 1.6 percentage points.

Consumer Health posts strong sales increase and even better earnings growth

Bayer’s sales of self-care products (Consumer Health) advanced significantly by 17.2 percent (Fx & portfolio adj.) to 1.512 billion euros. This strong development followed a weaker prior-year quarter driven by the pandemic. Growth was once again broad-based, with all regions and categories contributing. Allergy & Cold had the highest growth contribution with sales up 38.7 percent (Fx & portfolio adj.), despite Bayer’s comparatively smaller presence in Cough & Cold. The Nutritionals category delivered another outstanding quarter of growth at 15.4 percent (Fx & portfolio adj.) with strong brands outperforming the market.

EBITDA before special items at Consumer Health advanced by 32.9 percent to 388 million euros. This was mainly due to exceptional sales growth, active price management and cost control. Bayer also recorded one-time gains through the sale of a minor, nonstrategic brand. Investments associated with the launch of innovation behind Bayer brands and inflation-related increases in costs weighed on earnings. There were positive currency effects of 6 million euros (Q1 2021: minus 26 million euros). The EBITDA margin before special items improved significantly by 2.4 percentage points to 25.7 percent; currency effects had a dilutive effect of 0.3 percentage points.

Recognition of Bayer’s progress in the area of sustainability

Bayer has made good progress with its sustainability targets, as was confirmed by the investor-led CA100+ initiative’s Net-Zero Company Benchmark, in which Bayer was one of the top-rated companies. Bayer received seven (out of a total of ten) green indicators in the 2021 Benchmark published in late March (compared with only two in 2020), which was more than any other of the 166 evaluated companies. ISS ESG, one of the world’s leading rating agencies in the Environmental, Social and Governance sustainable investment segment, likewise honored Bayer as a "climate outperformer" in its Climate Awareness Scorecard. ESG ratings are primarily used by investors as an indicator of a company’s sustainability performance.

Furthermore, the Board of Management has decided to switch Bayer’s vehicle fleet worldwide to electromobility, to take place as soon as possible. The specific time frame will be mainly influenced by market conditions and the pace of expansion of the EV charging infrastructure.

On May 10, 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 first quarter ended March 31, 2022 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, MAY 10, 2022, View Source [SID1234614054]).

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Chief Executive Officer John Valliant, Ph.D. commented, "We entered 2022 with strong momentum using 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, all while continuing to maintain sharp focus on actinium supply and manufacturing capabilities. Our top priority continues to be executing on our Phase 1 clinical studies. We are progressing our Phase 1 trial of FPI-1434 and look forward to reporting data from the study in the second half of this year. In addition, we continue to expect to dose our first patient in the Phase 1 study of FPI-1966 in the second quarter of this year. In parallel, we are advancing additional programs with the investigational new drug application (IND) filing for FPI-2059 anticipated in the second quarter of 2022 and the first novel TAT under our collaboration agreement with AstraZeneca in IND-enabling studies."

Portfolio 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 clinical efficacy, and details on the dosing regimen, 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. Fusion expects to dose the first patient in the second quarter of 2022 and expects preliminary pharmacokinetic, imaging and safety data from the first patient cohort in the second quarter of 2023.

FPI-2059

FPI-2059 is a small molecule radioconjugate in development as a targeted alpha therapy for various solid tumors, including neuroendocrine differentiated (NED) prostate cancer. The molecule targets neurotensin receptor 1 (NTSR1), a promising target for cancer treatment, that is overexpressed in several solid tumors. FPI-2059 combines Ipsen’s IPN-1087 (previously studied in a Phase 1 clinical trial 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 second quarter of 2022.

Recent Updates

In April, Fusion entered into a loan and security agreement with Oxford Finance LLC, under which Oxford is providing term loans to Fusion in an aggregate principal amount of up to $75.0 million. The Company plans to use the proceeds of the term loans for working capital and general corporate purposes. The loan agreement provides a term loan commitment of $50.0 million in two potential tranches: (i) a $25.0 million Term A loan facility, with $10.0 million funded on the closing date and the remaining $15.0 million to be funded at the request of the Company on a one-time basis at any time prior to April 4, 2023; and (ii) a $25.0 million Term B loan facility to be funded at the request of the Company, no later than June 30, 2023. Both term loans have a maturity date of April 1, 2027. The loan agreement also provides access to an additional Term C loan facility in the amount of $25.0 million, funded at Oxford’s discretion. The debt facility strengthens Fusion’s balance sheet, provides additional financing flexibility and extends the Company’s cash runway into the first quarter of 2024.
First Quarter 2022 Financial Results

Cash and Investments: As of March 31, 2022, Fusion held cash, cash equivalents and investments of $206.7 million, compared to cash, cash equivalents and investments of $220.8 million as of December 31, 2021. Fusion expects its existing cash, cash equivalents and investments as of March 31, 2022, together with the proceeds available under the first tranche of the loan and security agreement with Oxford Finance LLC executed in April 2022, will be sufficient to fund operations into the first quarter of 2024.
Collaboration Revenue: For the first quarter of 2022, Fusion recorded $0.6 million of revenue under the AstraZeneca collaboration agreement.
R&D Expenses: Research and development expenses for the first quarter of 2022 were $12.7 million, compared to $10.7 million for the same period in 2021. The increase was primarily due to an increase in direct costs related to our FPI-1434 and FPI-1966 product candidates, specifically continued expenditures related to our Phase 1 clinical trials as well as preclinical research and manufacturing costs.
G&A Expenses: General and administrative expenses for the first quarter of 2022 were $8.4 million, compared to $7.0 million for the same period in 2021. The increase was primarily due to an increase in personnel-related and corporate expenses, partially offset by a decrease in professional fees.
Net Loss: For the first quarter of 2022, Fusion reported a net loss of $19.9 million, or $0.46 per share, compared with a net loss of $17.5 million, or $0.42 per share, for the same period in 2021.
Upcoming Events

Fusion will participate in a fireside chat and panel presentation at the Guggenheim Securities Radiopharmaceutical Day on May 17, 2022 in New York. The fireside chat will be available via webcast on Fusion’s website at View Source
Fusion will present at the Jefferies Healthcare Conference on Friday, June 10, 2022 at 10:30am ET in New York.
Fusion plans to present imaging data from the "cold antibody sub study" evaluating pre-administration of cold antibody (naked antibody without the isotope) prior to administration of the hot antibody (antibody with the isotope) in the Phase 1 study of FPI-1434 at the upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting taking place in Vancouver, British Columbia. The presentation titled, "Impact of Pre-Administration of Anti-IGF-1R Antibody FPI-1175 on the Dosimetry, Tumor Uptake, and Pharmacokinetics of the IGF-1R Targeted Theranostic Imaging Agent [111In]-FPI-1547 in Patients with Solid Tumors" will be presented on June 14, 2022.
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.