On May 9, 2022 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the first quarter 2022 and provided an update on the company’s recent developments (Press release, FibroGen, MAY 9, 2022, View Source [SID1234613912]).

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"We continue our progress in advancing pamrevlumab in three high value indications and are delighted to have completed enrollment of the ZEPHYRUS-1 Phase 3 study in idiopathic pulmonary fibrosis," said Enrique Conterno, Chief Executive Officer, FibroGen. "In addition, roxadustat is off to a strong start in 2022 in China with significant year over year volume growth."

Recent Developments:

Completed enrollment of the ZEPHYRUS-1 Phase 3 clinical trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
Completed enrollment of the LELANTOS-1 Phase 3 clinical trial of pamrevlumab in non-ambulatory patients with Duchenne muscular dystrophy (DMD).
Our partner Astellas received approval for roxadustat in Russia for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD), which triggered a $25 million milestone payable to FibroGen.
China Performance:

FibroGen’s net product revenue under U.S. GAAP from sale of roxadustat in China was $18.9 million compared to $15.4 million in the first quarter of 2021. Increase driven mainly due to release of deferred revenue.
First quarter total roxadustat net sales in China1 by FibroGen and the distribution entity (JDE) jointly owned by FibroGen and AstraZeneca was $43.5 million, flat as compared to the first quarter of 2021. This result was driven by an increase in volume of over 70% offset by the recent National Reimbursement Drug List (NRDL) price reduction.
Roxadustat continues to be the number one brand based on value share in the anemia of CKD market in China.
Upcoming Milestones:

Interim analysis of event free survival of the LAPIS Phase 3 study of pamrevlumab in locally advanced pancreatic cancer (LAPC) to be conducted in 2Q 2022.
Topline data from the LELANTOS-1 Phase 3 study of pamrevlumab in DMD expected 1H 2023.
Expect to complete enrollment in the LELANTOS-2 Phase 3 study of pamrevlumab in ambulatory patients with DMD in 2Q 2022.
Topline data from the ZEPHYRUS-1 Phase 3 study of pamrevlumab in IPF expected mid-2023.
Topline data from the MATTERHORN Phase 3 study of roxadustat in anemia of myelodysplastic syndromes (MDS) expected 1H 2023.
Financial:

Total revenue for the first quarter of 2022 was $60.8 million, as compared to $38.4 million for the first quarter of 2021.
Net loss for the first quarter of 2022 was $63.2 million, or $0.68 net loss per basic and diluted share, compared to a net loss of $71.8 million, or $0.78 net loss per basic and diluted share one year ago.
At March 31, 2022, FibroGen had $565.4 million in cash – defined as cash, cash equivalents, investments, and accounts receivable.
Based on our latest forecast, we estimate a 2022 ending cash balance of $310-340 million.
________________
1 Total roxadustat net sales in China includes sales made by the distribution entity as well as FibroGen China’s direct sales, each to its own distributors. The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements.

Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Monday, May 9, 2022, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the Company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (877) 658-9081 (U.S. and Canada) or 1 (602) 563-8732 (international), reference the FibroGen first quarter 2022 financial results conference call, and use confirmation number 2487763. A replay of the webcast will be available shortly after the call for a period of 7 days. To access the replay, please dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international) and use passcode 2487763.

About Pamrevlumab
Pamrevlumab is a potential first-in-class antibody being developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), an important biological mediator in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD). Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

About Roxadustat
Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for anemia of chronic kidney disease (CKD) and anemia associated with myelodysplastic syndromes (MDS), and for chemotherapy-induced anemia (CIA).

Roxadustat is approved in European Union (EU) member states, including the European Economic Area (EEA) countries, as well as in Japan, China, Chile, South Korea, Russia, and the UK for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca to regulatory authorities across the globe, and are currently under review.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets not licensed to Astellas.

On May 9, 2022 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported financial results for the first quarter ended March 31, 2022 (Press release, CRISPR Therapeutics, MAY 9, 2022, View Source [SID1234613911]).

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"I am pleased with the ongoing momentum across our broad portfolio of innovative gene therapy candidates and anticipate important company milestones in 2022. Alongside our partner Vertex, we remain on track to submit global regulatory filings for CTX001 in late 2022 and have dosed more than 75 patients across both trials to date. We have also initiated two new Phase 3 trials of CTX001 in pediatric patients with TDT and SCD," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. "We are also advancing our wholly-owned immuno-oncology pipeline, with new updates expected this year. In addition, enrollment and dosing continues in the Phase 1 clinical trial of VCTX210 for T1D with our partner, ViaCyte. We believe we are well positioned and well capitalized to advance our pipeline and platform to develop transformative medicines for patients suffering from serious diseases."

Recent Highlights and Outlook

Beta Thalassemia and Sickle Cell Disease

Following the completion of enrollment in the ongoing Phase 3 clinical trials for CTX001 in transfusion-dependent beta thalassemia (TDT) and severe sickle cell disease (SCD), announced last quarter, more than 75 patients across both trials have been dosed to date. CRISPR Therapeutics and Vertex anticipate presenting updated data from the clinical trials, with more patients and longer follow-up, at medical conferences in 2022.

CRISPR Therapeutics and Vertex have initiated two new Phase 3 studies of CTX001 in pediatric patients with TDT and SCD.

The companies anticipate submitting global regulatory filings for CTX001 in TDT and SCD in late 2022.

Immuno-Oncology Programs

CRISPR Therapeutics continues to enroll and dose patients in the pivotal trial of CTX110, its wholly-owned allogeneic chimeric antigen receptor T cell (CAR-T) investigational therapy targeting CD19+ B-cell malignancies. The Company expects to report additional data in 2022.

CRISPR Therapeutics’ Phase 1 clinical trials for CTX-120, its wholly-owned allogeneic CAR-T investigational therapy targeting B-cell maturation antigen for the treatment of relapsed or refractory multiple myeloma, and CTX130, its wholly-owned allogeneic CAR-T investigational therapy targeting CD70 for the treatment of both solid tumors and certain hematologic malignancies, are ongoing. Each trial is assessing safety and efficacy of several dose levels. The Company expects to provide updates from each trial in the first half of 2022.

Regenerative Medicine and In Vivo Programs

Enrollment and dosing are ongoing in the Phase 1 clinical trial of VCTX210 for the treatment of type 1 diabetes (T1D). VCTX210 is an investigational, allogeneic, gene-edited, stem cell-derived product developed in collaboration by applying CRISPR Therapeutics’ gene-editing technology to ViaCyte’s proprietary stem cell capabilities for the generation of pancreatic cells designed to evade recognition by the immune system. This immune-evasive cell replacement therapy is designed to enable patients to produce their own insulin.

Based upon ongoing progress with its in vivo approaches for liver gene editing utilizing both viral and non-viral delivery vehicles, CRISPR Therapeutics continues to expect to move multiple programs utilizing in vivo approaches into the clinic in the next 18 to 24 months.

Other Corporate Matters

In April, CRISPR Therapeutics proposed to elect Maria Fardis, Ph.D., MBA, to its Board of Directors at the Company’s upcoming annual general meeting of shareholders to be held later this year. The Company believes her extensive leadership in scaling companies and bringing novel therapies to patients will be an invaluable asset to CRISPR Therapeutics.

In April, CRISPR Therapeutics and Nkarta, Inc. presented preclinical data focused on its natural killer cell platform and pipeline at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022. The data shows that CD70/CISH/CBLB triple KO CD70-CAR NK cells demonstrated enhanced anti-tumor activity against relevant solid tumor cell lines and provided greater resistance to tumor microenvironment inhibition. These data support the further exploration of CD70/CISH/CBLB triple gene knockout CD70 CAR NK cells for clinical application.

In April, CRISPR Therapeutics was awarded the 2022 Facility of the Year Category Award (FOYA) for Innovation by the International Society for Pharmaceutical Engineering (ISPE) for its state-of-the art manufacturing facility in Framingham, Massachusetts, USA. ISPE’s Facility of the Year Awards program is the premier global awards program recognizing innovation and creativity in the pharmaceutical and biotechnology manufacturing industries. Projects selected for recognition set the standard by demonstrating excellence in facility design, construction, and operations.
First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $2,221.3 million as of March 31, 2022, compared to $2,379.1 million as of December 31, 2021. The decrease in cash of $157.8 million was primarily driven by cash used in operating activities to support ongoing research and development of the Company’s clinical and pre-clinical programs.

Revenue: Total collaboration revenue was $0.2 million for the first quarter of 2022 and 2021.

R&D Expenses: R&D expenses were $118.2 million for the first quarter of 2022, compared to $70.6 million for the first quarter of 2021. The increase in expense was driven by development activities supporting the advancement of our wholly-owned immuno-oncology programs, as well as expenses related to our new U.S. research and development headquarters.

G&A Expenses: General and administrative expenses were $28.0 million for the first quarter of 2022, compared to $24.5 million for the first quarter of 2021. The increase in general and administrative expenses was primarily driven by headcount-related expense.

Collaboration Expense: Collaboration expense, net, was $30.6 million for the first quarter of 2022, compared to $19.9 million for the first quarter of 2021. The increase in collaboration expense, net, was primarily driven by increased pre-commercial and manufacturing scale-up costs associated with our hemoglobinopathies programs under our collaboration with Vertex.

Net Loss: Net loss was $179.2 million for the first quarter of 2022, compared to a net loss of $113.2 million for the first quarter of 2021.
About CTX001
CTX001 is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy that is being evaluated for patients suffering from TDT or severe SCD, in which a patient’s hematopoietic stem cells are edited to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is a form of the oxygen-carrying hemoglobin that is naturally present at birth, which then switches to the adult form of hemoglobin. The elevation of HbF by CTX001 has the potential to alleviate or eliminate transfusion requirements for patients with TDT and reduce or eliminate painful and debilitating sickle crises for patients with SCD. Earlier results from these ongoing trials were published as a Brief Report in The New England Journal of Medicine in January of 2021.

Based on progress in this program to date, CTX001 has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for both TDT and SCD. CTX001 has also been granted Orphan Drug Designation from the European Commission, as well as Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), for both TDT and SCD.

Among gene-editing approaches being investigated/evaluated for TDT and SCD, CTX001 is the furthest advanced in clinical development.

About the CRISPR-Vertex Collaboration
Vertex and CRISPR Therapeutics entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. CTX001 represents the first potential treatment to emerge from the joint research program. Under a recently amended collaboration agreement, Vertex will lead global development, manufacturing and commercialization of CTX001 and split program costs and profits worldwide 60/40 with CRISPR Therapeutics.

About CLIMB-111
The ongoing Phase 1/2 open-label trial, CLIMB-Thal-111, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 12 to 35 with TDT. The trial will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up trial.

About CLIMB-121
The ongoing Phase 1/2 open-label trial, CLIMB-SCD-121, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 12 to 35 with severe SCD. The trial will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up trial.

About CLIMB-131
This is a long-term, open-label trial to evaluate the safety and efficacy of CTX001 in patients who received CTX001 in CLIMB-111 or CLIMB-121. The trial is designed to follow participants for up to 15 years after CTX001 infusion.

About CTX110
CTX110, a wholly owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting cluster of differentiation 19, or CD19. CTX110 is being investigated in the ongoing CARBON trial. CTX110 has been granted Regenerative Medicine Advanced Therapy designation from the FDA.

About CARBON
The ongoing Phase 1 single-arm, multi-center, open label clinical trial, CARBON, is designed to assess the safety and efficacy of several dose levels of CTX110 for the treatment of relapsed or refractory B-cell malignancies.

About CTX120
CTX120, a wholly-owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting B-cell maturation antigen, or BCMA. CTX120 is being investigated in an ongoing Phase 1 single-arm, multi-center, open-label clinical trial designed to assess the safety and efficacy of several dose levels of CTX120 for the treatment of relapsed or refractory multiple myeloma. CTX120 has been granted Orphan Drug designation from the FDA.

About CTX130
CTX130, a wholly-owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting cluster of differentiation 70, or CD70, an antigen expressed on various solid tumors and hematologic malignancies. CTX130 is being developed for the treatment of both solid tumors, such as renal cell carcinoma, and T-cell and B-cell hematologic malignancies. CTX130 is being investigated in two ongoing independent Phase 1, single-arm, multi-center, open-label clinical trials that are designed to assess the safety and efficacy of several dose levels of CTX130 for the treatment of relapsed or refractory renal cell carcinoma and various subtypes of lymphoma, respectively. CTX120 has been granted Orphan Drug designation for the treatment of T-cell lymphoma from the FDA.

About VCTX210
VCTX210 is an investigational, allogeneic, gene-edited, immune-evasive, stem cell-derived therapy for the treatment of type 1 diabetes (T1D). VCTX210 is being developed under a co-development and co-commercialization agreement between CRISPR Therapeutics and ViaCyte, Inc.

On May 9, 2022 IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the "Company" or "IPA") (NASDAQ: IPA) (TSXV: IPA) is pleased to share that IPA’s subsidiary Biostrand, a Belgian end-to-end multi-omics analysis platform provider, reported that it has received a €460,000 round of grant funding from VLAIO (Flanders Innovation & Entrepreneurship), the research fund of the Flemish regional government in Belgium (Press release, ImmunoPrecise Antibodies, MAY 9, 2022, View Source [SID1234613910]). Conditionally awarded in January this year, BioStrand recently satisfied the remaining criteria for the award, which follows an original grant from VLAIO of €235,000 in 2020. Commenting on the latest grant, Dr. Ingrid Brands, General Manager and co-founder of BioStrand, stated, "Thus far, our patented HYFT-based methodology has been applied predominantly to streamline analysis at the syntactic level and combines sequence information with natural language processing. Using the presence, occurrence, and distribution of HYFT patterns, the focus has been on analysis and integration of sequence-based ‘syntactical’ information. We are now extending the methodology to combine syntactical and structural information and to expand our services portfolio with HYFT-based structural and functional modelling functionalities. By linking HYFTs with the 3D structure (and function) of proteins and expanding platform capabilities for AI discovery, we will be able to support an even wider array of applications, including assay development, biomarker discovery, and computer-aided drug design."

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The strategic objective driving this HYFT-based synthesis of syntactical and structural information is to extend BioStrand’s technology to encompass the structure of proteins. A key advantage of this blended approach is the detection of protein sequences with similar structures (and function) but without high sequence similarity (distant homologs). A primary application for this approach will be in protein structure prediction, with a particular first focus on antibodies as well as G protein coupled receptors (GPCRs). This will be extended to cover protein-protein interaction prediction (PPI) at a later stage.

BioStrand is also working on an AI Discovery platform that will leverage advanced AI techniques to facilitate integrated protein structure and function analysis. Combined with existing R&R and Variant Analyzer modules, natural language analysis capabilities and the HYFT-based unified syntactical plus structural methodology, BioStrand’s AI discovery platform will empower researchers to fully analyse their data and gain insights across the entire analysis pipeline, from raw sequencing data to biologically relevant aspects such as diagnostics and drug discovery.

The expansion of BioStrand’s omics platform with these advanced functionalities is crucial to become an ambitious market player and position BioStrand as a one-stop-shop for omics analysis," said Dr. Brands. "We believe that integrating sequence and 3D structure analysis in combination with natural language processing will revolutionize protein structure and function prediction and boost developments in biotechnology and precision medicine. Providing a powerful, integrated, and user-friendly data analysis platform for life sciences researchers is our contribution to ramping up the effectiveness of R&D cycles and enabling the real-time analysis of actionable patient data that will bring precision medicine to the next level. It also takes us one step further in our mission to create a truly effective omics data analysis solution."

The Company also announces the departure of Stefan Lang, Chief Business officer of IPA, effective immediately, and wishes him the best in his future endeavors.

On May 9, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in cell-free, enzymatic DNA production, reported that it will report fiscal 2022 second quarter financial results after market close on Thursday, May 12, 2022 (Press release, Applied DNA Sciences, MAY 9, 2022, View Source [SID1234613909]). The Company’s management will discuss the results during a conference call and simultaneous webcast at 4:30 p.m. ET that same day. Presentation slides will also be posted to the ‘Company Events’ sub-page of the Company’s Investor Relations website and embedded into the live webcast.

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A telephonic replay of the conference call will be available for one week beginning one hour after the end of the live conference call.

On May 9, 2022 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported operating results for the first quarter ended March 31, 2022 (Press release, Seagen, MAY 9, 2022, View Source [SID1234613908]). During the quarter, the Company continued to engage with the US Food and Drug Administration (FDA) to identify an anticipated regulatory path toward potential resubmission of a Biologics License Application (BLA) for Vicineum for the treatment of non-muscle invasive bladder cancer (NMIBC). The Company has also initiated a process to review strategic alternatives with the goal of maximizing shareholder value.

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US Regulatory Update

On March 28, 2022, Sesen Bio participated in a Type C Meeting with the FDA. During the meeting, the FDA agreed to a majority of the Company’s proposed protocol and statistical analysis plan design elements for an additional Phase 3 clinical trial that it plans to conduct for potential resubmission of a BLA for Vicineum for the treatment of NMIBC. The Company plans to meet with the FDA in mid-2022 to align on the remaining outstanding items related to the additional Phase 3 clinical trial, and intends to request that meeting in the coming weeks.
In addition to working with the FDA to align on a study design, the Company has been addressing comments related to Chemistry, Manufacturing and Controls (CMC) that were included in the Complete Response Letter (CRL) for the BLA for Vicineum for the treatment of bacillus Calmette-Guérin (BCG)-unresponsive NMIBC. The Company has completed technical work on several of the key CMC comments and is continuing to make progress on the remaining items. The Company’s responses to the CMC comments will ultimately be reviewed by the FDA upon a potential BLA resubmission.

Other Business Updates

On January 6, 2022, Sesen Bio disclosed that it achieved a $20 million milestone payment pursuant to the Company’s exclusive license agreement (Roche License Agreement) with Roche for legacy Interleukin-6 (IL-6) antagonist antibody technology owned by Sesen Bio. Following this milestone payment, Sesen Bio has cumulatively received $50 million in upfront and milestone payments, with an additional $220 million in potential future milestone payments, as well as royalty payment obligations on future sales, remaining under the Roche License Agreement. As part of the Roche License Agreement, Roche also maintains the right to fully acquire the IL-6 technology.
On May 3, 2022, Sesen Bio announced that it had initiated a process to review strategic alternatives with the goal of maximizing shareholder value. Potential strategic alternatives to be explored and evaluated during the review process may include the sale of the Company, a merger, acquisition or other business combination, a strategic partnership with one or more parties, or the licensing, sale or divestiture of some of the Company’s proprietary technologies. The Company is actively working with an investment bank in this process. Pending any decision to undertake any strategic alternative, the Company is continuing its development activities in accordance with its existing business strategy.
On June 22, 2022, Sesen Bio will hold its Annual Meeting of Stockholders, one of the primary purposes of which will be to approve a proposal for a reverse stock split, which includes a proportionate reduction in authorized shares of common stock. The proposed reverse stock split, if approved, should allow the Company to remain listed on the Nasdaq Global Market, which should increase the range and attractiveness of strategic alternatives that the Company is able to consider to maximize shareholder value.
First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and restricted cash were $169.8 million as of March 31, 2022, compared to $110.0 million as of March 31, 2021.
R&D Expenses: Research and development expenses for the first quarter of 2022 were $4.8 million compared to $6.1 million for the same period in 2021. The decrease of $1.3 million was primarily due to lower costs associated with technology transfer and manufacturing ($1.4 million), regulatory and clinical consulting fees ($0.6 million) and license milestone fees ($0.6 million), which were partially offset by increases in employee-related compensation, primarily driven by increased headcount and the retention program implemented in the fourth quarter of 2021 ($1.2 million), and other R&D expenses ($0.1 million).
G&A Expenses: General and administrative expenses for the first quarter of 2022 were $9.0 million compared to $5.3 million for the same period in 2021. The increase of $3.7 million was due primarily to increases in legal expenses related, in part, to the independent internal review completed in February 2022 ($3.0 million), employee-related compensation, primarily driven by increased headcount and the retention program implemented in the fourth quarter of 2021 ($1.1 million), insurance expense ($0.1 million) and other general expenses ($0.2 million). This was partially offset by a decrease in consultant fees incurred in preparation for commercial launch as a result of the subsequent CRL received in August 2021 ($0.7 million).
Net Loss: Net loss was $0.8 million, or $0.00 per basic and per diluted share, for the first quarter of 2022, compared to net loss of $55.5 million, or $0.35 per basic and diluted share, for the same period in 2021. The decrease of $54.7 million in net loss was primarily attributable to the non-cash decrease in fair value of contingent consideration ($61.1 million), partially offset by decreased license and related revenue recognized ($4.3 million).
About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 clinical trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s Biologics License Application (BLA) file for Vicineum for the treatment of BCG-unresponsive NMIBC, granted Priority Review for the BLA and set a Prescription Drug User Fee Act (PDUFA) date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. After meeting with the FDA, the Company plans to conduct an additional Phase 3 clinical trial for Vicineum for the treatment of NMIBC in connection with the potential resubmission of a BLA. The Company plans to request a meeting with the FDA in the coming weeks to align on the remaining outstanding items related to the additional Phase 3 clinical trial. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.