On May 12, 2022 Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), reported that the company’s interim report for January–March 2022 is now available on the company’s website, www.isofolmedical.com (Press release, Isofol Medical, MAY 12, 2022, View Source [SID1234614268]).

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First quarter, January–March 2022
● Net revenue amounted to TSEK 4,006 (5,215) and other revenue to TSEK 1 (0)
● The result for the period amounted to TSEK -47,874 (-42,662)
● Earnings per share amounted to SEK -0.30 (-0.51)
● Cash and cash equivalents on March 31 amounted to TSEK 332,035 (77,524)

Significant events during the first quarter 2022
● Jenny Sundqvist assumed her role as Chief Commercial Officer on January 1, 2022.

Significant events after the event of the period
● Isofol’s Nomination Committee proposes the election of Jan Törnell as new Chairman of the Board at the Annual General Meeting on May 19, 2022.
● On April 22, Isofol announced that the process of analyzing study data from the AGENT study has begun.

CEO´s comment:
"During the first quarter, Isofol performed many crucial and important activities to lay the foundation for the presentation of the forthcoming study results in the AGENT study. Having now passed the cut-off point that enables the start of the data analysis process, we see several milestones ahead, presentation of top-line data and later also final data", says CEO Ulf Jungnelius.

Audiocast, May 12, at 11:00 a.m. CEST
In conjunction with the publication of the interim report for the first quarter of 2022, Isofol invites investors, analysts, and media to an audiocast on May 12, 2022 at 11:00 a.m. CEST. The presentation will be held by Isofol´s CEO Ulf Jungnelius and CFO Gustaf Albèrt, who will present and comment the report, followed by a Q&A-session. The presentation will be held in English.

The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CEST, on May 12, 2022.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global pivotal Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On May 12, 2022 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, being held in Vienna, Austria, and virtually, June 9-12 (Press release, Genmab, MAY 12, 2022, View Source [SID1234614319]). The presentations will include data from various clinical trials, including multiple arms of the phase 1b/2 EPCORE NHL-2 trial, evaluating the safety and preliminary efficacy of epcoritamab in combination with standard-of-care therapies for the treatment of B-cell non-Hodgkin lymphoma (NHL), including first-line, high-risk diffuse large B-cell lymphoma (DLBCL), relapsed or refractory DLBCL, and relapsed or refractory follicular lymphoma (FL). Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV).

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Additionally, results from several clinical trials evaluating Janssen Biotech, Inc. (Janssen’s)’s subcutaneous formulation of daratumumab, and Janssen’s bispecific programs leveraging Genmab’s DuoBody technology platform will be presented. Daratumumab is being developed by Janssen under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab, and the companies have a research and license agreement to create and develop bispecific antibodies using Genmab’s DuoBody technology platform.

All abstracts accepted for presentation have been published on the EHA (Free EHA Whitepaper) website.

"We are looking forward to presenting the results from a variety of clinical trials evaluating the safety and efficacy of epcoritamab at this year’s EHA (Free EHA Whitepaper), which shows the significant progress we have made developing epcoritamab," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "Together with AbbVie, we continue to evaluate epcoritamab in a variety of clinical settings and patient populations, with the shared commitment of potentially delivering a new treatment option to patients in need."

Abstracts accepted for presentation at EHA (Free EHA Whitepaper) include:

Epcoritamab (DuoBody-CD3xCD20):

Abstract #: P1214. Subcutaneous epcoritamab + R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma: phase 1/2 data update; Clausen et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Abstract #: P1135. Subcutaneous epcoritamab in combination with rituximab + lenalidomide in relapsed or refractory follicular lymphoma: phase 1/2 trial update; Belada et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Abstract #: P1215 Preliminary phase 1/2 results of subcutaneous epcoritamab + R-DHAX/C in patients with relapsed or refractory diffuse large B-cell lymphoma eligible for autologous stem cell transplant; Cordoba et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Abstract #: P1213. Subcutaneous epcoritamab with GemOx induced high response rates in patients with relapsed/refractory diffuse large B-cell lymphoma ineligible for autologous stem cell transplant; Wahlin et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Publication: Assessing safety, tolerability, and efficacy of subcutaneous epcoritamab in novel combinations with anti-neoplastic agents in patients with non-Hodgkin lymphoma in a phase 1b/2, open-label study; Sehn et al

Daratumumab:

Daratumumab, Bortezomib, and Dexamethasone (D-Vd) Versus Bortezomib and Dexamethasone (Vd) Alone in Chinese Patients With Relapsed or Refractory Multiple Myeloma (RRMM): Updated Analysis of LEPUS; Fu et al
Efficacy and safety of daratumumab (DARA) in pediatric and young adult patients (pts) with relapsed/refractory T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL): results from the phase 2 DELPHINUS study; Hogan et al
Daratumumab (DARA) in combination with bortezomib plus dexamethasone (D-Vd) or lenalidomide plus dexamethasone (D-Rd) in relapsed or refractory multiple myeloma (RRMM): subgroup analysis of the phase 3 CASTOR and POLLUX studies in patients (pts) with early or late relapse after initial therapy; Spencer et al
Time to response, duration of response, and patient-reported outcomes (PROs) with daratumumab (DARA) plus lenalidomide and dexamethasone (D-Rd) vs lenalidomide and dexamethasone (Rd) alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM): subgroup analysis of the phase 3 MAIA study; Facon et al
Daratumumab (DARA) + lenalidomide, bortezomib, and dexamethasone (RVd) in transplant-eligible newly diagnosed multiple myeloma (NDMM): a post hoc analysis of sustained minimal residual disease (MRD) negativity from GRIFFIN; Rodriguez et al

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells.i Epcoritamab was developed with selective, silencing mutations that may limit systemic, non-specific activity.ii CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.iii,iv Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration approval to treat certain multiple myeloma indications. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. The subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved for the treatment of certain multiple myeloma indications and the first and only approved treatment for certain patients with light-chain (AL) amyloidosis.v,vi,vii

Please see local country prescribing information for all labeled indication and safety information.

On May 12, 2022 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported financial results for the first quarter ended March 31, 2022 (Press release, Nkarta, MAY 12, 2022, View Source [SID1234614335]).

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"Last month marked an exciting new chapter for Nkarta and the field of cell therapy as we announced positive preliminary data for our co-lead NK cell therapy candidates, NKX101 and NKX1019, validating our best-in-class allogeneic NK cell platform," said Paul J. Hastings, President and CEO of Nkarta. "Independent clinical trials showed early evidence of powerful anti-tumor activity and beneficial safety profiles in patients with two distinct types of relapsed / refractory hematologic malignancies. Early signs of durability and deepening of responses with additional cycles of therapy were observed in both trials, including MRD negativity in patients with AML who received NKX101. Enrollment is underway at higher 3-dose monotherapy regimens of 1.5 billion cells per dose in both dose expansion studies, and Nkarta looks forward to presenting additional data later this year."

NKX101 Clinical Update

On April 25, 2022, Nkarta reported preliminary data from its Phase 1 study evaluating NKX101, an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses NK cells engineered to target NKG2D ligands on cancer cells, as a multi-dose, multi-cycle monotherapy in patients with relapsed / refractory (r/r) acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (MDS). As of data cut-off on April 21, 2022, 21 patients had been enrolled and dosed.
Three of five patients with heavily pre-treated AML treated at the higher dose level in a three-dose regimen achieved a complete response (60% CR) with hematologic recovery, with two of the three responses MRD (measurable residual disease) negative.
NKX101 was generally well tolerated. No dose-limiting toxicities were observed. No cytokine release syndrome (CRS), graft-versus-host disease (GvHD), or immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. The most common higher-grade adverse events were myelosuppression and infection, which are common in this patient population following lymphodepletion.
NKX019 Clinical Update

On April 25, 2022, Nkarta reported preliminary data from its Phase 1 study evaluating NKX019, an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses NK cells engineered to target the B-cell antigen CD19, as a multi-dose, multi-cycle monotherapy in patients with r/r B-cell malignancies. As of data cut-off on April 21, 2022, 13 patients had been enrolled and dosed.
Three of six patients treated at the higher dose level in a three-dose regimen showed a complete response (50% CR), including one patient with aggressive diffuse large B cell lymphoma (DLBCL) and one patient with mantle cell lymphoma (MCL).
NKX019 was generally well tolerated. No dose-limiting toxicities were observed. No CRS, GvHD, or neurotoxicity (ICANS) was observed. The most common higher-grade adverse events were myelosuppression, which is common in this patient population following lymphodepletion.
Anticipated Clinical Milestones

As previously announced, Nkarta plans to present additional clinical data in the second half of 2022 from its ongoing dose escalation clinical trials of NKX101 and NKX019. These data would include longer follow-up on previously reported responses as well as safety and activity data from patients being enrolled in the 3-dose monotherapy regimen of 1.5 billion CAR NK cells per dose.
Pipeline and Platform

In April 2022, Nkarta presented preclinical data from its engineered NK cell platform in four posters at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The posters included data on the use of CRISPR/Cas9 genome editing to enhance the ability of NK cells to target CD70 antigen (jointly presented with CRISPR Therapeutics); analytical and translational methods to better understand patterns of response to CAR NK cells; analysis of surface antigen expression in preclinical models of multiple myeloma; and immune masking strategies for extending the persistence of allogeneic cell therapies.
Other Corporate Highlights

In April 2022, Nkarta received approximately $215.5 million in net proceeds from a public offering of its common stock. This amount included the exercise in full by the underwriters of their option to purchase additional shares of common stock.
In March 2022, Nkarta appointed Angela M. Thedinga, MBA, MPH to its Board of Directors. Ms. Thedinga, an experienced manufacturing technology executive, brings extensive operational expertise in supply chain and commercial-scale manufacturing operations.
First Quarter 2022 and Recent Financial Highlights

Cash and Cash Equivalents: As of March 31, 2022, Nkarta had cash, cash equivalents, restricted cash, and short-term investments of $219.1 million. This amount does not include net proceeds of approximately $215.5 million from the public offering of common stock in April 2022.
R&D Expenses: Research and development (R&D) expenses were $19.6 million for the first quarter of 2022. Non-cash stock-based compensation expense included in R&D expense was $1.9 million for the first quarter of 2022.
G&A Expenses: General and administrative (G&A) expenses were $6.5 million for the first quarter of 2022. Non-cash stock-based compensation expense included in G&A expense was $2.2 million for the first quarter of 2022.
Net Loss: Net loss was $26.0 million, or $0.79 per basic and diluted share, for the first quarter of 2022. This net loss includes non-cash charges of $6.7 million that consisted primarily of share-based compensation of $4.1 million.
Financial Guidance

Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2025. This guidance reflects the proceeds received following the April 2022 public offering of common stock.
About NKX101
NKX101 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy donors. It is engineered with a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. NKX101 is also engineered with membrane-bound form of interleukin-15 (IL15) for greater persistence and activity without exogenous cytokine support. To learn more about the NKX101 clinical trial in adults with AML or MDS, please visit ClinicalTrials.Gov.

About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the NKX019 clinical trial in adults with advanced B cell malignancies, please visit ClinicalTrials.Gov.

On May 12, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported business highlights and financial results for the first quarter ended March 31, 2022 (Press release, Arcellx, MAY 12, 2022, View Source [SID1234614352]).

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"This is an exciting time for our company as we successfully completed our initial public offering in February, raising $142 million in gross proceeds and strengthened our balance sheet as we advance our pioneering platform to treat cancer and other incurable diseases," said Rami Elghandour, Arcellx’s chairman and chief executive officer. "In our first quarter as a public company, we continued to lay the foundation for our near-term and long-term success and our dedicated team made meaningful strides towards our 2022 milestones. We are looking forward to presenting additional patient and longer-term follow-up data on approximately 25 patients for our lead CART-ddBCMA program for patients with relapsed or refractory multiple myeloma (r/r MM) during an oral presentation at ASCO (Free ASCO Whitepaper) in June. Recently, we also advanced our development pipeline programs with the dosing of the first patient in our Phase 1 study evaluating ACLX-001 for patients with r/r MM utilizing our ARC-SparX technology. ARC-SparX has the potential to overcome some of the core challenges in cell therapy by reducing toxicities and addressing antigen heterogeneity, opening up significant market opportunities in harder to treat indications. In the second half of this year, we look forward to initiating our Phase 1 ARC-SparX clinical trial in patients with acute myeloid leukemia and high-risk myelodysplastic syndrome, our Phase 2 CART-ddBCMA pivotal trial in patients with r/r MM, and presenting longer-term patient data from our Phase 1 CART-ddBCMA expansion trial in r/r MM. The capstone of our progress is driven by our D-Domain technology which allows us to choose the right approach for the right indication, and we believe this differentiates our programs from traditional CAR-T therapies."

Recent Business Highlights

Clinical results from CART-ddBCMA Phase 1 study published in Blood Advances. On May 9, 2022, Arcellx announced the publication of clinical results from the dose escalation cohorts of its CART-ddBCMA Phase 1 study in patients with r/r MM in Blood Advances, the open-access journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). The data demonstrate 100% ORR and 75% CR/sCR; and evidence of durable clinical benefit in a population with poor prognostic features were observed in the dose escalation cohorts with CART-ddBCMA. The full online publication can be accessed here.

Dosed first patient in Phase 1 clinical trial evaluating ACLX-001 utilizing the ARC-SparX platform for the treatment of patients with r/r MM. On May 10, 2022, Arcellx announced that the first patient was dosed in its open-label, multicenter Phase 1 clinical trial (NCT04155749) to evaluate the company’s novel dosable and controllable ARC-SparX program in patients with r/r MM. ARC-SparX is comprised of SparX (soluble protein antigen receptor X-linkers) proteins engineered to target BCMA on myeloma cells together with ARC-T (Antigen Receptor Complex-T) cells that are dosed separately and engineered to activate only when engaged with a SparX protein bound to a myeloma cell. Both the ARC cells and the SparX proteins utilize the company’s proprietary novel synthetic binding scaffold called the D-Domain.

CART-ddBCMA accepted as an oral abstract presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. On April 27, 2022, Arcellx announced the presentation of new clinical data from its CART-ddBCMA Phase 1 trial in patients with relapsed or refractory multiple myeloma in an oral abstract session at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022, in Chicago, Illinois.

Oral Presentation Details:

Title: Phase 1 Study of CART-ddBCMA in Relapsed or Refractory Multiple Myeloma
Speaker: Matthew J. Frigault, M.D., Assistant Director of the Cellular Therapy Service at Massachusetts General Cancer Center, and Instructor at Harvard Medical School
Session Type/Title: Oral Abstract Session/Hematologic Malignancies—Plasma Cell Dyscrasia
Session Date: Sunday, June 5, 2022
Session Time: 8:00 a.m. – 11:00 a.m. CDT
Location: McCormick Place Convention Center, Chicago, Illinois
Abstract Number: 8003

Live webcast event with management and panel of clinician experts. On Sunday, June 5, 2022, at 7:00 p.m. CDT, Arcellx will host a live webcast event with an expert panel of clinicians to discuss the clinical results from its CART-ddBCMA study being presented during ASCO (Free ASCO Whitepaper). The event will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcast will be archived and available for 30 days following the event.

First Quarter 2022 Financial Highlights

Cash, cash equivalents, and marketable securities:
As of March 31, 2022, Arcellx had cash, cash equivalents, and marketable securities of $210.9 million, which is anticipated to fund its operations into the second half of 2023.

R&D expenses:
Research and development expenses were $24.4 million and $8.5 million for the quarters ended March 31, 2022 and 2021, respectively, an increase of $15.9 million. This increase was driven by higher external costs associated with the advancement of our CART-ddBCMA clinical program, preclinical development of our other pipeline candidates, and increased headcount.

G&A expenses:
General and administrative expenses were $8.0 million and $2.8 million for the quarters ended March 31, 2022 and 2021, respectively, an increase of $5.2 million. This increase was driven by increased headcount, professional fees related to consulting and accounting, audit services, and other expenses.

Net loss:
Net loss was $32.4 million and $11.3 million for the quarters ended March 31, 2022 and 2021, respectively.

About the ARC-SparX Platform Technology
The ARC-SparX platform is designed to allow for controllability and adaptability to potentially reduce toxicities that are often associated with serious dose-limiting adverse events and to overcome tumor heterogeneity. It is a modular therapy which utilizes a universal ARC-T cell combined with an off-the-shelf SparX protein to separate the tumor-recognition and tumor-killing functions. SparX (soluble protein antigen-receptor X-linkers) proteins utilize our D-Domain technology engineered to recognize antigens on the surface of diseased cells and flags those cells for detection by the ARC-T cells. ARC-T cells express a D-Domain-based CAR engineered to specifically recognize a unique TAG in the SparX protein. ARC-T cells are dosed separately and only activated to kill the target cell when they encounter a SparX protein bound to the target antigen and thus are controlled through SparX dose modulation. Arcellx has developed a collection of SparX proteins that bind different antigens on the surface of diseased cells. Multiple SparX proteins with different antigen specificity can be administered to potentially address antigen heterogeneity or antigen escape that contribute to relapsed and refractory disease.

On May 12, 2022 Theseus Pharmaceuticals, Inc. (NASDAQ: THRX) (Theseus or the Company), a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development and commercialization of transformative targeted therapies, reported business highlights and reported financial results for the first quarter ended March 31, 2022 (Press release, Theseus Pharmaceuticals, MAY 12, 2022, View Source [SID1234614386]).

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"We are pleased by the progress achieved in the first quarter of 2022 as we continue to make strides in advancing our pipeline of novel pan-variant targeted therapies. Notably, we began the year by enrolling patients in our first clinical trial of THE-630 in advanced GIST, and more recently presented encouraging preclinical data on our EGFR program at AACR (Free AACR Whitepaper) that support our approach of pan-variant inhibition in a single molecule," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus. "Over the next 12 months we have a robust set of milestones, including the nomination of a development candidate for our EGFR program and the expansion of our pipeline with a third TKI program. We look forward to seeing these developments over the remainder of 2022, and to sharing initial clinical data from THE-630 in the first half of 2023."

Recent Business Highlights and Upcoming Milestones:

Enrollment ongoing in Phase 1/2 clinical trial evaluating THE-630, targeting the receptor tyrosine kinase KIT, in patients with advanced GIST. In January 2022, the first patient was treated in a Phase 1/2 dose escalation and expansion clinical trial of THE-630 in patients with advanced GIST, a disease that remains largely KIT-dependent even after multiple lines of therapy. THE-630 is a single molecule pan-variant inhibitor of KIT, designed for patients whose cancer has developed resistance to earlier lines of therapy. The Company continues activating sites and enrolling patients in this study, with initial data from the Phase 1 portion of the clinical trial expected to be presented at a scientific conference in the first half of 2023.

Presented preclinical data supporting nomination of a development candidate for fourth-generation EGFR program, expected in the third quarter of 2022. At the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April, Theseus presented preclinical data demonstrating that pan-variant inhibition of all major single-, double-, and triple-EGFR mutants, including T790M and C797S, with selectivity over wild-type and central nervous system (CNS) penetration, can be achieved with a single molecule. Theseus expects to nominate a fourth-generation EGFR inhibitor designed to inhibit the full range of EGFR variants found in the tumors of patients with EGFR-mutant NSCLC that have developed C797S-mediated resistance to first- or later-line osimertinib treatment. Additional preclinical data on the development candidate are expected to be presented at a scientific conference in the fourth quarter of 2022 and Theseus expects to submit an IND for this program in 2023.

Additional TKI program expected to be disclosed by year-end 2022. Theseus continues advancing its preclinical discovery pipeline and expects to introduce a new kinase target program by the end of 2022.

Continued to strengthen leadership team. Theseus recently appointed Claire Coleman, Ph.D., as Vice President, Program Management. Dr. Coleman joined the Company from Allena Pharmaceuticals, where she served as Executive Director, Program Management, and earlier in scientific and program management roles of increasing responsibility at Momenta Pharmaceuticals. She will play an integral role in shepherding Theseus’ programs through preclinical and clinical-stage development.
First Quarter Financial Results:

Cash Position: As of March 31, 2022, Theseus had cash, cash equivalents and short-term and long-term investments of $237.0 million. Theseus expects its cash, cash equivalents, and investments to fund operations and capital expenditures into the second half of 2024 based on its current operating plan.

R&D Expenses: Research and development expenses were $6.5 million for the first quarter of 2022, as compared to $3.8 million for the same period in 2021. This increase was primarily due to $1.8 million of increased employee-related costs, and $0.8 million in increased expenses for clinical and preclinical studies.

G&A Expenses: General and administrative expenses were $4.0 million for the first quarter of 2022, as compared to $0.7 million for the same period in 2021. This increase was primarily due to $2.1 million of increased employee-related costs, as well as $1.1 million of increased general expenses, primarily driven by public company-related costs.

Net Loss: Net loss was $10.5 million for the first quarter of 2022, as compared to a net loss of $4.5 million for the same period in 2021.