On August 10, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported that it has signed a supply agreement with 3D Imaging LLC. (3DI), a Contract Development and Manufacturing Organisation (CDMO), covering Clarity’s diagnostic 64Cu SAR-bisPSMA product (Press release, Clarity Pharmaceuticals, AUG 10, 2022, View Source [SID1234618060]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The new agreement, effective on August 11th, 2022, enables increased production and will create excess capacity in the supply of Clarity’s differentiated PSMA product in advance of two potential diagnostic Phase III trials in the US, ensuring reliable and seamless supply. 3DI will centrally manufacture and distribute the 64Cu SAR-bisPSMA products from its facility in Little Rock, Arkansas, USA, located close to the Global FedEx hub.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to continue strengthening Clarity’s supply and manufacturing efforts and distinguishing ourselves from the current generation of radiopharmaceuticals that have many logistical limitations due to very short half-lives. In a field with all too many unforeseen product supply limitations and outages, we are building a reliable supply network with excess capacity."

Clarity’s 64Cu-based products can be centrally manufactured on existing cyclotrons and distributed broadly with a widespread geographical reach due to a significantly longer shelf-life of Clarity’s Targeted Copper Theranostics (TCT) products. A single cyclotron can supply 64Cu for the entire Phase III diagnostic clinical program.

"Clarity is overlaying several cyclotrons and manufacturers to enable TCTs’ future expansion into the larger commercial setting. By building a reliable and accessible supply chain that is consistent with that of the "big pharma" oncology model, Clarity aims to create a significant competitive advantage as we continue to pursue our ultimate goal of improving treatment outcomes for children and adults with cancer," said Dr Taylor.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two prostate-specific membrane antigen (PSMA) binding motifs to Clarity’s proprietary sarcophagene (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide1. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease2.

On August 10, 2022 Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing a diversified pipeline of targeted therapeutic candidates across multiple modalities for patients with cancer, reported on recent and upcoming business highlights and announced its financial results for the second quarter ended June 30, 2022 (Press release, Cullinan Oncology, AUG 10, 2022, View Source [SID1234618059]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the second quarter of 2022, Cullinan Oncology demonstrated significant portfolio advancement, including the closing of our agreement with Taiho Pharmaceutical for CLN-081, an oral presentation for CLN-081 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting, and continued progression of our pipeline of potential first-in-class and best-in-class oncology assets. These achievements demonstrate our commitment to creating new standards of care for patients with unmet need," said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology.

"We are pleased with the continued strengthening of CLN-081’s clinical profile," Ahmed continued. "Updated data released at ASCO (Free ASCO Whitepaper) highlighted a high response rate, favorable safety and tolerability, and improving durability of response from the ongoing Phase 1/2a study for patients with EGFR exon 20 insertion mutation non-small-cell lung cancer. Financially, the closing of the Taiho transaction for CLN-081 has extended our cash runway through 2026, giving us the financial flexibility to accelerate and expand the development of our diverse pipeline as well as obtain promising new oncology assets. Looking ahead, we continue to advance our earlier-stage programs, including CLN-619 and CLN-049, with initial Phase 1 data readouts expected by mid-2023, as well as CLN-617 and CLN-978, for which we anticipate IND filings in the first half of next year."

Portfolio Highlights

CLN-081: In June, Cullinan Oncology completed its strategic agreement with Taiho Pharmaceutical Co., Ltd. (Taiho Pharmaceutical) pursuant to which Cullinan Oncology received a $275 million upfront payment and is eligible to receive an additional $130 million tied to EGFR exon 20 non-small-cell lung cancer regulatory milestones in exchange for selling its equity interest in Cullinan Pearl, which holds worldwide rights to CLN-081 outside of Japan and Greater China. Additionally, Cullinan Oncology entered into an agreement with Taiho Oncology, Inc. (Taiho Oncology), a subsidiary of Taiho Pharmaceutical, to jointly develop and commercialize CLN-081 in the U.S. Pursuant to the co-development agreement, Cullinan Oncology and Taiho Oncology will share equally in the development expenses and future potential U.S. profits and losses for CLN-081.
Also in June, Cullinan Oncology presented updated data from its ongoing Phase 1/2a clinical study of CLN-081 in an oral presentation at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting. The updated data showed a median duration of response greater than 21 months, median progression free survival of 12 months and a confirmed overall response rate of 41% among 39 patients treated at the 100 mg BID dose, along with a continued favorable safety and tolerability profile. In collaboration with its partner, Taiho Oncology, Cullinan Oncology intends to initiate a pivotal study for CLN-081 in the second half of 2022 under the co-development agreement.
CLN-049: Cullinan Oncology continued dosing patients in its first-in-human clinical trial evaluating CLN-049 in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Initial clinical data are expected by mid-2023. CLN-049 is a FLT3/CD3-bispecific T cell-engaging antibody in an IgG format for the treatment of AML and MDS. CLN-049 targets the extracellular domain of FLT3, regardless of mutant or wild type FLT3 status.
CLN-619: Cullinan Oncology continued dosing subjects in its first-in-human clinical trial evaluating CLN-619 alone and in combination with pembrolizumab in patients with advanced tumors. Initial clinical data are expected by mid-2023. CLN-619 is a first-in-class monoclonal antibody with broad therapeutic potential across multiple cancer indications. CLN-619 stabilizes expression of MICA/MICB on the tumor cell surface to promote an antitumor response via activation of both natural killer (NK) cells and certain T cells.
Preclinical Portfolio:
Cullinan Oncology remains on track for Investigational New Drug (IND) submissions in the first half of 2023 for its two most advanced preclinical programs:
CLN-617, a cytokine fusion protein uniquely combining IL-12 and IL-2 with a collagen binding domain designed for retention in the tumor microenvironment (TME) following intratumoral injection, and
CLN-978, a novel CD19/CD3-bispecific construct with extended serum half-life and high potency against target cells expressing low levels of CD19.
Cullinan Oncology continues to progress its additional 3 preclinical programs, including Jade, Opal, and the HPK1 degrader collaboration with Icahn Mount Sinai.

Second Quarter 2022 Financial Results

Cash Position: Cash and investments were $656 million as of June 30, 2022. During the second quarter of 2022, we received cash proceeds of $270 million from the sale of Cullinan Pearl. The remaining $5 million of the $275 million upfront payment was held in escrow as of June 30 and is expected to be released in the third quarter of 2022. Based on current operating plans, the Company expects that its cash and investments will be sufficient to fund operations through 2026.
R&D Expenses: Research and development (R&D) expenses were $26.4 million for the second quarter of 2022, compared to $24.5 million for the first quarter of 2022. R&D expenses for the second and first quarters of 2022 included $4.4 million and $2.6 million of equity-based compensation expenses, respectively. The increase in R&D expenses is primarily related to expanded clinical activities for CLN-049 and CLN-619 and IND-enabling activities for CLN-617, which were partially offset by a decrease in chemistry, manufacturing, and control activities for CLN-081.
G&A Expenses: General and administrative (G&A) expenses were $10.7 million for the second quarter of 2022, compared to $8.1 million for the first quarter of 2022. G&A expenses in the second and first quarters of 2022 included $4.2 million and $3.8 million of equity-based compensation expenses, respectively. Nonrecurring expenses related to the Cullinan Pearl transaction were $1.7 million in the second quarter and $0.3 million in the first quarter.
Gain on sale of Cullinan Pearl: The Company recognized a gain on the sale of Cullinan Pearl of $276.8 million, which includes the upfront payment of $275 million, as well as the impact of net liabilities transferred to Taiho. As of June 30, 2022, the Company also recognized an income tax liability related to this gain of $46.5 million. The Company estimates the net income tax liability will be reduced to approximately $41 million based on our utilization of net operating losses we anticipate incurring during the remainder of 2022. We expect to make estimated tax payments in an amount equal to 75% of our tax liability in the third quarter of 2022 and the remainder in the fourth quarter of 2022.
Net Income: The Company generated net income (before items attributable to noncontrolling interest) of $174.1 million for the second quarter of 2022 compared to a net loss of $12.9 million for the first quarter of 2022.

On August 10, 2022 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, reported financial results for the second quarter ended June 30, 2022 and provided business updates (Press release, TScan Therapeutics, AUG 10, 2022, View Source [SID1234618058]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"During the second quarter we have made significant progress across our pipeline, including the IND clearance of our second TCR, TSC-101 targeting HA-2, enabling us to proceed with all components of our Phase 1 umbrella trial designed to prevent relapse in patients with hematologic malignancies undergoing hematopoietic stem-cell transplant. The trial is now open for patient enrollment," said David P. Southwell, President and Chief Executive Officer. "Our foundational technology was featured in presentations at ASGCT (Free ASGCT Whitepaper) highlighting our platform for the discovery of targets and high affinity TCRs, as well as in a peer-reviewed article in Cell further demonstrating the use of our screening technology as a valuable tool to identify novel, potent tumor antigens. We look forward to bringing our therapies to patients with hematologic malignancies in 2022 and to solid tumor patients in 2023."

Recent Corporate Highlights

TScan announced the U.S. Food and Drug Administration (FDA) clearance of its investigational new drug (IND) application for TSC-101, which targets minor histocompatibility antigen HA-2 for the prevention of relapse following hematopoietic cell transplantation (HCT) in hematologic malignancies. The trial is open and recruiting patients for all three arms of TScan’s umbrella Phase 1 clinical trial, which includes active treatment arms for TSC-100 (HA-1) and TSC-101, as well as a control arm using current standard-of-care for HCT patients.

The Company announced the publication of a peer-reviewed article in the journal Cell. The article highlights the power of TScan’s unbiased, genome-wide screening technology to identify novel tumor antigens and highly active TCRs for adoptive T cell therapy from patients responding to checkpoint blockade therapy. The publication details the characterization of tumor-infiltrating and circulating T cells in oral cancer patients treated with neoadjuvant anti-PD-1 or anti-PD-1/CTLA-4 agents in a Phase 2 open-label randomized clinical trial conducted by the Dana-Farber Cancer Institute, Brigham and Women’s Hospital and Harvard Medical School1. Single cell analysis revealed that tumor-infiltrating CD8 T cells which expanded upon treatment with checkpoint blockade exhibited specific and identifiable gene expression signatures. Analysis of the TCRs of these expanded T cells using TScan’s screening technology revealed several novel targets for TCR therapy. One of the TCRs described in the Cell paper forms the basis of TScan’s TSC-204-C7 TCR-T therapeutic candidate targeting MAGE-A1, for which the Company plans to file an IND by the end of 2022.

The Company expanded its leadership team with the appointment of Debora Barton, M.D., as Chief Medical Officer. Dr. Barton brings to TScan nearly two decades of expertise across global clinical research and development in executive leadership roles with large pharma and midsized and small biotech companies. Dr. Barton has specific experience in the use of cell therapy in oncology at two prior organizations. Prior to joining TScan, Dr. Barton was the Chief Medical Officer at Carisma Therapeutics Inc., where she was responsible for clinical development, clinical operations, medical affairs, and safety, including launching the first-in-class CAR Macrophages clinical trial. Previously Dr. Barton held positions of increasing responsibility in leading oncology companies including Iovance Biotherapeutics, Inc., Advanced Accelerator Applications S.A., Celgene Corporation, and Novartis. She holds an M.D. from Pontificia Universidade Catolica Sao Paulo and completed her fellowship at Federal University of Sao Paulo in Brazil.

In May, the Company hosted a conference call featuring Kai Wucherpfennig, M.D., Ph.D., Chair, Cancer Immunology and Virology and Director, Center for Cancer Immunology Research at the Dana-Farber Cancer Institute, Professor of Neurology, Brigham and Women’s Hospital and Harvard Medical School, and Associate Member, Broad Institute of MIT and Harvard, to discuss the Company’s solid tumor program strategy and highlights from its presentations at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting. The event provided an in-depth review of the oral and poster presentations related to solid tumor TCR-T therapy candidates TSC-200-A2 for HPV16 and TSC-204-C7 for MAGE-A1, as well as TScan’s approach to potentially overcome antigen heterogeneity and HLA loss with multiplexed TCR-T therapy. A replay of the event is archived on TScan’s website at ir.tscan.com.
Anticipated Near-Term and Upcoming Catalysts

Hematologic Malignancies Program: TScan’s two lead TCR-T therapy candidates, TSC-100 and TSC-101, are designed to target HA-1 and HA-2, respectively, in order to prevent relapse in patients undergoing allogeneic HCT with reduced intensity conditioning (RIC). Up to 40% of patients who receive HCT with RIC relapse within two years, at which point there are limited treatment options and poor prognosis. The longer-term objective is to enable increased use of RIC, a more tolerable chemotherapy than myeloablative conditioning.

The Phase 1 umbrella trial (NCT05473910) for TSC-100 and TSC-101 is now open, and the Company will provide an update by the end of 2022.
Solid Tumor Programs: TScan’s TCR-T therapy candidates for solid tumors include a combination of validated targets, such as HPV16 for TSC-200 and PRAME for TSC-203, as well as targets that are novel antigens for TCR-T therapy, such as MAGE-A1 for TSC-204 and those for TSC-201 and TSC-202. To address the resistance mechanisms of tumor heterogeneity and HLA loss, TScan is also developing TCRs for multiple HLAs across all of its targets and designates its TCR programs by their HLA restriction, such that the A*02:01 HLA restriction for the HPV TCR is known as TSC-200-A2.

The Company plans to progress IND-enabling studies for its solid tumor programs and submit IND applications for two TCRs by the end of 2022. These are expected to include TSC-200-A2 for HPV and TSC-204-C7 for MAGE-A1, which was the subject of a recent publication in Cell.

The Company plans to file additional INDs for its solid tumor programs, as well as release initial clinical data for TCRs in this series, by the end of 2023.
Second Quarter 2022 Financial Results

As of June 30, 2022, TScan Therapeutics had cash and cash equivalents of $125.6 million, excluding $5.0 million of restricted cash. Based on current operating plans, the Company believes that existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2024.

Revenue for the second quarter ended June 30, 2022, was $4.1 million, compared to $2.8 million for the second quarter ended June 30, 2021 (2021 Quarter). This increase is due to research activities related to TScan’s collaboration agreement with Novartis Institutes for Biomedical Research, which commenced in September 2020.

Research and development expenses for the second quarter ended June 30, 2022, were $14.5 million, compared to $10.8 million for the 2021 Quarter. The increase of $3.7 million was primarily a result of an increase in expenses to support pipeline development and solid tumor IND-enabling activities, clinical expenses related to Phase 1 activities for TSC-100 and TSC-101, personnel expense, and facility-related expenses.

General and administrative expenses for the second quarter ended June 30, 2022, were $4.8 million, compared to $2.7 million for the 2021 Quarter. The increase of $2.1 million in general and administrative expenses was primarily a result of an increase in personnel expenses related to public company staffing requirements, including stock-based compensation expense, as well as an increase in facilities costs, professional fees, and legal fees, also largely driven by public company costs.

For the second quarter ended June 30, 2022, TScan Therapeutics reported a net loss of $15.1 million, compared to a net loss of $10.7 million for the 2021 Quarter.

As of June 30, 2022, the Company had issued and outstanding shares of 24,072,968.

On August 10, 2022 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, reported its second quarter 2022 financial results and provided an operational and business update (Press release, Evaxion Biotech, AUG 10, 2022, View Source [SID1234618057]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Lars Wegner, CEO of Evaxion, said: "Evaxion announced multiple exciting milestones in the second quarter of 2022. We expanded our DNA oncology vaccine program into non-small cell lung cancer, identified gonorrhea as our second bacterial product target and successfully produced our personalized melanoma immunotherapies for our dedicated clinical trial of EVX-02 for resectable melanoma. We expect to begin the Phase 2b trial combining EVX-01 with Merck’s KEYTRUDA, for treatment of patients with metastatic melanoma, in the second half of 2022. We believe that these significant steps, including the progression of our clinical programs and the manufacture of clinical supplies, highlight the potential for our exciting pipeline of cancer therapies to improve the treatment landscape in melanoma and other cancers."

Dr. Wegner continued, "Evaxion’s goal is to develop our programs through Phase 2 before seeking to out-license them. We are actively discussing potential partnerships with multiple pharmaceutical and biotechnology companies. As of June 30, 2022, our cash reserves totaled $25.3 million. We expect these funds to support our product development efforts for the next 12 months."

Operational and Business Highlights in the Second Quarter of 2022

Selected EVX-03 as product candidate within our DNA technology platform to target new indication, NSCLC, due to encouraging data in the pre-clinical study
Announced successful production of all batches of personalized cancer immunotherapies for all patients enrolled in Phase 1/2a clinical trial for EVX-02 for resectable melanoma
Announced gonorrhea as second bacterial product target for treatment with our EVX-B2 vaccine product candidate
Hosted Key Opinion Leader webinar on metastatic melanoma and personalized cancer immunotherapies
Entered into equity financing arrangement for up to $40 million with Lincoln Park Capital Fund, LLC
Events after the Reporting Period

Announced executive leadership changes. Lars Wegner, M.D. to resign as Chief Executive Officer (CEO) and remain with the Company in advisory role to new CEO and Board of Directors. Per Norlén, M.D., PhD. to succeed Dr. Wegner as CEO within the next six months.
Expected Milestones in the Second Half of 2022

Initiation of Phase 2b first patient, first visit with EVX-01, in combination with Merck’s PD-1 inhibitor KEYTRUDA, for the treatment of metastatic melanoma (peptide-based, personalized cancer therapy)
Phase 1 regulatory filing for EVX-03 in patients with non-small cell lung cancer (targeted DNA-based personalized cancer therapy). Initiation of the study is contingent upon securing new capital to fund the costs of the clinical trial.
Phase 1 regulatory filing for EVX-B1 (S. aureus) in skin and soft tissue infections
Selection of first viral candidate from our RAVEN platform
Expected Milestones in First Half of 2023

Clinical readout of Phase 1/2a clinical study to evaluate EVX-02 in patients with resectable melanoma
Second Quarter 2022 Financial Results

Cash position: As of June 30, 2022, cash and cash equivalents were $25.3 million as compared to $32.2 million as of December 31, 2021. The decrease in cash and cash equivalents during the first six months of 2022 was primarily attributable to our operating expenses for the first six months of 2022, partially offset by the proceeds received from the first tranche of our loan from the European Investment Bank.
Research and Development expenses were $4.1 million for the three months ended June 30, 2022, compared to $5.1 million for the same period in 2021. The decrease was primarily due to lower external costs related to the clinical trials.
General and Administrative expenses were $2.1 million for the three months ended June 30, 2022 as compared to $1.9 million for the same period in 2021. The slight increase was primarily due to an increase in fees associated with the expansion of our business as a listed company.
Net loss was $4.8 million for the three months ended June 30, 2022, or ($0.20) loss per basic and diluted share as compared to $6.8 million, or ($0.36) loss per basic and diluted share for the three months ended June 30, 2021.
Guidance

We expect our existing cash and cash equivalents, including use of financing facilities, will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months.
Webcast and Conference Call

Evaxion will host a webcast and conference call today, August 10, at 8:30 a.m. EDT.

To dial-in for the conference call, please use the following details:

Alternatively to access the audio webcast, please visit the events page of Evaxion’s website at:
View Source

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On August 10, 2022 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported financial results and recent highlights for the second quarter ended June 30, 2022 (Press release, 2seventy bio, AUG 10, 2022, View Source [SID1234618056]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As 2seventy continues our first year as a new company, we remain on a solid growth trajectory with ongoing progress commercially with ABECMA and across our pipeline," said Nick Leschly, chief kairos officer. "We were extremely pleased to announce this morning that the prespecified interim analysis of our KarMMa-3 Phase 3 study of ABECMA met the primary endpoint of progression-free survival with a safety profile that was consistent with prior studies. We look forward to sharing these results with regulators with the goal of treating multiple myeloma patients in earlier lines. We will share additional data from the KarMMa-3 study, our plans for future investment in ABECMA, and pipeline and portfolio updates throughout 2H22 as we continue our mission to develop innovative, un-incremental treatments for people living with cancer."

ABECMA Commercial Summary and Business Update

Bristol Myers Squibb (BMS) reported total U.S. ABECMA (idecabtagene vicleucel; ide-cel) second quarter revenues of $72 million, representing 29% growth over the prior quarter. We continue to experience strong commercial demand and remain on track to achieve the upper end of our stated 2022 U.S. ABECMA revenue guidance of $250-300M. Given the continued strong demand and our growing belief in the potential for ABECMA to play an important role in earlier lines, we are continuing to advance our manufacturing strategy to expand capacity across the supply chain.

We reported share of collaboration loss of $4.3 million for the second quarter, which includes our share of gross profit/loss less costs associated with the commercialization of ABECMA in the U.S. In 2022, the collaboration experienced increased ABECMA manufacturing costs driven primarily by higher than anticipated vector costs. This has resulted in higher charges to 2seventy as part of our 50% share of U.S. costs with BMS. BMS is actively working with the vector manufacturer to lower costs and increase manufacturing capacity and 2seventy is supporting BMS in this work. Vector supply remains on track to meet our commercial plan for 2022 and we are continuing to invest in increasing manufacturing capacity in the future.

Given the increase in ABECMA costs that are shared by BMS with 2seventy, we are increasing our net cash spend guidance for 2022 to $245-265 million. All other spend for the rest of our business continues to track in line with previous guidance. We continue to forecast cash runway into 2025 based on current operating plans. This runway is sufficient to achieve important milestones across our business.

RECENT HIGHLIGHTS

KARMMA-3 STUDY DELIVERS AT INTERIM: MET PRIMARY ENDPOINT – 2seventy, in partnership with BMS announced this morning positive topline results from the KarMMa-3 Phase 3 Study of ABECMA in adults with relapsed and refractory multiple myeloma who have had two to four prior lines of therapy and are refractory to the last regimen. This makes ABECMA the first B-cell maturation antigen (BCMA)-directed CAR T cell therapy to demonstrate superiority versus standard regimens in a randomized controlled trial. The study met its primary endpoint of demonstrating a statistically significant improvement in progression-free survival. Treatment with ABECMA also showed an improvement in the key secondary endpoint of overall response rate compared to standard regimens. Follow-up for overall survival, a key secondary endpoint, remains ongoing. Safety results were consistent with the well-established and predictable profile demonstrated in the pivotal KarMMa trial. The companies expect to present additional data from this study at a medical meeting in the future and discuss these findings with health authorities.
ABECMA REAL-WORLD DATA AT ASCO (Free ASCO Whitepaper) – In June 2022, the largest data set to date for ABECMA patients treated in the commercial setting was presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting by the Multiple Myeloma Cell Therapy Consortium of academic institutions. The data presented were consistent with what was seen in the pivotal KarMMa study, reinforcing the efficacy and safety profile of ABECMA, even with 77% of the patients having comorbidities which would have rendered them too sick to participate in the KarMMa clinical trial.
ADDITIONAL ASCO (Free ASCO Whitepaper) PRESENTATIONS – Additional updates from 2seventy bio’s portfolio of oncology cell therapies were presented at the meeting, including a correlative analysis, in partnership with BMS, defining patient profiles associated with manufacturing and clinical success in patients treated with ide-cel, a trial in progress poster on CRC-403, a phase 1/2 study on bbT369 in patients with relapsed and/or refractory B-NHL, and a trial in progress poster on PLAT-08, a phase 1 study of SC-DARIC-33 in relapsed or refractory pediatric and young adult acute myeloid leukemia (AML), presented by Seattle Children’s Therapeutics.
UPCOMING ANTICIPATED MILESTONES

Anticipated $250-300 million total U.S. commercial revenue in 2022; profits and losses shared with BMS
Increasing manufacturing capacity expected over 2022 and in the future
KarMMa-2 study in high-risk multiple myeloma proof-of-concept data in 2022
SELECT SECOND QUARTER 2022 FINANCIAL RESULTS

BMS reported total U.S. revenues of $72 million for ABECMA for the three months ended June 30, 2022. 2seventy bio and BMS share equally in all profits and losses related to development, manufacturing and commercializing ABECMA in the U.S. We reported share of collaboration loss of $4.3 million and $9.6 million for the three months and six months ended June 30, 2022, which includes our share of gross profit/loss less costs associated with the commercialization of ABECMA in the U.S. The collaboration reported a loss this quarter due to continued investment in manufacturing scale-up and commercialization.
Total 2seventy revenues were $13.5 million for the three months ended June 30, 2022 compared to $7.3 million for the three months ended June 30, 2021. Total revenues were $21.9 million for the six months ended June 30, 2022 compared to $19.2 million for the six months ended June 30, 2021. The increase for the three- and six-month period was primarily driven by an increase in collaboration revenue during the second quarter of 2022, primarily attributable to an increase in collaboration-related activities with Regeneron.
Research and development expenses were $68.4 million for the three months ended June 30, 2022 compared to $63.7 million for the three months ended June 30, 2021. Research and development expenses were $137.7 million for the six months ended June 30, 2022, compared to $141.3 for the six months ended June 30, 2021. The increase for the three-month period was primarily driven by an increase in material production costs and IT and other facility-related costs. The decrease for the six-month period was primarily driven by decreased collaboration research funding costs, which is primarily driven by a decrease in our share of research and development costs under our collaboration with BMS.
Selling, general and administrative expenses were $17.3 million for the three months ended June 30, 2022, compared to $21.4 million for the three months ended June 30, 2021. Selling, general and administrative expenses were $41.1 million for the six months ended June 30, 2022, compared to $46.0 million for the six months ended June 30, 2021. The decrease for both the three- and six-month periods was primarily driven by decreased employee compensation expenses, reflective of efforts to streamline 2seventy’s operating model and a decrease in IT and other facility-related costs.
Net loss was $77.4 million for the three months ended June 30, 2022, compared to $84.0 million for the three months ended June 30, 2021. Net loss was $163.1 million for the six months ended June 30, 2022, compared to $171.2 million for the six months ended June 30, 2021.
2seventy bio ended the second quarter of 2022 with cash, cash equivalents and marketable securities of $398.6 million.
Conference Call Information

2seventy bio will host a conference call and live webcast today, August 10, at 8:00 a.m. ET to discuss 2Q 2022 financial results and recent business highlights. To access the conference call, please register at: https://register.vevent.com/register/BI3e6a40291152487788cdc808e17e6e59. Upon registering, each participant will be provided with call details and access codes. The live webcast may be accessed by visiting the event link at: View Source A replay of the webcast may be accessed from the News and Events page in the Investors and Media section of the company’s website at View Source A replay will be archived on 2seventy bio’s site for 30 days following the event.