ON November 14, 2023 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, reported financial results for the third quarter and nine months ended September 30, 2023 and provided an update on recent business events (Press release, CorMedix, NOV 14, 2023, View Source [SID1234637620]).

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Recent Corporate Highlights:

The FDA completed a preapproval inspection for CorMedix’s primary finished dosage CMO site in September and the Company is pleased with the outcome. In addition, the FDA has also conducted preapproval inspections for DefenCath at suppliers of active pharmaceutical ingredients, contract laboratories involved in testing of product specifications and packaging facilities, and CorMedix is not aware of any outstanding deficiencies or review issues at this time.
CorMedix has intensified preparations for commercial launch with a number of new hires in market access, sales training, pricing and contracting, commercial operations, field medical, and drug safety and pharmacovigilance.
In the event CorMedix receives final FDA approval over the coming days, the Company is targeting a commercial launch before the end of the first quarter of 2024.
The United States Patent and Trademark Office (USPTO) issued a patent with claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters. This Patent reflects the unique and proprietary nature of DefenCath, and will extend the Company’s intellectual property protection with an expiration date of April 15, 2042.
Cash and short-term investments, excluding restricted cash, at September 30, 2023 amounted to $86.6 million.
Joe Todisco, CorMedix CEO, commented, "I am very pleased with the Company’s progress on all fronts, most notably the outcomes of the preapproval inspections at our primary CMO facility and other key vendors, as well as our preparations toward commercial readiness. We have accelerated multiple work streams aimed at commercial launch, and made a number of key hires over the past quarter that are essential to ensuring a successful commercial launch following a potential FDA approval of DefenCath. We look forward to providing additional updates over the coming days as we anticipate a response from FDA on or around our target action date."

Third Quarter and Nine Month 2023 Financial Highlights

For the third quarter of 2023, CorMedix recorded a net loss of $9.7 million, or $0.17 per share, compared with a net loss of $6.9 million, or $0.17 per share, in the third quarter of 2022. The higher net loss recognized during the third quarter of 2023 compared with 2022 was attributable to net increase in operating expenses primarily due to increased pre-launch commercial activities for DefenCath.

Operating expenses in the third quarter of 2023 increased approximately 50% to $10.5 million, compared with $7.0 million in the third quarter of 2022. R&D expense increased approximately 14% to $2.7 million compared to $2.3 million in the third quarter of 2022, mainly due to a net increase in costs related to medical affairs activities and increase in personnel related expenses due to additional hires in 2023 as compared with 2022. SG&A expense increased approximately 69% to $7.8 million compared with $4.6 million in the third quarter of 2022. This increase was driven primarily by an increase in costs related to market research studies and pre-launch activities in preparation for the potential marketing approval of DefenCath and as a result of additional hires in 2023 as compared with 2022.

For the nine months ended September 30, 2023, CorMedix recorded a net loss of $31.6 million, or $0.65 per share, compared with a net loss of $21.5 million, or $0.54 per share, in the first nine months of 2022. The increase in net loss in the first nine months of 2023 was driven primarily by an increase in operating expenses.

Operating expenses in the first nine months of 2023 were $33.3 million compared with $22.3 million during the comparable period in 2022, an increase of approximately 49%. This increase was primarily attributable to costs related to market research studies and pre-launch activities in preparation for the potential marketing approval of DefenCath, and an increase in personnel expenses due to additional hires in 2023.

Total cash on hand and short-term investments as of September 30, 2023 was $86.6 million, excluding restricted cash of $0.2 million. The Company believes that, based on the Company’s cash resources at September 30, 2023, it has sufficient resources to fund operations at least twelve months from the filing of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2023.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, November 14, 2023, at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows:

Domestic: 1-888-886-7786
International: 1-416-764-8658
Conference ID: 16013968
Webcast: Webcast Link

On November 14, 2023 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the third quarter ended September 30, 2023, and announced that the Company is implementing a further reduction in its workforce of approximately 40% while maintaining the necessary support to continue exploring potential strategic transactions and business alternatives (Press release, Atreca, NOV 14, 2023, View Source [SID1234637619]).

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"Since our founding, Atreca has leveraged a unique discovery platform to identify numerous antibodies binding novel targets in oncology, as well as infectious and autoimmune disease," said John Orwin. "We remain focused on advancing APN-497444 through preclinical testing and continue to believe that our approach has potential to unlock meaningful tumor targets undiscoverable by conventional approaches. Nevertheless, given current financial market conditions and the funding needs required to advance ‘444 and our other antibody-drug conjugate programs into clinical development, we have made the difficult decision to further reduce our headcount as we explore strategic alternatives. I’d like to thank all employees impacted for their contributions."

Third Quarter 2023 Financial Results

As of September 30, 2023, cash and cash equivalents and investments totaled $21.4 million.
Research and development expenses for the three months ended September 30, 2023, were $10.4 million, including non-cash stock-based compensation expense of $1.0 million.
General and administrative expenses for the three months ended September 30, 2023, were $5.4 million, including non-cash stock-based compensation expense of $1.3 million.
Atreca reported a net loss of $36.2 million, or basic and diluted net loss per share attributable to common stockholders of $0.92, for the quarter ended September 30, 2023.

On November 14, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the publication of results from the Phase 1 study at Roswell Park Comprehensive Cancer Center in patients with metastatic triple-negative breast cancer using chemokine modulation therapy, including AIM ImmunoTech Inc.’s drug candidate Ampligen (also known as rintatolimod), interferon α-2b and celecoxib, followed by pembrolizumab (Press release, AIM ImmunoTech, NOV 14, 2023, View Source [SID1234637617]). The data were published in a manuscript titled, "Systemic Infusion of TLR3-Ligand and IFNα in Breast Cancer Patients Reprograms Local Tumor Microenvironment for Selective CTL Influx," in The Journal for ImmunoTherapy of Cancer.

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The pilot study evaluated the safety of systemic CKM composed of intravenous rintatolimod (Ampligen; selective TLR3 ligand), interferon α-2b and celecoxib, and the combination’s ability to promote local CTL influx to mTNBC lesions. Principal investigator and first author Shipra Gandhi, MD, of the Department of Medicine at Roswell Park, led the study under the scientific leadership of Pawel Kalinski, MD, PhD, senior author of the paper, Chair of Immunology and Senior Vice President for Team Science at Roswell Park. For more information about the study, please visit ClinicalTrials.gov: NCT03599453.

For more information, please visit Roswell Park’s website to read its press release titled "Novel Immunotherapy Approach at Roswell Park Shows Promise in Metastatic Triple-Negative Breast Cancer."

On November 14, 2023 Affimed N.V. (Nasdaq: AFMD) ("Affimed" or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported financial results and provided an update on clinical and corporate progress for the third quarter of 2023 (Press release, Affimed, NOV 14, 2023, View Source [SID1234637616]).

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"We initiated our phase 2 clinical study of acimtamig in combination with AlloNK and received encouraging feedback on the design of our LuminICE-203 trial from the FDA," said Dr. Adi Hoess, CEO of Affimed. "We also continued to make progress with AFM24 in combination with atezolizumab and advanced AFM28 in the dose escalation. This positions our company well to report further updates on all three clinical programs within the next few months."

Program Updates

Acimtamig (CD30/CD16A)

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Initiated LuminICE-203, a phase 2 clinical study to investigate acimtamig in combination with Artiva’s AlloNK natural killer (NK) cells in patients with relapsed / refractory (r/r) classical Hodgkin lymphoma (HL). The study will also include a cohort of 20 r/r PTCL patients. The Company expects to report initial efficacy and safety data from the LuminICE-203 study in the first half of 2024.

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Received encouraging feedback from FDA regarding questions for the Type C meeting: The FDA is highly engaged in supporting the progress and design of the study evaluating the combination of acimtamig and AlloNK as evidenced by the fast-track designation and Type C meeting feedback. According to written feedback for the Type C meeting, the LuminICE-203 study, designed based on the FDA’s recommendations and guidelines, could support accelerated approval, depending on the demonstrated magnitude of clinical benefit. In addition, the FDA agrees with Affimed’s approach to address the contribution of single components by adding a cohort to the study evaluating AlloNK/IL-2 only.

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AFM13-104 abstract selected for oral presentation at the ASH (Free ASH Whitepaper) 2023 Annual Meeting. The oral presentation by Dr. Yago Nieto, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson at the ASH (Free ASH Whitepaper) 2023 Annual Meeting will include data on a total of 42 r/r CD30-positive Hodgkin lymphoma (HL) and Non-Hodgkin lymphoma (NHL) patients enrolled in the study with 36 patients treated at the recommended phase 2 dose (RP2D). All patients were heavily pretreated and refractory to their most recent line of therapy with active progressive disease at the time of enrollment. The acimtamig precomplexed NK cells treatment followed by three weekly infusions of acimtamig achieved an overall response rate (ORR) of 94.4% with a complete response rate of 72.2% at RP2D. Acimtamig in combination with NK cells continues to demonstrate a good safety and tolerability profile with no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or graft versus host disease (GVHD) of any grade. An in-depth analysis including updated EFS/OS data will be presented during Dr. Nieto’s oral presentation.

AFM24 (EGFR/CD16A)

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On track to report data in December 2023 from the first three expansion cohorts of AFM24-102, a Phase 1/2a combination study of AFM24 in patients with advanced EGFR-expressing solid tumors. Expansion cohorts of the study enrolled patients with (1) EGFR-wildtype non-small cell lung cancer (NSCLC) (2) gastric /gastroesophageal junction adenocarcinoma and (3) a basket cohort evaluating pancreatic, hepatocellular, and biliary tract cancer. Based on the results from the AFM24 monotherapy study, a fourth expansion cohort of patients with EGFR-mutant NSCLC has been added to the AFM24-102 study and is enrolling and treating patients. Data from this cohort is expected in the first half of 2024.

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AFM24 combination with NK cells. The Company is continuing to investigate the possibility of a combination of AFM24 with an allogeneic, off-the-shelf NK cell product.

AFM28 (CD123/CD16A)

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AFM28 is investigated in a multi-center Phase 1 open-label, dose-escalation study (AFM28-101), in r/r AML. Dose level three was completed with no dose-limiting toxicities; completed enrollment in the fourth dose cohort.

Clinical development of AFM28 is planned as both single-agent and in combination with an allogeneic off-the-shelf NK cell product.

Partnerships and Collaborations

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Affimed has completed its work on novel molecules for both Genentech and Roivant. Further development of these product candidates is at the discretion of the respective companies.

Planned Upcoming Milestones:

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Follow-up data from AFM13-104 to be presented at the ASH (Free ASH Whitepaper) Annual Meeting in December 2023.

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Initial data readout from the LuminICE-203 study planned in H1 2024.

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Data release from the first three expansion cohorts of the Phase 1/2a study AFM24+atezolizumab combination study planned in December 2023.

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Data from the EGFR-mutant NSCLC cohort planned in H1 2024.

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Further progress updates from AFM28-101 dose escalation planned in H1 2024.

Third Quarter 2023 Financial Highlights

Affimed’s consolidated financial statements are prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standard Board (IASB). The consolidated financial statements are presented in Euros (€), the Company’s functional and presentation currency.

As of September 30, 2023 cash, cash equivalents and financial assets totaled €97.5 million compared to €190.3 million on December 31, 2022. Based on our current operating plan and assumptions, we anticipate that our cash and cash equivalents will support operations into 2025.

Net cash used in operating activities for the quarter ended September 30, 2023 was €18.2 million compared to €19.0 million for the quarter ended September 30, 2022.

Total revenue for the quarter ended September 30, 2023, was €2.0 million compared with €14.9 million for the quarter ended September 30, 2022. Revenue in 2022 and 2023 predominantly relates to the Roivant and Genentech collaborations, for which we have completed the work assigned to us under the respective collaboration agreements.

Research and development expenses for the quarter ended September 30, decreased by 17.7% from €26.1 million in 2022 to €21.5 million in 2023. The decrease is primarily due to the completion of our work under the Roivant and Genentech collaborations, together with a decline in head count and related costs after the reorganization, also resulting in a decline in the share-based payment expense which is further impacted by the decline in the underlying fair value of share options. The decline in research and development expenses have, however, been partially offset by the increase in higher expenses associated with the development of AFM13.

General and administrative expenses decreased 33.5% from €8.1 million in the quarter ended September 30, 2022 to €5.4 million in the quarter ended September 30, 2023. The decrease was due to a decline in legal, consulting and insurance expenses, as well as share-based payment expenses.

Net finance income/costs for the quarter ended September 30, 2023 decreased from income of €2.7 million in the quarter ended September 30, 2022, to income of €0.6 million in the quarter ended September 30, 2023. Finance income/costs in the three months ended September 30, 2023 primarily consisted of the interest expense incurred on the Bootstrap (formerly Silicon Valley Bank) loan, set-off by the interest earned on the financial assets, term deposits and cash balances. 2022 primarily consisted of foreign exchange gains/losses related to cash and cash equivalents denominated in U.S. dollars as a result of the change in the value of the U.S. dollar compared to the Euro.

Net loss for the quarter ended September 30, 2023, was €24.4 million, or €0.16 loss per common share compared with a net loss of €16.5 million, or €0.11 loss per common share, for the quarter ended September 30, 2022.

The weighted number of common shares outstanding for the for quarter ended September 30, 2023 was 149.3 million.

Additional information regarding these results will be included in the notes to the consolidated interim financial statements as of September 30, 2023, included in Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)

Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB. None of the financial statements were prepared in accordance with U.S. Generally Accepted Accounting Principles. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information

Affimed will host a conference call and webcast on November 14, 2023, at 8:30 a.m. EST / 14:30 CET to discuss third quarter 2023 financial results and corporate developments.

The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source To access the call by phone, please use link: https://register.vevent.com/register/BId6f0cfc054b84432a7272424edf98afd, and you will be provided with dial-in details and a pin number.

Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call.

On November 14, 2023 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported financial results and recent highlights for the third quarter ended September 30, 2023 (Press release, 2seventy bio, NOV 14, 2023, View Sourcenews-releases/news-release-details/2seventy-bio-reports-third-quarter-financial-results-and-1" target="_blank" title="View Sourcenews-releases/news-release-details/2seventy-bio-reports-third-quarter-financial-results-and-1" rel="nofollow">View Source [SID1234637615]).

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"This quarter, 2seventy completed a significant reshaping of our organization, enabling us to advance our pipeline in an efficient and more cost-effective manner. We are also supporting BMS’ efforts to return Abecma to growth through a variety of commercial and medical affairs initiatives, including adding more treatment sites and boots on the ground," said Nick Leschly, chief kairos officer. "Collectively, we believe these measures will give us the ability to continue our mission of delivering time to patients, operate within a more disciplined cost structure and deliver value for our shareholders."

SELECT COMMERCIAL AND FINANCIAL HIGHLIGHTS

Third quarter Abecma U.S. revenues, as reported by Bristol Myers Squibb (BMS), were $69 million. The decline in third quarter sales was due to increased competition from other BCMA-targeted therapies in addition to the planned manufacturing maintenance in June. The Company anticipates that competitive dynamics will continue to impact Abecma sales in the fourth quarter. Based on year-to-date results and current expectations for the fourth quarter, 2seventy bio does not expect to achieve the original revenue guidance of $470-570 million for 2023.
In order to restore growth in Abecma, BMS and 2seventy bio are focused on rapidly expanding the treating site footprint, competitively differentiating Abecma’s real-world data and safety profile, and educating on treatment sequencing and the emerging data supporting the use of Abecma before T cell engagers and antibody drug conjugates, including those targeting BCMA.
2seventy bio and BMS share equally in all profits and losses related to development, manufacturing, and commercialization of Abecma in the United States. 2seventy bio reported collaborative arrangement revenue of $0.5 million and $48.0 million for the three months and nine months ended September 30, 2023, respectively.
In September, the Company announced a restructuring of its business operations and research and development model to significantly reduce costs while supporting the execution of a prioritized plan for the long-term growth of the Company. This restructuring is expected to achieve $130+ million savings in 2024-2025 period.
The Company anticipates staying within the previously-guided net cash spend range of $180-220 million for 2023.
2seventy bio ended the third quarter of 2023 with cash, cash equivalents and marketable securities of $284.3 million. While the Company has sufficient cash to fund current planned operations for at least 12 months, we are no longer providing specific cash runway guidance.
"While Abecma performance was impacted due to the evolving competitive landscape, we and our partners at BMS believe in the long-term potential of Abecma to meaningfully impact the lives of multiple myeloma patients. We support BMS’ efforts to improve the commercial performance for the product," said Chip Baird, chief operating officer. "As we gain more visibility to the commercial trajectory for Abecma, we will continue to carefully manage our cash to preserve our financial runway."

SELECTED ABECMA DATA TO BE PRESENTED AT ASH (Free ASH Whitepaper)

Oral Presentation: Idecabtagene Vicleucel (ide-cel) Versus Standard Regimens in Patients (pts) with Triple-Class Exposed (TCE) Relapsed and Refractory Multiple Myeloma (RRMM): Updated Analysis from KarMMa-3
Presenter: Paula Rodriguez-Otero
Date & Time: Monday, December 11, 4:45pm PT

In the final progression-free survival (PFS) analysis from the Phase 3 KarMMa-3 study in patients with RRMM who received 2-4 prior regimens, significantly longer PFS was maintained with ide-cel versus standard regimens. In pts who received ide-cel (n = 225) or a standard regimen (n = 126), median PFS (95% CI) was 15.7 (12.5–18.9) vs 4.4 (3.4–5.8) months, respectively. The ide-cel safety profile was consistent with previous reports, with no parkinsonism or Guillain–Barré syndrome reported. Ide-cel continued to demonstrate durable, clinically meaningful improvements in pt-reported outcomes, including symptoms, functioning, and quality of life (QOL) vs standard regimens. Interim overall survival (OS) will be included in the presentation.

Poster Presentation: Efficacy and Safety of Idecabtagene Vicleucel (ide-cel) in Patients with Clinical High-Risk Newly Diagnosed Multiple Myeloma (MM) with an Inadequate Response to Frontline Autologous Stem Cell Transplantation (ASCT): KarMMa-2 Cohort 2c Extended Follow-up
Presenters: Madhav Dhodapkar; Melissa Alsina
Date & Time: Saturday, December 9, 5:30 – 7:30pm PT

In updated data from the KarMMa-2 cohort 2c study, ide-cel continued to demonstrate deep, durable responses in patients with an inadequate response to frontline ASCT. No new safety signals were observed with extended follow-up, and no deaths were reported. No patients who received lenalidomide maintenance post ide-cel experienced disease progression.

"The updated clinical data to be presented on Abecma reinforces the potential of this therapy to play an important role in earlier lines," said Steve Bernstein, chief medical officer. "In the extended follow-up from the KarMMa-3 study, we saw responses from some patients continue to deepen. The additional data from the KarMMa-2, cohort 2c study is supportive of our registrational KarMMa-9 study in a similar patient population which is now open and enrolling. We look forward to presenting these data at ASH (Free ASH Whitepaper) along with additional sub-analyses that reinforce the impact of Abecma on patient-reported outcomes, quality of life and clinical use."

RECENT UPDATES

MUC16 DATA PRESENTED AT SITC (Free SITC Whitepaper) – In November, 2seventy bio presented new pre-clinical data on its MUC16-targeted CAR T-cell therapy in ovarian cancer, being developed as part of our expanded collaboration with Regeneron, in a poster presentation at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). These preclinical data support the IND submission for MUC16, which is on track for end of year. The Company recently completed 270-MPH, an in-house clinical drug product manufacturing site, to more effectively support growing U.S. clinical needs. MUC16 will be the first program to be manufactured in this facility.
EXPANSION OF PARTNERSHIP WITH JW THERAPEUTICS – In September, 2seventy bio and JW Therapeutics announced their intention to expand their strategic alliance. The expansion, based on the partnership that was established last year, builds upon the companies’ translational and clinical cell therapy development platform originally designed to more rapidly explore T cell-based immunotherapy therapy products in Greater China. Specifically, the companies intend to add up to two additional candidates from the 2seventy bio portfolio, one in solid tumor indications using T-cell receptor (TCR) based technology and a second in autoimmune disease using a CAR T cell approach.
UPCOMING ANTICIPATED PIPELINE MILESTONES

Submission of an Investigational New Drug (IND) application for MUC16 program in ovarian cancer, being developed in partnership with Regeneron, anticipated by end of 2023.
Led by JW Therapeutics, initiation of an investigator-initiated study in China of 2seventy bio’s potency enhanced MAGE-A4 T cell receptor (TCR) program in solid tumors anticipated by end of 2023.
SELECT THIRD QUARTER FINANCIAL RESULTS

Total 2seventy bio revenues were $12.0 million for the three months ended September 30, 2023, compared to $13.4 million for the three months ended September 30, 2022. Total revenues were $89.7 million for the nine months ended September 30, 2023, compared to $35.3 million for the nine months ended September 30, 2022.
Research and development expenses were $51.3 million for the three months ended September 30, 2023, compared to $58.2 million for the three months ended September 30, 2022. Research and development expenses were $179.5 million for the nine months ended September 30, 2023, compared to $188.6 million for the nine months ended September 30, 2022.
Selling, general and administrative expenses were $13.0 million for the three months ended September 30, 2023, compared to $19.6 million for the three months ended September 30, 2022. Selling, general and administrative expenses were $53.2 million for the nine months ended September 30, 2023, compared to $60.7 million for the nine months ended September 30, 2022.
Net loss was $71.6 million for the three months ended September 30, 2023, compared to $67.9 million for the three months ended September 30, 2022. Net loss was $160.7 million for the nine months ended September 30, 2023, compared to $231.0 million for the nine months ended September 30, 2022.

Conference Call Information

2seventy bio will host a conference call and live webcast today, November 14, at 8:00 a.m. ET to discuss 3Q 2023 financial results and recent business highlights. To join the live conference call, please register at: https://register.vevent.com/register/BI2148ebda1eeb4055a857a3dbe4e61710. 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 and will be available for 30 days following the event.