On November 14, 2023 NKGen Biotech Inc. (Nasdaq: NKGN) (NKGen or the Company), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer (NK) cell therapeutics, reported its financial results for the third quarter ended September 30, 2023, and provided business highlights (Press release, NKMax America, NOV 14, 2023, View Source [SID1234637633]).

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"We had a very exciting quarter as a newly Nasdaq-listed company," said Paul Y. Song, M.D., CEO of NKGen. "We recognize the volatility in the market, but we believe in our NK cell therapy approach to address some of society’s biggest healthcare challenges. Our approach continues to show promise, including by our recent IND approval and the continued progress observed in our autologous SNK01 program with the completion of, and positive data readouts from, our Phase I clinical study in Alzheimer’s disease."

"We are highly focused on raising additional capital to fund our trials and operations and advance our differentiated NK cell therapy programs," continued Dr. Song. "We remain on track with our near-term milestones, including commencing our Phase I/IIa clinical trial for Alzheimer’s Disease by year end, an IND filing for our SNK01 program for Parkinson’s Disease, and a preliminary data readout of our SNK02 allogeneic Phase I study in solid tumors, the first and only product candidate that does not require lymphodepletion, the latter two which are anticipated in the first quarter of 2024."

Third Quarter 2023 Key Business Highlights

The Company closed its previously announced business combination with Graf Acquisition Corp. IV (Graf), pursuant to which NKGen became a wholly-owned subsidiary of Graf, and changed its name to NKGen Operating Biotech, Inc.
Presented Phase I clinical trial data at the 16th Annual Clinical Trials on Alzheimer’s Disease (CTAD) Conference.
90% of patients demonstrated improvement or maintained stable cognitive function as per Alzheimer’s disease composite score (ADCOMS) following 11 weeks.
SNK01 given intravenously (IV) appears to cross the blood-brain barrier to reduce Cerebrospinal Fluid (CSF) Aβ42/40 and pTau181 levels and neuroinflammation, as measured by Glial Fibrillary Acidic Protein (GFAP); this effect appears to be persistent at Week 22.
No treatment related adverse events were observed.
Poster can be viewed here: PowerPoint Presentation (www.nkgenbiotech.com).
FDA clearance of IND for SNK01 NK cell therapy to treat moderate Alzheimer’s Disease.
First patient dosed in Phase I clinical trial of SNK02, allogeneic NK cell therapy product candidate, for the treatment of solid tumors.
Presentations at the NKGen Investor Event on July 20, 2023 and the Cantor Fitzerald Healthcare Conference on September 27, 2023 presented topics on NKGen’s differentiated intellectual property and approach to NK cell therapy for Alzheimer’s and Parkinson’s diseases, NKGen’s Phase I clinical trial data of SNK01 to treat patients with Alzheimer’s disease, and preclinical compassionate use case studies.
Third Quarter 2023 Financial Results

Cash position: As of September 30, 2023, the Company had total cash of $8.8 million, after partial payment of transaction expenses.

Research and development (R&D) expenses: R&D expenses for the third quarter of 2023 were $3.9 million compared to $4.1 million in the same period in 2022. The decrease was primarily due to decreased clinical trial subject recruitment costs.

General and administrative (G&A) expenses: G&A expenses for the third quarter of 2023 were $3.0 million compared to $1.9 million in the same period in 2022. The increase was primarily due to stock option grants made during the first quarter of 2023.

Net loss: For the third quarter of 2023, the Company reported a net loss of $33.2 million, compared to a net loss of $6.7 million in the same period in 2022. The increase was primarily due to loss from issuance of the forward purchase agreements entered into in connection with the closing of the business combination as well as the recognition of transaction costs related to the business combination that were allocated to liability-classified instruments issued.

Debt: As of September 30, 2023, the Company had total debt liabilities of $20.2 million, comprised of $4.9 million in bank debt, $5.3 million in related party loans, and $10.0 million in form of a senior convertible note held by NKMAX Co., Ltd.

Business Combination: In connection with the business combination with Graf, the Company received approximately $21.9 million in gross proceeds, comprising approximately $1.7 million from the Graf trust account and approximately $20.2 million from the transactions in relation to the issuance of warrants and senior convertible notes. In addition, in accordance with the forward purchase agreements, $32.9 million in funds were deposited into escrow accounts, which were not received by the Company in connection with the closing of the business combination. The escrowed funds may be released to the Company, the investors, or a combination of both. In addition, the Company’s legacy convertible notes converted into shares of common stock of the Company. Furthermore, in connection with the business combination, approximately $14.3 million in transaction costs and deferred underwriting fees were settled at or prior to the closing of the business combination, and approximately $7.3 million remained unpaid as of September 30, 2023.

On November 14, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its revenues and cash position for the first nine months of 2023 (Press release, Innate Pharma, NOV 14, 2023, View Source [SID1234637630]).

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"With our strong cash position, we continue to execute against our strategy to develop innovative proprietary and partnered assets with key players. We look forward to this year’s ASH (Free ASH Whitepaper) Annual Meeting where we will present the final results of the lacutamab TELLOMAK Phase 2 study in patients with Sézary syndrome. We are also very pleased that at the same meeting, our partner Sanofi will share updated data from the Phase 1/2 study using SAR443579 / IPH6101 in patients with hematologic malignancies, a product using Innate’s innovative ANKET NK cell engager platform," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "As monalizumab continues to progress in Phase 2 and 3 lung cancer trials with AstraZeneca, we look forward to sharing further updates on our proprietary portfolio as we progress our lead proprietary ANKET NK cell engager, IPH6501 and our Nectin-4 targeted ADC, IPH45 towards the clinic."

Webcast and conference call will be held today at 2:00pm CET (8:00am ET)

The live webcast will be available at the following link:

View Source

Webcast participants can use the chat tool to ask written questions during the conference.

Participants may also join via telephone to ask oral questions during the conference using the following registration link: View Source

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.

Pipeline highlights:

Lacutamab (anti-KIR3DL2 antibody):

TELLOMAK, the ongoing Phase 2 trial of lacutamab in cutaneous T-cell lymphoma (CTCL), completed enrollment in Q2 2023 (n=170 patients). Final data in Sézary syndrome will be presented in an oral presentation at the ASH (Free ASH Whitepaper) (American Society of Hematology) Annual Meeting 2023. The Company plans to share the results with the regulatory authorities. The Company still expects final data from the mycosis fungoides (MF) cohort in H2 2023.
The Company announced that it will report positive final data from the Phase 2 TELLOMAK study in Sézary syndrome at the ASH (Free ASH Whitepaper) 2023 Annual Congress on 9 December. The ASH (Free ASH Whitepaper) abstract states that the data demonstrate that lacutamab showed promising clinical activity and an overall favorable safety profile. In the heavily pre-treated post-mogamulizumab patient population with an average of six prior lines of therapy, in the Intention to treat population (ITT), the global confirmed objective response rate (ORR) was 37.5% (21/56). Confirmed ORR in the skin was 46.4% (26/56) and confirmed ORR in the blood was 48.2% (27/56). Median progression-free survival was 8.0 months (95% CI 4.7-21.2). Additional data will be presented at the ASH (Free ASH Whitepaper) 2023 Annual Congress.
Two parallel clinical trials to study lacutamab in patients with KIR3DL2-expressing, relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL) are ongoing. The Phase 1b trial is a Company-sponsored clinical trial to evaluate lacutamab as a monotherapy in patients with KIR3DL2-expressing relapsed PTCL. The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial is an investigator-sponsored, randomized trial by The Lymphoma Study Association (LYSA) to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL.
Initial data from the Phase 1b trial will be presented in a poster session at the ASH (Free ASH Whitepaper) Annual Meeting 2023. The ASH (Free ASH Whitepaper) 2023 abstract states that preliminary Phase 1b data in patients with R/R PTCL confirm the acceptable safety profile of lacutamab monotherapy.
The Phase 2 KILT study is ongoing.
In October 2023, the US Food and Drug Administration (FDA) placed a partial clinical hold on the lacutamab IND leading to a pause in new patient enrollment to the Company’s ongoing lacutamab trials IPH4102-201 (Phase 2 TELLOMAK) and 102 (Phase 1b PTCL). The partial clinical hold follows one fatal case of hemophagocytic lymphohistiocytosis (HLH), a rare hematologic disorder. Patients already on study treatment who are deriving clinical benefit may continue treatment after being reconsented. The Company is currently undertaking efforts to address the US FDA requests, which include incorporation of risk mitigation and management strategies for hemophagocytic lymphohistiocytosis in ongoing lacutamab studies.
ANKET (Antibody-based NK cell Engager Therapeutics):

ANKET is Innate’s proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer. Innate’s pipeline includes four public drug candidates born from the ANKET platform: SAR443579/IPH6101 (CD123-targeted), SAR’514/IPH6401 (BCMA-targeted), IPH62 (B7-H3-targeted) and tetra-specific IPH6501 (CD20-targeted). Several other undisclosed proprietary preclinical targets are being explored.

SAR443579/IPH6101, SAR’514/IPH6401 and IPH62 (partnered with Sanofi)

SAR443579/IPH6101

The Phase 1/2 clinical trial by Sanofi is progressing well, evaluating SAR443579 / IPH6101, a trifunctional anti-CD123 NKp46×CD16 NK cell engager and ANKET platform lead asset, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS).
At ASH (Free ASH Whitepaper) 2023, a presentation from the Sanofi oncology pipeline will report updated efficacy and safety results and show data across all dose levels tested, including observed clinical remissions. Abstract details include:
As of July 5, 2023, 43 patients (42 R/R AML and 1 HR-MDS) across 8 Dose Levels (DLs) at 10 – 6000 μg/kg/dose were included. Patients had received a median of 2.0 (1.0 – 10.0) prior lines of treatment with 13 patients (30.2%) reporting prior hematopoiectic stem cell transplantation and 36 patients (83.7%) with prior exposure to venetoclax. In DLs with a highest dose of 1000 μg/kg QW, 5/15 AML (33.3%) patients achieved a CR (4 CR / 1 CRi) as of the cut-off date. Data from PK/PD and in vitro mechanistic analyses studying dose-response relations will also be presented. SAR443579 was well tolerated up to doses of 6000 μg/kg QW with observed clinical benefit in patients with R/R AML. The results are consistent with the predicted favorable safety profile.
Preliminary Pharmacokinetics (PK) and Pharmacodynamic (PD) Analysis of the CD123 NK Cell Engager SAR’579/IPH6101 in patients with relapsed or refractory AML, B-ALL or HR-MDS were presented during the ESMO (Free ESMO Whitepaper) (European Society for Medical Oncology) Congress 2023. As of the data cut-off on August 7, 2023, two responders remained in remission after 8.8 and 12.2 months of treatment.
SAR’514/IPH6401

The Phase 1/2 clinical trial with SAR’514 / IPH6401, a trifunctional anti-BCMA Nkp46xCD16 NK cell engager, led by Sanofi, in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA) is ongoing.
IPH62

As announced on December 19, 2022, Sanofi licensed IPH62, a NK cell engager program targeting B7-H3 from Innate’s ANKET platform, and the company has the option to add up to two additional ANKET targets. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization. Under the terms of the agreement, Innate received a €25m upfront payment and is eligible for up to €1.35bn total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales.
IPH6501 (proprietary)

Following approval of the IND-filing by the FDA in July 2023, IPH6501, Innate’s proprietary CD20 targeted tetra-specific ANKET continues toward a Phase 1 clinical trial in 2023.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

Innate continues to see progress for monalizumab in the early non-small cell lung cancer (NSCLC) setting, with the ongoing Phase 3 PACIFIC-9 trial run by AstraZeneca. The trial is evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III NSCLC who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT).
IPH5201 (anti-CD39), partnered with AstraZeneca:

The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, is ongoing and recruitment is on track.
IPH5301 (anti-CD73):

The investigator-sponsored CHANCES Phase 1 trial of IPH5301 by Institut Paoli-Calmettes is ongoing.
Antibody Drug Conjugates:

Fueling its R&D engine, the Company continues to develop different approaches for the treatment of cancer utilizing its antibody engineering capabilities to deliver novel assets, with its innovative ANKET platform and continuing to explore Antibody Drug Conjugates (ADC) formats. Beyond its proprietary programs, the Company has an ongoing agreement with Takeda on ADCs.

IPH45 (Nectin-4 ADC):

IPH45 is Innate’s proprietary Nectin-4 targeting antibody drug conjugate including a Topoisomerase I inhibitor payload. IPH45 continues toward a Phase 1 clinical trial.
Corporate update

Dr. Sonia Quaratino, MD, PhD, has been appointed as Executive Vice President and Chief Medical Officer of Innate Pharma, effective October 2023. Dr. Quaratino brings over 25 years of experience in basic research, clinical development, and translational medicine, having worked in academia, global large pharmaceuticals, and biotechs. Recently, Dr. Quaratino was Chief Medical Officer at Georgiamune INC.(USA) and prior to that she was Chief Medical Officer at Kymab (UK), a clinical-stage biopharmaceutical company with a focus on immune-mediated diseases and immuno-oncology, acquired by Sanofi in 2021. Previously, she held roles at Novartis (Switzerland) and Merck Serono (Germany) and was Professor of Immunology in UK at the University of Southampton. Her research has been published in high impact scientific journals.
On April 26, 2023, Innate announced the establishment of an At-The-Market (ATM) program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million American Depositary Shares ("ADS"). Each ADS representing one ordinary share of Innate. As of September 30, 2023, the balance available under our April 2023 sales agreement remains at $75 million.
Financial Results:

Cash, cash equivalents and financial assets of the Company amounted to €121.9 million as of September 30, 2023. At the same date, financial liabilities amounted to €40.3 million.

Revenues for the first nine months of 2023 amounted to €36.5 million (€44.3 million for the same period in 2022). For the nine-month period, ended September 30, 2023, revenue from collaboration and licensing agreements mainly results from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca, Sanofi and Takeda.

On November 14, 2023 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease ("PD"), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported financial results for the third quarter ended September 30, 2023 and highlighted recent developments (Press release, Inhibikase Therapeutics, NOV 14, 2023, View Source [SID1234637629]).

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"We are very pleased with the progress of the last quarter," noted Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. "Our efforts to improve drug delivery for protein kinase inhibitors brought IkT-001Pro to pre-NDA stage just 15 months after opening of the IND. Our neurodegenerative disease programs with risvodetinib are expanding, with 20% of the Phase 2 201 Trial in untreated Parkinson’s disease enrolled coupled with our efforts to initiate a Phase 2 program in Multiple System Atrophy. Finally, our internal and external medicinal chemistry programs are yielding important insights into the design of next generation Abl kinase inhibitors that could lead to a pipeline of beneficial products for Abl kinase-related diseases. Collectively, this has been a very productive period for the Company."

Recent Developments and Upcoming Milestones:

Advancing Phase 2 ‘201’ Trial of Risvodetinib (IkT-148009) in untreated Parkinson’s disease: As of November 10, 2023, 28 sites are open and actively evaluating prospective trial participants. Twenty-four participants have been enrolled, 7 prospective participants are in screening and 15 potential participants are going through informed consents.

The 201 Trial patient portal (www.the201trial.com) has been visited by more than 20,000 unique people since launch in September, 2023. The pre-qualification process has led to 201 unique individuals to contact open clinical sites, the first step in the evaluation process that could lead to enrollment. Monthly site enrollments have increased month-over-month since this patient outreach program was initiated.
Unblinded functional analysis from the 201 Trial are encouraging: In August 2023, unblinded functional assessments of 11 patients with untreated Parkinson’s disease were presented at the Movement Disorder Congress in Copenhagen, Denmark. These participants were withdrawn from the trial following the FDA’s temporary clinical hold in November, 2022, which was lifted January, 2023. These assessments showed that patients receiving the 200 mg dose of risvodetinib (N=3) saw a greater than 10 point improvement over placebo in the sum of motor and non-motor scores after once daily treatment for up to 11 weeks; by contrast, a typical patient with Parkinson’s disease would worsen by 3 to 6 points in the sum of motor and non-motor score assessments over a 12 month period. While the number of treated participants is too small for the Company to conclude a clinical benefit, these early data are cautiously encouraging.
Received Orphan Drug Designation in Multiple System Atrophy (MSA): In October 2023, risvodetinib was granted Orphan Drug Designation by the FDA for the treatment of MSA. In animal model studies of MSA, risvodetinib was shown to be therapeutically active. The designation by the FDA underscores the need for innovative treatment options for patients afflicted with this rare and rapidly progressing Parkinson’s-related disorder. The Company is pursuing a comparable designation in the European Union, or E.U., as part of its efforts to initiate a Phase 2 clinical trial to evaluate risvodetinib in MSA. The Company is discussing conduct of the trial with private foundations, Federal and industry stakeholders in an effort to initiate this trial in the future.
Completed the ‘501’ bioequivalence studies with IkT-001Pro: In October 2023, Inhibikase completed its bioequivalence studies of IkT-001Pro, measuring the bioequivalent dose to both 400 mg and 600 mg imatinib mesylate. The study enrolled a total of 66 healthy volunteers in three parts. In single dose studies, bioequivalent IkT-001Pro induced fewer neurological, musculoskeletal and gastrointestinal adverse events relative to 400 mg imatinib mesylate. Gastrointestinal adverse events were more persistent for imatinib mesylate in the study evaluating bioequivalence to 600 mg imatinib mesylate. Measures of bioequivalence along with safety and tolerability data are being submitted as briefing materials for a pre-NDA meeting with the FDA to reach agreement on the requirements for approval of IkT-001Pro under the 505(b)(2) statute.
Initiated preclinical development of second-generation c-Abl inhibitors: In August 2023, Inhibikase initiated preclinical development of new molecules arising from internal medicinal chemistry and external collaborations identifying second generation molecules that could enhance suppression of neurodegeneration or address other diseases that could benefit from Abl kinase inhibition.
Third Quarter Financial Results

Net Loss: Net loss for the three months ended September 30, 2023 was $4.60 million, or $0.86 per share, compared to a net loss of $4.49 million, or $1.06 per share in the quarter ended September 30, 2022.

R&D Expenses: Research and development expenses were $3.23 million for the quarter ended September 30, 2023 compared to $2.98 million in the quarter ended September 30 2022. The increase was primarily due to the Company’s ongoing Phase 2 ‘201’ PD clinical trial costs.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended September 30, 2023 were $1.62 million compared to $1.54 million for the quarter ended September 30, 2022. The increase was driven by net increase in normal selling, general and administrative expenses.

Cash Position: Cash, cash equivalents and marketable securities were $16.83 million as of September 30, 2023. The Company expects that existing cash and cash equivalents will be sufficient to fund operations into the fourth quarter of 2024.

Conference Call Information
The conference call can be accessed by dialing 1-833-816-1414 (United States) or 1-412-317-0506 (International) with the conference code 0866324. A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

On November 14, 2023 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immuno-oncology therapies and next-generation vaccines, reported financial results for the three and nine months ended September 30, 2023 (Press release, IMUNON, NOV 14, 2023, View Source [SID1234637628]). The Company also provided an update on its clinical development programs with IMNN-001 (formerly GEN-1), a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of first-line locally advanced ovarian cancer; on its PlaCCine modality, a proprietary mono- or multi-cistronic non-viral and synthetic DNA technology for the expression of pathogen antigens in preclinical studies for the development of next-generation vaccines; and on the early developments with its new FixPlas modality for cancer vaccines.

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Highlights of the third quarter of 2023 and recent weeks include:

Reported promising interim progression-free survival (PFS) and overall survival (OS) data with IMNN-001 in the Phase 1/2 OVATION 2 Study in advanced ovarian cancer. Interim data from the intent-to-treat (ITT) population showed efficacy trends in PFS, demonstrating a delay in disease progression in the treatment arm of approximately 33% compared with the control arm and preliminary OS data following a similar trend, showing an approximate nine-month improvement in the treatment arm over the control arm
Enrolled the first patient in a Phase 1/2 clinical trial evaluating IMNN-001 in combination with bevacizumab in advanced ovarian cancer at the University of Texas MD Anderson Cancer Center
Continued on track to submit an Investigational New Drug (IND) application in the first quarter of 2024 for a Phase 1/2 trial with IMNN-101, a seasonal COVID-19 booster vaccine, following positive pre-IND feedback from the U.S. Food and Drug Administration (FDA)
Presented updated promising data on IMNN-101 at the 3rd Annual World Vaccines Congress
Entered into a Cooperative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the immunogenicity and efficacy of PlaCCine DNA vaccine constructs against Lassa virus in guinea pig and non-human primate disease models
Held a virtual R&D Day with presentations by management and key opinion leaders (KOLs) on cancer and infectious disease vaccines
Reported cash and cash equivalents of $19.5 million as of September 30, 2023
"The third quarter and recent weeks have been marked by excellent progress across all our platform modalities," said Dr. Corinne Le Goff, IMUNON’s president and chief executive officer. "We reported interim data from our Phase 1/2 OVATION 2 Study that showed patients treated with a PARP inhibitor (PARPi) as maintenance therapy had longer PFS and OS if they were also treated with IMNN-001, compared with patients treated with neoadjuvant chemotherapy (NACT) only. This is not a pre-specified subgroup as PARP inhibitors were approved after this study was initiated. Although a small subgroup, the data support continued development and suggest that IMNN-001 may have a place in new treatment regimens and important commercial value. We expect to report final topline results in mid-2024."

"Interest in IMNN-001 continues to be strong," Dr. Le Goff continued, "as evidenced by the initiation of a Phase 1/2 clinical trial in advanced ovarian cancer in combination with bevacizumab, or Avastin, at the University of Texas MD Anderson Cancer Center. We are looking forward to adding prestigious cancer sites to this study, along with driving enrollment in this research with mainly third-party funding."

"Development of our PlaCCine modality reached important milestones with confirmation of PlaCCine versatility as a plug-and-play modality by demonstrating preclinically the immunogenicity and safety of our vaccines against many pathogens of concern including COVID-19, Marburg, Lassa, monkeypox and influenza viruses. We expect to file our IND application and begin patient enrollment in a Phase 1/2 trial in the first half of 2024 for IMNN-101, a next-generation COVID-19 seasonal booster."

"Our DNA infectious disease vaccines are well positioned to become the next generation of vaccines. I am excited about their potential with the preclinical demonstration of more durable antigen expression and T-cell responses versus protein and mRNA vaccines, and better antibody response kinetics following a single dose. In addition, our vaccines offer superior commercial handling and distribution properties versus mRNA vaccines, as well as greater manufacturing flexibility with better shelf-life of at least 12 months at 4°C, one month at room temperature and at least two weeks at 37°C. Our DNA cancer vaccines modality, FixPlas, is equally well positioned to play an important role in a new era of immunotherapy, with promising results in a mouse melanoma model."

Dr. Le Goff concluded, "With exciting and deep technology directed toward important medical problems, IMUNON has a promising future. The collaborations we formed this year are a blueprint for future partnerships, particularly those with shared development expenses."

RECENT DEVELOPMENTS

IMNN-001 Immunotherapy

Reported Interim PFS and OS Data in OVATION 2 Study in Advanced Ovarian Cancer. In September 2023, the Company announced interim PFS and OS data with IMNN-001 in its OVATION 2 Study. This study is evaluating the dosing, safety, efficacy and biological activity of intraperitoneal IMNN-001 in combination with NACT in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. NACT is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor.

The study is directional and designed with an 80% confidence interval to show an approximate 33% improvement in PFS, when comparing the treatment arm (NACT + IMNN-001) with the control arm (NACT only). The secondary endpoints include OS, objective response rate (ORR), pathological response, surgical response and serologic response. The final readout of this study is expected in mid-2024. A positive readout would inform next development steps.

Interim data from the ITT population showed efficacy trends in PFS, demonstrating a delay in disease progression in the treatment arm of approximately 33% compared with the control arm, with the hazard ratio nearing the per protocol value. Preliminary OS data follows a similar trend, showing an approximate nine-month improvement in the treatment arm over the control arm.
Subgroup analyses show patients treated with a PARPi as maintenance therapy had longer PFS and OS if they were also treated with IMNN-001, compared with patients treated with NACT only.
The median PFS in the PARPi + NACT group and the PARPi + NACT + IMNN-001 group was 15.7 months and 23.7 months, respectively.
The median OS in the PARPi + NACT group was 45.6 months and has not yet been reached in the PARPi + NACT + IMNN-001 group.
Continued benefits were seen in other secondary endpoints including an approximately 20% higher R0 tumor resection score and a doubling of the CRS 3 chemotherapy response score to approximately 30% in the treatment arm, versus 14% in the control arm. A complete tumor resection (R0) is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Chemotherapy response score is considered a good prognostic indicator in ovarian cancer. Safety analyses continue to show good tolerability of IMNN-001 in this setting.

Began Treatment in a Phase 1/2 Clinical Trial Evaluating IMNN-001 in Combination with Bevacizumab in Advanced Ovarian Cancer. In October 2023, the first patient was enrolled in this trial at the University of Texas MD Anderson Cancer Center, which is expected to enroll 50 patients with Stage III/IV ovarian cancer. Patients undergoing frontline neoadjuvant therapy will be randomized 1:1 to receive standard chemotherapy plus bevacizumab, or standard chemotherapy plus bevacizumab and IMNN-001. The trial’s primary endpoint is detection of minimal residual disease (MRD) by second look laparoscopy (SLL), and the secondary endpoint is PFS. Initial SLL data are expected within one year following the completion of enrollment and final PFS data are expected approximately three years following the completion of enrollment. This trial will also include a wealth of translational endpoints aimed at understanding the clonal evolution and immunogenomic features of the MRD phase of ovarian cancer that is currently undetectable by imaging or tumor markers.

PlaCCine: Developing the Prophylactic Vaccines of the Future

Chief Science Officer Presented at the 3rd International Vaccines Congress. In October 2023, Khursheed Anwer, Ph.D. delivered a presentation titled "A DNA-based Vaccine Technology Independent of Virus or Device," which described the multiple advantages of the PlaCCine modality over current commercial vaccine platforms. The presentation also described the versatility of the PlaCCine modality, demonstrating the activity against Marburg and influenza viruses in collaboration with the Wistar Institute, and activity against Lassa virus being evaluated at the NIH/NIAID.

Entered into a CRADA for Preclinical Studies of the PlaCCine Modality in Preventive Vaccines Against Lassa Virus. In August 2023, the Company announced it entered into a CRADA with the NIAID to evaluate the immunogenicity and efficacy of two IMUNON DNA-based Lassa virus vaccine candidates in animal models. Under the three-year agreement, the NIAID will assess the efficacy of PlaCCine DNA constructs against Lassa virus in guinea pig and non-human primate disease models, including both prime and prime-boost vaccine strategies. The Laboratory of Virology at the NIAID is researching a potential solution for combatting this life-threatening pathogen by evaluating a DNA-based vaccine approach for the treatment of the Lassa virus due to its durable antigen expression, longer shelf-life at workable, standard refrigerated temperatures and flexible manufacturing to potentially address the limitations of current commercial products, particularly in developing countries.

Preclinical Data with PlaCCine DNA-based Vaccines Modality Published Online on bioRxiv. In August 2023, a manuscript titled "Strong immunogenicity & protection in mice with PlaCCine: A COVID-19 DNA vaccine formulated with a functional polymer" was published on the preprint server bioRxiv [here]. The study used IMUNON’s proprietary formulation against the spike proteins from two SARS-CoV-2 variants, both alone and in combination. These results add to the growing body of preclinical data confirming the efficacy and desirable features of IMUNON’s PlaCCine vaccine modality. Data from the study show:

IMUNON’s proprietary formulation of functionalized polymer protected DNA from degradation, while the combination with an adjuvant led to an increase in protein expression
DNA formulated with PlaCCine resulted in a DNA vaccine product that was stable for up to one year at 4°C, one month at room temperature and over two weeks at 38°C
DNA formulated in PlaCCine resulted in the induction of spike-specific neutralizing antibodies and cytotoxic T cells
In the in vivo challenge model, the vaccine-induced immune response was capable of suppressing viral replication
Multiple inserts can be cloned into the PlaCCine backbone (a plug-and-play strategy), therefore allowing for an immune response with broader protection
Corporate Developments

Hosted a Virtual R&D Day. In September 2023, IMUNON management along with guest KOLs in immuno-oncology and vaccine development held a virtual R&D Day to discuss the Company’s progress in developing its PlaCCine platform, IMNN-001 and other achievements. IMUNON’s speakers included Dr. Le Goff and Dr. Anwer. Guest KOL presenters included:

Sallie Permar, M.D., Ph.D., Chair of the Department of Pediatrics at Weill Cornell Medicine and Pediatrician-in-Chief at New York-Presbyterian/Weill Cornell Medical Center and New York-Presbyterian Komansky Children’s Hospital.
Patrick Ott, M.D., Ph.D., Clinical Director of the Melanoma Disease Center and the Director, Clinical Sciences, of the Center for Immuno-Oncology at the Dana-Farber Cancer Institute.
Dr. Permar’s presentation focused on the "Vaccines of the Future" while Dr. Ott discussed "Immuno-Oncology: The remaining unmet need." A webcast of the event is available in the Scientific Presentations section of IMUNON’s website or here.

Expanded Scientific Advisory Board with the Addition of Dr. Patrick Ott and Dr. Sachet Shukla. They join current scientific advisory board members Dan H. Barouch, M.D., Ph.D., Luke D. Handke, Ph.D. and John W. Shiver, Ph.D. As the Company advances FixPlas and IndiPlas into universal and personalized cancer vaccines, Drs. Ott and Shukla will provide invaluable assistance.

THIRD QUARTER FINANCIAL RESULTS

IMUNON reported a net loss for the third quarter of 2023 of $3.5 million, or $0.37 per share, compared with a net loss of $6.1 million, or $0.87 per share, for the third quarter of 2022. Operating expenses were $3.9 million for the third quarter of 2023, a decrease of $2.4 million, or 38%, from $6.3 million for the third quarter of 2022.

Net cash used for operating activities was $4.5 million for the third quarter of 2023 compared with $4.6 million for the comparable prior-year period. The decrease was primarily due to the decrease in net loss and change in accounts payable. Cash provided by financing activities of $0.1 million during the third quarter of 2023 resulted from equity sales under the Company’s At-the-Market Equity Facility. The Company had $19.5 million in cash, investments and accrued interest receivable as of September 30, 2023. The Company also has approximately $1.8 million of future planned sales of its State of New Jersey net operating losses ($1.5 million in 2023 and $300,000 in 2024).

Research and development (R&D) expenses were $2.0 million for the third quarter of 2023 compared with $2.4 million for the comparable period in 2022. R&D costs to support the OVATION 2 Study as well as the Phase 3 OPTIMA Study decreased to $0.1 million for the third quarter of 2023 compared with $0.6 million for the same period of 2022. Other clinical and regulatory costs were $0.3 million for the third quarter of 2023 compared with $0.4 million for the third quarter of 2022. R&D costs associated with the preclinical development of the PlaCCine DNA vaccine modality increased to $0.8 million for the third quarter of 2023 compared with $0.5 million for the same period of 2022. R&D costs associated with the preclinical development of IMNN-001 decreased to $0.3 million for the third quarter of 2023 compared with $0.6 million for the same period of 2022. Chemistry, manufacturing and controls (CMC) costs increased to $0.5 million for the third quarter of 2023 compared with $0.3 million for the third quarter of 2022 due to higher costs related to the development of in-house pilot manufacturing capabilities for DNA plasmids and nanoparticle delivery systems.

General and administrative expenses were $1.9 million for the third quarter of 2023 compared with $3.9 million for the comparable prior-year period. The decrease was primarily due to lower non-cash stock-compensation expense and lower professional fees, including legal fees to defend various lawsuits filed after the announcement in July 2020 of the Phase 3 OPTIMA Study results, offset by higher compensation expenses related to the CEO succession plan announced in July 2022 and higher staffing costs.

Other non-operating income was $0.4 million for the third quarter of 2023 compared with $26 thousand for the prior-year period. This increase was due to higher investment income from the Company’s short-term investments.

NINE MONTH FINANCIAL RESULTS

For the nine months ended September 30, 2023, the Company reported a net loss of $14.6 million, or $1.64 per share, compared with a net loss of $22.7 million, or $3.42 per share, for the same period of 2022. Operating expenses were $15.1 million for the first nine months of 2023, a decrease of $3.3 million, or 18%, from $18.4 million for the same period of 2022.

Net cash used for operating activities was $15.3 million for the first nine months of 2023 compared with $18.1 million for the same period in 2022. The decrease was primarily due to the one-time payment of $4.5 million in interest expense resulting from the sale and subsequent redemption of $30 million of Series A & B convertible redeemable preferred stock in the first quarter of 2022. Cash used by financing activities of $3.7 million during the first nine months of 2023 resulted from the early repayment of the Company’s loan facility with Silicon Valley Bank ($6.4 million), offset by sales of equity under the Company’s At-the-Market Equity Facility ($2.8 million). The Company also received net proceeds of $1.6 million from the sale of its unused New Jersey NOLs in the first quarter of 2023.

R&D expenses were $7.7 million for the first nine months of 2023 compared with $8.7 million for the comparable period in 2022. R&D costs to support the OVATION 2 Study as well as the Phase 3 OPTIMA Study decreased to $0.7 million for the first nine months of 2023 compared with $2.2 million for the comparable 2022 period. Other clinical and regulatory costs were $1.1 million for the first nine months of 2023 compared with $1.7 million for the same period of 2022. R&D costs associated with the preclinical development of the PlaCCine DNA vaccine modality increased to $3.1 million for the first nine months of 2023 compared with $1.6 million for the same period of 2022. R&D costs associated with the preclinical development of IMNN-001 decreased to $1.0 million for the first nine months of 2023 compared with $2.4 million for the same period of 2022. CMC costs increased to $1.8 million for the first nine months of 2023 compared with $0.9 million for the comparable 2022 period due to higher costs related to the development of in-house pilot manufacturing capabilities for DNA plasmids and nanoparticle delivery systems.

General and administrative expenses were $7.3 million for the first nine months of 2023 compared with $9.6 million for the same period of 2022. The $2.3 million decrease was primarily due to lower non-cash stock-compensation expense and lower professional fees, including legal fees to defend various lawsuits filed after the announcement in July 2020 of the Phase 3 OPTIMA Study results, offset by higher compensation expenses related to the CEO succession plan and higher staffing costs.

Other non-operating income was $0.4 million for the first nine months of 2023 compared with $4.7 million for the comparable prior-year period. The decrease was primarily attributable to the one-time payment of $4.5 million in interest expense resulting from the sale and subsequent redemption of $30 million of Series A & B convertible redeemable preferred stock in the first quarter of 2022.

CONFERENCE CALL AND WEBCAST

The Company is hosting a conference call to provide a business update, discuss third quarter 2023 financial results and answer questions at 10:00 a.m. ET today. To participate in the call, please dial 866-777-2509 (Toll-Free/North America) or 412-317-5413 (International/Toll) and ask for the IMUNON Third Quarter 2023 Earnings Call. A live webcast of the call will be available here.

The call will be archived for replay until November 28, 2023. The replay can be accessed at 877-344-7529 (U.S. Toll-Free), 855-669-9658 (Canada Toll-Free) or 412-317-0088 (International Toll), using the replay access code 7035449. A webcast of the call will be available here for 90 days.

On November 14, 2023 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported a business update and provided financial results for the quarter ended September 30, 2023 (Press release, Immatics, NOV 14, 2023, View Source [SID1234637627]).

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"Immatics has had a strong quarter and made steady progress both in terms of the advancement of our clinical programs and in business development. This includes an equity investment by Bristol Myers Squibb, the initiation of a long-term strategic collaboration with Moderna, the first patient dosed in our TCER IMA402 clinical trial and now the data update on our ACTengine IMA203 GEN1 and GEN2 TCR-T monotherapies that demonstrated the potential for durable clinical benefit for advanced-stage solid cancer patients," said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "As we continue to move IMA203 towards a pivotal trial next year, in conjunction with over $500 million on our balance sheet, we are well positioned for 2024. We look forward to providing first clinical data for our two next-generation TCR Bispecifics programs, IMA401 targeting MAGEA4/8 and IMA402 targeting PRAME, among other updates."

Third Quarter 2023 and Subsequent Company Progress

Adoptive Cell Therapy Programs

ACTengine IMA203

On November 8, 2023, the company announced interim data from the ongoing Phase 1 trial with ACTengine IMA203 in patients with recurrent and/or refractory solid cancers (data cut-off September 30, 2023). The update was focused on IMA203 GEN1 in melanoma patients at the recently defined recommended Phase 2 dose (RP2D, 1.0-10×109 total TCR-T cells) and the first clinical data for IMA203CD8 GEN2.

IMA203 GEN1 in melanoma patients treated at RP2D in Phase 1a and Cohort A:

Interim update on first-generation IMA203 that includes functional CD8 T cells targeting an HLA-A*02-presented peptide derived from PRAME.
Safety population (N=16 patients infused): IMA203 GEN1 monotherapy continues to be well tolerated. All 16 patients experienced cytopenia (Grade 1-4) associated with lymphodepletion as expected. Patients had mostly mild-moderate cytokine release syndrome (CRS), of which 10 patients (63%) had Grade 1, and 5 patients (31%) Grade 2 and 1 patient (6%) Grade 3 CRS. One non-serious, mild (Grade 1) immune effector cell associated neurotoxicity syndrome (ICANS) was observed. No dose-dependent increase of CRS, no dose-limiting toxicities (DLTs) and no IMA203-related death was observed. The safety profile for non-melanoma patients treated with IMA203 GEN1 was generally consistent with safety in the melanoma subset.
Efficacy population (N=13 patients infused with at least one available response assessment): Patients received a median total infused dose of 1.73×109 IMA203 TCR-T cells (range 1.07-5.12×109 TCR-T cells). Most patients were heavily pre-treated with a median of 4 lines of systemic therapies, thereof a median of 2 lines of checkpoint inhibitors; all 8 cutaneous melanoma patients were checkpoint inhibitor-refractory and 5 of 8 were BRAF inhibitor-pretreated.
50% (6/12) confirmed objective response rate (cORR) and 62% (8/13) initial ORR (RECIST 1.1).
Durability of responses ongoing beyond 12 months in one patient and beyond 15 months in two patients following infusion.
Median duration of response (mDOR) was not reached (min 2.2+ months, max 14.7+ months) at a median follow-up (mFU) of 14.4 months.
Development strategy: Immatics has recently received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for IMA203 GEN1 in multiple PRAME-expressing cancers, including cutaneous and uveal melanoma, and is now targeting a registration-enabling Phase 2 trial in cutaneous melanoma potentially bundled with uveal melanoma in 2024. Discussions with FDA to align on patient population, trial design and CMC aspects of the planned Phase 2 trial are ongoing. An update on the clinical development plan is expected in the first quarter of 2024.

IMA203CD8 GEN2 in Cohort C:

First clinical data on second-generation IMA203CD8 that includes functional CD8 and CD4 T cells targeting an HLA-A*02-presented peptide derived from PRAME.
12 patients in this basket trial were infused with IMA203CD8 GEN2 across DL3 (0.2-0.48×109 TCR-T cells/m2 BSA), DL4a (0.481-0.8×109 TCR-T cells/m2 BSA) and DL4b (0.801-1.2×109 TCR-T cells/m2) with a median total infused dose of 1.17×109 IMA203CD8 TCR-T cells (range 0.64-2.05×109 TCR-T cells).
All patients were heavily pre-treated with a median of 3 lines of systemic therapies.
IMA203CD8 GEN2 exhibits a manageable tolerability profile. All patients experienced cytopenia (Grade 1-4) associated with lymphodepletion as expected. 11 out of 12 patients (92%) experienced a cytokine release syndrome (CRS), of which 8 patients (67%) had Grade 1 or 2 CRS, 2 patients (17%) had Grade 3 CRS (both treated at DL4b) and 1 patient (8%) had a Grade 4 CRS (treated at DL4b). The latter patient also had a reported Grade 4 neurotoxicity. No ICANS or neurotoxicity was reported for the other patients. No IMA203CD8-related deaths were observed. Dose-limiting toxicities (DLTs) were reported for 2 of 4 patients treated at DL4b. No DLT was reported for all 4 patients treated at DL3, or all 4 patients treated at DL4a. DL4a dose cohort is ongoing.
Initial clinical activity was observed during dose escalation across all dose levels with a cORR of 56% (5/9) and initial ORR of 58% (7/12) (RECIST 1.1).
6 of 7 responses (including two unconfirmed responses with no subsequent scan available at data cut-off) were ongoing at data cut-off with longest response at >12 months after infusion.
mDOR was not reached (min 2.0+ months, max 11.5+ months) at a mFU of 4.8 months.
Reduction of tumor size was observed in 11 out of 12 patients, with a deepening of response from initially stable disease (SD) to partial response (PR) observed in two patients.
Translational data showed enhanced pharmacology of IMA203CD8 GEN2: trend towards responses at lower T cell dose and higher tumor burden compared to IMA203 GEN1; IMA203CD8 GEN2 achieved higher peak expansion (Cmax) when normalized to infused dose and T cells showed higher initial activation levels without exhaustion over time.

Development path for IMA203 GEN1 and IMA203CD8 GEN2 monotherapies
The goal of Immatics’ development strategy is to make its cell therapies targeting PRAME available to the broadest possible solid cancer patient population with an initial focus on the US market. To achieve this, Immatics has announced a three-step development strategy for leveraging the full breadth of PRAME, a target that is highly expressed in various solid cancers.

Focus on IMA203 GEN1 in cutaneous melanoma (potentially bundled with uveal melanoma), targeted to enter a registration-enabling Phase 2 clinical trial in 2024. Discussions with FDA to align on patient population, clinical trial design and CMC aspects are ongoing under the RMAT designation achieved for IMA203 GEN1 in multiple cancer types including cutaneous and uveal melanoma. There are up to 3,300 HLA-A*02 and PRAME-positive cutaneous and uveal melanoma last-line patients per year in the US. An update on the clinical development plan is expected in the first quarter of 2024.

In parallel, commence dedicated dose expansion cohorts for signal finding in ovarian and uterine cancer, preferentially with IMA203CD8 GEN2. Enrollment of patients with these cancer types is already ongoing. There are up to 9,000 HLA-A*02 and PRAME-positive ovarian and uterine last-line cancer patients per year in the US.

The development of a broader tumor-agnostic label in PRAME-positive solid cancers, including in NSCLC, triple-negative breast cancer, and others. This could leverage the full potential of PRAME across multiple solid cancer types.

TCR Bispecifics Programs

Immatics’ T cell engaging receptor (TCER) candidates are next-generation, half-life extended TCR Bispecific molecules designed to maximize efficacy while minimizing toxicities in patients through Immatics’ proprietary format using a high-affinity TCR domain against the tumor target and a low-affinity T cell recruiter binding to the T cell.

TCER IMA401 (MAGEA4/8) – The Phase 1 trial to evaluate safety, tolerability and initial anti-tumor activity of TCER IMA401 in patients with recurrent and/or refractory solid tumors is ongoing. IMA401 targets an HLA-A*02:01-presented peptide that occurs identically in two different proteins, MAGEA4 and MAGEA8. This target peptide has been selected based on natural expression in native solid tumors at particularly high target density (peptide copy number per tumor cell identified by Immatics’ proprietary quantitative mass spectrometry engine XPRESIDENT). MAGEA4 and MAGEA8 are expressed in multiple solid cancers including lung cancer, head and neck cancer, melanoma, ovarian cancer, sarcoma and others. IMA401 is being developed in collaboration with Bristol Myers Squibb. First clinical data is expected to be announced in 2024.

TCER IMA402 (PRAME) – Immatics initiated the Phase 1/2 trial investigating the company’s fully owned TCER candidate IMA402 in patients with recurrent and/or refractory solid tumors in August and dosed the first patients. Initial focus indications are ovarian cancer, lung cancer, uterine cancer, and cutaneous and uveal melanoma, among others. IMA402 targets an HLA-A*02:01-presented peptide derived from the tumor antigen PRAME. This target peptide has been selected based on natural expression in native solid primary tumors and metastases at particularly high target density (peptide copy number per tumor cell identified by Immatics’ proprietary quantitative mass spectrometry engine XPRESIDENT). An update with first clinical data on TCER IMA402 is anticipated in 2024.

Corporate Developments

On September 11, Immatics announced a strategic multi-platform collaboration with Moderna, combining Immatics’ target and TCR platforms with Moderna’s cutting-edge mRNA technology. The collaboration spans various therapeutic modalities including bispecifics, cell therapy and cancer vaccines. Under the terms of the agreement, Immatics received an upfront payment of $120 million. In addition, Immatics will receive research funding and is eligible to receive development, regulatory and commercial milestone payments that could exceed $1.7 billion. Immatics is also eligible to receive tiered royalties on global net sales of TCER products and certain vaccine products that are commercialized under the agreement. Under the agreement, Immatics has an option to enter into a global profit and loss share arrangement for the most advanced TCER. The strategic R&D collaboration between Moderna and Immatics focuses on three pillars:

Applying Moderna’s mRNA technology for in vivo expression of Immatics’ next-generation, half-life extended TCR Bispecifics (TCER) targeting cancer-specific HLA-presented peptides.
Enabling the discovery and development of novel mRNA-based cancer vaccines by leveraging Moderna’s mRNA science and customized information from Immatics’ target discovery platform XPRESIDENT and its bioinformatics and AI platform XCUBE.
Evaluating Immatics’ IMA203 TCR-T therapy targeting PRAME in combination with Moderna’s PRAME mRNA-based cancer vaccine. The collaboration contemplates conducting preclinical studies and a Phase 1 clinical trial evaluating the safety and efficacy of the combination with the objective of further enhancing IMA203 T cell responses.
On July 24, 2023, Bristol Myers Squibb purchased 2,419,818 ordinary shares in a private placement transaction at a subscription price per share of $14.461. Pursuant to their rights under the agreement, Bristol Myers Squibb appointed Anne Kerber, M.D., Senior Vice President, Head of Cell Therapy Development at Bristol Myers Squibb, to the Immatics Scientific Advisory Board (SAB).

Third Quarter 2023 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €366.0 million ($387.7 million2) as of September 30, 2023, compared to €362.2 million ($383.7 million2) as of December 31, 2022. The increase is mainly due to the opt-in payment for one TCR-T candidate received from Bristol Myers Squibb and equity raised in the period, partially offset by our ongoing research and development activities and does not include the upfront payment of $120 million received from Moderna in October 2023. The company projects a cash runway well into 2026.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €5.9 million ($6.3 million2) for the three months ended September 30, 2023, compared to €15.1 million ($16.0 million2) for the three months ended September 30, 2022. The decrease is mainly related to lower non-cash recognition of deferred revenue from initial upfront payments.

Research and Development Expenses: R&D expenses were €30.5 million ($32.3 million2) for the three months ended September 30, 2023, compared to €28.6 million ($30.3 million2) for the three months ended September 30, 2022. The increase mainly resulted from higher costs associated with the advancement of the clinical pipeline of ACTengine IMA203 and TCER IMA401 and IMA402 candidates.

General and Administrative Expenses: G&A expenses were €8.9 million ($9.4 million2) for the three months ended September 30, 2023, compared to €8.4 million ($8.9 million2) for the three months ended September 30, 2022.

Net Profit and Loss: Net loss was €26.5 million ($28.1 million2) for the three months ended September 30, 2023, compared to a net loss of €20.9 million ($22.1 million2) for the three months ended September 30, 2022. The increased net loss mainly resulted from lower non-cash revenue recognition.

Upcoming Investor Conferences

Jefferies London Healthcare Conference, London, U.K. – November 14-16, 2023
Leerink Partners Global Biopharma Conference, Miami, FL – March 11-13, 2024
Jefferies Biotech on the Bay Miami Summit, Miami, FL – March 12-13, 2024