On November 9, 2023 MaaT Pharma, a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported a business update and reported its cash position as of September 30, 2023 (Press release, MaaT Pharma, NOV 9, 2023, View Source [SID1234637380]).

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"The positive DSMB review of MaaT013 in its Phase 3 trial and the commencement of the MaaT033 Phase 2b trial underscores our leadership position in oncology-focused microbiome therapeutics. It also demonstrates our ability to execute our clinical plan and prepare for commercialization through expanded production capacities that were completed in Q3. We are proud to achieve these milestones and we will continue to work on generating value for our shareholders," stated Siân Crouzet, CFO of MaaT Pharma. "Our progress and achievements put us in good stead as we look towards the months ahead and the completion of patient recruitment in the Phase 3 clinical study in 2024."

Pipeline highlights

MET-N

MaaT013

In hemato-oncology:
In July 2023, the Company announced that clinical data on MaaT013 as a treatment for aGvHD was published in eClinicalMedicine, one of the Lancet Discovery Science suite of journals.
As a post period event, in October 2023, the Company announced that the DSMB unanimously recommended that the open-label, single arm pivotal Phase 3 clinical trial evaluating MaaT013 in acute Graft-versus-Host Disease (aGvHD), named ARES, can continue without modification. The Overall Response Rate (ORR) was superior to pre-defined protocol assumptions. Therefore, the DSMB concluded that the benefit/risk ratio with "high efficacy and low toxicity" was favorable in this patient population.
As a post period event, in November 2023, the Company announced that extended results from its Early Access Program of MaaT013 in 111 patients (additional 30 patients included in the Program compared to last year) with aGvHD have been selected for poster presentations at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
In immuno-oncology:
The Phase 2a PICASSO trial, evaluating MaaT013 in combination with immune checkpoint inhibitors in metastatic melanoma, is on schedule, and results should be available in late 2024 or early 2025.
MaaT033

In hemato-oncology:
In September 2023, the Company announced that the European Medicines Agency (EMA) had granted MaaT033 an orphan drug designation. MaaT033 aims to improve overall survival in patients undergoing hematopoietic stem cell transplantation (HSCT) and the EMA had recognized the significant benefit that MaaT033 could therefore bring to this patient population. The status offers key benefits including market exclusivity, clinical protocol assistance, waivers or reductions in regulatory fees.
As a post period event, in November 2023, the Company announced that the first patient has been treated as part of its Phase 2b trial (PHOEBUS) investigating the efficacy of MaaT033 in improving overall survival at 12 months for patients with blood cancer receiving allo-HSCT. The international, multi-center, randomized, double-blind, placebo-control study (NCT05762211), will be conducted in up to 56 clinical investigation sites and is expected to enroll 387 patients. It is, to date, the largest randomized controlled trial assessing a microbiome therapy in oncology.
As a post period event, in November 2023, the Company announced that the design of its Phase 2b study evaluating MaaT033 has been selected for a poster presentation at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
In neurodegenerative diseases:
In September 2023, the Company announced that the first patient was dosed in the IASO Phase 1b pilot study (NCT05889572) in ALS (also known as Lou Gehrig’s disease in the U.S. and Charcot’s disease in French-speaking countries).
MET-C

MaaT034

In immuno-oncology:
As a post period event, in November 2023, the Company had two presentations at the 38th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting including in vitro results for its new Artificial Intelligence (AI)-generated lead product, MaaT034, designed to improve responses to immunotherapy for patients with solid tumors. MaaT034 is the first member of the MET-C platform. Data presented at SITC (Free SITC Whitepaper) 2023 shows that MaaT034 replicates, at large industrial scale, the richness and diversity of healthy native-based microbiome ecosystems, restores the integrity of a damaged gut barrier, activates AhR pathway involved in gut homeostasis, and stimulates both myeloid and lymphoid immune cells and improves immune cell response to immune checkpoint inhibitor (ICI) therapy. The first clinical batches are expected to be produced in 2024 and the first-in-human testing is planned for 2025.
Corporate update

In July 2023, MaaT Pharma joined the Microbiome Therapeutics Innovation Group (MTIG).
In September 2023, the Company and Skyepharma announced completion of the cGMP manufacturing facility and the transfer of MaaT Pharma’s Production and Development teams to the new site.
Cash position1

As of September 30, 2023, total cash and cash equivalents were EUR 31.7 million, as compared to EUR 35.1 million as of June 30, 2023, and EUR 35.2 million as of December 31, 2022. The net decrease in cash of EUR 3.4 million during the third quarter 2023 reflects continued investment in R&D activities across the pipeline, offset in part by partial reimbursement of the 2022 R&D tax credit of EUR 0.5 million. The Company believes it has sufficient cash to cover needs of the development programs into the second quarter of 2024.
Revenues in Q3 2023

MaaT Pharma reported revenues from its compassionate access program of EUR 0.4 million for the quarter ended September 30, 2023 comparable with the third quarter of 2022. Total revenues for the first three quarters of 2023 amount to EUR 1.8 million compared with EUR 0.9 million for the first three quarters of 2022[1]. This trend is a direct reflection of the continued demand from the medical community for MaaT Pharma’s drug candidate MaaT013.

Upcoming investor and medical conference participation

November 14-17, 2023 – London, UK Investor Meetings
November 14-16, 2023 – Boston, MA – USA, Microbiome Connect
November 15-17, 2023 – Lille, France, 22nd Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) Congress – Booth #12
December 9-12, 2023 – San Diego, CA – USA, 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting – Posters presentation
January 8-12, 2024 – San Francisco, CA – USA, Investor Meetings
[1] Unaudited data

[2] The Company would like to correct a clerical error that was present in its Q2 results press release of July 27, 2023. The revenue from H1 2022 was EUR 0.5 million, and not EUR 0.9 million as reported in the press release. The EUR 0.9 million figure was the difference in revenue between H1 2023 and H1 2022 (EUR 1.4 million vs. EUR 0.5 million).

On November 9, 2023 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical‑stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for patients with solid tumors, reported that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to LYL845, an investigational tumor infiltrating lymphocyte (TIL) product candidate for the treatment of patients with stage IIB-IV melanoma (Press release, Lyell Immunopharma, NOV 9, 2023, View Source [SID1234637379]).

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"There remains a high unmet medical need for patients with advanced melanoma and we believe LYL845 has the potential for differentiated potency and durability needed to deliver better outcomes for patients with melanoma as well as other solid tumors where TIL therapy has not yet been widely effective," said Lynn Seely, M.D., Lyell’s President and CEO. "We are pleased to have received Orphan Drug Designation for LYL845 in advanced melanoma and look forward to presenting initial clinical data from this program next year."

LYL845, an autologous TIL product candidate enhanced with Lyell’s Epi-R manufacturing protocols, is currently being investigated in a Phase 1 clinical trial in patients with relapsed or refractory metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). In nonclinical studies, LYL845 TIL expanded with Epi-R exhibit characteristics that have previously been associated with improved clinical response rate, including a higher percentage of cytotoxic T cells and stemness phenotypes. LYL845 TIL have also demonstrated enhanced T-cell potency and maintenance of tumor-reactive polyclonality in nonclinical experiments. Initial data from Lyell’s ongoing Phase 1 clinical trial are expected in 2024.

The FDA’s Orphan Drug Designation program provides orphan status to drugs or biologics intended for the prevention, diagnosis, or treatment of diseases that affect fewer than 200,000 people in the United States. Sponsors of medicines that are granted Orphan Drug Designation are entitled to certain incentives, including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval.

Phase 1 Trial Design (NCT05573035)

The Phase 1 clinical trial is an open-label, dose-escalation trial for patients with relapsed and/or refractory metastatic or locally advanced melanoma with expansion cohorts for patients with melanoma, NSCLC, and CRC. The primary objective of the trial is to determine safety, tolerability and a recommended phase 2 dose range of LYL845. The secondary objective is to determine antitumor activity as evaluated by response rates, duration of response, progression-free survival and overall survival. Exploratory biomarkers of T-cell stemness will also be assessed.

About Melanoma

Melanoma of the skin is among the most common cancers in the United States. It is one of the most common cancers in young adults and especially in young women. It is estimated there are over 100,000 new cases of melanoma diagnosed in the United States per year. Melanoma arises due to genetic mutations in melanocytes, the pigment producing cells, which can be found in the skin, eye, inner ear and leptomeninges, and represents the most aggressive and the deadliest form of skin cancer. Although melanoma accounts for only ~1% of all dermatologic cancers, it is responsible for ~80% of deaths from skin cancer, with only ~14% of patients with advanced melanoma surviving for five years.

About LYL845

LYL845 is an investigational autologous TIL product enhanced with Epi-R manufacturing protocols for patients with relapsed and/or refractory metastatic or locally advanced melanoma, NSCLC and CRC. In nonclinical studies, Epi-R creates polyclonal populations of T cells that demonstrate properties of durable stemness and anti-tumor functionality. Durable stemness is the ability of T cells to persist and self-renew to drive durable tumor cytotoxicity.

TIL products are created by expanding T cells taken from the patient’s own tumor. Previous clinical experiences suggest that the efficacy of adoptive transfer of ex vivo expanded TILs is largely driven by specific recognition of mutated tumor neoantigens specific to each patient. To date, broad efficacy of TIL therapies has been limited by variable and often poor product quality, lack of stemness or potential durability of expanded TILs, failure to maintain polyclonality of TILs during production, and failure to enrich the TIL product with tumor-reactive T cells. TIL products manufactured using Lyell’s Epi-R manufacturing protocol aim to overcome these challenges. Nonclinical studies supporting the development of LYL845 suggest Epi-R technology improves TIL products by maintaining properties of durable stemness, which leads to superior ex vivo cell expansion and product qualities, maintenance of tumor reactive clones, and enhanced polyclonality.

On November 9, 2023 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported financial and operating results for the third quarter ended September 30, 2023 and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and provide a business update (Press release, Lineage Cell Therapeutics, NOV 9, 2023, View Source [SID1234637378]).

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"The Lineage team has continued to advance our clinical and preclinical pipeline of differentiated cell transplant programs, supporting our alliances and working to establish new collaborations," stated Brian M. Culley, Lineage CEO. "The most important area of attention for our team remains our partnership with Roche and Genentech and our support for the ongoing Phase 2a clinical study of OpRegen in patients with geographic atrophy secondary to AMD. Through presentations at medical and scientific conferences, we have broadened awareness of OpRegen’s potential to provide durable anatomical and functional improvements in patients with GA. Most recently, additional observations of rapid improvements to outer retinal structure in the initial Phase 1/2a clinical study of OpRegen were reported; improvements were detectable within the first three months following a single administration, suggesting that OpRegen RPE cells may provide support to the patients’ remaining retinal cells within atrophic areas. Looking forward, we are working with our partners, Roche, and Genentech, on additional clinical data updates on the OpRegen program."

"In addition, our team continued the necessary work to submit our Investigational New Drug amendment for OPC1 to enable us to initiate the DOSED clinical study in subacute and chronic spinal cord injury patients," Mr. Culley added. "In parallel, we also initiated certain development activities under our partnership with Eterna Therapeutics, reflecting a key step in a corporate strategy to capitalize on our existing process development capabilities by combining them with cutting-edge cell engineering and editing technologies, to create novel and potentially superior product profiles. As always, we intend to advance our business and programs in a responsible and fiscally conservative way, with an overarching focus on providing a meaningful impact for patients through the development of differentiated allogeneic cell transplants."

Recent milestones and activities included:

RG6501 (OpRegen)
Continued execution under our collaboration with Roche and Genentech across multiple functional areas, including support for the ongoing Phase 2a multi-center clinical study in patients with GA secondary to AMD. Additional sites expected to come online for the Phase 2a study.
Results of imaging analyses demonstrating rapid improvement in outer retinal structure from patients enrolled in the prior Phase 1/2a clinical study, were presented at the 23rd EURETINA Congress:
All five patients who had extensive coverage of the GA lesion with the surgical bleb containing OpRegen in suspension demonstrated evidence of improvement in outer retinal structure as assessed by optical coherence tomography (OCT) within the first three months after treatment.
Retinal structural improvements were initially observed on day 1 (n=1), day 14 (n=1), month 1 (n=2), and month 3 (n=1).
Structural improvement on OCT was qualitatively defined as meeting all pre-specified criteria on at least two non-adjacent B scans including: 1) reduction in outer plexiform layer (OPL) and/or inner nuclear layer (INL) subsidence; 2) reappearance of external limiting membrane (ELM); and 3) increased hyperreflectivity and/or thickness of RPE and/or Bruch’s membrane or reduction of hypertransmission on at least two non-adjacent B scans.
Structural improvement was only observed within GA lesions with extensive coverage with the surgical bleb, suggesting that OpRegen RPE cells provide support to the remaining retinal cells within atrophic areas.
These five patients had an average of 4.4 letter best corrected visual acuity (BCVA) gain by 3 months and 12.8 letter BCVA gain by 1 year compared to baseline.
U.S. Patent No.11,746,324 entitled "Large Scale Production of Retinal Pigment Epithelial Cells," issued.
Investigational New Drug (IND) amendment preparation for clinical testing of novel OPC1 spinal cord delivery system continues
Company remains on track to submit IND amendment to FDA in Q4 2023 to enable initiation of the DOSED clinical study in subacute and chronic spinal cord injury patients.
Initiated Development Activities for Hypoimmune Pluripotent Cell Line for Neurology Indications Under Partnership with Eterna Therapeutics
Lineage evaluated its development strategy with a group of leading neurology experts in the U.S. and abroad and following an assessment of the competitive landscape, finalized its selection of specific gene edits for the initial cell lines to be developed by Eterna.
The edits include: the targeted deletion of the B2M gene, designed to reduce the immunogenicity of product candidates derived from the lines by inhibiting rejection by CD8+ T cells; the targeted insertion of the HLA-E gene, designed to overexpress HLA-E and prevent the allogeneic NK cell response; and a third undisclosed edit intended to confer clinical differentiation and a competitive advantage in the applicable indications.
Positive ANP1 initial proof of concept results from collaboration with the University of Michigan
Initial results demonstrated delivery, engraftment, and survival of ANP1 cells into specific target areas.
Results support advancement of the ANP1 program into functional preclinical testing.
Balance Sheet Highlights

Cash, cash equivalents, and marketable securities totaled $41.3 million as of September 30, 2023, which is expected to support planned operations into Q1 2025.

Third Quarter Operating Results

Revenues: Lineage’s revenue is generated primarily from licensing fees, royalties, collaboration revenues, and research grants. Total revenues for the three months ended September 30, 2023 were $1.2 million, a net decrease of $1.8 million as compared to approximately $3.0 million for the same period in 2022. The decrease was primarily driven by lower collaboration and licensing revenue recognized from deferred revenues from the Collaboration and License Agreement among Lineage and Roche and Genentech entered into in December 2021.

Operating Expenses: Operating expenses are comprised of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended September 30, 2023 were $7.8 million, a decrease of $0.2 million as compared to $8.0 million for the same period in 2022.

R&D Expenses: R&D expenses for the three months ended September 30, 2023 were $3.7 million, a net increase of $0.1 million as compared to $3.6 million for the same period in 2022. The net increase was primarily driven by $0.2 million in higher OPC1 program-related expenses, and $0.5 million in expenses to support preclinical and other research and development programs. These increases were partially offset by a $0.5 million decrease in our VAC program, primarily related to reduced manufacturing activities.

G&A Expenses: G&A expenses for the three months ended September 30, 2023 were $4.0 million, a net decrease of approximately $0.4 million as compared to $4.4 million for the same period in 2022. The decrease was primarily attributable to an overall reduction in costs incurred for services by third parties, consulting costs, and recruiting related expenses.

Loss from Operations: Loss from operations for the three months ended September 30, 2023 was $6.7 million, an increase of $1.5 million as compared to a loss of $5.2 million for the same period in 2022.

Other Income/(Expenses), Net: Other income (expenses), net for the three months ended September 30, 2023 reflected other expense, net of approximately ($0.4) million, compared to other expense, net of ($0.3) million for the same period in 2022. The net change was primarily driven by exchange rate fluctuations related to Lineage’s international subsidiaries and fair market value changes in marketable equity securities, partially offset by interest income from our marketable debt securities.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended September 30, 2023 was $7.1 million, or $0.04 per share (basic and diluted), compared to a net loss attributable to Lineage of $6.1 million, or $0.04 per share (basic and diluted), for the same period in 2022.

Conference Call and Webcast

Interested parties may access today’s conference call and webcast, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through November 16, 2023, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 2323932.

On November 9, 2023 Kiromic BioPharma, Inc. (OTC PINK: KRBP) ("Kiromic" or the "Company"), a clinical-stage, fully-integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell therapies with a focus on immuno-oncology, reported the Deltacel Phase 1 Clinical Trial is now recruiting patients at the Beverly Hills Cancer Center (BHCC) (Press release, Kiromic, NOV 9, 2023, View Source [SID1234637377]). The study will evaluate Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with metastatic non-small cell lung cancer (NSCLC).

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The Company continues to engage additional clinical trial sites across the U.S, and will provide updates as additional sites are activated, and as patient recruitment starts at those locations.

The Phase 1 trial, titled "Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Stage 4 Metastatic NSCLC" (ID# NCT06069570), expects to enroll up to 48 patients. In this open-label, two-part trial, patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel along with four courses of low-dose, localized radiation, over a 10-day period. The primary objective of the study is to evaluate the safety of Deltacel in combination with low-dose radiation; the secondary outcome measures are objective response, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.

"We are delighted to announce the start of patient recruitment in our first clinical trial, and we look forward to working with BHCC and the other prestigious trial sites we will be activating across the U.S. Importantly, we are on target to dose our first patient, and we expect to have early tolerability and safety data from this patient available by the end of 2023," stated Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "We plan to assess preliminary efficacy by end of January 2024, and complete the dose-escalation portion of the study by the second half of 2024, at which point we expect to have sufficient evidence supporting the tolerability and the efficacy of Deltacel. These are crucial steps forward as we advance our goal to bring a transformative new treatment to patients with advanced NSCLC."

About Deltacel (KB-GDT-01)

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of non–small cell lung cancer. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is Kiromic BioPharma’s lead candidate in its GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial focus on NSCLC, the most prevalent type of lung cancer and representing about 80% to 85% of lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

About Beverly Hills Cancer Center

As a private, academic, community-based cancer center, Beverly Hills Cancer Center not only provides state-of-the-art cancer treatment modalities all under one roof, but also leading clinical trials and research for cancer that are offered at very few centers in the world, attracting patients globally and saving lives. By providing access to groundbreaking clinical trials, the Beverly Hills Cancer Center offers patients the opportunity to participate in the most advanced cancer treatments in development in the world. Beverly Hills Cancer Center is comprised of an internationally recognized multidisciplinary medical team consisting of medical oncologists, radiation oncologists, radiologists, hematologists, and internists who provide exceptional patient care and support services including a robust and highly efficient team of clinical research professionals. For more information, visit: www.bhcancercenter.com.

On November 9, 2023 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate" or the "Company"), a clinical-stage precision oncology company, reported financial results for the third quarter of 2023 and recent corporate updates (Press release, Kinnate Biopharma, NOV 9, 2023, View Source [SID1234637376]).

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Nima Farzan, chief executive officer of Kinnate Biopharma Inc., stated, "Following the announcement of the Company’s strategic reprioritization, we are focused on advancing our pan-RAF inhibitor exarafenib in combination with binimetinib and our c-MET inhibitor KIN-8741, and are focusing our discovery efforts around our CDK4 selective inhibitor program. We remain committed to pursuing therapies that can improve outcomes and make a positive impact on patients’ lives while also maximizing value for our shareholders."

Previously Announced Strategic Reprioritization and Pipeline Updates

Kinnate previously announced a strategic reprioritization and workforce restructuring based on a strategic review of its business (View Release).
As a result of the reprioritization, the Company is prioritizing the exarafenib combination, KIN-8741 and discovery efforts around its CDK4 selective program.
Dose exploration for the combination of exarafenib, the Company’s investigational pan-RAF inhibitor, and binimetinib is currently underway in the KN-8701 clinical trial, with a primary focus on NRAS mutant melanoma. In the fourth quarter of 2023, the Company intends to select two doses for further development.
Kinnate expects to file an Investigational New Drug ("IND") application for KIN-8741, the Company’s investigational c-MET inhibitor, with the U.S. Food and Drug Administration in the fourth quarter of 2023.
Kinnate is evaluating lead potentially brain-penetrant, selective CDK4 inhibitors for potential selection as a drug candidate and expects to nominate a drug candidate in the fourth quarter of 2023.
Additionally, as part of the reprioritization plan, Kinnate previously announced it will not initiate a clinical trial for KIN-7136, the Company’s investigational MEK inhibitor, and will explore strategic alternatives for exarafenib monotherapy and KIN-3248, an investigational FGFR inhibitor.
Kinnate implemented a workforce restructuring to align with its refined focus, reducing the Company’s workforce by approximately 70%. The Company is also taking related measures to reduce operating expenses.
Financial Results

As of September 30, 2023, total cash, cash equivalents and investments were $180.3 million, which is expected to fund current operations into at least the second quarter of 2026.
Third quarter research and development expenses for 2023 were $24.5 million, compared to $23.5 million for the same period in 2022.
Third quarter general and administrative expenses for 2023 were $6.6 million, compared to $7.8 million for the same period in 2022.
Third quarter operating expenses for 2023 included $2.0 million of restructuring costs.
Third quarter net loss for 2023 was $30.7 million, compared to $30.7 million for the same period in 2022.