On November 7, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that it will report its financial results for the quarter ended September 30, 2022 on Thursday, November 10th (Press release, Moleculin, NOV 7, 2022, View Source [SID1234623255]). Moleculin management will host its inaugural quarterly conference call and live audio webcast to discuss the operational and financial results at 5:00 PM ET that same day.

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The call will be led by Walter Klemp, Chairman and Chief Executive Officer of Moleculin and Jonathan Foster, Executive VP & Chief Financial Officer of Moleculin. Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call. The live webcast will be accessible on the Events page of the Investors section of the Moleculin website, moleculin.com, and will be archived for 90 days.

On November 7, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported financial results for the third quarter ended September 30, 2022 (Press release, Mersana Therapeutics, NOV 7, 2022, View Source [SID1234623254]).

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

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"The year 2022 has already been an incredibly productive period for Mersana as we have advanced UpRi, expanded our clinical pipeline and strengthened our balance sheet with two notable partnerships," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "With significant support from global investigators, we were able to enroll approximately 270 patients in UPLIFT within just one year, positioning us for a planned top-line data readout and potential BLA submission next year. We also initiated UP-NEXT, our randomized Phase 3 clinical trial that has the potential to be our post-approval confirmatory trial in the United States, support approvals in other countries and bring UpRi into an earlier disease setting. Additionally, we view our recent collaborations as a reflection of the progress we have made in advancing our three innovative platforms and our position as a partner of choice within the ADC field. We believe these accomplishments strengthen our foundation and will enable us to enter 2023 with momentum."

Strategic Goals, Recent Developments and Anticipated Milestones

Build Upifitamab Rilsodotin (UpRi), a First-in-Class NaPi2b-Targeting ADC, into a Foundational Medicine in Ovarian Cancer
Completed Enrollment in UPLIFT Registrational Trial: UpRi is a first-in-class NaPi2b-targeting ADC with a novel scaffold-linker-payload that enables high drug-to-antibody ratio and controlled bystander effect.​ The trial’s primary endpoint is the objective response rate (ORR) in the NaPi2b positive population, and secondary endpoints include the ORR in the overall population, as well as duration of objective response and incidence and severity of adverse events. While analysis of patient biopsies is ongoing, the company has already exceeded its minimum targeted number of NaPi2b-positive patients necessary for the primary endpoint analysis. The company plans to report topline data from the trial in mid-2023 and, assuming positive data, submit a potential BLA for UpRi for the treatment of patients with platinum-resistant ovarian cancer to the U.S. Food and Drug Administration (FDA) by the end of 2023.

Initiated Patient Enrollment and Dosing in UP-NEXT Trial: Patient dosing is now underway in UP-NEXT, the company’s Phase 3 clinical trial of UpRi as monotherapy maintenance following treatment with platinum doublets in recurrent platinum-sensitive ovarian cancer. If successful, UP-NEXT could serve as a post-approval confirmatory trial in the United States, support potential approvals outside of the United States and support UpRi’s expansion into earlier lines of therapy.

Nearing Completion of Dose Escalation in UPGRADE-A Trial: The dose escalation portion of UPGRADE-A, the company’s Phase 1/2 trial of UpRi in combination with carboplatin, is now nearly complete. The company expects to enter the dose expansion portion of UPGRADE-A in the first quarter of 2023 and plans to present data from the trial in the second half of 2023.

Build a Pipeline of Highly Impactful Cancer Medicines
Initiated Phase 1 Patient Dosing and Received Fast Track Designation for XMT-1660: XMT-1660 is a B7-H4-directed Dolasynthen ADC with a precise, target-optimized drug-to-antibody ratio (DAR 6) and Mersana’s clinically validated DolaLock microtubule inhibitor payload with controlled bystander effect. The company has initiated patient dosing in its multicenter Phase 1 trial investigating XMT-1660 in patients with breast, endometrial and ovarian cancers. The FDA has granted Fast Track designation to XMT-1660 for the treatment of adult patients with advanced or metastatic triple-negative breast cancer.

Readying for Initiation of XMT-2056 Phase 1 Trial: XMT-2056 is a systemically administered Immunosynthen STING agonist ADC (DAR 8) that is designed to target a novel HER2 epitope and locally activate STING signaling in both tumor-resident immune cells and in tumor cells, providing the potential to treat patients with HER2-high or -low tumors as monotherapy or in combination with standard-of-care agents. The company expects to initiate a multicenter Phase 1 open-label trial of XMT-2056 in previously treated patients with advanced/recurrent solid tumors expressing HER2, including breast, gastric, colorectal and non-small-cell lung cancers later in the fourth quarter of 2022.

Build Mersana with Strategic Partners
Received $100 Million Upfront Option Purchase Fee from GSK: In August 2022, Mersana announced a global collaboration providing GSK plc an exclusive option to co-develop and commercialize XMT-2056. Under the terms of the agreement, Mersana received an upfront option purchase fee of $100 million. Mersana is also eligible to receive up to $1.36 billion in the form of an option exercise payment and development, regulatory and commercial milestone payments if GSK exercises its option. Mersana has retained options to profit-share and to co-promote in the United States. If it exercises its profit-share option, Mersana will be eligible to receive tiered royalties on net sales outside of the United States. If Mersana does not elect to profit-share, it is eligible to receive double-digit tiered royalties on global net sales.
Third Quarter 2022 Financial Results

Net cash provided by operating activities in the third quarter of 2022, including the impact of the aforementioned $100 million upfront payment from GSK, was $54.6 million.

Cash, cash equivalents and marketable securities as of September 30, 2022, were $290.1 million, compared to cash and cash equivalents of $177.9 million as of December 31, 2021. Mersana expects that its available funds will be sufficient to support its operating plan commitments into the first half of 2024.

Collaboration revenue for the third quarter of 2022 was $5.6 million, compared to an immaterial amount for the same period in 2021. The year-over-year increase was primarily related to the company’s recent collaboration agreements with Janssen and GSK.

Research and development (R&D) expenses for the third quarter of 2022 were $50.6 million, compared to $35.3 million for the same period in 2021. Included in third quarter 2022 R&D expenses were $2.9 million in non-cash stock-based compensation expenses. The year-over-year increase in R&D expenses was primarily related to higher manufacturing and clinical costs related to UpRi and to an increase in headcount.

General and administrative (G&A) expenses for the third quarter of 2022 were $14.6 million, compared to $10.1 million during the same period in 2021. Included in third quarter 2022 G&A expenses were $2.5 million in non-cash stock-based compensation expenses. The year-over-year increase in G&A expenses was primarily related to increases in consulting and professional fees, and in headcount.

Net loss for the third quarter of 2022 was $59.8 million, or $0.61 per share, compared to a net loss of $45.5 million, or $0.63 per share, for the same period in 2021.
Conference Call Reminder
Mersana will host a conference call today at 8:00 a.m. ET to discuss business updates and its financial results for the third quarter of 2022. To access the call, please dial 646-307-1963 (domestic) or 800-715-9871 (international) and provide the Conference ID 9941053. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for approximately 90 days.

On November 7, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported the company’s scientific and management team’s participation in several scientific and investor conferences in November (Press release, MaaT Pharma, NOV 7, 2022, View Source [SID1234623253]).

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Details of the events are as follows:

Scientific conferences

November 8-10, 2022 – 9th International Human Microbiome Consortium (IHMC) Congress: Hervé Affagard, CEO and cofounder of MaaT Pharma, and Dr. Aurore Duquenoy, R&D specialist at MaaT Pharma will present three scientific posters at the conference in Kobe, Japan.
Link to the Congress here.
November 9-11, 2022 – 21st Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) Congress – Booth #10: Emilie Plantamura, Head of Clinical Development at MaaT Pharma and Claire de Condé, Head of Clinical Operations at MaaT Pharma, will attend the congress in Bordeaux, France and will be available for discussions at MaaT Pharma’s booth #10.
Link to the event here.

Investor conferences

November 14, 2022 – 7th annual conference Inve€$tival Showcase – LSX Leaders in partnership with Jefferies: Siân Crouzet, Chief Financial Officer of MaaT Pharma and Dr. Carole Schwintner, Chief Technology Officer of MaaT Pharma will attend the investor event in London, United Kingdom.
More information available here.
November 29, 2022 – Investir Day: Siân Crouzet, Chief Financial Officer of MaaT Pharma and Dr. Savita Bernal, Chief Business Officer of MaaT Pharma will attend the investor event in Paris, France.
More information available here.

On November 7, 2022 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage T-cell reprogramming company dedicated to developing curative cell therapies for patients with solid tumors, is presenting preclinical data at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) on its product candidates and new genetic and epigenetic reprogramming technologies (Press release, Lyell Immunopharma, NOV 7, 2022, View Source [SID1234623252]). This includes new preclinical research on the potential to generate more potent T cells to provide durable anti-tumor functions against certain aggressive solid tumor cancers.

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"Our SITC (Free SITC Whitepaper) presentations showcase compelling preclinical data underlying our lead TIL product candidate, LYL845, as well as the exciting progress Lyell’s research team is making to advance our understanding of how to counter T-cell exhaustion and generate T cells with properties of durable stemness," said Gary Lee, Ph.D., chief scientific officer at Lyell. "We are applying this research to grow our pipeline by creating new stackable reprogramming technologies as we continue to work toward our mission of developing adoptive T-cell therapies that deliver consistent, reliable and durable responses in solid tumors."

Preclinical Data on LYL845

Two presentations on Friday, Nov. 11 highlight preclinical data on LYL845, Lyell’s tumor-infiltrating lymphocyte (TIL) product candidate being evaluated for safety, tolerability and anti-tumor activity in a first-in-human Phase 1 clinical trial (NCT05573035). (Abstract Nos. 370 and 340).

The first presentation, titled "The Epi-R technology produces a polyclonal TIL product (LYL845) with a greater expansion success rate across hot and cold tumors, improved product phenotype, and maintenance of TCR diversity," showcases the ability of Epi-R technology to successfully expand TIL across three tumor types as compared to the standard (control) process. In this study, expanding TIL with Epi-R technology resulted in 100 percent success rate vs. 70 percent with control, including tumor samples collected from checkpoint inhibitor experienced melanoma patients. The study also includes colorectal tumor samples which have been considered more challenging to expand with standard processes. Further, in this study Epi-R technology yielded a product (LYL845) with a greater proportion of CD8+ T-cells and enriched for T-cells with stem-like profiles, better metabolic fitness, and preserved polyclonality compared to control TIL. These qualities have been linked with anti-tumor functionality and improved outcomes in previous TIL clinical trials.

The second presentation, titled "The Epi-R technology produces a polyclonal TIL product (LYL845) with diverse tumor-reactive clones that have stem-like qualities and anti-tumor function," highlights bioinformatic analyses demonstrating that LYL845 products expanded using Epi-R technology were highly polyclonal and retained putative tumor reactive clones with increased stemness and reduced exhaustion-associated genes compared to TIL products derived from the standard process. Moreover, tumor-specific reactivities of LYL845 were confirmed, and anti-tumor functions, including dose-dependent cytolytic activities and cytokine secretion, in tumor cell specific co-culture assays were demonstrated.

Stackable Genetic and Epigenetic Reprogramming Technologies in LYL119, a Second-Generation CAR T-cell therapy targeting ROR1+ solid tumors

Two presentations describe preclinical data on Lyell’s new, stackable reprogramming technologies – NR4A3 knockout and Stim-R – being incorporated in LYL119, a second-generation ROR1 targeting CAR T-cell product candidate.

An abstract titled "NR4A3 gene editing and c-Jun overexpression synergize to limit exhaustion and enhance functional activity of ROR1 CAR T cells in vitro and in vivo" being presented on Thursday, Nov. 10 demonstrates that the combination of two genetic reprogramming technologies, NR4A3 gene knockout and c-Jun overexpression, enhances the functional activity of ROR1 CAR T cells. This is demonstrated by higher levels of cytokine production, increased CAR T-cell persistence and reduced surface expression of inhibitory receptors after repetitive antigen stimulation, as well as significant improvement in tumor control in vivo (Abstract No. 243). NR4A3 and c-Jun both function within the activator protein 1 (AP-1) transcription factor pathway, which plays a key role in regulating T-cell function. This new research furthers the hypothesis that reprogramming of AP-1 transcription factor pathway in T cells may delay exhaustion and improve anti-tumor function. Lyell plans to incorporate these two stackable genetic reprogramming technologies in its new product candidate, LYL119, currently in preclinical development.

An abstract titled "Engineering potent CAR T-cell therapies by controlling T-cell activation signaling parameters using the Stim-R technology, a programmable synthetic cell-signaling platform" being presented on Friday, Nov. 11 describes Stim-R, Lyell’s new epigenetic reprogramming technology. Stim-R is a synthetic cell mimic that mediates precise signal molecule presentation to generate arrays of diverse ROR1-targeted CAR T-cell products (Abstract No. 252). This research demonstrates that Stim-R generates potent CAR T-cell products with increased polyfunctionality, persistence, anti-tumor activity, and reduced exhaustion following repeated antigen stimulation in vitro. These cells also showed greater CAR T-cell proliferation and persistence in vivo, as well as improved tumor control. Lyell also plans to incorporate this technology in LYL119.

On November 7, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning ("M.L.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported operational highlights and financial results for the third quarter ended September 30, 2022 (Press release, Lantern Pharma, NOV 7, 2022, View Source [SID1234623251]).

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"Leveraging large scale biomarker and clinical data, machine learning and artificial intelligence to fundamentally transform the cost, timeline and risk in developing oncology medicines has been the focus of Lantern. We are now advancing two drug-candidates in the Phase 2 clinical stage, and expect to launch two additional drug-candidates into first in human clinical trials in early 2023. We have rapidly advanced our new drug-candidates, LP-184 and LP-284, and been focused on advancing our rescued drug-candidates, LP-100 and LP-300 towards precise and meaningful treatment indications. Also, we have several additional therapeutic programs that we expect to introduce in the coming quarters with both our existing molecules and with new molecules and combinations that we have been validating with both AI-guided development and in highly targeted wet-lab studies," stated Panna Sharma, CEO and President of Lantern Pharma.

"The compression of costs and timeline, that we are creating with our drug development process, have allowed us to grow our portfolio from 3 programs 15 months ago to 11 programs today. We expect many of these programs to create high-value opportunities for our investors and potentially life-transforming therapies for patients," continued Sharma.

Portfolio Highlights:

LP-300 – Harmonic is a Phase 2 clinical trial for never smoker patients with relapsed NSCLC and will assess the effect of LP-300 in combination with standard-of-care (SOC) chemotherapy, pemetrexed and carboplatin, on patient overall and progression-free survival. This quarter Northwest Oncology and Hematology and Gabrail Cancer Center were activated as Harmonic’s first two clinical trial sites. Both sites are in the process of screening patients and are targeting to enroll the first patients this quarter. Several additional trial sites across the US are expected to be activated in Q4 2022 and Q1 2023 and will bolster patient recruitment and enrollment. Additional trial information on the Harmonic trial can be found at the new Harmonic website and the clinicaltrials.gov website.

The United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,471,431 for LP-300 uses, extending commercial protection for uses of LP-300 until late 2032. The patent is directed at increasing the survival time of cancer patients receiving LP-300 for cancers that are marked by overexpression of the regulatory proteins thioredoxin (TRX) or glutaredoxin (GRX) and/or exhibition of TRX- or GRX-mediated resistance to one or more chemotherapeutic interventions. Lantern’s current patent estate for LP-300 includes 43 patents, covering 8 patent families. Additionally, Lantern has multiple additional pending patent applications relating to LP-300 and is continuing to file patent applications in this area. The strengthened patent estate relating to LP-300 will stimulate the opportunity for future partnering discussions with biopharma companies.
LP-184 – The completion of IND enabling studies and the submission of the IND application to the US Food and Drug Administration (FDA) are anticipated for Q1 2023. LP-184 is under development for two major classes of cancers: solid tumors, including genetically defined pancreatic and bladder cancers, and several central nervous system (CNS) cancers, including glioblastoma (GBM) and brain metastases (brain mets.). Based on the differences in clinical needs and SOC for these cancer classes, two separate Phase 1 clinical trials are planned for LP-184 and are anticipated to launch in Q2 2023. In the US, the stand-alone market potential of these programs is estimated to be $5.0 billion for CNS cancers and over $1.0 billion for solid tumors.

In addition to LP-184’s adult cancer programs, LP-184 is also being developed for several rare pediatric cancers, including Atypical Teratoid Rhabdoid Tumors (ATRT), a highly aggressive and malignant pediatric CNS cancer with no existing SOC therapy. Lantern is in discussions with ATRT key opinion leaders (KOLs) about a pediatric trial design for a potential Phase 1 clinical trial.

Lantern presented new preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference for Pancreatic Cancer in collaboration with Igor Astsaturov, M.D., Ph.D. from The Marvin and Concetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center. The presentation highlighted results demonstrating that LP-184 has potent anti-tumor effects in pancreatic cancer mouse models harboring mutations in the DNA damage response genes ATR and BRCA1. Additionally, LP-184 was demonstrated to act synergistically in vitro and in vivo with several SOC agents including spironolactone and radiation therapy. These combined results exemplify the potential for LP-184 as a therapeutic agent for pancreatic cancer as a monotherapy or in combination with other approved therapies. The LP-184 AACR (Free AACR Whitepaper) poster can be viewed on Lantern’s website.
LP-284 – The IND enabling studies for LP-284 are estimated to be completed in Q1 2023, with the IND filing to the US FDA and Phase 1 clinical trial launch anticipated for Q2 2023. Lantern is developing LP-284 for non-Hodgkin’s B-cell lymphomas (NHL), where LP-284 has shown nanomolar potency across multiple in vitro and in vivo studies and where there is a demonstrated clinical need. NHL indications for LP-284 are targeted to include: Mantle Cell Lymphoma (MCL), Double Hit Lymphoma (DHL), and other NHL cancer subtypes. Globally, MCL and DHL alone are estimated to impact over 45,000 patients each year, with virtually all patients relapsing 2-5 years after treatment. There is a significant clinical need for additional late stage therapeutic options for these patients.

At the Society of Hematology and Oncology (SOHO) annual meeting, Lantern scientists presented new research on LP-284 for NHLs. The poster presentation featured results demonstrating that LP-284 has nanomolar anti-tumor potency in several MCL cell lines, including those that are resistant to SOC agents Ibrutinib and Bortezomib. LP-284’s anti-tumor efficacy in MCL SOC resistant cell lines supports its potential for patients who relapse or are resistant to these agents. The LP-284 SOHO poster can be viewed on Lantern’s website.
RADR Platform Growth and Development:

RADR, Lantern’s A.I and M.L. platform, continues to rapidly expand its oncology focused datapoints, at a pace well ahead of our year end goal. RADR’s data growth has advanced concurrently with significant upgrades to its functionality, computational infrastructure, and library of 200+ advanced machine learning algorithms, all of which continue to markedly accelerate and de-risk the drug programs of Lantern and its collaborators.
The RADR collaboration between Lantern and Actuate Therapeutics is advancing for the development of Actuate’s drug candidate elraglusib (formerly 9-ING-41). RADR-aided insights have accelerated development initiatives for elraglusib including identification of candidate biomarkers and development of M.L. models for clinical response. Highlights from the ongoing success of this collaboration are planned to be shared in an upcoming webinar.
Novel RADR-driven research was recently published and provides foundational insights into how A.I. can be applied to discover new indications for cancer drugs in record times and at significantly reduced costs. The research was done in collaboration with the National Cancer Institute (NCI) and highlights how large scale biological data, A.I., and M.L. were leveraged to rapidly identify ATRT as an indication for LP-184. A PDF of the new publication can be downloaded here, or read online on the Frontiers in Drug Discovery website.
Scientific Collaborations Update:

Lantern and Johns Hopkins University extended their productive research collaboration until the second half 2023. The collaboration will continue to facilitate future work for Lantern’s drug candidates for GBM and other CNS cancers.
In December, Lantern will host a KOL webinar on synthetic lethality, a key mechanism of action of Lantern’s drug candidates LP-184, LP-284, and LP-100. The webinar will feature an internationally recognized expert in synthetic lethality, Zoltan Szallasi, M.D., who serves joint appointments as principal investigator at The Danish Cancer Research Center and as assistant professor of pediatrics at Boston Children’s Hospital, a Harvard Medical School affiliate. Additional details about the KOL webinar will be announced in the coming weeks.
During Childhood Cancer Awareness Month in September, Lantern hosted a KOL webinar featuring Dr. Peter Houghton, Ph.D., a leading expert in childhood cancers at the Greehey Children’s Cancer Research Institute at the University of Texas Health Science Center – San Antonio. The webinar focused on challenges in drug development for pediatric cancers and preliminary results from Lantern’s drug candidates in preclinical pediatric cancer models. A replay of the KOL webinar can be found here.
Third Quarter 2022 Financial Overview

Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $57.8 million as of September 30, 2022, compared to approximately $70.7 million as of December 31, 2021. The quarterly cash burn rate continues to reflect our capital-efficient, collaborator-centered business model.
R&D Expenses: Research and development expenses were approximately $0.7 million for the quarter ended September 30, 2022 compared to approximately $2.96 million for the quarter ended September 30, 2021.

A substantial portion of this decrease in expenses relates to a $935,000 payment we received in July 2022 from one of our service providers in connection with the resolution of a difference of views regarding the service provider agreement. This payment contributed to an approximately $1,555,000 reduction in product candidate manufacturing related expenses during the three months ended September 30, 2022. In addition, we made a $1,000,000 upfront payment to Allarity Therapeutics during the three months ended September 30, 2021, which is nonrecurring.
G&A Expenses: General and administrative expenses were approximately $1.4 million for the quarter ended September 30, 2022, compared to approximately $1.2 million for the quarter ended September 30, 2021.
Net Loss: Net loss was approximately $2.3 million (or $0.21 per share) for the quarter ended September 30, 2022, compared to a net loss of approximately $4.1 million (or $0.36 per share) for the quarter ended September 30, 2021.
Earnings Call and Webinar Details

Lantern will host its third quarter fiscal year 2022 earnings call and webinar today, Monday, November 7, 2022 at 4:30 p.m. ET.

View Source
Related presentation materials will be accessible at: View Source
Replay Details

A replay of the Q3 2022 earnings call and webinar will be available at View Source.