On May 9, 2024 Commit Biologics, a pioneer in the activation of the complement system to treat cancer and autoimmune disease, reported it exits from stealth with €16m in seed funding from Bioqube Ventures and Novo Holdings (Press release, Commit Biologics, MAY 9, 2024, View Source [SID1234642908]).

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Commit plans to accelerate development of its Bispecific Complement Engaging (BiCE) platform, which uses single domain antibodies that bind to the complement protein C1q to activate the complement system, a fast-acting and potent part of the innate immune system. BiCE is a modular system that can arm antibodies to direct the complement system in a highly targeted way, so that it selectively kills cancer cells or immune cells that drive autoimmune diseases.

Commit is a spin-out from Aarhus University in Denmark, which has built a global reputation as a center of excellence in complement system biology over the last three decades. The Company was initially incubated and supported by the BioInnovation Institute in Denmark.

Krishna Polu, MD, Chief Executive Officer of Commit Biologics, said: "This financing from Novo Holdings and Bioqube Ventures validates our pioneering approach of engaging and activating the complement system for therapeutic purposes. Our BiCE platform gives us the ability to engage the complement system so that it attacks targeted cells in a highly selective manner. This platform also means we can use established antibodies, which cuts development times and reduces risk, to develop best-in-class therapeutics. This is a novel way of harnessing the immune system to tackle cancer and autoimmune disease, and we are confident in the tremendous potential it offers."

Jeroen Bakker, Partner at Novo Holdings, said: "With over 30 years of academic rigor from leaders in the complement field behind it, Commit is now unlocking the potential of the complement system to transform the fight against cancer and autoimmune diseases. The team has an incredible track record of domain expertise, and we look forward to working with them to support them on their journey."

Roderick Verhelst, Principal at Bioqube Ventures, said: "We believe Commit is doing something truly novel in the field of complement and advancing a technology with a multitude of therapeutic applications. Through its direct engagement of the complement system, this BiCE technology is a best-in-class approach for complement activation. The ability to arm conventional antibodies with potent complement activators for the development of targeted cell killing therapeutics is also a very attractive way of accelerating and derisking product development."

Commit’s uniquely engineered and highly specific approach to triggering the complement system is expected to have a wide therapeutic index and broad applicability. BiCE technology is modular and active across multiple tumor-associated and target antigens. This approach to activating the immune system can be used in conjunction with other mechanisms of action, such as T-cell directed therapies or other targeted treatments. While antibody drug conjugates, T-cell engagers and CAR-Ts have made important advances in recent years, these approaches can be limited by toxicities, specific target density considerations, and – with T-cell directed therapies – T-cell exhaustion. The BiCE technology can potentially address these limitations to enable the development of effective therapeutic options for the treatment of cancer and autoimmune diseases.

On May 9, 2024 Cimeio Therapeutics, a biotechnology company leading the field of epitope shielding, reported data for its CD52 program during this week’s Annual Meeting of the American Society of Cell & Gene Therapy (ASGCT) (Free ASGCT Whitepaper) in Baltimore (Press release, Cimeio Therapeutics, MAY 9, 2024, View Source [SID1234642983]). The abstract is titled "Molecular Shielding of CD52 Retains Expression, Anti-Phagocytic Don’t Eat Me Function and Protects from Alemtuzumab-Mediated Depletion."

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The study is the first showing that T cells expressing an engineered CD52 can be effectively shielded from Alemtuzumab-mediated depletion, while maintaining the general features of this receptor. Cimeio’s research team also showed for the first time that CD52 mediates an anti-phagocytotic ‘Don’t Eat Me’ signal, which is retained by the engineering. This program can serve as the basis for a novel approach to treating patients with T cell malignancies, non-genotoxic conditioning, and aiding in improving the persistence of allogeneic CAR T cells.

"Exhaustive screening as well as comprehensive expression, glycan and functional analyses allowed us to identify a base editable point mutation that protected T cells from Alemtuzumab, while allowing CD52 to maintain its cell surface expression, processing and function," said Stefanie Urlinger, Ph.D., Chief Scientific Officer at Cimeio. "We are excited to explore the full potential of our engineered CD52 receptor in the future. This can represent a viable alternative to CD52 knock-out on allogeneic CAR T cells, mediating resistance to lymphodepletion using Alemtuzumab and perhaps also contributing to a prolonged in vivo persistence."

On May 9, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence ("AI") company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning ("ML") platform with multiple clinical-stage drug programs, reported operational highlights and financial results for the first quarter 2024, ended March 31, 2024 (Press release, Lantern Pharma, MAY 9, 2024, View Source [SID1234642999]).

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"Our company made meaningful progress across multiple clinical trials and in furthering our AI platform this past quarter while advancing our internal capabilities to both support data-driven, precision oncology trials and accelerate the cost-effective development of drug-conjugates. Our team is at the forefront of demonstrating how combining emerging AI technologies, cancer biology and biomarker expertise along with focused clinical operations holds the promise of transforming timelines and costs in biopharma development." said Panna Sharma, President and CEO of Lantern Pharma.

Sharma continued, "Over the past several months, we have experienced growing interest in machine-learning enabled drug development and, in our RADR, AI platform. Our team is energized by the growing desire to adopt and leverage AI-driven innovations in biopharma and in the meaningful progress we are making with our own drug-candidates. We are excited about the opportunities we have in front of us to drive increased collaborations on our AI platform this year, and also propel the streamlined development of our own portfolio of high-value, high-impact drug-candidates."

Highlights of AI-Powered Pipeline:

LP-184 – Five cohorts of patients, comprised of dose levels 1 thru 5, have been enrolled and dosed – in escalating doses – in the ongoing Phase 1A clinical trial. This is a first-in-human Phase 1 trial across multiple solid tumor indications that are advanced and refractory to existing standard-of-care therapies. The trial is actively enrolling and dosing patients at dose level 6 that have relapsed/refractory advanced solid tumors, such as pancreatic cancer, glioblastoma (GBM), lung, triple-negative breast cancer, and multiple other solid tumor types. There have not been any observed dose-limiting toxicities to date.

The company believes that enrollment should be complete this summer and on-track for a readout of data in late summer or early fall. Current efforts are underway to focus enrollment efforts on cancer patients with tumors that have DDR(1) (DNA damage repair) deficiency. DDR deficient tumors have been observed to have higher sensitivity to LP-184. The company has also submitted a dose optimization and expansion protocol (Supplement A) to the FDA related to LP-184 in non-CNS solid tumors, including TNBC (triple negative breast cancer) with DDR alterations. Additionally, the company in collaboration with Starlight Therapeutics, has also submitted to the FDA a dose optimization and expansion protocol in recurrent IDH wild-type high grade gliomas (Supplement B).

The dosage and safety data obtained in the Phase 1a and 1b trials are expected to be used to advance the central nervous system (CNS) indications for a future Phase 2 trial to be sponsored by Lantern’s wholly owned subsidiary, Starlight Therapeutics. The Phase 1a data will also inform other anticipated later phase trials in select solid tumors, most likely with genomic signatures signifying DDR (DNA damage repair) deficiency, that have shown responsiveness to LP-184. Genomic identification of these patients and biomarker characterization of their underlying tumor is central to our focus of personalizing treatment and developing efficient later stage clinical trials. To further this effort, Lantern has also initiated the development of a PCR-based molecular diagnostic test that may help in identifying cancer patients with the best likelihood of response and benefit from treatment with LP-184.

AI and preclinical studies are ongoing to further refine drug combination studies supporting the use of LP-184 to improve the durability or overall response rates in combination with FDA approved drugs that are widely used in cancer treatment. Globally, the aggregate annual market potential of LP-184’s target indications is estimated to be approximately $12+ billion, consisting of $4.5+ billion for CNS cancers and $7.5+ billion for solid tumors.

LP-284 – The initial two cohorts of patients have been dosed, and no dose-limiting toxicities have been observed in the Phase 1a clinical trial. The company expects to open additional sites in the US throughout the second quarter with the potential to advance to Phase 1b/2 by the close of 2024. LP-284 has shown nanomolar potency across multiple published in vitro and in vivo studies, including mantle cell lymphoma (MCL), double hit lymphoma (DHL), and other advanced NHL cancer subtypes and certain sarcomas with DDR deficiencies, notably those with compromised functioning of the ataxia-telangiectasia mutated (ATM) gene due to mutations or deletions. Nearly all MCL, DHL, and HGBL patients relapse from the current standard-of-care agents and there is an urgent and unmet need for novel improved therapeutic options for these patients. In the US and Europe, MCL, DHL, and HGBLs are diagnosed in 16,000-20,000 patients each year and have an estimated annual market potential of over USD 3+ billion.

LP-300 – The phase 2 Harmonic clinical trial sites in the US are continuing to screen for patients and have also increased the pace of enrollment. This past quarter we also received approval to proceed with the Phase 2 clinical trial in Japan and Taiwan. This is expected to accelerate the collection of patient and response data needed for the next-stage of evaluation and development of LP-300, an investigational therapeutic for the treatment of relapsed and inoperable primary adenocarcinoma of the lung given in combination with chemotherapy Additionally, it may also bring a needed therapeutic option for LCINS (Lung Cancer In Never Smokers) diagnosed patients in Japan and Taiwan, where one-third of all lung cancer diagnoses are made among those who have never smoked.

Dr. Yashushi Goto, a physician and researcher focused on lung cancer at the National Cancer Center of Japan, will be leading the phase 2 trial in Japan, where the incidence of non-small cell lung cancer (NSCLC) in never-smokers is double or more than that of the United States. Lantern believes that this improves the positioning for drug-candidate LP-300 to develop collaborative and co-development partnerships with global biopharma companies with a primary focus in serving the Asian markets.

The Harmonic trial is assessing the effect of LP-300 in combination with standard-of-care chemotherapy (carboplatin and pemetrexed) in LCINS patients with relapsed NSCLC. Globally, LCINS patients are a growing population of patients and do not respond well to PD-1/PD-L1-based therapies or the available chemotherapy doublets, leaving them with reduced treatment options. In the US it is estimated that LP-300 has an annual market potential of $1.5 billion, and a global estimated annual market potential of over $2.6 billion. LCINS is the eighth leading cause of cancer-related mortality in the USA and the fifth most common cause of cancer-related deaths worldwide.

RADR Platform Growth and Development:

RADR continues to advance in size, scope, and capabilities and is progressing towards becoming a standard for AI-driven drug development in oncology – for both early-stage development and later-stage patient biomarker and combination therapy identification. The company recently announced a artificial intelligence (AI)-driven collaboration to optimize the development of a protein disulfide isomerase (PDI) inhibitor drug candidate, XCE853, for a variety of novel and targeted cancer indications. The collaboration is leveraging RADR’s AI-based capabilities, including 200+ machine learning (ML) algorithms and foundational models for oncology drug development to uncover biomarkers and molecular correlates of efficacy and define potential combination regimens to sharpen and accelerate XCE853’s drug development strategy. Lantern Pharma is receiving equal IP co-ownership and drug development rights in newly discovered biomarkers, novel indications, and use for new pharmacological strategies for XCE853.

The scope of RADR’s data has broadened with a strategic focus on additional classes of compounds, including drug-conjugates such as ADCs and inclusion of detailed data on chemical and biochemical features and drug-interaction data. Additionally, data from clinical studies such as those being obtained from liquid biopsy, and data from preclinical combination studies that aim to define drug interaction and optimal dosage are being incorporated into the datapoints and data sets powering RADR. Lantern expects to pursue additional biopharma and technology partnerships during 2024 to further advance and commercialize the RADR AI platform.

Starlight Therapeutics:

Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma focused on CNS and brain cancers with STAR-001, continues advancements with the filing of a clinical trial protocol for the Phase 1B dose optimization and expansion cohort in recurrent IDH wild-type high grade gliomas. IDH wild-type glioblastomas are the most malignant glial tumors with median survival of only 14–16 months after diagnosis; patients aged ≥ 65 years have reportedly worse outcomes.(3) Lantern formed a wholly-owned subsidiary, Starlight Therapeutics Inc. ("Starlight"), in early 2023 for the clinical development of drug candidate LP-184’s central nervous system (CNS) and brain cancer indications – including GBM, brain mets., and several rare pediatric CNS cancers. Starlight will refer to the molecule LP-184, as it is developed in CNS indications, as "STAR-001". The indications and mechanistic insights powering the creation of Starlight and the identification of multiple CNS tumors that can be potentially impacted were largely driven by insights and analysis from the RADR AI platform.

During Q4 of 2023 Lantern announced that it had hired a CMO, Dr. Marc Chamberlain, who will focus on Starlight’s clinical trials, development of personnel to execute on the planned clinical trials and overall support in corporate development activity. Starlight and Lantern expect to initiate Phase 1b/2 clinical trials during the second half of 2024. The market potential for the currently planned indications for Starlight’s synthetically-lethal, cancer-cell DNA damaging agent – STAR-001 – is estimated to be 4.5 billion to 5+ billion USD across both adult and pediatric primary and secondary CNS cancers.

ADC & Drug Conjugate Programs:

During the first quarter, Lantern, in collaboration with academic research partners in Germany, advanced the development, synthesis, and preclinical proof-of-concept of a novel, highly potent, cryptophycin-based ADC (cpADC). The cpADC has shown picomolar potency in a wide range of solid tumors tested in preclinical development and is being further evaluated for clinical potential in six solid tumor indications. In preclinical work, the cpADC produced an 80% cancer cell kill rate which was more than other commonly used approved ADCs, including in a cancer sub-type, medium and low HER-2 expression cancers, which is an area of critical patient need. Lantern expects to move towards IND development of its ADC program during 2024 with a focus on select solid tumors that are unresponsive or refractory to current therapies.

Additionally, Lantern has advanced its AI module for differentiated, machine-learning based ADC development, characterization, analysis and bioactivity prediction. The ADC module is being developed as an extension to RADR and leverages the data and biomarker insights curated by and generated in RADR. Lantern has plans to further advance the development through partnerships and collaborations with both technology and biopharma companies.

Additional Operational Highlights:

A new publication on the lethal activity of LP-184, inducing elevated levels of DNA double-strand breaks, in HR deficient (HRD) cancer cells was published by research scientists at Lantern Pharma in collaboration with Georgetown University Medical Center in Cancer Research Communications. The publication showcased that depletion of key HR components BRCA2 or ataxia telangiectasia mutated (ATM) in cancer cells conferred up to 12-fold increased sensitivity to LP- 184 and that LP-184 showed nanomolar potency in a diverse range of HRD cancer models. A link to the publication titled "LP-184, a Novel Acylfulvene Molecule, Exhibits Anticancer Activity against Diverse Solid Tumors with Homologous Recombination Deficiency" can be accessed here.

New data and scientific findings for LP-284 and the ongoing clinical trial were presented at AACR (Free AACR Whitepaper) (American Association for Cancer Research) during the 2024 Annual Meeting in San Diego – Phase 1a/1b clinical trial of LP-284, a highly potent TP53 mutation agnostic DNA damaging agent, in patients with refractory or relapsed lymphomas and solid tumors (NCT06132503)

The company also announced during April that it will hosting a series of educational and informative webinars focused on updates on Lantern’s areas of research, clinical trials and AI efforts titled Webinar Wednesdays. The first of these webinars was held on April 24th and featured Dr. Joseph Treat, a Professor in the Department of Hematology and Oncology, Vice Chair of Education, and Medical Director of Ambulatory Care at Fox Chase Cancer Center discussing LP-300 and the Harmonic clinical trial focused on LCINS patients.

First Quarter 2024 Financial Highlights

Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $38.4 million as of March 31, 2024, compared to approximately $41.3 million as of December 31, 2023. The quarterly cash burn rate continues to reflect our capital-efficient, collaborator-centered business model.

R&D Expenses: Research and development expenses were approximately $4.3 million for the quarter ended March 31, 2024, compared to approximately $2.6 million for the quarter ended March 31, 2023. This increase was largely driven by an increase in clinical trial activity and clinical trial site activations.

G&A Expenses: General and administrative expenses were approximately $1.5 million for the quarter ended March 31, 2024, compared to approximately $1.7 million for the quarter ended March 31, 2023.

Net Loss: Net loss was approximately $5.4 million (or $0.51 per share) for the quarter ended March 31, 2024, compared to a net loss of approximately $3.9 million (or $0.36 per share) for the quarter ended March 31, 2023.

Warrant Exercises: Lantern issued 20,132 shares of common stock during Q1 2024, relating to the cashless exercise of warrants to purchase 79,021 shares. Also, in Q1 2024, Lantern issued 17,481 shares of common stock for aggregate proceeds of approximately $55,000, relating to the exercise of warrants for cash. Following these exercises, there remain 81,496 warrants outstanding to purchase Lantern common stock at a weighted average exercise price of $16.55 per share.

Earnings Call and Webinar Details:

Lantern will host its 1st quarter 2024 earnings call and webinar today, May 9, 2024, at 4:30 p.m. ET. A link to register can be accessed at: Lantern 1st Quarter 2024 Earnings Call & Webinar Link

Related presentation materials will be accessible at: View Source
A replay of the 1st quarter 2024 earnings call and webinar will be available at: View Source

On May 9, 2024 Recursion (Nasdaq: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, reported business updates and financial results for its first quarter ending March 31, 2024 (Press release, Recursion Pharmaceuticals, MAY 9, 2024, View Source [SID1234643015]).

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"We are excited about the multiple upcoming value catalysts that could potentially occur in the near-term, including clinical trial readouts, partnership option exercises, new partnerships, and interest in Recursion’s data and technology solutions," said Chris Gibson, Ph.D., Co-founder and CEO of Recursion. "It is great to see individuals from both the biopharma and technology industries demonstrating an understanding and appetite for the power of combining large-scale computing resources with the ability to generate a proprietary source of large-scale data. To that end, we are thrilled to welcome Dr. Najat Khan to Recursion who will help lead our R&D and commercialization efforts."

Summary of Business Highlights
•Pipeline
◦Cerebral Cavernous Malformation (CCM) (REC-994): Our Phase 2 SYCAMORE clinical trial is a randomized, double-blind, placebo-controlled study of two doses of REC-994 in participants with CCM. The primary endpoint of the study is safety and tolerability. Secondary and exploratory endpoints, including clinician measured outcomes, imaging of CCM lesions, patient reported outcomes, and selected biomarkers, will be evaluated. This trial was fully enrolled in June 2023 with 62 participants, where the vast majority of participants who completed 12 months of treatment have entered the long-term extension study. We expect to share Phase 2 data in Q3 2024.

◦Neurofibromatosis Type 2 (NF2) (REC-2282): Our adaptive Phase 2/3 POPLAR clinical trial is a randomized, two part study of REC-2282 in participants with progressive NF2-mutated meningiomas. Part 1 of the study is ongoing and is exploring two doses of REC-2282 in approximately 23 adults and 9 adolescents, with enrollment in adults expected to complete in Q2 2024. We expect to share Phase 2 safety and preliminary efficacy data in Q4 2024.
◦Familial Adenomatous Polyposis (FAP) (REC-4881): Our Phase 1b/2 TUPELO clinical trial is an open label, multicenter, two part study of REC-4881 in participants with FAP. Part 1 is complete and enrollment in Part 2 has commenced. We expect to share Phase 2 safety and preliminary efficacy data in H1 2025.

◦AXIN1 or APC Mutant Cancers (REC-4881): Our Phase 2 LILAC clinical trial is an open label, multicenter study of REC-4881 in participants with unresectable, locally advanced or metastatic cancer with AXIN1 or APC mutations. This study was initiated at the end of 2023 with the first participant dosed in Q1 2024. Since that time, multiple participants are now enrolled. We expect to share Phase 2 safety and preliminary efficacy data in H1 2025.
◦Clostridioides difficile Infection (REC-3964): REC-3964 is a first-in-class C. difficile toxin inhibitor and the first new chemical entity developed by Recursion, with promising preclinical efficacy data seen in relevant models (superiority versus bezlotoxumab). Full Phase 1 data from our healthy volunteers study will be presented at the World Congress on Infectious Diseases in Paris in June 2024. We expect to initiate a randomized Phase 2 study in patients at high risk for C. difficile infection recurrence in 2024.

◦Advanced HR-Proficient Cancers (RBM39): RBM39 is a novel CDK12-adjacent target identified by the Recursion OS. We intend to position our lead candidate as a single agent for the potential treatment of advanced HR-proficient cancers including ovarian and other solid tumors. We expect to submit an IND in H2 2024 and anticipate initiating a Phase 1 open label study of our lead candidate in participants with relapsed/refractory cancer. The primary endpoint of the study will be safety and tolerability. Secondary endpoints will explore pharmacokinetics and preliminary signs of anti-tumor activity.

◦Undisclosed Indication in Fibrosis (Target Epsilon): This program originated under our initial fibrosis collaboration with Bayer and we have since in-licensed from Bayer all rights to this program. We are advancing our lead candidate through IND-enabling studies with IND submission expected in the near-term.

•Platform

◦Supercomputer Expansion: We worked with our partner NVIDIA to design and build BioHive-2, our next generation supercomputer with over 500 H100 GPUs. We have nearly completed the build out of BioHive-2 and began performance benchmarking tests. We believe that the performance of our supercomputer may place BioHive-2 in the top 50 of the next TOP500 list, making it one of the most powerful supercomputers in the world across any industry and the most powerful supercomputer owned and operated by any biopharma company. These computational resources, paired with Recursion’s vast datasets and data generation capabilities, enable the construction of Recursion’s large foundation models for biology, chemistry and causal patient outcomes.
◦Whole-Genome Transcriptomics Map: We continue to focus on key technologies that enhance our ability to generate, extract and validate novel insights for therapeutic advancements. Over the past year, we have scaled our transcriptomics technology in order to validate phenotypic-insights and relate to patient-derived RNA sequencing data. In April, we announced sequencing our 1 millionth transcriptome. We believe that we are one of the largest transcriptomics sequencers in the world and are advancing the development of a whole-genome knockout transcriptomics map, which we expect to complete in the coming quarters. Such platform capabilities are important for curating scaled datasets that are relatable and provide a more complete understanding of biology, chemistry, and patient outcomes.

◦Active Learning: We have been applying active learning approaches to predict where our OS should generate and enrich biological and chemical datasets via phenotypic and ADME compound profiling across existing and new cellular contexts. These capabilities enable Recursion to rapidly construct multiomics maps that are enriched for areas of biology and chemistry that may be of high value for translating insights into therapeutic programs. We believe that such approaches enable Recursion to more rapidly expand its data moat and see active learning capabilities as an important step towards autonomous drug discovery.

•Partnerships

◦Helix Collaboration: Recursion entered into a multi-year agreement with Helix to access hundreds of thousands of de-identified records including Helix’s Exome+(R) genomic data and data from longitudinal health records. Recursion plans to use this data to train causal AI models and design biomarker and patient stratification strategies across broad disease areas. The Helix dataset expands Recursion’s integration of real-world patient data and complements Recursion’s access to Tempus’ oncology data.
◦Transformational Collaborations: We continue to advance efforts to discover potential new therapeutics with our strategic partners in the areas of undruggable oncology (Bayer) as well as neuroscience and a single indication in gastrointestinal oncology (Roche-Genentech). In the near-term, there is the potential for option exercises associated with partnership programs, option exercises associated with map building initiatives or data sharing and additional partnerships in large, intractable areas of biology or technological innovation.

Additional Corporate Updates
•L(earnings) Call: Recursion will host a L(earnings) Call on May 9, 2024 at 5:00 pm Eastern Time / 3:00 pm Mountain Time. Recursion will broadcast the live stream from Recursion’s X (formerly Twitter), LinkedIn and YouTube accounts and there will be opportunities to ask questions of the company.
•Chief R&D Officer and Chief Commercialization Officer: In April 2024, Recursion named Najat Khan, Ph.D. as Chief R&D Officer and Chief Commercialization Officer. Previous to joining Recursion, Dr. Khan worked at Johnson & Johnson for over 6 years, serving most recently as Chief Data Science Officer and Global Head of Strategy & Portfolio Organization for Innovative Medicine R&D. Dr. Khan has also been appointed to Recursion’s Board of Directors.
•London Office: In March 2024, Recursion announced plans to open a new office in London in order to recruit top TechBio talent within the areas of computational biology, machine learning and data science. Additionally, Recursion announced that Prof. Michael Bronstein, DeepMind Professor of Artificial Intelligence at Oxford University, will join Recursion as a Scientific Advisor.
•Annual Shareholder Meeting: Recursion’s Annual Shareholder Meeting will be held on June 3, 2024 at 10:00 am Eastern Time / 8:00 am Mountain Time.

First Quarter 2024 Financial Results

•Cash Position: Cash and cash equivalents were $296.3 million as of March 31, 2024.

•Revenue: Total revenue was $13.8 million for the first quarter of 2024, compared to $12.1 million for the first quarter of 2023. The increase was due to revenue recognized from our partnership with Roche, as our mix of work on the three performance obligations shifted towards higher cost processes including the progression of work related to one of our neuroscience performance obligations.

•Research and Development Expenses: Research and development expenses were $67.6 million for the first quarter of 2024, compared to $46.7 million for the first quarter of 2023. The increase in research and development expenses was across all development phases as we continue to expand and upgrade our platform, including our chemical technology, machine learning and transcriptomics platform. Our discovery costs increased as we advanced our preclinical pipeline including our work on Target Epsilon. Our clinical costs grew as we continued to progress through our various clinical trials.

•General and Administrative Expenses: General and administrative expenses were $31.4 million for the first quarter of 2024, compared to $22.9 million for the first quarter of 2023. The increase in general and administrative expenses was due to an increase in salaries and wages of $3.9 million and increases in software and depreciation expenses.
•Net Loss: Net loss was $91.4 million for the first quarter of 2024, compared to a net loss of $65.3 million for the first quarter of 2023.

•Net Cash: Net cash used in operating activities was $102.3 million for the first quarter of 2024, compared to net cash used in operating activities of $73.3 million for the first quarter of 2023. The increase in net cash used in operating activities compared to the same period last year was due to higher operating costs incurred for research and development and general and administrative due to Recursion’s expansion and upgraded capabilities. Net cash used in operating activities was $74.1 million for the fourth quarter of 2023. The increase in net cash used compared to the fourth quarter of 2023 was due to paying our annual cash bonuses to employees of $18.0 million, timing of accrual payments of $6.4 million and a lease deposit prepayment for our BioHive-2 supercomputer of $1.6 million.

On May 9, 2024 Coya Therapeutics, Inc. (Nasdaq: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, reported a corporate update and announces its financial results for the quarter ended March 31, 2024 (Press release, Coya Therapeutics, MAY 9, 2024, View Source [SID1234643046]).

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Recent Corporate Highlights

Announced successful pre-IND and Type C meetings with FDA in January 2024 to advance the development of COYA 302 for the treatment of ALS; IND expected to be filed in 2Q24 followed by initiation of Ph. 2 trial with COYA 302 in ALS
Expanded pipeline of COYA 302 in January 2024 beyond ALS to also include Frontotemporal Dementia (FTD), with an IND planned in 2H24, and Parkinson’s disease (PD), with animal data to be released in 2H24
Expanded patent estate surrounding next-generation immune modulatory biologics in February 2024 through a license from the University of Nebraska Medical Center to cover multiple LD IL-2 combinations, including those with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
Expanded pipeline of COYA 302 in February 2024 to include AD; COYA 302 to now be explored in four neurodegenerative diseases (ALS, PD, FTD, and AD) – Coya to leverage data from the Ph. 2 LD IL-2 study in AD to inform on strategy and next steps for COYA 302 in AD
Presented data in March 2024 on immune system and Regulatory T Cell (Treg) contribution in Frontotemporal Dementia (FTD) patients at the AD/PD 2024 Conference
Presented novel biomarker data in March 2024 documenting serum levels of a biomarker (4-HNE) that strongly correlate with rate of progression and survival in patients with ALS at the Society of Neuroimmune Pharmacology conference. Coya has filed intellectual property on multiple uses of 4-HNE in ALS
Presented updated biomarker data in late April 2024 at the 2nd Annual Johnson Center Symposium that showed 4-HNE levels were predictive of survival in ALS patients and are elevated at diagnosis in bulbar vs. limb onset ALS
"During the first quarter of 2024, we expanded our clinical pipeline with our lead asset COYA 302 beyond the initial indication of ALS and into FTD, Parkinson’s, and Alzheimer’s diseases," stated Howard Berman, Ph.D., Coya’s Chief Executive Officer. "Based on our work to date, we believe the dual mechanism of action from COYA 302, a combination of our proprietary low-dose IL-2 and CTLA4-Ig, holds immense potential in treating such neurodegenerative diseases that have complex immune pathways. The combination effect of restoring Tregs via low-dose IL-2 and inhibiting other inflammatory cell types via CTLA4-Ig could be a significant breakthrough therapeutic approach, much like the growing acceptance of combination therapy in treating cancer or viral diseases. Many patients, families, and caregivers are looking for meaningful new therapies for these neurodegenerative diseases.

"We expect to report clinical progress from a number of initiatives over the balance of 2024 with COYA 302, our ‘pipeline in a product.’ In ALS, our lead indication, we expect to file the IND for COYA 302 in 2Q24 and subsequently initiate the Ph. 2 trial. Over the last two months, we have presented encouraging data in patients with ALS that strongly correlates the biomarker 4-HNE with the rate of progression and survival in patients with ALS. We are in discussions with the FDA about the inclusion of 4-HNE in the expected Ph. 2 trial. Additionally, clinical data from the previously completed investigator-initiated trial in patients with ALS is also anticipated in the second quarter.

"In Alzheimer’s disease, data from the Ph. 2 investigator-initiated trial involving COYA 301, or low-dose IL-2 alone, is expected in the summer of 2024. Given our previously announced decision to move forward in Alzheimer’s with COYA 302, data from this trial will help guide us in the subsequent trial design of COYA 302 in AD. Obviously, Alzheimer’s disease is a huge unmet need, so we eagerly anticipate results from the Ph. 2 trial of COYA 301.

"In 2H24, we expect to file the IND in FTD and subsequently initiate a Ph. 2 trial thereafter. Data shared in March 2024 at the AD/PD 2024 Conference in Lisbon highlighted the reduction in Treg suppressive function and the simultaneous elevated inflammatory environment in patients with FTD. This data in FTD is consistent with Treg dysfunction and increased inflammatory levels in other progressive and neurodegenerative diseases and supports the multi-pathway combination approach of COYA 302.

"The potential therapeutic applications with COYA 302 in neurodegenerative diseases are vast. Dr. Reddy’s Laboratories was granted an exclusive license in December 2023 for COYA 302 in ALS patients in the U.S., Canada, the EU, and the U.K. We continue to have discussions about additional commercial partnerships and license opportunities for COYA 302 in other indications outside of ALS, including FTD, Parkinson’s and Alzheimer’s diseases. Our cash and cash equivalents balance of $36.0 million provides us a runway into 2026, so we can be patient with any future commercial negotiations in order to maximize shareholder value. I look forward to sharing additional corporate, clinical, and regulatory progress as warranted," concluded Berman.

Unaudited Financial Results

As of March 31, 2024, Coya had cash and cash equivalents of $36.0 million.

Research and development (R&D) expenses were $3.1 million for the three months ended March 31, 2024, compared to $1.2 million for the three months ended March 31, 2023. The change was primarily due to a $1.7 million increase in our preclinical expenses and a $0.2 million increase in internal research and development expenses.

General and administrative expenses were $2.4 million for the three months ended March 31, 2024 and $1.7 million for the three months ended March 31, 2023, a change of approximately $0.7 million. The increase was primarily due to an increase in personnel related expenses and consulting fees as we continue to expand our operations to support our research and development efforts.

Net loss was $5.1 million for the three months ended March 31, 2024, compared to net loss of $2.7 million for the three months ended March 31, 2023.