On May 9, 2024 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported a business update and announced first quarter 2024 financial results (Press release, Oncternal Therapeutics, MAY 9, 2024, View Source [SID1234643012]).

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"We are encouraged by the fast pace of execution for our clinical programs, and we are looking forward to important clinical data readouts in the coming months. Our Phase 1/2 study of ONCT-534 in patients with R/R mCRPC has advanced swiftly through the initial dose escalation cohorts and we are optimistic, based on preclinical data, that the 300 mg dose may be within the active dose range for antitumor activity. We believe that the novel mechanism of action of ONCT-534, which includes interaction with both the N-terminal and ligand-binding domains of the AR has the potential to address important unmet needs of prostate cancer patients who have progressed after treatment with approved AR pathway inhibitors," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "Our ROR1 CAR T Phase 1/2 study is now open and enrolling patients after implementing protocol amendments. We continue to be encouraged by the initial response signals we observed, and we look forward to reporting additional clinical data in patients with relapsed or refractory aggressive B cell lymphoma, including those who have relapsed after CD19 CAR T treatment."

Recent Highlights

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In April 2024, we announced that the first patient had been dosed in the fourth cohort of our Phase 1/2 study of ONCT-534 for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI). Patients in the fourth dosing cohort will receive 300 mg of ONCT-534 taken orally each day. The fourth cohort is now fully enrolled with three subjects treated.
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Our dose escalation/dose expansion Phase 1/2 Study ONCT-808-101, evaluating our ROR1-targeting autologous CAR T cell therapy, ONCT-808, for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma, is open and enrolling patients. Protocol changes that include modified eligibility criteria, increased monitoring for early infection, and evaluating lower doses have now been implemented.

Expected Upcoming Milestones

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ONCT-534, our dual-action androgen receptor inhibitor
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Initial clinical data update in the second quarter of 2024
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Additional clinical data readouts in the fourth quarter of 2024
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ONCT-808, our autologous ROR1-targeted CAR T cell therapy
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Clinical data update in mid-2024
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Additional clinical data readouts in the fourth quarter of 2024
First Quarter 2024 Financial Results

Our grant revenue was $0.6 million for the first quarter ended March 31, 2024. Our total operating expenses for the first quarter ended March 31, 2024 were $9.3 million, including $1.4 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $6.0 million, and general and administrative expenses for the quarter totaled $3.3 million. Net loss for the first quarter was $8.4 million, or a net loss of $2.83 per share, basic and diluted. As of March 31, 2024, we had approximately 3.0 million shares of common stock outstanding, $27.0 million in cash, cash equivalents and short-term investments and no debt. These funds are expected to be sufficient to fund our operations into the first quarter of 2025.

On May 9, 2024 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, reported new preclinical data supporting the potential of its fully non-viral lead genetic medicines programs and related platform technologies (Press release, Poseida Therapeutics, MAY 9, 2024, View Source [SID1234643043]). The data was included in three oral and three poster presentations at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2024 Annual Meeting, being held in Baltimore, MD and virtually on May 7-11, 2024.

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"Poseida’s unique and proprietary toolkit, which enables non-viral gene insertion, high-fidelity gene editing, and associated delivery and manufacturing technologies, has been the driving force behind our emerging genetic medicines programs and our clinical stage allogeneic CAR-T pipeline," said Blair Madison, Ph.D., Chief Scientific Officer, Gene Therapy at Poseida Therapeutics. "Starting with our recent R&D Day, and continuing with ASGCT (Free ASGCT Whitepaper), we have showcased the maturity and power of our tools specific to enabling a fully non-viral and potentially tunable approach to in vivo genetic medicine. We believe this could provide our medicines with a superior profile featuring a minimized risk of off-target effects that can be customized to each patient, when appropriate. Taken together, these data give us confidence as we continue to validate our non-viral approach, seeking to achieve durable correction in patients suffering from rare diseases such as Hereditary Angioedema and Hemophilia A."

Oral Presentations

Title: Highly Specific Non-Viral Gene Editing with P-KLKB1-101 for Hereditary Angioedema
Presenting Author: Blair Madison, Ph.D., Poseida Therapeutics, Inc.
Session Title: Correction of Genetic Disorders of the Blood and Immune System
Presentation Date/Time: Thursday, May 9, 2024, 1:30 – 1:45 PM ET
Location: Room 314-317
Abstract Number: 170

Hereditary Angioedema (HAE) is a rare inherited disorder characterized by recurrent episodes of fluid accumulation outside of blood vessels, causing rapid swelling of tissues. HAE patients have significant unmet need for a durable, effective, and convenient treatment option that eliminates recurrent attacks. P-KLKB1-101 is a fully non-viral investigational gene editing therapy designed to enable high fidelity editing at pre-kallikrein, or KLKB1, for targeted correction of HAE. It utilizes the Cas-CLOVER nuclease to achieve clean site-specific gene editing that is engineered for high specificity. In pre-clinical studies, P-KLKB1-101 demonstrates excellent efficiency editing liver cells with off-target edits <0.1% over a wide range of lipid nanoparticle (LNP) concentrations. Poseida’s gene editing delivery technologies, including novel ionizable lipid and LNP, enable a highly controlled dose response. Interim non-human primate (NHP) data demonstrate favorable tolerability and liver editing approaching the desired therapeutic range. Development of P-KLKB1-101 is ongoing, including continuation of dose-finding studies in NHPs, CMC manufacturing, scale-up, and additional preparations for IND-enabling studies.

Title: Sustained FVIII Expression with a Tolerable, Titratable, Fully Non-Viral Gene Therapy for Hemophilia A
Presenting Author: Brian Truong, Ph.D., Poseida Therapeutics, Inc.
Session Title: Liver Genetic Diseases
Presentation Date/Time: Thursday, May 9, 2024, 5:00 – 5:15 PM ET
Location: Room 324-326
Abstract Number: 210

P-FVIII-101 is a fully non-viral gene insertion-based therapy for the treatment of Hemophilia A, an X-linked bleeding disorder caused by a deficiency in coagulation Factor VIII (FVIII). It utilizes Poseida’s proprietary transposon technology combined with nanoparticle delivery to achieve site-specific gene insertion into DNA. Data demonstrate that a single dose of P-FVIII-101 achieves Hemophilia A disease correction with sustained FVIII expression observed over the 13-month duration of the mouse study. The pre-clinical data also support the potential for repeat dosing, enabled by the fully non-viral approach. P-FVIII-101 can also be combined with Poseida’s new proprietary modulator switch, which allows inducible down-regulation to enable patient-specific fine tuning of FVIII levels, which is seen as an important product attribute by the hemophilia community.

Development of P-FVIII-101 is ongoing with final optimization of the nanoparticle delivery modality to be validated in NHPs.

Title: A Durable Gene Therapy with a Robust AAV-LNP Delivery System Allowing for a Reduced AAV Dose
Presenting Author: Jack Rychak, Ph.D., Poseida Therapeutics, Inc.
Session Title: AAV Vectors – Preclinical and Proof-of-Concept: Technology Focus
Presentation Date/Time: Friday, May 10, 2024, 1:45 – 2:00 PM ET
Location: Ballroom 2
Abstract Number: 248

This presentation highlights data from studies exploring the feasibility of combining existing adeno-associated virus delivery vectors (AAVs) with Poseida’s piggyBac DNA insertion system. This approach is intended to achieve stable integration of a transgene into a large percentage of hepatocytes for maximal therapeutic benefit, which cannot be readily achieved using an AAV or episomal approach. Pre-clinical data demonstrate exceptional efficacy in mouse models of severe Ornithine Transcarbamylase Deficiency (OTCD). Additionally, robust potency is observed in mouse models of Phenylketonuria (PKU), using low AAV doses, and enabled by the integration of a therapeutic transgene with the SPB transposase. These data highlight the utility of the hybrid platform for enabling effective treatment with lower AAV doses, even in the growing liver early in life. With Poseida’s current internal focus on fully non-viral approaches, as announced at the Company’s recent R&D Day, the Company may opportunistically consider partnering transactions with respect to its P-PAH-101 and P-OTC-101 programs.

Poster Presentations

Title: Advanced Gene Editing with an Enhanced Site-Specific Nuclease for Knock-Out and Knock-In Applications
Presenting Author: Oscar Alvarez, Ph.D., Poseida Therapeutics, Inc.
Session Title: Wednesday Posters: Gene Targeting and Gene Correction New Technologies
Session Date/Time: Wednesday, May 8, 2024, 12:00 PM ET
Location: Exhibit Hall
Abstract Number: 717

Poseida’s Cas-CLOVER nuclease system represents a key advancement in gene editing technology with high-fidelity performance that significantly exceeds that of traditional nucleases. Poseida developed its Cas-CLOVER system by incorporating an S44P mutation which confers a two to three-fold improvement in on-target Cas-CLOVER editing efficiency, while fully preserving fidelity and with no increase in off-target editing. The enhanced Cas-CLOVER system exhibits remarkable capabilities for site-specific insertion of genes, as evidenced by the successful integration of a therapeutic transgene in mouse liver cells and associated phenotypical disease rescue in a PKU mouse model.

The Company plans to evaluate homology-independent targeting using its rapidly advancing fully non-viral DNA delivery technology for the precise insertion of genes and related gene expression regulators to specific sites in the genome.

Title: Optimizing Lipid Nanoparticle Formulations for Enhanced Non-Viral Gene Therapy: Overcoming DNA Delivery Challenges and Achieving High-Efficiency Transgene Integration
Presenting Author: George Wang, Ph.D., Poseida Therapeutics, Inc.
Session Title: Thursday Posters: Other Nonviral Delivery
Session Date/Time: Thursday, May 9, 2024, 12:00 PM ET
Location: Exhibit Hall
Abstract Number: 1239

This study demonstrates the optimization of DNA delivery to hepatocytes, in vivo, and genomic integration using Poseida’s piggyBac DNA insertion system. Poseida has synthesized and evaluated novel terpene-based lipids exhibiting unique DNA encapsulation and delivery properties in vivo. Poseida also identified a class of amphipathic small molecules called Poseida Delivery Excipients (PDEs) with unique capabilities for enhancing DNA delivery. Data demonstrated that inclusion of these PDEs in LNPs improved the insertion of targeted genes and decreased pro-inflammatory cytokine release. LNPs comprising novel ionizable lipids and PDEs also significantly enhanced genomic insertion of therapeutically relevant transgenes in vivo. These unique combinations of LNPs and PDEs could further enhance the potential of Poseida’s non-viral DNA platform technology and piggyBac DNA insertion system for treating serious genetic disorders.

Title: Novel Biodegradable Lipid Nanoparticles (LNP) for Co-Encapsulation of Complex Nucleic Acid Payloads for In Vivo Genome Editing
Presenting Author: Alicia Davis, Ph.D., Poseida Therapeutics
Session Title: Friday Posters: Other Nonviral Delivery
Session Date/Time: Friday, May 10, 2024, 12:00 PM ET
Location: Exhibit Hall
Abstract Number: 1737

This presentation highlights the development of an LNP capable of robustly co-encapsulating and delivering Poseida’s Cas-CLOVER nuclease system to the liver, while avoiding unintended uptake. Poseida has identified and characterized a novel class of biodegradable ionizable lipids for in vivo mRNA delivery. The Company has identified lipid S, which demonstrated potent mRNA delivery potency and improved clearance from the liver. These studies demonstrate Poseida’s discovery chemistry and formulation capabilities to generate high-performing LNPs for the efficient delivery of next-generation genetic medicine platforms such as Cas-CLOVER.

About P-KLKB1-101

P-KLKB1-101 is an investigational liver-directed non-viral gene editing approach designed using Cas-CLOVER Site-Specific Gene Editing System, Poseida’s proprietary high-fidelity nuclease, for site-specific gene editing of the KLKB1 gene, for the treatment of Hereditary Angioedema (HAE). HAE is a rare, inherited disorder that results in the swelling of the skin, intestinal tract, and airways, which can be both debilitating and life-threatening. Preclinical data demonstrate therapeutically relevant reduction of pre-kallikrein levels in both mouse and NHP models.

About P-FVIII-101

P-FVIII-101 is an investigational liver-directed gene insertion program combining Poseida’s non-viral transposon platform and nanoparticle delivery technologies for the in vivo treatment of Hemophilia A. Hemophilia A is a hereditary bleeding disorder caused by a deficiency in Factor VIII production with a high unmet need, resulting in excessive bleeding occurring either spontaneously or due to trauma and leading to pain and permanent joint damage in patients. P-FVIII-101 utilizes the piggyBac gene integration system delivered via lipid nanoparticle, which has demonstrated the potential to correct Factor VIII deficiency in juvenile and adult animal models using Poseida’s fully non-viral insertion system that is capable of whole gene correction.

On May 9, 2024 The Jackson Laboratory (JAX), an independent, nonprofit biomedical research organization, and AbTherx, an innovator in biotechnology, reported a strategic partnership to develop and commercialize cutting-edge tools to expedite antibody discovery and derisk the development of vital new therapies (Press release, AbTherx, MAY 9, 2024, View Source [SID1234644017]). This collaboration will include co-development activities and leverages JAX’s extensive experience in model research and AbTherx’s Atlas Mouse platform to address critical challenges facing drug developers of all sizes.

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The Atlas Mouse technologies are engineered to leverage in vivo antibody selection and maturation processes for the creation of human antibodies and are specifically designed to overcome the limitations of historical antibody discovery technologies by offering enhanced speed, diversity, developability, and affinity. Such traits are essential for developing viable lead candidates more swiftly than traditional methods currently allow.

JAX will also become the exclusive distributor of select AtlasTM Mouse models, including AbTherx’s Full Human Diversity Mouse for monoclonal antibody development as well as the Binary Fixed Light Chain Mouse for bispecific and multispecific antibody development. JAX and AbTherx are additionally exploring opportunities to develop and distribute future models to expand on this existing suite of innovative tools.

"By combining JAX’s expertise in high-quality mouse models with the innovative capabilities of our Atlas Mouse platform, we are setting new industry standards," said Justin Mika, CEO of AbTherx. "This collaboration not only enhances our ability to create additional impactful technologies but also ensures that these advancements are within reach of researchers and developers globally, fostering a new era of medical innovation."

"Providing access to high-quality research tools is paramount at The Jackson Laboratory, and we are thrilled to extend our capabilities with innovative models that are pivotal for the creation of new therapeutics," said Mitchell Kennedy, Executive Vice President of The Jackson Laboratory and President of JAX Mice, Clinical & Research Services. "Our partnership with AbTherx is a natural synergy, combining our decades of expertise in mouse model development with their deep knowledge in antibody discovery. Together, we are not only enhancing the tools available to researchers but also accelerating the pace at which impactful treatments can reach patients worldwide."

An early access program is set to launch in the second half of the year, during which time drug developers are invited to test and evaluate these groundbreaking platforms. For more details or to participate in the early access program, please contact JAX at [email protected].

On May 09, 2024 Attovia Therapeutics reported the closing of a $105 million oversubscribed Series B financing, bringing the total capital raised by the Company since its launch in June 2023 to $165 million (Press release, Attovia Therapeutics, MAY 9, 2024, View Source [SID1234647437]). Proceeds from the financing will be used to advance the Company’s lead programs ATTO-1310 and ATTO-002 through initial clinical data readouts, expand the Company’s immunology and inflammation pipeline, and to further develop the ATTOBODY platform.

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The Series B financing was led by Goldman Sachs Alternatives, with participation from new investors Cormorant Asset Management, Nextech Ventures, Redmile Group, EcoR1 Capital, Marshall Wace, and Logos Capital. Attovia’s existing investors Frazier Life Sciences, venBio, and Illumina Ventures, also participated in the round. Concurrent with the financing, Colin Walsh, Ph.D., Managing Director within Life Sciences Investing at Goldman Sachs Alternatives, was appointed to the Company’s Board of Directors.

"The strong investor interest and timing of this financing underscore the rapid progress we made with Attovia’s differentiated pipeline since the company inception, and the unique potential of our proprietary platform to develop attractive, next-generation immunology product candidates," said Tao Fu, chief executive officer of Attovia. "We are grateful for the support from such a strong group of investors, allowing us to advance our lead programs to the clinic in the near term, further expand our pipeline in novel bi-specifics, and catalyze potential business development opportunities."

Attovia is advancing a pipeline of spatially optimized biparatopic biologics generated from its ATTOBODY platform. The Company’s lead programs, ATTO-1310, a potential first-in-class, long half-life anti-IL31 ATTOBODY, and ATTO-002, a bispecific anti-IL31 x IL13 ATTOBODY, represent potential best-in-class therapeutics for a range of immune-mediated diseases. ATTO-1310 is currently in IND enabling studies and is on track to enter the clinic around year-end 2024 for the treatment of atopic dermatitis and other pruritic diseases. Attovia expects to nominate a development candidate for ATTO-002 in the second half of 2024 and advance the candidate to IND in 2025. The Company is also developing discovery stage programs that expand the ATTOBODY platform footprint to novel, difficult-to-drug targets, and offer additional multi-specific combinations.

"We believe Attovia is well positioned to be a leader in the development of best-in-class novel biologics for patients suffering from a range of diseases in immunology and inflammation," said Colin Walsh, Managing Director within Life Sciences Investing at Goldman Sachs Alternatives. "In a short amount of time, Attovia has leveraged its ATTOBODY platform to generate an impressive pipeline, and we are thrilled to support the further buildout of the company at this pivotal stage."

On May 9, 2024 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported a business update and announced financial results for the three months ended March 31, 2024 (Press release, Lisata Therapeutics, MAY 9, 2024, View Source [SID1234642981]).

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"2024, a pivotal year for Lisata, is off to a very strong start," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. "Although we project multiple data readouts over the next 18 months, topline results from the Phase 2b ASCEND trial later this year have transformative potential for the Company. These results will be instrumental in determining the future of Lisata, and we plan to use them to explore conditional approvals with various regulatory agencies and/or to design an optimized Phase 3 program in pancreatic ductal adenocarcinoma. Since the start of the year, we have received both U.S. FDA Orphan Drug and Rare Pediatric Disease designations for certepetide, previously known as LSTA1, in osteosarcoma, further validating the broad therapeutic potential of this innovative therapy. We are energized by the progress we are making and excited about Lisata’s prospects."

Dr. Mazzo added, "Our continued prudent financial management allows us to reaffirm our projection that currently available cash will fund operations into early 2026, providing a solid foundation to fund all ongoing and planned trials through to completion. More than ever, we remain confident in our ability to execute our development activities with the goal of reaching critical milestones at the earliest possible juncture."

Development Portfolio Highlights

Certepetide as a treatment for solid tumors in combination with other anti-cancer agents
Certepetide is an investigational drug designed to activate the CendR uptake pathway that allows co-administered or molecularly bound anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide is designed to actuate this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor, to the exclusion of normal tissues. In preclinical models, certepetide has also shown the ability to modify the tumor microenvironment, leading to the expectation that tumors will become more susceptible to immunotherapies and inhibiting the metastatic cascade (i.e., the spread of cancer to other parts of the body). Lisata and its development partners have amassed significant non-clinical data demonstrating enhanced delivery of a range of existing and emerging anti-cancer therapies, including chemotherapeutics, immunotherapies, and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability and activity in completed and ongoing clinical trials designed to test its ability to enhance delivery of standard-of-care ("SOC") chemotherapy for metastatic pancreatic cancer ("mPDAC"). Certepetide has been granted orphan drug designation for pancreatic cancer in the U.S. and Europe as well as for glioblastoma multiforme ("GBM") and osteosarcoma in the U.S. It also received a Fast Track designation from the FDA for pancreatic cancer and, just recently, a Rare Pediatric Disease designation from the FDA for osteosarcoma. Currently, certepetide is the subject of multiple ongoing or planned Phase 2a and 2b clinical studies being conducted globally in a variety of solid tumor types in combination with a variety of anti-cancer regimens:

•ASCEND: Phase 2b double-blind, randomized, placebo-controlled clinical trial evaluating two dosing regimens of certepetide in combination with gemcitabine/nab-paclitaxel SOC chemotherapy in patients with mPDAC. Cohort A of the study receives a single dose of 3.2 mg/kg certepetide essentially simultaneously with SOC, while Cohort B is identical to Cohort A, but with a second dose of 3.2mg/kg of certepetide given four hours after the first. The trial is being conducted at 25 sites in Australia and New Zealand led by the Australasian Gastro-Intestinal Trials Group in collaboration with the University of Sydney and with the National Health and Medical Research Council Clinical Trial Centre at the University of Sydney as the Coordinating Centre. The conclusion of a planned interim futility analysis in 2023 by the Independent Data Safety Monitoring Committee was that the conditions for futility were not met and that the study should proceed to completion. With trial enrollment completed in the fourth quarter of 2023, Lisata expects topline data from the 95 patients assigned to Cohort A of the study to be reported in the fourth quarter of 2024 and the complete data set of all 158 patients from the study to be available by mid-2025.
•BOLSTER: Phase 2a double-blind, placebo-controlled, multi-center, randomized trial in the U.S. evaluating certepetide in combination with SOC in first-line cholangiocarcinoma. The trial is actively enrolling with enrollment completion expected by the end of the third quarter of 2024.
•CENDIFOX: Phase 1b/2a open-label trial in the U.S. of certepetide in combination with neoadjuvant FOLFIRINOX based therapies in pancreatic, colon and appendiceal cancers. The trial continues to make steady progress with enrollment completion for all three arms expected by the end of 2024.
•Qilu Pharmaceutical, the licensee of certepetide in the Greater China territory, is currently evaluating certepetide in combination with gemcitabine and nab-paclitaxel as a treatment for mPDAC. During the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting, Qilu Pharmaceutical presented an abstract sharing preliminary data from the study which corroborated previously reported findings from the Phase 1b/2a trial of certepetide plus gemcitabine and nab-paclitaxel conducted in Australia in patients with mPDAC. As recently announced, Qilu has begun treating patients in their Phase 2 placebo-controlled trial in mPDAC. The study is planned to take approximately 18 months to complete enrollment and another 13 months for patient follow-up and data analysis and reporting.
•iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia evaluating certepetide in combination with the checkpoint inhibitor, durvalumab, plus standard-of-care gemcitabine and nab-paclitaxel chemotherapy versus standard-of-care alone in patients with locally advanced non-resectable PDAC. Enrollment completion is expected in the second half of 2024.
•A Lisata-funded Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide in combination with standard-of-care temozolomide versus temozolomide alone in patients with newly diagnosed GBM is being conducted across multiple sites in Estonia and Latvia and is targeted to enroll 30 patients with a randomization of 2:1 in favor of the certepetide treatment group.
First Quarter 2024 Financial Highlights
For the three months ended March 31, 2024, operating expenses totaled $6.6 million, compared to $6.8 million for the three months ended March 31, 2023, representing a decrease of $0.2 million or 3.6%.
Research and development expenses were approximately $3.2 million for the three months ended March 31, 2024, compared to $3.2 million for the three months ended March 31, 2023, representing an essentially unchanged spend. The minor increase of $62,000 or 2.0% was primarily due to an increase in expenses associated with enrollment activities in the current year for the BOLSTER trial, partially offset by a reduction in expenses associated with the Phase 2b ASCEND trial which completed enrollment in the prior year.
General and administrative expenses were approximately $3.4 million for the three months ended March 31, 2024, compared to $3.7 million for the three months ended March 31, 2023, representing a decrease of $0.3 million or 8.3%. This was primarily due to a decrease in staffing costs associated with the elimination of the Chief Business Officer position on May 1, 2023, a reduction in option assumption equity expense in connection with the Company’s merger with Cend Therapeutics, Inc., a decrease in directors and officers insurance premiums, and a reduction in spend on consulting and legal fees partially offset by one-off settlement-related costs.

Overall, net losses were $5.4 million for the three months ended March 31, 2024, compared to $6.2 million for the three months ended March 31, 2023.
Balance Sheet Highlights
As of March 31, 2024, Lisata had cash, cash equivalents, and marketable securities of approximately $43.3 million. Based on its current expected capital needs, the Company believes that its projected capital will fund its current proposed operations into early 2026, encompassing anticipated data milestones from all its ongoing and planned clinical trials.
Conference Call Information
Lisata will hold a live conference call today, May 9, 2024, at 4:30 p.m. Eastern Time to discuss financial results, provide a business update and answer questions.
Those wishing to participate must register for the conference call by way of the following link: CLICK HERE TO REGISTER. Registered participants will receive an email containing conference call details with dial-in options. To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time.
A live webcast of the call will also be accessible under the Investors & News section of Lisata’s website and will be available for replay beginning two hours after the conclusion of the call for 12 months.
About Lisata Therapeutics
Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s lead product candidate, certepetide, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Based on Lisata’s CendR Platform Technology, Lisata has already established noteworthy commercial and R&D partnerships. The Company expects to announce numerous clinical study and business milestones over the next two years and has projected that its current business and development plan is funded with available capital through these milestones and into early 2026. For more information on the Company, please visit www.lisata.com.