On February 27, 2025 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, reported that the first patient has been dosed with IO-108 in a global clinical collaboration with Roche (Press release, Immune-Onc Therapeutics, FEB 27, 2025, View Source [SID1234650732]). The Phase 1b/2 trial is designed to evaluate IO-108, a first-in-class antibody targeting LILRB2 (also known as ILT4), in combination with Roche’s atezolizumab and bevacizumab as a potential first-line treatment for patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC).

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"IO-108 has demonstrated promising clinical efficacy as a single agent and has a well-established safety profile to combine with different standard of care regimens. Dosing the first patient in this trial represents a significant advancement for Immune-Onc and, more importantly, for people battling advanced liver cancer," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "We are excited to work with Roche to investigate how this combination therapy with IO-108 could enhance the current standard of care and offer improved outcomes for those who urgently need new therapeutic options."

The atezolizumab and bevacizumab combination is the first cancer immunotherapy regimen approved by the U.S. Food and Drug Administration for HCC and is the standard of care recommended by the National Comprehensive Cancer Network. By modulating myeloid cells in the tumor environment, IO-108 may reduce immune suppression, thereby enhancing the overall anti-tumor response and the potential to improve patients’ clinical outcomes.

The trial, sponsored by Roche, is expected to enroll 40 patients across 25 sites worldwide in the IO-108-containing arm. This arm will be compared to an active control arm of the atezolizumab and bevacizumab combination.

ABOUT THE RANDOMIZED CLINICAL TRIAL

The Phase 1b/2 global, randomized HCC study is part of Roche’s Morpheus-Liver program. It will evaluate IO-108 in combination with atezolizumab and bevacizumab versus atezolizumab and bevacizumab, the standard of care in patients with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment.

Initially, 40 patients will be enrolled across 25 sites worldwide in the IO-108 triplet combination, which will be compared to an active control arm of the atezolizumab and bevacizumab doublet combination. The study’s primary endpoint is objective response rate, and key secondary endpoints include progression-free survival and overall survival.

Under the terms of the clinical collaboration agreement, Roche will manage the study operations, and Immune-Onc will supply IO-108 to support the trial while retaining global rights to IO-108.

Tecentriq (atezolizumab) and Avastin (bevacizumab) are registered trademarks of Genentech, a member of the Roche Group.

Learn more about the trial here.

ABOUT HEPATOCELLULAR CARCINOMA

According to the American Cancer Society1, more than 800,000 people are diagnosed with liver cancer each year worldwide. It is also one of the leading causes of cancer deaths worldwide, accounting for more than 700,000 deaths each year. The number of people diagnosed is predicted to rise, with the incidence of liver cancer increasing by 55.0% and the number of deaths increasing by 56.4% between 2020 and 20402. Hepatocellular carcinoma is the most common form of liver cancer in the United States, making up almost 90% of cases3. Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD), and cirrhosis resulting from these conditions4.

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards the myeloid checkpoint, LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A, and CD1d. Clinical data from the U.S. Phase 1 dose escalation study of IO-108 (NCT05054348) was selected as an oral presentation at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting and published in the Journal for ImmunoTherapy of Cancer in 2024, which demonstrated a favorable safety profile and encouraging clinical benefit utilizing IO-108 as a monotherapy and in combination with anti-PD-1 across multiple tumor types. A global, randomized Phase 1b/2 study is underway to evaluate IO-108 in combination with atezolizumab and bevacizumab as a potential first-line therapy for hepatocellular carcinoma (HCC).

On February 27, 2025 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 annonced financial results for the twelve months ended December 31, 2024 (Press release, Lisata Therapeutics, FEB 27, 2025, View Source [SID1234650691]).

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"Throughout 2024 and now into early 2025, we continue to advance our development portfolio centered around our novel product candidate, certepetide," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. "Following the encouraging preliminary results from the ASCEND and iLSTA trials reported at this year’s ASCO (Free ASCO Whitepaper)-GI Symposium, we remain committed to exploring the broad application of certepetide’s unique mechanism of action. Our development portfolio encompasses multiple clinical and preclinical trials evaluating certepetide for the treatment of various solid tumors, including pancreatic cancer, cholangiocarcinoma, glioblastoma, colon cancer, appendiceal cancer, and melanoma. In addition, we are exploring certepetide’s versatility in non-cancerous settings such as endometriosis. For Lisata, we expect 2025 to be a data-rich year and we look forward to sharing key developments as they become available."

Development Portfolio Highlights

Certepetide as a treatment for solid tumors in combination with other anti-cancer agents

Certepetide (formerly LSTA1) is an internalizing RGD, or iRGD, (arginylglycylaspartic acid) cyclic peptide designed to selectively activate the C-end rule active transport mechanism in a tumor specific manner, resulting in systemically co-administered anti-cancer agents more efficiently penetrating and accumulating in the tumor. Additionally, certepetide has been shown to modify the tumor microenvironment, diminishing its immunosuppressive nature, enhancing cytotoxic T cell concentration and inhibiting the metastatic cascade. Lisata and its collaborators have amassed significant non-clinical data demonstrating enhanced delivery of various existing and emerging anti-cancer therapies, including chemotherapies, immunotherapies, and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to demonstrate its ability to enhance the effectiveness of standard-of-care (SoC) chemotherapy for pancreatic cancer as well as the combination of chemotherapy and immunotherapy in a variety of solid tumors. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma, osteosarcoma, and cholangiocarcinoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.). Currently, certepetide is the subject of multiple ongoing or planned clinical studies being conducted globally across several solid tumor types in combination with a variety of anti-cancer regimens, including:

•ASCEND: Phase 2b double-blind, randomized (2:1 ratio), placebo-controlled trial evaluating two dosing regimens of certepetide in combination with SoC chemotherapy (gemcitabine/nab-paclitaxel) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial is being conducted across 25 sites in Australia and New Zealand led by the Australasian Gastro-Intestinal Trials Group (AGITG) and coordinated by the National Health and Medical Research Council Clinical Trial Centre at the University of Sydney. Cohort A, with 95 patients receiving a single intravenous (IV) dose of certepetide 3.2 mg/kg or placebo in combination with SoC, completed enrollment in the third quarter of 2023. Preliminary Cohort A data presented at the 2025 ASCO (Free ASCO Whitepaper)-GI Symposium showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in the placebo

treated group. Data from Cohort B, with 63 patients receiving two IV doses of certepetide 3.2 mg/kg or placebo administered 4 hours apart in combination with SoC, is expected in the coming months with a final analysis of both cohorts available thereafter. The exact timing is dependent on accumulating the requisite number of endpoint events in Cohort B and is not something that can be accurately predicted.

•BOLSTER: Phase 2a double-blind, placebo-controlled, multi-center, randomized trial in the U.S. evaluating certepetide in combination with SoC chemotherapy in first- and second-line cholangiocarcinoma (CCA). The Company achieved complete enrollment in first-line CCA nearly six months ahead of plan, accelerating anticipated topline data readout to mid-2025. Based on this rapid enrollment rate and the pressing need to improve treatment outcomes in patients that have progressed after first-line CCA treatment, a second cohort has been added to the BOLSTER trial evaluating certepetide in combination with SoC in subjects with second-line CCA. In September 2024, Lisata announced first patient treated in the second-line CCA cohort, with enrollment completion targeted for later this year.

•CENDIFOX: Phase 1b/2a open-label trial in the U.S. evaluating certepetide in combination with neoadjuvant FOLFIRINOX based therapies in pancreatic, colon and appendiceal cancers. In December 2024, the Company announced enrollment completion in all three cohorts. The single-center study, conducted solely at the University of Kansas Cancer Center, was designed with a 3-cycle run-in period to ensure patients met specific criteria before receiving treatment. Of the 66 patients enrolled, 50 patients met the criteria and were treated with certepetide across three cohorts, including 24 with resectable or borderline resectable pancreatic cancer, 15 with high-grade colon or appendiceal cancer and peritoneal metastasis, and 11 with oligometastatic colon cancer. The trial will provide Lisata with valuable pre- and post-treatment tumor tissue data for immune profiling, along with long-term patient outcome information. CENDIFOX data are expected in the coming months; however, given this is an investigator-initiated study, the exact timing is not in Lisata’s control. The trial is funded by the University of Kansas Cancer Center and Lisata is supplying certepetide.
•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 first-line 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 first-line mPDAC. Qilu has completed enrollment in its Phase 2 trial and data are expected in the coming months.
•iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia, funded by WARPNINE Inc., is evaluating certepetide in combination with SoC chemotherapy (nab-paclitaxel and gemcitabine) plus SoC immunotherapy (durvalumab) versus SoC alone in patients with locally advanced non-resectable PDAC. An interim analysis of the iLSTA trial, presented at the 2025 ASCO (Free ASCO Whitepaper) GI Symposium, showed preliminary results from the first 17 of the 30 targeted patients, corroborating preclinical data that certepetide enhances the effectiveness of immunotherapy. With 27 of the 30 patients enrolled, enrollment remains on track to be completed by the first half of 2025.
•A Lisata-funded Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide in combination with SoC temozolomide versus temozolomide alone in patients with newly diagnosed glioblastoma multiforme (GBM) is being conducted across multiple sites in Estonia and Latvia and is planned to also include a site in Lithuania. The study is targeted to enroll 30 patients with a randomization of 2:1 in favor of the certepetide treatment group. Enrollment completion is targeted for the second half of 2025.

•FORTIFIDE: Phase 1b/2a, double-blind, placebo-controlled, three-arm, randomized study in the U.S. evaluating the safety, tolerability, and efficacy of a 4-hour continuous infusion of certepetide in combination with SoC in subjects with first-line mPDAC. As part of this study, Lisata has engaged Haystack Oncology to use its MRD technology to measure circulating tumor DNA levels at multiple timepoints in patients throughout the study as an exploratory endpoint for analyzing the early therapeutic effect of certepetide. The Company expects to enroll the first patient in the study in the first half of 2025. However, in parallel, management is investigating a potentially faster and more cost-effective approach to achieving the study objective, which may become the preferred strategy.
Lisata has entered into multiple research collaborations, including a sponsored research agreement with the University of Cincinnati to assess certepetide in combination with bevacizumab (a VEGF inhibitor) in a preclinical murine model for the treatment of endometriosis. Lisata is also partnering with Valo Therapeutics (ValoTx) to investigate the benefits of combining certepetide with ValoTx’s platform technology, PeptiCRAd, an oncolytic virus, and a checkpoint inhibitor in a preclinical murine model for the treatment of melanoma.

In November 2024, Lisata entered into an Exclusive License and Collaboration Agreement with Kuva Labs, Inc. ("Kuva"), in which Lisata granted Kuva an exclusive license to explore the synergistic potential of certepetide as a targeting and delivery agent for Kuva’s NanoMark imaging technology in solid tumors. Under the agreement, Kuva will assume full responsibility for research, development, and commercialization costs, while Lisata will be responsible for supplying certepetide pursuant to a Clinical Supply Agreement. As consideration for the license, the Company is to receive a $1.0 million upfront license fee and is eligible for certain development and commercial milestone payments of up to $19.0 million, as well as a single-digit percentage royalty on net sales.

Full Year 2024 Financial Highlights

For the year ended December 31, 2024, revenue totaled $1.0 million in connection with an upfront license fee related to the Exclusive License and Collaboration Agreement with Kuva Labs, Inc. The Company did not have any revenue for the year ended December 31, 2023.

For the year ended December 31, 2024, operating expenses totaled $23.4 million compared to $25.7 million for the year ended December 31, 2023, representing a decrease of $2.3 million or 8.9%.
Research and development expenses were approximately $11.3 million for the year ended December 31, 2024, compared to $12.7 million for the year ended December 31, 2023, representing a decrease of approximately $1.4 million, or 11.0%. This was primarily due to a reduction in expenses associated with the Phase 2b ASCEND trial which completed enrollment in the prior year, lower spend on chemistry, manufacturing and controls, and lower equity expense.
General and administrative expenses were approximately $12.1 million for the year ended December 31, 2024, compared to $13.0 for the year ended December 31, 2023, representing a decrease of approximately $0.9 million or 6.9%. This was primarily due to one-off related severance costs in the prior year associated with the elimination of the Chief Business Officer position on May 1, 2023, a reduction in equity expenses, a decrease in directors’ and officers’ insurance premiums, and a reduction in spend on legal fees partially offset by one-off settlement related costs and an increase in consulting expenses.

Overall, net losses were $20.0 million and $20.8 million for the years ended December 31, 2024 and 2023, respectively.

Balance Sheet Highlights

As of December 31, 2024, Lisata had cash, cash equivalents, and marketable securities of approximately $31.2 million. Based on its existing and planned activities, the Company believes available funds will support current operations into the second quarter of 2026.

Net Operating Loss Sale
Earlier this year Lisata received $0.9 million in non-dilutive funding as an approved participant of the Technology Business Tax Certificate Transfer Program (the "Program") sponsored by the New Jersey Economic Development Authority (NJEDA). The Program enables qualifying New Jersey-based biotechnology or technology companies to sell a percentage of their New Jersey net operating losses and research and development tax credits to unrelated qualifying corporations with a lifetime cap on the tax benefit sales of $20.0 million. To date, under the Program, the Company has sold $19.6 million in tax benefits for net proceeds of $18.4 million.
Conference Call Information
Lisata will hold a live conference call today, February 27, 2025, 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, the Company encourages 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.

On February 27, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline and business progress, reiterated key anticipated milestones, and announced fourth quarter and full year 2024 financial results (Press release, Nuvalent, FEB 27, 2025, View Source [SID1234650712]).

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"The efficient execution by the Nuvalent team to date reflects a shared sense of urgency driven by patient need for additional treatment options – a need that we believe has been clearly demonstrated by the robust enrollment momentum in our ARROS-1 and ALKOVE-1 trials," said Darlene Noci, A.L.M., Chief Development Officer at Nuvalent. "We believe we are on track to report pivotal data for TKI pre-treated patients from both trials this year and to submit our first NDA by mid-year 2025."

Ms. Noci continued, "In parallel to advancing initial registration paths for zidesamtinib and neladalkib for TKI pre-treated patients, we continue to work with regulators towards our goal of bringing new therapies to all patients with ROS1-positive or ALK-positive NSCLC. Development programs for TKI-naïve patients are underway for both our ROS1 and ALK programs. To ensure patient access to these therapies, we are also pleased to announce the recent launch of global Expanded Access Programs for patients who are eligible and have no other treatment options outside of a clinical trial."

"As we transition towards becoming a fully integrated commercial-stage biopharmaceutical company, we reiterate our commitment to meeting the medical needs of patients by advancing our programs as quickly as possible," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "This is an important time for Nuvalent and with a steady cadence of anticipated milestones across our pipeline this year, a strong balance sheet and a dedicated and proven team at the helm, we believe we are well-positioned to deliver on our near-, mid- and long-term goals."

Recent Pipeline Progress and Anticipated Milestones

ROS1 Program

•
Nuvalent has implemented a global Expanded Access Program (EAP) for zidesamtinib for eligible patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have previously received at least one prior ROS1 tyrosine kinase inhibitor (TKI) and lack satisfactory therapeutic alternatives and are unable to access zidesamtinib through a clinical trial.
•
As of December 31, 2024, a total of 430 patients had been enrolled in the Phase 1 and Phase 2 portions of the ongoing ARROS-1 Phase 1/2 trial of zidesamtinib for patients with advanced ROS1-positive NSCLC and other solid tumors, which is designed with registrational intent for TKI pre-treated and TKI-naïve patients with advanced ROS1-positive NSCLC. The company expects to report pivotal data for TKI pre-treated patients with advanced ROS1-positive NSCLC in the first half of 2025 in support of an anticipated New Drug Application (NDA) submission by mid-year 2025, with an initial target indication of TKI pre-treated patients with advanced ROS1-positive NSCLC. The company plans to continue engagement with the U.S. Food and Drug Administration (FDA) on accelerated opportunities towards a potential line-agnostic indication supported by the ongoing TKI-naïve cohort in the Phase 2 portion of the ARROS-1 trial.
ALK Program

•
Nuvalent has implemented a global EAP for neladalkib for eligible patients with locally advanced or metastatic ALK-positive NSCLC who have previously received lorlatinib or a second-generation ALK TKI and lack satisfactory therapeutic alternatives and are unable to access neladalkib through a clinical trial.
•
As of December 31, 2024, a total of 596 patients had been enrolled in the Phase 1 and Phase 2 portions of the ongoing ALKOVE-1 Phase 1/2 trial of neladalkib for patients with advanced ALK-positive NSCLC and other solid tumors, which is designed with registrational intent for TKI pre-treated patients. The company expects to report pivotal data for TKI pre-treated patients with advanced ALK-positive NSCLC by year-end 2025.
•
Nuvalent plans to initiate the ALKAZAR Phase 3 trial, its front-line development strategy for the company’s ALK program, in the first half of 2025. The Phase 3 ALKAZAR trial will be a global, randomized, controlled trial designed to evaluate neladalkib versus the current standard of care for the treatment of patients with TKI-naïve ALK-positive NSCLC. Patients will be randomized 1:1 to receive neladalkib monotherapy or ALECENSA (alectinib) monotherapy, reflecting input from collaborating physician-scientists and alignment with the FDA.
HER2 Program

•
Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330’s pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. The company expects to continue to progress the HEROEX-1 trial throughout 2025.
Business Updates

•
Appointed Grant Bogle to Board of Directors: As previously announced, Nuvalent appointed Grant Bogle to its board of directors in December 2024. Mr. Bogle brings nearly four decades of proven leadership in building and growing biotechnology companies to the Nuvalent board. Throughout his career, he has served in senior leadership roles at several specialty pharmaceutical and biotechnology companies and worked alongside oncologists as part of the leadership of U.S. Oncology, the largest network of community oncology practices in the United States. He has a proven track record of success in the field of oncology and has guided numerous products from early-stage development to commercialization. Most recently, Mr. Bogle was the Chief Executive Officer at Epizyme, Inc., and oversaw the 2022 acquisition of the company by Ipsen. Prior to that, Mr. Bogle was Senior Vice President and Chief Commercial Officer of TESARO, which was acquired by GlaxoSmithKline in 2018. Earlier, he served as Senior Vice President of Pharmaceutical and Biotech Solutions at McKesson Specialty Health (formerly U.S. Oncology).
Fourth Quarter and Full Year 2024 Financial Results

•
Cash Position: Cash, cash equivalents and marketable securities were $1.1 billion as of December 31, 2024. Nuvalent continues to believe that its existing cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into 2028.
•
R&D Expenses: Research and development (R&D) expenses were $69.4 million for the fourth quarter of 2024 and $217.8 million for the year ended December 31, 2024.
•
G&A Expenses: General and administrative (G&A) expenses were $16.9 million for the fourth quarter of 2024 and $62.6 million for the year ended December 31, 2024.
•
Net Loss: Net loss was $74.8 million for the fourth quarter of 2024 and $260.8 million for the year ended December 31, 2024.

On February 27, 2025 AbCellera (Nasdaq: ABCL) reported financial results for the full year 2024. All financial information in this press release is reported in U.S. dollars, unless otherwise indicated (Press release, AbCellera, FEB 27, 2025, View Source [SID1234650733]).

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"In 2024 we made significant progress in transitioning from a platform company to a clinical-stage biotech, including advancing our internal pipeline and completing significant investments in our capabilities. We also maintained our strong cash position, closing the year with over $800 million in available liquidity to execute on our strategy," said Carl Hansen, Ph.D., founder and CEO of AbCellera. "As a result, we enter 2025 on track to initiate Phase 1 clinical trials for our first two programs, ABCL635 and ABCL575, and to start activities in our new clinical manufacturing facility."

FY 2024 Business Summary

Earned $28.8 million in total revenue.
Generated a net loss of $162.9 million, compared to net loss of $146.4 million in 2023.
Reached a cumulative total of 96 partner-initiated program starts with downstreams.
Reporting the advancement of three additional molecules in the clinic, bringing the cumulative total to 16 molecules to have reached the clinic.
Key Business Metrics

Cumulative Metrics

December 31, 2023

December 31, 2024

Change %

Partner-initiated program starts with downstreams

87

96

10

%

Molecules in the clinic

13

16

23

%

AbCellera started discovery on an additional nine partner-initiated programs with downstreams to reach a cumulative total of 96 partner-initiated program starts with downstreams in 2024 (up from 87 on December 31, 2023). AbCellera’s partners have advanced a cumulative total of 16 molecules into the clinic (up from 13 on December 31, 2023).

Discussion of FY 2024 Financial Results

Revenue – Total revenue was $28.8 million, compared to $38.0 million in 2023. In both periods, the majority of revenues were research fees generated by our partnerships.
Research & Development (R&D) Expenses – R&D expenses were $167.3 million, compared to $175.7 million in 2023, reflecting underlying continued growth in program execution, platform development, and investments in internal programs.
Sales & Marketing (S&M) Expenses – S&M expenses were $12.8 million, compared to $14.2 million in 2023.
General & Administrative (G&A) Expenses – G&A expenses were $72.7 million, compared to $61.0 million in 2023.
Net Loss – Net loss of $162.9 million, or $(0.55) per share on a basic and diluted basis, compared to net loss of $146.4 million, or $(0.51) per share on a basic and diluted basis, in 2023.
Liquidity – $652.9 million of total cash, cash equivalents, and marketable securities and approximately $186 million in available non-dilutive government funding, bringing total available liquidity to approximately $840 million to execute on AbCellera’s strategy.
Q4 Highlights and Financial Results

Abdera advanced ABD-147 into a Phase 1 clinical trial. AbCellera is a founding partner in Abdera, has a low-single-digit royalty stake in Abdera’s programs, and has a mid-single-digit equity ownership position.
Reporting the advancement of two Trianni-license molecules into the clinic.
Started one partner-initiated program with downstreams.
Revenue for the fourth quarter of 2024 was $5.1 million, the majority of which was research fees generated by our partnerships, representing 18% of total revenue for 2024.
Operating expenses totaled $77.8 million in the fourth quarter, or 23% of the total for 2024, and included investments made in co-development and internal programs.
The net loss for the fourth quarter was $34.2 million, or $(0.12) per share, on a basic and diluted basis.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

On February 27, 2025 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update (Press release, Cardiff Oncology, FEB 27, 2025, View Source [SID1234650690]).

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"2024 was a significant year for Cardiff Oncology as we shared positive data from the first 30 patients in our lead program in first-line RAS-mut mCRC," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "We were excited to report that patients on the 30mg onvansertib dose arm demonstrated a 64% response rate, compared to a 33% response rate in the control arm. In the experimental arm, we observed a dose response relationship with the 30mg dose of onvansertib demonstrating increased ORR and deeper tumor regression compared to the 20mg dose of onvansertib with similar safety profiles for both doses. We believe this correlation between the dose of onvansertib and the magnitude of therapeutic effect serves as validation that onvansertib is a biologically active drug for the treatment of cancer, which we believe may translate to additional oncology indications in our pipeline. In addition to the robust efficacy signal in the CRDF-004 trial, these data suggest that onvansertib could safely be combined with both standard of care first-line chemotherapy options for mCRC in the U.S. With our balance sheet strengthened by a $40M investment from biotech specialist investors, we now look forward to sharing additional clinical updates from CRDF-004 in H1 2025."

Upcoming expected milestones

•
Additional clinical data from CRDF-004 trial expected in 1H 2025

Company highlights for the quarter ended December 31, 2024, and subsequent weeks include:

•
Announced positive initial data from ongoing first-line RAS-mutated mCRC clinical trial (CRDF-004)
▪
Phase 2 trial is currently enrolling patients with mCRC who have a documented KRAS or NRAS mutation. Onvansertib is added to standard-of-care (SoC) consisting of FOLFIRI plus bevacizumab ("bev") or FOLFOX plus bev. Patients will be randomized to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone.
▪
Patients on the 30mg onvansertib dose arm demonstrated 64% objective response rate (ORR) versus 33% ORR in the control arm.
▪
The 30mg dose of onvansertib demonstrated a higher ORR and deeper tumor regression compared to the 20mg dose of onvansertib (64% vs. 50%)
▪
Onvansertib was well tolerated at both doses.

•
Raised $40 million in an oversubscribed underwritten registered direct offering
▪
The financing included participation from new and existing healthcare dedicated investors.
•
Patent issuance from the United States Patent and Trademark Office (USPTO)
▪
U.S. patent No. 12,144,813 has an expected expiration date of no earlier than 2043. The patent claims cover the method of using onvansertib in combination with bev for the treatment of KRAS mutated mCRC patients who have not previously been treated with bev ("bev naïve"). This patent is supported by the unexpected benefits of the treatment in such bev naïve patients.
•
Presented two posters at the San Antonio Breast Cancer Symposium
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Onvansertib demonstrated synergy in combination with paclitaxel in hormone receptor positive (HR+) breast cancer cell lines and robust antitumor activity in patient-derived xenograft (PDX) models resistant to first-line therapies. These data support that onvansertib in combination with paclitaxel represents a promising therapeutic strategy for HR+ breast cancer patients after progression on endocrine therapy and CDK4/6 inhibitors. A phase 1b/2 clinical trial is ongoing to evaluate the safety and efficacy of onvansertib in combination with paclitaxel in advanced triple negative breast cancer (NCT05383196).
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Onvansertib in combination with trastuzumab deruxtecan (T-DXd) was well tolerated, overcame T-DXd resistance, and displayed enhanced anti-tumor activity compared to monotherapies in drug resistant HR+ breast cancer patient derived xenograft (PDX) models. The combination of T-DXd with onvansertib represents a promising therapeutic strategy for HR+ breast cancer patients resistant to first-line therapies.
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Published clinical data of the combination of onvansertib with FOLFIRI and bev in second-line KRAS mutant mCRC in the peer-reviewed Journal of Clinical Oncology, the flagship publication of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)
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Phase 2 clinical trial treating patients with KRAS-mutant mCRC (NCT03829410) demonstrated that onvansertib combined with FOLFIRI and bev was well-tolerated and exhibited clinical activity in the second-line setting.
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A post hoc analysis revealed a greater clinical benefit in bev naïve patients, who demonstrated an ORR of 77% and mPFS of 14.9 months compared to an ORR of 10% and mPFS of 6.6 months in those previously exposed to bev.

Full Year 2024 Financial Results:

Liquidity, cash burn, and cash runway

As of December 31, 2024, Cardiff Oncology had approximately $91.7 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the full year 2024 was approximately $37.7 million, an increase of approximately $6.8 million from $30.9 million for the same period in 2023.

Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q1 2027.

Operating results

Total operating expenses were approximately $49.3 million for the full year ended December 31, 2024, an increase of $3.4 million from $45.9 million for the same period in 2023. The increase in operating expenses was primarily due to costs associated with clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib, and higher salaries and staff costs primarily due to increased headcount and stock-based compensation for additional grants to employees.

Conference Call and Webcast

Cardiff Oncology will host a corresponding conference call and live webcast today at 4:30 p.m. ET/1:30 p.m. PT. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company’s website at www.cardiffoncology.com. A webcast replay will be available in the investor relations section on the company’s website following the completion of the call.