On May 2, 2024 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, reported financial results and business highlights for the first quarter 2024 (Press release, Geron, MAY 2, 2024, View Source [SID1234642586]).

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"Since the FDA ODAC’s 12 to 2 vote in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in patients with lower-risk MDS in March, we have continued working with the FDA as they complete their review of our New Drug Application, which has a June 16, 2024 PDUFA target action date," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "We are actively preparing for a successful launch of imetelstat in the U.S., if approved, including most recently onboarding our sales force last month, refining our market research and completing buildout of our enterprise capabilities and systems to support our transition from a clinical to commercial-stage company."

U.S. Commercial Preparation

Geron has now completed onboarding its commercial team, with the buildout of the full sales organization in April. Other commercial preparations for the U.S. are ongoing and on target, including enhancing and/or establishing company processes and systems to support an expected commercial launch, refining market research in TD LR-MDS, and engaging in marketing, commercial access, payer, and reimbursement preparatory efforts.

Clinical Development Update

The Phase 3 IMpactMF clinical trial, which has a primary endpoint of overall survival, is ongoing in myelofibrosis patients who are relapsed/refractory to JAK inhibitors. Last month, the data monitoring committee evaluated unblinded data and recommended the clinical trial continue. In addition, the Company reviewed enrollment rates and blinded death rates, which are lower than anticipated based on initial planning assumptions. Accordingly, guidance is being updated to extend the timelines by half a year, with the interim analysis now expected in early 2026 and the final analysis expected in early 2027.

First Quarter 2024 Financial Results

As of March 31, 2024, the Company had approximately $465 million in cash and marketable securities, including proceeds from an underwritten public offering of common stock and a pre-funded warrant in March 2024 for net proceeds of approximately $141 million.

For the first quarter of 2024, the Company reported a net loss of $55.4 million, or $0.09 per share, compared to $38.1 million, or $0.07 per share, for the first quarter of 2023.

Revenues for the first quarter of 2024 were $304,000, compared to $21,000 for the same period in 2023. Royalty revenues in 2024 and 2023 primarily reflect estimated royalties from sales of cell-based research products from the Company’s divested stem cell assets.

Total operating expenses for the first quarter of 2024 were $56.4 million, compared to $40.1 million for the same period in 2023. Research and development expenses for the first quarter of 2024 were $29.4 million, compared to $27.2 million for the same period in 2023. The increase in research and development expenses for the three months ended March 31, 2024, compared to the same period in 2023, primarily reflects the net result of higher manufacturing costs due to the timing of imetelstat manufacturing batches and increased personnel-related expenses for additional headcount. We expect research and development expenses to remain consistent in the future as we support IMpactMF, IMproveMF and IMpress, as well as the long-term treatment and follow-up of remaining patients in IMerge. General and administrative expenses for the first quarter of 2024 were $27.1 million, compared to $12.9 million for the same period in 2023. The increase in general and administrative expenses for the three months ended March 31, 2024, compared to the same period in 2023, primarily reflects new costs for commercial preparatory activities and higher personnel-related expenses for additional headcount.

Interest income for the first quarter of 2024 was $4.2 million, compared to $3.9 million for the same period in 2023. The increase in interest income for the three months ended March 31, 2024, compared to the same period in 2023, primarily reflects a larger marketable securities portfolio with the receipt of net cash proceeds from the underwritten offering completed in March 2024, as well as higher yields from recent marketable securities purchases.

Interest expense for the first quarter of 2024 was $3.4 million, compared to $1.9 million for the same period in 2023. The increase in interest expense for the three months ended March 31, 2024, compared to the same period in 2023, primarily reflects higher interest rates. Currently, we have $80.0 million in principal debt outstanding. Interest expense reflects interest owed under our loan facility.

2024 Financial Guidance

For fiscal year 2024, the Company expects total operating expenses to be in the range of approximately $270 million to $280 million, which includes non-cash items such as stock-based compensation expense, amortization of debt discounts and issuance costs, and depreciation and amortization.

The fiscal year 2024 financial guidance reflects costs to support regulatory processes with the FDA and EMA in 2024; continued support of ongoing clinical trials; manufacturing of commercial inventory of imetelstat; build out of our commercial organization to support the potential U.S. commercial launch of imetelstat in the U.S.; increases in headcount in preparation for transition to a commercial-stage company; and interest payments on outstanding debt.

Based on our current operating plans and our assumptions regarding the timing of the potential approval and commercial launch of imetelstat in lower risk MDS in the U.S., we believe that our existing cash, cash equivalents, and current and noncurrent marketable securities, together with projected revenues from U.S. sales of imetelstat, if approved, potential proceeds from the exercise of our outstanding warrants, and potential future drawdowns under our loan facility, will be sufficient to fund our projected operating requirements into the second quarter of 2026.

As of March 31, 2024, we had 162 full-time employees, prior to the onboarding of our salesforce in April 2024. Subject to approval of imetelstat in the U.S., the Company plans to grow to a total of approximately 250-300 employees by year-end 2024.

Conference Call

Geron will host a conference call at 8:00 a.m. ET on Thursday, May 2, 2024, to discuss business updates and first quarter financial results.

A live webcast of the conference call and related presentation will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the webcast by registering online using the following link, View Source

About Imetelstat

Imetelstat is a novel, first-in-class investigational telomerase inhibitor exclusively owned by Geron and being developed by Geron in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies, resulting in malignant cell apoptosis. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of adult patients with transfusion-dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to Janus kinase (JAK) inhibitor treatment. Imetelstat is currently not approved by any regulatory authority.

About IMpactMF

IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis (MF) who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete remission, partial remission, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations, and current status, visit ClinicalTrials.gov/NCT04576156.

On May 2, 2024 Genmab reported Interim Report for the First Quarter Ended March 31, 2024 (Press release, Genmab, MAY 2, 2024, View Source [SID1234642585]).

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Highlights

The U.S. Food and Drug Administration (U.S. FDA) granted Priority Review for the supplemental Biologics License Application (sBLA) for EPKINLY (epcoritamab-bysp) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy, with a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2024
An additional Phase 3 clinical trial was initiated, evaluating epcoritamab in combination with rituximab and lenalidomide compared to chemoimmunotherapy in previously untreated follicular lymphoma
The U.S. FDA accepted for Priority Review the sBLA seeking to convert the accelerated approval of Tivdak (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy
Genmab announced the decision of its arbitration appeal under its daratumumab license agreement with Janssen Biotech, Inc. (Janssen)
Genmab revenue increased 46% compared to the first quarter of 2023, to DKK 4,143 million

"The acceptance for Priority Review by the U.S. FDA of the sBLAs for EPKINLY and Tivdak that we received in the first quarter are important events that support our commitment to continue to deliver innovative treatment options that have the potential to profoundly impact the lives of patients. These regulatory acceptances for priority review also reflect our dedication to working with our partners, AbbVie Inc. (AbbVie) and Pfizer Inc. (Pfizer) to expand the labels for EPKINLY and Tivdak, respectively, in order to maximize the potential of both medicines and bring them to as many patients in need of alternative therapeutic options as possible," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter of 2024

Revenue was DKK 4,143 million for the first three months of 2024 compared to DKK 2,834 million for the first three months of 2023. The increase of DKK 1,309 million, or 46%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Janssen and Novartis Pharma AG (Novartis), respectively, EPKINLY net product sales, and a milestone achieved under our collaboration with AbbVie.
Royalty revenue was DKK 3,104 million in the first three months of 2024 compared to DKK 2,408 million in the first three months of 2023, an increase of DKK 696 million, or 29%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta.
Net sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.) by Janssen were USD 2,692 million in the first three months of 2024 compared to USD 2,264 million in the first three months of 2023, an increase of USD 428 million or 19%.
Total costs and operating expenses were DKK 3,342 million in the first three months of 2024 compared to DKK 2,417 million in the first three months of 2023. The increase of DKK 925 million, or 38%, was driven by the expansion of our product pipeline, EPKINLY post launch activities in the U.S. and Japan, the continued development of Genmab’s broader organizational capabilities and related increase in team members to support these activities, as well as profit-sharing amounts payable to AbbVie related to EPKINLY sales.
Operating profit was DKK 801 million in the first three months of 2024 compared to DKK 417 million in the first three months of 2023.
Net financial items resulted in income of DKK 915 million for the first three months of 2024 compared to an expense of DKK 151 million in the first three months of 2023. The increase of DKK 1,066 million was primarily driven by movements in USD to DKK foreign exchange rates impacting Genmab’s USD denominated cash and cash equivalents and marketable securities, with strengthening of the USD/DKK rate in the first three months of 2024 compared to the weakening of the USD/DKK rate in the first three months of 2023.
Subsequent Event

April: Genmab and ProfoundBio, Inc. (ProfoundBio) announced that the companies have entered into a definitive agreement for Genmab to acquire ProfoundBio in an all-cash transaction. The acquisition will give Genmab worldwide rights to three candidates in clinical development, including rinatabart sesutecan (Rina-S), plus ProfoundBio’s novel antibody-drug conjugate (ADC) technology platforms. Genmab will acquire ProfoundBio for USD 1.8 billion in cash, payable at closing (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses). The proposed transaction is expected to close in the first half of 2024. The closing of the proposed transaction is subject to the satisfaction of customary closing conditions.

Outlook
Genmab is maintaining its 2024 financial guidance published on February 14, 2024.

Following the announcement of the proposed acquisition of ProfoundBio, Genmab’s operating expenses before expenses incurred by it in connection with the proposed transaction are now anticipated to be at or moderately above the upper end of the previously disclosed guidance range of DKK 12.4 -13.4 billion. The anticipated increase reflects the incremental R&D investment to support the advancement of ProfoundBio’s clinical programs, primarily Rina-S. Genmab’s revenue guidance is unchanged and expected to be in the previously disclosed guidance range of DKK 18.7 – 20.5 billion.

We expect to update our guidance no later than in connection with our second quarter 2024 earnings.

Conference Call
Genmab will hold a conference call to discuss the results for the first quarter of 2024 today, Thursday, May 2, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: https://register.vevent.com/register/BIcaf0da755ddb4d7f81f4dd2c0229135e. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.

On May 2, 2024 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported financial results for the quarter ended March 31, 2024, and highlighted recent business achievements (Press release, Elevation Oncology, MAY 2, 2024, View Source;utm_medium=rss&utm_campaign=elevation-oncology-reports-first-quarter-2024-financial-results-and-highlights-recent-business-achievements [SID1234642584]).

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"In recent months, we focused on advancing our growing pipeline of differentiated ADCs, each with broad therapeutic potential, and extending our cash runway into 2026, beyond upcoming milestones for EO-3021 and our HER3-ADC program," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "At AACR (Free AACR Whitepaper), we shared preclinical proof-of-concept data from our HER3-ADC program, demonstrating HER3-dependent cell killing and robust anti-tumor activity. These data support continued development of our HER3-ADC program, and we look forward to nominating a development candidate later this year."

Mr. Ferra continued, "In parallel, we continue to enroll patients in our Phase 1 clinical trial of EO-3021 in the U.S. and Japan. We remain on track to share details of our planned EO-3021 combination study in the first half of 2024, as well as initial safety and efficacy data from our ongoing trial by mid-third quarter, as we work to change the treatment paradigm for patients living with Claudin 18.2-expressing tumors, who are in significant need of new therapeutic options."

Recent Business Achievements

In April 2024, Elevation Oncology presented preclinical proof-of-concept data from its HER3-ADC program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data showed HER3-dependent cell killing and robust anti-tumor activity in a patient-derived xenograft model of pancreatic cancer with high HER3 expression, highlighting the therapeutic potential of Elevation Oncology’s HER3-ADC program across a range of HER3-expressing cancers.
Expected Upcoming Milestones

EO-3021:

Share details on planned Phase 1 combination study evaluating EO-3021 in the first half of 2024.
Provide update from ongoing Phase 1 clinical trial of EO-3021 at a corporate event by mid-third quarter 2024, including initial safety and efficacy data from at least three dose cohorts.
Additional data expected in the first half of 2025.
HER3-ADC:

Nominate development candidate from HER3-ADC program in the second half of 2024.
First Quarter 2024 Financial Results

As of March 31, 2024, the Company had cash, cash equivalents and marketable securities totaling $104.1 million, compared to $83.1 million as of December 31, 2023. The increase in cash reflects net proceeds of $29.7 million, which Elevation Oncology raised through its at-the-market (ATM) facility in the first quarter of 2024, partially offset by cash used to fund operating activities. Subsequent to the first quarter of 2024, Elevation Oncology raised an additional $14.5 million through its ATM facility.

Research and development (R&D) expenses for the first quarter of 2024 were $6.0 million, compared to $7.3 million for the first quarter 2023. The decrease in R&D expenses in the first quarter of 2024 was primarily due to decreased clinical trial expenses associated with Elevation Oncology’s former lead program, partially offset by increased clinical trial expenses associated with the ongoing EO-3021 Phase 1 trial.

General and administrative (G&A) expenses for the first quarter of 2024 were $3.9 million, compared to $4.3 million for the first quarter 2023. The decrease in G&A expenses in the first quarter of 2024 was primarily due to decreased administrative costs, including directors’ and officers’ insurance, and decreased personnel costs, including stock-based compensation.

Net loss for the first quarter of 2024 was $10.7 million, compared to $17.1 million for the first quarter of 2023.

Financial Outlook

Elevation Oncology expects its existing cash, cash equivalents and marketable securities as of March 31, 2024, together with the $14.5 million in net proceeds raised under its ATM facility subsequent to the first quarter of 2024, to be sufficient to fund its current operations into 2026.

On May 2, 2024 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, reported that it has entered into a securities purchase agreement with new and existing investors to raise approximately $30.6 million dollars in aggregate gross proceeds through the sale of shares of its common stock, par value $0.0001 per share (the "Common Stock") and pre-funded warrants to purchase Common Stock in lieu thereof (the "Pre-Funded Warrants"), and accompanying common warrants to purchase Common Stock (or Pre-Funded warrants in lieu thereof) (the "Common Warrants," and together with the Common Stock and Pre-Funded Warrants, the "Securities"), excluding the proceeds, if any, from the exercise of the Pre-Funded Warrants and the Common Warrants and before deducting offering expenses (Press release, Corvus Pharmaceuticals, MAY 2, 2024, View Source [SID1234642583]).

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The offering includes participation from health-care dedicated investors including Point72, Samlyn Capital, Armistice Capital, OrbiMed, Puissance Capital and Altamont Pharmaceutical Holdings, and other existing investors including Richard Miller, the Company’s chief executive officer.

The purchase and sale will be completed via a registered direct offering of 13,512,699 shares of Common Stock and accompanying Common Warrants to purchase 13,078,509 shares of Common Stock (or Pre-Funded Warrants in lieu thereof) at a combined offering price of $1.7312 per Share, and Pre-Funded Warrants to purchase 4,144,085 shares of Common Stock and accompanying Common Warrants to purchase 4,010,927 shares of Common Stock (or Pre-Funded Warrants in lieu thereof) at a combined offering price of $1.7311 per share underlying each Pre-Funded Warrant and Common Warrant, which equals the offering price per share of the Common Stock and Common Warrant less the $0.0001 exercise price per share of the Pre-Funded Warrants. The Pre-Funded Warrants have an exercise price of $0.0001 per share of Common Stock and are exercisable at any time after the date of issuance, subject to certain ownership limitations. The Common Warrants have an exercise price of $3.50 per share of Common Stock (or $3.4999 per Pre-Funded Warrant in lieu thereof) and are exercisable at any time after the date of issuance, subject to certain ownership limitations, and expire on June 30, 2025.

All of the Securities are being offered by Corvus. The offering is expected to close on or about May 6, 2024, subject to the satisfaction of customary closing conditions. Since the offering of the Securities was made without an underwriter or a placement agent, the Company will not be paying any underwriting discounts or placement agent fees in connection with the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The Securities are being offered by Corvus Pharmaceuticals pursuant to a registration statement on Form S-3 (File No. 333-270921) previously filed and declared effective by the Securities and Exchange Commission ("SEC"). A final prospectus supplement and accompanying base prospectus relating to and describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

On May 2, 2024 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 first quarter ended March 31, 2024, and provided a business update (Press release, Cardiff Oncology, MAY 2, 2024, View Source [SID1234642581]).

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"During the start of 2024, we presented several important new data sets supporting our first-line RAS-mutated mCRC strategy and the broader opportunity for onvansertib," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "The data from the ONSEMBLE trial replicated, in a second independent and randomized dataset, the bev naïve signal from our earlier Phase 1b/2 KRAS-mutated mCRC trial. And the Phase 1b data published in the peer-reviewed journal Clinical Cancer Research, and the additional data we presented in one of our five posters at AACR (Free AACR Whitepaper), further substantiated our lead program in RAS-mutated mCRC. The additional AACR (Free AACR Whitepaper) posters also point toward new indications for onvansertib in RAS wild-type mCRC, small cell lung cancer and ovarian cancer. Looking ahead, we believe that our upcoming data readout from our first-line trial in RAS-mutated mCRC has the potential to serve as a key value inflection point for our company and revolutionize the treatment of RAS-mutated mCRC, an area with no new treatments approved in over two decades."
Upcoming expected milestones

•The Company has updated its expectation of the timing for an initial readout from the first-line RAS-mutated metastatic colorectal cancer (mCRC) randomized CRDF-004 trial to 2H 2024, based on the enrollment trends observed from active clinical trial sites
Company highlights for the quarter ended March 31, 2024 and subsequent weeks include:
•Presented updated data at AACR (Free AACR Whitepaper) Annual Meeting 2024 that supports ongoing first-line RAS-mutated mCRC clinical study.
◦In a poster titled "A Phase 1b/2 Clinical Study of Onvansertib in Combination with FOLFIRI/Bev Revealed a New Role of PLK1 in regulating the Hypoxia Pathway in KRAS-mutated mCRC," updated clinical and preclinical data further supported the ongoing CRDF-004 Phase 2 trial of onvansertib + chemo/bev for the first-line treatment of RAS-mutated mCRC patients, who by definition are bev naïve.
◦In vitro, onvansertib inhibited activation of the hypoxia pathway through the regulation of transcription factor HIF1α and its downstream targets.

◦Bev naïve patients treated with onvansertib + FOLFIRI/bev demonstrated a significantly greater overall response rate [odds ratio=13.64, p<0.001] and longer PFS [hazard ratio=0.21, p=0.003] compared to bev exposed patients.
•Announced first patient dosed for lead program in randomized first-line Phase 2 trial, CRDF-004, for patients with RAS-mutated mCRC.
◦The trial, whose clinical execution is being conducted by our partner, Pfizer Ignite, is designed to confirm the dose of onvansertib for a subsequent registrational trial, and generate safety and efficacy data for onvansertib when added to standard of care (SoC) vs. SoC alone.
◦Interim topline results from CRDF-004 are expected in 2H 2024. Contingent upon the results, Cardiff Oncology will initiate a Phase 3, randomized trial, CRDF-005, with registrational intent.
•Provided a clinical update on Phase 2 randomized second-line ONSEMBLE trial in mCRC.
◦New clinical data from second-line randomized ONSEMBLE trial, that closed for enrollment in 2023, provide further evidence of onvansertib’s role in improving the efficacy of SoC (FOLFIRI+bev) therapy in bev naïve patients.
◦In the trial (n = 21), patients who were bev naïve and who received onvansertib in combination with SoC demonstrated an objective response rate (ORR) of 50% (2 of 4). No clinical responses were observed in bev naïve patients who received SoC alone (n = 3), or patients who were previously exposed to bev (n = 14).
◦The ONSEMBLE data serves as a second independent, randomized, prospective data set providing evidence of the strong efficacy signal in bev naïve patients.
•Announced the publication of data from Phase 1b study in second line KRAS-mutated mCRC in the peer-reviewed journal Clinical Cancer Research.
◦Findings from the Phase 1b portion of company’s Phase 1b/2 study in second-line KRAS-mutated mCRC highlight the safety and promising efficacy of onvansertib in combination with SoC.
◦These peer-reviewed published data are part of the Phase 1b/2 data announced in August 2023 and informed the shift to investigation in first-line RAS-mutated mCRC (CRDF-004).
•Presented three posters at AACR (Free AACR Whitepaper) Annual Meeting 2024 in therapeutic areas outside of RAS-mutated mCRC
◦In a poster titled "The PLK1 Inhibitor Onvansertib is Active as Monotherapy and in Combination with Cetuximab in RAS Wild-type mCRC Patient-derived Xenografts," single agent onvansertib successfully induced tumor stasis or regression in 70% (14/20) of the RAS wild-type mCRC patient-derived xenograft (PDX) models tested which included both models sensitive to cetuximab (5/7, 71%) and resistant to cetuximab (9/13, 69%). Additionally, onvansertib in combination with cetuximab induced tumor stasis or regression in 90% (18/20) of the models tested. The antitumor activity of the combination was superior compared to monotherapy with either agent in both cetuximab sensitive and resistant models.

◦In a poster titled "The PLK1 Inhibitor, Onvansertib, Synergizes with Paclitaxel in Small Cell Lung Cancer (SCLC)," onvansertib in combination with paclitaxel was well-tolerated and demonstrated superior efficacy over monotherapies in cisplatin sensitive and resistant SCLC PDX models. These preclinical findings in SCLC and previous data generated in breast cancer suggest that onvansertib in combination with paclitaxel has the potential to become a highly promising combination strategy across multiple cancer indications.

◦In a poster titled "In vivo anti-tumor activity of onvansertib, a PLK1 inhibitor, combined with gemcitabine or carboplatin in platinum-resistant ovarian carcinoma patient-derived xenograft models," onvansertib was synergistic in vitro in both combinations in an ovarian cancer cell line. Both combinations demonstrated antitumor activity in vivo in platinum-resistant ovarian cancer PDX models and was well tolerated. These data support the potential of onvansertib to improve SoC treatments for platinum-resistant ovarian cancer patients.

First Quarter 2024 Financial Results
Liquidity, cash burn, and cash runway
As of March 31, 2024, Cardiff Oncology had approximately $67.2 million in cash, cash equivalents, and short-term investments.
Net cash used in operating activities for the first quarter of 2024 was approximately $7.7 million, a decrease of approximately $1.0 million from $8.7 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 Q3 of 2025.
Operating results
Total operating expenses were approximately $11.1 million for the three months ended March 31, 2024, a decrease of $1.0 million from $12.1 million for the same period in 2023. The decrease in operating expenses was primarily due to a reduction in chemistry, manufacturing and controls costs compared to the prior period.
Conference Call and Webcast
Cardiff Oncology will host a corresponding conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on May 2, 2024. 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.