On May 4, 2023 Cerus Corporation (Nasdaq: CERS) reported financial results for the first quarter ended March 31, 2023 (Press release, Cerus, MAY 4, 2023, View Source [SID1234631024]).

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Recent highlights include:

First quarter 2023 total revenue of $38.5 million was comprised of (in thousands, except %):

Three Months Ended

March 31,

Change

2023

2022

$

%

Product Revenue

$

30,974

$

37,444

$

(6,470

)

-17

%

Government Contract Revenue

7,502

5,576

1,926

35

%

Total Revenue

$

38,476

$

43,020

$

(4,544

)

-11

%

The Company is reiterating its full-year 2023 annual product revenue guidance range of $165 million to $170 million.
Completed successful debt refinancing, providing for longer time before principal repayments are required, company options for an additional $20 million and expansion of the revolving line of credit up to $35 million.
Received Medical Device Regulation (MDR) certification for INTERCEPT platelets processing sets.
Submitted INTERCEPT platelets dossier to the Chinese regulatory authority, the National Medical Products Administration (NMPA).
Cash, cash equivalents, and short-term investments were $94.7 million at March 31, 2023.
"With anticipated first-quarter headwinds largely behind us as more normalized customer order patterns resume, we continue to be optimistic about our return to growth for the duration of 2023, supporting our full-year product revenue guidance of $165-170 million," said William "Obi" Greenman, Cerus’ president and chief executive officer. "The INTERCEPT Blood System continues to be the technology of choice in the U.S. for platelet safety, and we expect to see continued adoption in other geographies this year as well."

"We have multiple commercial milestones on tap this year, including ongoing roll-out of INTERCEPT platelets in Canada as well as regulatory progress in China via our joint venture. We remain committed to achieving adjusted EBITDA breakeven this year which, combined with our strong balance sheet and recently completed debt refinancing, would put us in a strategically strong position. Accordingly, this would allow us to reinvest cash flows into continued growth, margin expansion and scale, and new product development," Greenman continued.

Revenue

Product revenue during the first quarter of 2023 was $31.0 million, compared to $37.4 million during the prior year period. The decrease in product revenue was driven primarily by the anticipated short-term U.S. customer inventory drawdown, discussed during the Company’s fourth-quarter 2022 call. The Company expects that this dynamic has largely played out.

First-quarter 2023 government contract revenue was $7.5 million, compared to $5.6 million during the prior year period. Reported government contract revenue in the first quarter 2023 increased versus the prior year period primarily due to funding associated with development of a lyophilized INTERCEPT Fibrinogen Complex. In addition to this funding, our government contract revenue was comprised of funding associated with research and development (R&D) activities related to the INTERCEPT Blood System for Red Blood Cells as well as efforts related to the development of next-generation pathogen reduction technology to treat whole blood.

Product Gross Profit & Margin

Product gross profit for the first quarter of 2023 was $17.3 million, down by 11% over the prior year period. Product gross margin for the first quarter of 2023 was 55.8% compared to 51.7% for the first quarter of 2022. The first quarter of 2023 represents the fifth consecutive quarter of gross margin expansion. The Company expects that a number of initiatives aimed at lowering cost of goods sold will contribute to continued margin expansion over time.

Operating Expenses

Total operating expenses for the first quarter of 2023 were $38.9 million compared to $34.8 million for the same period of the prior year, reflecting a year-over-year increase of 12%.

Selling, general, and administrative (SG&A) expenses for the first quarter of 2023 totaled $21.6 million, compared to $20.7 million for the first quarter of 2022. The year-over-year increase in SG&A expenses for the first quarter was tied to investments in field-based personnel in support of commercial growth, costs of attracting and retaining our employees, legal fees, and non-cash stock-based compensation.

R&D expenses for the first quarter of 2023 were $17.4 million, compared to $14.1 million for the first quarter of 2022. The year-over-year increase in R&D expenses in the first quarter was tied to the development of our next-generation illuminator and increased clinical research activities.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the first quarter of 2023 was $15.6 million, or $0.09 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $12.3 million, or $0.07 per basic and diluted share, for the first quarter of 2022.

Non-GAAP Adjusted EBITDA

Non-GAAP Adjusted EBITDA for the first quarter of 2023 was negative $9.8 million, compared to non-GAAP Adjusted EBITDA of negative $3.7 million for the first quarter of 2022. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.

Balance Sheet & Cash Use

At March 31, 2023, the Company had cash, cash equivalents and short-term investments of $94.7 million, compared to $102.2 million at December 31, 2022.

As of March 31, 2023, the Company had $55.0 million outstanding on its term loan and $18.0 million drawn on its revolving credit facility. The Company has access to $17 million under its revolving line of credit.

For the first quarter of 2023, net cash used in operating activities totaled $8.5 million as compared to $21.5 million during the prior year period, primarily due to the timing of cash collections and payments, offset by continued inventory related purchases.

Reiterating 2023 Product Revenue Guidance

The Company expects full-year 2023 product revenue will be in the range of $165-$170 million, underscoring a return to growth with the short-term customer inventory drawdown largely complete.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source

A replay will be available on Cerus’ website approximately three hours after the call through May 18, 2023.

On May 4, 2023 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted treatments for cancer, reported financial results for the first quarter ended March 31, 2023 and provided a corporate update (Press release, Cellectar Biosciences, MAY 4, 2023, View Source [SID1234631022]).

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First Quarter and Recent Corporate Highlights

· Presented at both the Roth Capital Partners 35th Annual Conference on March 13, 2023, and the Oppenheimer 33rd Annual Healthcare Conference on March 14, 2023. A replay of the Oppenheimer presentation is available on the Events Page of the Company’s IR website.

"We maintained strong operational momentum in the first quarter, with our primary focus being the execution of our pivotal trial of iopofosine in Waldenstrom’s macroblobulinemia (WM). In parallel with study enrollment and anticipated conclusion, we continue to prepare for the commercial launch of iopofosine." said James Caruso, president and CEO of Cellectar. "At the same time, we are advancing other key programs for iopofosine and are encouraged by the data observed, some of which we presented at recent scientific conferences. We remain pleased with the depth of our clinical program and collectively believe 2023 will be a very meaningful year for us as we look forward to key data announcements including topline data from our WM pivotal study."

First Quarter 2023 Financial Highlights

· Cash and Cash Equivalents: As of March 31, 2023, the company had cash and cash equivalents of $12.7 million, compared to $19.9 million as of December 31, 2023. Net cash used in operating activities during the three months ended March 31, 2023 was approximately $7.2 million. The company believes its cash on hand is adequate to fund budgeted operations into the fourth quarter of 2023.

· Research and Development Expense: R&D expense for the three months ended March 31, 2023 was approximately $6.7 million, compared to approximately $3.9 million for the three months ended March 31, 2022. The overall increase in research and development expense was driven by increased clinical, manufacturing and related costs.

· General and Administrative Expense: G&A expense for the three months ended March 31, 2023 was $2.1 million, compared to $2.3 million for the same period in 2022. The overall decrease in G&A costs was primarily driven by a decrease in professional fees, partially offset by increased personnel costs.

· Net Loss: The net loss attributable to common stockholders for the three months ended March 31, 2023 was ($8.6) million, or ($0.76) per share, compared to ($6.1) million, or ($1.00) per share, for the three months ended March 31, 2023.

On May 4, 2023 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported financial results for the first quarter ended March 31, 2023 and provided a corporate update (Press release, Celldex Therapeutics, MAY 4, 2023, View Source [SID1234631021]).

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"This quarter, we were excited to report additional positive data from our barzolvolimab Phase 1b multi-dose study in chronic spontaneous urticaria. We believe the rapid, durable and profound responses and the favorable safety profile observed in this study continue to position barzolvolimab as a potential best-in-class addition to a historically limited treatment landscape for patients and their physicians," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We look forward to presenting additional data from this study and also from the cholinergic cohort in the Phase 1b CIndU study at EAACI next month, where both data sets have been accepted for oral presentations."

"Importantly, our Phase 2 studies in chronic urticaria continue to progress as planned and we are on track to complete enrollment of the Phase 2 CSU study by the end of the third quarter, with topline data expected late this year or in the first quarter of 2024. We continue to expand the barzolvolimab program into indications where we believe its unique mechanism could potentially provide new therapeutic options to patients suffering from these difficult diseases and look forward to providing updates on our eosinophilic esophagitis and prurigo nodularis studies throughout the year."

Recent Program Highlights

Barzolvolimab – KIT Inhibitor Program

Barzolvolimab is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells.

In June and July 2022, Celldex announced that the first patients had been dosed in the Phase 2 clinical studies of barzolvolimab for the treatment of Chronic Spontaneous Urticaria (CSU) and the two most common forms of chronic inducible urticaria (CIndU) – cold urticaria (ColdU) and symptomatic dermographism (SD). These randomized, double-blind, placebo-controlled, parallel group Phase 2 studies are evaluating the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients who remain symptomatic despite antihistamine therapy, to determine the optimal dosing strategies. Based on current enrollment projections, Celldex anticipates that enrollment to the CSU study will be completed by the end of Q3 2023 and plans to report topline data either late this year or in the first quarter of 2024.

Data from the Phase 1b multiple dose study in patients with antihistamine refractory CSU were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting on Sunday, February 26, 2023 by Dr. Marcus Maurer, Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin and a lead investigator on the study. Updated data from this study have been accepted for oral presentation at the EAACI Hybrid Congress 2023, to be held in Hamburg, Germany, June 9 – 11 and on the EAACI Digital Events Platform.

AAAAI 2023 Data Summary:

As of the data cut-off date on November 29, 2022, enrollment was complete with 45 patients with moderate to severe CSU refractory to antihistamines enrolled and treated [35 barzolvolimab (n=9 in 0.5 mg/kg; n=8 in 1.5 mg/kg; n=9 in 3.0 mg/kg; n=9 in 4.5 mg/kg) and 10 placebo]. The 0.5 mg/kg, 1.5 mg/kg and 3.0 mg/kg cohorts had completed study participation through 24 weeks; 6 of 9 patients in the 4.5 mg/kg cohort had completed through the week 20 visit. Complete data were included for all patients in dose levels through 3.0 mg/kg through 24 weeks. All available data for the 4.5 mg/kg and placebo dose levels were presented for adverse events. Activity data for the 4.5 mg/kg dose level were reported through week 20. Activity data for the 0.5 mg/kg and placebo group were only included through week 12 because, as expected, most patients from these groups had significant symptoms ahead of week 24 and discontinued follow up. Two patients did not receive all doses of study treatment [4.5 mg/kg (1), placebo (1)].

Barzolvolimab resulted in rapid, marked and durable responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment. The 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg dose groups showed similar markedly improved urticaria symptoms and disease control with sustained durability up to 24 weeks.

Mean reduction from baseline in urticaria activity (UAS7) at week 12 of 67% in the 1.5 mg/kg dose group (n=8), 67% in the 3.0 mg/kg dose group (n=9) and 82% in the 4.5 mg/kg dose group (n=9). Complete response (UAS7=0) at week 12 of 57% in the 1.5 mg/kg dose group, 44% in the 3.0 mg/kg dose group and 67% in the 4.5 mg/kg dose group.

Well-controlled disease (UCT≥ 12) at week 12 of 75% in the 1.5 mg/kg dose group, 63% in the 3.0 mg/kg dose group and 89% in the 4.5 mg/kg dose group.

Patients with prior omalizumab therapy had similar symptom improvement as all patients.

Barzolvolimab was well tolerated with a favorable safety profile; effects of multiple dose administration were consistent with observations in single dose studies. Most AEs were mild or moderate in severity and resolved while on study.

Celldex has completed enrollment in the barzolvolimab Phase 1b open label study in chronic inducible urticaria. Data from the cholinergic cohort in this study have been accepted for oral presentation at the EAACI Hybrid Congress 2023, to be held in Hamburg, Germany, June 9 – 11 and on the EAACI Digital Events Platform.

Celldex has closed enrollment at 24 patients in the barzolvolimab Phase 1b multi-center, randomized, double-blind, placebo-controlled study in patients with prurigo nodularis (PN), a chronic skin disease characterized by the development of hard, intensely itchy (pruritic) nodules on the skin. The study remains blinded. Celldex plans to present data from the ongoing study, including 24 weeks of follow-up, in the fourth quarter at a medical meeting and is planning for the initiation of a Phase 2 subcutaneous study in PN in late 2023 or early 2024.

Celldex plans to initiate a Phase 2 international trial of barzolvolimab in eosinophilic esophagitis (EoE), the most common type of eosinophilic gastrointestinal disease, in June of 2023.
Bispecific Antibody Platform

CDX-585 – Bispecific ILT4 & PD-1

CDX-585 combines highly active PD-1 blockade with anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells. ILT4 is emerging as an important immune checkpoint on myeloid cells.

CDX-585 has successfully completed GMP manufacturing and IND-enabling studies to support clinical development. CDX-585 will initially be developed for the treatment of solid tumors either as monotherapy or in combination with other oncologic treatments and is expected to enter the clinic in mid-2023 in patients with advanced malignancies.
First Quarter 2023 Financial Highlights and 2023 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2023 were $278.4 compared to $305.0 million as of December 31, 2022. The decrease was primarily driven by cash used in operating activities of $28.6 million, partially offset by proceeds from stock issuances under employee benefit plans and unrealized gains due to higher interest rates. At March 31, 2023, Celldex had 47.2 million shares outstanding.

Revenues: Total revenue was $1.0 million in the first quarter of 2023, compared to $0.2 million for the comparable period in 2022. The increase in revenue was primarily due to an increase in services performed under our manufacturing and research and development agreement with Rockefeller University.

R&D Expenses: Research and development (R&D) expenses were $26.8 million in the first quarter of 2023, compared to $17.1 million for the comparable period in 2022. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial, barzolvolimab contract manufacturing, and personnel expenses.

G&A Expenses: General and administrative (G&A) expenses were $6.6 million in the first quarter of 2023, compared to $6.9 million for the comparable period in 2022. The decrease in G&A expenses was primarily due to a decrease in legal expenses, partially offset by an increase in stock-based compensation expense.

Changes in Fair Value Remeasurement of Contingent Consideration: The Company recorded a $0.5 million gain on fair value remeasurement of contingent consideration for the three months ended March 31, 2022, primarily due to changes in discount rates.

Net Loss: Net loss was $29.4 million, or ($0.62) per share, for the first quarter of 2023, compared to a net loss of $23.1 million, or ($0.49) per share, for the comparable period in 2022.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2023 are sufficient to meet estimated working capital requirements and fund planned operations through 2025, which include our ongoing Phase 1b studies in urticaria and prurigo nodularis and our ongoing and planned Phase 2 studies in CSU, CIndU and EoE.

On May 4, 2023 Cardinal Health (NYSE: CAH) reported third quarter fiscal year 2023 revenues of $50.5 billion, an increase of 13% from the third quarter of fiscal year 2022 (Press release, Cardinal Health, MAY 4, 2023, View Source [SID1234631020]). Third quarter GAAP operating earnings were $572 million and GAAP diluted earnings per share (EPS) were $1.34. Third quarter non-GAAP operating earnings increased 11% to $606 million due to a significant increase in Pharmaceutical segment profit, partially offset by a decline in Medical segment profit. Non-GAAP diluted EPS increased 20% to $1.74, reflecting the improvement in non-GAAP operating earnings, a lower share count and lower interest expense, partially offset by a higher non-GAAP effective tax rate.

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"Our third quarter results were led by continued momentum and growth in the Pharmaceutical segment," said Jason Hollar, CEO of Cardinal Health. "With the strong overall performance in the quarter, we are pleased to raise our full year non-GAAP EPS guidance by $0.35 at the midpoint. In Medical, we continue to see improvement in underlying performance and remain confident in our Medical Improvement Plan initiatives. Across the enterprise, we continue to operate with urgency to drive our businesses forward and create value for our shareholders."

Q3 FY23 summary

Q3 FY23

Q3 FY22

Y/Y

Revenue

$50.5 billion

$44.8 billion

13 %

Operating earnings/(loss)

$572 million

$(97) million

N.M.

Non-GAAP operating earnings

$606 million

$545 million

11 %

Net earnings/(loss) attributable to Cardinal Health, Inc.

$345 million

$(1,391) million

N.M.

Non-GAAP net earnings attributable to Cardinal Health, Inc.

$447 million

$402 million

11 %

Effective Tax Rate2

36.3 %

(916.5) %

Non-GAAP Effective Tax Rate

22.4 %

20.1 %

Diluted EPS attributable to Cardinal Health, Inc.

$1.34

$(5.05)

N.M.

Non-GAAP diluted EPS attributable to Cardinal Health, Inc.

$1.74

$1.45

20 %

Segment results

Pharmaceutical segment

Q3 FY23

Q3 FY22

Y/Y

Revenue

$ 46.8 billion

$ 41.0 billion

14 %

Segment profit

$ 600 million

$ 487 million

23 %

Third-quarter revenue for the Pharmaceutical segment increased 14% to $46.8 billion, driven by brand and specialty pharmaceutical sales growth from existing customers.

Pharmaceutical segment profit increased 23% to $600 million in the third quarter, driven by positive generics program performance and a higher contribution from brand and specialty products.

Medical segment

Q3 FY23

Q3 FY22

Y/Y

Revenue

$ 3.7 billion

$ 3.9 billion

(5) %

Segment profit

$ 20 million

$ 59 million

(66) %

Third-quarter revenue for the Medical segment decreased 5% to $3.7 billion, driven by lower Products and Distribution sales, primarily due to PPE volumes and pricing.

Medical segment profit decreased 66% to $20 million in the third quarter, primarily due to lower Products and Distribution volumes and unfavorable sales mix. Additionally, these results reflect both net unfavorable non-recurring adjustments, including simplification actions, and an improvement in PPE margins.

Fiscal year 2023 outlook1

The company raised and narrowed its fiscal year 2023 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. to $5.60 to $5.80, from $5.20 to $5.50.

This guidance includes an update to fiscal year 2023 Pharmaceutical segment profit outlook to 10.5% to 12% growth, from 4% to 6.5% growth and Medical segment profit outlook to a decline of approximately 50%, from flat to a decline of 20%.

Additionally, the company now expects interest and other in the range of $95 to $105 million, a non-GAAP effective tax rate of 22% to 23%, diluted weighted average shares outstanding of 262 to 263 million, capital expenditures of ~$450 million and adjusted free cash flow of $2.0 to $2.3 billion.

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

Investor Day

The company plans to host an Investor Day at 9:00 a.m. Eastern Standard Time on June 8 in New York City to detail its growth strategies and provide updates on its long-term outlook, capital allocation framework and the ongoing business and portfolio review. The event will be live-webcast and archived on Cardinal Health’s Investor Relations website.

Business Review Committee and Cooperation Agreement update

Business Review Committee and Cooperation Agreement update Cardinal Health’s management and Board of Directors, with support from the Business Review Committee, continue to work through the comprehensive review of the company’s strategy, portfolio, capital allocation framework, and operations. Given the importance of the work in maximizing Cardinal Health’s potential for the benefit of all stakeholders, the Board has extended the term of the Business Review Committee for an additional year through July 15, 2024. In connection with this extension, Cardinal Health has also extended the term of the company’s Cooperation Agreement with Elliott Investment Management L.P. ("Elliott") until the later of July 15, 2024 or until Elliott’s representative ceases to serve on, or resigns from, the company’s Board of Directors.

Recent highlights

Cardinal Health initiated and completed a $250 million dollar accelerated share repurchase program in the third quarter, resulting in a total of $1.5 billion year-to-date share repurchases in fiscal year 2023.
Cardinal Health announced the opening of two new distribution centers in Central Ohio. Both facilities support the company’s Medical segment, focusing on its U.S. Medical Products and Distribution and at-Home Solutions businesses.
Cardinal Health announced its collaboration with Signify Health to offer in-home clinical and medication management services through its Outcomes business.
Cardinal Health was selected by Autolus to provide core distribution capabilities required for U.S. commercialization of CAR T-cell therapies.
Cardinal Health recently introduced the Kangaroo OMNI Enteral Feeding platform, which is designed to accurately deliver thick formula and meet enteral feeding needs, from the hospital to home and infancy to end of life. OMNI is expected to launch in the United States and Canada in early fiscal year 2024.
Webcast

Cardinal Health will host a webcast today at 8:30 a.m. Eastern Standard Time to discuss third-quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available on the Investor Relations page for 12 months.

On May 4, 2023 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, reported financial results for the first-quarter ended March 31, 2023, and provided a business update (Press release, Cardiff Oncology, MAY 4, 2023, View Source [SID1234631019]).

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"We are delighted to have dosed the first patient in our Phase 2 ONSEMBLE trial. This randomized trial will evaluate the efficacy of onvansertib combined with standard of care in patients with KRAS/NRAS-mutated mCRC, who historically have limited treatment options," said Mark Erlander, PhD, Chief Executive Officer of Cardiff Oncology. "In addition, we are excited to have appointed Fairooz Kabbinavar, MD, FACP, as our new Chief Medical Officer, who brings deep expertise in the treatment of patients with CRC as well as expertise in using bevacizumab in the clinical setting. We believe Dr. Kabbinavar adds significant value to our clinical development program for onvansertib. We also formally introduced the full membership of our Scientific Advisory Board, a group of highly esteemed oncology experts who are providing a diverse range of insights that strengthen our clinical programs."

Upcoming potential milestones

•Metastatic pancreatic ductal adenocarcinoma (mPDAC) data readout from Phase 2 trial expected in mid-2023
•Small cell lung cancer (SCLC) data readout from investigator-initiated (with UPMC) Phase 2 trial expected in mid-2023
•Triple negative breast cancer (TNBC) data readout from investigator-initiated (with Dana-Farber Cancer Institute) Phase 1b/2 trial expected in the fourth-quarter of 2023 or first-quarter of 2024
•mCRC randomized data readout from Phase 2 ONSEMBLE trial expected in the second-half of 2024

Company Highlights for the quarter ended March 31, 2023

•Announced the Appointment of Fairooz Kabbinavar, MD, FACP, as Chief Medical Officer. Dr. Kabbinavar oversees the clinical development program for the Company’s investigational drug onvansertib and reports directly to Chief Executive Officer, Mark Erlander, PhD.
•Formally introduced the full membership of its Scientific Advisory Board (SAB). The SAB is comprised of a distinguished group of academic and industry experts who bring depth and breadth of knowledge in oncology drug development, clinical trial design, translational science and clinical research. In most cases, these individuals have been advising the Company for several years and will now collectively serve a critical role as we advance the clinical development of

onvansertib. The Company anticipates that over time the membership of the SAB may expand to add additional expertise in new indications or stages of clinical development.
•Announced First Patient Dosed in ONSEMBLE Phase 2 Randomized Trial of Onvansertib in Patients with Metastatic Colorectal Cancer. The Phase 2 ONSEMBLE trial includes patients with mCRC who have a documented KRAS or NRAS mutation and have previously received one prior chemotherapy regimen with or without bevacizumab in the first line metastatic setting. Patients are being randomized to onvansertib plus FOLFIRI/bevacizumab versus FOLFIRI/bevacizumab (standard of care).

First-Quarter 2023 Financial Results

Liquidity, cash burn, and cash runway

As of March 31, 2023, Cardiff Oncology had approximately $97.0 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the first quarter of 2023 was approximately $8.7 million, a decrease of approximately $1.5 million from $10.2 million for the same period in 2022.

Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into 2025.

Operating results

Total operating expenses were approximately $12.1 million for the three months ended March 31 2023, an increase of $1.0 million from $11.1 million for the same period in 2022. The increase in operating expenses was primarily due to higher costs associated with clinical programs and outside service costs related to the development of the company’s lead drug candidate, salaries and staff costs primarily due to increased headcount.