On August 9, 2023 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics to improve patient care, reported financial results for the second quarter ended June 30, 2023 and provided a corporate update (Press release, Immunome, AUG 9, 2023, View Source [SID1234634114]).

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"We believe combining Immunome and Morphimmune’s technologies represents a major step in our long-term strategy of creating a preeminent oncology therapeutics company," stated Purnanand Sarma, PhD, President and CEO of Immunome. "Targeted cancer therapies have made great strides in recent years, and the possible synergy between Morphimmune’s Targeted Effector Platform and Immunome’s proprietary Discovery Engine presents an opportunity to discover and develop truly novel therapies that can help cancer patients. We look forward to completing the merger by the end the year."

Highlights

Immunome and Morphimmune Announce Definitive Merger Agreement and Simultaneous Private Placement Investment of $125 Million to Develop Targeted Cancer Therapies. In June 2023, Immunome and Morphimmune, a private biotechnology company focused on developing targeted oncology therapeutics, announced that the two companies entered into a definitive merger agreement. The closing of the transaction is subject to customary closing conditions, including the effectiveness of the registration statement on Form S-4 to be filed by Immunome, and the receipt of required stockholder approvals from Immunome and Morphimmune stockholders.
The combined company, which will operate as Immunome, will feature a synergistic platform expected to enable the development of best-in-class targeted cancer therapies across multiple modalities
Clay B. Siegall, Ph.D., current Morphimmune President & CEO and former co-founder & CEO of Seagen, Inc., to serve as Chairman and CEO of combined company
A concurrent $125 million private placement investment with leading institutional investors will support development of a combined pipeline expected to submit three investigational new drug applications (INDs) within 18 months of closing
Immunome Published Preclinical Research Demonstrating that Inhibition of IL-38 Using an Antibody Leads to Anti-Tumor Activity. In May 2023, Immunome announced the publication of data highlighting efficacy of its preclinical IL-38 blocking antibody, titled "IL-38 blockade induces anti-tumor immunity by abrogating tumor-mediated suppression of early immune activation," in the peer-reviewed journal mAbs. The data in the article demonstrates that antibody-based targeting of IL-38 leads to activation of the immunostimulatory anti-tumor mechanisms within the tumor microenvironment in preclinical testing.
Financial Highlights

Collaboration Revenue: Collaboration Revenue from the Collaboration Agreement with AbbVie for the three months ended June 30, 2023 was $4.3 million.
Research and development (R&D) expenses: R&D expenses for the three months ended June 30, 2023 were $5.7 million.
General and administrative (G&A) expenses: G&A expenses for the three months ended June 30, 2023 were $4.2 million.
Net loss: Net loss for the three months ended June 30, 2023 was $5.6 million, or $0.46 per share.
Cash and cash equivalents: As of June 30, 2023, cash and cash equivalents totaled $38.4 million.

On August 9, 2023 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported financial results and operational highlights for the second quarter ended June 30, 2023 (Press release, Adicet Bio, AUG 9, 2023, View Source [SID1234634113]).

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"We are initiating an expansion cohort, EXPAND, in post CAR T LBCL patients based on our Phase 1 GLEAN study, and will continue to enroll mantle cell lymphoma patients, as we progress towards initiating our potentially pivotal program in 2024."

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"Throughout the first half of 2023, Adicet has achieved several clinical, regulatory and scientific milestones. Specifically, we are encouraged by the clinical results observed in our ongoing Phase 1 study of ADI-001 in patients heavily pretreated with a median of 4 prior lines therapy. The results were particularly meaningful given that 50% of patients enrolled in our study had previously progressed following autologous CAR T therapy," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "We are initiating an expansion cohort, EXPAND, in post CAR T LBCL patients based on our Phase 1 GLEAN study, and will continue to enroll mantle cell lymphoma patients, as we progress towards initiating our potentially pivotal program in 2024."

Mr. Schor added, "We declared our third clinical candidate, ADI-270, which serves as our first foray to solid tumors, starting with renal cell carcinoma. ADI-270 leverages our gamma delta1 T cells, which are designed to home to solid tumors as a key differentiated property, with a highly specific targeting moiety for CD70 and an armoring technology of dominant negative TGF beta to address immunosuppressive factors in the tumor microenvironment. We expect to file an IND for ADI-270 in the first half of 2024, following our IND for ADI-925 in the second half of 2023."

Second Quarter 2023 and Recent Operational Highlights:

Announced additional safety and efficacy data from ongoing Phase 1 study of ADI-001. In June, Adicet reported safety and efficacy data from the Company’s ongoing Phase 1 study of ADI-001 for the potential treatment of relapsed or refractory aggressive B-cell NHL. As of the May 4, 2023 data-cut date, ADI-001 demonstrated 71% overall response rate (ORR) and 63% complete response (CR) rate across all dose levels in patients with median 4 prior lines of therapy. ADI-001 was generally well-tolerated in the study and there were no occurrences of dose-limiting toxicities or graft vs host disease.

In May, the Company completed a Type B meeting with the U.S. Food and Drug Administration and plans to transition the ADI-001 program into a potentially pivotal single arm Phase 2 study in post-CAR T LBCL under an accelerated approval pathway in 2024. Adicet is initiating an expansion cohort, EXPAND, in post CAR T LBCL patients based on the Phase 1 study, and will continue to enroll mantle cell lymphoma patients as the Company progresses towards initiating its potentially pivotal program in 2024. Adicet expects to provide a clinical update in the second half of 2024.

Continuing to advance broad pipeline of CAR and chimeric antigen adaptor (CAd) gamma delta T cell product candidates. The Company continues to advance its pipeline of first-in-class CAR and CAd gamma delta T cell product candidates targeting hematologic and solid malignancies. Adicet expects to submit an IND for ADI-925 in the second half of 2023.

In May, Adicet presented encouraging preclinical data at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) demonstrating proof-of-concept for ADI-270, an armored CD70-targeted allogeneic gamma delta CAR T cell development candidate. Adicet expects to submit an IND Application for ADI-270 in the first half of 2024.
Appointed Katie Peng to Board of Directors. In July, Adicet announced the appointment of Katie Peng to the Company’s Board of Directors. Ms. Peng brings extensive industry and commercial expertise to the Board. She currently serves as Chief Commercial Officer at Denali Therapeutics Inc., where she is leading the global commercialization efforts of Denali’s pipeline.

Financial Results for Second Quarter 2023:

Research and Development (R&D) Expenses: R&D expenses were $28.4 million for the three months ended June 30, 2023, compared to $16.2 million during the same period in 2022. The $12.2 million increase is primarily driven by a $3.7 million increase in payroll and personnel expenses resulting from an increase in overall headcount and a $3.4 million increase in expenses related to contract drug manufacturing organizations and other externally conducted research and development. There was also a $2.7 million increase in allocated facility expenses and a $2.1 million increase in laboratory expenses. Payroll and personnel expenses for the three months ended June 30, 2023 includes $2.4 million of non-cash stock-based compensation expense compared to $1.9 million during the same period in 2022.

General and Administrative (G&A) Expenses: G&A expenses were $6.5 million for the three months ended June 30, 2023, compared to $6.5 million during the same period in 2022. Payroll and personnel expenses for the three months ended June 30, 2023 includes $2.6 million of non-cash stock-based compensation expense compared to $2.4 million during the same period in 2022.

Net Loss: Net loss for the three months ended June 30, 2023 was $32.4 million, or a net loss of $0.75 per basic and diluted share, including non-cash stock-based compensation expense of $5.0 million, as compared to a net loss of $22.5 million during the same period in 2022, or a net loss of $0.56 per basic and diluted share, including non-cash stock-based compensation expense of $4.3 million.
Cash Position: Cash and cash equivalents were $205.5 million as of June 30, 2023, compared to $257.7 million as of December 31, 2023. The Company expects that current cash and cash equivalents as of June 30, 2023, will be sufficient to fund its operating expenses into the first half of 2025.

On August 9, 2023 GenScript Biotech, the world’s leading life-science research tools and services provider, and T-MAXIMUM Biotech, a biotechnology company pioneering universal cell therapies, reported to have formed a strategic collaboration agreement to enable the development of T-MAXIMUM’s development CAR-T cell therapy using GenScript’s CRISPR nucleic acid reagents (Press release, GenScript, AUG 9, 2023, View Source [SID1234634112]).

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GenScript will provide T-MAXIMUM Biotech with various CRISPR reagents to support the development of its universal CAR-T products from discovery to commercialization. The partnership with GenScript will support T-MAXIMUM Biotech’s strategic development plan to progress multiple products to the Phase II clinical research stage and deliver products to market within the next five years.

Dr. Shang Xiaoyun, CEO of T-MAXIMUM, said: "We are delighted to establish a strategic cooperation with GenScript. T-MAXIMUM focuses on recurrent high-grade gliomas without effective standard therapies and is committed to the development of universal CAR-T cell therapies. Gene editing reagents are crucial raw materials for the quality and efficacy of our products. We are confident that this collaboration will accelerate the regulatory processes in China and the United States, expediting T-MAXIMUM’s first product pipeline to benefit patients in need as soon as possible."

"We are honored to collaborate with T-MAXIMUM Biotech," said Dr. Li Hong, VP of R&D and manufacturing at GenScript. "Our R&D-to-GMP-level sgRNA will support their UCAR-T products for solid tumors. While CAR-T cell therapies have made remarkable strides in hematological tumors, addressing the unmet need for solid tumors remains crucial. We look forward to the further achievements of T-MAXIMUM Biotech’s cell therapy products—and to bringing good news to more patients."

T-MAXIMUM Biotech targets solid tumors with universal cell therapy

T-MAXIMUM Biotech is a clinical-stage cell therapy development company with core technology published in top journals such as Nature, Nature Biotechnology, Nature Methods, and Cell. Its universal CAR-T cell therapy product, MT027, is being developed for the treatment of recurrent high-grade gliomas. T-MAXIMUM Biotech uses the CRISPR system and electroporation RNP technology to knock out the TRAC and HLA genes, eliminating GVHD and TCR receptor signal interference, reducing rejection reactions, and prolonging the survival time of CAR-T cells in the body.

In February of this year, based on comprehensive preclinical research and positive results from investigator-initiated clinical studies (IIT), T-MAXIMUM Biotech’s MT027 obtained FDA ODD certification — a breakthrough milestone in T-MAXIMUM’s mission to "solve the treatment of diseases with no available drugs."

FDA’s certification of orphan drug designation (ODD) to T-MAXIMUM Biotech

In June of this year, the latest clinical research data of MT027 was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), further validating the feasibility of the product:

Safety: no severe CRS or ICANS occurred, no GvHD was observed, and all adverse events were grade 1-2.
Efficacy: disease control rate (DCR) was 100%, objective response rate (ORR) was 42.9%, and the 12-month survival rate after relapse was 85.7% — significantly higher than historical data of 14%.
GenScript’s GMP sgRNA service supports ODD

With 20 years of expertise in nucleic acid synthesis, GenScript has developed optimized processes, strict quality control, and extensive expertise in establishing a complete research-to-cGMP level CRISPR nucleic acid reagent product line. GenScript has supported seven successful IND approvals for gene and cell therapy (GCT) projects worldwide based on CRISPR technology and is committed to accelerating the development and commercialization process of GCT companies to the benefit of more patients.

GenScript offers one-stop chemical synthesized sgRNA and non-viral HDR knock-in templates, including GenExact linear ssDNA, GenWand linear closed-end dsDNA, and GenCircle circular miniature dsDNA, enabling high editing efficiency, low cytotoxicity, and low off-targets. From research use only to cGMP-quality products, GenScript aims to provide fast and quality services to meet the needs of cell- and gene-therapy researchers at different stages and to accelerate development of this area of fast-growing sector.

On August 9, 2023 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the second quarter of fiscal year 2023, which include the consolidated financial results for GRAIL (Press release, Illumina, AUG 9, 2023, View Source [SID1234634111]).

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"Illumina’s second quarter consolidated revenue grew 8% sequentially from the first quarter, and we saw higher-than-anticipated NovaSeq X shipments," said Charles Dadswell, Interim Chief Executive Officer. "Despite additional placements, we expect our second half revenue to be negatively impacted by customers remaining more cautious in their purchasing, a more protracted recovery in China, and a larger-than-expected temporary decline in high throughput consumables as customers transition to the NovaSeq X. In response, we are increasing customer support for the NovaSeq X and continue to manage our expense base in a disciplined way."

Second quarter consolidated results

GAAP

Non-GAAP (a)

Dollars in millions, except per share amounts

Q2 2023

Q2 2022

Q2 2023

Q2 2022

Revenue

$ 1,176

$ 1,162

$ 1,176

$ 1,162

Gross margin

62.2 %

66.0 %

66.5 %

69.4 %

Research and development ("R&D") expense

$ 358

$ 327

$ 345

$ 327

Selling, general and administrative ("SG&A") expense

$ 450

$ 410

$ 355

$ 339

Legal contingency and settlement

$ 12

$ 609

$ —

$ —

Operating (loss) profit

$ (88)

$ (579)

$ 82

$ 141

Operating margin

(7.5) %

(49.8) %

7.0 %

12.2 %

Tax rate

(163.8) %

16.0 %

39.3 %

25.8 %

Net (loss) income

$ (234)

$ (535)

$ 50

$ 91

Diluted (loss) earnings per share

$ (1.48)

$ (3.40)

$ 0.32

$ 0.57

(a) See the tables included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.

Capital expenditures for free cash flow purposes were $47 million for Q2 2023. Cash flow provided by operations was $105 million, compared to $125 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $58 million for the quarter, compared to $54 million in the prior year period. Depreciation and amortization expenses were $108 million for Q2 2023. At the close of the quarter, the company held $1,559 million in cash, cash equivalents and short-term investments, compared to $2,037 million as of January 1, 2023. On July 12, 2023, the European Commission imposed a €432 million fine due to the completion of the GRAIL acquisition during the pendency of the European Commission’s review. While expected and accrued for over the last year, Illumina believes that the fine is unlawful, inappropriate, and disproportionate, and is appealing the decision. Illumina plans to issue a guarantee and defer the payment of the fine pending the outcome of the appeal of the EU General Court’s ruling that the European Commission has jurisdiction to review the GRAIL acquisition.

Second quarter segment results

Illumina has two reportable segments, Core Illumina and GRAIL.

Core Illumina

GAAP

Non-GAAP (a)

Dollars in millions

Q2 2023

Q2 2022

Q2 2023

Q2 2022

Revenue (b)

$ 1,159

$ 1,156

$ 1,159

$ 1,156

Gross margin (c)

65.5 %

69.3 %

67.0 %

69.8 %

R&D expense

$ 274

$ 249

$ 261

$ 249

SG&A expense

$ 359

$ 339

$ 270

$ 270

Legal contingency and settlement

$ 12

$ 609

$ —

$ —

Operating profit (loss)

$ 115

$ (396)

$ 245

$ 288

Operating margin

9.9 %

(34.3) %

21.2 %

24.9 %

(a) See Table 3 included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.

(b) Core Illumina revenue for Q2 2023 was flat as compared to Q2 2022, and up 2% on a constant currency basis. Amounts for Q2 2023 and Q2 2022 included intercompany revenue of $5 million and $6 million, respectively, which is eliminated in consolidation.

(c) The year-over-year decrease in gross margin was primarily driven by lower instrument margins due to the NovaSeq X launch, which is typical with a new platform introduction, less fixed cost leverage on lower manufacturing volumes, and higher field services and installation costs.

GRAIL

GAAP

Non-GAAP (a)

In millions

Q2 2023

Q2 2022

Q2 2023

Q2 2022

Revenue

$ 22

$ 12

$ 22

$ 12

Gross (loss) profit

$ (24)

$ (29)

$ 9

$ 4

R&D expense

$ 89

$ 86

$ 89

$ 86

SG&A expense

$ 91

$ 72

$ 85

$ 70

Operating loss

$ (204)

$ (187)

$ (164)

$ (152)

(a) See Table 3 included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.

As previously stated, Illumina is committed to moving as quickly as possible through the legal and regulatory processes associated with its acquisition of GRAIL. If the company loses either its appeal in the US Court of Appeals for the Fifth Circuit or its appeal in the European Court of Justice (ECJ), Illumina expects to move quickly to divest GRAIL in a manner that serves the best interests of its shareholders. Should the company win both appeals, Illumina would undertake a detailed review of the GRAIL business, as it would no longer be subject to the hold separate, and determine the optimal outcome for the asset, also in the best interests of Illumina’s shareholders. Success in the ECJ appeal removes any fines; prevailing in the appeals increases the options to deliver value to shareholders. The legal and regulatory processes are finite; Illumina expects decisions from the US Court of Appeals for the Fifth Circuit in late 2023 and from the ECJ in late 2023 or early 2024.

Key announcements by Illumina since Illumina’s last earnings release

Announced the five founding members of the Alliance for Genomic Discovery (AGD), in which AbbVie, Amgen, AstraZeneca, Bayer, and Merck will co-fund the sequencing of 250,000 whole-genomes and have access to the data for use in drug discovery and therapeutic development
Launched DRAGEN 4.2, which expands upon award-winning accuracy combined with renowned flexibility and scalability to enable efficient workflows and extract meaningful insights from genomic data
Announced strategic partnership with Pillar Biosciences, Inc. to make Pillar’s suite of oncology assays commercially available globally as part of the Illumina portfolio of oncology products
Unveiled PrimateAI-3D, an artificial intelligence (AI) algorithm that predicts with unprecedented accuracy disease-causing genetic mutations in patients
Named three new independent directors to the board: Stephen P. MacMillan, Chairman, President and CEO of Hologic, Scott B. Ullem, Corporate Vice President and CFO of Edwards Lifesciences, and Andrew Teno, Portfolio Manager at Icahn Capital LP
Elected Stephen P. MacMillan as non-executive chair of the board
Appointed Charles Dadswell, General Counsel, as Interim Chief Executive Officer
A full list of recent Illumina announcements can be found in the company’s News Center.

Key announcements by GRAIL since Illumina’s last earnings release

Announced results from the prospective SYMPLIFY study, showing strong performance of Galleri in the symptomatic population of more than 6,000 patients and demonstrated the feasibility of using a Multi-Cancer Early Detection (MCED) test to assist clinicians with decisions regarding referral from primary care
Presented data at ASCO (Free ASCO Whitepaper), showing support that real-world performance of Galleri is consistent with previous large-scale clinical studies, including the cancer signal detection (CSD) rate and accuracy of the Cancer Signal Origin (CSO) prediction to guide diagnostic workup
Announced results from a retrospective analysis of the interventional PATHFINDER study, demonstrating that in the majority of cases (78%), the test’s CSO-directed initial diagnostic evaluation led to a diagnostic resolution
Completed second year study visits for the NHS-Galleri study, in which 130,000 participants came back for their second appointment (retention rate of 91.3%)
A full list of recent GRAIL announcements can be found in GRAIL’s Newsroom.

Financial outlook and guidance

The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance, including the company’s Core Illumina and GRAIL segments. Please see our Reconciliation of Consolidated Non-GAAP Financial Guidance included in this release for a reconciliation of these GAAP and non-GAAP financial measures.

For fiscal year 2023, the company now expects consolidated revenue growth of approximately 1% compared to fiscal year 2022. The company now expects Core Illumina revenue to be approximately flat compared to fiscal year 2022. GRAIL revenue is still expected to be in the range of $90 million to $110 million.

The company now expects GAAP diluted loss per share of $(2.08) to $(1.93) and non-GAAP diluted earnings per share of $0.75 to $0.90. The GAAP and non-GAAP diluted (loss) earnings per share guidance ranges continue to assume that the existing R&D capitalization requirements are not repealed in fiscal year 2023 and, as a result, reflect a tax expense impact of approximately $75 million.

Conference call information

The conference call will begin at 2 p.m. Pacific Time (5 p.m. Eastern Time) on Wednesday, August 9, 2023. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "Company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 877.400.0505 or +1.313.209.4906 outside North America, both using conference ID 8615466. To ensure timely connection, please dial in at least ten minutes before the scheduled start of the call.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On August 9, 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 second quarter ended June 30, 2023, and provided a business update (Press release, Cardiff Oncology, AUG 9, 2023, View Source [SID1234634110]).

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"2023 has been transformative for Cardiff Oncology, highlighted by the advancement of our lead program to the first-line mCRC setting and an expansion of our relationship with Pfizer," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "The shifting of our clinical development program to the first-line was a data-driven decision based on a strong signal from new clinical and preclinical findings, with agreement from the FDA. There are 48,000 new patients in the U.S. annually in the first-line RAS-mutated mCRC setting, with no ongoing clinical trials or new treatments approved in the past 20 years. We believe that there is a tremendous opportunity for onvansertib to provide a meaningful benefit to a substantial number of patients who are fighting cancer in challenging indications. Looking ahead, we anticipate commencing enrollment in our first-line trial this fall with interim topline data expected in mid-2024."

Upcoming expected milestones

mPDAC data readout from Phase 2 trial expected in Q3 ’23
SCLC data readout from Phase 2 trial expected in Q3 ’23 (investigator-initiated trial with UPMC)
First patient dosed in first-line mCRC trial expected fall ’23
TNBC data readout from Phase 1b/2 trial expected Q4 ’23/Q1 ’24 (investigator-initiated trial with Dana-Farber Cancer Institute)
First-line mCRC randomized data readout expected in mid-2024
Company highlights for the quarter ended June 30, 2023 and resent announcements

Announced new lead program in mCRC and expanded Pfizer relationship.
Cardiff Oncology will initiate a first-line trial, CRDF-004, a Phase 2 randomized trial generating preliminary safety and efficacy data and evaluating two different doses of onvansertib to confirm an optimal dose. Onvansertib will be added to standard-of-care consisting of FOLFIRI plus bevacizumab, or FOLFOX plus bevacizumab.
Contingent upon the results of CRDF-004, Cardiff Oncology will initiate CRDF-005, a Phase 3, randomized trial with registrational intent. The FDA has agreed that a seamless trial with objective response rate at an interim point is an acceptable endpoint to pursue accelerated approval, with progression-free survival and trend in overall survival being the endpoints for full approval.
Pfizer Ignite will be responsible for the clinical execution of the CRDF-004 trail, leveraging Pfizer’s significant R&D capabilities, scale and expertise.
Our new partnership with Pfizer Ignite expands the relationship established in November 2021 when Pfizer made an equity investment in Cardiff Oncology and nominated Adam Schayowitz, Ph.D., Vice President & Medicine Team Group Lead for Breast Cancer, Colorectal Cancer and Melanoma, Pfizer Global Product Development as a Scientific Advisory Board member.
Second Quarter 2023 Financial Results

Liquidity, cash burn, and cash runway

As of June 30, 2023, Cardiff Oncology had approximately $89.4 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the second quarter of 2023 was approximately $7.1 million, an increase of approximately $0.4 million from $6.7 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 $12.3 million for the three months ended June 30, 2023, an increase of $1.8 million from $10.5 million for the same period in 2022. The increase in operating expenses was primarily due to higher salaries and staff costs primarily due to increased headcount and stock-based compensation for additional grants to employees.