On November 8, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported third quarter 2022 financial results and provided a business update (Press release, CytomX Therapeutics, NOV 8, 2022, View Source [SID1234623515]).

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"CytomX’s progress in the third quarter highlights the potential of our pipeline as well as the breadth and versatility of the Probody platform. CX-2051 and CX-801 are wholly owned, next generation therapeutic candidates that build on our deep experience with conditional activation," said Sean McCarthy, D.Phil., chief executive officer and chairman at CytomX Therapeutics. "We also continued to make progress in our collaborator programs, including CX-904, our first T-cell engager in the clinic, and BMS-986249, for which Bristol Myers Squibb presented updated Phase 1 safety and efficacy data at ESMO (Free ESMO Whitepaper) 2022."

Third Quarter Business Highlights and Recent Developments

CX-2051, EpCAM-directed Antibody Drug Conjugate (ADC), unveiled at World ADC in San Diego – CX-2051 is a wholly-owned, conditionally activated ADC directed toward the epithelial cell adhesion molecule (EpCAM), with potential applicability across multiple EpCAM-expressing cancers. CX-2051 is tailored to optimize the therapeutic index for systemic treatment of EpCAM-expressing cancers, an opportunity that, to date, has not been realized due to dose-limiting toxicities. CytomX’s strategy with CX-2051 is to match target expression and sensitivity to the camptothecin payload with prioritized indications. CX-2051 data presented at World ADC demonstrated strong preclinical activity and a favorable predicted therapeutic index. CytomX anticipates submitting an IND for CX-2051 in the second half of 2023.

CX-801, Interferon (IFN) alpha-2b, preclinical data at SITC (Free SITC Whitepaper) Annual Meeting – CX-801 is a wholly-owned IFN alpha-2b Probody therapeutic that in preclinical studies has demonstrated a wide therapeutic index and potent antitumor effects. At the SITC (Free SITC Whitepaper) 2022 Annual Meeting starting November 9th, pre-clinical data will be presented highlighting CX-801’s tolerability profile, preferential activity in the tumor microenvironment, and the potential for synergistic effects in combination with checkpoint inhibitors. CytomX anticipates submitting an IND for CX-801 in the second half of 2023.

Bristol Myers Squibb presented updated ipilimumab Probody data at ESMO (Free ESMO Whitepaper) 2022 – At the ESMO (Free ESMO Whitepaper) Congress 2022, Bristol Myers Squibb presented updated Phase 1 safety, efficacy, pharmacokinetic, and pharmacodynamic data from the Phase 1/2 study of BMS-986249, a Probody version of ipilimumab, alone and in combination with nivolumab in patients with advanced cancers. The safety profile and disease control rate observed in the updated Phase 1 data for BMS-986249 with and without nivolumab appears promising. BMS-986249 appears to be tolerated at higher doses than traditional ipilimumab clinical dosing, and an encouraging case study was reported of a partial response in microsatellite-stable colorectal cancer. BMS-986249 is being evaluated in a randomized Phase 2 study in combination with nivolumab versus ipilimumab plus nivolumab in patients newly diagnosed with advanced melanoma. This novel combination is also being studied in advanced hepatocellular carcinoma, castration-resistant prostate cancer, and triple-negative breast cancer.

Bristol Myers Squibb presentations on next generation anti-CTLA4 programs at SITC (Free SITC Whitepaper) 2022 – During Q3, Bristol Myers Squibb also presented a webinar titled "Building on the Legacy of Ipilimumab" at the SITC (Free SITC Whitepaper) "Targets for Cancer IO: A Deep Dive Webinar Series." This presentation focused on the company’s next generation anti-CTLA-4 molecules, which includes the Probody therapeutics BMS-986249 and BMS-986288. BMS-986288 is a Probody version of non-fucosylated ipilimumab and is being evaluated as monotherapy and in combination with nivolumab in a Phase 1 study in advanced solid tumors. Additionally, at the SITC (Free SITC Whitepaper) annual meeting, a poster presentation will be presented by Bristol Myers Squibb titled "Phase 1/2a study of the novel nonfucosylated anti-CTLA monoclonal antibody BMS-986218 ± nivolumab in advanced solid tumors: Part 1 results," focused on BMS-986218, the non-masked version of BMS-986288. This presentation includes preclinical data on BMS-986288.

CX-2029, CD71-directed antibody-drug conjugate (ADC), program update – CX-2029 is a conditionally activated ADC directed toward CD71, the transferrin receptor, that is being co-developed by CytomX and AbbVie. Patient enrollment in the Phase 2 expansion study has been completed across the squamous non-small cell lung cancer (sqNSCLC), head and neck squamous cell carcinoma, and esophageal/gastro-esophageal junction (E/GEJ) cancer cohorts. A data update for the sqNSCLC cohort is expected in the fourth quarter of 2022. Data from the E/GEJ cancer cohort continues to mature.

CX-904, T-cell-engaging bispecific (TCB) EGFRxCD3, program update – CX-904 is a conditionally activated TCB designed to target the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells within the tumor microenvironment. CX-904 is partnered with Amgen and is being evaluated by CytomX in an ongoing Phase 1 study in patients with advanced solid tumors. The first patient was dosed in Q2 2022 and the dose escalation portion of the study continues to advance. Additionally, CytomX’s preclinical work highlighting the potential for a conditionally active, EGFR-CD3 Probody TCB to expand the safety window while maintaining efficacy was recently highlighted in Cancer Research, in a publication titled, "A Probody T-cell-engaging bispecific antibody targeting EGFR and CD3 inhibits colon cancer growth with limited toxicity."
Priorities for 2022-2023

Provide a data update for the Phase 2 study of CX-2029 in patients with squamous non-small cell lung cancer in the fourth quarter of 2022
Continue enrolling patients with advanced solid tumors in the Phase 1 study of CX-904
Submit INDs for CX-801 and CX-2051 in the second half of 2023
Provide updated data from the Phase 2 study of praluzatamab ravtansine in advanced breast cancer at the San Antonio Breast Cancer Symposium
Continued progress within the BMS alliance including the anti-CTLA-4 Probody programs
Complete company restructuring announced in July 2022 by the end of 2022
Third Quarter 2022 Financial Results
Cash, cash equivalents and investments totaled $194.3 million as of September 30, 2022, compared to $305.2 million as of December 31, 2021.

Total revenue was $16.9 million for the three months ended September 30, 2022, compared to $17.6 million for the corresponding period in 2021.

Research and development expenses increased by $1.2 million during the three months ended September 30, 2022 to $30.4 million compared to $29.1 million for the third quarter of 2021. The increase was primarily due to restructuring expenses, offset by a decrease in personnel related expense and clinical trial expenses due to the workforce reduction and pipeline reprioritization announced in July 2022.

General and administrative expenses decreased by $0.6 million during the third quarter of 2022 to $10.5 million. The decrease was mainly driven by a decrease in personnel related expenses due to the workforce reduction announced in July 2022 and a decrease in outside consulting, legal and intellectual property services, partially offset by restructuring expenses.

Overall expenses related to the company restructuring announced in July 2022 were $7.1 million consisting primarily of employee-related expenses and severance benefits. Total anticipated expenses as a result of the restructuring are expected to be approximately $7.9 million.

Conference Call & Webcast Information
CytomX management will host a conference call and simultaneous webcast today at 5:00 p.m. ET (2:00 p.m. PT) to discuss the financial results and provide a business update. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at View Source Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the Company’s website.

On November 8, 2022 Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a diversified clinical-stage company developing drugs for patients who have unmet medical conditions and/or require better treatment options to improve a patient’s survival and/or quality of life, reported financial results for the quarter ended September 30, 2022, and provided an update on its clinical programs (Press release, Processa Pharmaceuticals, NOV 8, 2022, View Source [SID1234623514]).

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Dr. David Young, President and CEO of Processa, commented, "We are delighted to report our push to enroll patients in PCS12852 (Gastroparesis) and PCS6422 (Next Generation Capecitabine) has helped us get critical data and report successful preliminary results in both trials. The data from these trials will help us design Phase 2B trials for both programs.

●Next Generation Capecitabine (NGC) (a combination of PCS6422 and capecitabine): we have identified lower capecitabine dosage regimens when administered in NGC that will help avoid dose-limiting toxicities such as hand-foot syndrome, yet provide approximately 50-times greater potency than capecitabine alone. We will complete this study in the near future and seek FDA confirmation of our plans to implement the principles of the Project Optimus Oncology Initiative, wherein the objective is to optimize dosing to achieve a better balance between efficacy and safety than merely using the maximum tolerated dose.
●PCS12852: we have shown a statistical difference in the gastric emptying rate between the 6 patients on 0.5 mg of PCS12852 and the 8 patients on placebo at p-value < 0.10 with mild to moderate adverse events. We anticipate having the analysis of the gastroparesis symptoms completed by the end of the year.

All our energies have been directed towards the completion of these trials that inform the next steps for these much-needed therapies.

Advancing these drugs in their respective clinical trial allows us to obtain the clinical data to better define each pivotal trial as well as provide us with more insight into how the FDA will review each of these products as we plan the road maps for designing the studies for our New Drug Applications to FDA.

Financial Results for the Nine Months Ended September 30, 2022

Our cash balance on September 30, 2022, was $9.1 million, which should be sufficient to complete our three on-going clinical trials and fund our operations into the third quarter of 2023. During the nine months ended September 30, 2022, we spent $7.1 million in cash for these three clinical trials and in our operations. This is significantly less than our GAAP net loss of $14.4 million due to the effect of non-cash items like amortization and stock-based compensation, and the application of amounts we had prepaid to our CROs last year.

Our net loss for the nine months ended September 30, 2022, was $14.4 million or $0.90 per share compared to a net loss of $8.2 million, or $0.54 per share for the same period of 2021. The increase in our net loss relates primarily to increased clinical trial costs we incurred in our three ongoing trials. For the nine months ended September 30, 2022, we incurred $8.3 million in research and development costs, an increase of $3.5 million when compared to the same period of 2021. We anticipate clinical trial costs will continue to increase for the rest of the year as our trials continue to progress and we fund development activities for the other drugs in our pipeline.

During the nine months ending September 30, 2022, our general and administrative expenses totaled $6.1 million compared to $3.4 million for the same period in 2021. The increase related primarily to increases in non-cash or stock-based compensation costs, along with other operating and consulting costs. We allocated $6.1 million of non-cash compensation costs between our R&D and G&A costs, with the majority recorded as G&A.

Our net cash used in operating activities during the nine months ended September 30, 2022, increased by $1.1 million to $7.1 million, compared to $6 million for the same period in 2021. While we experienced increased GAAP costs related to our clinical trials and operations, we continued to make use of equity incentives to compensate our executive and development team, thereby reducing our cash outflow, and we were able to apply previously made advanced payments to our CROs against current trial costs.

As of September 30, 2022, we had 15.9 million common shares outstanding.

On November 8, 2022 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported financial results for the third quarter of 2022 and provided a business update (Press release, Caribou Biosciences, NOV 8, 2022, View Source [SID1234623513]).

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"We have seen highly promising results from our lead allogeneic cell therapy, CB-010, at the lowest starting dose in the ANTLER clinical trial in patients with relapsed or refractory B cell non-Hodgkin lymphoma," said Rachel Haurwitz, Ph.D., Caribou’s president and chief executive officer. "The safety and antitumor activity for CB-010 at dose level 1 are encouraging, and we look forward to generating additional efficacy and durability data from the dose escalation phase of the ANTLER trial. In addition, progress continues across our pipeline as we submitted our second IND, for CB-011, in the fourth quarter and plan to submit our third IND, for CB-012, in 2023. Later this year, we look forward to sharing the target selection for CB-020, the lead program in our CAR-NK platform for solid tumors."
Recent Business Highlights
Pipeline and Technology
•For CB-011, an investigational new drug (IND) application was submitted to the U.S. Food and Drug Administration (FDA) in Q4 2022 for relapsed or refractory multiple myeloma (r/r MM).
•CB-010 and the ANTLER Phase 1 trial:
◦In October 2022, a poster for a case report on long-term follow up for the first patient dosed in the ANTLER Phase 1 trial was presented at the Lymphoma, Leukemia, & Myeloma (LL&M) Congress. This patient achieved a complete response (CR) at day 28 and maintained a long-term CR at 15 months following a single dose of CB-010 at dose level 1 (40×106 CAR-T cells). Before joining the ANTLER trial, the patient had received eight prior lines of systemic anti-cancer therapy for relapsed aggressive B cell non-Hodgkin lymphoma (r/r B-NHL).
◦Based on the promising initial safety data and response rates at dose level 1, the ANTLER trial is currently enrolling patients at dose level 2 (80×106 CAR-T cells).
◦In September 2022, CB-010 was granted Orphan Drug Designation (ODD) for follicular lymphoma (FL) by the FDA. Patients with aggressively behaving FL are 1 of 7 subtypes of r/r B-NHL patients eligible for enrollment in the dose escalation portion of the ANTLER Phase 1 trial.
◦As previously reported:
▪6 of 6 patients (100%) achieved a CR as their best response
▪3 of 6 patients (50%) maintained a CR at 6 months
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▪15 months has been the longest CR, achieved by the first patient dosed with CB-010
▪CB-010 at dose level 1 was generally well tolerated in the ANTLER trial
Anticipated Milestones for Fourth Quarter 2022 and Beyond
•CB-010: Caribou plans to share additional data from cohort 1 of the ongoing ANTLER Phase 1 trial for CB-010, an allogeneic anti-CD19 CAR-T cell therapy for r/r B-NHL, by YE 2022.
•CB-011: Caribou anticipates the FDA’s response to Caribou’s IND application for CB-011, an allogeneic anti-BCMA CAR-T cell therapy for r/r MM, by YE 2022.
•CB-020: Caribou expects to announce target selection for CB-020, an iPSC-derived CAR-NK cell therapy for solid tumors, in Q4 2022. Additionally, Caribou expects to disclose armoring strategies under development for its CAR-NK cell platform in Q4 2022.
•CB-012: Caribou expects to submit an IND application for CB-012, an allogeneic anti-CLL-1 CAR-T cell therapy for relapsed or refractory acute myeloid leukemia (r/r AML), in 2023.
Upcoming Meetings
•American Society of Hematology (ASH) (Free ASH Whitepaper) 64th Annual Meeting, December 10-13, 2022
◦Trial-in-progress poster presentation for the ANTLER Phase 1 trial of CB-010 in r/r B-NHL
•Caribou management plans to participate in the following upcoming investor conferences:
◦November 14: Barclays 2022 Gene Editing & Gene Therapy Summit
◦November 17: Jefferies Global Healthcare Conference
◦November 30: 5th Annual Evercore ISI HealthCONx Conference
◦December 7: BofA Securities Biotech SMID Cap Conference
Third Quarter 2022 Financial Results
Cash, cash equivalents, and marketable securities: Caribou had $342.6 million in cash, cash equivalents, and marketable securities as of September 30, 2022, compared to $413.5 million as of December 31, 2021.
Licensing and collaboration revenue: Revenue from Caribou’s licensing and collaboration agreements was $3.3 million for the three months ended September 30, 2022, compared to $4.0 million for the same period in 2021. The decrease was primarily due to a decrease in revenue under the AbbVie collaboration and license agreement.
R&D expenses: Research and development expenses were $20.0 million for the three months ended September 30, 2022, compared to $15.8 million for the same period in 2021. The increase was primarily due to costs to advance pipeline programs; increased headcount, including stock-based compensation; and facilities and other expenses; partially offset by a decrease related to the timing of external manufacturing activities.
G&A expenses: General and administrative expenses were $9.8 million for the three months ended September 30, 2022, compared to $6.8 million for the same period in 2021. The increase was
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primarily due to costs for increased headcount, including stock-based compensation; facilities and other expenses; and legal, accounting, insurance, and other expenses necessary to support the growth and operation of a clinical-stage public company.
Net loss: Caribou reported a net loss of $26.6 million for the three months ended September 30, 2022, compared to a net loss of $21.0 million for the same period in 2021.
About Caribou’s Novel Next-Generation CRISPR Platform
CRISPR genome editing uses easily designed, modular biological tools to make DNA changes in living cells. There are two basic components of Class 2 CRISPR systems: the nuclease protein that cuts DNA and the RNA molecule(s) that guide the nuclease to generate a site-specific, double-stranded break, leading to an edit at the targeted genomic site. CRISPR systems are capable of editing unintended genomic sites, known as off-target editing, which may lead to harmful effects on cellular function and phenotype. In response to this challenge, Caribou has developed CRISPR hybrid RNA-DNA guides (chRDNAs; pronounced "chardonnays") that direct substantially more precise genome editing compared to all-RNA guides. Caribou is deploying the power of its Cas12a chRDNA technology to carry out high efficiency multiple edits, including multiplex gene insertions, to develop CRISPR-edited therapies.

On November 8, 2022 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a fireside chat at the Stifel 2022 Healthcare Conference on Tuesday, Nov. 15, 2022 at 8:00 a.m. ET (1:00 p.m. GMT) (Press release, Alkermes, NOV 8, 2022, View Source [SID1234623512]). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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On November 8, 2022 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, reported that William Collier, Arbutus’ President and Chief Executive Officer, will present at the Jefferies London Healthcare Conference on Wednesday, November 16, 2022, at 11:30 am GMT / 6:30 am EDT (Press release, Arbutus Biopharma, NOV 8, 2022, View Source [SID1234623511]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the presentation can be accessed through the Investors section of Arbutus’ website at www.arbutusbio.com. An archived replay of the webcast will be available on the Arbutus website after the event.