On November 14, 2023 CG Oncology, Inc. reported that interim Phase 3 monotherapy data from the BOND-003 study will be presented as a late-breaking abstract at the upcoming 24th Annual Meeting of the Society of Urologic Oncology (SUO), held November 28-December 1, 2023, at the Omni Shoreham Hotel in Washington, DC (Press release, CG Oncology, NOV 14, 2023, View Source [SID1234637674]).

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BOND-003 (NCT04452591) is a single-arm, open-label, Phase 3 clinical trial evaluating cretostimogene grenadenorepvec as monotherapy in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). The study enrolled 116 patients with BCG-unresponsive NMIBC across North America and the Asia-Pacific region. The primary endpoint of the study is complete response (CR) at any time, with duration of response measured as a secondary endpoint.

Details of the oral presentation are as follows:

First results from BOND-003, a Phase 3 study of intravesical Cretostimogene grenadenorepvec monotherapy for patients with high-risk Bacillus Calmette-Guerin (BCG)-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

Abstract Number: 3396
Session: Urothelial Cancer Session I
Presenter: Mark D. Tyson, M.D., Urologic Oncologist at Mayo Clinic, Scottsdale, AZ
Date & Time: Thursday, November 30, 2023, from 11:59am-12:04pm Eastern Standard Time

About Cretostimogene Grenadenorepvec

Cretostimogene grenadenorepvec is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in BOND-003, a Phase 3 clinical trial for the treatment of BCG-unresponsive Non-Muscle Invasive Bladder Cancer. Cretostimogene grenadenorepvec is also being evaluated in a Phase 2 clinical trial (CORE-001) in combination with pembrolizumab in the same indication. In addition, cretostimogene grenadenorepvec is being evaluated in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle invasive bladder cancer.

About Bladder Cancer

More than 82,000 people are estimated to be diagnosed with bladder cancer in 2023. NMIBC is the most common form of bladder cancer, representing approximately 75% of newly diagnosed cases. Bladder cancer is the sixth most common form of cancer in the United States, and men account for three quarters of newly diagnosed cases.

On November 14, 2023 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer and other diseases of the lung, reported financial results for the three and nine months ended Sept. 30, 2023, and provided a business update (Press release, BioAffinity Technologies, NOV 14, 2023, View Source [SID1234637673]).

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Highlights from the third quarter of 2023 and subsequent weeks included:

Corporate and Commercial Highlights

The Company’s wholly owned Precision Pathology Laboratory Services (PPLS) subsidiary acquired the non-medical assets of Village Oaks Pathology Services on Sept. 18, 2023. The clinical laboratory, certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and accredited by the College of American Pathologists (CAP), is now owned and operated by PPLS.
The Centers for Medicare and Medicaid Services (CMS) released a preliminary payment decision in September 2023 for the Current Procedural Terminology (CPT) code for CyPath Lung, our noninvasive test for lung cancer, issued by the American Medical Association (AMA) in June 2023. CMS is expected to finalize the 2024 payment for CyPath Lung in November 2023 with an effective date of Jan. 1, 2024. CMS’ final payment determination is expected to favorably impact PPLS’ established fee schedule for CyPath Lung, determining reimbursement by private insurance carriers.
The U.S. Department of Defense (DOD) purchased CyPath Lung tests for use in an observational study on active military personnel at high risk for developing lung cancer (NCT05870592) and for research on the use of bronchoalveolar lavage fluid to assess cardiopulmonary function and exercise performance in military personnel post-COVID-19 infection.
Dallas J. Coleman joined the Company as National Director of Sales responsible for leading the CyPath Lung sales team, sourcing new business opportunities and expanding the pilot market launch across Texas in preparation for the national rollout. Previously, Mr. Coleman was an Executive Account Manager for the respiratory portfolio of Olympus America’s therapeutic solutions division.
Management Commentary

"The transformative strategic acquisition of PPLS in September gives us a strong revenue base as we move forward with the rollout of our game-changing CyPath Lung test. PPLS is forecast to contribute $8.7 million in net revenue over the next 12 months, with additional upside as we work to expand sales of CyPath Lung regionally and nationally," bioAffinity President and Chief Executive Officer Maria Zannes said.

"We achieved another significant milestone in September when we received a preliminary payment decision from CMS for CyPath Lung that is in line with the July 2023 payment recommendation from the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. The CMS payment determination is a crucial step forward in our commercial rollout of our noninvasive test to improve detection of early-stage lung cancer," Ms. Zannes said. " As we begin our pilot marketing program for CyPath Lung in Texas, we look forward to applying what we learned in our beta market testing and informing and accelerating our regional and national rollout plans. As we plan to expand the geographic reach, add prescribing physicians, and partner with larger medical systems, we anticipate substantial revenue growth for CyPath Lung."

Third Quarter Financial Results

Revenue for the third quarter of 2023 increased to $298,484, up from $1,150 in the prior-year period. Prior to the Sept. 18, 2023, acquisition of PPLS, bioAffinity Technologies’ revenue was generated from royalties from sales of CyPath Lung as a laboratory developed test (LDT), clinical flow cytometry services related to CyPath Lung, and CyPath Lung tests purchased by the DOD. Post-acquisition of PPLS, beginning Sept. 19, 2023, the income from royalties and clinical flow cytometry services was classified as related party income and eliminated from consolidated net revenues, while additional revenue streams from PPLS were consolidated. PPLS generates three sources of revenue: patient service fees, histology service fees and medical director fees. Sales to the DOD were $4,500 for the third quarter of 2023.

Research and development expenses were $330,376 for the third quarter of 2023, compared with $319,744 for the comparable period in 2022. The increase was primarily due to higher compensation costs from adding research personnel and higher costs for lab supplies and reagents.

Clinical development expenses were $106,422 for the third quarter of 2023, compared with $60,941 for the third quarter of 2022. The increase was primarily due to higher professional fees related to clinical strategy evaluation for the pivotal clinical trial of CyPath Lung.

Selling, general and administrative expenses were $2.0 million for the third quarter of 2023, compared with $595,702 for the comparable period in 2022. The increase was primarily attributed to higher accounting, legal and professional fees related to the acquisition of PPLS and being a publicly traded company, higher board compensation, employee and stock-based compensation, and sales and marketing costs for commercialization of CyPath Lung.

Net loss for the third quarter of 2023 was $2.3 million, or $0.26 per share, compared with a net loss of $4.9 million, or $1.17 per share, for the comparable period in 2022.

Cash and cash equivalents were $4.5 million as of Sept. 30, 2023, compared with $11.4 million as of December 31, 2022. Management will assess opportunities to raise additional capital when the markets are favorable.

2023 Financial Outlook and Next Twelve Months

The Company expects to generate between $2.1 and $2.3 million in net revenues for 2023. This is up from $4,800 in 2022. Over the next 12 months (fourth quarter 2023 to third quarter 2024), the Company expects to generate between $8.4 and $9.0 million in net revenues.

CyPath Lung sales are expected to trend up as the Company expands its sales force and marketing efforts. Through Sept. 30, 2023, the pilot marketing program for CyPath Lung had 20 physicians enrolled, 15 physicians who had ordered tests for their patients and 44 CyPath Lung diagnostic tests conducted. Over the next 12 months (fourth quarter 2023 to third quarter 2024), the Company expects to grow the number of physicians enrolled to 82, the number of physicians that have ordered to 61, and the number of CyPath Lung diagnostic tests conducted to 284, which will contribute gross revenues of $457,166. To achieve this growth, the Company plans to expand its sale force from two to five in strategic metropolitan areas of Texas, promote CyPath Lung through branding and marketing assets, and benefit from broader reimbursement from private payers and public health insurance programs, including Medicare and Medicaid, based on CMS’ final payment determination.

ON November 14, 2023 Calidi Biotherapeutics, Inc. (NYSE American: CLDI or "Calidi"), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, reported its financial results for the third quarter 2023 and reviews recent business highlights (Press release, Calidi Biotherapeutics, NOV 14, 2023, View Source [SID1234637672]).

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"We are highly encouraged by our clinical progress, highlighted by our partner City of Hope dosing the first patient in June this year in a Phase 1 clinical trial evaluating CLD-101, our NeuroNova platform, in high-grade glioma patients," said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. "Our CLD-201 program, which we believe represents the future of immunotherapy as a novel allogeneic approach, continues to advance closer to the clinic, supported by promising preclinical data presented at the 2023 SITC (Free SITC Whitepaper) annual meeting. With access to the public markets and recent key leadership and Board appointments, we feel well positioned to deliver on the promise of our novel programs and look forward to sharing interim results from our ongoing CLD-101 study in recurrent high-grade glioma patients in the first half of next year."

Third Quarter 2023 and Recent Corporate Developments

Presented updated CLD-201 (SuperNova) data demonstrating inhibition of tumor growth and the induction of robust anti-tumor immunity in preclinical models at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting. The poster presentation exhibited CLD-201’s greater resistance to inactivation compared to unprotected CAL1 virus, significant inhibition of the growth of tumors even at very low doses, and the induction of robust anti-tumor immunity. The poster also detailed the clinical readiness of the product and plans to launch a Phase 1 study in 2024.
Appointed Andrew Jackson to the role of Chief Financial Officer. Mr. Jackson most recently served as Chief Financial Officer of Eterna Therapeutics and brings 25 years of corporate finance experience with success in publicly traded life science companies and venture capital-backed startups. The company also announced the appointment of Alan Stewart, previously a Calidi advisor, to the Board of Directors. Mr. Stewart brings extensive experience in finance and public company governance.
Closed business combination transaction and commenced trading on the NYSE American on September 13, 2023. In conjunction with the transaction closing, Calidi entered into a forward purchase agreement with a consortium of funds for up to $10 million.
Announced City of Hope, in partnership with Calidi, dosed the first patient in June 2023 in a Phase 1 clinical trial evaluating CLD-101 (NeuroNova) for the treatment of recurrent high-grade gliomas. The trial seeks to determine the safety, immunogenicity, and preliminary clinical efficacy of treatment with multiple intracerebral doses of CLD-101.
Upcoming Anticipated Milestones

4Q 2023: First patient dosed in CLD-101 Phase 1 trial in collaboration with Northwestern University for newly diagnosed high-grade glioma patients
1H 2024: Interim clinical results from CLD-101 Phase 1 trial in collaboration with City of Hope for recurrent high-grade glioma patients
1H 2024: First patient dosed in CLD-201 Phase 1 trial
Third Quarter Financial Results

The company reported a net loss of $2.0 million, or $0.14 per share, for the three months ended September 30, 2023, compared to a net loss of $5.4 million, or $0.63 per share, for the same period in 2022.

Research and development expenses were $3.3 million for the three months ended September 30, 2023, compared to $1.9 million for the comparable period in 2022, an increase of $1.4 million. The increase in research and development spend primarily reflects an increase in lab expenses for preclinical and clinical candidates of $0.7 million, an increase in salaries and benefits due to higher headcount of $0.5 million, and an increase in rent expense related to the San Diego Lease of $0.2 million.

General and administrative expenses were $4.0 million for the three months ended September 30, 2023, compared to $5.0 million for the comparable period in 2022, a decrease of $1.0 million. The decrease was primarily related to a decrease in transaction costs of $1.8 million, partially offset by an increase in salaries and benefits of $0.5 million, director and consulting costs of $0.2 million, and accounting related services of $0.1 million.

The company had approximately $10.1 million in cash and $0.2 million in restricted cash as of September 30, 2023, compared to $0.4 million in cash and $0.2 million in restricted cash as of December 31, 2022.

On November 14, 2023 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, reported that members of its management team are scheduled to participate in the Piper Sandler 35th Annual Healthcare Conference on Tuesday, November 28, 2023 (Press release, Fulgent Genetics, NOV 14, 2023, View Source [SID1234637671]).

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These representatives of the company will conduct a presentation beginning at approximately 12:00 p.m. Eastern Time (9:00 a.m. Pacific Time).

A live webcast of the session will be available on the Investor Relations section of the Fulgent Genetics website at ir.fulgentgenetics.com. A replay of the webcast will be accessible at the same location beginning approximately one hour following the completion of the event.

On November 14, 2023 BerGenBio ASA (OSE: BGBIO), a clinical-stage bio-pharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported financial results for the quarter ended September 30, 2023, and provided a business update (Press release, BerGenBio, NOV 14, 2023, View Source [SID1234637670]).

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"We are pleased to report continued advancement of our focused strategy to study our lead compound bemcentinib, a highly selective AXL inhibitor, in first line (1L) Non-Small Cell Lung Cancer (NSCLC) patients harboring mutations in the STK11 gene (STK11m). The increasing recognition of STK11m as a poor prognostic factor for 1L NSCLC patients, as evidenced by real-world data presented at prestigious medical conferences, continues to substantiate high unmet medical needs and our clinical data continues to validate the potential role of bemcentinib in combination with standard of care therapies to improve the outcome for these patients. During the quarter, we activated additional clinical trial sites in the US and prepared for the addition of sites in Europe in anticipation of the expected initiation of the Ph2a portion of our study in 1L NSCLC STK11m patients in the first half of 2024. Our operating expenses in the quarter amounted to NOK 28.1 million compared to NOK 62.4 million in Q3 2022 reflecting the effects of our focused strategy and cost containment implemented in connection with the Rights Issue. At 30th September 2023 our cash position stood at NOK 169.3 million. We believe that our singular focus on advancing bemcentinib in 1L NSCLC STK11m combined with the potential funding from the exercise of outstanding warrants issued in the Rights Issue enable us to generate data that can position the significant potential of bemcentinib in NSCLC," said Martin Olin, Chief Executive Officer of BerGenBio.

Clinical Development

Bemcentinib

BerGenBio’s lead compound, bemcentinib, is a potentially first-in-class, oral, highly selective inhibitor of the receptor tyrosine kinase AXL, which is expressed and activated in response to oxidative stress, inflammation, hypoxia and drug treatment, resulting in several deleterious effects in cancer and severe respiratory infections. Bemcentinib selectively inhibits AXL activation to prevent the progression of serious diseases through the modulation of resistance mechanisms and the adaptive immune system.

Bemcentinib is currently being developed in 1L STK11 mutated NSCLC and severe respiratory infections. Its novel mechanisms of action and primary accumulation in the lungs uniquely position it to address these severe lung diseases.

Oncology: NSCLC

1L STK11m NSCLC (BGBC016)

We continue to advance our focused strategy through the conduct of BGBC016, a global, open-label Phase 1b/2a trial designed to determine the safety, tolerability and efficacy of bemcentinib in combination with standard of care treatments in untreated advanced/metastatic non-squamous NSCLC patients with STK11m and no actionable mutations. Sites in the US have been activated and enrollment is ongoing while expansion into European sites is well underway, with regulatory approval to proceed received from regulatory authorities in the US and several European countries.

The Phase 1b portion of the study is evaluating the safety and feasibility of three different doses of bemcentinib in combination with pembrolizumab and doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients, regardless of STK11 status. To date, no significant safety concerns have arisen in the Phase 1b study. The Phase 2a expansion will assess the safety and efficacy of up to two doses of bemcentinib in the same treatment combination in 1L advanced/metastatic non-squamous NSCLC patients with STK11m.

A significant subgroup comprising of up to 20 % (> 30,000 patients in US and EU5) of 1L non-squamous NSCLC patients harbor STK11m, which are associated with immunosuppression and poor prognosis with standard 1L NSCLC treatment. Data suggests that STK11m NSCLC patients almost universally express AXL in tumors and/or on immune cells, resulting in the development of drug resistance, immune evasion, and metastases.

Post-quarter, the Company announced that the final data from the BGBC008 study (2L+ NSCLC, bemcentinib in combination with pembrolizumab) presented on October 23rd at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2023 Annual Meeting held in Madrid. The Company believes that these data along with study BGBIL005 (2L+ NSCLC, bemcentinib in combination with docetaxel) provide clinical evidence of the anti-tumor effects of bemcentinib and its ability to modulate the tumor microenvironment to enhance the effects of immunotherapy and chemotherapy. We believe that the reversal of the effects of AXL with bemcentinib holds the promise of providing substantial survival benefits to NSCLC patients and specifically in patients harboring STK11m and potentially other hard-to treat mutations such as KRAS and KEAP1. We expect to report additional clinical data at upcoming major medical meetings during the remainder of 2023, including the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting and the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

Description of the 2L+ NSCLC Trial (BGBC008)

The Ph2 BGBC008 trial enrolled 90 evaluable 2L+ NSCLC patients who had received at least one prior line of therapy: chemotherapy, immunotherapy or the combination.

An analysis of AXL biomarker status indicates that the presence of AXL expression on either tumor cells and/or immune cells is predictive of improved survival in patients treated with bemcentinib + pembrolizumab. The vast majority (88%) of patients met the criteria for AXL presence (AXL positive patients) and obtained clinically meaningful benefits:
Median overall survival was highly statistically significant at p=0.001 in AXL positive vs. AXL negative patients (14.1 mos. vs 6.5 mos).
Median progression free survival was 6.0 mos. in AXL positive patients vs. 5.8 AXL negative patients.
Analysis of available data for patients treated in subsequent therapies (3L+) following treatment with bemcentinib + pembrolizumab identified a higher than expected response rate, potentially pointing to long-lasting immune response benefits.
Data from the BGBC008 study also indicate that patients with PD-L1 negative (TPS score <1%) benefit from the combination treatment of bemcentinib and pembrolizumab. Currently PD-L1 negative patients respond less well to immune checkpoint inhibition, potentially providing an opportunity to expand the patient population eligible for treatment with bemcentinib.
The combination of bemcentinib and pembrolizumab appeared to benefit patients with mutations associated with poor outcome with available therapies, including STK11, KRAS, KEAP-1 and SMARCA4 mutations. These mutational patient populations may represent an incremental opportunity for bemcentinib and will be further assessed in our on-going BGBC016 study in 1L NSCLC patients.
Severe Respiratory Infections (SRIs)

The Company believes that bemcentinib blocks viral entry and replication, stimulates the innate immune system, and promotes lung tissue repair positioning it for the treatment of severe respiratory infections.

On April 25, 2023, the Company decided to pause the bemcentinib arm of the Phase 2b EUSolidAct trial evaluating bemcentinib in hospitalized COVID-19 patients due to the limited number of hospitalizations observed across all European countries. The Company and the EU-SolidAct have agreed to maintain this study on pause until and unless such time both parties agree to resume the trial arm due to increased COVID hospitalizations or should a new pandemic arise.

Bemcentinib is currently being evaluated in preclinical studies for SRIs causing Acute Respiratory Distress Syndrome (ARDS) and initial results are expected during 2023.

Corporate Activities

Rights Offering

On June 13, 2023, the Company completed a rights issue raising gross proceeds of NOK 250m. The proceeds from this offering including any additional proceeds from the exercise of warrants will be dedicated to the conduct of BGBC016 in 1L STK11m NSCLC patients, preclinical studies in severe respiratory infections and for general corporate purposes.

Warrants

The outstanding warrants issued in the Rights Issue can be exercised in two defined windows; from 15 November 2023 09:00 am CET to 28 November 2023 4:30 pm CET, or 1 April 2024 to 14 April 2024 at an exercise price of the volume-weighted average price (VWAP) of the Company’s shares on the Oslo Stock Exchange over the three last trading days prior to the exercise period less 30%, but in any event not less than NOK 0.10 and not higher than NOK 0.13. Additional information and instructions for exercise of warrants can be found on the Company’s website.

Our Chief Operating Officer James Barnes, decided to pursue new opportunities and will leave the company during December 2023. In connection with the implementation of the focused strategy, the role of Chief Operating Officer will not be replaced.

Third Quarter 2023 Financial Highlights

(Figures in brackets = same period 2022 unless otherwise stated)

– Revenue was NOK 0 million (NOK 0 million) for the third quarter.

– Total operating expenses for the third quarter were NOK 28.1 million (NOK 62.4 million)

– The operating loss for the quarter came to NOK 28.1 million (NOK 62.4 million)

– Cash and cash equivalents amounted to NOK 169.3 million by the end of September 2023 (NOK 226.0 million by end of June 2023).

Presentation and Webcast Details

The Q3 2023 presentation and Financial Report are available at the Company’s website.

BerGenBio’s senior management team will provide a business update today at 10:00 am CET. The presentation will webcast live. To participate in the webcast please use the following link:

https://channel.royalcast.com/landingpage/hegnarmedia/20231114_1/

A recording of the webcast will be available at www.bergenbio.com in the Investors/Financial Reports section shortly afterwards.