On November 14, 2023 TriSalus Life Sciences Inc., (Nasdaq: TLSI), a publicly traded oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, reported its financial results for the third quarter ended September 30, 2023, and provided a business update (Press release, TriSalus Life Sciences, NOV 14, 2023, View Source [SID1234637675]).

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"Today marks an important milestone for TriSalus as we host our first quarterly earnings call as a public company. I am proud of our team’s considerable progress in the commercialization of the TriNav Infusion System, our Pressure Enabled Drug Delivery (PEDD) method, which achieved $5.2 million in revenues in the quarter, up over 30% from the third quarter of 2022," said Mary Szela, Chief Executive Officer of TriSalus. "We remain focused on integrating the TriNav system with immunotherapy to transform treatment for patients with liver and pancreatic tumors by solving two main barriers to tumor treatment in the tumor microenvironment (TME): mechanical barriers that limit drug delivery and biological barriers to driving immunosuppression."

"Data from our three Phase 1/1b trials indicates that our innovative immunotherapy approach for liver and pancreas tumors has been well tolerated, with evidence of SD-101 being delivered into difficult to reach tumors, potentially overcoming limitations posed by intravenous or direct needle injection approaches. The mechanical and biologic TME barriers that TriSalus is targeting are commonly present in solid tumors, creating a significant opportunity to impact a large patient population across cancer types," commented Steven Katz, MD, FACS, Chief Medical Officer of TriSalus.

Third Quarter 2023 and Subsequent Highlights

PERIO-01 Phase 1 Data Selected for Late Breaking Podium Presentation at the 2023 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting

In November, TriSalus announced that SITC (Free SITC Whitepaper) had selected the PERIO-01 Phase 1 data for a late breaking podium presentation and participation in the press conference of its 2023 annual meeting. The data demonstrated that delivery of SD-101 by TriNav plus systemic immune checkpoint inhibitor (ICI) in uveal melanoma with liver metastases (UMLM) patients results in clinical activity with median progression free survival (PFS) of 11.7 months, myeloid derived suppressor cell (MDSC) re-programming, and evidence of peripheral and intra-tumoral immune activation.

PERIO-03 Phase 1 Initial Safety and Feasibility Data Selected for Poster Presentation at SITC (Free SITC Whitepaper) Annual Meeting

In November, the company presented data on its PERIO-03 Phase 1 clinical trial on pressure enabled intra-pancreatic delivery of SD-101 with checkpoint blockade for locally advanced pancreatic adenocarcinoma. The data demonstrated that TriNav pancreatic retrograde venous infusions (PRVI) of SD-101 were well tolerated in the initial three patients and infusions were associated with potentially favorable immune changes in the periphery and tumors. These findings support continuing with single-agent dose escalation and subsequent combination with systemic ICI.

The PERIO-03 Phase 1 study with single-agent SD-101 is expected to be completed at the end of 2023 with subsequent initiation of the Phase 1b PERIO-03 dose expansion beginning early 2024. In the expansion study, intravenous anti-PD-1 therapy will be added to SD-101 delivered by PEDD. The trial will target patients with unresectable, locally advanced pancreatic adenocarcinoma who failed or progressed on at least one line of standard therapy.

Jodi Devlin appointed as President, Commercial Operations

In September, TriSalus announced that Jodi Devlin was appointed as President, Commercial Operations. Ms. Devlin joined TriSalus with more than two decades of experience in building brands in a wide range of therapeutic areas, with expertise in developing and executing strategies across sales, marketing, medical affairs, market access, and policy for biotech and pharmaceutical products.

Financial Results

Revenue, all of which is from the sale of TriNav, was $5.2 million and $12.8 million, respectively, in the three and nine months ended September 30, 2023. These amounts represent growth vs. prior year of 32% in the third quarter and 39% for nine months year to date, primarily due to continued market share increases.

Gross margins were 89% in the third quarter ended September 30, 2023, and 84% for nine months year to date versus 82% and 84%, respectively, in the third quarter and year to date in 2022. The seven percent improvement in the third quarter of 2023 is due to increased factory volumes and improved operations efficiency.

Operating losses are $18.5 million and $40.0 million, respectively, for the third quarter and nine months ended September 30, 2023. These amounts include non-recurring professional service fee costs of $4.8 million in the quarter and $7.7 million year to date, primarily related to the completion of our deSPAC process in August 2023. These amounts compare to prior year losses of $8.1 million and $24.7 million, respectively. The Company increased investments in 2023 in R&D to support clinical program progress and in sales and marketing, primarily to expand its sales force to continue to increase market penetration.

Net losses attributable to common stockholders are $1.7 million and $27.0 million, respectively, for the third quarter and nine months ended September 30, 2023. These amounts compare to prior year losses of $8.1 million and $24.6 million, respectively. Net losses include the impact of a non-cash related gain on revaluation of contingent earnout liabilities of $19.9 million in the third quarter and nine-month period of 2023. In addition, net losses include the impact of non-cash related gains/(losses) associated with revaluation of tranche and warrant liabilities of ($2.8) million and $0.7 million, respectively, for the third quarter and nine-month period ending September 30, 2023. The nine-month period ending September 30, 2023 also includes a non-cash related loss on equity issuance of $4.2 million.

Basic and diluted loss per share for the three and nine months ended September 30, 2023, was $0.13 and $5.68, respectively, compared to a basic and diluted loss per share of $25.95 and $82.17 for the three and nine months ended September 30, 2022, respectively.

Conference Call

The event will be webcast live on the investor relations section of TriSalus’ website at View Source Following the conclusion of the event, a webcast replay will be available on the website for approximately 90 days. Interested parties participating by phone will need to register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin.

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.