On November 7, 2024 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported financial results and recent highlights for the third quarter ended September 30, 2024 (Press release, Cardiff Oncology, NOV 7, 2024, View Source [SID1234647923]).

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"This quarter has been exciting as our Phase 2 clinical trial in second-line KRAS-mutant mCRC was published in one of the most esteemed medical journals in the field of oncology, Journal of Clinical Oncology. Our findings demonstrated that onvansertib combined with FOLFIRI/bev was well-tolerated, and revealed a 7.7x greater clinical benefit in bev naïve patients compared to patients who were previously treated with bev," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "We believe the results of our JCO publication validate our ongoing CRDF-004 trial evaluating onvansertib + chemo for the treatment of mCRC in the first-line setting, where all patients are bev naïve. Furthermore, we are pleased with the progress we have made in the trial as we leverage Pfizer’s resources and capabilities, and are grateful for the commitment from the patients and investigators at our trial sites across the U.S. As of today, the trial continues to generate patient data that will allow us to provide an initial data release by the end of the year. Overall, we are optimistic about onvansertib’s potential to become a meaningful treatment option for the 50,000 new patients diagnosed with RAS-mutated mCRC in the U.S. every year who have not had access to any new treatment options in several decades."

Upcoming expected milestones

•
First-line RAS-mutated metastatic colorectal cancer (mCRC) randomized initial data readout from the CRDF-004 trial expected by end of 2024

Company highlights for the quarter ended September 30, 2024 and subsequent weeks include:

•
Published clinical data of the combination of onvansertib with FOLFIRI and bev in second-line KRAS mutant mCRC in the peer-reviewed Journal of Clinical Oncology, the flagship publication of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)
•
Phase 2 clinical trial treating patients with KRAS-mutant mCRC (NCT03829410) demonstrated that onvansertib combined with FOLFIRI and bev was well-tolerated, and exhibited clinical activity in the second-line setting.
•
A post hoc analysis revealed a greater clinical benefit in bev naïve patients, who demonstrated an ORR of 77% and mPFS of 14.9 months compared to an ORR of 10% and mPFS of 6.6 months in those previously exposed to bev.

•
Published promising preclinical data demonstrating the combination of onvansertib and alpelisib in PIK3CA-mutated HR-positive breast cancer resistant to palbociclib and endocrine therapy in the peer-reviewed journal, Cancers
•
The combination of onvansertib and alpelisib synergistically inhibited cell viability, suppressed PI3K signaling, and induced G2/M arrest and apoptosis in PI3K-activated cell lines.
•
The combination demonstrated superior anti-tumor activity compared to the single agents in three PDX models.
•
Pharmacodynamic studies confirmed inhibition of both PLK1 and PI3K activity and pronounced apoptosis in the combination-treated tumors.
•
The findings support that targeting PLK1 and PI3Kα with onvansertib and alpelisib, respectively, may be a promising strategy for patients with PIK3CA-mutant HR+ breast cancer failing ET + CDK4/6i therapies and warrant clinical evaluation.
Third Quarter 2024 Financial Results

Liquidity, cash burn, and cash runway

As of September 30, 2024, Cardiff Oncology had approximately $57.7 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the third quarter of 2024 was approximately $10.5 million, an increase of approximately $2.5 million from $8.0 million for the same period in 2023.

Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q1 2026.

Operating results

Total operating expenses were approximately $12.8 million for the three months ended September 30, 2024, an increase of $1.8 million from $11.0 million for the same period in 2023. The increase in operating expenses was primarily due to clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib.

On November 7, 2024 Nimbus Therapeutics, LLC ("Nimbus Therapeutics" or "Nimbus"), a biotechnology company that designs and develops breakthrough medicines for patients through its powerful computational drug discovery engine, reported the presentation of new clinical and translational data from its ongoing Phase 1/2 trial of NDI-101150, a novel, oral, potent and selective small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor, for the treatment of advanced solid tumors (Press release, Nimbus Therapeutics, NOV 7, 2024, View Source [SID1234647940]). Results will be highlighted in two poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, taking place November 6-10, 2024 in Houston, Texas.

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The Phase 1/2 multicenter, open-label trial (NCT05128487) is designed to assess NDI-101150 as a monotherapy (50-200 mg QD dose) and in combination with pembrolizumab (200 mg Q3W) in the treatment of adults with advanced solid tumors. The clinical results being presented at the SITC (Free SITC Whitepaper) Annual Meeting include updated safety data from 53 patients in the dose escalation cohorts (n=41 on monotherapy, n=12 on combination therapy) and additional data from 35 patients in the dose expansion cohorts as well as updated efficacy data from 17 response-evaluable patients with renal cell carcinoma (RCC) who received NDI-101150 monotherapy. Results, as of August 12, 2024, showed:

Safety Profile

NDI-101150 was generally well-tolerated with immune-related adverse events supporting the proposed mechanism of action of HPK1 inhibition, which results in immune activation.
Grade ≥3 treatment-related adverse events (TRAEs) occurred in 14% of all patients exposed to NDI-101150 (n=88). The most common TRAEs were nausea, diarrhea, vomiting and fatigue.
Efficacy and Target Engagement

Treatment with NDI-101150 monotherapy resulted in objective responses in 18% (3/17) of response-evaluable RCC patients, including one complete response (CR) and two partial responses (PRs).
A clinical benefit rate (CR + PR + stable disease [SD] ≥6 months) of 29% (5/17) and a disease control rate of 65% (11/17) were observed in response-evaluable RCC patients treated with NDI-101150 monotherapy.
NDI-101150 effectively inhibited its target across multiple dose levels, providing strong pharmacodynamic evidence of the molecule’s activity in patients.
Supporting Mechanistic Evidence

Analysis of tumor biopsies showed a more robust presence of immune cells post-treatment, with increased numbers of tumor-infiltrating lymphocytes and dendritic cells in the tumor microenvironment.
Comprehensive gene expression profiling demonstrated broad activation of immune-related pathways, including enhanced interferon response and T cell activation signals.
"These clinical results of NDI-101150 are highly encouraging, particularly in the context of renal cell carcinoma patients who have experienced disease progression on prior checkpoint inhibitors," said Nathalie Franchimont, M.D., Ph.D., Chief Medical Officer of Nimbus. "The objective responses and disease control rates seen thus far with NDI-101150 in heavily pretreated patients as well as the current safety profile support further evaluation of NDI-101150 in the clinic."

"The clinical and translational data package being presented at SITC (Free SITC Whitepaper) demonstrates both the therapeutic potential of NDI-101150 and the power of our computational drug discovery engine to design highly selective molecules against challenging targets like HPK1," said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. "The monotherapy activity we observed is particularly noteworthy, as many second-generation immunotherapy compounds have struggled to show clinical benefit on their own. Together with its safety profile and the immune activation signals we’ve observed, these data support NDI-101150’s potential as a novel oral non-checkpoint immunotherapy option for patients who need new treatment approaches beyond current checkpoint inhibitors."

The abstracts are available in the Journal for ImmunoTherapy of Cancer (JITC), the official journal of SITC (Free SITC Whitepaper), here and the details of the poster presentations are as follows:

Title: Ongoing Phase 1/2 Trial of the HPK1 Inhibitor NDI-101150 as Monotherapy and in Combination with Pembrolizumab: Clinical Safety Update and Renal Cell Carcinoma (RCC) Efficacy Analysis

Lead Author: David Sommerhalder, M.D., Director of Clinical Research, NEXT Oncology

Date: Saturday, November 9, 2024

Time: 9:00 a.m. – 8:30 p.m. CST

Category: Clinical Trials in Progress

Abstract Number: 682

Link to poster here.

Title: Tumor Immune Microenvironment Characterization from Pre- and Post-Dose Tumors Collected from a Phase 1/2 Study of NDI-101150, a Hematopoietic Progenitor Kinase 1 (HPK1) inhibitor

Lead Author: Scott Daigle, Senior Director, Translational Medicine, Nimbus Therapeutics

Date: Friday, November 8, 2024

Time: 9:00 a.m. – 7:00 p.m. CST

Category: Biomarkers, Immune Monitoring and Novel Technologies

Abstract Number: 83

On November 7, 2024 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the third quarter ended September 30, 2024 (Press release, Nektar Therapeutics, NOV 7, 2024, View Source [SID1234647968]).

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Cash and investments in marketable securities on September 30, 2024 were $249.0 million as compared to $329.4 million at December 31, 2023. Nektar’s cash and marketable securities are expected to support strategic development activities and operations into the fourth quarter of 2026.

"We made excellent progress this quarter advancing our I&I pipeline, including the ongoing Phase 2b studies of rezpegaldesleukin in atopic dermatitis and alopecia areata," said Howard W. Robin, President and CEO of Nektar. "We see rapid enrollment in the 400-patient atopic dermatitis study for rezpegaldesleukin, and we remain on track for topline data in the first half of 2025. Our Phase 2 study in alopecia areata is also enrolling nicely with topline data expected in the second half of 2025."

"Beyond rezpegaldesleukin, we are focused on advancing our earlier stage TNFR2 antibody and bispecific programs, NKTR-0165 and NKTR-0166, with at least one of these slated to enter the clinic next year," continued Robin. "Next week, we are looking forward to presenting highly promising data at the 2024 ACR Convergence Meeting for our preclinical PEG-CSF program, NKTR-422. Finally, we recently published important data for our IL-15 agonist, NKTR-255, highlighting its potential as a validated mechanism in oncology."

Summary of Financial Results

Revenue in the third quarter of 2024 was $24.1 million compared to the same $24.1 million in the third quarter of 2023. Revenue for the first nine months of 2024 was $69.3 million compared to $66.2 million in the first nine months of 2023.

Total operating costs and expenses in the third quarter of 2024 were $58.5 million compared to $69.0 million in the third quarter of 2023. Total operating costs and expenses in the first nine months of 2024 were $188.8 million compared to $296.4 million in the first nine months of 2023. Operating costs and expenses for the first nine months of 2024 decreased primarily due to decreases in restructuring, impairment and costs of terminated programs and a one-time $76.5 million non-cash goodwill impairment recognized in the first quarter of 2023.

R&D expense in the third quarter of 2024 was $35.0 million compared to $24.1 million for the third quarter of 2023. For the first nine months of 2024, R&D expense was $92.2 million compared to $84.2 million in the first nine months of 2023. R&D expense increased for both the third quarter and the first nine months of 2024 primarily due to increases in development expenses for rezpegaldesleukin and NKTR-0165, partially offset by decreases in employee and related facilities costs, as well as development expenses for NKTR-255.

G&A expense was $19.0 million in the third quarter of 2024 compared to $21.1 million in the third quarter of 2023. G&A expense was $59.6 million for the first nine months of 2024 compared to $60.1 million in the first nine months of 2023. G&A expense decreased for both the third quarter and the first nine months of 2024 primarily due to decreases in employee costs, partially offset by the reduction of facilities costs allocated to research and development expenses.

Non-cash restructuring and impairment charges were less than $0.1 million in the third quarter of 2024 and $14.3 million in the first nine months of 2024. These non-cash charges are related to the declining San Francisco commercial real estate market and real estate lease obligations held by Nektar.

Net loss for the third quarter of 2024 was $37.1 million or $0.18 basic and diluted loss per share compared to a net loss of $45.8 million or $0.24 basic and diluted loss per share in the third quarter of 2023. Net loss in the first nine months of 2024 was $126.2 million or $0.62 basic and diluted loss per share compared to a net loss of $234.0 million or $1.23 basic and diluted loss per share in the first nine months of 2023. Excluding the $14.3 million in non-cash restructuring and real estate impairment charges, net loss, on a non-GAAP basis, for the first nine months of 2024 was $111.9 million, or $0.55 basic and diluted loss per share.

Third Quarter 2024 and Recent Business Highlights

● In September 2024, Nektar presented several posters for rezpegaldesleukin (REZPEG) at the 2024 European Academy of Dermatology and Venereology (EADV) Congress. In addition to two trial-in-progress posters, new proteomic analyses were also presented, which showed that rezpegaldesleukin increased the protein levels of immune-regulating pathways and reduced specific serum proteins known to be elevated in patients with atopic dermatitis.

● In October 2024, Nektar and collaborators announced the publication of data from a Phase 1 trial evaluating NKTR-255 in combination with CD19/22 CAR-T cell therapy in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) in Blood, an open-access journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). The data show that eight out of nine patients (89%) achieved complete remission, all without detectable measurable residual disease (MRD).

● In October 2024, Nature Communications published results from Phase 1b studies of rezpegaldesleukin in two inflammatory skin diseases, demonstrating durable dose-dependent improvements in physician-assessed disease activity and patient-reported outcomes for both studies. Rezpegaldesleukin was evaluated in patients with moderate-to-severe atopic dermatitis (AD) (NCT04081350) or chronic plaque psoriasis (PsO) (NCT04119557). AD patients receiving high dose rezpegaldesleukin demonstrate an 83% improvement in EASI score after 12 weeks of treatment. EASI improvement of ≥ 75% (EASI-75) and vIGA-AD responses were maintained for 36 weeks after treatment discontinuation in 71% and 80% of week 12 responders, respectively. Results validate the role of IL-2-induced Treg proliferation and activation in the AD treatment paradigm, and support the advancement of rezpegaldesleukin in the Phase 2b study in AD.

● In November, Nektar announced a definitive agreement with Ampersand Capital Partners to sell its commercial PEGylation manufacturing business in Huntsville, Alabama for $90 million in enterprise value, which is comprised of $70 million in cash and $20 million in equity ownership in the new portfolio company. The Huntsville-based facility will be spun out as a standalone Ampersand portfolio company and Ampersand has committed to invest additional growth equity capital into the new company. All of Nektar’s employees at the Huntsville facility will be offered employment at the new portfolio company, ensuring continuity in the high-quality manufacturing and PEGylation expertise that longstanding customers trust and rely on. Nektar and the new Ampersand portfolio company will also enter into manufacturing supply agreements to meet Nektar’s PEG reagent needs for rezpegaldesleukin and certain pipeline programs. The transaction will be subject to customary closing conditions and costs and is expected to close by December 2, 2024. Following the closing, Nektar will retain all rights to current and future royalty streams and milestones related to existing PEGylated product license agreements. Nektar will also be entitled to appoint a representative to the board of the new Ampersand portfolio company

● Enrollment remains on track for the two Phase 2b studies of REZPEG, one in patients with moderate-to-severe atopic dermatitis and one in patients with severe to very severe alopecia areata. Nektar expects topline data from these studies in the first half and in the second half of 2025, respectively.

Nektar also announced presentations at the following medical meetings:

2024 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting

Late-breaking Abstract (LBA) 1489: " REStoring lymphoCytes Using NKTR-255 after chemoradiothErapy in solid tumors (RESCUE): Preplanned Interim Safety and Efficacy Analysis", Lin, S.

Presentation Type: Poster
ePoster will be on display on the SITC (Free SITC Whitepaper) 2024 virtual meeting platform on Thursday, November 7, 2024, at 9:00 a.m. CST

2024 American College of Rheumatology (ACR) Convergence

Abstract 1866120: "A Novel Therapeutically Active CSF-1R Agonist Promotes Tissue Macrophages Inflammation Resolution and Induces Tissue Repair Pathways", Kivimae, S.
Presentation Type: Oral
Session: Abstracts: Cytokines & Cell Trafficking
Presentation Time: Monday, November 18 at 3:15 PM – 3:30 PM

2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting

Abstract 203576: "NKTR-255 Vs Placebo to Enhance Complete Responses and Durability Following CD19-Directed CAR-T Therapy in Patients with Relapsed/Refractory (R/R) Large B-cell Lymphoma (LBCL)", Ahmed, S.
Presentation Type: Poster
Session: Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities
Presentation Time: Saturday, December 7 at 5:30 PM – 7:30 PM

Conference Call to Discuss Third Quarter 2024 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on November 7, 2024.

This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through December 8, 2024.

To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

On November 7, 2024 Clasp Therapeutics, a biotechnology company bringing unparalleled precision to immuno-oncology using next-generation TCEs, reported new data validating the potential of its lead program, CLSP-1025 (Press release, Clasp Therapeutics, NOV 7, 2024, View Source [SID1234647991]). CLSP-1025 is a half-life extended TCE targeting cancer cells expressing the p53R175H mutant peptide presented by HLA-A*02:01. Data demonstrating the therapeutic potential of CLSP-1025 will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 39th Annual Meeting on November 8, 2024.

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Clasp’s innovative approach focuses on developing TCEs with absolute tumor specificity (i.e., no anticipated off-tumor binding) by targeting shared cancer neoantigens derived from oncogenic driver mutations presented by human leukocyte antigen (HLA) on cancer cells. The company’s proprietary pHLAre platform mimics the natural immune synapse by bridging cancer cells and T cells through CD3 binding. This engagement activates T cells, resulting in potent targeting and destruction of cancer cells. CLSP-1025 targets the p53R175H mutation, which is prevalent in a range of solid tumors such as colorectal, esophageal, gastric, gynecological, lung, pancreatic and prostate cancers.

Together, Clasp’s data support advancing CLSP-1025 into clinical trials. CLSP-1025 is expected to be the first TCE targeting a shared cancer neoantigen to reach the clinic, with the first-in-human trial anticipated to begin in early 2025.

"Clasp was built to bring absolute precision to the power of immunotherapies, thereby improving and extending the lives of people with cancer," said Chief Executive Officer Rob Ross, M.D. "Building on this promising preclinical data, we look forward to advancing CLSP-1025 into the clinic. Today’s presentation marks a significant milestone in our mission to deliver a new class of precision TCEs that expand the reach of immunotherapy."

Data Highlights:

Selectivity: CLSP-1025 demonstrates high selectivity for p53R175H presented on HLA-A*02:01
Specifically binds the R175H mutant peptide and spares wildtype p53;
No reactivity with any other human peptides presented on HLA-A*02:01;
Sensitivity: CLSP-1025 activates T cells and effectively kills patient-derived organoids, demonstrating activity at endogenous target expression levels;
Activity: CLSP-1025 induces the regression of established tumors in vivo.

On November 7, 2024 Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported financial results for the third quarter ended September 30, 2024, and provided an update on its corporate activities and product pipeline (Press release, Cidara Therapeutics, NOV 7, 2024, View Source [SID1234647924]).

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"The recent initiation of our Phase 2b NAVIGATE clinical trial, which will evaluate the efficacy and safety of CD388 for the pre-exposure prophylaxis of seasonal influenza, represents an important clinical achievement for our company," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Additionally, the realignment of our organization will ensure the most efficient use of our resources, enabling us to focus on advancing our promising CD388 clinical program. Based on the compelling data generated to date, we believe CD388 has the potential to provide long-term protection against both seasonal and pandemic strains of influenza with a single dose per flu season."

Recent Corporate Highlights

Dosed first subjects in Phase 2b NAVIGATE trial evaluating efficacy and safety of CD388 for the pre-exposure prophylaxis of seasonal influenza. In September 2024, Cidara initiated a randomized, double-blind, controlled Phase 2b trial targeting enrollment of 5,000 healthy, unvaccinated adult subjects who are not at risk of complications from influenza. Three CD388 dose groups and one placebo group are being randomized in a 1:1:1:1 ratio and we administered CD388 at the beginning of this influenza season. Subjects will be followed for the remainder of the influenza season to monitor for breakthrough cases. Rates of laboratory and clinically confirmed influenza will be compared between subjects receiving the various single doses of CD388 or placebo. The study includes sites in the U.S. and UK.
Highlighted CD388 in two presentations at the 2024 IDWeek Conference. In October 2024, positive Phase 2a human challenge study data were presented in an oral presentation, which demonstrated that a single subcutaneous dose of CD388 administered five days prior to influenza challenge was shown to be effective in preventing symptomatic disease. Positive first-in-human data from a Phase 1 trial studying the safety and PK of CD388 administered by intramuscular and subcutaneous injection were also presented. The results showed that CD388 was rapidly absorbed to achieve target exposure levels and slowly eliminated, regardless of administration route, with no concerning safety signals, supporting the potential for a single dose of CD388 per flu season.
Highlighted CD388 in an oral and poster presentation at the 2024 OPTIONS XII for the Control of Influenza conference. Phase 1 and Phase 2a safety data from three clinical trials on the Company’s CD388 asset were presented in oral presentation format, and pharmacokinetics and safety of CD388 following subcutaneous administration in healthy Japanese participants were presented. Overall, results were consistent with a previous Phase 1 clinical study in Western participants. CD388 injection was well tolerated, and the data support further clinical studies with CD388 in the Japanese population for the prevention of seasonal influenza.
Strengthened Scientific Advisory Board (SAB) with four infectious disease experts. In September 2024, Rick Bright, Ph.D., Philip Krause, M.D., Mario Barro, Ph.D., and Frederick Hayden, M.D., FACP, were appointed to the Company’s SAB. The new members’ collective expertise working in infectious diseases including influenza, pandemic preparedness, and clinical and regulatory processes will be instrumental as Cidara conducts its CD388 Phase 2b NAVIGATE trial.
Appointed Jim Beitel as Chief Business Officer. In August 2024, Jim Beitel joined Cidara as Chief Business Officer. Mr. Beitel brings over 20 years of experience in life science corporate development, including strategy, business development, commercialization, finance, and other roles.
Restructured workforce to focus on planned clinical development of CD388. In September 2024, Cidara announced an approximate 30% reduction in workforce to focus on the clinical development of its novel DFC candidate for influenza A and B, CD388. This restructuring is expected to substantially reduce Cidara’s capital needs related to recurring personnel costs.
Third Quarter 2024 Financial Results

Cash and cash equivalents totaled $127.4 million as of September 30, 2024, compared with $35.8 million as of December 31, 2023.
Revenue was zero and $1.3 million for the three and nine months ended September 30, 2024, respectively, compared to $9.2 million and $20.5 million for the same periods in 2023, respectively. Revenue for the three and nine months ended September 30, 2024 and 2023 related to research and development and clinical supply services provided to J&J Innovative Medicine, previously Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), under our license and collaboration agreement with Janssen (the Janssen Collaboration Agreement). The Janssen Collaboration Agreement was terminated upon the effectiveness of our license and technology transfer agreement with Janssen (the Janssen License Agreement) on April 24, 2024.
Acquired in-process research and development expenses were $84.9 million for the nine months ended September 30, 2024 and related to an upfront payment of $85.0 million paid to Janssen under the Janssen License Agreement, on April 24, 2024, plus $0.4 million in direct transaction costs, offset by a settlement gain of $0.5 million to settle the preexisting Janssen Collaboration Agreement relationship.
Research and development expenses were $12.4 million and $25.0 million for the three and nine months ended September 30, 2024, respectively, compared to $10.4 million and $28.8 million for the same periods in 2023, respectively. The increase in research and development expenses for the three months ended September 30, 2024, compared to the three months ended September 30, 2023 is primarily due to higher expenses associated with our CD388 Phase 2b NAVIGATE study and higher personnel costs, including $1.2 million for severance payments and employee benefits related to a reduction in force, offset by lower nonclinical expenses associated with our Cloudbreak platform. The decrease in research and development expenses for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023 is primarily due to lower nonclinical expenses associated with our Cloudbreak platform, offset by higher expenses associated with our CD388 Phase 2b NAVIGATE study and higher personnel costs, including $1.2 million for severance payments and employee benefits related to a reduction in force.

Selling, general and administrative (SG&A) expenses were $5.0 million and $13.3 million for the three and nine months ended September 30, 2024, respectively, compared to $3.3 million and $10.1 million for the same periods in 2023, respectively. The SG&A expenses for all periods primarily relate to consulting, personnel and legal costs.
On April 24, 2024, Cidara entered into an asset purchase agreement with Napp Pharmaceutical Group Limited (Napp) an affiliate of Mundipharma Medical Company, pursuant to which we sold to Napp all of our rezafungin assets and related contracts. We completed all conditions of the sale on April 24, 2024. We determined that the sale of rezafungin represented a strategic shift that will have a major effect on our operations and financial results. Accordingly, the sale of rezafungin is classified as discontinued operations. We have separately reported the financial results of rezafungin as discontinued operations in the condensed consolidated statements of operations and comprehensive loss for all periods presented. Net loss from discontinued operations for the three months ended September 30, 2024, was $0.5 million and net income from discontinued operations for the nine months ended September 30, 2024 was $0.4 million, compared to net loss from discontinued operations of $5.3 million and $2.8 million for the same periods in 2023, respectively.

Net loss for the three and nine months ended September 30, 2024 was $16.0 million and $117.5 million, respectively, compared to a net loss of $9.1 million and $19.7 million for the same periods in 2023, respectively.
On July 18, 2024, the Company’s stockholders approved the issuance of up to 16,800,000 shares of common stock upon conversion of 240,000 shares of Series A Convertible Voting Preferred Stock issued in our private placement completed in April 2024. On July 19, 2024, the Company issued 2,469,250 shares of common stock upon automatic conversion of 35,275 shares of Series A Convertible Voting Preferred Stock.
During the three and nine months ended September 30, 2024, Cidara did not sell any shares of common stock pursuant to its at-the-market sales agreement.

As of September 30, 2024, Cidara had 7,046,633 shares of common stock outstanding, 204,725 shares of Series A Convertible Voting Preferred Stock outstanding, which are convertible into 14,330,750 shares of common stock, and 2,104,472 shares of Series X Convertible Preferred Stock outstanding, which are convertible into 1,052,236 shares of common stock, for a total of 22,429,619 shares of common stock equivalents outstanding.