On November 20, 2023 Tvardi Therapeutics, Inc. ("Tvardi"), a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, reported that the management team will present at the 35th Annual Piper Sandler Healthcare Conference on Tuesday, November 28, 2023, and will participate in one-on-one meetings with investors throughout the day, in New York, NY (Press release, Tvardi Therapeutics, NOV 20, 2023, View Source [SID1234637861]).

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Presentation Details:
Date: Tuesday, November 28, 2023
Time: 10:10 a.m.-10:30 a.m. EST
Location: Lotte New York Palace, 455 Madison Ave, New York, NY 10022

On November 20, 2023 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform (PDP) to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that it has licensed its proprietary PDP of CRO-independent clinical research to a clinical stage biotech company for a $3.0 million upfront payment (Press release, Tracon Pharmaceuticals, NOV 20, 2023, View Source [SID1234637860]).

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"We are excited to announce the first license of our PDP to a company that recognizes the value of internalizing its clinical operations to reap the benefits of CRO-independent clinical trial implementation that we enjoy at TRACON," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. "We are now in a position to widely license our PDP to allow clinical stage biotechnology and pharmaceutical companies to transform their clinical operations with the expectation of potentially dramatic cost reductions and shorter clinical trial timelines."

Under the terms of the Agreement, TRACON granted a non-exclusive and non-transferable license of its PDP to the clinical stage biotech company for the design, conduct and administration of clinical trials and related research and development activities, including activities relating to regulatory filings, submissions and approvals. A licensee can integrate TRACON’s configuration documentation with a widely-used software package, enabling validation and qualification of the software package, in conjunction with TRACON’s standard operation procedure documents, policies, work instructions, and clinical operation templates.

On November 20, 2023 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-classi therapeutics that combine both targeted and immune-mediated mechanisms, reported that management will participate in a fireside chat at the 35th Annual Piper Sandler Healthcare Conference on Tuesday, November 28, 2023 at 3:00 p.m. ET (Press release, Tempest Therapeutics, NOV 20, 2023, View Source [SID1234637856]).

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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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To access the live or archived recording of the discussion, please visit the investor section of the Tempest website at View Source

On November 20, 2023 Novartis reported that it will present data from over 100 trials across its breast cancer and hematology portfolios at the 2023 San Antonio Breast Cancer Symposium (SABCS) and the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (Press release, Novartis, NOV 20, 2023, https://www.novartis.com/news/media-releases/novartis-showcases-significant-data-updates-from-kisqali-iptacopan-and-scemblix-sabcs-and-ash [SID1234637853]). The new data will highlight the latest advances across our breast cancer and hematology portfolios and pipeline, such as the Phase III NATALEE trial and Phase III APPLY-PNH trial.

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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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"We’re developing new therapies across a range of cancers and blood disorders as well as evaluating the potential of our priority medicines in earlier stages of disease," said Jeff Legos, Executive Vice President, Global Head of Oncology Development at Novartis. "Among the new findings we will present at SABCS and ASH (Free ASH Whitepaper) this year are additional follow-up Kisqali data from NATALEE, adding to the body of evidence of ribociclib in early breast cancer, as well as new 48-week data from the Phase III APPLY-PNH trial for iptacopan."

Key highlights of data accepted by SABCS include:

Medicine Abstract Title Abstract Number/ Presentation Details    
Kisqali (ribociclib)*   

Ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) as adjuvant treatment in patients with HR+/HER2− early breast cancer: final invasive disease–free survival (iDFS) analysis from the NATALEE trial

Abstract #GS03-03
Oral Presentation
Friday, December 8
8:15 – 11:15 AM CT
Kisqali (ribociclib)*   

    Invasive disease-free survival as a surrogate for overall survival in patients with hormone receptor−positive/human epidermal growth factor receptor 2−negative early breast cancer: a real-world analysis

Abstract #PO1-17-07
Poster Session
Wednesday, December 6
12:00 – 2:00 PM CT
Kisqali (ribociclib)*    Patient preferences for CDK4/6 inhibitor treatments in HR+/HER2− early breast cancer: a discrete choice survey study

Abstract #PO2-01-09
Poster Session
Wednesday, December 6
5:00 – 7:00 PM CT
 
Key highlights of data accepted by ASH (Free ASH Whitepaper) include: 

Medicine or Disease State Abstract Title    Abstract Number/ Presentation Details    
Iptacopan (LNP023)     

    Factor B Inhibition with Oral Iptacopan Monotherapy Demonstrates Sustained Long-Term Efficacy and Safety in Anti-C5-Treated Patients (pts) with Paroxysmal Nocturnal Hemoglobinuria (PNH) and Persistent Anemia: Final 48-Week Results from the Multicenter, Phase III APPLY-PNH Trial

Abstract #571
Oral Presentation
Sunday, December 10
4:30 PM PT
Iptacopan (LNP023)  Patient-Reported Improvements in Fatigue and Health-Related Quality of Life in the Phase 3 Studies APPLY-PNH and APPOINT-PNH Evaluating the Use of Iptacopan in C5 Inhibitor-Treated and Treatment-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria

Abstract #487
Oral Presentation
Sunday, December 10
9:30 AM PT
Iptacopan (LNP023)      Categorization of Hematological Responses to Oral Iptacopan Monotherapy in Anti-C5-Treated Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) and Persistent Anemia in the Phase III APPLY-PNH Trial and Complement Inhibitor-Naïve Patients in the Phase III APPOINT-PNH Trial

Abstract #4084
Poster Presentation
Monday, December 11
6:00 – 8:00 PM PT 
Iptacopan (LNP023)  Clinical Breakthrough Hemolysis (BTH) during Monotherapy with the Oral Factor B Inhibitor Iptacopan Is Generally Not Severe and Managed without Treatment Discontinuation: 48-Week Data from the Phase III APPLY-PNH and APPOINT-PNH Trials in Paroxysmal Nocturnal Hemoglobinuria (PNH)

Abstract #1338
Poster Presentation
Saturday, December 9
5:30 – 7:30 PM PT
Scemblix (asciminib)   Sustained Efficacy and Safety with Asciminib (ASC) after Almost 4 Years of Median Follow-up from ASCEMBL, a Phase 3 Study of ASC vs Bosutinib (BOS) in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) after ≥2 Prior Tyrosine Kinase Inhibitors (TKIs): An End of Study Treatment (EOS Tx) Update, Including Results from Switch Population

Abstract #4536
Poster Presentation
Monday, December 11
6:00 – 8:00 PM PT  
Scemblix (asciminib)   With up to 8 Years of Therapy, Asciminib (ASC) Monotherapy Demonstrated Continued Favorable Efficacy, Safety, and Tolerability in Patients (Pts) with Philadelphia Chromosome–Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP) without the T315I Mutation: Final Results from the Phase 1 X2101 Study

Abstract #450
Oral Presentation 
Sunday, December 10 
10:45 AM PT   
Sickle Cell Disease

Targeted Degradation of the Wiz Transcription Factor for Gamma Globin De-Repression

Abstract #2
Plenary Scientific Session
Sunday, December 10
2:00 – 4:00 PM PT

Kymriah  

(tisagenlecleucel)  Clinical Outcomes of Patients with Relapsed/Refractory Follicular Lymphoma Treated with Tisagenlecleucel: Phase 2 Elara 3-Year Follow-up

Abstract #601
Oral Presentation
Sunday, December 10
4:30 PM PT
Jakavi (ruxolitinib)   Ruxolitinib in Patients With Chronic Graft-Versus-Host Disease: 3-Year Final Analysis of Efficacy and Safety From the Phase III REACH3 study

Abstract #654
Oral Presentation
Sunday, December 10
5:45 PM PT  
Immune Thrombocytopenia (ITP) The lack of tolerable treatment options that can induce durable responses without fear of relapse after discontinuation represents a significant unmet need for patients (pts) with immune thrombocytopenia (ITP): Results from the ITP world impact survey (I-WISh) 2.0

Abstract #1212
Poster Presentation
Saturday, December 9
5:30 – 7:30 PM PT  

Product Information 
For full prescribing information, including approved indications and important safety information about marketed products, please visit View Source

On November 20, 2023 NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company specializing in the end-to-end development, manufacturing, and commercialization of innovative therapies, reported strategic, financial, and operational updates for the quarter ended September 30, 2023 (Press release, NightHawk Biosciences, NOV 20, 2023, View Source [SID1234637850]).

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Jeff Wolf, Chief Executive Officer of NightHawk, commented, "We are very pleased with the progress of our Scorpius San Antonio facility where operations are advancing well and the feedback from our customers has been extremely positive. As a result, we are currently evaluating a variety of strategic options to maximize the potential of the business. We look forward to providing further updates on our efforts in the near future."

Third Quarter 2023 Financial Results

In August, the Company determined to make available for sale the equity interests of Elusys Therapeutics, Inc. Therefore, the results of operations have been reclassified as discontinued operations on a retrospective basis for all periods presented.
For the three months ended September 30, 2023 we recognized $6.7 million of revenue from product sales, which is included in discontinued operations, $0.6 million of revenue from process development and $0.1 million from service revenue. For the three months ended September 30, 2022 we recognized $5.98 million of product sales revenue, which is included in discontinued operations, and $0.5 million of grant revenue. The increase in product sales revenue is due to the completion of the manufacturing conversion of ANTHIM and the increase in process development revenue is attributable to the operations of the San Antonio CDMO facility. No grant revenue was recognized in 2023 as the CPRIT grant has ended.
Cost of revenues were $2.7 million for the three months ended September 30, 2023. $2.2 million of these expenses primarily reflect the manufacturing conversion costs from the sale of ANTHIM which are included in discontinued operations. The remaining $0.5 million primarily consists of direct cost of labor, overhead and material costs at Scorpius. We recognized $6.4 million of product cost of revenues for the three months ended September 30, 2022, driven by the sale of ANTHIM to Canada which is included in discontinued operations.
Research and development expenses decreased approximately 3.7% to $5.2 million for the three months ended September 30, 2023, compared to $5.4 million for the three months ended September 30, 2022. The components of R&D expense are as, in millions: HS-110 expense decreased by $0.1 million primarily due to the discontinuation of the clinical trial in 2022; HS-130 expense decreased to $0.0 from $0.1 million due to the de-prioritization of our oncology assets; PTX-35 expense decreased by $0.5 million primarily due to the discontinued clinical trial and development of the product candidate in the third quarter of 2022; other programs expense stayed consistent at $0.3 million and primarily relate to close out costs of our R&D facility; and unallocated research expenses increased by $0.5 million primarily due to increased personnel costs, depreciation expense, amortization expense and scientific hardware and software.
Selling, general and administrative expenses were $6.1 million and $4.8 million for the three months ended September 30, 2023 and 2022, respectively. The increase was primarily due to increases in marketing expense of $0.6 million, personnel expense of $0.4 million, depreciation and amortization of $0.2 million, and rent expense of $0.2 million, offset by a decrease in insurance expense of $0.1 million.
As of September 30, 2023, the Company had approximately $9.5 million in cash, cash equivalents, and short-term investments of which $3.3 million is in current assets held for sale.