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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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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"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.

On November 20, 2023 NanOlogy LLC, a clinical-stage oncology company, reported that an abstract reporting interim results from its lung cancer trial has been accepted for poster presentation at the IASLC North America Conference on Lung Cancer (NACLC) being held December 1-3, 2023, at the Chicago Marriott Downtown Magnificent Mile (Press release, NanOlogy, NOV 20, 2023, View Source;utm_medium=rss&utm_campaign=nanology-announces-an-abstract-has-been-accepted-for-presentation-at-the-iaslc-north-america-conference-on-lung-cancer [SID1234637846]).

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The abstract (PP01.111) entitled: "Phase 2a Intratumoral Large Surface Area Microparticle Paclitaxel in Stage 3/4 Lung Cancer" will be presented by Hiren Mehta, MD (University of Florida Health) during poster sessions on Saturday, December 2nd, and Sunday, December 3rd.

A press release summarizing presentation data will be issued following the conference.

The IASLC North America Conference on Lung Cancer (NACLC)

On November 20, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, reported that it is scheduled to participate in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference on Thursday, Nov. 30, 2023, at 1:20 p.m. ET (Press release, Merck & Co, NOV 20, 2023, View Source [SID1234637841]).

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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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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.