On May 7, 2024 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported the presentation of positive interim data for Annamycin from its ongoing acute myeloid leukemia (AML) clinical development program (Press release, Moleculin, MAY 7, 2024, View Source [SID1234642792]). As previously announced, the Company will host a virtual AML Clinical Day, today, May 7, 2024, at 11:00 AM ET (details below) to discuss these results.

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"Adding the latest two subjects in MB-106 AML trial with AnnAraC brings the composite complete remission (CRc) rate up from 37% to 45% for all of the 20 subjects with prior therapies ranging from none to six. This adds to our growing body of positive data which continues to provide a clear line of sight for our clinical and regulatory strategies towards registration for Annamycin in AML," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "Focusing on 2nd line subjects, a CRc rate of 60% and with 50% of those being full CRs, AnnAraC has the potential to offer 2nd line patients a viable alternative, regardless of prior treatments or mutations. While we believe that the full trial results are impressive, we continue to believe that our results in 2nd line subjects, where there is a significant unmet need, are exceptional and believe the CRc rate demonstrated by AnnAraC in 2nd line patients substantially exceeds the performance reported by any drug currently approved for use in 2nd line AML."

"We continue to progress our preparations for an End of Phase 2 meeting with FDA and believe following this meeting we will be in a position to commence a pivotal registration study as a 2nd line therapy in AML early next year," added Mr. Klemp.

Ongoing AML Clinical Trial Overview

The Company is currently conducting its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy (MB-106). clinicaltrialsregister.eu: EudraCT 2020-005493-10 or clinicaltrials.gov: NCT05319587.

During 2023, Moleculin commenced its MB-106 clinical trial with AnnAraC for the treatment of AML in an all-comers trial, accepting subjects without regard to the number of prior therapies in the Phase 1 portion with a limit of two prior therapies in the Phase 2 portion. Nine clinical sites in Poland and Italy have been activated for the MB-106 clinical trial.

To date, 20 subjects have been enrolled in the full MB-106 Phase 1B/2 study. The median durability of remission (DoR) is 4.9 months and climbing. DoR is defined as the time from initiation of treatment to the point of disease relapse or death. At the end of January 2024, the Company completed recruiting the desired number of 2nd line subjects and began preparation for an End of Phase 2 (EoP2) meeting with the FDA. In addition, Moleculin expanded the MB-106 study protocol to include 1st line subjects to provide data to enable the designing of a potential confirmatory Phase 3 post-approval study for the added indication of 1st line subjects, however, the Company does not expect the addition of this cohort to delay the EoP2 meeting. The study has recruited three 1st line subjects to date with two achieving CRs.

Moleculin’s current planned pathway for initial NDA approval indication for Annamycin in combination with Cytarabine for the treatment of AML is as a 2nd line therapy. Therefore, the focus is primarily on securing an accelerated approval pathway for the treatment of 2nd line subjects (those who were relapsed from or refractory to a 1st line AML therapy, regardless of whether the subject was deemed "fit" or "unfit" for intensive chemotherapy). Moleculin continues to recruit 1st line subjects into MB-106 to provide data for a possible future confirmatory Phase 3 clinical trial in 1st line patients.

Summary of MB-106 Data

A summary table of the MB-106 preliminary results is shown below. These subjects had 0-6 prior therapies. The preliminary data for MB-106 demonstrate a CRc rate of 45% and an overall remission rate (ORR) of 55% for all subjects, regardless of the number of prior treatments (N=20). Segmenting the MB-106 subject population for 1st line (N=3) and, most notably, 2nd line (N=10) therapies in the trial, yields a CRc rate of 67% and 60% and an ORR of 67% and 70%, both respectively.

Median durability for MB-106 is 4.9 months and climbing with one death (suspected to be related to pneumonia) and one relapse to date out of the 9 CRcs. The first subject with a CRc (and who has yet to relapse) was treated in February 2023. Durability of CRs is confirmed by repeat bone marrow aspirates (BMAs). The median age of all subjects recruited is 69, ranging from 19 to 78. Median durability will be updated as the trial data mature. This trial may enroll up to 28 subjects, however, having already recruited the desired number of 2nd line subjects to support an EoP2 meeting with the FDA, the Company may elect to complete this trial with fewer than 28 subjects.

The trial continues recruitment for treatment as 1st line and 3rd line therapy. Since Moleculin intends to position AnnAraC for initial approval as a 2nd line therapy, the Company believes that the most important data from this trial are the results in 2nd line subjects (excluding subjects who are either 1st line or 3rd line and beyond). All data from MB-106 are interim, preliminary, and subject to change until a clinical trial report is published.

On May 7, 2024 Rigel Pharmaceuticals, Inc. reported financial results for the first quarter ended March 31, 2024, including sales of TAVALISSE (fostamatinib disodium hexahydrate) tablets for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment and sales of REZLIDHIA (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test (Press release, Rigel, MAY 7, 2024, View Source [SID1234642784]).

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"Results for the first quarter of 2024 continued to demonstrate strong commercial demand with the highest number of TAVALISSE and REZLIDHIA bottles sold in a quarter since launch. We are also excited about the recent acquisition of GAVRETO and are on track to include this product in our commercial portfolio in July of this year," said Raul Rodriguez, Rigel’s president and CEO. "At the same time, we are progressing the development of olutasidenib with our strategic collaborators, MD Anderson and CONNECT, and driving forward our other pipeline programs."

Business Update

· In the first quarter of 2024, a total of 2,193 TAVALISSE bottles were sold in the U.S. driven by 2,483 bottles shipped to patients and clinics, the highest number in a quarter since launch. Bottles remaining in distribution channels decreased by 290 bottles during the quarter.

· In the first quarter of 2024, a total of 390 REZLIDHIA bottles were sold in the U.S., significantly accelerating sales growth over last year. This growth was driven by increased demand, with 326 bottles shipped to patients and clinics.

· In April 2024, Rigel announced a peer-reviewed publication in Leukemia & Lymphoma on data from an analysis of the Phase 2 study evaluating REZLIDHIA in patients with mIDH1 AML who were R/R to prior venetoclax-based regimens. The findings from these analyses suggest that REZLIDHIA may provide an effective treatment for patients with recurrent AML following venetoclax combination therapy. REZLIDHIA induced durable remissions consistent with those observed in the pivotal trial and had a favorable tolerability profile.

· In March 2024, Rigel appointed Lisa Rojkjaer, M.D. as Executive Vice President and Chief Medical Officer. Dr. Rojkjaer is an industry veteran with over 20 years of clinical development, regulatory, and medical affairs experience with a focus on hematology and oncology. She is a board-certified hematologist with an international clinical practice background.

· In February 2024, Rigel announced the acquisition of the U.S. rights to GAVRETO (pralsetinib). GAVRETO is a once daily, small molecule, oral, kinase inhibitor of wild-type RET (rearranged during transfection) and oncogenic RET fusions. GAVRETO is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and advanced or metastatic thyroid cancer. The acquisition of this product further expands Rigel’s portfolio and leverages Rigel’s existing infrastructure in both the institutional and community settings. Rigel expects to complete the transition of the asset and start recognizing product sales in July 2024.

· In January 2024, Rigel and CONNECT announced a strategic development collaboration to evaluate REZLIDHIA (olutasidenib) in combination with temozolomide in patients with high-grade glioma (HGG) harboring an IDH1 mutation. Under the collaboration, CONNECT will include olutasidenib in CONNECT’s TarGeT-D, a molecularly guided Phase 2 umbrella clinical trial for HGG. In the Rigel-sponsored arm, adolescents and young adult patients (≤39 years old) with newly diagnosed IDH1-mutation positive HGG will receive maintenance therapy with olutasidenib in combination with temozolomide for the first year after radiotherapy, followed by olutasidenib monotherapy for the second year. Rigel will provide CONNECT funding up to $3 million and study material over the four-year collaboration.

· Rigel continues to advance its Phase 1b clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R2891, a novel and selective IRAK1/4 inhibitor, in patients with relapsed/refractory lower-risk myelodysplastic syndrome (LR-MDS). Enrollment in the third cohort of the trial has been completed and the company is planning to include two additional cohorts with twice daily dosing regimens. Preliminary data are expected by the end of 2024.

Financial Update

For the first quarter of 2024, total revenues were $29.5 million, consisting of $21.1 million in TAVALISSE net product sales, $4.9 million in REZLIDHIA net product sales, and $3.5 million in contract revenue from collaborations. Although TAVALISSE bottles shipped to patients and clinics reached the highest quarterly number of bottles since launch, net product sales were $21.1 million compared to $22.3 million in the same period of 2023, primarily due to a decrease in the number of bottles remaining in distribution channels. REZLIDHIA net product sales were $4.9 million compared to $1.5 million in the same period of 2023. Contract revenue from collaborations consisted of $2.3 million from Kissei Pharmaceutical Co., Ltd. related to delivery of drug supplies, $1.1 million from Grifols S.A. related to earned royalties, and $0.1 million from Medison Pharma Trading AG related to delivery of drug supplies and earned royalties.

For the first quarter of 2024, total costs and expenses were $36.5 million compared to $38.8 million for the same period of 2023. The decrease in costs and expenses was partly due to decreased research and development costs due to the timing of clinical trial activities related to the IRAK 1/4 inhibitor program, as well as the timing of trial completion activities related to two Phase 3 clinical trials of fostamatinib in patients with COVID-19 and wAIHA. In addition, the decrease was due to lower consulting and third-party services as well as lower facility-related costs. These decreases were partially offset by higher stock-based compensation expenses, mainly from performance-based awards.

For the first quarter of 2024, Rigel reported a net loss of $8.2 million, or $0.05 per basic and diluted share, compared to a net loss of $13.5 million, or $0.08 per basic and diluted share, for the same period of 2023.

As of March 31, 2024, Rigel had cash, cash equivalents and short-term investments of $49.6 million, compared to $56.9 million as of December 31, 2023. In April 2024, Rigel entered into an amendment to the Credit Agreement with MidCap Financial Trust. As part of the amendment, Rigel extended the maturity date and interest only period by one year.

Conference Call and Webcast with Slides Today at 4:30pm Eastern Time

Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).

Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

About ITP

In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AML

Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 20,800 new cases in the United States, most in adults, in 2024.2

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.3 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.4 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.

About NSCLC

It is estimated that over 230,000 adults in the U.S. will be diagnosed with lung cancer in 2024. Lung cancer is the leading cause of cancer death in the U.S, with NSCLC being the most common type accounting for 80-85% of all lung cancer diagnoses.5 RET fusions are implicated in approximately 1-2% of patients with NSCLC.6

About TAVALISSE

Indication

TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information

Warnings and Precautions

· Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.

· Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to ≥3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.

· Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.

· Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.

· TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

Drug Interactions

· Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.

· It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.

· Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.

· Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

Adverse Reactions

· Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).

· Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

Please see www.TAVALISSEUSPI.com for Full Prescribing Information.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE is a registered trademark of Rigel Pharmaceuticals, Inc.

On May 7, 2024 Quest Diagnostics Incorporated (NYSE: DGX), a leader in diagnostic information services, reported that Jim Davis, Chairman, CEO and President, will speak on the company’s strategy, performance and the latest market developments and trends during a fireside chat at the 2024 Leerink Partners Healthcare Crossroads Conference in Austin, Texas on Wednesday, May 29, 2024, at 10:20 a.m. Eastern Time (Press release, Quest Diagnostics, MAY 7, 2024, View Source [SID1234642783]).

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The fireside chat and Q&A session will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. In addition, the archived webcast will be available within 24 hours after the conclusion of the live event and will remain available until June 28, 2024.

On May 7, 2024 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the first quarter ended March 31, 2024 and provided an update on recent clinical development pipeline and other corporate developments (Press release, Prelude Therapeutics, MAY 7, 2024, View Source [SID1234642782]).

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"The first quarter of this year was marked by growing momentum for Prelude, led by the continued clinical progress of our two lead drug candidates, PRT3789, a highly-selective, first-in-class SMARCA2 degrader and PRT2527, a potentially best-in-class CDK9 inhibitor," stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude. "We are on track to present initial Phase 1 data for both compounds in the second half of this year and to advance both into the next phase of development in cancers with patients who are in need of safe and effective new therapies, provided the data are supportive."

Dr. Vaddi continued, "In addition to the continued advancement of our clinical compounds, we strengthened our leadership team with the additions of Sean Brusky, our new Chief Business Officer and Robert Doody, our new head of Investor Relations, both of whom bring proven operational capabilities and important strategic insights to the Prelude team in anticipation of our expected progress and growth over the coming years."

Clinical Program Updates and Upcoming Milestones

SMARCA2 degrader PRT3789 on track to complete monotherapy dose escalation mid- year and combination with docetaxel has been initiated; initial proof-of concept data expected in second half of 2024.

PRT3789 is a potent and highly selective, first-in-class SMARCA2 degrader, designed to be used in patients with a SMARCA4 mutation. Cancers with a SMARCA4 mutation represent a high unmet medical need. Patients with the SMARCA4 mutation have poor prognosis and limited treatment options.

PRT3789 is in Phase 1 clinical development in biomarker selected SMARCA4 mutant patients. Enrollment remains on track, and the Company expects to conclude monotherapy dose escalation mid-2024 and identify recommended Phase 2 dose. In addition, enrollment of patients into back-fill cohorts enriched for NSCLC and SMARCA4 loss-of-function mutations is ongoing. Objectives for this first Phase 1 clinical trial are to establish the safety and tolerability profile of PRT3789 as both monotherapy and in combination with docetaxel, evaluate activity, pharmacokinetics and pharmacodynamics and determine a dose and potential indications for advancement into a registrational clinical trial.

Oral SMARCA2 degrader PRT7732 expected to enter Phase 1 clinical trial in the second half of 2024

Prelude’s discovery team has identified a series of highly selective and orally bioavailable SMARCA2 degraders. The lead oral molecule, PRT7732, is currently in investigational new drug (IND) enabling preclinical studies and on track to enter Phase 1 clinical development in the second half of 2024. PRT7732 is structurally distinct from PRT3789 and may provide clinically meaningful differences, including potential utility in earlier lines of therapy.

CDK9 inhibitor PRT2527 on track to complete monotherapy dose escalation mid-2024; initiated dosing in combination with zanubrutinib in first quarter of 2024; initial hematological proof-of-concept data expected in second half of 2024

PRT2527 is a potent and selective CDK9 inhibitor that has the potential to avoid off target toxicity. The Company is currently advancing PRT2527 as monotherapy in hematological indications such as B-cell malignancies and acute myeloid leukemia (AML) and has initiated the combination with zanubrutinib in B-cell malignancies.

PRT2527 is currently in Phase 1 clinical development and is expected to complete monotherapy dose escalation in B-cell malignancies mid-year. A second cohort of patients with AML is expected to initiate in the first half of 2024.

2024 AACR (Free AACR Whitepaper) Annual Meeting: Prelude participated in the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, presenting three preclinical poster presentations. New preclinical data was presented for the company’s highly selective oral SMARCA2 degrader, its potentially best-in-class CDK9 inhibitor, and its next-generation oral CDK4/6 inhibitor. Copies of this information can be found on the Company’s website under Publications – Prelude Therapeutics (preludetx.com).

Corporate Updates: In April 2024, Prelude appointed Sean Brusky to the newly created position of Chief Business Officer. Mr. Brusky joins Prelude from Pardes Biosciences where he served as both Chief Commercial Officer and Chief Business Officer. Prior to Pardes, Mr.

Exhibit 99.1

Brusky served in roles of increasing seniority at Genentech/Roche, Vertex Pharmaceuticals and Bain & Company.

Additionally, in April 2024, Prelude appointed Robert Doody to the newly created position of Senior Vice President, Investor Relations. Mr. Doody most recently served as Head of Investor Relations at Aclaris Therapeutics. Prior to Aclaris Therapeutics, Mr. Doody served as Investor Relations Lead at Provention Bio, Idera Pharmaceuticals and ViroPharma Incorporated.

First Quarter 2024 Financial Results 

Cash and Cash Equivalents:

Cash, cash equivalents and marketable securities as of March 31, 2024 were $201.9 million. The Company anticipates that its existing cash, cash equivalents and marketable securities will fund Prelude’s operations into 2026. 

Research and Development (R&D) Expenses:

For the first quarter of 2024, R&D expense increased to $27.4 million from $21.8 million for the prior year period. Research and development expenses increased primarily due to the timing of our clinical research programs. We expect our R&D expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.  

General and Administrative (G&A) Expenses:

For the first quarter of 2024, G&A expenses decreased to $6.9 million from $7.3 million for the prior year period. The decrease is primarily due to a decrease in non-cash expense related to stock-based compensation, partially offset by an increase in professional fees incurred as we expand our operations to support our research and development efforts.

Net Loss:

For the three months ended March 31, 2024, net loss was $31.4 million, or $0.42 per share compared to $27.7 million, or $0.58 per share, for the prior year period. Included in the net loss for the quarter ended March 31, 2024, was $5.5 million of non-cash expenses related to the impact of expensing share-based payments, including employee stock options, as compared to $6.3 million for the same period in 2023.

On May 7, 2024 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported the company will present at the BofA Securities 2024 Health Care Conference at 11:20 a.m. Pacific Time (2:20 p.m. Eastern Time) on Tuesday May 14, 2024 in Las Vegas (Press release, Neurocrine Biosciences, MAY 7, 2024, View Source [SID1234642781]). Kevin Gorman, Chief Executive Officer, Matt Abernethy, Chief Financial Officer, and Kyle Gano, Chief Business Development and Strategy Officer, will present at the conference.

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The live presentation will be webcast and may be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.