On May 4, 2023 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us") reported that updated NXC-201 clinical data has been selected for presentation at the upcoming 26th Annual Meeting of The American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) to be held in Los Angeles May 16-20, 2023 (Press release, Immix Biopharma, MAY 4, 2023, View Source [SID1234631029]).

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"We are delighted to present additional clinical data for what we believe is the only CAR-T in development in AL Amyloidosis at the upcoming 26th Annual Meeting of The American Society of Gene & Cell Therapy," said Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and principal study investigator for the NEXICART-1 Phase 1b/2a clinical trial of NXC-201. "A potential one-time treatment such as CAR-T NXC-201 in AL amyloidosis would be a welcome option for this devastating disease."

Oral Presentation:

Title: "BCMA-Targeted CART (HBI0101), a Safe and Efficacious Novel Modality of Treatment for Light Chain Amyloidosis Patients"
Oral Presentation Date/Time: Friday May 19, 2023, 9:15am – 9:30am
Event: 26th Annual Meeting of The American Society of Gene and Cell Therapy, Los Angeles, CA
Session Title: Late-Breaking Abstracts 1
Session Date/Time: Friday May 19, 2023, 8:00am – 9:45am

About NEXICART-1

NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2a, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed or refractory multiple myeloma and AL amyloidosis.

The primary objective of the Phase 1b portion of the study is to characterize the safety and confirm the Maximally Tolerated Dose (MTD) and Phase 2 dose of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 with endpoints of overall survival, progression-free survival and response rates according to International Myeloma Working Group (IMWG) Uniform Response Criteria.

The Phase 1b portion of the ongoing Phase 1b/2 clinical trial has been successful in determining the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells. Over the coming months, Nexcella (an Immix Biopharma subsidiary) plans to submit an IND application to the FDA for a Phase 1b/2 of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis in order to expand the ongoing clinical trial to the U.S. The expected primary endpoint for the Phase 2 portion of the ongoing Phase 1b/2a clinical trial of NXC-201 in relapsed/refractory multiple myeloma is overall response rate and duration of response. Nexcella plans to submit data to the FDA in multiple myeloma once 100 patients are treated with NXC-201. The expected primary endpoint for NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate. Nexcella plans to submit data to the FDA in AL amyloidosis once 30-40 patients are treated with NXC-201.

About NXC-201

NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.

About Multiple Myeloma

Multiple myeloma ("MM") is an incurable blood cancer of plasma cells that starts in the bone marrow and is characterized by an excessive proliferation of these cells. Despite initial remission, unfortunately, most patients are likely to relapse. There are 35,730 patients in the United States diagnosed with MM each year. Prognosis for patients who do not respond to or relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents remains poor. The $13.9 billion Multiple Myeloma market in 2017 is expected to reach $28.7 billion in 2027 according to Wilcock, et al. Nature Reviews.

About AL Amyloidosis

AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded amyloid proteins produced by plasma cells cause buildup in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage, and high mortality rates.

AL amyloidosis affects roughly 30,000 – 40,000 patients in total throughout the U.S. and Europe, and it is estimated that there are approximately 3,000 – 4,000 new cases of AL amyloidosis annually in the U.S. The annual global incidence of AL Amyloidosis is ~15,000 patients.

The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research.

On May 4, 2023 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that HOOKIPA’s management team will participate in and present at the following upcoming investor conferences (Press release, Hookipa Biotech, MAY 4, 2023, View Source [SID1234631028]):

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BofA Securities 2023 Healthcare Conference, May 9-11, Las Vegas

The JMP Securities Life Sciences Conference – May 15-16, New York
Corporate Presentation: May 15, 3:00pm ET

2023 RBC Capital Markets Global Healthcare Conference, May 16-17, New York
Fireside Chat: May 16, 1:35pm ET

For conference presentations that are webcast, links will be available within the Investors & Media section of HOOKIPA’s website at View Source Archived replays will be accessible for 30 days following each event.

On May 4, 2023 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2023 (Press release, Cytokinetics, MAY 4, 2023, View Source [SID1234631027]). Net loss for the first quarter was $131.3 million, or $1.38 per share, compared to net loss for the first quarter of 2022 of $89.4 million, or $1.05 per share. Cash, cash equivalents and investments totaled $704.4 million at March 31, 2023.

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"In the first quarter we continued to prioritize the broad development program for aficamten for the potential treatment of obstructive and non-obstructive HCM and with focus to SEQUOIA-HCM, our pivotal Phase 3 clinical trial in obstructive HCM. We expect to complete patient enrollment in the coming weeks and read out the results later this year," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "In parallel, we continue to deepen our specialty cardiology pipeline with the advancement of CK-136 and CK-586 in earlier phase clinical trials. Finally, as good stewards of shareholder capital, we are reducing our spending to ensure we maintain over two years of cash runway."

Q1 and Recent Highlights

Cardiac Muscle Programs

aficamten (cardiac myosin inhibitor)

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Presented data from Cohort 4 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), a Phase 2 clinical trial of aficamten in patients with non-obstructive hypertrophic cardiomyopathy, at the American College of Cardiology 72nd Annual Scientific Session (ACC.23), showing that treatment with aficamten resulted in significant
improvements in heart failure symptoms as measured by New York Heart Association (NYHA) Class, as well as in NT-proBNP and high-sensitivity troponin I, cardiac biomarkers.

•
Presented 48-week data from FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM) at ACC.23 showing that long-term treatment with aficamten was associated with sustained treatment effect, well-tolerated with no treatment-related serious adverse events, and was associated with rapid and sustained improvements in echocardiographic hemodynamics paralleled by significant improvements in NYHA class.

•
Continued enrolling patients in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the first Phase 3 trial of aficamten in obstructive hypertrophic cardiomyopathy (HCM).

•
Continued preparations for the start of MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), the second Phase 3 clinical trial of aficamten as monotherapy in patients with obstructive HCM.

•
Began preparations for the Phase 3 clinical trial of aficamten in non-obstructive HCM.

•
Published the following manuscripts:

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"Phase 2 Study of Aficamten in Patients with Obstructive Hypertrophic Cardiomyopathy" in the Journal of the American College of Cardiology.

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"Effects of Aficamten on Cardiac Contractility in a Feline Translational Model of Hypertrophic Cardiomyopathy" in Scientific Reports.

•
"Pharmacokinetics of a Single Dose of Aficamten (CK-274) on Cardiac Contractility in a A31P MYBPC3 Hypertrophic Cardiomyopathy Cat Model" in the Journal of Veterinary Pharmacology and Therapeutics.

omecamtiv mecarbil (cardiac myosin activator)

•
Announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for omecamtiv mecarbil.

•
Continued to support review of the Marketing Authorization Application (MAA) for omecamtiv mecarbil by the European Medicines Agency (EMA) for the treatment of advanced or worsening HFrEF.

•
Published the following manuscripts:

•
"Omecamtiv Mecarbil in Black Patients with Heart Failure and Reduced Ejection Fraction: Insights From GALACTIC-HF" in the Journal of the American College of Cardiology: Heart Failure.

•
"Efficacy of Omecamtiv Mecarbil in Heart Failure with Reduced Ejection Fraction According to N-terminal pro-B-type Natriuretic Peptide Level: Insights from the GALACTIC-HF Trial" in the European Journal of Heart Failure.

CK-3828136 (CK-136, cardiac troponin activator)

•
Completed 3 single ascending dose cohorts in the Phase 1 study of CK-136 in healthy volunteers.

Skeletal Muscle Program

reldesemtiv (fast skeletal muscle troponin activator (FSTA))

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Announced that COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS) met criteria for futility at the second planned interim analysis. The company will conclude study conduct and plans to discontinue treatment with reldesemtiv in all patients, including those in the open-label extension study, COURAGE-ALS OLE.

Pre-Clinical Development and Ongoing Research

•
Received U.S. Food & Drug Administration (FDA) clearance for the Investigational New Drug (IND) application to initiate a Phase 1 study of CK-4021586 (CK-586).

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Continued research activities directed to our other muscle biology research programs.

Corporate

•
Released inaugural Corporate Responsibility Report outlining the Company’s commitment to social and environmental responsibility, ethics and governance and patient and community engagement.

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Joined with the European Organisation for Rare Diseases (EURORDIS) and the National Organization for Rare Disorders (NORD) to recognize Rare Disease Day, an international campaign elevating the public understanding of rare diseases.

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Awarded Cytokinetics Communications Fellowship Grants to patient advocacy organizations serving the heart failure, HCM and ALS communities to support increased capacity in communications, awareness building and community engagement for nonprofit organizations serving the patient community.

2023 Corporate Milestones

Cardiac Muscle Programs

aficamten (cardiac myosin inhibitor)

•
Present additional data from Cohort 4 of REDWOOD-HCM at the European Society of Cardiology Heart Failure 2023 Congress on May 20, 2023.

•
Complete patient enrollment in SEQUOIA-HCM in Q2 2023, with results expected in Q4 2023.

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Begin MAPLE-HCM, the second Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol in patients with obstructive HCM, in Q2 2023.

•
Begin a Phase 3 clinical trial of aficamten in non-obstructive HCM in 2H 2023.

•
Advance U.S. go-to-market strategy for aficamten.

omecamtiv mecarbil (cardiac myosin activator)

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Continue to pursue potential international approvals for omecamtiv mecarbil in Europe and China.

CK-3828136 (CK-136, cardiac troponin activator)

•
Expect single ascending dose data from the Phase 1 study of CK-136 in 2H 2023.

CK-4021586 (CK-586, cardiac myosin inhibitor)

•
Expect to advance CK-586 into a first-in-human study in Q2 2023.

Skeletal Muscle Program

reldesemtiv (fast skeletal muscle troponin activator (FSTA))

•
Conclude clinical trial conduct and complete majority of close-out activities for COURAGE-ALS in Q2 2023; expect to share results from COURAGE-ALS in 2H 2023.

Financials

Revenues for the first quarter 2023 were $4.6 million compared to $1.1 million for the corresponding period in 2022. The increase in revenues is due to our recognizing a $2.5 million milestone from Ji Xing Pharmaceuticals in anticipation of the start of a Phase 3 trial on nHCM.

Research and development expenses for the first quarter 2023 increased to $79.4 million compared to $45.9 million for the same period in 2022, due primarily to increased spending for our clinical development activities for our cardiac myosin inhibitor programs and COURAGE-ALS.

General and administrative expenses for the first quarter 2023 increased to $49.7 million from $33.1 million for the same period in 2022 due primarily to higher personnel related costs including stock-based compensation and precommercial launch expenses.

The company expects to reduce spending in 2023, primarily through a reduction in planned outsourced services and headcount growth, thereby resulting in projected savings of more than 10% relative to forecasted spending for 2023.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s first quarter 2023 results on a conference call today at 4:30 PM Eastern Time. The conference call will be simultaneously webcast and can be accessed from the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by registering in advance at the following link: Cytokinetics Q1 2023 Earnings Conference Call. Upon registration, participants will receive a dial-in number and a unique passcode to access the call. An archived replay of the webcast will be available via Cytokinetics’ website for twelve months.

On May 4, 2023 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its business update and financial results for the first quarter ended March 31, 2023 (Press release, Curis, MAY 4, 2023, View Source [SID1234631026]).

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"I am pleased with our progress in the TakeAim leukemia study. We enrolled the additional patients requested by FDA ahead of schedule in the first quarter – which is indicative of both the clear unmet need in leukemia and the excitement among the clinical community for this novel agent. We are on track to collect data from these patients in the second quarter and discuss these data with the FDA in the third quarter of this year. I am also pleased to announce the expansion of the Curis Executive Team with the addition of Jonathan Zung, Ph.D. as our Chief Development Officer. Dr. Zung is a well-respected leader in the industry and brings a wealth of experience from senior roles across the industry, most recently at Evelo. We look forward to his contributions toward our mission at Curis," said James Dentzer, President and CEO of Curis.

"I am excited to be joining the Curis team during this critical time, as the company advances its first-in-class IRAK4 inhibitor, emavusertib. In biotech, it is rare to find a novel target with such broad therapeutic potential in that exciting period between the initial demonstration of clear single agent activity and the final stage of clinical development. I look forward to working with the Curis team on the clinical development of emavusertib and helping to establish it as a cornerstone therapy in hematologic malignancies," said Dr. Zung.

First Quarter 2023 and Recent Operational Highlights

Appointed new CDO

Dr. Zung was appointed as Chief Development Officer of Curis on May 1, 2023. Prior to joining Curis, he served as CDO of Evelo Biosciences, where he was responsible for the operational design and execution of Evelo’s clinical programs. Dr. Zung held previous leadership roles at WCG, Covance, UCB, Bristol Myers Squibb, and Pfizer. He also serves on the advisory board of Saama Technologies. He received his Ph.D. in analytical chemistry from Emory University.

Upcoming Milestones

Curis completed the enrollment of 9 additional patients at the 200mg BID dose level requested by FDA, is collecting data on those patients in the second quarter, and expects to discuss those data with FDA in the third quarter of 2023. Discussions with the FDA are expected to determine the recommended Phase 2 dose and resolution of the partial clinical hold on emavusertib development in leukemia.
First Quarter 2023 Financial Results

For the first quarter of 2023, Curis reported a net loss of $11.6 million or $0.12 per share on both a basic and diluted basis as compared to $16.1 million or $0.18 per share on both a basic and diluted basis, for the same period in 2022.

Revenues for the first quarter of 2023 were $2.3 million as compared to $2.1 million for the same period in 2022. Revenues for both periods consist of royalty revenues from Genentech’s and Roche’s sales of Erivedge.

Research and development expenses were $9.1 million for the first quarter of 2023, as compared to $11.4 million for the same period in 2022. The decrease is primarily attributable to the timing of manufacturing costs and lower employee related costs due to a reduction in headcount.

General and administrative expenses were $4.8 million for the first quarter of 2023, as compared to $5.7 million for the same period in 2022. The decrease was mainly attributable to lower employee related costs due to a reduction in headcount.

Other income, net was $0.1 million for the first quarter of 2023, as compared to other expense, net of $1.0 million for the same period in 2022. Other income (expense), net primarily consisted of interest income partially offset by expense related to future royalty payments.

As of March 31, 2023, Curis’s cash, cash equivalents and investments totaled $71.8 million, and the Company had approximately 96.6 million shares of common stock outstanding. Curis expects its existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2025.

Conference Call Information

Curis management will host a conference call today, May 4, 2023, at 4:30 p.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website in the Investors section.

On May 4, 2023 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), (Nasdaq: CRNX) reported financial results for the first quarter ended March 31, 2023 (Press release, Crinetics Pharmaceuticals, MAY 4, 2023, View Source [SID1234631025]).

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"We plan to share topline results from PATHFNDR-1 next quarter, which should provide an important look at the impact that paltusotine may have on patients’ lives," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We designed the two PATHFNDR studies to address both treatment-naïve patients as well as patients who may switch from standard of care, the two patient populations specifically outlined in the recently released draft guidance from the FDA on Developing Drugs for Acromegaly Treatment."

Dr. Struthers continued, "Enrollment in PATHFNDR-2 has benefited from enthusiastic participation of treatment-naïve patients. This enables us to take advantage of a prespecified opportunity to increase the study’s enrollment target while maintaining our estimated timeline of topline data in the first quarter of 2024. We anticipate this will provide an even clearer picture of paltusotine’s potential to treat patients who have been recently diagnosed with acromegaly and could strengthen the competitive position of paltusotine from a market and payer perspective, if approved."

CLINICAL PROGRAM UPDATES:
Paltusotine’s Phase 3 PATHFNDR-1 study: enrollment complete with topline data expected in 3Q 2023. PATHFNDR-1 is a placebo-controlled Phase 3 clinical study of once-daily, oral paltusotine in participants with acromegaly switching from standard-of-care peptide depots. It is designed to support an indication for the maintenance of acromegaly treatment. The study enrolled participants with acromegaly who were biochemically controlled (IGF-1 ≤ 1.0x upper limit of normal) on octreotide or lanreotide depot monotherapy. The primary endpoint of the study is the proportion of participants who maintain biochemical control on paltusotine vs. placebo. Final study enrollment is 58 participants with topline data expected in the third quarter of 2023.
Paltusotine’s Phase 3 PATHFNDR-2 study: enrollment ongoing with enrollment target increased to up to 98; topline data expected in 1Q 2024. PATHFNDR-2 is a placebo-controlled Phase 3 clinical study designed to support an indication for the treatment of acromegaly. The study is enrolling participants with acromegaly with elevated IGF-1 levels who are either treatment-naïve or untreated for at least four months (Stratum 1), or who wash out of prior octreotide or lanreotide therapy (Stratum 2). The current enrollment has included a higher enrollment of participants in Stratum 1 as compared to Stratum 2. Accordingly, Crinetics has elected to adjust PATHFNDR-2’s sample size to enable enrollment of up to 98 participants, which was an option prespecified in the study protocol. In addition to preserving statistical power to detect a difference on the primary endpoint, increasing the study’s sample size may enable a statistical comparison of Stratum 1 participants receiving either paltusotine or placebo. Topline data from the study are expected in the first quarter of 2024, in line with prior guidance.
Paltusotine NDA Submission anticipated in 2024. Pending a successful outcome from the PATHFNDR studies, Crinetics plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking regulatory approval for paltusotine in acromegaly with both treatment and maintenance of treatment indications.
Phase 2 open-label study of paltusotine in carcinoid syndrome ongoing. The Phase 2 open-label study of paltusotine in carcinoid syndrome associated with neuroendocrine tumors continues to enroll participants with preliminary data expected in the fourth quarter of 2023.

Advancing CRN04894 studies in Cushing’s disease and congenital adrenal hyperplasia. Based on successful Phase 1 studies demonstrating pharmacologic proof-of-concept, Crinetics is conducting clinical studies of CRN04894 in patients with Cushing’s disease and congenital adrenal hyperplasia. Data from both studies is expected in 2024.

CRN04777 progress. In November 2022, the FDA informed Crinetics that its planned Phase 2 study of CRN04777 in pediatric participants with congenital hyperinsulinism was not yet permitted to proceed. Crinetics plans to submit additional information and data to the FDA to support a release of the clinical hold on the planned Phase 2 study. The planned Phase 2 study is supported by pharmacologic proof-of-concept results from a successful Phase 1 study in healthy adult volunteers conducted under a Clinical Trial Application in Germany.

FIRST QUARTER 2023 FINANCIAL RESULTS

Research and development expenses were $38.5 million for the three months ended March 31, 2023, compared to $28.3 million for the same period in 2022. The increase was primarily attributable to an increase in personnel costs of $7.0 million and increased consulting and outside services of $1.4 million to support paltusotine, CRN04894, CRN04777, and our preclinical programs.

General and administrative expenses were $12.2 million for the three months ended March 31, 2023, compared to $8.7 million for the same period in 2022. The increase was primarily attributable to an increase in personnel costs of $2.7 million and an increase in other corporate expenditures of $0.8 million.
Net loss for the three months ended March 31, 2023 was $46.0 million, compared to a net loss of $34.6 million for the same period in 2022.

Revenues were $2.7 million for the three months ended March 31, 2023, compared to $3.1 million for the same period in 2022. Revenues in both periods were derived from out-licensing arrangements: for CRN01941 in March 2023 and paltusotine in February 2022.

Unrestricted cash, cash equivalents, and investments totaled $296.1 million as of March 31, 2023, compared to $334.4 million as of December 31, 2022. Based on its current projections, the company expects that its cash, cash equivalents and short-term investments will fund its current operating plan through 2024.
The company had 53,994,770 common shares outstanding as of May 1, 2023.