On May 4, 2023 INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the quarter ended March 31, 2023 and provides a business update (Press release, INmune Bio, MAY 4, 2023, View Source [SID1234631031]).

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Q1 2023 Corporate Highlights:

DN-TNF Platform Highlights (XPro and INB03):

● AD02 blinded randomized Phase 2 clinical trial in patients with early Alzheimer’s Disease (AD) continues to enroll in Australia and Canada. The company is actively pursuing other regulatory venues to expand the clinical trial footprint. The company announced consolidation of the mild ADi and Mild Cognitive Impairment Phase 2 programs into a single trial to improve the efficiency and align the program with the most probable Phase 3 design. Discussions with the FDA have provided a clear pathway to lifting the clinical hold before the end of year.

● Announced data in acute mdx model of Duchene’s Muscular Dystrophy (DMD) and formed DN02, Inc. a wholly owned subsidiary to facilitate partnering and development of DN-TNF in the treatment of DMD. Results from the long-term D2.mdx model are expected soon. Data presented to date suggests DN-TNF may improve treatment from boys with DMD by promoting muscle fiber regeneration and eliminating the need for corticosteroids. Corticosteroids, the current standard-of-care, is responsible for many of the metabolic and physical complications suffered by boys with DMD.

● Presented additional data on combination of INB03 DN-TNF with trastuzumab-deruxtecan (Enhertu, TDxd) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual scientific meeting in April showing that triple negative breast cancer (TNBC) often express MUC4. MUC4 expressing cancers, breast cancer, HER2+ breast cancer, TNBC, gastric and pancreatic cancer, are candidates for combination therapy with DN-TNF. In pre-clinical models, INB03 DN-TNF reduced MUC4 expression to decrease resistance to immunotherapy including tyrosine kinase inhibitors (TKIs), trastuzumab and TDxd. The Company is developing a novel DN-TNF-bioconjugate compound with distinct intellectual property protections and testing in a variety of animal models in preparation of launching a strategic partnering program in oncology.

● Announced pre-clinical, mouse model data that support the use of XPro as an early treatment following Traumatic Brain Injury (TBI) to prevent the development of amyloid pathology. Data shows neuroinflammation drives the development of amyloid pathology after TBI and can be prevented by neutralizing sTNF with XPro. These data implicated TBI as a contributing factor for the development of AD.

INKmune Platform:

● IND filed in April for the use of INKmune to treat patients with metastatic castration-resistant prostate cancer (mCRPC) in the US. Excluding skin cancer, prostate cancer is the most common cancer in men. The Phase I/II design will enroll patients at several medical centers in the US.

● Additional sites have opened to support the ongoing Phase 1 trial in high risk MDS/AML. A second site in the UK, The Royal Hallamshire Hospital at Sheffield University Medical School treated their first patient on March 9th. A third site in Europe, Attikon University Hospital in Athens, Greece, has opened for recruitment and INKmune is being imported into Greece in readiness for patient enrollment.

● Our CSO Mark Lowdell co-hosted a session at the Innate Killer Summit in La Jolla in March focused on the expanding world of memory-like NK cells in cancer immunotherapy and the ability of INKmune to generate these cells in vivo.

● On June 1st, Dr Lowdell will present the opening plenary presentation in the Presidential Session at the annual International Society of Cell & Gene Therapy (ISCT) where he will share the latest data on INKmune.

Upcoming Events and Milestones:

● Top-line results for the Phase 2 XPro trial for treatment of neuroinflammation as a cause of Alzheimer’s Disease is expected in 2H 2024.

● Initiate a Phase 2 trial of XPro in patients with Treatment Resistant Depression that is partially funded by a $2.9 million NIH grant upon resolution of the FDA manufacturing review.

● Additional open-label Phase 1 trial data of INKmune in high-risk MDS/AML in 2023.

● Opening of a Phase I/II trial studying INKmune in prostate cancer upon the acceptance of the IND by the FDA.

Financial Results for the Quarter Ended March 31, 2023:

Net loss attributable to common stockholders for the quarter ended March 31, 2023 was approximately $6.5 million, compared to approximately $6.9 million during the quarter ended March 31, 2022.

Research and development expense totaled approximately $4.1 million for the quarter ended March 31, 2023 compared to approximately $4.3 million during the quarter ended March 31, 2022.

General and administrative expenses were approximately $2.3 million for the quarter ended March 31, 2023 compared to approximately $2.3 million during the quarter ended March 31, 2022.

Other expense was approximately $0.1 million for the quarter ended March 31, 2023 compared to approximately $0.4 million during the quarter ended March 31, 2022.

In addition, the Company received research and development rebates from Australia and the United Kingdom during the three months ended March 31, 2023 that totaled approximately $6.5 million.

As of March 31, 2023, the Company had cash and cash equivalents of approximately $51.0 million.

As of May 3, 2023, the Company had approximately 17.9 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio First Quarter Conference Call when reaching an operator.

Date: May 3, 2023
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-844-826-3035 Participant Dial-in (international): 1-412-317-5195
Conference ID: 10177985

A live audio webcast of the call can be accessed using this link or clicking here:
View Source

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through May 10 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 10177985.

About XPro

XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

About INKmune

INKmune is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to convert the cancer patient’s resting NK cells into tumor killing memory-like NK cells. INKmune treatment’s effect on NK cells is akin to treatment with at least three cytokines in combination (IL-12, IL-15, IL-18) to form memory-like NK cells. In patients, INKmune primed tumor killing NK cells persist for more than 100 days and function in the in the hypoxic TME because due to upregulated nutrient and mitochondrial survival proteins. INKmune is a patient friendly therapy that can be easily transported, stored and delivered to the patient by a simple intravenous infusion without the need for patient conditioning or premedication. INKmune is tumor agnostic; it can be used to treat many types of NK-resistant tumors including leukemia, lymphoma, myeloma, lung, ovarian, breast, renal and nasopharyngeal cancer. INKmune is treating patients in an open label Phase I trial in high-MDS/AML in the UK and Europe. The company plans an open label Phase I/II trial in metastatic castration-resistant prostate cancer in the US this year.

On May 4, 2023 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the pricing of an underwritten public offering of 26,000,000 shares of its common stock at a price of $12.50 per share, before underwriting discounts and commissions (Press release, ImmunoGen, MAY 4, 2023, View Source [SID1234631030]). The offering is expected to close on or about May 9, 2023, subject to satisfaction of customary closing conditions. ImmunoGen also granted the underwriters a 30-day option to purchase up to an additional 3,900,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock in the offering are to be sold by ImmunoGen.

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ImmunoGen anticipates the total gross proceeds from the offering (before deducting the underwriting discounts and estimated offering expenses) will be $325 million, excluding any exercise of the underwriters’ option to purchase additional shares.

ImmunoGen intends to use the net proceeds from this offering to fund its operations, including, but not limited to, global commercialization activities, supply of ELAHERE (mirvetuximab soravtansine-gynx) drug product, clinical trial activities, pipeline research and development activities, business development activities, and capital expenditures.

Jefferies, Goldman Sachs & Co. LLC, and Guggenheim Securities are acting as joint book-running managers for the proposed offering. Canaccord Genuity is acting as lead manager for the proposed offering.

The securities described above are being offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by phone at (866) 471-2526, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, or by email at [email protected] or by telephone at (212) 518-9544.

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)

•
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:

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

•
"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))

•
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).

•
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.

•
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.

•
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.

•
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)

•
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.