On April 26, 2023 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the first quarter ending March 31, 2023 (Press release, Integra LifeSciences, APR 26, 2023, View Source [SID1234630526]).

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First Quarter 2023 Highlights
•First quarter revenues of $380.8 million increased 1.1% on a reported basis and increased 4.6% on an organic basis compared to the prior year.

•First quarter GAAP earnings per diluted share of $0.29, compared to $0.39 in the prior year; adjusted earnings per diluted share of $0.74, compared to $0.74 in the prior year.

•The Company is reaffirming its full-year 2023 revenue and adjusted earnings per share guidance with a range of $1,602 million to $1,620 million and $3.43 to $3.51 respectively.

•The company is hosting its Investor Day on May 4, 2023 in New York. A live webcast will be available on the Investors section of the Company’s website at investor.integralife.com.

"Our first quarter sales performance continues to demonstrate the strength of our diverse portfolio. We experienced solid growth and demand across many of our product lines and saw positive dynamics in our markets," said Jan De Witte, Integra’s president and chief executive officer. "We remain focused on delivering profitable growth while making critical investments to support our long-term strategic objectives and commitments."

First Quarter 2023 Consolidated Performance

Total reported revenues of $380.8 million increased 1.1% on a reported basis and increased 4.6% on an organic basis compared to the prior year.
The Company reported GAAP gross margin of 61.1%, compared to 62.1% in the first quarter of 2022. Adjusted gross margin was 67.3%, compared to 67.7% in the prior year.
Adjusted EBITDA for the first quarter of 2023 was $92.3 million, or 24.2% of revenue, compared to $93.5 million million, or 24.8% of revenue, in the prior year.
The Company reported GAAP net income of $24.2 million, or $0.29 per diluted share, in the first quarter of 2023, compared to a GAAP net income of $32.9 million, or $0.39 per diluted share, in the prior year.
Adjusted net income for the first quarter of 2023 was $60.7 million, or $0.74 per diluted share, compared to $62.0 million, or $0.74 per diluted share, in the prior year.

First Quarter 2023 Segment Performance
•Codman Specialty Surgical (~65% of Revenues)
•Total revenues were $248.1 million, representing reported growth of 0.3% and organic growth of 3.5% compared to the first quarter of 2022, driven by strength in CUSA Clarity capital and disposables and Certas Plus valves, including high single-digit growth for international, led by Japan and China. The growth momentum was partially offset by the lack of CereLink monitor revenue in the quarter, following the third quarter 2022 recall, as well as continued supply challenges.

Tissue Technologies (~35% of Revenues)
•Total revenues were $132.7 million, representing reported growth of 2.6% and organic growth of 6.8% compared to the first quarter of 2022, driven by broad strength in our Wound Reconstruction portfolio, with double digit growth from Integra Skin, MicroMatrix, Gentrix, and Cytal and high single-digit growth from SurgiMend, partially offset by the continued pressure in Private Label as our partners normalize their inventory levels.

Key Products and Business Highlights

•Strong market demand and procedure volumes near pre-COVID levels
•Expanded the CUSA Clarity portfolio with the launch of the single-sided bone tip in the U.S., Canada, Australia and New Zealand
•Launched MicroMatrix in the Europe
•Progressed return-to-market plans for the CereLink ICP monitor with expectation to re-launch late third quarter
•Advanced PMA projects for SurgiMend and DuraSorb
◦Submission of PMA supplement for SurgiMend still expected in third quarter
◦SIA integration and DuraSorb PMA clinical trial on track
◦Paused production at the Boston manufacturing site in March while pulling forward quality system upgrades project into the first half of 2023
•Enhanced our leadership and clinical capability with the appointment of Stuart Hart, M.D., as chief medical officer
•Strengthened our balance sheet by amending and extending our credit facility from 2025 to 2028
•Returned value to shareholders by initiating a $150 million accelerated share repurchase

Balance Sheet, Cash Flow and Capital Allocation
The Company generated cash flow from operations of $26 million in the quarter. Total balance sheet debt and net debt at the end of the quarter were $1.45 billion and $1.15 billion, respectively, and the consolidated total leverage ratio was 2.5x.

As of quarter end, the Company had total liquidity of approximately $1.61 billion, including $307 million in cash and the remainder available under the revolving credit facility.

2023 Outlook
For the full year 2023, the Company is reaffirming its February revenue and adjusted EPS expectations of $1,602 to $1,620 million and $3.43 to $3.51, respectively. The revenue range represents reported growth of 2.9% to 4.0%, with organic growth of 4.0% to 5.2%.

For the second quarter 2023, the Company expects reported revenues in the range of $396 million to $400 million, representing reported growth of -0.5% to 0.5% and organic growth of 1.5% to 2.5%. Adjusted earnings per diluted

share are expected to be in the range of $0.75 to $0.79, including the impact of the acceleration of the Boston quality system upgrades from the second half of the year into the second quarter.

The Company’s guidance for the second quarter and full-year organic sales growth excludes acquisitions and divestitures, the effects of foreign currency and the year-over-year change in revenue from discontinued products. Organic growth excludes sales from the TWC divestiture as of September 1, 2022, and sales from the acquisition of SIA through December 1, 2023. Adjusted earnings per share guidance reflects the impact of the divestiture of the TWC business, the SIA acquisition and the impact of foreign currency.

On April 26, 2023 Inhibrx, Inc. (Nasdaq: INBX), a clinical-stage biopharmaceutical company dedicated to the development of therapeutics for oncology and rare diseases, reported that it has initiated a registration-enabling trial for INBRX-101, an optimized recombinant human AAT-Fc fusion protein, for treatment of patients with emphysema due to alpha-1 antitrypsin deficiency (AATD) (Press release, Inhibrx, APR 26, 2023, View Source [SID1234630525]). Additionally, the Company announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on studies evaluating its death-receptor 5 (DR5) agonist, INBRX-109.

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INBRX-101

The ElevAATe trial is designed as a randomized, controlled, double-blind, head-to-head superiority study examining INBRX-101 against plasma-derived AAT (pdAAT). The study design is as follows: 36 patients dosed every three weeks with INBRX-101 at 120 mg/kg, 36 patients dosed every four weeks with INBRX-101 at 120 mg/kg, and 18 patients dosed weekly with pdAAT at the FDA-approved dose. The treatment period is 32 weeks and will be conducted at approximately 35 sites in the United States, Australia and New Zealand.

The primary endpoint of the trial is the mean change in the average functional AAT (fAAT) concentration as measured by anti-neutrophil elastase capacity (ANEC) from baseline to average serum trough fAAT concentration at steady state (Ctrough,ss). Secondary endpoints are a comparison of the mean change in fAAT concentration from baseline to fAAT average concentration at steady state (Cavg,ss), and the percentage of days with fAAT above the lower limit of the normal range during steady-state dosing. A bronchoscopy sub-study of approximately 30 patients will also run at designated sites.

The initial read-out from the ElevAATe trial is expected to occur in late 2024.

INBRX-109

In March 2023, the Company announced the pause in patient enrollment for the INBRX-109 (DR5 agonist) trials as a result of the pre-defined stopping rules built into the Phase 2 protocol. This did not impact active patients who were already on treatment and remained on the trial. With data from over 200 patients dosed with INBRX-109 to date, the Company was able to more precisely identify elderly individuals with fatty liver disease as the at-risk population for severe liver toxicity. As a result, the Company amended its protocol to include the Hepatic Steatosis Index (HSI) as part of the screening criteria.

Exhibit 99.1
In April 2023, the FDA lifted the partial clinical hold. Patient enrollment is expected to resume next month. Phase 1 combination cohorts are expected to begin reading out by the end of 2023 and data from the registration-enabling trial in unresectable or metastatic conventional chondrosarcoma is expected during the second half of 2024.

About INBRX-101 and AATD

INBRX-101 is a precisely engineered recombinant human AAT-Fc fusion protein designed to safely achieve and maintain levels of alpha-1 antitrypsin (AAT) found in healthy individuals with the potential for a less frequent dosing interval compared to the weekly infusion interval of the currently available plasma-derived AAT therapies.

AATD is an inherited orphan disease affecting an estimated 100,000 patients in the United States. AATD is characterized by deficient levels of the AAT protein, which causes loss of lung tissue and function and decreased life expectancy. Augmentation therapy with plasma-derived AAT is the current standard of care but does not maintain patients in the normal AAT range, requires frequent and inconvenient once-weekly IV dosing, and relies on plasma collection practices that might not be sustainable.

Data from the Phase 1 multiple ascending dose study of INBRX-101 at 40, 80 and 120 mg/kg IV every three weeks showed the expected accumulation of functional AAT levels and the ability to achieve fully normal functional AAT levels in severely deficient AATD patients. Based on PK modeling, accumulation is expected to continue following subsequent doses and reach steady state after a total of approximately five to six consecutive doses, administered every three or four weeks.

Treatment was well tolerated with no severe or serious adverse events related to the study drug. Drug-related adverse events were predominantly mild and those few that were moderate in severity were all transient and reversible, with minimal or no symptomatic care. No safety-related or PK/PD-related signs of neutralizing anti-drug antibodies were observed.

In March 2022, the FDA granted orphan-drug designation for INBRX-101 for the treatment of AATD.

About INBRX-109 and Chondrosarcoma

INBRX-109 is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation.

Chondrosarcoma is an orphan bone cancer with approximately 2,800 new patients diagnosed annually in the United States and the EU. There are currently no therapeutics approved for the treatment of chondrosarcoma.

In 2021, the FDA granted Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma and orphan-drug designation to INBRX-109 for chondrosarcoma in the United States.

In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, potential registration-enabling Phase 2 trial of INBRX-109 in conventional chondrosarcoma. This trial, in addition to the additional Phase 1 cohorts examining INBRX-109 in combination with certain chemotherapies, are currently ongoing.

On April 26, 2023 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that a Trial in Progress poster on its ongoing Phase 1/2 clinical study (NCT05553639) of HB-300 in prostate cancer has been accepted for presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6, 2023 (Press release, Hookipa Biotech, APR 26, 2023, View Source [SID1234630524]).

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"We’re excited to present an overview of our ongoing HB-300 Phase 1/2 clinical trial at ASCO (Free ASCO Whitepaper)," said Joern Aldag, Chief Executive Officer at HOOKIPA. "HB-300 is our second oncology immunotherapy program currently in the clinic. We look forward to sharing more about this novel compound as we seek to address unmet clinical needs in prostate cancer."

Details of the presentation are:

HB-300, a novel arenavirus-based cancer immunotherapy in patients with metastatic castration-resistant prostate cancer
Abstract #TPS5108; Poster Session: Genitourinary Cancer – Prostate, Testicular, and Penile
Saturday, June 3, 2023; 8:00-11:00 am CT
The full abstract will become public at 5:00 pm ET on Thursday, May 25.

About HB-300
HB-300 is an alternating, 2-vector replicating arenaviral immunotherapy for metastatic castration-resistant prostate cancer (mCRPC). HB-300 uses the lymphocytic choriomeningitis virus (LCMV) and pichinde virus (PICV) as arenaviral backbones, with each expressing two well-defined antigens of prostate cancer, prostatic acid phosphatase (PAP) and prostate-specific antigen (PSA). HOOKIPA’s approach is designed to focus the immune response against the target antigens and has demonstrated the ability to induce potent antigen-specific T cells responses and anti-tumor activity in preclinical and clinical settings.

On April 26, 2023 GlycoMimetics, Inc. (Nasdaq: GLYC), reported that it will host a conference call and webcast to report first quarter 2023 financial results on Wednesday, May 3, 2023, at 8:30 a.m. ET (Press release, GlycoMimetics, APR 26, 2023, View Source [SID1234630523]).

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To access the call by phone, please go to this registration link and you will be provided with dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.

A live webcast of the call will be available on the "Investors" tab on the GlycoMimetics website. A webcast replay will be available for 30 days following the call.

On April 26, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that data from the pivotal IMerge Phase 3 clinical trial evaluating the Company’s first-in-class telomerase inhibitor, imetelstat, in lower risk myelodysplastic syndromes (MDS), was accepted for oral presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Geron, APR 26, 2023, View Source [SID1234630522]). The data in the ASCO (Free ASCO Whitepaper) abstract will be embargoed per ASCO (Free ASCO Whitepaper) guidelines until May 25, 2023 at 5 p.m. Eastern Time. ASCO (Free ASCO Whitepaper) is taking place in Chicago, IL from June 2-6, 2023.

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Details for the oral presentation are as follows:

Title: IMerge: Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Imetelstat in Patients (pts) With Heavily Transfusion Dependent (TD) Non-Del(5q) Lower-Risk Myelodysplastic Syndromes (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESA).

Presenter: Amer Methqal Zeidan, Yale School of Medicine

Abstract number: 7004

Date: Friday, June 2, 2023

Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

About IMerge Phase 3

The Phase 3 portion of the IMerge Phase 2/3 study is a double-blind, 2:1 randomized, placebo-controlled clinical trial to evaluate imetelstat in patients with IPSS Low or Intermediate-1 risk (lower risk) transfusion dependent MDS who were relapsed after, refractory to, or ineligible for, erythropoiesis stimulating agent (ESA) treatment, had not received prior treatment with either a HMA or lenalidomide and were non-del(5q). To be eligible for IMerge Phase 3, patients were required to be transfusion dependent, defined as requiring at least four units of packed red blood cells (RBCs), over an eight-week period during the 16 weeks prior to entry into the trial. The primary efficacy endpoint of IMerge Phase 3 is the rate of RBC-TI lasting at least eight weeks, defined as the proportion of patients without any RBC transfusion for at least eight consecutive weeks since entry to the trial (8-week TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week TI), the duration of TI and the rate of hematologic improvement erythroid (HI-E), which is defined as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden. A total of 178 patients were enrolled in IMerge Phase 3 across North America, Europe, Middle East and Asia.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of adult patients with transfusion dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment. Geron plans to submit a New Drug Application (NDA) in the U.S. in mid-2023 and a Marketing Authorization Application (MAA) in the EU in the second half of 2023 in the lower risk MDS indication.