On August 8, 2024 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported its financial results for the second quarter of 2024 and provided an update on recent company developments (Press release, Inovio, AUG 8, 2024, View Source [SID1234645606]).

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"We continue to make progress with our lead candidate, INO-3107, which has the potential to significantly improve the lives of patients with RRP. We expect all non-device related elements of our BLA package to be completed by year end and our pre-BLA meeting last week with the FDA provided us with confidence that we remain on the right track for the regulatory submission. However, as part of the testing process required for BLA submission, we’ve recently identified a manufacturing issue with the single use disposable administration component of our device that we believe is resolvable, but will take additional time to rectify," said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer. "We’re taking corrective steps to address the issue, and while we have not altered our ultimate expectations for INO-3107 to be a potentially transformative therapeutic option for RRP patients that could be the first DNA medicine approved for use in the United States, we now expect to be able to submit the BLA in mid-2025. We will continue to work hard to advance all other elements necessary for INO-3107’s success, including working to initiate our confirmatory trial, advancing plans for our redosing trial, making key regulatory progress in Europe and the U.K., and continuing commercial preparations to be launch-ready if we receive approval. These efforts will help maintain the momentum that’s carried us from Breakthrough Therapy Designation to BLA preparation in less than a year."

"We’ve continued making progress in other key areas of our business as well," Dr. Shea continued. "We submitted our Phase 3 clinical plans for INO-3112 to European regulatory authorities, anticipate re-submitting our Phase 2 clinical plans for our Ebola booster vaccine candidate, INO-4201, to the FDA in the third quarter, and are continuing discussions with partners to advance INO-5401 as a potential treatment for GBM. We also welcomed Steve Egge to our leadership team as our Chief Commercial Officer. Steve brings extensive launch experience in HPV-related diseases, cancer, immunology and rare diseases and I know his commercial expertise will be invaluable as we work to advance INO-3107 and our other promising candidates."

Recent Business Highlights

INO-3107 – Recurrent Respiratory Papillomatosis (RRP)

INOVIO continued advancing preparations for submitting its BLA under the FDA’s Accelerated Approval pathway, including holding a pre-BLA meeting with the FDA, advancing development of all BLA modules, trial site preparations and ongoing commercial readiness plans. However, INOVIO has identified an issue related to the manufacturing of the single use disposable administration component of the CELLECTRA device that will delay its BLA submission, now anticipated in mid-2025. INOVIO is working to rectify the issue as quickly as possible, using all resources available, and expects to provide further updates at the next quarterly report.
INO-3107 was designated an innovative medicine as part of the U.K.’s Innovative Licensing and Access Pathway (ILAP). The designation, called an Innovation Passport, is the first step on a development pathway that offers enhanced access to regulators and development tools that could accelerate the timeline for achieving U.K. regulatory approval.
INO-3107 received an Advanced Therapy Medicinal Product (ATMP) Certification from the European Medicines Agency’s Committee for Advanced Therapies (CAT) after review of chemistry, manufacturing and controls (CMC) and nonclinical data. This certification confirms that the data reviewed complies with the standards that would be used to evaluate a European marketing-authorization application.
Immunology data for INO-3107 has been accepted at the following fourth quarter conferences:
Fall Voice, a leading conference for clinicians focused on vocal disorders
36th International Papillomavirus Conference,a platform for sharing cutting-edge international HPV research
International Society for Vaccines Annual Congress
INO-3112 – Oropharyngeal Squamous Cell Carcinoma (OPSCC)

INOVIO submitted its Phase 3 trial design for INO-3112 to European regulatory authorities. The proposed multi-center Phase 3 trial will investigate INO-3112 in combination with LOQTORZI as a potential treatment for oropharyngeal squamous cell carcinoma (OPSCC). INOVIO plans to conduct the trial in Europe and North America. INOVIO received positive feedback on this study protocol from the FDA in the first quarter of 2024. The manufacturing issue with the single use disposable administration component of the device that is impacting INO-3107 will also need to be resolved before we can commence the Phase 3 trial with INO-3112.
The combination of INO-3112 with LOQTORZI has the potential to address a substantial unmet need in patients with HPV-16 and -18 related high-risk throat cancer. The Phase 3 study will investigate whether LOQTORZI can help amplify the tumor-infiltrating abilities of the antigen-specific T cells generated by INO-3112. INO-3112 is a DNA medicine candidate containing a DNA plasmid encoding HPV-16/-18 E6 and E7 antigens combined with another DNA plasmid encoding IL-12 as an immune activator. LOQTORZI is an FDA-approved PD-1 inhibitor approved for the treatment of recurrent locally advanced/metastatic nasopharyngeal carcinoma.
INO-4201 for Ebola

INOVIO anticipates submitting its revised protocol to the FDA for a Phase 2/3 clinical trial with INO-4201 as a heterologous boost to the FDA licensed Ebola vaccine, Ervebo, in the third quarter. INOVIO previously announced positive results from a Phase 1b clinical trial evaluating INO-4201 as a booster in healthy adult participants who previously received a single injection of Ervebo. In the trial, INO-4201 was well-tolerated and boosted humoral responses in 100% (36 of 36) of treated participants.
Operational and Financial Updates

INOVIO appointed Steve Egge as Chief Commercial Officer to lead the company’s commercial strategy and operations as it prepares to launch INO-3107. Mr. Egge has extensive experience in many different therapeutic areas, including immunology and vaccines, HPV, and rare disease. Mr. Egge spent 20 years at Merck, where he held a number of different commercial leadership roles, including leading Merck’s HPV Vaccines Franchise and serving as Chief Marketing Officer for the Vaccine Division. Over the course of his career, he has overseen or contributed to more than 13 commercial product launches. INOVIO welcomes his expertise, particularly in creating and growing new therapeutic areas as well as driving market share in competitive markets.
INOVIO strengthened its balance sheet with an offering of common stock and pre-funded warrants in April 2024; net proceeds from the offering, after deducting underwriting discounts and commissions and offering expenses, were $33.2 million.
Second Quarter 2024 Financial Results

Cash, Cash Equivalents and Short-term Investments: As of June 30, 2024, cash, cash equivalents and short-term investments were $110.4 million compared to $145.3 million as of December 31, 2023.
Research and Development (R&D) Expenses: R&D expenses for the three months ended June 30, 2024, were $23.1 million compared to $23.7 million for the same period in 2023. The slight decrease in R&D expenses was primarily the result of overall lower drug manufacturing costs and lower employee and consultant compensation, including non-cash stock-based compensation, among other variances.
General and Administrative (G&A) Expenses: G&A expenses were $10.2 million for the three months ended June 30, 2024 compared to $13.5 million for the same period in 2023. The decrease in G&A expenses was primarily related to a decrease in employee compensation, including non-cash employee and consultant stock-based compensation, and a decrease in legal expenses, among other variances.
Total Operating Expenses: Total operating expenses were $33.3 million for the three months ended June 30, 2024, compared to $37.3 million for the same period in 2023.
Net Loss: INOVIO’s net loss for the three months ended June 30, 2024 was $32.2 million, or $1.19 per basic and diluted share, compared to net loss of $35.5 million, or $1.61 per basic and diluted share, for the three months ended June 30, 2023.
Shares Outstanding: As of June 30, 2024, INOVIO had 26.0 million common shares outstanding, 2.1 million pre-funded warrants outstanding, and 29.9 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting, and conversion, as applicable, of its outstanding pre-funded warrants, options, restricted stock units and convertible preferred stock.
INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s quarterly report on Form 10-Q for the quarter ended June 30, 2024, which can be accessed at: View Source

Cash Guidance

INOVIO estimates its cash runway to extend into the third quarter of 2025. This projection includes an operational net cash burn estimate of approximately $28 million for the third quarter of 2024. These cash runway projections do not include any further capital-raising activities that INOVIO may undertake.

Conference Call / Webcast Information

INOVIO’s management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO’s financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

On August 8, 2024 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for solid and hematologic cancers, reported financial results for the second quarter ended June 30, 2024 and recent corporate highlights (Press release, In8bio, AUG 8, 2024, View Source [SID1234645605]).

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"Gamma-delta T cell therapies have the potential to revolutionize cancer treatment," said William Ho, CEO and co-founder of IN8bio. "In the second quarter of 2024, our team presented industry-leading data demonstrating that our gamma-delta T cell therapeutic approach in INB-100 and INB-200 can drive durable complete remissions compared to the current standard-of-care in certain aggressive cancers like GBM and AML, where patients have typically faced poor outcomes. This novel approach that leverages gamma-delta T cells seeks to target residual tumors, including chemo-resistant and cancerous stem cells that often result in relapse. We look forward to providing additional updates on our gamma-delta T cell programs as we generate longer patient follow-up and advance our pipeline."

Corporate Highlights and Recent Developments

Presented data at EHA (Free EHA Whitepaper) 2024, showing 100% of treated patients with leukemia (n=10/10) in the Phase 1 trial of INB-100 remained progression-free for at least one year, including high-risk and relapsed AML and one with acute lymphocytic leukemia (ALL) who had previously failed multiple lines of therapy, including CAR-T.
Data continue to show long-term in vivo expansion and persistence of haplo-matched allogeneic gamma-delta T cells 365 days following a single administration post-transplant, demonstrating the first-ever durable persistence and in vivo expansion of an allogeneic cellular therapy.
As of May 31, 2024, two of the patients treated with INB-100 remain alive and relapse free for over three and a half years, and a third patient is nearing three years.
Poster presentation at ASCO (Free ASCO Whitepaper) 2024 demonstrated that 92% of evaluable patients treated with INB-200 exceeded a median PFS of seven months with concomitant temozolomide (TMZ), as of a data cutoff date of May 30, 2024.
The survival data along with radiographic improvements are indicative of positive treatment effects, which highlight the potential of IN8bio’s genetically modified, chemotherapy-resistant gamma-delta T cells as a potential first-in-class therapy for patients with newly diagnosed GBM to extend PFS.
The safety profile of gamma-delta T cells continues to be strong across all three dose cohorts with no cell therapy-related toxicities such as immune effector cell-associated neurotoxicity syndrome or cytokine release syndrome reported in any patients across both Phase 1 trials to date (up to the maximum dose of six infusions of therapy).
Multiple presentations at the International Society for Cell & Gene Therapy (ISCT) 2024 demonstrated how IN8bio’s manufacturing process influences product characteristics and the ability to generate a robust, activated and reproducible final product.
DeltEx gamma-delta T cell manufacturing platform has enabled the development of multiple investigational candidates which are now moving into multi-center Phase 2 clinical trials and are designed to target and potentially eradicate cancer cells to help improve patient outcomes.
The cellular characteristics of products from the company’s proprietary clinical-scale gamma-delta T cell manufacturing platform were shown across different donor populations at the ASGCT (Free ASGCT Whitepaper) 2024 Annual Meeting.
Data demonstrated that the manufacturing process results in investigational products with upregulated markers of potency, effector functions and trafficking capabilities, which IN8bio believes represents a significant advancement in the characterization of gamma-delta T cell-based therapies.
Second Quarter 2024 Financial Highlights

Research and Development (R&D) expenses: R&D expenses were $5.2 million, compared to $4.1 million for the comparable prior year period. The increase was primarily due to a $0.5 million increase in personnel-related costs, including salaries and non-cash stock-based compensation due to increased headcount. Direct clinical costs increased by $0.5 million due to increased enrollment costs for our clinical programs, partially offset by a decrease of $0.1 million in facilities costs.
General and administrative expenses: General and administrative expenses remained flat at $3.5 million, compared to $3.6 million for the comparable prior year period.
Net loss: Net loss was $8.6 million, or $0.19 per basic and diluted common share, compared to a net loss of $7.7 million, or $0.27 per basic and diluted common share, for the comparable prior year period.
Cash position: As of June 30, 2024, the Company had cash of $10.2 million, compared to $21.3 million, as of December 31, 2023.

On August 8, 2024 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported its financial results for the second quarter ended June 30, 2024 and provided a business update (Press release, Immunocore, AUG 8, 2024, View Source [SID1234645604]).

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"Over the next 18 months, we will present multiple data read-outs including brenetafusp and the HIV MAD data, while progressing three Phase 3 trials, with registrational data expected in 2026, 2027 and 2028. We will also advance our new autoimmune and oncology clinical and pre-clinical programs," said Bahija Jallal, Chief Executive Officer of Immunocore.

"In the first half of 2024, we expanded KIMMTRAK’s reach in the US community setting and globally with 9 new launches and 2 additional reimbursement agreements, in the context of a challenging market access environment in Europe," said Ralph Torbay, Immunocore’s Chief Commercial Officer. "We are exploring the potential of KIMMTRAK to benefit more patients and deliver revenue growth beyond metastatic uveal melanoma with our two ongoing Phase 3 registrational trials in previously treated cutaneous melanoma and in adjuvant uveal melanoma."

Second Quarter 2024 Highlights (including post-period)

KIMMTRAK
The Company’s lead product, KIMMTRAK, is approved in 38 countries and has been launched in 19 countries globally to date for HLA-A*02:01 positive patients with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK continues to be the standard of care in most markets where it is launched. The Company sees three key growth areas for the KIMMTRAK opportunity, including: continued global expansion in mUM, as well as the potential expansion into 2L+ advanced cutaneous melanoma (CM) and adjuvant uveal melanoma.

Metastatic uveal melanoma

In Q2 2024, KIMMTRAK net product sales were $75 million and $146 million for the three and six months ended June 30, respectively, representing increases of 32% and 34% respectively, compared to the prior year periods.
US growth driven by increased penetration in community setting and duration of treatment.
As of July 1, 2024, KIMMTRAK is launched in 19 countries. Reimbursement agreements reached in Sweden and Poland with expected launches in second half of 2024.
Published data at ASCO (Free ASCO Whitepaper) 2024 demonstrating that KIMMTRAK-treated mUM patients with stable disease and any confirmed tumor reduction have similar clinical outcomes to patients with RECIST partial response.
New T cell fitness insights from the Phase 2 KIMMTRAK trial in previously treated uveal melanoma will be an oral presentation during the "Basic Science & Translational Research" proffered session at the 2024 ESMO (Free ESMO Whitepaper) Congress.

2L + Previously treated cutaneous melanoma

Converted Phase 2/3 TEBE-AM trial into registrational Phase 3 trial, which will continue three arms: KIMMTRAK monotherapy, KIMMTRAK in combination with pembrolizumab, and control.
Over 120 patients already randomized into the original Phase 2 portion will now be included in the Phase 3 trial, which we expect will accelerate time to final endpoint by up to 12 months.
Expect enrollment to be completed in the first half of 2026.

Adjuvant uveal (or ocular) melanoma

Randomization in the ATOM Phase 3 trial, led by the European Organisation for Research and Treatment of Cancer (EORTC), expected to start in the second half of 2024.

PRAME franchise
Brenetafusp (IMC-F106C) is the Company’s lead PRAME-A02 ImmTAC bispecific candidate. Brenetafusp is being evaluated in combination with nivolumab, in a Phase 3 registrational trial (PRISM-MEL-301) in patients with first-line advanced cutaneous melanoma (CM) and in a Phase 1/2 clinical trial, as monotherapy and in combination, across multiple tumor types, including platinum resistant ovarian, non-small cell lung (NSCLC), and endometrial carcinoma.

PRISM-MEL-301 – First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced or metastatic HLA-A*02:01 positive cutaneous melanoma

In 2Q, the Company randomized the first patient in PRISM-MEL-301.
Trial is evaluating brenetafusp + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab.
Phase 1/2 clinical trial of brenetafusp (PRAME-A02) in multiple solid tumors

Presented data at ASCO (Free ASCO Whitepaper) 2024 from the Phase 1/2 trial with brenetafusp in patients with late-line CM showing promising brenetafusp monotherapy disease control (partial response and stable disease), progression free survival (PFS), and circulating tumor DNA (ctDNA) molecular response. In PRAME positive patients, the disease control rate was 58% and median PFS was 4.2 months. Brenetafusp was well tolerated as monotherapy and in combination with anti-PD1.
Clinical data from monotherapy and chemotherapy combinations in heavily pre-treated platinum-resistant high grade serous ovarian cancer will be presented as a poster at ESMO (Free ESMO Whitepaper) 2024 (Phase 1 safety and efficacy of brenetafusp, a PRAME × CD3 ImmTAC T cell engager, in platinum resistant ovarian cancer (PROC), Poster 750P). The next step is to further evaluate brenetafusp in combination with non-platinum chemotherapies in platinum resistant disease and to test the combination with platinum chemotherapy and with bevacizumab in platinum sensitive disease.
The Company plans to present clinical data for brenetafusp in late-line non-small cell lung cancer (NSCLC) in the fourth quarter of 2024. The next step is to evaluate brenetafusp in combinations with docetaxel and with osimertinib in earlier-line NSCLC.
IMC-P115C (PRAME-A02 Half-Life Extended) & IMC-T119C (PRAME-A24)

Submitted Clinical Trial Application (CTA) for IMC-P115C in the second quarter of 2024, which is currently under review.
Remain on track for regulatory submission of Investigational New Drug (IND) or Clinical Trial Application (CTA) for IMC-T119C in the fourth quarter of 2024.
Additional Oncology Candidates

IMC-R117C (first PIWIL1-A02 targeted immunotherapy) for colorectal and other gastrointestinal cancers
The Company has leveraged its proprietary peptidomic database to validate a novel target, PIWIL1. PIWIL1 is a negative prognostic marker and is expressed across a range of tumors including colorectal, which is historically insensitive to immune checkpoints, as well as gastro-esophageal, and pancreatic cancer.

The CTA for IMC-R117C was accepted in April 2024 by the EMA, and the Phase 1 clinical trial is expected to start in the second half of 2024.
ImmTAV Candidates for a Functional Cure in Infectious Diseases
The Company’s bispecific TCR technology platform has potential to offer a new approach for the treatment of chronic infections and aims to eliminate evidence of remaining virus in circulation after the patient stops taking medication – known as a "functional cure". Two investigational candidates are in Phase 1 clinical trials for people living with human immunodeficiency virus (HIV) and people with chronic Hepatitis B infection (HBV).

Phase 1 trial of IMC-M113V (Gag-A02) for people living with HIV

The objective of the clinical trial is to identify a safe and tolerable dose and evaluate whether IMC-M113V could lead to reduction in the viral reservoir and, after stopping antiretroviral therapies (ART) and IMC-M113V, delay or prevent HIV rebound.
Historically, viral rebound occurs rapidly after ART interruption at a median of 2 weeks, and approximately 98% of people will have >200 viral copies/ml (the threshold for transmission) by week 8 (Feher C et. al, 2019).
In the MAD portion, the Company has enrolled 3 cohorts with 5 people living with HIV (PLWH) per cohort. The highest tested dose is 300 mcg.
A biologically active dose has been reached and the Company plans to enroll more PLWH to characterize anti-viral activity and to explore higher doses. This will move the planned data release from fourth quarter of 2024 into first quarter of 2025.
Phase 1 trial of IMC-I109V (Envelope-A02) for people living with HBV or HBV-positive hepatocellular carcinoma

Patient enrollment continues into the single ascending dose portion of the clinical trial.
Tissue-specific Down Modulation of the Immune System for Autoimmune Diseases
The Company is expanding its platform into autoimmune diseases with two new, first-in-class bispecific candidates recently entering its pipeline. The key differentiator of the Company’s ImmTAAI (Immune Modulating Monoclonal TCRs Against AutoImmune disease) platform is tissue-specific down modulation of the immune system whereby, when tethered to the tissue of interest, the new candidates suppress pathogenic T cells via PD1 receptor agonism.

IMC-S118AI (pre-pro insulin A02 x PD1), intended for disease-modifying treatment in type 1 diabetes

IMC-S118AI recognizes a peptide from pre-proinsulin presented by HLA-A02 on beta cells, coupled with a PD1 agonist effector arm.
IMC-S118AI is advancing towards GMP manufacturing in 2024.
Undisclosed non-HLA restricted (universal) candidate for inflammatory dermatological diseases

The candidate is an antigen presenting cell (APC) tethered ImmTAAI and is not HLA restricted (i.e. universal for all populations).
ESMO Congress 2024 – Presentation and poster details

Title: Phase 1 safety and efficacy of brenetafusp, a PRAME × CD3 ImmTAC T cell engager, in platinum resistant ovarian cancer (PROC) (Poster 750P)
Presenting author: Claire F. Friedman
Session: Poster Session – Gynaecological cancers, Saturday 14 September 2024; 09:00 a.m. – 5:00 p.m. CEST / 04:00 a.m. – 12:00 p.m. ET

Title: Chemotherapy and hypomethylating agents enhance anti-tumor activity of PRAME ImmTAC
Presenting author: Adel Benlahrech
Session: Poster Session – Investigational immunotherapy, Saturday 14 September 2024; 09:00 a.m. – 5:00 p.m. CEST / 04:00 a.m. – 12:00 p.m. ET (Poster 1021P)

Title: Association of a blood T cell fitness gene signature with clinical benefit from ImmTAC bispecific T cell engagers (Oral 66O)
Presenting author: Joseph Sacco
Session: Proffered paper session 2 – Basic Science and Translational Research, Monday 16 September 2024; 02:45-04:15 p.m. CEST / 09:45-11:15 a.m. ET

Financial Results
For the second quarter ended June 30, 2024, the Company generated net product sales of $75.3 million compared to $56.9 million for the same period in 2023. This increase was due to revenue from KIMMTRAK, of which $55.6 million was in the United States, $15.4 million (net of an increase in estimated reserves related to prior periods of $6.7 million) in Europe, and $4.3 million in international regions. The increase in net product sales was due primarily to increased volume in the United States and global country expansion, as the Company continued its commercialization efforts.

For the second quarter ended June 30, 2024, research and development (R&D) expenses were $51.1 million, compared to $38.2 million for the same period in 2023. This increase was primarily driven by expenses incurred for the PRAME programs, including the initiation of the Company’s Phase 3 clinical trial.

For the quarter ended June 30, 2024, SG&A expenses were $38.6 million, compared to $35.0 million for the same period in 2023. This increase was primarily related to additional employees engaged in business support functions, including medical and regulatory activities, to support our growing pipeline and commercial activities.

Basic and diluted loss per share was $0.23 for the quarter ended June 30, 2024, as compared to a basic and diluted loss per share of $0.35 for the same period in 2023. Net loss for the quarter ended June 30, 2024 was $11.6 million, as compared to $17.0 million for the same period in 2023.

Cash, cash equivalents, and marketable securities at June 30, 2024 were $859.6 million. The Company plans to use $50 million to repay its existing loan by the end of 2024, and also expects to pay approximately $40 million in sales-related rebate accruals in the second half of 2024.

About ImmTAC molecules for cancer

Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumors.

About ImmTAV molecules and infectious diseases

ImmTAV (Immune mobilizing monoclonal TCRs Against Virus) molecules are novel bispecifics that are designed to enable the immune system to recognize and eliminate virally infected cells. Immunocore is advancing clinical candidates to achieve functional cure for patients with HIV and hepatitis B virus (HBV). The Company aims to achieve sustained control of HIV after patients stop anti-retroviral therapy (ART), without the risk of virological relapse or onward transmission. This is known as ‘functional cure’. For the treatment of HBV, the Company aims to achieve sustained loss of circulating viral antigens and markers of viral replication after stopping medication for people living with chronic HBV.

About ImmTAAITM molecules and autoimmune diseases

ImmTAAI (Immune mobilizing monoclonal TCRs Against AutoImmune disease) molecules are novel bispecifics that are designed for tissue-specific down modulation of the immune system. When tethered to the tissue of interest, ImmTAAI candidates suppress pathogenic T cells via PD1 receptor agonism. The Company is currently advancing two candidates for autoimmune diseases, including type 1 diabetes and inflammatory dermatological diseases.

About PRISM-MEL-301 (NCT06112314) – Phase 3 trial with brenetafusp (IMC-F106C, PRAME-A02) in 1L advanced cutaneous melanoma

The Phase 3 registrational trial is randomizing HLA-A*02:01-positive patients with previously untreated advanced melanoma to brenetafusp + nivolumab versus nivolumab or nivolumab + relatlimab, depending on the country where the patient is enrolled. The trial will initially randomize to three arms: two brenetafusp dose regimens (40 mcg and 160 mcg) and a control arm. One of the two brenetafusp dose regimens will be discontinued after an initial review of the first 60 patients randomized to the two experimental arms (90 patients randomized total). The primary endpoint of the trial is progression free survival (PFS) by blinded independent central review (BICR), with secondary endpoints of overall survival (OS) and overall response rate (ORR).

About the IMC-F106C-101 Phase 1/2 trial

IMC-F106C-101 is a first-in-human, Phase 1/2 dose escalation trial in patients with multiple solid tumors, including non-small cell lung cancer (NSCLC), small-cell lung cancer (SCLC), endometrial, ovarian, cutaneous melanoma, and breast cancers. The Phase 1 dose escalation trial was designed to determine the maximum tolerated dose (MTD), as well as to evaluate the safety, preliminary anti-tumor activity and pharmacokinetics of IMC-F106C (brenetafusp), a bispecific protein built on Immunocore’s ImmTAC technology, and the Company’s first molecule to target the PRAME antigen. The Company is enrolling patients into three expansion arms in NSCLC, as well as ovarian and endometrial carcinomas. The IMC-F106C-101 trial is adaptive and includes the option for Phase 2 expansion, allowing for approximately 100 patients treated per tumor type in the Phase 1 and 2 expansion arms. Dose escalation continues in additional solid tumors as well as plans for combination arms with standards-of-care, including checkpoint inhibitors, chemotherapy, and tebentafusp.

About TEBE-AM – Phase 3 registrational trial with tebentafusp in previously treated advanced cutaneous melanoma

The trial is randomizing patients with second-line or later advanced cutaneous melanoma who have progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a BRAF kinase inhibitor. Patients are randomized to one of three arms, including tebentafusp – as monotherapy or in combination with an anti-PD1 – or a control arm. The primary endpoint is overall survival.

About the ATOM Phase 3 trial

The EORTC-led Phase 3 clinical trial will include sites in 10 EU countries and the United States and will randomize HLA-A*02:01-positive patients with high-risk primary uveal melanoma after definitive treatment, by surgery or radiotherapy, and no evidence of metastatic disease on imaging. The trial is expected to enroll a total of 290 patients who will be randomized 1:1 to one of two arms: tebentafusp as monotherapy or observation. The primary endpoint of the trial is relapse-free survival (RFS), with secondary objectives of overall survival and safety and tolerability of tebentafusp. Exploratory objectives include comparison of health-related quality of life between the treatment arms and evaluation of the role of circulating tumor DNA (ctDNA) as a biomarker for the presence of residual disease.

About Uveal Melanoma

Uveal melanoma is a rare and aggressive form of melanoma affecting the eye. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, and up to 50% of people with uveal melanoma will eventually develop metastatic disease. Unresectable or metastatic uveal melanoma typically has a poor prognosis and had no approved treatment until KIMMTRAK.

About Cutaneous Melanoma

Cutaneous melanoma (CM) is the most common form of melanoma. It is the most aggressive skin carcinoma and is associated with the vast majority of skin cancer-related mortality. The majority of patients with CM are diagnosed before metastasis but survival remains poor for the large proportion of patients with metastatic disease. Despite recent progress in advanced melanoma therapy, there is still an unmet need for new therapies that improve first-line response rates and duration of response as well as for patients who are refractory to first-line treatments.

About KIMMTRAK

KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform, designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.

IMPORTANT SAFETY INFORMATION

Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK, with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS.

Skin Reactions

Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions.

Elevated Liver Enzymes

Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity.

Embryo-Fetal Toxicity

KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose.

The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.

For more information, please see full Summary of Product Characteristics (SmPC) or full U.S. Prescribing Information (including BOXED WARNING for CRS).

About KIMMTRAKConnect

Immunocore is committed to helping patients who need KIMMTRAK obtain access via our KIMMTRAKConnect program. The program provides services with dedicated nurse case managers who provide personalized support, including educational resources, financial assistance, and site of care coordination. To learn more, visit KIMMTRAKConnect.com or call 844-775-2273.

On August 8, 2024 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and recent business highlights for the second quarter of 2024 (Press release, Hookipa Biotech, AUG 8, 2024, View Source [SID1234645602]).

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"It is an honor to be appointed CEO of HOOKIPA at such an important time for the Company. I am optimistic about the Company’s prospects, based on the strength of the pipeline, early clinical data, and the experience and dedication of the accomplished team we have in place," said Malte Peters, Chief Executive Officer of HOOKIPA. "Our best-in-class Phase 2 data that were presented at ASCO (Free ASCO Whitepaper) has generated significant momentum among investigators and this has enhanced the pace of enrollment in our ongoing Phase 2 study. In the meantime, preparations are well underway for our AVALON-1 pivotal adaptive Phase 2/3 trial of eseba-vec, expected to be initiated in the fourth quarter of this year."

"We have important work ahead of us in the second half of this year," added Terry Coelho, Executive Vice President and Chief Financial Officer of HOOKIPA. "We are keenly focused on clinical execution and operational excellence, and I look forward to working closely with Malte to explore opportunities to ensure that we are sufficiently capitalized to reach these goals."

Anticipated Catalysts

Oncology

Eseba-vec (HPV16+ OPSCC): AVALON-1 pivotal study start (Q4 2024)
HB-700 (KRAS): Partnering and collaborations under evaluation
Infectious Disease: Partnered with Gilead

HB-400 (HBV): Complete Phase 1b enrollment and initiate Phase 2 study (timing to be determined by Gilead)
HBV-500 (HIV): Actively enrolling Phase 1b trial
Business Highlights and Recent Developments

Oncology

Eseba-vec: HOOKIPA is on track to start a seamless pivotal Phase 2/3 trial of eseba-vec in combination with pembrolizumab for the treatment of patients with Human Papillomavirus 16-positive (HPV16+) recurrent/metastatic PD-L1 CPS ≥ 20 OPSCC in the first line setting.
The AVALON-1 Phase 2/3 trial design and protocol has been aligned with the FDA with a path to potential accelerated approval.
The Company anticipates the trial will start in the fourth quarter of 2024.
Updated data from a Phase 2 trial of eseba-vec in combination with pembrolizumab were reported at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting. The data strongly validate the Company’s clinical development plan.
HB-700: The HB-700 program is a novel arenaviral immunotherapy for KRAS-mutated cancers, including the five mutations that are the primary causes of lung, pancreatic and colon cancers. The Company received clearance from the FDA for its IND application for HB-700 for the treatment of KRAS-mutated cancers. Effective April 25, 2024, HOOKIPA regained full control of the associated intellectual property portfolio and has full collaboration and licensing rights for this program.
Preclinical data published at the ASCO (Free ASCO Whitepaper) 2024 Annual Meeting demonstrated that HB-700 was well tolerated and induced KRAS mutation specific T cell responses in HLA transgenic mice.
Infectious Disease

HB-400: HB-400 is an investigational therapeutic vaccine for the treatment of chronic hepatitis B (HBV) and is currently being evaluated in a Phase 1 trial. HB-400 is one of two independent development programs in HOOKIPA’s collaboration and license agreement with Gilead. Gilead is solely responsible for further development and commercialization of the HBV product candidate.
HB-500: HB-500 is an investigational therapeutic vaccine for the treatment of HIV, also partnered with Gilead. On July 1, 2024, HOOKIPA dosed the first eligible person living with HIV in the Phase 1b clinical trial of HB-500.
Under the collaboration agreement with Gilead, HOOKIPA received a $5 million milestone payment associated with the first dosing for this trial.
HOOKIPA and Gilead also published two peer-reviewed preclinical research papers on HB-500 during the quarter:
In articles published in the Journal of Virology, and Vaccines, research demonstrated robust immunogenicity in non-human primates driven by administration of HB-500. The research also demonstrated the potential of immunogenicity of HB-500 to be enhanced when combined with a Flt3L-Fc fusion protein.
These findings show the potential that HB-500 can be a critical component of a curative treatment for HIV.
Corporate and Financial Updates

Corporate Highlights

Reverse Split: On July 9, 2024, the Company effected a reverse stock split of the outstanding shares of its common stock on a one-for-ten (1:10) basis. The reverse stock split is part of the Company’s plan to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market.
New Leadership Team: On July 22, 2024, the Board of Directors appointed Malte Peters, M.D., as Chief Executive Officer and Terry Coelho as Executive Vice President and Chief Financial Officer to lead the Company through its next phase of development and realize the significant opportunity eseba-vec represents.
Board Appointment: Sean A. Cassidy was appointed to the Board of Directors on July 22, 2024, and will serve as the chair of the Audit Committee and member of the Compensation Committee.
Financial Highlights

Roche: In April, HOOKIPA received a final $10.0 million milestone payment under its now-terminated HB-700 collaboration agreement with Roche. The success-based milestone payment was achieved in connection with HOOKIPA’s submission of an IND application for HB-700 for the treatment of KRAS mutated tumors.
Gilead: In July, HOOKIPA received a $5.0 million milestone payment under its collaboration and license agreement with Gilead. The success-based milestone payment was achieved in connection with the dosing of the first person in a Phase 1b clinical trial of HB-500 for the treatment of HIV.
Second Quarter 2024 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of June 30, 2024 was $77.4 million compared to $117.5 million as of December 31, 2023. The decrease was primarily attributable to cash used in operating activities.

Revenue: Revenue was $1.3 million for the three months ended June 30, 2024, compared to $2.7 million for the same period in 2023. The decrease was primarily due to lower partial recognition of the upfront and milestone payments under the Roche collaboration as a result of the termination of the collaboration agreement with Roche.

Research and Development Expenses: HOOKIPA’s research and development expenses were $19.7 million for the three months ended June 30, 2024, and June 30, 2023, respectively. The primary changes in research and development expenses were lower personnel-related and laboratory-related expenses as well as lower manufacturing expenses, offset by higher clinical study expenses for the eseba-vec program.

General and Administrative Expenses: General and administrative expenses amounted to $3.9 million for the three months ended June 30, 2024, compared to $4.4 million for the same period in 2023. The primary driver of the decrease in general and administrative expenses was a decrease in personnel-related expenses and in professional and consulting fees.

Restructuring Expenses: Restructuring expenses amounted to $0.1 million for the three months ended June 30, 2024, and resulted from severance and other personnel costs as well as consulting costs associated with the Company’s restructuring plan announced in January 2024. The restructuring plan was completed as of June 30, 2024.

Net Loss: HOOKIPA’s net loss was $19.1 million for the three months ended June 30, 2024, compared to a net loss of $18.0 million for the same period in 2023. This increase was primarily due to lower revenues resulting from lower partial recognition of the upfront and milestone payments under the terminated Roche Collaboration.

On August 8, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) reported its second quarter 2024 results of operations (Press release, Gilead Sciences, AUG 8, 2024, View Source [SID1234645601]).

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"Gilead has had another strong quarter with 6% year-over-year growth in our base business. This was driven by sales of our therapies for HIV, Oncology and Liver Disease, including 8% growth for Biktarvy," said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. "One of the key highlights of the quarter was interim data from the Phase 3 PURPOSE 1 trial showing 100% efficacy for lenacapavir in HIV prevention for cisgender women. We look forward to additional clinical readouts in the coming months, and to potentially launching seladelpar for primary biliary cholangitis in the United States."
Second Quarter 2024 Financial Results
•Total second quarter 2024 revenue increased 5% to $7.0 billion, compared to the same period in 2023, primarily due to higher product sales in HIV, Liver Disease and Oncology.
•Diluted earnings per share ("EPS") was $1.29 in the second quarter 2024, compared to $0.83 in the same period in 2023. The increase was primarily driven by lower operating expenses, including a 2023 expense of $525 million for settlements with certain plaintiffs in HIV antitrust litigation which did not repeat in 2024, as well as higher revenues and lower income tax expense, partially offset by higher net unrealized losses on equity securities.
•Non-GAAP diluted EPS was $2.01 in the second quarter 2024, compared to $1.34 in the same period in 2023. The increase was primarily driven by lower operating expenses and higher revenues.
•As of June 30, 2024, Gilead had $2.8 billion of cash, cash equivalents and marketable debt securities, compared to $8.4 billion as of December 31, 2023. The decrease primarily reflects the $3.9 billion acquisition of CymaBay Therapeutics, Inc. and a $1.75 billion repayment of senior notes.
•During the second quarter 2024, Gilead generated $1.3 billion in operating cash flow, net of a $1.2 billion transition tax payment associated with the Tax Cuts and Jobs Act of 2017.
•During the second quarter 2024, Gilead paid dividends of $972 million and repurchased $100 million of common stock.
Second Quarter 2024 Product Sales
Total second quarter 2024 product sales increased 5% to $6.9 billion, compared to the same period in 2023. Total product sales, excluding Veklury, increased 6% to $6.7 billion in the second quarter 2024, compared to the same period in 2023, primarily due to higher product sales in HIV, Liver Disease and Oncology.

August 8, 2024
2

HIV product sales increased 3% to $4.7 billion in the second quarter 2024, compared to the same period in 2023, primarily driven by higher demand across treatment and prevention, partially offset by lower average realized price due to channel mix.
•Biktarvy (bictegravir 50mg/emtricitabine 200mg ("FTC")/tenofovir alafenamide 25mg ("TAF")) sales increased 8% to $3.2 billion in the second quarter 2024, compared to the same period in 2023, primarily driven by higher demand.
•Descovy (FTC 200mg/TAF 25mg) sales decreased 6% to $485 million in the second quarter 2024, compared to the same period in 2023, primarily driven by lower average realized price due to channel mix, partially offset by higher demand.
The Liver Disease portfolio sales increased 17% to $832 million in the second quarter 2024, compared to the same period in 2023. This was primarily driven by higher average realized price due to channel mix in the United States, as well as higher demand in products for chronic hepatitis C virus ("HCV"), chronic hepatitis B virus ("HBV") and, in Europe, chronic hepatitis D virus ("HDV").
Veklury sales decreased 16% to $214 million in the second quarter 2024, compared to the same period in 2023, primarily driven by lower rates of COVID-19 related hospitalizations.
Cell Therapy product sales increased 11% to $521 million in the second quarter 2024, compared to the same period in 2023.
•Yescarta (axicabtagene ciloleucel) sales increased 9% to $414 million in the second quarter 2024, compared to the same period in 2023, primarily driven by higher demand in relapsed or refractory ("R/R") large B-cell lymphoma ("LBCL") outside the United States.
•Tecartus (brexucabtagene autoleucel) sales increased 21% to $107 million in the second quarter 2024, compared to the same period in 2023, driven by higher demand in R/R mantle cell lymphoma and R/R adult acute lymphoblastic leukemia ("ALL").
Trodelvy (sacituzumab govitecan-hziy) sales increased 23% to $320 million in the second quarter 2024, compared to the same period in 2023, primarily driven by higher demand in second-line metastatic triple negative breast cancer and pre-treated HR+/HER2- metastatic breast cancer.
Second Quarter 2024 Product Gross Margin, Operating Expenses and Effective Tax Rate
•Product gross margin was 77.7% in the second quarter 2024, compared to 78.0% in the same period in 2023. Non-GAAP product gross margin was 86.0% in the second quarter 2024, compared to 86.9% in the same period in 2023.
•Research & development ("R&D") expenses were $1.4 billion in the second quarter 2024 and in the same period in 2023. Non-GAAP R&D expenses were $1.3 billion in the second quarter 2024, compared to $1.4 billion in the same period in 2023. The changes were primarily driven by timing of clinical activities, including wind-down of studies.
•Acquired IPR&D expenses were $38 million in the second quarter 2024.
•Selling, general and administrative ("SG&A") expenses and non-GAAP SG&A expenses were $1.4 billion in the second quarter 2024, compared to $1.8 billion in the same period in 2023. The decreases in GAAP and non-GAAP SG&A expenses were primarily driven by the 2023 legal settlement expense referenced earlier which did not repeat in 2024.
•The effective tax rate ("ETR") was 21.4% in the second quarter 2024, compared to 34.6% in the same period in 2023. The decrease in ETR primarily reflects a remeasurement of certain deferred tax liabilities in the prior year and a settlement with a tax authority in the second quarter 2024. Non-GAAP ETR was 17.8% in the second quarter 2024, compared to 21.0% in the same period in 2023. The decrease in non-GAAP ETR primarily reflects a settlement with a tax authority.

August 8, 2024
3

Guidance and Outlook
For the full-year 2024, Gilead expects:
(in millions, except per share amounts)
August 8, 2024 Guidance
Low End High End Comparison to April 25, 2024 Guidance
Product sales $ 27,100 $ 27,500
Unchanged
Product sales, excluding Veklury $ 25,800 $ 26,200
Unchanged
Veklury $ 1,300 $ 1,300 Unchanged
Diluted EPS $ 0.00 $ 0.30
Previously $0.10 to $0.50
Non-GAAP diluted EPS $ 3.60 $ 3.90
Previously $3.45 to $3.85

Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2024 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below.
Key Updates Since Our Last Quarterly Release
Virology
•Presented data from the Phase 3 PURPOSE 1 trial evaluating twice-yearly subcutaneous lenacapavir for HIV prevention in cisgender women at the International AIDS Conference ("AIDS 2024"). At the interim analysis, lenacapavir demonstrated 100% efficacy with zero HIV infections and superiority to both background HIV incidence and once-daily oral Truvada (FTC 200mg and tenofovir disoproxil fumarate 300mg ("TDF")). Lenacapavir was generally well-tolerated and no new safety concerns were identified. The use of lenacapavir for PrEP is investigational.
•Highlighted long-term, five-year data for Biktarvy at AIDS 2024, demonstrating virologic suppression in Hispanic/Latine people with HIV, as well as older adults with comorbidities. Additionally, presented results from Gilead’s investigational treatment pipeline, including 48-week data from the Phase 2 portion of the Phase 2/3 ARTISTRY study of once-daily oral bictegravir plus lenacapavir, once-weekly oral agents GS-1720 and GS-4182, as well as twice-yearly lenacapavir in combination with two broadly neutralizing antibodies, teropavimab and zinlirvimab.
•Announced U.S. Food and Drug Administration ("FDA") approval of an updated label for Biktarvy to include additional data for the treatment of pregnant adults with HIV-1 with suppressed viral loads.
•Presented Phase 2b MYR201 data demonstrating potential for the investigational combination of bulevirtide 10 mg with pegylated interferon alfa-2a as finite therapy for people with chronic HDV at the European Association for the Study of the Liver ("EASL") meeting. These data were simultaneously published in the New England Journal of Medicine.
•Presented 144-week follow-up data from the Phase 3 MYR301 study at EASL that reinforced bulevirtide as an efficacious and generally well-tolerated long-term treatment option as monotherapy in adults with chronic HDV. Bulevirtide 2 mg remains the only approved treatment for HDV in the EU and is not approved in the U.S. Bulevirtide 10 mg is an investigational product and is not approved anywhere globally.
Oncology
•Announced Trodelvy did not meet the primary endpoint of improvement in overall survival ("OS") in the intention-to-treat ("ITT") population of the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer. A numerical improvement in OS favoring Trodelvy was observed, in addition to trends in improvement for select pre-specified non-alpha controlled subgroups analyses and secondary endpoints of progression-free survival and overall response rate. In the ITT population, there was a higher number of deaths due to adverse events with Trodelvy compared to single-agent chemotherapy, which were primarily observed early in treatment and related to neutropenic complications, including infection.