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GRAIL Reports Second Quarter 2024 Financial Results and Provides a Strategic Update

On August 13, 2024 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported business and financial results for the second quarter 2024 (Press release, Grail, AUG 13, 2024, View Source [SID1234645834]).

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Revenue in the second quarter was $32.0 million, representing 43% growth year over year. Net loss for the quarter, which includes amortization and impairment of acquisition-related intangible items, was $(1.6) billion. Our gross loss was $(17.9) million. Non-GAAP adjusted gross profit was $16.0 million and Non-GAAP adjusted EBITDA was $(139.4) million.1

"GRAIL completed the separation from Illumina on June 24, 2024, and we are pleased to report our quarterly results for the first time as an independent public company. In the second quarter of 2024, GRAIL continued to deliver U.S. commercial growth, and as of June 30, we have sold more than 215,000 Galleri tests. We are focused on detecting cancer early, when it can be cured, and are committed to serving Galleri patients, providing support for ordering physicians, advancing our commercial and research partnerships, and building our clinical and real-world evidence base," said Bob Ragusa, Chief Executive Officer at GRAIL. "We have an unprecedented opportunity to establish a new standard of care by adding Galleri to existing single-cancer screenings, and to establish and maintain the market leading position in multi-cancer detection."

For the three months ended June 30, 2024, as compared to the three months ended July 2, 2023, GRAIL reported:

Revenue: Total revenue, comprised of screening and development services revenue, was $32.0 million, an increase of $9.6 million or 43%.
Net loss: Net loss was $1.59 billion, an increase of $1.39 billion or 721%. Net loss includes goodwill and intangible impairment of $1.42 billion.
Gross loss: Gross loss was $(17.9) million, an improvement of $6.4 million or 26%.
Adjusted gross profit1: Adjusted gross profit was $16.0 million, an increase of $6.4 million or 66%.
Adjusted EBITDA1: Adjusted EBITDA was $(139.4) million, a decrease of $2.8 million or 2%.
Cash position: Cash and cash equivalents totaled $958.8 million as of June 30, 2024.
Recent business highlights include:

Commenced enrollment in the REACH study. The REACH study, also known as the Galleri-Medicare study, will enroll 50,000 individuals and allow for three annual screens to provide clinical validation and utility in the Medicare population, with a focus on health equity. Medicare beneficiaries are among those most at risk for cancer due to age and other risk factors, representing an important unmet need for early cancer detection.
Completed enrollment of more than 35,000 participants in the registrational PATHFINDER 2 study. The PATHFINDER 2 study is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in a population of individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States.
Completed final study visits for the registrational NHS-Galleri trial. The NHS-Galleri trial is a prospective, randomized controlled clinical utility trial of over 140,000 participants between the ages of 50-77 at the time of enrollment, each of whom provided three annual blood samples to evaluate the implementation of Galleri alongside existing NHS standard of care screenings.
Strategic update:

Following a portfolio review, we are reducing our overall spend and focusing our resources on our core multi-cancer early detection ("MCED") priorities, including progress toward completion of our registrational studies and our premarket approval application submission.

As part of this restructure, we are reducing existing headcount and planned hires for 2024 by approximately 30% and substantially decreasing investment in product programs beyond Galleri. We are also reducing the size of our commercial organization, focusing our field-based activities on the most productive provider territories and streamlining investments in our enterprise business, which includes the Company’s employer and life insurance businesses. In addition, we are making reductions in general and administrative expense to reflect the focus on our MCED opportunity. We will continue to invest in our biopharmaceutical partnerships, and are committed to working with our partners to leverage GRAIL’s proprietary methylation technology in precision oncology applications.

We expect these cost reductions to extend our existing cash runway from the second half of 2026 into 2028. As a result, we anticipate reducing our burn in 2025 to $325 million. In 2024, we expect $27 million in savings, net of anticipated severance and benefits costs.

Conference Call and Webcast
A webcast and conference call will be held today, Aug. 13, 2024, at 1:30 p.m. PT / 4:30 p.m. ET. Individuals interested in listening to the conference call may access it on the investor relations section of GRAIL’s website at investors.grail.com.

A replay of the webcast will be available on GRAIL’s website for 30 days.

TC BioPharm Announces Pricing of $2.0 Registered Direct Offering

On August 13, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported it has entered into definitive agreement for the purchase and sale of 2,000,000 shares of its American Depository Shares and Pre-Funded Warrants at an offering price of $1 per share in a registered direct offering and an additional 2,000,000 cash exercise only Series G warrants with an exercise price of £0.78 with a single investor (Press release, TC Biopharm, AUG 13, 2024, View Source [SID1234645833]).

The gross proceeds to the Company from the offering are expected to be $2.0 million.

The Company intends to use the net proceeds from this offering to support its upcoming clinical trial focusing on relapse/refractory Acute Myeloid Leukemia, and for continuing operating expenses and working capital. A final prospectus supplement containing additional information relating to the offering, will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the offering, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Inhibrx Biosciences Reports Second Quarter 2024 Financial Results and Recent Corporate Highlights

On August 13, 2024 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx Biosciences" or the "Company"), a biopharmaceutical company with two programs in ongoing clinical trials and a strong emerging pipeline, reported financial results for the second quarter of 2024 and provided an update on recent corporate highlights (Press release, Inhibrx, AUG 13, 2024, https://www.prnewswire.com/news-releases/inhibrx-biosciences-reports-second-quarter-2024-financial-results-and-recent-corporate-highlights-302221636.html [SID1234645832]).

Separation from the Former Parent

In January 2024, Inhibrx, Inc. (the "Former Parent") announced its intent, as approved by its board of directors, to effect the spin-off of INBRX-101, an optimized, recombinant alpha-1 antitrypsin ("AAT"), augmentation therapy currently in a registrational trial for the treatment of patients with alpha-1 antitrypsin deficiency.

On May 30, 2024, the Former Parent completed the transaction, pursuant to which (i) all assets and liabilities primarily related to INBRX-101 (the "101 Business"), were transferred to Aventis Inc. (the "Acquirer"), a wholly-owned subsidiary of Sanofi S.A. ("Sanofi"); and (ii) by way of a pre-closing reorganization (the "Separation"), the Company acquired the assets and liabilities and corporate infrastructure associated with its ongoing programs, INBRX-106 and ozekibart (INBRX-109), and its discovery pipeline, as well as the remaining close-out obligations related to its previously terminated program, INBRX-105.

Upon the closing, each Former Parent stockholder received: (i) $30.00 per share in cash, (ii) one contingent value right per share, representing the right to receive a contingent payment of $5.00 in cash upon the achievement of a regulatory milestone, and (iii) one SEC-registered, publicly listed, share of Inhibrx Biosciences for every four shares of the Former Parent’s common stock held. The Former Parent retained an equity interest in Inhibrx Biosciences of 8% upon the distribution of shares to the Former Parent stockholders (the "Distribution").

In connection with the Separation, the Acquirer paid transaction consideration totaling approximately $2.2 billion in aggregate value, including the $35.00 per share consideration and the assumption of the third-party debt obligations of the Former Parent. In addition, the Acquirer assumed all assets and liabilities under contracts primarily related to INBRX-101 upon close of the transaction. The Acquirer also reimbursed the Company or paid on behalf of the Company $68.0 million in transaction costs.

From and after the closing, Inhibrx Biosciences continues to operate as a stand-alone, publicly traded company focused on its two clinical programs, ozekibart (INBRX-109) and INBRX-106. Inhibrx Biosciences continues to trade as INBX on the Nasdaq Global Market. We do not expect the results of operations directly arising from and related to the Separation and Distribution to occur in future periods.
Financial Results

Cash and Cash Equivalents. As of June 30, 2024, Inhibrx Biosciences had cash and cash equivalents of $226.9 million, compared to $255.4 million as of May 30, 2024 following the Separation from the Former Parent. The Company’s cash outflows during this period relate primarily to the distribution of consideration totaling $17.7 million, which was paid out to the Former Parent’s optionholders and remitted by the Company within ten business days of the close of the transaction in accordance with the terms of the Separation and Distribution. Other cash outflows during the period relate to the Company’s ongoing operations.

R&D Expense. Research and development expenses were $67.6 million during the second quarter of 2024, compared to $34.1 million during the second quarter of 2023. The increase in research and development expenses was primarily due to the following factors:

stock option expense recognized upon the acceleration of outstanding stock options in connection with the Separation and Distribution;

an increase in CMC expenses due to the nature of the development and manufacturing activities performed at its CDMO and CRO partners supporting the Company’s clinical and preclinical therapeutic candidates, which reflect the stage-specific needs of its programs during each period, including early and late-stage drug substance clinical manufacturing, analytical development, quality control, testing and stability studies, drug product development, scale-up, robustness studies, and selected biologics license applications-enabling activities; and

offset in part by a decrease in clinical trial expenses following the termination of the Company’s INBRX-105 program and the removal of the INBRX-101 program following the Separation.

G&A Expense. General and administrative expenses were $93.4 million during the second quarter of 2024, compared to $7.3 million during the second quarter of 2023. The increase in general and administrative expenses was primarily due to the following factors:

an increase in legal, advisory, and consulting fees incurred in connection with the Separation and Distribution;

stock option expense recognized upon the acceleration of outstanding stock options in connection with the Separation and Distribution;

an increase in pre-commercialization expenses, which was primarily related to increases in consulting services to support the Company’s commercial operations business intelligence strategies and market research expenses related to ozekibart (INBRX-109) and INBRX-101 prior to the transaction;

an increase in professional service expenses related to legal services which support the Company in its general corporate and intellectual property matters, and legal proceedings.

Other Income (Expense). Other income was $2.0 billion during the second quarter of 2024, compared to other expense of $5.7 million during the second quarter of 2023. Other income during the second quarter of 2024 consists of gains recorded in connection with the completion of the Separation and Distribution, related to (i) the consideration paid by the Acquirer for all outstanding common stock, warrants, and stock options, (ii) the extinguishment of the Company’s outstanding debt which was assumed by the Acquirer, (iii) assets and liabilities related to the 101 Business, which were assumed by the Acquirer, and (iv) transaction costs paid for by the Acquirer.

Net Income (Loss). Net income was $1.9 billion during the second quarter of 2024, or earnings per share of $127.10, basic, and $125.48, diluted, compared to a net loss of $47.1 million during the second quarter of 2023, or $4.31 per share, basic and diluted.

Immutep Announces First Participant Dosed in Phase I Study of IMP761, a First in Class Agonist LAG-3 Antibody

On August 14, 2024 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported that the first participant has been successfully dosed in the first-inhuman Phase I trial of IMP761 (Press release, Immutep, AUG 13, 2024, View Source [SID1234645831]). This first-in-class agonist LAG-3 antibody is designed to restore balance to the immune system by enhancing the "brake" function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases.

The single and multiple ascending dose, placebo-controlled, double-blind Phase I study is being conducted by the Centre for Human Drug Research (CHDR), a world-class institute in Leiden, the Netherlands, specializing in cutting-edge early-stage clinical drug research. The study aims to enrol 49 healthy volunteers, to assess safety, pharmacokinetics (PK) and pharmacodynamics (PD).

CHDR will implement its unique keyhole limpet haemocyanin (KLH) challenge model allowing for the evaluation of IMP761’s pharmacodynamic activity at the earliest stages of clinical development. Immutep anticipates the first safety data from the Phase I study to be available before end of the year with assessment of PK/PD relationships to follow in the first half of CY2025.

The immune checkpoint LAG-3 has been identified as a promising target for agonist LAG-3 immunotherapy to treat rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, among other autoimmune diseases.1,2,3 In preclinical studies, IMP761 has led to a large decrease in inflammatory cytokines and demonstrated its effectiveness in suppressing antigen-specific T cell–mediated immune responses.

About IMP761

IMP761, a first-in-class immunosuppressive LAG-3 agonist antibody, has the potential to address the root cause of many autoimmune diseases by specifically silencing autoimmune memory T cells that accumulate at disease sites and restoring balance to the immune system. As published in the Journal of Immunology, encouraging pre-clinical in vivo and in vitro studies show IMP761 inhibits peptide-induced T cell proliferation, activation of human primary T cells, and an antigen-specific delayed-type hypersensitivity (DTH) reaction. Additional preclinical data in oligoarticular juvenile idiopathic arthritis (o-JIA) published in Pediatric Research details how IMP761 led to a decrease in a broad spectrum of effector cytokines in just 48 hours. This study also showed children with o-JIA have a skewed LAG-3 metabolism and suggested they can benefit from agonistic LAG-3 activity.

Theriva™ Biologics Reports Second Quarter 2024 Operational Highlights and Financial Results

On August 13, 2024 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported financial results for the second quarter ended June 30, 2024, and provided a corporate update (Press release, Theriva Biologics, AUG 13, 2024, View Source [SID1234645830]).

"We remain on track to complete enrollment for VIRAGE, our Phase 2b trial in metastatic PDAC during the third quarter and are pleased with the FDA’s decision to grant FTD to VCN-01, highlighting the urgent need for new options to treat this deadly disease," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Our lead oncolytic virus (OV) product candidate, VCN-01 is uniquely designed for co-administration with chemotherapy and/or immunotherapy to enhance tumor access by these agents and elicit a persistent antitumor immune response. The ongoing VIRAGE trial is evaluating VCN-01 in combination with standard-of-care chemotherapy, gemcitabine/nab-paclitaxel, as a first line therapy to enable the earliest possible use in metastatic PDAC. We look forward to building upon the compelling clinical data from Phase 1 studies that underscores VCN-01’s multiple modes of action and potential to overcome historical challenges around systemic OV administration. Beyond PDAC, we continue to pursue opportunities that maximize the therapeutic potential of VCN-01. To that end, we are excited by the grant of RPDD to VCN-01 for the treatment of children with retinoblastoma. We will continue to build a portfolio of potentially improved therapeutic combinations as part of our broader strategy to address unmet needs for difficult to treat cancers. Additionally, we have taken steps to further rationalized our burn, which will allow us to extend our cash runway by an additional quarter and bring us closer to the completion and data readout of the VIRAGE trial."

Recent Program Highlights and Anticipated Milestones:

VCN-01:

Pancreatic Ductal Adenocarcinoma (PDAC):
Dosing is underway and enrollment is nearing completion for VIRAGE, the randomized, controlled, multicenter, open-label Phase 2b trial of VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy in newly diagnosed metastatic PDAC patients. The trial intends to enroll 92 evaluable patients across sites in the U.S. and Spain, and is expected to complete enrollment in the third quarter of 2024.
The U.S. FDA granted FTD to lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. Overall survival and progression free survival are the primary and key secondary endpoints respectively in the ongoing VIRAGE study. Both the FDA and EMA previously granted orphan drug designation to VCN-01 for treatment of PDAC.
Retinoblastoma:
Results from the investigator sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma were determined to be positive by the study Monitoring Committee. Discussions with key opinion leaders worldwide, as well as with regulatory agencies, are ongoing to refine our retinoblastoma clinical strategy.
The U.S. FDA granted RPDD to lead clinical candidate VCN-01 to treat pediatric patients with retinoblastoma. The FDA has previously granted orphan drug designation to VCN-01 in this indication.
If a Biologics License Application for VCN-01 for the treatment of retinoblastoma is ultimately approved by the FDA, Theriva may be eligible to receive a Priority Review Voucher that can be redeemed to receive a priority review for any subsequent marketing application, or may be sold or transferred.
SYN-004 (ribaxamase):

Dosing and safety follow-up were completed for the second cohort of the Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD).
If the Data Safety and Monitoring Committee recommends continuation of the trial, enrollment into the third cohort could commence in the second half of 2024 contingent on adequate funding.
Second Quarter Ended June 30, 2024 Financial Results

General and administrative expenses decreased to $1.5 million for the three months ended June 30, 2024, from $2.7 million for the three months ended June 30, 2023. This decrease of 45% is primarily comprised of the decrease in employee compensation costs, consulting fees, audit fees, lower director and officer insurance, and a decrease in fair value of the contingent consideration adjustment, offset by increased investor relation costs. The charge related to stock-based compensation expense was $114,000 for the three months ended June 30, 2024, compared to $106,000 for the three months ended June 30, 2023.

Research and development expenses decreased to $3.0 million for the three months ended June 30, 2024, from approximately $3.1 million for the three months ended June 30, 2023. This decrease of 6% is primarily the result of lower clinical trial expenses related to our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC and lower expenses related to our Phase 1a clinical trial of SYN-020 which has completed, offset by increased expenses to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients. We anticipate research and development expense to increase as we continue enrollment in our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, advance our VCN-01 program in retinoblastoma, expand GMP manufacturing activities for VCN-01, and continue supporting our other preclinical and discovery initiatives. The charge related to stock-based compensation expense was $58,000 for the three months ended June 30, 2024, compared to $40,000 related to stock-based compensation expense for the three months ended June 30, 2023.

During the quarter ended June 30, 2024, we experienced a sustained decline in the quoted market price of our common stock and we deemed this to be a triggering event for impairment. The Company performed an interim impairment analysis using the "Income approach" that requires significant judgments, including primarily the estimation of future development costs, the probability of success in various phases of its development programs, potential post-launch cash flows and a risk-adjusted weighted average cost of capital. We concluded that the IPR&D was not impaired as of June 30, 2024, however, goodwill with a carrying value of $5.5 million was written down to its estimated fair value of $1.5 million and an impairment charge of $4.0 million was recorded during the quarter ended June 30, 2024. The decrease in the valuation was primarily driven by an increase in the discount rate which was impacted by an increase in the company specific risk premium, and not by material changes to the clinical and administrative operations of the business.

Other income was $172,000 for the three months ended June 30, 2024 compared to other income of $377,000 for the three months ended June 30, 2023. Other income for the three months ended June 30, 2024 is primarily comprised of interest income of $173,000 and an exchange loss of $1,000. Other income for the three months ended June 30, 2023 is primarily comprised of interest income of $381,000 and exchange loss of $4,000.

Cash and cash equivalents totaled $16.6 million as of June 30, 2024, compared to $23.2 million as of December 31, 2023.