On February 8, 2024 Sana Biotechnology, Inc. (Nasdaq: SANA), a company focused on changing the possible for patients through engineered cells, reported that it has priced its underwritten upsized public offering of 17,272,728 shares of its common stock at a price to the public of $5.50 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 12,727,272 shares of common stock at a price to the public of $5.4999 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.0001 per share exercise price for each pre-funded warrant (Press release, Sana Biotechnology, FEB 8, 2024, View Source [SID1234639944]). All of the shares and pre-funded warrants are to be sold by Sana. In addition, Sana has granted the underwriters a 30-day option to purchase up to an additional 4,500,000 shares of its common stock. The gross proceeds from the offering are expected to be approximately $165.0 million before deducting underwriting discounts and commissions and other offering expenses and excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about February 12, 2024, subject to satisfaction of customary closing conditions.

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Morgan Stanley, J.P. Morgan, Goldman Sachs & Co. LLC, and BofA Securities are acting as joint book-running managers for the offering.

The offering is being made pursuant to a Registration Statement on Form S-3, including a base prospectus, previously filed with and declared effective by the SEC, and Sana has filed with the SEC a preliminary prospectus supplement and accompanying prospectus relating to the offering. A final prospectus supplement and accompanying prospectus relating to the offering will also be filed with the SEC. These documents can be accessed for free through the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014 or by email at [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; Goldman Sachs & Co. LLC, Attn: Prospectus Department, at 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; or BofA Securities, Attn: Prospectus Department, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001 or by email at [email protected].

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

On February 8, 2024 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, reported financial results for the fiscal third quarter ended December 31, 2023, and provided a business update (Press release, Replimune, FEB 8, 2024, View Source [SID1234639943]).

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"The collective data for RP1 shows that it has the potential to be a safe and effective treatment option for patients with a range of different skin cancers in various treatment settings. We plan to submit a BLA for the treatment of patients with anti-PD1 failed melanoma in 2H 2024. Subsequently, we will explore the potential for additional submissions based on the evolving data from our multiple non-melanoma skin cancer studies," said Philip Astley-Sparke, CEO of Replimune. "We are excited about the data we have seen to-date with RP2 including as monotherapy in very difficult to treat tumors. Planning is underway for a clinical trial in advanced uveal melanoma as a foundational study for establishing a rare cancer franchise. Following the decision to reprioritize our pipeline, we have extended our cash runway to fund operations into 2H 2026, leaving us well positioned to bring our lead product to market."

Program Highlights & Milestones

RP1

RP1 combined with Opdivo (nivolumab) in anti-PD1 failed melanoma
The Company presented initial data from the full population enrolled into the registration directed anti-PD1 failed melanoma cohort from the IGNYTE clinical trial in December 2023. In the full data set of 156 patients (140 patients from the registration-directed expansion cohort and 16 anti-PD1 failed cutaneous melanoma patients from the prior phase 2 cohort), had an overall response rate (ORR) of 31.4% with a complete response rate (CR) of 12% showing activity consistent with the prior snapshot of 91 patients. RP1 combined with nivolumab continues to be well-tolerated, with mainly Grade 1-2 "on target" side effects, observed.
Following a Type C meeting with the U.S. Food and Drug Administration (FDA), a confirmatory study design concept consisting of a 2-arm randomized trial with physician’s choice of treatment as a comparator arm in anti-PD1 failed melanoma patients was agreed. The FDA requested that the Phase 3 confirmatory trial be underway at the time of a BLA submission under the accelerated approval pathway. The FDA also indicated that all patients should be followed for at least 12 months and have undergone central review by RECIST v1.1. A BLA submission for RP1 in combination with nivolumab in anti-PD1 failed melanoma is planned for 2H 2024.

CERPASS clinical trial of RP1 combined with Libtayo (cemiplimab-rwlc) in CSCC
Following the initial report of the primary analysis data from the CERPASS clinical trial in December 2023, it is intended that a further analysis of the time-based endpoints of duration of response (DOR), progression free survival (PFS) and overall survival (OS) will be conducted when the data set has further matured.
RP1 in solid organ transplant recipients with skin cancers
Presented initial data from the ARTACUS clinical trial of RP1 monotherapy in solid organ transplant recipients with skin cancers at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting in November 2023. The data included 23 evaluable patients with CSCC (n=20) and MCC (n=3).
The data demonstrated an ORR of 34.8% and a CR of 21%.
RP1 monotherapy was well tolerated, and the safety profile was similar to non-immunocompromised patients with advanced skin cancers (i.e. from the IGNYTE study). No immune-mediated adverse events or evidence of allograft rejection were observed.
RP1 combined with Opdivo in anti-PD1 failed non-melanoma skin cancers (NMSC)
Recruitment remains ongoing into the cohort of patients with anti-PD1 failed NMSC. The Company provided a data from the first 30 patients with at least 6 months of follow up including patients with CSCC, Merkel cell carcinoma (MCC), basal cell carcinoma, and angiosarcoma in December 2023.
The data showed that treatment with RP1 in combination with nivolumab led to an ORR of 30% which is consistent with data from the anti-PD1 failed melanoma cohort with approximately a third of patients responding and 60% demonstrating clinical benefit. The combination of RP1 and nivolumab was well tolerated in this patient population with a safety profile consistent with the overall experience seen with this treatment regimen to date.
RP2

RP2 in second-line (2L) uveal melanoma
The Company presented positive safety and efficacy data from a cohort of metastatic uveal melanoma patients enrolled in the open-label, multicenter Phase 1 study of RP2 as a single agent and in combination with nivolumab at the 20th Annual International Society for Melanoma Research Congress on November 8, 2023.
Based on the data in this population, planning is underway for a potentially registrational clinical trial of RP2 in advanced uveal melanoma as a foundational study for establishing a rare cancer franchise.
Financial Highlights

Cash Position: As of December 31, 2023, cash, cash equivalents and short-term investments were $466.4 million, as compared to $583.4 million as of March 31, 2023. The decrease was primarily related to cash utilized in operating activities in advancing the Company’s clinical development plans.

Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of December 31, 2023, will enable the Company to fund operations into the second half of 2026.
Debt: As of December 31, 2023, the debt (net of discount) balance was $44.4 million, as compared to $28.6 million as of March 31, 2023. The increase was primarily related to the draw down of $15M in December 2023, at the time of the closing of the second amendment to the loan and security agreement with Hercules.
R&D Expenses: Research and development expenses were $42.8 million for the third quarter ended December 31, 2023, as compared to $30.3 million for the third quarter ended December 31, 2022. This increase was primarily due to increased clinical and manufacturing expenses driven by the Company’s lead programs and increased personnel expenses. Research and development expenses included $3.8 million in stock-based compensation expenses for the third quarter ended December 31, 2023.
S,G&A Expenses: Selling, general and administrative expenses were $13.7 million for the third quarter ended December 31, 2023, as compared to $11.4 million for the third quarter ended December 31, 2022. The increase was primarily driven by personnel related costs, including sales and marketing personnel associated with pre-launch planning and build of the Company’s commercial infrastructure. Selling, general and administrative expenses included $4.5 million in stock-based compensation expenses for the third quarter ended December 31, 2023.
Net Loss: Net loss was $51.1 million for the third quarter ended December 31, 2023, as compared to a net loss of $39.7 million for the third quarter ended December 31, 2022.
About RP1
RP1 is Replimune’s lead product candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2
RP2 is a derivative of RP1, Replimune’s lead product candidate that is based on a proprietary new strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP-R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.

On February 8, 2024 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its financial results for the year and final quarter of 2023 (Press release, Ipsen, FEB 8, 2024, View Source [SID1234639941]).

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Extract of consolidated results for FY 2023 and FY 20226:

FY 2023 FY 2022 % change
€m €m Actual CER1
Total Sales 3,127.5 3,025.0 3.4% 6.7%
Core Operating Income 1,001.0 1,115.4 -10.3%
Core operating margin 32.0% 36.9% -4.9% pts
Core Consolidated Net Profit 765.5 872.4 -12.3%
Core earnings per share (fully diluted) €9.15 €10.51 -13.0%
IFRS Operating Income 816.0 729.9 11.8%
IFRS operating margin 26.1% 24.1% 2.0% pts
IFRS Consolidated Net Profit 647.2 647.5 –
IFRS earnings per share (fully diluted) €7.73 €7.81 -1.0%
Free Cash Flow 710.9 817.2 -13.0%
Closing net cash 65.1 398.8 -83.7%

"Solid results in the year have provided an excellent platform for Ipsen in 2024, an exciting period in which we anticipate four launches and further opportunities to expand the pipeline", commented David Loew, Chief Executive Officer, Ipsen. "As Ipsen transforms, improving execution is supporting consistent sales growth, while the productive pipeline is yielding further encouraging results for patients.

"Our external-innovation strategy, underpinned by a strong balance sheet, continues to extend the number of potential medicines across our three therapeutic areas. Following the acquisition of Albireo in 2023 and the successful launch of Bylvay, we look forward to more milestones this year and enriching the pipeline over time through additional external-innovation transactions. I am confident that this strategy will deliver more medicines for patients and ensure the sustainable growth of Ipsen."

2023 progress

Ipsen continued to deliver successfully in 2023 on its strategy, Focus. Together. For patients and society. The growth platforms produced a further double-digit performance, with Cabometyx and Dysport up by 22.9%7 and 14.5%7, respectively. There were contributions from the new medicines, Bylvay (odevixibat), Sohonos (palovarotene) and Tazverik (tazemetostat), while Somatuline (lanreotide), continuing its gradual erosion (-10.4%7), represented only 34% of total sales (FY 2022: 40%).

The decline in the core operating margin to 32.0% (FY 2022: 36.9%) reflected enhanced investment from the acquisitions of Albireo and Epizyme, including a higher level of R&D expenses to fund the new pipeline. Ipsen ended the year with net cash of €65.1m, driven by solid free cash-flow generation of €710.9m.

In March 2023, Ipsen enriched its Rare Disease portfolio and pipeline by acquiring Albireo, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases. The primary focus of the transaction was Bylvay, a potent, once-daily, oral, non-systemic ileal bile acid transport inhibitor.

Favorable pipeline developments in 2023 included positive results from the Phase III trials of elafibranor in primary biliary cholangitis (PBC) and Cabometyx in prostate cancer, respectively. Regulatory submission acceptances were received for Onivyde in first-line pancreatic ductal adenocarcinoma
(1L PDAC), as well as for elafibranor. Sohonos and Bylvay were also granted approval during the year by the U.S. Food and Drug Administration (FDA) in fibrodysplasia ossificans progressiva (FOP) and Alagille syndrome, respectively.

2024 priorities and financial guidance
Ipsen anticipates four commercial launches in 2024, following regulatory decisions for Onivyde in 1L PDAC in the U.S (H1), elafibranor in second-line PBC in the U.S. (H1) and in the E.U. (H2), as well as odevixibat in Alagille syndrome in the E.U. (H2). Sohonos, in FOP, was recently launched in the U.S.

The Company will continue to drive benefits from its global efficiencies program, leveraging its current platform, which provide significant further investment for launches and the pipeline.

Ipsen has set the following financial guidance for FY 2024, which excludes any impact from potential late-stage external-innovation transactions:

Total-sales growth greater than 6.0%, at constant currency. Based on the average level of exchange rates in January 2024, an adverse impact on total sales of around 1% from currencies is expected
Core operating margin around 30% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities
Guidance on total sales incorporates expectations for Somatuline of further generic lanreotide products in the U.S and E.U.

Capital-markets day and mid-term financial outlook

Ipsen outlined its next phase of growth at its capital-market day, held in December 2023. Several current and potential near-term launches are set to be complemented by many pipeline milestones over the mid-term to build a strengthened and diversified business, including a combination of seven anticipated and current medicines, each with expected peak sales of at least €500m. This will be augmented by an active external-innovation strategy, designed to provide a platform to drive sustainable pipeline growth.

The Company outlined the following mid-term financial outlook8:

Total-sales average growth of at least 7% per year for the period 2023-2027 at constant exchange rates
A core operating margin in 2027 of at least 32% of total sales
Environment, Social and Governance: Generation Ipsen
Ipsen presented an ambitious sustainability roadmap at the aforementioned capital-markets day, based on Generation Ipsen, the strategy focused on four pillars: Environment, Patients, People and Governance. Good progress was made in 2023.

Ipsen is committed to science-based reductions in greenhouse-gas emissions across the entire value chain. The Company achieved a 36% reduction in Scope 1 & 2 emissions in 2023 vs the 2019 baseline. Scope 3 reductions in 2023, against the same baseline year, amounted to 29%. Ipsen has the ambition to be carbon-neutral by the end of 2025 and reach net-zero emissions by 2045.

With a key focus on patients, the Company has made progress to reduce the length of time between clinical-trial readouts and non-FDA/EMA9 regulatory submissions by 25%. In 2023, 53% of the GLT was comprised of women versus 48% in 2022, while 43% of colleagues were engaged in healthcare or environmental projects in 2023.

Finally, ISO37001 certification for anti-corruption management was renewed in the year.

Consolidated financial statements

The Board of Directors approved the consolidated financial statements on 7 February 2024. The consolidated financial statements have been audited and the Statutory Auditors’ report is in the process of being published. Ipsen’s comprehensive audited financial statements will be available in due course on ipsen.com (regulated-information section).

Conference call
A conference call and webcast for investors and analysts will begin today at 2pm CET. Participants can access the call and its details by registering here; webcast details can be found here.

On February 8, 2024 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the fourth quarter and fiscal year 2023, which include the consolidated financial results for GRAIL (Press release, Illumina, FEB 8, 2024, View Source [SID1234639940]).

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"I’m pleased that in the fourth quarter, my first full quarter with the company, Illumina delivered results ahead of our expectations, driven by NovaSeq X instrument and consumables sales," said Jacob Thaysen, Chief Executive Officer. "While our customers generally remain constrained in their purchasing, we are well-positioned for growth as market conditions improve. Illumina is focused on three key priorities to accelerate value creation: driving our top line; focusing on operational excellence, including boosting productivity, cost savings, and customer-focused innovation; and working to resolve GRAIL as quickly as possible."

Fourth quarter consolidated results
GAAP Non-GAAP (a)
Dollars in millions, except per share amounts Q4 2023 Q4 2022 Q4 2023 Q4 2022
Revenue $ 1,122 $ 1,083 $ 1,122 $ 1,083
Gross margin 60.1 % 62.1 % 64.4 % 66.6 %
Research and development ("R&D") expense $ 341 $ 346 $ 329 $ 339
Selling, general and administrative ("SG&A") expense $ 485 $ 432 $ 342 $ 351
Goodwill and intangible impairment $ 6 $ — $ — $ —
Legal contingency and settlement $ 6 $ 21 $ — $ —
Operating (loss) profit $ (164) $ (127) $ 51 $ 31
Operating margin (14.6) % (11.7) % 4.6 % 2.9 %
Tax provision (benefit) $ 8 $ (28) $ 26 $ 9
Tax rate (4.9) % 16.8 % 55.4 % 29.3 %
Net (loss) income $ (176) $ (140) $ 22 $ 22
Diluted (loss) earnings per share $ (1.11) $ (0.89) $ 0.14 $ 0.14

(a) See the tables included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.

Capital expenditures for free cash flow purposes were $51 million for Q4 2023. Cash flow provided by operations was $224 million, compared to cash flow provided by operations of $147 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $173 million for the quarter, compared to $59 million in the prior year period. Depreciation and amortization expenses were $109 million for Q4 2023. At the close of the quarter, the company held $1,054 million in cash, cash equivalents and short-term investments.

Fourth quarter segment results
Illumina has two reportable segments, Core Illumina and GRAIL.

Core Illumina
GAAP Non-GAAP (a)
Dollars in millions Q4 2023 Q4 2022 Q4 2023 Q4 2022
Revenue (b)
$ 1,097 $ 1,065 $ 1,097 $ 1,065
Gross margin (c)
63.3 % 65.9 % 64.7 % 67.3 %
R&D expense $ 260 $ 264 $ 248 $ 257
SG&A expense $ 391 $ 347 $ 259 $ 271
Goodwill and intangible impairment $ 6 $ — $ — $ —
Legal contingency and settlement $ 6 $ 21 $ — $ —
Operating profit
$ 33 $ 70 $ 203 $ 190
Operating margin 3.0 % 6.6 % 18.5 % 17.8 %

(a) See Table 3 included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.
(b) Core Illumina revenue for Q4 2023 was up 3% as compared to Q4 2022 and up 3% on a constant currency basis. Amounts for Q4 2023 and Q4 2022 both included intercompany revenue of $5 million, which is eliminated in consolidation.
(c) The year-over-year decrease in gross margin was primarily driven by the mix of lower margin strategic partnership revenue, lower instrument margins due to the NovaSeq X launch, which is typical with a new platform introduction, and increased field services and installation costs, partially offset by lower freight costs.

GRAIL
GAAP Non-GAAP (a)
In millions Q4 2023 Q4 2022 Q4 2023 Q4 2022
Revenue $ 30 $ 23 $ 30 $ 23
Gross (loss) profit $ (19) $ (26) $ 14 $ 8
R&D expense $ 84 $ 85 $ 84 $ 85
SG&A expense $ 94 $ 86 $ 83 $ 81
Operating loss $ (197) $ (197) $ (152) $ (159)

(a) See Table 3 included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.

Fiscal year 2023 consolidated results
GAAP Non-GAAP (a)
Dollars in millions, except per share amounts 2023 2022 2023 2022
Revenue $ 4,504 $ 4,584 $ 4,504 $ 4,584
Gross margin 60.9 % 64.8 % 65.3 % 68.6 %
R&D expense $ 1,354 $ 1,321 $ 1,325 $ 1,313
SG&A expense $ 1,612 $ 1,297 $ 1,367 $ 1,346
Goodwill and intangible impairment (b)
$ 827 $ 3,914 $ — $ —
Legal contingency and settlement $ 20 $ 619 $ — $ —
Operating (loss) profit $ (1,069) $ (4,179) $ 247 $ 487
Operating margin (23.7) % (91.2) % 5.5 % 10.6 %
Tax provision $ 44 $ 68 $ 98 $ 118
Tax rate (3.9) % (1.6) % 41.8 % 26.0 %
Net (loss) income $ (1,161) $ (4,404) $ 137 $ 336
Diluted (loss) earnings per share $ (7.34) $ (28.00) $ 0.86 $ 2.12

(a) See the tables included in "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.
(b) The company recognized $712 million in goodwill and $109 million in intangible asset (IPR&D) impairment related to the GRAIL segment in 2023. The goodwill impairment was primarily due to a decrease in the company’s consolidated market capitalization and a higher discount rate selected for the fair value calculation of the GRAIL reporting unit. The IPR&D impairment was primarily due to a decrease in projected cash flows and a higher discount rate selected for the fair value calculation of the GRAIL IPR&D asset. In 2022, the company recognized $3.91 billion in goodwill impairment related to the GRAIL segment.
Capital expenditures for free cash flow purposes were $195 million for fiscal year 2023. Cash flow provided by operations was $478 million, compared to $392 million in the prior year. Free cash flow (cash flow provided by operations less capital expenditures) was $283 million for the year, compared to $106 million in the prior year. Depreciation and amortization expenses were $432 million for fiscal year 2023.

Fiscal year 2023 segment results

Core Illumina
GAAP Non-GAAP (a)
In millions 2023 2022 2023 2022
Revenue (b)
$ 4,438 $ 4,553 $ 4,438 $ 4,553
Gross margin 64.4 % 68.2 % 65.8 % 69.1 %
R&D expense $ 1,030 $ 1,004 $ 1,001 $ 996
SG&A expense $ 1,248 $ 1,003 $ 1,032 $ 1,069
Goodwill and intangible impairment $ 6 $ — $ — $ —
Legal contingency and settlement $ 20 $ 619 $ — $ —
Operating profit $ 552 $ 481 $ 885 $ 1,081
Operating margin 12.4 % 10.6 % 19.9 % 23.8 %

(a) See Table 3 included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.
(b) Core Illumina revenue for 2023 was down 3% from 2022, and down 1% on a constant currency basis. Amounts for 2023 and 2022 included intercompany revenue of $26 million and $24 million, respectively, which is eliminated in consolidation.

GRAIL
GAAP Non-GAAP (a)
In millions 2023 2022 2023 2022
Revenue $ 93 $ 55 $ 93 $ 55
Gross (loss) profit $ (96) $ (117) $ 38 $ 17
R&D expense $ 338 $ 330 $ 338 $ 330
SG&A expense $ 366 $ 296 $ 337 $ 279
Goodwill and intangible impairment $ 821 $ 3,914 $ — $ —
Operating loss $ (1,621) $ (4,657) $ (638) $ (592)

(a) See Table 3 included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.

Key announcements by Illumina since Illumina’s last earnings release
•Announced the decision to divest GRAIL, executed through a third-party sale or capital markets transaction, with the goal of finalizing terms by the end of the second quarter 2024
•Submitted a confidential, draft registration statement on Form 10 related to the GRAIL divestment to the U.S. Securities and Exchange Commission
•Signed agreement with Janssen Research & Development, LLC (Janssen) to collaborate on the development of Illumina’s novel molecular residual disease (MRD) assay
•Expanded the Alliance for Genomic Discovery, adding Bristol Myers Squibb (BMS), GSK and Novo Nordisk to join founding member organizations AbbVie, Amgen, AstraZeneca, Bayer, and Merck, who together will co-fund the whole-genome sequencing (WGS) of 250,000 data samples and have access to the resulting data for use in drug discovery and therapeutic development
•Launched the Global Health Access Initiative to support access to pathogen sequencing tools for public health in low- and middle-income countries (LMICs)
•Conducted a stewardship-focused non-deal roadshow led by Illumina’s independent board directors; held discussions with shareholders owning more than half of outstanding shares

A full list of recent Illumina announcements can be found in the company’s News Center.

Key announcements by GRAIL since Illumina’s last earnings release
•Highlighted the presentation of analytical and clinical validation data on a novel prognostic test in early-stage lung cancer, generated through collaboration with the Samsung Medical Centre and AstraZeneca, demonstrating sensitive and specific detection of circulating tumor DNA (ctDNA) for Lung Adenocarcinoma (LUAD) at a clinically meaningful threshold for disease prognostication
•Announced that it will initiate Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity (REACH/Galleri-Medicare study) following the U.S. Food and Drug Administration’s (FDA) approval of GRAIL’s Investigational Device Exemption (IDE) application and the Centers for Medicare and Medicaid Services’ (CMS) approval for Medicare coverage of the study
•Announced BeniComp, a customized health plan provider, and Curative Insurance, a pioneering healthcare services company, will make Galleri available to eligible patients

A full list of recent GRAIL announcements can be found in GRAIL’s Newsroom.

Financial outlook and guidance
For fiscal year 2024, the company expects Core Illumina revenue to be approximately flat compared to fiscal year 2023 and Core Illumina non-GAAP operating margin to be approximately 20%. While Illumina continues to move as quickly as possible to resolve GRAIL, the company is focusing its financial outlook on Core Illumina, as the specific timing and impact of the GRAIL divestment remains uncertain.

The company provides forward-looking guidance on a non-GAAP basis. The company is unable to provide a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures because it is unable to predict with reasonable certainty the financial impact of items such as acquisition-related expenses, gains and losses from our strategic investments, fair value adjustments related to contingent consideration and contingent value rights, potential future asset impairments, restructuring activities, and the ultimate outcome of pending litigation without unreasonable effort. These items are uncertain, inherently difficult to predict, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the company is unable to address the significance of the unavailable information, which could be material to future results.

Conference call information
The conference call will begin at 2 p.m. Pacific Time (5 p.m. Eastern Time) on Thursday, February 8, 2024. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website at investor.illumina.com. Alternatively, individuals can access the call by dialing 877.400.0505 or +1.323.701.0225 outside North America, both using conference ID 1615812. To ensure timely connection, please dial in at least ten minutes before the scheduled start of the call.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On February 8, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported that the Compensation Committee of the company’s Board of Directors granted six employees nonqualified stock options to purchase an aggregate of 147,000 shares of its common stock with an exercise price of $2.26, which is equal to the closing price of Gritstone’s common stock on February 6, 2024, the date of the grant (Press release, Gritstone Bio, FEB 8, 2024, View Source [SID1234639939]). These stock options are part of an inducement material to the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates. The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.