BioCryst to Present at Upcoming Investor Conferences

On February 19, 2025 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company plans to present at the following conferences (Press release, BioCryst Pharmaceuticals, FEB 19, 2025, View Source [SID1234650371]):

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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

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TD Cowen 45th Annual Health Care Conference in Boston on Wednesday, March 5, 2025, at 9:10 a.m. ET.
Barclays 27th Annual Global Healthcare Conference in Miami on Tuesday, March 11, 2025, at 10:00 a.m. ET.

Links to the live audio webcasts and replays of the presentations may be accessed in the Investors & Media section of BioCryst’s website at http://www.biocryst.com.

Clarity receives US FDA Fast Track Designation for the treatment of metastatic castration-resistant prostate cancer patients with Cu-67 SAR-bisPSMA

On February 19, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that the United States (US) Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for 67Cu-SAR-bisPSMA for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with androgen receptor pathway inhibition (ARPI) (Press release, Clarity Pharmaceuticals, FEB 19, 2025, View Source [SID1234650344]).

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This milestone builds on Clarity’s earlier receipt of 2 FTDs for the diagnostic 64Cu-SAR-bisPSMA in patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy1, as well as patients with biochemical recurrence (BCR) of prostate cancer following definitive therapy2, with 2 Phase III registration trials underway (CLARIFY [NCT06056830]3 and AMPLIFY, respectively). These 3 FTDs demonstrate the quality of the data generated to date on the 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA products in addressing serious unmet needs in prostate cancer. The FTDs will enable Clarity to accelerate the development of its comprehensive program with the optimised SAR-bisPSMA agent to be used in patients with prostate cancer throughout the management of their cancer, from initial to late-stage disease, with an opportunity to completely change the entire treatment landscape for the large prostate cancer market.

The FDA’s FTD is designed to expedite the development and regulatory review of novel drugs addressing serious conditions with significant unmet medical needs. For SAR-bisPSMA, it provides a number of product development advantages. The designations pave the way for a faster review process once Clarity submits its product approval applications. Additionally, it enables more frequent communication with the FDA, allowing for rapid resolution of queries during development. Furthermore, Clarity can submit completed sections of its application as they are ready, rather than waiting for the entire package to be finished before it can be lodged with the FDA. These benefits would reduce the review time needed to bring this innovative and proprietary molecule to the prostate cancer imaging and therapy markets.

The data for this FTD submission was based on the preliminary results to date from the Phase I/IIa SECuRE study (NCT04868604)4, which is investigating the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of mCRPC patients. The first 3 cohorts in the dose escalation phase of the trial were successfully completed with no dose limiting toxicities (DLTs) reported in any of the participants dosed (15 participants). No adverse events (AEs) related to 64Cu-SAR-bisPSMA were observed. Most AEs related to 67Cu-SAR-bisPSMA were low grade (grade 1 or 2). The most common AE reported was mild dry mouth (grade 1, 5/15 participants, 33.3%).

Preliminary data shows that the majority of participants in the SECuRE study enrolled to date had bone metastasis (77%), high median prostate-specific antigen (PSA) level at baseline (112.86 ng/mL, range 0.1-1503.1) and were heavily pre-treated (59% of participants received 3 or more lines of therapy). Despite how heavily pre-treated these participants were, and how much disease they had, 73% of them across all cohorts (including the lowest dose cohort of 67Cu-SAR-bisPSMA at 4 GBq, single dose) showed reductions in PSA levels. The majority of patients that had an increase in PSA were on the single, lowest dose cohort 1 (4 GBq). PSA reductions of greater than 50% were seen in 45% of all trial participants, despite the overwhelming majority of participants only receiving a single dose of 67Cu-SAR-bisPSMA (4, 8 or 12 GBq) in the trial. In cohorts 2, 3 and 4 (8 and 12 GBq single dose and 12 GBq multi-dose, respectively), in which most participants also only received 1 dose of 67Cu-SAR-bisPSMA, PSA reductions of greater than 35% were observed in almost 75% of participants and PSA was reduced by 80% or more in almost half of the participants so far, as patients continue in follow-up.

The trial is currently progressing through the highest dose cohort where participants were administered multiple doses of 12 GBq of 67Cu-SAR-bisPSMA. Recruitment into cohort 4 is complete, and the remaining 3 participants are currently in the safety and efficacy follow-up period after receiving their first 2 doses. Following completion of the follow-up up period, the safety review committee meeting is planned for March 2025. The largest drop in prostate-specific antigen (PSA) in cohort 4 to date is a decline of 98% (from a baseline of 157.4 ng/mL). This participant, who had failed multiple lines of therapy prior to receiving 67Cu-SAR-bisPSMA (androgen deprivation therapy [ADT], ARPI and an investigational agent), has already had a radiographic partial response based on the investigator’s assessment of Response Evaluation Criteria in Solid Tumours v1.1 (RECIST) criteria. Preliminary analysis showed a reduction of 60.6% in tumour volume evaluated by PSMA positron emission tomography [PET] imaging with 64Cu-SAR-bisPSMA.

Cohort expansion of the SECuRE trial to assess the combination of 67Cu-SAR-bisPSMA with enzalutamide

For a long time, Clarity has been working closely with many important global medical experts in the field of prostate cancer, including the Company’s Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, to optimise the development of all of its products in prostate cancer. Those discussions have led to a recent protocol amendment for the SECuRE trial, which aims to investigate ways to further improve the treatment outcomes for these patients. The protocol amendment is aligned with the positive results of the Enza-p trial presented by Prof Emmett first at the European Society for Medical Oncology in 20235 and more recently at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers (ASCO GU) Symposium in 20256, which confirmed the hypothesis that targeting both androgen signalling and PSMA receptors concurrently would improve anti-cancer activity in mCRPC. The latest SECuRE protocol amendment increased the number of participants in the cohort expansion phase from 14 to 24 patients in the mCRPC pre-chemotherapy setting, with a subset of patients to receive the combination therapy of 67Cu-SAR-bisPSMA with enzalutamide. This protocol amendment has now been approved at many of the participating trial sites, and the changes are expected to further enhance the already positive results of 67Cu-SAR-bisPSMA observed in the SECuRE trial to date. This strategy focuses on the commercialisation of the product firstly in the largest market for prostate cancer therapies in mCRPC, with pre-chemotherapy being 3 times larger than the post-chemotherapy setting, and creates opportunities for the use of 67Cu-SAR-bisPSMA with a range of ARPIs in future clinical development. Addressing the radiopharmaceuticals supply issues with current treatments in such a large indication requires a streamlined approach for which Clarity’s 64Cu/67Cu platform is well and uniquely suited.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "Receiving 3 FTDs for the one molecule, SAR-bisPSMA, within the last 6 months is an incredible achievement for Clarity, highlighting how impressive our science and development are, the significance of the diagnostic and therapeutic data so far, and the high unmet need for better therapies and diagnostics in prostate cancer.

"The dual-targeted bisPSMA molecule was developed at the benchtop of Australian science with the intent of overcoming the shortfalls of the current generation of PSMA-targeting products. It was optimised with two PSMA ligands, which increases not only the amount of product in the lesions, but also how long the product is retained in the lesions over time, making it an ideal candidate for both diagnosis and therapy. The clinical data in both diagnostic and therapeutic indications that we are generating is remarkable, confirming the results that we initially saw in preclinical development. The granting of FTDs by the US FDA for 3 distinct indications in prostate cancer that we are aiming to address with this product is testament to the incredible work of our team and collaborators. This latest FTD will allow us flexibility to develop 67Cu-SAR-bisPSMA in both pre- and post-chemotherapy patients in the mCRPC setting, with initial focus on the largest market segment. The SECuRE study will also provide invaluable information on the potential of 67Cu-SAR-bisPSMA to be combined with enzalutamide and other ARPIs in future, creating opportunities for the broader use of 67Cu-SAR-bisPSMA in those patients with such high unmet medical need.

"These designations will allow us to work closely with the FDA to facilitate the development process and accelerate the approval of what could become best-in-class therapy and diagnostic agents, and our team and collaborators are committed to making this our priority in order to achieve our ultimate goal of improving treatment outcomes for people with cancer."

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

64Cu-SAR-bisPSMA is an unregistered product. The safety and efficacy of 64Cu-SAR-bisPSMA has not been assessed by health authorities such as the U.S. FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available.

About the SECuRE trial
SECuRE (NCT04868604)4 is a Phase I/IIa theranostic trial for identification and treatment of an advanced form of prostate cancer, mCRPC. It is a multi-centre, single arm, dose escalation study with a cohort expansion. The aim of this trial is to determine the safety and tolerability of both 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA, as well as the efficacy of 67Cu-SAR-bisPSMA as a therapy. A recent protocol amendment has increased the number of participants in the cohort expansion phase from 14 to 24, and a subset of participants will receive the combination of 67Cu-SAR-bisPSMA with enzalutamide.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide7. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the U.S. and around 35,770 deaths from the disease.

Agreement and Plan of Merger

On February 18, 2025, Intra-Cellular Therapies, Inc., a Delaware corporation (the "Company"), filed its definitive proxy statement on Schedule 14A (as such may be supplemented from time to time, the "Proxy Statement") with the Securities and Exchange Commission (the "SEC") with respect to the special meeting of the Company’s stockholders (the "Special Meeting") to be held in connection with transactions contemplated by that certain Agreement and Plan of Merger (the "Merger Agreement"), dated as of January 10, 2025, by and among the Company, Johnson & Johnson, a New Jersey corporation ("Johnson & Johnson"), and Fleming Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Johnson & Johnson ("Merger Sub"), pursuant to which, subject to the terms and conditions thereof, Merger Sub will merge with and into the Company (the "Merger"), with the Company surviving as a wholly owned subsidiary of Johnson & Johnson (Filing, 8-K, Intra-Cellular Therapies, MAR 18, 2025, View Source [SID1234651221]).

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The Special Meeting is scheduled for March 27, 2025, beginning at 9:00 a.m. Eastern Time. The Company’s stockholders of record as of the close of business on February 13, 2025 will be eligible to vote at the Special Meeting. The information contained in this Current Report on Form 8-K (this "Form 8-K") should be read in conjunction with the Proxy Statement, which should be read in its entirety.

Litigation Relating to the Merger

On February 26, 2025 a purported stockholder of the Company filed a lawsuit in the New York State Supreme Court against the Company and its Board of Directors, captioned Morgan v. Intra-Cellular Therapies, Inc., et al., Index No. 651153/2025 (the "Morgan Complaint"). On February 27, 2025, a purported stockholder of the Company filed a lawsuit in the New York State Supreme Court against the Company and its Board of Directors, captioned O’Neill v. Intra-Cellular Therapies, Inc., et al., Index No. 651115/2025 (the "O’Neill Complaint"). The Morgan Complaint and the O’Neill Complaint generally allege, among other things, that the Proxy Statement negligently misrepresents and/or fails to disclose material information in violation New York law. The Morgan Complaint and the O’Neill Complaint each seek, among other things, injunctive relief, rescissory or other unspecified monetary damages, and an award of attorneys’ fees and expenses.

On March 3, 2025, a purported stockholder of the Company filed a lawsuit in the Superior Court of New Jersey, Somerset County, against the Company, its Board of Directors and Johnson & Johnson, captioned Drulias v. Mates, et al., Case No. SOM C-012016-25 (the "Drulias Complaint" and together with the Morgan Complaint and the O’Neill Complaint, the "Complaints"). The Drulias Complaint generally alleges, among other things, that the Company’s Board of Directors breached its fiduciary duties under Delaware law in entering into the Merger, that the Company and its Board of Directors failed to disclose material information in the Proxy Statement, and that Johnson & Johnson aided and abetted those breaches. The Drulias Complaint seeks, among other things, a declaration that the defendants have breached their fiduciary duties and/or aided and abetted such breaches, an order requiring corrective disclosures, injunctive relief, unspecified compensatory and/or rescissory damages, and an award of attorneys’ fees and expenses.

As of the date of this Form 8-K, attorneys representing multiple purported stockholders of the Company have also delivered demand letters to the Company (collectively, the "Demand Letters") alleging that the disclosures contained in the Proxy Statement are deficient and requesting that the Company supplement such disclosures prior to the Special Meeting. The Demand Letters threaten the Company with lawsuits in the event that the purported deficiencies in the Proxy Statement are not addressed.

It is possible that additional, similar complaints may be filed, that the Complaints described above may be amended, or that additional demand letters will be received by the Company. If this occurs, the Company does not intend to announce the filing or receipt of each additional, similar complaint or demand letter or any amended complaint unless required by law.

The Company believes that the claims asserted in the Complaints and the Demand Letters are without merit. However, in order to moot the unmeritorious disclosure claims, alleviate the costs, risks and uncertainties inherent in potential litigation and provide additional information to its stockholders, the Company has determined to voluntarily supplement the Proxy Statement as described in this Form 8-K. Nothing in this Form 8-K shall be deemed an

admission of the legal necessity or materiality under applicable laws of any of the disclosures set forth herein. To the contrary, the Company specifically denies all allegations set forth in the Complaints and the Demand Letters that any additional disclosure in the Proxy Statement was or is required.

Supplemental Disclosures

The following disclosures supplement the disclosures contained in the Proxy Statement and should be read in conjunction with the disclosures contained in the Proxy Statement, which should be read in its entirety. To the extent the information set forth herein differs from or updates information contained in the Proxy Statement, the information set forth herein shall supersede or supplement the information in the Proxy Statement. All page references are to pages in the Proxy Statement, and terms used below, unless otherwise defined, have the meanings set forth in the Proxy Statement.

(a)
The disclosure under the section entitled " — Opinions of ITI’s Financial Advisors – Opinion of Centerview Partners LLC" is hereby amended and supplemented by deleting the bulleted list of selected companies beginning on page 49 of the Proxy Statement, and replacing it with the following chart:

Company
EV / 2027 Revenue Multiple

Acadia Pharmaceuticals Inc.

1.8x
Alkermes plc.

2.9x
Amicus Therapeutics, Inc.

3.1x
Apellis Pharmaceuticals, Inc.

3.6x
Axsome Therapeutics, Inc.

3.0x
Neurocrine Biosciences, Inc.

3.6x
Sarepta Therapeutics, Inc.

3.1x
TG Therapeutics, Inc.

4.7x

(b)
The disclosure under the section entitled " — Opinions of ITI’s Financial Advisors – Opinion of Centerview Partners LLC" is hereby amended and supplemented by adding the following double underlined language to a new rightmost column of the table set forth on page 51 of the Proxy Statement:

Date Announced
Target

Acquiror TV / Three-Year
Forward Revenue
Multiple
December 2022 Horizon Therapeutics Public Limited Company Amgen Inc. 5.4x
August 2022 Global Blood Therapeutics, Inc. Pfizer Inc. 7.3x
May 2022 Biohaven Pharmaceutical Holding Company Ltd. Pfizer Inc. 6.0x
February 2021 GW Pharmaceuticals plc Jazz Pharmaceuticals Public
Limited Company 6.0x
December 2020 Alexion Pharmaceuticals, Inc. AstraZeneca PLC 5.2x
January 2018 Bioverativ Inc. Sanofi SA 7.0x
January 2017 Actelion Ltd. Johnson & Johnson 9.9x
January 2016 Baxalta Incorporated Shire plc 4.6x
January 2015 NPS Pharmaceuticals, Inc. Shire plc 6.9x

(c)
The disclosure under the section entitled " — Opinions of ITI’s Financial Advisors – Opinion of Centerview Partners LLC" is hereby amended and supplemented by adding the following double underlined language to the last paragraph beginning on page 51 of the Proxy Statement:

In performing this analysis, Centerview calculated a range of equity values for shares of our common stock by (a) discounting to present value as of December 31, 2024 using discount rates ranging from 10.25% to 12.25% (reflecting

Centerview’s analysis of ITI’s weighted average cost of capital) and using a mid-year convention: (i) the forecasted risk-adjusted, after-tax unlevered free cash flows of ITI over the period beginning on January 1, 2025 and ending on December 31, 2047, utilized by Centerview based on the Projections, (ii) a range of implied terminal values of ITI, calculated by Centerview by adjusting ITI’s fiscal year 2047 risk-adjusted, after-tax unlevered free cash flow based on the Projections to account for normalized levels of working capital and research and development expenses, and applying a selected range of perpetuity growth rates of 0.0% to 3.0% (which range Centerview was instructed to use by ITI’s management), based on information provided by ITI management as of January 9, 2025 and set forth in the internal data and (iii) tax savings from usage of ITI’s estimated federal net operating losses as of December 31, 2024 of $468 million and research and development tax credits as of December 31, 2024 of $51 million and ITI’s future losses, in each case which amount was provided by ITI management as set forth in the internal data and (b) adding to the foregoing results ITI’s estimated net cash as of December 31, 2024 of approximately $1 billion, which amount was provided by ITI management as set forth in the internal data. Centerview divided the result of the foregoing calculations by the number of fully diluted outstanding shares of ITI’s common stock (determined using the treasury stock method and taking into account approximately 106.2 million shares of ITI’s common stock, approximately 3.1 million outstanding in-the-money options with a weighted average exercise price of $31.23, approximately 2.0 million restricted stock units, and approximately 0.2 million performance stock units (including assumptions regarding the vesting of such performance stock units)), based on information provided by ITI management as set forth in the internal data. This analysis resulted in a range of implied equity values per share of our common stock of $102.90 to $127.70, rounded to the nearest $0.05. Centerview then compared this range to the Merger Consideration of $132.00 per share to be paid to the holders of our common stock (other than Excluded Shares) pursuant to the Merger Agreement.

(d)
The disclosure under the section entitled " — Opinions of ITI’s Financial Advisors – Opinion of Centerview Partners LLC" is hereby amended and supplemented by adding the following double underlined language to the second and third bullets under the first full paragraph beginning on page 52 of the Proxy Statement:


Analyst Price Targets Analysis. Centerview reviewed stock price targets for shares of ITI’s common stock in 14 publicly available Wall Street research analyst reports as of January 8, 2025 which indicated low and high stock price targets for ITI ranging from $87.00 to $135.00 per share (with a median price target of $101.00 per share).


Precedent Premiums Paid Analysis. Centerview performed an analysis of premiums paid in the selected transactions involving publicly traded scaled commercial stage biotechnology companies, as set forth above in "Selected Precedent Transaction Analysis". The premiums in this analysis were calculated by comparing the per share acquisition price in each transaction to the closing price of the target company’s common stock for the date one day prior to the date on which the trading price of the target company’s common stock was perceived by Centerview to be affected by a potential transaction, which indicated low and high premiums of 37% and 102% (with a median of 51%). Based on the analysis above and other considerations that Centerview deemed relevant in its professional judgment, Centerview applied a premium range of 35% to 85% to ITI’s closing stock price on January 8, 2025 (the last full trading day prior to the date on which the Board of Directors met to approve the Merger) of $82.56, which resulted in an implied price range of approximately $111.45 to $152.75 per share, rounded to the nearest $0.05.

(e)
The disclosure under the section entitled " —Opinions of ITI’s Financial Advisors – Opinion of Jefferies LLC" is hereby amended and supplemented by adding the following double underlined language to a new rightmost column of the table beginning on page 56 of the Proxy Statement:

Date Announced
Target

Acquiror Enterprise Value /
Peak Sales Multiples
December 2023 Karuna Therapeutics, Inc. Bristol-Myers Squibb Company 1.6x
July 2023 Reata Pharmaceuticals, Inc. Biogen Inc. 2.4x
April 2023 IVERIC bio, Inc. Astellas Pharma Inc. 1.4x
August 2022 Global Blood Therapeutics, Inc. Pfizer Inc. 1.8x

May 2022 Biohaven Pharmaceutical Holding Company Ltd. Pfizer Inc. 1.8x
February 2021 GW Pharmaceuticals plc Jazz Pharmaceuticals Public
Limited Company 2.4x
October 2020 MyoKardia, Inc. Bristol-Myers Squibb Company 1.7x
November 2019 The Medicines Company Novartis AG 1.5x

(f)
The disclosure under the section entitled " —Opinions of ITI’s Financial Advisors – Opinion of Jefferies LLC" is hereby amended and supplemented by deleting the bulleted list of selected companies below the third paragraph on page 57 of the Proxy Statement, and replacing it with the following chart:

Company Enterprise Value / 2027 Revenue Multiples
Acadia Pharmaceuticals Inc. 1.8x
Alkermes plc. 2.9x
Amicus Therapeutics, Inc. 3.1x
Apellis Pharmaceuticals, Inc. 3.6x
Axsome Therapeutics, Inc. 3.0x
Neurocrine Biosciences, Inc. 3.6x
Sarepta Therapeutics, Inc. 3.1x
TG Therapeutics, Inc. 4.7x

(g)
The disclosure under the section entitled " —Opinions of ITI’s Financial Advisors – Opinion of Jefferies LLC" is hereby amended and supplemented by adding the following double underlined language to the second paragraph on page 58 of the Proxy Statement:

Jefferies performed a discounted cash flow analysis of ITI by calculating the estimated present value of the stand-alone risk-adjusted unlevered free cash flows, as described further in the section of this proxy statement captioned " —Certain Financial Projections", that ITI was forecasted to generate during the fiscal years ending December 31, 2025 through December 31, 2047 based on the Projections. Jefferies also calculated a range of terminal values for ITI by adjusting ITI’s fiscal year 2047 risk-adjusted unlevered free cash flow based on the Projections to account for normalized levels of working capital and research and development expenses, and applying a selected range of perpetuity growth rates of 0.0% to 3.0% (which range Jefferies was instructed to use by ITI’s management). The net present value as of December 31, 2024 of the risk-adjusted unlevered free cash flows and terminal value of ITI described in the preceding sentences were then calculated using the mid-year convention and a selected discount rate range of 10.25% to 12.25%, based on Jefferies’ estimate of ITI’s weighted average cost of capital. This resulted in a range of implied enterprise values for ITI. Jefferies then added ITI’s estimated net cash as of December 31, 2024 of approximately $1 billion, and the present value of ITI’s estimated federal net operating loss carryforwards of $468 million and research and development credits of $51 million, each as of December 31, 2024, and future losses (in each case as provided by ITI’s management), to calculate a range of implied equity values. Jefferies divided the result by the number of fully diluted outstanding shares of our common stock as of January 9, 2025 (determined using the treasury stock method and taking into account approximately 106.2 million shares of ITI’s common stock, approximately 3.1 million outstanding in-the-money options with a weighted average exercise price of $31.23, approximately 2.0 million restricted stock units, and approximately 0.2 million performance stock units (including assumptions regarding the vesting of such performance stock units)), as provided by ITI’s management, to calculate a range of implied per share equity values for ITI. This analysis indicated a reference range of implied per share equity values of $102.90 to $127.70 per share, as compared to the Merger Consideration of $132.00 per share.

(h)
The disclosure under the section entitled " —Opinions of ITI’s Financial Advisors – Opinion of Jefferies LLC" is hereby amended and supplemented by adding the following double underlined language to the second bullet under the third full paragraph on page 58 of the Proxy Statement:


the publicly available stock price targets for our shares of common stock by 14 research analysts, which indicated low and high stock price targets ranging from $87.00 per share to $135.00 per share (with a median price target of $101.00 per share), as compared to the Merger Consideration of $132.00 per share.

Additional Information and Where to Find It

On February 18, 2025, the Company filed the Proxy Statement with the SEC in connection with the proposed acquisition of the Company by Parent. Beginning on February 18, 2025, the Proxy Statement and proxy card were mailed to the Company’s stockholders of record as of February 13, 2025. Other documents regarding the transaction may be filed with the SEC. This Current Report on Form 8-K is not a substitute for the Proxy Statement or any other document that the Company may file with the SEC and send to its stockholders in connection with the transaction. Before making any voting decision, the Company’s stockholders are urged to read all relevant documents filed or to be filed with the SEC, including the Proxy Statement, as well as any amendments or supplements to those documents, when they become available, because they contain or will contain important information about the Company and the proposed acquisition.

The Company’s stockholders are or will be able to obtain a free copy of the Proxy Statement, as well as other filings containing information about Parent and the Company, free of charge, at the SEC’s website (www.sec.gov). Copies of the Proxy Statement and other documents filed by the Company with the SEC may be obtained from the Company, free of charge, by contacting the Company through its website at View Source

Participants in the Solicitation

Parent and the Company and certain of their respective directors and executive officers, under SEC rules, may be deemed to be "participants" in the solicitation of proxies from stockholders of the Company in connection with the proposed transaction. Information about Parent’s directors and executive officers is available in Parent’s Annual Report on Form 10-K for the year ended December 29, 2024, which was filed with the SEC on February 13, 2025, and Parent’s definitive proxy statement for its 2024 annual meeting of stockholders, which was filed with the SEC on March 13, 2024. Information about the Company’s directors and executive officers is available in the Proxy Statement, which was filed with the SEC on February 18, 2025. To the extent holdings of Parent’s or the Company’s securities by their respective directors or executive officers have changed since the amounts set forth in such proxy statements, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC. Investors and stockholders of the Company are or will be able to obtain these documents free of charge from the SEC’s website at www.sec.gov, from Parent on Parent’s website at www.jnj.com, from the Company on the Company’s website at www.intracellulartherapies.com or on request from Parent or the Company.

Sigyn Therapeutics to Present at Tomorrow’s Emerging Growth Conference

On February 18, 2025 Sigyn Therapeutics, Inc. ("Sigyn" or the "Company") (OTCQB: SIGY), a developer of next-generation blood purification therapies to address cancer and life-threatening infectious disease disorders, reported that Jim Joyce, the Company’s CEO will give a live presentation at tomorrow’s Emerging Growth Conference (Press release, Sigyn Therapeutics, FEB 18, 2025, View Source [SID1234650380]).

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Date: February 19th

Time: 4:10pm – 4:40pm Eastern

Registration: View Source;tp_key=a17d7ff4c2&sti=sigy

This will be a live, interactive online event where participants are invited to ask the company questions in real-time. If attendees are not able to join the event live on the day of the conference, an archived webcast will be made available on EmergingGrowth.com and on the Emerging Growth YouTube Channel, View Source

Foundation Medicine Collaborates with Sumitomo Pharma America to Advance Investigational Treatment for Patients with Acute Leukemia with NPM1 Mutations or KMT2A Rearrangements Using the FoundationOne®Heme Platform

On February 18, 2025 Foundation Medicine, Inc., a genomics company committed to transforming cancer care, reported a collaboration with Sumitomo Pharma America, Inc. (SMPA) to develop the FoundationOneHeme platform as a companion diagnostic to identify patients with acute leukemia with a KMT2A rearrangement, also known as mixed lineage leukemia (MLL) rearrangement, or NPM1 mutations for potential treatment with SMPA’s enzomenib (DSP-5336), an investigational menin inhibitor (Press release, Foundation Medicine, FEB 18, 2025, View Source [SID1234650356]).

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

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Acute leukemia requires immediate treatment as the blood cells multiply rapidly, leading to a sudden onset of symptoms.1 Approximately 30% of acute myeloid leukemia (AML) patients have NPM1 mutations, 2 and 5-10% of AML patients have KMT2A (MLL) rearrangements.3

Menin inhibitors are emerging as a promising targeted therapy option for acute leukemia with KMT2A (MLL) rearrangements or NPM1 mutations.4 Menin is a protein that interacts with the KMT2A gene, playing a crucial role in regulating gene expression and protein interactions involved in hematopoiesis.5 Menin inhibitors are designed to disrupt this interaction, inhibiting the proliferation of leukemic cells.4

"Thanks to advancements in comprehensive genomic profiling, we have seen an increased focus on developing new targeted therapies for patients with hematological malignancies, which may help bring the promise of precision medicine to more patients," said Foundation Medicine’s Chief Biopharma Officer Troy Schurr. "We’re excited to work with Sumitomo to advance our FoundationOne Heme platform as a companion diagnostic as they advance investigation of this promising potential treatment option for acute leukemia patients with a KMT2A rearrangement and NPM1 mutations."

Foundation Medicine’s portfolio of tests offers physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. Foundation Medicine is the global leader in companion diagnostic approvals, with more than 50% of all approved companion diagnostic indications for next-generation sequencing (NGS) testing in the United States and Japan.