Mural Oncology to Present at the TD Cowen 45th Annual Health Care Conference

On February 18, 2025 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered therapies targeting cytokine pathways, reported that CEO Caroline Loew, Ph.D., will present at the TD Cowen 45th Annual Health Care Conference on March 4, 2025 and 3:10 p.m. ET (Press release, Mural Oncology, FEB 18, 2025, View Source [SID1234650339]). A live webcast of the presentation will be available at View Source A replay of the webcast will be archived and available following the event.

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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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Oncolytics Biotech® Strengthens Its Pipeline in 2025 with Key Pancreatic and Anal Cancer Advances in Addition to Metastatic Breast Cancer

On February 18, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported to make good progress in 2025 with key regulatory and clinical advancements, reinforcing pelareorep’s potential in hard-to-treat cancers (Press release, Oncolytics Biotech, FEB 18, 2025, View Source [SID1234650340]). Oncolytics is pleased to highlight two significant developments for its immunotherapy, pelareorep: the safety and regulatory clearance to advance enrollment in its pancreatic cancer study and the recent presentation of new efficacy and safety data at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in late January.

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"We’re hitting critical milestones that validate our progress and set the stage for what we believe will be an exciting year," said Wayne Pisano, Interim CEO and Chair of Oncolytics’ Board of Directors. "With positive feedback from regulators in place, we’re advancing our pancreatic cancer study toward full enrollment, and our ASCO (Free ASCO Whitepaper) GI presentations highlighted pelareorep’s strong safety and efficacy results in two hard-to-treat cancers. We remain focused on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025."

German Regulatory Agency Gives Green Light for Pancreatic Cancer Study to Continue as Planned

•Approval to Fully Enroll the Cohort Secured: Germany’s Paul-Ehrlich-Institute (PEI) has given Oncolytics the go-ahead to continue enrolling patients in its pancreatic cancer trial (GOBLET Cohort 5) after a positive safety review.
•What This Means: Pelareorep, in combination with modified FOLFIRINOX with and without atezolizumab, is now progressing toward full enrollment, with 30 patients set to participate in Stage 1 across the two treatment arms.
•Next Steps: Oncolytics will continue to collect safety data, and an initial efficacy readout is expected later this year.

ASCO GI 2025 Data Confirms Pelareorep’s Potential in Pancreatic and Anal Cancers

At ASCO (Free ASCO Whitepaper) GI 2025, Oncolytics presented new clinical results demonstrating pelareorep’s potential in two challenging cancer types:
•Anal Cancer: Patients receiving pelareorep + atezolizumab continue to show stronger responses than expected based on published studies with checkpoint inhibitors alone.
•Pancreatic Cancer: Pelareorep previously demonstrated a strong efficacy signal when administered with gemcitabine, nab-paclitaxel, and atezolizumab. The most recent data supports a favorable safety profile when combining pelareorep with a different chemotherapy regimen (modified FOLFIRINOX) with and without the checkpoint inhibitor atezolizumab, potentially expanding its treatment applications.

Why This Matters: These findings further de-risk pelareorep’s development and could pave the way for larger registration-enabling clinical trials in these indications.

Looking Ahead: More Catalysts in 2025

Oncolytics is entering a pivotal year with multiple upcoming milestones, including:

•Additional data readouts from ongoing trials in gastrointestinal cancers, including translational results that further characterize pelareorep’s mechanism of action.
•Interactions with Regulatory Agencies that could accelerate future trials and move pelareorep closer to potential registration-enabling studies in breast cancer and gastrointestinal cancers.

"We’re seeing clinical validation across multiple studies," added Pisano. "With encouraging regulatory interactions in hand and data readouts ahead, 2025 is shaping up to be an exciting year for Oncolytics and our investors. As we have shown in GOBLET, BRACELET-1, and numerous previous studies, pelareorep has a favorable safety profile and efficacy signals across multiple indications with a high unmet need. We are excited about the potential for moving to a registration-enabling study in breast cancer and advancing our clinical program in gastrointestinal cancers."

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. Favorable safety and positive clinical efficacy signals have been seen in the pancreatic and anal cancer cohorts.

About GOBLET Cohort 5
The modified FOLFIRINOX (mFOLFIRINOX) cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed metastatic pancreatic ductal adenocarcinoma patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.

About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

ORIC® Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Updates

On February 18, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter and year ended December 31, 2024 (Press release, ORIC Pharmaceuticals, FEB 18, 2025, View Source [SID1234650341]).

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"2024 was a year of significant advancements across several areas," stated Jacob M. Chacko, M.D., president and chief executive officer. "Key achievements included initiation of multiple cohorts for ORIC-114 in non-small cell lung cancer and ORIC-944 in metastatic castration-resistant prostate cancer. We also established three strategic partnerships with major pharmaceutical companies, expanded our leadership team’s expertise, and secured $125 million in financing, which extends our cash runway into late 2026. We anticipate seven data readouts in the next year and a half and are working towards potential registration studies for ORIC-114 in the latter half of 2025 and for ORIC-944 in early 2026."

2024 Key Accomplishments

ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor

Entered into a clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate ORIC-114 in combination with subcutaneous (SC) amivantamab for the 1L treatment of patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.
Initiated a cohort to evaluate ORIC-114 monotherapy for the 1L treatment of patients with NSCLC harboring EGFR exon 20 insertion mutations.
Announced the completion of the dose escalation portion of the Phase 1b trial of ORIC-114 and the selection of two provisional recommended phase 2 doses; after which, initiated dosing of patients across three expansion cohorts in the Phase 1b trial of ORIC-114 in patients with mutated NSCLC, including 2L EGFR exon 20 insertion (EGFR exon 20 inhibitor naïve), 2L+ HER2 exon 20 insertion, and 2L+ EGFR atypical mutations.
Presented preclinical data demonstrating potential best-in-class properties, including potency and selectivity, of ORIC-114 to treat NSCLC harboring EGFR exon 20 insertion mutations and other atypical EGFR mutations at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics.
ORIC-944: a potent and selective allosteric inhibitor of PRC2

Reported encouraging early safety and efficacy data in ongoing dose escalation trial for ORIC-944 in combination with apalutamide in patients with metastatic castration resistant prostate cancer (mCRPC).
Initiated dosing of ORIC-944 in combination with ERLEADA (apalutamide) and in combination with NUBEQA (darolutamide) in mid-2024 in the ongoing Phase 1b trial for prostate cancer.
Entered into clinical trial collaboration and supply agreements with Johnson & Johnson and Bayer to support the ongoing Phase 1b trial of ORIC-944 in combination with AR inhibitors for the treatment of mCRPC.
Reported initial Phase 1b single agent data for ORIC-944 in metastatic prostate cancer supporting advancement into combination development and demonstrating the potential as a best-in-class PRC2 inhibitor, including a clinical half-life of ~20 hours, robust target engagement, no signs of CYP autoinduction that was observed with first-generation PRC2 inhibitors, and a generally well-tolerated safety profile.
Presented preclinical data at the 2024 AACR (Free AACR Whitepaper) Annual Meeting demonstrating superior drug properties and synergy data in prostate cancer models, reinforcing the promise of ORIC-944 as a potential best-in-class treatment for combination with AR inhibitors.
Corporate Highlights:

Strengthened cash position and runway with a $125 million private placement financing from new and existing healthcare specialist funds.
Expanded the leadership team with the appointment of industry veteran Keith Lui as Senior Vice President of Commercial and Medical Affairs.
Anticipated Program Milestones

ORIC anticipates the following upcoming data milestones:

ORIC-114 (NSCLC):
1H 2025: 2L EGFR exon 20 and 2L+ HER2 exon 20
2H 2025: 2L+ EGFR atypical
1H 2026: 1L EGFR exon 20
Mid-2026: 1L EGFR exon 20 combination with SC amivantamab and 1L EGFR atypical
ORIC-944 (mCRPC):
4Q 2025 / 1H 2026: Combination with AR inhibitors
Fourth Quarter and Full Year 2024 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $256 million as of December 31, 2024, which is expected to fund the current operating plan into late 2026.
R&D Expenses: Research and development (R&D) expenses were $32.0 million for the three months ended December 31, 2024, compared to $24.5 million for the three months ended December 31, 2023, an increase of $7.5 million. For the year ended December 31, 2024, R&D expenses were $114.1 million compared to $85.2 million for the same period in 2023, an increase of $28.9 million. The increases were due to a net increase in external expenses related to the advancement of product candidates, as well as higher personnel costs, including additional non-cash stock-based compensation.
G&A Expenses: General and administrative (G&A) expenses were $7.6 million for the three months ended December 31, 2024, compared to $6.9 million for the three months ended December 31, 2023, an increase of $0.7 million. For the year ended December 31, 2024, G&A expenses were $28.8 million compared to $25.6 million for the same period in 2023, an increase of $3.2 million. The increases were primarily due to higher personnel costs, including additional non-cash stock-based compensation.

Cartesian Therapeutics to Participate in Upcoming Investor Conferences

On February 18, 2025 Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the "Company"), a clinical-stage biotechnology company pioneering mRNA cell therapies for autoimmune diseases, reported that its management expects to participate in the following investor conferences in February and March (Press release, Cartesian Therapeutics, FEB 18, 2025, View Source [SID1234650345]):

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A fireside chat at the H.C. Wainright & Co. 3rd Annual Cell Therapy Virtual Conference at 1:00 p.m. ET on Tuesday, February 25, 2025
A presentation at the TD Cowen 45th Annual Health Care Conference at 1:50 p.m. ET on Monday, March 3, 2025 in Boston, MA
A fireside chat at the Leerink Global Healthcare Conference at 8:40 a.m. ET on Monday, March 10, 2025 in Miami, FL
A live webcast of the presentation and fireside chats is expected to be accessible in the Events section of the Company’s website at www.cartesiantherapeutics.com, where an archived replay of the events will also be available for a limited time.

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.