On December 22, 2022 Amgen Inc. ("Amgen") reported that Citibank, N.A. ("Citibank"), as administrative agent, Bank of America, N.A. ("Bank of America"), as syndication agent, Citibank, Bank of America, Goldman Sachs Bank USA and Mizuho Bank, Ltd. as lead arrangers and book runners, and Goldman Sachs Bank USA and Mizuho Bank, Ltd. as documentation agents entered into a Term Loan Credit Agreement (the "Term Loan Credit Agreement") (Filing, 8-K, Amgen, DEC 22, 2022, View Source [SID1234625529]). The Term Loan Credit Agreement provides for a (1) a $2,000,000,000 18-month term loan tranche (the "18-Month Tranche") and (2) a $2,000,000,000 3-year term loan tranche (the "3-Year Tranche", and together with the 18-Month Tranche, the "Term Loan Credit Facility"), with the commitments under the Bridge Credit Agreement entered into by Amgen, as borrower, Citibank, as administrative agent, Bank of America, as syndication agent, and Citibank and Bank of America as lead arrangers and book runners, on December 12, 2022 (the "Bridge Credit Facility") (as filed in our Current Report on Form 8-K on December 12, 2022) to be automatically reduced by a corresponding amount. The Term Loan Credit Facility is available to finance the payment of the transaction consideration in connection with the acquisition by Amgen of Horizon Therapeutics plc ("Horizon") (the "Acquisition"), the repayment of certain existing indebtedness of Horizon, and the payment of fees and expenses related to the Acquisition. Advances under the Term Loan Credit Facility will be available after the Effective Date, subject to the satisfaction of certain conditions set forth in the Term Loan Credit Agreement and will mature on, for the 18-Month Tranche, the date that is 18 months after, and for the 3-Year Tranche, the date that is three years after, the date on which the advances are made under the Term Loan Credit Facility. The commitments under the Term Loan Credit Facility, unless previously terminated, terminate on the earlier of (i) the date on which the Acquisition has been completed and the other purposes of the Term Loan Credit Facility have been achieved without the making of any advances under the Term Loan Credit Facility and (ii) the time after certain mandatory cancellation events occur, including the abandonment of the Acquisition.

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Advances under the Term Loan Credit Agreement will bear interest at an annual rate of, at Amgen’s option, either (i) term SOFR plus 0.10%, plus between 0.875% and 1.375%, depending on the rating of our senior long-term unsecured debt, or (ii) the highest of (A) Citibank’s base commercial lending rate, (B) the overnight federal funds rate plus 1⁄2 of 1.00% and (C) one-month adjusted term SOFR plus 1.00%, plus between 0.000% and 0.375%, depending on the rating of our senior long-term unsecured debt. We are also required to pay, commencing on March 12, 2023 and under both the 18-Month Tranche and the 3-Year Tranche, a ticking fee of 0.125% per annum that will accrue on the aggregate undrawn commitments under the applicable tranche.

The Term Loan Credit Agreement contains customary affirmative and negative covenants that will apply after the Effective Date, including limitations on mergers, consolidations and sales of assets, limitations on liens and sales and leasebacks, limitations on transactions with affiliates and limitations on subsidiary indebtedness. In addition, the Term Loan Credit Agreement requires maintenance of a minimum consolidated interest coverage ratio of EBITDA to total interest expense, each on a consolidated basis.

The foregoing description of the Term Loan Credit Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Term Loan Credit Agreement, a copy of which is filed as Exhibit 10.1 hereto and incorporated herein by reference into this Item 1.01.

Item 2.03
Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

On December 22, 2022, Amgen entered into the Term Loan Credit Agreement as described under Item 1.01 above. The commitments under the Bridge Credit Facility shall be automatically reduced on the Effective Date by the amount of the Term Loan Credit Facility. The foregoing description of the Term Loan Credit Agreement set forth in Item 1.01 and the full text of the Term Loan Credit Agreement, a copy of which is filed as Exhibit 10.1 hereto, are incorporated herein by reference into this Item 2.03.

Forward-Looking Statements

This Current Report on Form 8-K contains certain statements about Horizon and Amgen that are or may be forward-looking statements which include, but are not limited to, statements regarding expected timing, completion and effects of the Acquisition. These forward-looking statements are subject to the safe harbor provisions under the U.S. Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts included in this Announcement may be forward-looking statements. Without limitation, forward-looking statements often include words such as "expect," "anticipate," "outlook," "could," "target," "project," "intend," "plan," "believe," "seek," "estimate," "should," "may," "assume" and "continue" as well as variations of such words and similar expressions are intended to identify such forward-looking statements. Horizon’s and Amgen’s expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks, and changes in circumstances, including but not limited to risks and uncertainties related to: the ability of the parties to complete the transactions contemplated by the transaction agreement entered into by and among Amgen, Pillartree Limited and Horizon on December 11, 2022 (the "Transaction Agreement"), including the Acquisition, in a timely manner or at all; the satisfaction (or waiver) of conditions to the consummation of the transactions contemplated by the Transaction Agreement, including the Acquisition, including with respect to the approval of Horizon’s shareholders and required regulatory approvals; potential delays in consummating the transactions contemplated by the Transaction Agreement, including the Acquisition; the ability of Horizon and Amgen to timely and successfully achieve the anticipated strategic benefits, synergies or opportunities expected of the transactions contemplated by the Transaction Agreement, including the Acquisition; the successful integration of Horizon into Amgen subsequent to the consummation of the transactions contemplated by the Transaction Agreement, including the Acquisition and the timing of such integration; the impact of changes in global, political, economic, business, competitive, market and regulatory forces; the impact of health pandemics, including the COVID-19 pandemic, on Horizon’s or Amgen’s respective businesses; the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the Transaction Agreement; adverse effects on the market price of Horizon’s or Amgen’s securities and on Horizon’s or Amgen’s operating results because of a failure to complete the Acquisition; the effect of the announcement or pendency of the Acquisition on Horizon’s or Amgen’s business relationships, operating results and business generally; costs related to the transactions contemplated by the Transaction Agreement, including the Acquisition; and the outcome of any legal proceedings that may be instituted against Horizon, Amgen, Pillartree Limited or any of their respective directors or officers related to the Transaction Agreement or the transactions contemplated by the Transaction Agreement, including the Acquisition. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Horizon’s most recent filings with the SEC, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, and Amgen’s most recent filings with the SEC, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, and any subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the SEC by Horizon or Amgen from time to time and available at www.sec.gov. These documents can be accessed on Horizon’s web page at View Source or on Amgen’s web page at View Source

The forward-looking statements included in this Current Report on Form 8-K are made only as of the date hereof. Neither Amgen nor Horizon assumes any obligation to, and neither Amgen nor Horizon intends to, update these forward-looking statements, except as required by law.

On December 22, 2022 Alligator Bioscience (Nasdaq Stockholm: ATORX) today reported the publication of a peer-reviewed article highlighting data from a Phase 1 dose-escalation study evaluating the safety, dose-limiting toxicities (DLTs), pharmacokinetic (PK) and pharmacodynamic (PD) profile of its lead clinical asset mitazalimab in patients with advanced solid malignancies (NCT02829099) (Press release, Alligator Bioscience, DEC 22, 2022, View Source [SID1234625528]).

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The publication in the journal Investigational New Drugs highlights the manageable safety profile of mitazalimab in multiple advanced solid malignancies. Mitazalimab was administered at doses up to 2000 μg/kg (with pre-infusion corticosteroids) and 1200 μg/kg (without corticosteroids). No Dose-Limiting Toxicities (DLTs) were seen at doses up to 900 μg/kg, the dose which is being pursued in the ongoing clinical study OPTIMIZE-1. Unlike other CD40 agonists, no cytokine release syndrome was reported. Pharmacokinetic profile was favorable, typical of a CD40 agonist mAb. Pharmacodynamic results demonstrated immune activation, as indicated by increased cytokines and chemokines, consistent with its proposed mechanism as a CD40 agonist.

Mitazalimab displayed clinical anti-tumor activity in this study with a partial response observed in a patient with renal cell carcinoma and stable disease (SD) reported in 36.8% of patients with varied tumor types, which lasted for more than six months in 9 patients (thymoma [n=3], sarcoma, adamantinoma, melanoma, cholangiocarcinoma, salivary gland carcinoma, and pancreatic adenocarcinoma [n=1 each]).

Overall, these findings support our ongoing and future trials exploring mitazalimab as an immunomodulatory agent in patients with advanced solid malignancies in combination with standard of care.

The full article, entitled "A Phase 1 Study of Intravenous Mitazalimab, a CD40 Agonist Monoclonal Antibody, in Patients with Advanced Solid Tumors", is available online via this link.

"The data presented in this publication provides further evidence of mitazalimab’s good safety and tolerability profile and adds to our growing knowledge about this CD40 agonist and the potential it possesses," said Søren Bregenholt, CEO of Alligator Bioscience. "We are very pleased to have these data published as it provides additional insights supporting ongoing clinical development of mitazalimab, particularly the OPTIMIZE-1 trial, which is making great progress towards its 2024 top-line readout."

Alligator is evaluating mitazalimab in combination with mFOLFIRINOX in OPTIMIZE-1, a Phase 1b/2 trial in first-line metastatic pancreatic cancer (NCT04888312). Data from the Phase 1b dose escalation phase of the trial showed mitazalimab in combination with mFOLFIRINOX is safe and well tolerated at the recommended dose of 900 μg/kg. Interim data from the study is expected the first weeks of January, and top-line data in Q1 2024.

The information was submitted for publication, through the agency of the contact person set out below, at 9:30 a.m. CET on December 22, 2022.

On December 22, 2022 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported that it has
revised and updated the long-term nancial guidance most recently included in its November 1, 2022 press release
announcing its nancial results for the third quarter of 2022 (Press release, Acorda Therapeutics, DEC 22, 2022, View Source [SID1234625527]). The revised guidance corrects certain errors identied
in the Company’s year-end budgeting process that overstated the Company’s projected Adjusted EBITDA and
ending cash balances for 2022-2027.
The revised guidance also reects updates from actual nancial results from October and November 2022 and from
the Company’s year-end budgeting process. These updates include the Company’s projected sales of Inbrija outside
the United States and total Inbrija sales for 2024-2027. The revised long-term nancial guidance does not aect
Acorda’s previously reported nancial results for the period ended September 30, 2022 or Inbrija U.S. net revenue
guidance for 2022 of between $27.8 – $28.7 million.
In addition, the Finnish government has advised the Company that it has satised all conditions to receive a waiver
of approximately $27.0 million of loans including accrued interest (based on the current exchange rate), that were
issued to its wholly owned subsidiary, Biotie Therapies Ltd. Upon receipt of formal notication, which is expected
shortly, these will no longer be carried on the Company’s balance sheet and will result in a corresponding increase
in net income in 2022. This will have no impact on the nancial guidance below, which does not reference net
income, and will be reected in the Company’s annual audited nancial statements.
Key Assumptions Underlying Business Plan and Guidance Remain Unchanged
INBRIJA will continue to grow in the U.S.
INBRIJA will expand into additional ex-U.S. markets
AMPYRA will continue to lose market share, but at a stabilizing rate
1
Acorda expects to be cash-ow positive in 2023
Continued Nasdaq listing
Renancing of 6.00% convertible senior secured notes due December 1, 2024
INBRIJA
The Company believes that INBRIJA has a signicant opportunity to expand the total market for on-demand
treatments
INBRIJA currently enjoys a 67% market share within the on-demand treatment class1
Healthcare professionals report they are generally more comfortable with INBRIJA than apomorphinebased on-demand treatments2
<2% of the 380,000 people with Parkinson’s who experience OFF periods are actively on any on-demand
treatment3
Acorda is implementing high-potential initiatives to grow the INBRIJA business
Launching new brand campaigns for physicians and people with Parkinson’s
Expanding usage of recently launched E-prescribing platform, which has increased fulllment rates
Introducing cash-pay option to improve patient access
Ex-U.S. revenue is expected to increase in 2023 and 2024 as the Germany launch progresses and additional
launches commence in Spain and Latin America
Partner discussions are in progress for Asia and additional EU markets

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AMPYRA

Alkermes arbitration ruling signicantly improves operating margins
An aggregate of $18.2 million received in fourth quarter 2022, which is $1.7 million greater than
previously announced due to correction of a computational error by the arbitration panel subsequent
to the initial award
No further royalty payments and ability to nd lower-cost supply, which has already been secured
$10 – $12 million savings in 2023 annual cost of goods (based on volume)
AMPYRA net sales currently at ~13% of peak sales
AMPYRA currently holds ~15% of dalfampridine market4
Long-term value of the brand expected at ~10% of peak sales through 2027
Field team continues to promote the brand
~200 health care professionals resumed prescribing AMPYRA in 2022
~70% of all covered lives have access to AMPYRA5

2022-2027 Financial Guidance

For the full year 2022, Acorda continues to expect AMPYRA net revenue and adjusted operating expenses to be
within the original guidance ranges. The nancial guidance provided below includes non-GAAP projections of
adjusted operating expenses (adjusted OPEX) and adjusted earnings before income taxes depreciation and
amortization (adjusted EBITDA), as described below under "Non-GAAP Financial Measures."
The EBITDA, Ending Cash Balance and Cash Flow gures in the table below have been revised to reect the
correction of an error embedded in the Company’s nancial forecasting model that did not impact other line items.
Net revenue gures increased slightly as a result of the Company’s year-end budgeting process.
Guidance Ranges in
U.S.$M 2022 2023 2024 2025 2026 2027
NET REVENUE
Inbrija U.S. $27.8 – $28.7 $37.3 – $41.2 $50.3 – $55.6 $58.8 – $65.0 $63.2 – $69.8 $70.3 – $77.7
Inbrija OUS $2.8 – $2.9 $7.3 – $8.1 $15.1 – $16.7 $27.3 – $30.2 $36.9 – $40.8 $48.2 – $53.2
Inbrija Sales $30.6 – $31.6 $44.6 – $49.3 $65.4 – $72.2 $86.1 – $95.1 $100.1 – $110.7 $118.5 – $131.0
Ampyra U.S. $71.4 – $73.6 $64.9 – $71.7 $61.9 – $68.4 $61.6 – $68.1 $64.3 – $71.0 $62.2 – $68.8
Fampyra Royalty $12.0 – $12.4 $9.7 – $10.7 $8.6 – $9.5 $8.6 – $9.5 $7.6 – $8.4 $7.6 – $8.4
Ampyra Sales $83.4 – $86.0 $74.6 – $82.4 $70.4 – $77.8 $70.1 – $77.5 $71.9 – $79.4 $69.8 – $77.2
ARCUS Development $0.0 – $0.0 $1.1 – $1.3 $1.5 – $1.6 $1.5 – $1.6 $1.5 – $1.6 $1.5 – $1.6
Neurelis Royalty $2.0 – $2.1 $1.9 – $2.1 $0.0 – $0.0 $0.0 – $0.0 $0.0 – $0.0 $0.0 – $0.0
Net Revenue
$116.0 –
$119.7
$122.2 –
$135.1
$137.3 –
$151.7
$157.7 –
$174.2
$173.5 –
$191.7
$189.8 –
$209.8
Adjusted OPEX $110.2 – $113.5 $89.6 – $99.0 $90.3 – $99.8 $93.0 – $102.8 $95.8 – $105.8 $98.6 – $109.0
Adjusted EBITDA $5.6 – $5.8 $22.0 – $24.3 $29.6 – $32.7 $39.1 – $43.2 $45.2 – $50.0 $50.5 – $55.8
Ending Cash Balance $43.2 – $44.5 $42.5 – $47.0 $55.4 – $61.2 $75.0 – $82.8 $97.6 – $107.9 $122.8 – $135.8
Cash Flow ($21.0) – ($21.7) ($0.4) – $2.8 $12.9 – $14.2 $19.6 – $21.6 $22.6 – $25.0 $25.3 – $27.9

Non-GAAP Financial Measures

This press release includes certain forward-looking non-GAAP nancial measures. In particular, Acorda has
provided 2022-2027 adjusted operating expense and adjusted EBITDA guidance on a non-GAAP basis. Non-GAAP
nancial measures are not an alternative for nancial measures prepared in accordance with GAAP.
Adjusted OPEX includes (i) research and development expenses and (ii) selling, general, and administrative
expenses and excludes (i) costs of goods sold, (ii) amortization of intangible assets, (iii) change in fair value of
derivative liability, and (iv) change in fair value of acquired contingent liability. Adjusted EBITDA is GAAP net income
(loss) before income taxes excluding (i) non-cash compensation charges and benets that are substantially
dependent on changes in the market price of our common stock, (ii) interest due on our convertible debt, (iii) noncash interest charges related to the accounting for our convertible debt which are in excess of the actual interest
expense owing on such convertible debt, as well as non-cash interest related to the Fampyra royalty monetization
and acquired Biotie debt, (iv) changes in the fair value of acquired contingent consideration which do not correlate
to our actual cash payment obligations in the relevant periods, (v) expenses that pertain to corporate restructurings
which are not routine to the operation of the business, and (vi) changes in the fair value of derivative liability
relating to the 2024 convertible senior secured notes, which is a non-cash charge and not related to the operation
of the business. We are unable to reconcile these forward-looking non-GAAP measures to GAAP due to the forwardlooking nature of the adjustments that are needed to determine this information, which includes information
regarding future compensation charges, future changes in the market price of our common stock, and changes in
the fair value of derivative and contingent liabilities, none of which are available at this time.
Non-GAAP nancial measures are not an alternative for nancial measures prepared in accordance with GAAP, and
the calculation of the non-GAAP nancial measures included herein may dier from similarly titled measures used
by other companies. The Company believes that the presentation of these non-GAAP nancial measures provides
investors with a more meaningful understanding of our ongoing and projected operating performance because it
excludes (i) expenses that pertain to corporate restructurings not routine to the operation of our business, (ii) noncash charges that are substantially dependent on changes in the market price of our common stock, and (iii) other
items as set forth above that are not ascertainable at the present time. We believe these non-GAAP nancial
measures help indicate underlying trends in the Company’s business and are important in comparing current
results with prior period results and understanding expected operating performance. Also, management uses these
non-GAAP nancial measures to establish budgets and operational goals, and to manage the Company’s business
and evaluate its performance.

On December 22, 2022 AB Science SA (Euronext – FR0010557264 – AB) reported today that it has received payment of €6.0 million
as the first tranche of a €15 million loan from the European Investment Bank (EIB)(Press release, AB Science, DEC 22, 2022, View Source [SID1234625526]).
As previously announced [1], the agreement signed with the EIB provides a financing in two tranches of EUR
6.0 million and a third tranche of EUR 3.0 million, each subject to the fulfillment of certain conditions
precedent, which have been satisfied for the first two tranches. Each tranche is accompanied by the issue of
warrants, the number of which is calculated in relation to a reference price of 14 euros according to the
following formula : Number of warrants = Amount of the tranche / (14 x m) with m = 3.4 for tranche 1 and
3.7 for tranche 2.
The first tranche has a maturity of six years and is therefore repayable in December 2028. It carries a
capitalized annual interest rate of 9.0% and the issuance of 126,050 warrants, each giving the right to
subscribe to one ordinary share of AB Science at 8.61 euros for 15 years. These warrants represent 0.24% of
the current capital of the Company (if they were to be exercised in their entirety).
The EIB also has a put option at intrinsic value (i.e. the difference between the stock market price and the
exercise price) allowing it to require the Company to repurchase all or part of the warrants then exercisable
but not yet exercised, under certain circumstances (for example in the event of a change of control or at the
reimbursement date of the first tranche). In addition, the Company has a right of first refusal to redeem any
warrants offered for sale to a third party, subject to certain exceptions.
On the basis of 126,050 new shares of the Company that could be issued upon exercise of all of these
warrants, the Company could potentially receive gross proceeds amounting to 1,085,290 euros. There is no
guarantee that the EIB will exercise all or part of the warrants or that the Company will receive any proceeds
from the exercise of these warrants.

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On December 21, 2022, Madrigal Pharmaceuticals, Inc. (the "Company" or "Madrigal") entered into a Securities Purchase Agreement (the "Securities Purchase Agreement") with a group of institutional investors (collectively, the "Investors") (Filing, 8-K, Madrigal Pharmaceuticals, DEC 21, 2022, View Source [SID1234625600]). The Securities Purchase Agreement provides for the issuance and sale to the Investors of (i) 400,000 shares of the Company’s new Series B Convertible Preferred Stock ("Series B Preferred Stock") at a price of $225.00 per share, and (ii) 44,444 shares of the Company’s common stock ("Common Stock") at a price of $225.00 per share.

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The Series B Preferred Stock is convertible by the holders into shares of Common Stock at a conversion price of $225.00 per share, subject to adjustment as provided in the Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (the "Certificate of Designation"). With the exception of the conversion price, the terms of the Series B Preferred Stock are substantially similar to the terms of the Company’s existing Series A Convertible Preferred Stock ("Series A Preferred Stock").

The gross proceeds from the transaction will be $100 million in the aggregate before estimated transaction expenses, which gross proceeds are comprised of $90 million for the shares of Series B Convertible Preferred Stock and $10 million for the shares of common stock. The net proceeds received by the Company from the transaction will be used for the Company’s clinical development program and preparation for a potential launch of resmetirom in the U.S. and general corporate purposes, including, without limitation, research and development expenditures, clinical trial expenditures, manufacture and supply of drug substance and drug products, acquisitions of new technologies, capital expenditures and working capital.

Each of the Investors are existing stockholders of the Company.

The Company will file a prospectus supplement with the Securities and Exchange Commission ("SEC") concerning the offer and sale of the Series B Preferred Stock and Common Stock being sold under the Securities Purchase Agreement (the "Offering"). The prospectus supplement will be filed under the Company’s effective shelf registration statement on Form S-3 (File No. 333-256666), and the base prospectus contained therein, filed with the SEC on June 1, 2021. The Offering is expected to close on or about December 23, 2022, subject to customary closing conditions. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Series B Preferred Stock or the Common Stock. The legal opinion of Hogan Lovells US LLP relating to the legality of the issuance and sale of the Series B Preferred Stock and the Common Stock pursuant to the Offering is attached as Exhibit 5.1 to this Current Report on Form 8-K and is incorporated by reference herein.

A copy of the Securities Purchase Agreement is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference. The foregoing summary of the Offering and the documentation related thereto is qualified by reference to such Exhibit to this Current Report on Form 8-K. The Securities Purchase Agreement has been included to provide investors and security holders with information regarding its terms. It is not intended to provide any other factual information about the Company. The representations, warranties and covenants contained in the Securities Purchase Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. The representations and warranties have been made for the purposes of allocating contractual risk between the parties to the Securities Purchase Agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to other investors generally.

On December 22, 2022, the Company also entered into an amendment (the "Amendment") to that certain Securities Purchase Agreement, dated June 20, 2017, with funds affiliated with Baker Bros. Advisors LP (the "Baker Bros. Investors"). Pursuant to the Amendment, the Baker Bros. Investors’ right to nominate one director to the Company’s board of directors was amended such that in order to exercise the right, among other conditions, the Baker Bros. Investors must hold both (i) at least 50% of the Company’s Series A Preferred Stock (including conversion shares) that they originally acquired and (ii) at least 9.5% of the outstanding shares of the Company’s common stock.

A copy of the Amendment is filed as Exhibit 10.2 to this Current Report on Form 8-K and is incorporated herein by reference.