On January 14, 2022, X4 Pharmaceuticals, Inc. (the "Company" and Lincoln Park Capital Fund, LLC ("Lincoln Park") reported that entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement"), pursuant to which the Company has the right to sell to Lincoln Park shares of the Company’s common stock, par value $0.001 per share (the "Common Stock"), having an aggregate value of up to $50,000,000 (the "Purchase Shares"), subject to certain limitations and conditions set forth in the Purchase Agreement (Filing, 8-K, X4 Pharmaceuticals, JAN 14, 2022, View Source [SID1234605498]). The Company will control the timing and amount of any sales of Purchase Shares to Lincoln Park pursuant to the Purchase Agreement.

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In consideration for entering into the Purchase Agreement, the Company agreed to issue 230,414 shares of Common Stock (the "Initial Commitment Shares") to Lincoln Park as an initial commitment fee. The Company will not receive any cash proceeds from the issuance of the Commitment Shares.

Upon execution of the Purchase Agreement and the Registration Rights Agreement on January 14, 2022, the Company sold to Lincoln Park, as an initial purchase under the Purchase Agreement, 1,382,488 shares of common stock, at a per share price of $2.17 per share, for aggregate consideration of approximately $3,000,000.

Under the Purchase Agreement, on any business day after January 14, 2022 selected by the Company over the 36-month term of the Purchase Agreement (each, a "Purchase Date"), the Company may direct Lincoln Park to purchase up to 50,000 shares of Common Stock on such Purchase Date (a "Regular Purchase") if the closing sale price per share of the Common Stock on the Nasdaq Capital Market is not below $1.00 on the applicable Purchase Date; provided, however, that (i) a Regular Purchase may be increased to up to 75,000 shares, if the closing sale price per share of the Common Stock on Nasdaq is not below $7.50 on the applicable Purchase Date; and (ii) a Regular Purchase may be increased to up to 100,000 shares, if the closing sale price per share of the Common Stock on Nasdaq is not below $10.00 on the applicable Purchase Date. In any case, Lincoln Park’s maximum obligation under any single Regular Purchase will not exceed $2,000,000, unless the Company and Lincoln Park mutually agree to increase the maximum amount of such Regular Purchase. The above-referenced share amount limitations and closing sale price thresholds are subject to adjustment for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction as provided in the Purchase Agreement. The purchase price per share for each such Regular Purchase will be equal to the lesser of:
•the lowest sale price for the Common Stock on the Nasdaq Capital Market on the date of sale; and
•the average of the three lowest closing sale prices for the Common Stock on the Nasdaq Capital Market during the 10 consecutive business days ending on the business day immediately preceding the purchase date.

The Company also has the right to direct Lincoln Park, on any business day on which the Company has properly submitted a Regular Purchase notice for the maximum amount the Company is then permitted to sell to Lincoln Park in such Regular Purchase, to purchase an additional amount of the Common Stock (an "Accelerated Purchase") of up to the lesser of:
•300% of the number of shares to be purchased pursuant to such Regular Purchase; and
•30% of the aggregate shares of the Common Stock traded on the Nasdaq Capital Market during all or, if certain trading volume or market price thresholds specified in the Purchase Agreement are crossed on the applicable Accelerated Purchase date, the portion of the normal trading hours on the applicable Accelerated Purchase date prior to such time that any one of such thresholds is crossed, which period of time on the applicable Accelerated Purchase date is referred to as the Accelerated Purchase Measurement Period.

The parties may mutually agree to increase the number of shares to be purchased by Lincoln Park pursuant to any Accelerated Purchase.

The purchase price per share for each such Accelerated Purchase will be equal to 97% of the lessor of:
•the volume-weighted average price of the Common Stock on the Nasdaq Capital Market during the applicable Accelerated Purchase Measurement Period on the applicable Accelerated Purchase date; and
•the closing sale price of the Common Stock on the Nasdaq Capital Market on the applicable Accelerated Purchase date.

The Company also has the right to direct Lincoln Park on any business day on which an Accelerated Purchase has been completed and all of the shares to be purchased thereunder have been properly delivered to Lincoln Park in accordance with the Purchase Agreement to purchase an additional amount of the Common Stock (an "Additional Accelerated Purchase") of up to the lesser of:
•300% of the number of shares purchased pursuant to the applicable corresponding Regular Purchase; and
•30% of the aggregate shares of the Common Stock traded on the Nasdaq Capital Market during all or, if certain trading volume or market price thresholds specified in the Purchase Agreement are crossed on the applicable Additional Accelerated Purchase date, the portion of the normal trading hours on the applicable Additional Accelerated Purchase date prior to such time that any one of such thresholds is crossed, which period of time on the applicable Additional Accelerated Purchase date is referred to as the Additional Accelerated Purchase Measurement Period.

The parties may mutually agree to increase the number of shares to be purchased by Lincoln Park pursuant to any Additional Accelerated Purchase.

The Company may, in its sole discretion, submit multiple Additional Accelerated Purchase notices to Lincoln Park on a single Accelerated Purchase date, provided that all prior Accelerated Purchases and Additional Accelerated Purchases (including those that have occurred earlier on the same day) have been completed and all of the shares to be purchased thereunder have been properly delivered to Lincoln Park in accordance with the Purchase Agreement.

The purchase price per share for each such Additional Accelerated Purchase will be equal to 97% of the lower of:
•the volume-weighted average price of the Common Stock on the Nasdaq Capital Market during the applicable Additional Accelerated Purchase Measurement Period on the applicable Additional Accelerated Purchase date; and
•the closing sale price of the Common Stock on the Nasdaq Capital Market on the applicable Additional Accelerated Purchase date.

In the case of Regular Purchases, Accelerated Purchases and Additional Accelerated Purchases, the purchase price per share will be equitably adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction occurring during the business days used to compute the purchase price.
Other than as described above, there are no trading volume requirements or restrictions under the Purchase Agreement, and the Company will control the timing and amount of any sales of Common Stock to Lincoln Park.

The Purchase Agreement prohibits the Company from directing Lincoln Park to purchase any shares of Common Stock if those shares, when aggregated with all other shares of Common Stock then beneficially owned by Lincoln Park (as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder), would result in Lincoln Park beneficially owning more than 9.99% of the then total outstanding shares of Common Stock.

Under applicable rules of the Nasdaq Capital Market, the Company may not issue or sell to Lincoln Park under the Purchase Agreement more than 19.99% of the shares of the Common Stock outstanding immediately prior to the execution of the Purchase Agreement (the "Exchange Cap") (or 5,622,718 shares, based on 28,127,657 shares outstanding immediately prior to the execution of the Purchase Agreement), unless (i) the Company obtains stockholder approval to issue shares of its common stock in excess of the Exchange Cap to Lincoln Park under the Purchase Agreement in accordance with applicable Nasdaq rules or (ii) the average price of all applicable sales of Common Stock to Lincoln Park under the Purchase Agreement equals or exceeds $2.17 per share, which is the lower of (A) the official closing price of the Common Stock on Nasdaq on the date immediately preceding the execution Purchase Agreement and (B) the average official closing price of the Common Stock on Nasdaq for the five consecutive trading days immediately preceding date of the Purchase Agreement, such that the transactions contemplated by the Purchase Agreement are exempt from the Exchange Cap limitation under applicable Nasdaq rules.

The Purchase Agreement does not limit the Company’s ability to raise capital from other sources at its sole discretion, except that, subject to certain exceptions, for a period set forth in the Purchase Agreement, the Company may not enter into any equity line of credit or similar continuous offering other than with Lincoln Park, excluding an "at the market offering" of Common Stock exclusively through one or more registered broker dealers.

The Purchase Agreement and Registration Rights Agreement each contain customary representations, warranties, and agreements of the Company and Lincoln Park, indemnification rights and other obligations of the parties. The Offering of Common Stock pursuant to the Purchase Agreement will terminate on the date that all shares offered by the Purchase Agreement have been sold or, if earlier, the expiration or termination of the Purchase Agreement. The Company has the right to terminate the Purchase Agreement at any time, without fee, penalty or cost to the Company.

Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Common Stock.

The aggregate net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which shares of Common Stock are sold to Lincoln Park. Actual sales of shares of Common Stock to Lincoln Park under the Purchase Agreement and the amount of such net proceeds will depend on a variety of factors to be determined by the Company from time to time, including (among others) market conditions, the trading price of the Common Stock and determinations by the Company as to other available and appropriate sources of funding for the Company. The Company expects to use any proceeds from the sale of the Purchase Shares to develop its product pipeline, for working capital and for general corporate purposes.

The issuance of the Purchase Shares and Commitment Shares have been registered pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-242372) (the "Registration Statement"), and the related base prospectus included in the Registration Statement, as supplemented by a prospectus supplement filed on January 14, 2022. A copy of the legal opinion as to the legality of the shares of Common Stock subject to the Purchase Agreement is filed as Exhibit 5.1 attached hereto.

The foregoing is a summary description of certain terms of the Purchase Agreement and the Registration Rights Agreement and, by its nature, is incomplete. Copies of the Purchase Agreement and the Registration Rights Agreement are attached hereto as Exhibit 10.1 and Exhibit 10.2, respectively, and are incorporated herein by reference. The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to such exhibits.

The Purchase Agreement and Registration Rights Agreement contain customary representations and warranties, covenants and indemnification provisions that the parties made to, and solely for the benefit of, each other in the context of all of the terms and conditions of such agreements and in the context of the specific relationship between the parties thereto. The provisions of the Purchase Agreement and Registration Rights Agreement, including any representations and warranties contained therein, are not for the benefit of any party other than the parties thereto and are not intended as documents for investors and the public to obtain factual information about the current state of affairs of the parties thereto. Rather, investors and the public should look to other disclosures contained in the Company’s annual, quarterly and current reports the Company may file with the Securities and Exchange Commission ("SEC").

The information contained in this Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the shares of Common Stock discussed herein, nor shall there be any offer, solicitation or sale of the shares in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On January 13, 2022 Onxeo S.A. (Euronext Growth Paris: ALONX, First North Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), in particular against rare or resistant cancers, reported its financial agenda for 2022 (Press release, Onxeo, JAN 13, 2022, View Source [SID1234605460]).

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Event Date*
Full-year 2021 results Wednesday, March 30, 2022
Shareholders’ general meeting Thursday, May 12, 2022
Half-year 2022 results Thursday, July 28, 2022

* This preliminary agenda may be modified.

On January 13, 2022 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with sarcomas, pediatric cancers, and other cancers, reported a definitive agreement with DeuteRx, LLC to acquire an oral, small molecule targeted protein degradation portfolio (Press release, Salarius Pharmaceuticals, JAN 13, 2022, View Source [SID1234605477]). The acquisition includes a lead drug candidate that Salarius has renamed SP-3164 (formerly DRX-164), the related patent family, including issued composition of matter patents, and the opportunity to develop additional undisclosed cancer-fighting assets in the targeted protein degradation space. Targeted protein degradation takes advantage of the body’s own degradation system to promote the selective elimination of disease-causing proteins.

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"This strategic acquisition is a transformative event for Salarius that significantly expands our development pipeline while building upon the momentum of our lead clinical-stage candidate, seclidemstat, our existing infrastructure and our scientific expertise," stated David Arthur, Chief Executive of Salarius Pharmaceuticals. "SP-3164 provides entry into the exciting field of protein degradation, a fast-growing area of cancer drug research that is attracting substantial interest from some of the world’s largest pharmaceutical companies because of the potential advantages of protein degraders, including the ability to go after previously undruggable cancer-promoting targets."

SP-3164 is a next-generation cereblon-binding molecular glue. Molecular glues are small molecules that commandeer the body’s normal protein-degradation processes and induce selective elimination of cancer-causing proteins. Derived from avadomide, SP-3164 was developed by using deuterium-enabled chiral switching (DECS), a unique strategy that utilizes deuterium to stabilize the preferred, active (S)-enantiomer from the first-generation compound, avadomide. This creates a new molecular entity with the potential for increased efficacy and improved safety. Salarius plans to develop SP-3164 as a potential treatment for hematological cancers and solid tumors and plans to begin the first clinical trial in 2023.

Mr. Arthur continued, "In addition to advancing seclidemstat, our goal at Salarius is to develop a multiprong internal pipeline and advance cancer therapies that address the unmet needs of patients and, by doing so, generate value for patients and shareholders. With SP-3164, Salarius plans to enter the protein degradation space which generated global sales of over $15 billion dollars in 2020. Funded with existing financial resources, this acquisition capitalizes on our strong cash position and our seclidemstat momentum."

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As part of the agreement, Salarius and DeuteRx will collaborate to complete SP-3164 development activities and collaborate on the research and development of future products.

Under the terms of the agreement, DeuteRx will receive from Salarius an upfront payment consisting of $1.5 million in cash and 1 million shares of restricted stock. Based upon the success of SP-3164, DeuteRx is also entitled to receive up to $53 million in future clinical and regulatory event-driven milestone payments and sales achievement milestone payments of up to $135 million, as well as escalating royalties on net sales. Additionally, DeuteRx is eligible to receive event-driven clinical, regulatory and sales achievement milestone payments of up to $84 million, as well as escalating royalties on net sales, for each of two future products.
"DeuteRx is excited to collaborate with the team at Salarius to advance SP-3164 and additional programs for the benefit of patients in need of better treatment options," said Sheila DeWitt, Ph.D., President and CEO of DeuteRx. "Our agreement with Salarius aligns with our goal to partner with innovative companies to unlock the value of our DECS technology platform and our differentiated drug candidates. I look forward to seeing this exciting new therapy advance through the clinic."
Conference Call Information:
Salarius Pharmaceuticals will host a conference call and live audio webcast on Thursday, January 13, 2022, at 8:30 a.m. EST, to discuss the asset acquisition agreement with DeuteRx. Interested participants and investors may access the conference call by dialing:
(833) 423-0481 (U.S.) or (918) 922-2375 (international)
Conference ID: 6528776
Investors may submit questions to Salarius prior to the conference call by e-mail to [email protected]. Please use the e-mail subject heading "Salarius/DeuteRx Acquisition" to ensure that the information is received. Salarius’ management will respond to select questions during the conference call.
An audio webcast will be accessible via the Investors Events and Presentations section of the Company’s website View Source An archive of the webcast will remain available for 90 days beginning at approximately 8:30 a.m. ET, on January 13, 2022.

About SP-3164
SP-3164, formerly DRX-164, is the next-generation, deuterium-stabilized (S)-enantiomer of avadomide. DRX-164 was developed by DeuteRx LLC. Avadomide is one of the most extensively studied molecular glues, a class of targeted protein degraders. It has been studied in more than 400 subjects across 10 clinical trials for patients with hematological cancers and solid tumors and has demonstrated efficacy when used as a single agent and when used in combination

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therapy. SP-3164 is a patent-protected new molecular entity with the potential for increased efficacy and improved safety compared to avadomide.
Avadomide is a 1:1 mixture of two mirror-image compounds ((R)- and (S)-enantiomers) that interconvert in vitro and in vivo. Using deuterium, DeuteRx stabilized each enantiomer and characterized their dramatically different pharmacological properties. In in vitro studies, SP-3164, the deuterium-stabilized (S)-enantiomer, has been shown to be the active enantiomer as it is primarily responsible for the cereblon-binding and the anti-inflammatory activity of avadomide1. As a result, in a preclinical efficacy model, SP3164 exhibited the anti-tumorigenic activity while the (R)-enantiomer appears to promote tumor growth2. Based upon preclinical results to date, SP-3164 has the potential to exhibit a better therapeutic profile than avadomide and will be the first stabilized, single enantiomer cereblon-binding protein degradation agent to enter the clinic.

On January 13, 2022 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that operational and preliminary financial highlights for the fourth quarter and fiscal year ending December 31, 2021 (Press release, Quanterix, JAN 13, 2022, View Source [SID1234605461]).

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"The healthcare industry will reach its next inflection point in 2022 requiring novel solutions to combat COVID-19 and its new variants like Omicron, in addition to treating challenging neurodegenerative disorders, including Alzheimer’s and Parkinson’s, which affect more than seven million people in the United States alone," said Kevin Hrusovsky, Chairman and Chief Executive Officer, Quanterix.

"Our ultra-sensitive biomarker detection technology has been making unprecedented progress in these key therapeutic areas, particularly with the recent Breakthrough Device Designation for our plasma pTau-181 Alzheimer’s test and COVID-19 Antigen EUA label expansion for asymptomatic and saliva testing. Quanterix continues to empower drug developers with tests that improve drug trial efficiency, and which also show promise to payors for early disease detection, treatment for improved outcomes, and cost-effective patient monitoring to deliver clinical evidence in support of coverage decisions. We believe that the high sensitivity and accuracy of these tests ultimately have the potential to transform reactive, symptomatic medicine, or ‘sick-care,’ to proactive, asymptomatic healthcare," continued Hrusovsky.

2021 Operational Highlights

Quanterix’ pTau-181 assay was granted Breakthrough Device Designation from the U.S. FDA as an aid in the diagnosis of Alzheimer’s disease.
Eli Lilly presented new data from its Phase 2 TRAILBLAZER-ALZ study, which employed Quanterix’ ultra-sensitive Simoa HD-X technology to measure plasma pTau-217, using antibodies developed by Lilly. Lilly reported a significant reduction in blood levels of phosphorylated Tau protein after treatment with donanemab, and that a reduction in plasma pTau-217 levels correlated with the slowing of cognitive decline.
Following the FDA approval of ADUHELM, Biogen conducted Simoa biomarker studies on Phase 3 EMERGE and ENGAGE trial samples, utilizing Quanterix’ Simoa HD-X to measure plasma pTau-181. Dr. Oskar Hansson from University of Lund reported preliminary data showing a dose-dependent reduction in plasma pTau-181 levels following treatment with ADUHELM, which correlated with decreases in amyloid PET and a slowing of cognitive decline across four independent assessment tools.
Quanterix received label expansion on the Emergency Use Authorization for its COVID Antigen Test.
Instrument installations increased by 32% in 2021 to 708, with many HD-X instruments being used for neuro-related applications.
Data presented at 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference described a prototype Simoa plasma pTau-231 assay and the potential role for this emerging biomarker in the detection of Alzheimer’s disease pathology even earlier in the disease continuum, when patients are asymptomatic and not yet exhibiting brain pathology in PET imaging studies.
Academic publication pull-through performance continued to be strong. Quanterix’ Simoa technology was highlighted in a record 465 new publications in 2021, bringing total Simoa-specific inclusions to over 1,585.
The Company strengthened its balance sheet by successfully raising $287.5 million in gross proceeds through a follow-on offering. Quanterix had $411 million in cash and cash equivalents on the balance sheet at the end of Q3 FY21.
Hired President and CCO in 2021 to accelerate the operational scaling of Quanterix’ RUO opportunity and to catalyze the symbiotic relationship between Research and Diagnostic.
In an interview with Managed Healthcare Executive for the "Tuning into the C-Suite Podcast," Hrusovsky discussed successful tools to improve precision health. The podcast was named one of the most popular multimedia posts for 2021.
Quanterix was named a finalist for the Deloitte Fast 500 list, which ranks the fastest-growing technology, media, telecommunications and life sciences companies based in North America. The annual ranking is based on percentage revenue growth over the Company’s last three fiscal years.
Preliminary Non-Audited Financial Highlights:

Q4 2021

Expect total revenue, which includes one-time grant revenue, of $29-31 million(1); product and service revenue of $28-30 million; and product (consumables and instruments) revenue of $21-23 million.
Product and service revenue represents an increase of approximately 35% over prior Q4.
Product revenue represents an increase of approximately 45% over prior Q4.
Full Year 2021

Expect total revenue, which includes one-time grant revenue, of $109-111 million(2); product and service revenue of $104-106 million; and product revenue of $80-82 million.
Product and service revenue growth represents an increase of approximately 53% year over year.
Product revenue growth represents an increase of approximately 84% year over year.
(1) Total revenue for Q4 2021 includes approximately $1 million in RADx-related grant revenue, which is subject to adjustment pending finalization of contract accounting for Q4. Total revenue for Q4 2020 includes approximately $4.5 million in RADx-related grant revenue.

(2) Total revenue for full year 2021 includes the approximate $1 million in Q4 RADx-related grant revenue noted above plus an additional $4 million of RADx revenue that was recognized in the first three quarters of 2021. Total revenue for full year 2020 includes (i) $6.4 million in RADx revenue; and (ii) $11.2 million revenue recognized in connection with certain license agreements with Abbott laboratories.

The estimated unaudited financial results as of and for the fourth quarter and full fiscal year ended December 31, 2021 presented above are preliminary and are subject to completion of our quarter-end and year-end closing procedures and further financial review. This preliminary financial information has not been audited by our independent auditing firm. Our actual results may differ from these estimates as a result of the completion of our quarter-end and year-end closing procedures, review adjustments and other developments that may arise between now and the time our financial results for the fourth quarter and year are finalized.

Presentation at JP Morgan Healthcare Conference

As previously announced, Hrusovsky will be presenting the Company’s growth and vision for the sixth consecutive year at the 40th Annual J.P. Morgan Healthcare Conference. Hrusovsky’s session will take place on Thursday, Jan. 13, 2022, at 8:15 a.m., EST (5:15 a.m., PST) and will be made available to attendees and the general public. In addition to Hrusovsky’s session, he will also be hosting one-on-one meetings with institutional investors during the conference.

To access the live webcast of Quanterix’ presentation, please visit: View Source;kiosk=true

On January 13, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its fourth quarter and full year 2021 financial and operating results on Friday, February 4, 2022, before the U.S. financial markets open (Press release, Regeneron, JAN 13, 2022, View Source [SID1234605462]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
Participants may access the conference call live via webcast on the ‘Investors and Media’ page of Regeneron’s website at View Source To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.