On June 1, 2022 Regeneron Pharmaceuticals, Inc., a New York corporation ("Regeneron" or the "Company"), and Sanofi Biotechnology SAS, a société par actions simplifée organized under the laws of France ("Sanofi Biotechnology"), reported that entered into the Amended and Restated Immuno-Oncology License and Collaboration Agreement (the "A&R IO LCA"), which amends the Immuno-Oncology License and Collaboration Agreement, dated as of July 1, 2015 and executed as of July 27, 2015 (as amended), by and between the Company and Sanofi Biotechnology (the "Original IO LCA") (Filing, 8-K, Regeneron, JUN 1, 2022, View Source [SID1234615411]). The A&R IO LCA is subject to and will become effective on the first day of the first month following receipt of all necessary authorizations and expiration of all necessary waiting periods applicable to the consummation of the A&R IO LCA (such date, the "A&R Effective Date").

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The Original IO LCA provides for Regeneron and Sanofi Biotechnology to collaborate on the development and commercialization of certain immuno-oncology products, including Libtayo (cemiplimab). From and after the A&R Effective Date, Regeneron will have the sole right to develop and commercialize Libtayo worldwide and no other products will be subject to the A&R IO LCA; and Regeneron will also obtain a license under certain intellectual property rights of Sanofi Biotechnology to develop and commercialize Libtayo worldwide and Sanofi Biotechnology will transfer to Regeneron certain regulatory, promotional, and other rights relating to the commercialization of Libtayo outside the United States. The parties have also entered into a transition services agreement, a transitional distribution agreement, and a manufacturing services agreement, pursuant to which, during certain transitional periods, Sanofi Biotechnology will perform for Regeneron certain transition, distribution, and manufacturing services, respectively.

Under the A&R IO LCA, the quarterly period ended March 31, 2022 is the last quarter for which Sanofi Biotechnology and Regeneron share net profits and losses for Libtayo under the Original IO LCA. From and after April 1, 2022 (after giving effect to certain true-up payments as set forth in the A&R IO LCA), Regeneron will be entitled to all profits from Libtayo and will pay Sanofi Biotechnology an 11% royalty on net product sales of Libtayo through March 31, 2034. In addition, the A&R IO LCA provides for the following payments by Regeneron to Sanofi Biotechnology: (i) a $900 million upfront payment, payable within 10 business days after the A&R Effective Date; (ii) a $100 million development milestone payment upon the first marketing approval from the U.S. Food and Drug Administration or the European Commission of Libtayo in non-small cell lung cancer in combination with chemotherapy; and (iii) sales milestone payments of up to $100 million in the aggregate upon achieving certain amounts of worldwide net product sales of Libtayo in 2022 or 2023.

Under the A&R IO LCA, the amount of development costs incurred under the Original IO LCA for which Regeneron is obligated to reimburse Sanofi Biotechnology is $35 million. Regeneron will reimburse Sanofi Biotechnology for such development costs by paying Sanofi a 0.5% royalty on Regeneron’s net product sales of Libtayo until Regeneron has reimbursed Sanofi Biotechnology for all such development costs.

Fifth Amendment to Antibody LCA. On June 1, 2022, Regeneron, Sanofi Biotechnology, and Sanofi, a société anonyme organized under the laws of France ("Sanofi Parent"), entered into the Fifth Amendment to Amended and Restated License and Collaboration Agreement (the "Fifth Amendment"), which amends the Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009 (as amended), by and between the Company, Sanofi Biotechnology (as successor in interest to Aventis Pharmaceuticals Inc.) and Sanofi Parent (the "Antibody LCA") and will become effective on the A&R Effective Date. Pursuant to the Fifth Amendment, the parties amended the Antibody LCA, among other matters, to, from and after April 1, 2022, increase from 10% to 20% the percentage of Regeneron’s share of profits used to reimburse Sanofi Biotechnology for the remaining development costs incurred under the Antibody LCA subject to reimbursement by Regeneron.

The foregoing description of the A&R IO LCA and the Fifth Amendment is qualified in its entirety by reference to the full text of the A&R IO LCA and the Fifth Amendment, a copy of each of which will be filed with the U.S. Securities and Exchange Commission as an exhibit to the Quarterly Report on Form 10-Q to be filed by the Company for the quarterly period ending June 30, 2022.

On June 1, 2022 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing both restorative therapeutics and pan-caspase and caspase selective inhibitors focused on treatments for infectious and inflammatory diseases, reported that its Board of Directors has approved a 1-for-20 reverse stock split of the Company’s issued and outstanding common stock (the "Reverse Stock Split") (Press release, Conatus Pharmaceuticals, JUN 1, 2022, View Source [SID1234615427]). The Reverse Stock Split will be effective at 4:01 p.m. Eastern Time on June 2, 2022. The Company’s common stock is expected to begin trading on The Nasdaq Capital Market on a split-adjusted basis on June 3, 2022.

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On June 1, 2022, the Company’s Board of Directors approved the Reverse Stock Split at the ratio of 1-for-20 shares. Also on June 1, 2022, the Company’s stockholders approved the Reverse Stock Split at the annual meeting of stockholders held on June 1, 2022 at a ratio ranging from 1-for-5 up to a ratio of 1-for-20, such ratio and the implementation and timing of such Reverse Stock Split to be determined by the Company’s Board of Directors.

The principal purpose of the Reverse Stock Split is to decrease the total number of shares of common stock outstanding and proportionately increase the market price of the common stock in order to meet the continuing listing requirements of The Nasdaq Capital Market. In connection with the Reverse Stock Split, the Company’s CUSIP number will change to 43358Y202 as of June 3, 2022. The Company’s common stock will continue to trade under the symbol "HSTO."

As a result of the Reverse Stock Split, every 20 shares of the Company’s common stock issued and outstanding will be automatically reclassified into one new share of common stock. The Reverse Stock Split will not modify any rights or preferences of the shares of the Company’s common stock. Proportionate adjustments will be made to the exercise prices and the number of shares underlying the Company’s outstanding equity awards, as applicable, and warrants, as well as to the number of shares issued and issuable under the Company’s equity incentive plans. The common stock issued pursuant to the Reverse Stock Split will remain fully paid and non-assessable. The Reverse Stock Split will not affect the number of authorized shares of common stock or the par value of the common stock nor will it change the authorized shares of Preferred Stock or the relative voting power of such holders of our outstanding common stock and Preferred Stock.

No fractional shares will be issued in connection with the Reverse Stock Split. Stockholders who would otherwise be entitled to receive fractional shares as a result of the Reverse Stock Split will be entitled to a cash payment in lieu thereof at a price equal to the fraction to which the stockholder would otherwise be entitled multiplied by the closing trading price per share of the common stock (as adjusted for the reverse stock split) on the Nasdaq Capital Market on the trading day immediately preceding the effective time of the reverse stock split.

American Stock Transfer & Trust Company, LLC has been appointed by the Company to act as its exchange agent for the reverse stock split. Stockholders owning pre-split shares via a bank, broker or other nominee will have their positions automatically adjusted to reflect the Reverse Stock Split and will not be required to take further action in connection with the Reverse Stock Split, subject to brokers’ particular processes. Similarly, registered stockholders holding pre-split shares of the Company’s common stock electronically

in book-entry form are also not required to take further action in connection with the Reverse Stock Split. Holders of certificated shares will be contacted by the Company or its exchange agent with further details about how to surrender old certificates.

Additional information about the Reverse Stock Split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission (the "SEC") on April 21, 2022, which is available free of charge at the SEC’s website, www.sec.gov, and on the Company’s website at www.histogen.com.

On June 1, 2022 PharmaMar (MSE:PHM) reported that they and their partners will present eight new abstracts from several clinical studies with Zepzelca (lurbinectedin) and Yondelis (trabectedin) during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, to be held June 3-7, 2022 in situ in Chicago, USA and virtually (Press release, PharmaMar, JUN 1, 2022, View Source [SID1234615308]).

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Among the studies to be presented are the poster entitled "Analysis of patients with relapsed small cell lung cancer (SCLC) receiving single-agent lurbinectedin in the phase 3 ATLANTIS trial", which shows the results of a subgroup of 50 patients with SCLC from the phase III ATLANTIS trial who, after having received 10 cycles of lurbinectedin 2.0mg/m2 in combination with doxorubicin, went on to be treated with lurbinectedin as a single agent at the approved dose of 3.2 mg/m2. The results show that these patients tended to maintain or better the tumor response obtained with the combination when switched to lurbinectedin monotherapy, including an increase in the rate of complete responses. These patients also had favorable Overall Survival (OS), with a median of 20.7 months, and no new signs of toxicity were identified.

Under the title "Efficacy and safety of lurbinectedin as second-line therapy in Chinese patients with small cell lung cancer: Preliminary results of a phase 1 study", the results of the phase I trial will be presented, in which lurbinectedin monotherapy has shown promising efficacy as a second-line treatment in Chinese patients with SCLC, with acceptable tolerability and a manageable safety profile.

Results from the Phase I trial of lurbinectedin in combination with immunotherapy will also be presented. This poster, entitled "A phase 1/2 trial of lurbinectedin (L) in combination with pembrolizumab (P) in relapsed small cell lung cancer (SCLC): The LUPER study", shows the phase I results of this trial, which demonstrates a manageable safety profile and preliminary antitumor activity of the combination of lurbinectedin with pembrolizaumab in second-line patients with relapsed SCLC, and the trial’s expansion phase is already ongoing.

Finally, with regards to lurbinectedin, data from the cohort of patients with BRCA1/2-associated breast cancer from the Phase II trial with lurbinectedin as a single agent will be presented. The poster "Lurbinectedin in patients with pretreated BRCA1/2-associated metastatic breast cancer: Results from a phase II basket study" confirms the activity of lurbinectedin previously observed in this indication.

Studio e la Cura dei Tumori (Italy) will give an oral presentation of the abstract entitled "Neoadjuvant chemotherapy in high-risk soft tissue sarcomas: Results of the expanded cohort of myxoid liposarcoma of the randomized clinical trial from the Italian Sarcoma Group (ISG), the Spanish Sarcoma Group (GEIS), the French Sarcoma Group (FSG), and the Polish Sarcoma Group (PSG)", in which he will present the efficacy results of trabectedin in high-grade myxoid liposarcoma. Thanks to the previous results obtained in this study, the ESMO (Free ESMO Whitepaper) Guidelines included trabectedin as a treatment option for this subtype of sarcoma in 2021.

All ASCO (Free ASCO Whitepaper) poster presentations are available on request to registered participants for 180 days from May 26, 2022: View Source

Highlighted studies at ASCO (Free ASCO Whitepaper) 2022

Zepzelca (lurbinectedin)

TITLE
LEAD AUTHOR ABSTRACT
Analysis of patients with relapsed small cell lung cancer (SCLC) receiving single-agent lurbinectedin in the phase 3 ATLANTIS trial Alejandro Navarro MD ABSTRACT: 207436 POSTER SESION: Lung Cancer—Non-Small Cell Local-Regional/Small
Efficacy and safety of lurbinectedin as second-line therapy in Chinese patients with small cell lung cancer: Preliminary results of a phase 1 study Ying Cheng MD ABSTRACT: 207457 POSTER SESSION: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
A phase 1/2 trial of lurbinectedin (L) in combination with pembrolizumab (P) in relapsed small cell lung cancer (SCLC): The LUPER study Antonio Calles MD, MSc ABSTRACT: 210025 POSTER SESSION: Breast Cancer—Metastatic
Lurbinectedin in patients with pretreated BRCA1/2-associated metastatic breast cancer: Results from a phase II basket study Valentina Boni MD ABSTRACT: 210025 POSTER SESSION: Breast Cancer—Metastatic
Efficacy of lurbinectedin in a clinical trial versus other standard of care in a real-world comparator arm in relapsed/refractory small cell lung cancer patients Apar Kishor Ganti MD ABSTRACT: 208920 PUBLICATION ONLY: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Yondelis (trabectedin)

Neoadjuvant chemotherapy in high-risk soft tissue sarcomas: Results of the expanded cohort of myxoid liposarcoma of the randomized clinical trial from the Italian Sarcoma Group (ISG), the Spanish Sarcoma Group (GEIS), the French Sarcoma Group (FSG), and the Polish Sarcoma Group (PSG) Alessandro Gronchi MD ABSTRACT: 208036 ORAL ABSTRACT SESSION: Sarcoma
Randomized phase III trial on trabectedin (ET-743) single agent versus clinician’s choice chemotherapy in recurrent ovarian, primary peritoneal, or fallopian tube cancers of BRCA-mutated or BRCAness phenotype patients (MITO23) Giovanni Scambia MD ABSTRACT: 206849 ORAL ABSTRACT SESSION: Gynecologic Cancer
Trabectedin in advanced retroperitoneal well differentiated/dedifferentiated liposarcoma and leiomyosarcoma (TRAVELL): Results of a phase 2 study from Italian sarcoma group (ISG) Roberta Sanfilippo MD ABSTRACT: 211471 POSTER SESSION: Sarcoma

On June 1, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported Scott Hutton, Chief Executive Officer of Biodesix, will present at the 42nd Annual William Blair Growth Stock Conference being held June 6-9, 2022 at the Lowes Chicago Hotel in Chicago, IL (Press release, Biodesix, JUN 1, 2022, View Source [SID1234615326]).

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42nd Annual William Blair Growth Stock Conference
Date: Wednesday, June 8, 2022
Time: 9:20 a.m. CT

In addition to the presentation, the management team will host investor meetings. Investors participating in the conference who are interested in meeting with Biodesix management should contact their William Blair representative.

A live webcast of the presentation will be available under "News & Events" in the Investors section of the Company’s website at www.biodesix.com. A replay will be available for 90 days following the event.

On June 1, 2022 Immunocore Holdings Plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, reported that management will present at the following upcoming investor conferences (Press release, Immunocore, JUN 1, 2022, View Source [SID1234615343]):

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2022 Jefferies Healthcare Conference
Fireside chat date: Wednesday, June 8, 2022
Time: 2:30 PM ET

43rd Annual Goldman Sachs Global Healthcare Conference
Fireside chat date: Wednesday, June 15, 2022
Time: 4:00 PM PT

The presentations will be webcast live during the conference and will be available in the ‘Investors’ section of Immunocore’s website at www.immunocore.com. A replay of the presentation will be made available for a limited time.