Predicted therapeutic range dose levels reached in ATOR-1017 Phase I

On October 27, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported additional positive interim safety data from its ongoing clinical Phase I study of the drug candidate ATOR-1017, its wholly owned 4-1BB antibody in development for the treatment of metastasized cancer (Press release, Alligator Bioscience, OCT 27, 2020, View Source [SID1234569134]).

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The Data Review Committee that monitors the safety of the patients in the Phase I study, has cleared a 100 mg dose and approved to start dosing at 200 mg, corresponding to approximately 3.2 mg/kg. The majority of the observed drug related adverse events have been mild or moderate (grade 1 or 2) and there are indications that ATOR-1017 activates the immune system of patients.

"ATOR-1017 is now administered at the dose levels we aimed for when designing the study: we are in fact more than 20 times higher in dose than the benchmark product urelumab. This is an important milestone for the program and for the upcoming Phase II efficacy study. ATOR-1017 was designed to overcome the challenges of the first generation 4-1BB antibodies, in particular severe immune-related adverse events. The emerging safety profile, based on data seen this far, suggests that we have been successful", said Per Norlén, CEO at Alligator Bioscience.

The Phase I study is planned to read out in H1 2021, with a Phase Ib/II efficacy study starting in H2 2021.

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 2:00 p.m. CET on October 27, 2020.

Lexicon Pharmaceuticals to Host Third Quarter 2020 Financial Results Conference Call and Webcast on October 29, 2020

On October 27, 2020 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported that it will release its third quarter 2020 financial results on Thursday, October 29, 2020 before the markets open (Press release, Lexicon Pharmaceuticals, OCT 27, 2020, View Source [SID1234569133]). Management will conduct a conference call and live webcast at 8:00 a.m. ET (7:00 a.m. CT) that day to discuss the financial results and to provide a clinical update.

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The dial-in replay will be available for 14 days following the call. An audio webcast will be available online at www.lexpharma.com/events, with a webcast replay accessible for 14 days after the call.

Allakos Previews Preliminary Financial Results for the Three Months Ended September 30, 2020

On October 27, 2020 Allakos Inc. (Nasdaq: ALLK) ("Allakos" or "the Company"), a biotechnology company developing AK002 for the treatment of eosinophil and mast cell related diseases, reported that results for the three months ended September 30, 2020 (Press release, Allakos, OCT 27, 2020, View Source [SID1234569132]). The preliminary financial results are subject to finalization of the Company’s customary quarterly financial close process.

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Allakos estimates that net loss will be between $40.0 million and $50.0 million for the three months ended September 30, 2020 as compared to $21.7 million for the three months ended September 30, 2019, an increase of between $18.3 million and $28.3 million.

Allakos estimates that cash, cash equivalents and investments in marketable securities will be $419.8 million as of September 30, 2020.
The Company expects to report its complete financial results for the third quarter ended September 30, 2020 before the market opens on November 9, 2020.

Information Regarding Preliminary Results

The preliminary estimated financial information contained in this press release reflects management’s estimates based solely upon information available to it as of the date of this press release and is not a comprehensive statement of our financial results for the three months ended September 30, 2020. In addition, the preliminary estimated financial information presented above has not been audited by our independent registered public accounting firm, Ernst & Young LLP. Accordingly, Ernst & Young LLP does not express an opinion on or any other form of assurance with respect thereto and assumes no responsibility for this information. The information presented above should not be considered a substitute for the financial information to be filed with the Securities and Exchange Commission (the "SEC") in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 once it becomes available and should not be regarded as a representation by us or our management as to our actual financial results for the three months ended September 30, 2020. The ranges for the preliminary estimated financial results described above constitute forward-looking statements. The preliminary estimated financial information presented above is subject to change, and our actual financial results may differ from such preliminary estimates and such differences could be material. Accordingly, you should not place undue reliance upon these preliminary estimates.

Exact Sciences Announces Entry into Agreements to Sell $869 Million of Common Stock in Registered Direct Offering

On October 27, 2020 Exact Sciences Corporation (Nasdaq: EXAS) reported the entry into agreements to sell an aggregate of 8,605,483 shares (the "Shares") of its common stock, par value $0.01 per share, in a registered direct offering to ten institutional investors, including some of its largest shareholders as well as healthcare specialist firms Casdin Capital and Rock Springs Capital (Press release, Exact Sciences, OCT 27, 2020, View Source [SID1234569131]).

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Each Share is being sold for a purchase price of $101.00 per share, resulting in gross proceeds of approximately $869.2 million and net proceeds, after estimated offering expenses, of approximately $866.0 million. The offering is being made without an underwriter or a placement agent.

The offering is expected to close on or about October 29, 2020, subject to customary closing conditions. Exact Sciences intends to use the net proceeds from the offering for general corporate purposes, which may include the repayment of debt, working capital and business acquisitions, including the payment of the cash consideration related to our pending acquisition of Thrive Earlier Detection Corp. ("Thrive"), as disclosed in further detail in the prospectus supplement to be filed in connection with the offering.

The Shares were offered pursuant to an automatically effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") on June 1, 2020. The final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there be any sale of the Shares in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Acorda Third Quarter 2020 Update: Webcast/Conference Call Scheduled for November 3, 2020

On October 27, 2020 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that it will host a conference call and webcast in conjunction with its third quarter 2020 update and financial results on Tuesday, November 3 at 4:30 p.m. ET (Press release, Acorda Therapeutics, OCT 27, 2020, View Source [SID1234569130]).

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To participate in the Webcast/Conference call, please note there is a new pre-registration process.

To register for the Webcast/Conference Call, use the link below:
View Source
**When registering please type your phone number with no special characters**
Once you have registered, you will receive a confirmation email with Webcast/Conference Call details. For the Webcast you will receive an email 2 hours prior to the start of the call with the link to join. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 7:30 p.m. ET on November 3, 2020 until 11:59 p.m. ET on December 3, 2020. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 4177747. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.