On September 30, 2020 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that management will participate in a fireside chat at the Jefferies Cell Therapy Virtual Summit on Tuesday, October 6, 2020 and 2:30 p.m. E.T (Press release, Fate Therapeutics, SEP 30, 2020, View Source [SID1234567817]).

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A live webcast of the presentation will be available through the investor relations section of the Company’s website at www.fatetherapeutics.com.

On September 30, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that its tender offer to purchase any and all issued and outstanding shares of common stock of Pfenex Inc. (NYSE American: PFNX) at an offer price of $12.00 per share in cash, plus one non-transferable contractual contingent value right per share representing the right to receive a contingent payment of $2.00 in cash, if a certain specified milestone is achieved, expired at midnight (New York City time), at the end of the day on Tuesday, September 29, 2020 (Press release, Ligand, SEP 30, 2020, View Source [SID1234567818]).

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The depositary for the tender offer has advised that, as of the expiration of the tender offer, a total of approximately 27,591,554 shares were validly tendered and not withdrawn in the tender offer (including shares delivered through notices of guaranteed delivery), representing approximately 80.3% of Pfenex’s outstanding shares. Ligand’s wholly-owned subsidiary will accept for payment all shares that were validly tendered and not withdrawn prior to expiration of the tender offer, and payment for such shares will be made promptly, in accordance with the terms of the tender offer.

Ligand expects the merger to close on October 1, 2020, with Pfenex becoming a wholly owned subsidiary of Ligand. As a consequence of the merger, each outstanding Pfenex share not tendered and purchased in the offer (other than those as to which holders properly exercise dissenters’ rights and those owned at the commencement of the tender offer by Ligand or its direct and indirect subsidiaries) will be converted into the right to receive the same $12.00 per share in cash, plus one non-transferable contractual contingent value right per share representing the right to receive a contingent payment of $2.00 in cash, if a certain specified milestone is achieved, without interest and less any required withholding taxes, that was offered in the tender offer. Following completion of the merger, Pfenex’s common stock will cease to be traded on the New York Stock Exchange American.

On September 30, 2020 CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, reported that congratulated Orphazyme A/S (ORPHA.CO) (NASDAQ:ORPH) ("Orphazyme") on the September 29, 2020 pricing of its global offering, consisting of an initial public offering of American Depositary Shares in the U.S. and a concurrent private placement of ordinary shares in Europe. According to Orphazyme, the aggregate gross proceeds from its global offering will amount to approximately DKK 534,534,637 ($83,777,606 using a DKK/USD exchange rate of 6.3804) (assuming no exercise of the option to purchase additional shares) and DKK 614,714,770 ($96,344,237 using a DKK/USD exchange rate of 6.3804) (assuming full exercise of the option to purchase additional shares). CytRx has an agreement with Orphazyme that can yield milestone payments and royalties based on potential future sales of arimoclomol.

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In connection with Orphazyme’s global offering, it disclosed receipt of a filing communication from the U.S. Food and Drug Administration ("FDA") relating to the agency’s ordinary course review of its new drug application ("NDA") for arimoclomol in the treatment of Niemann-Pick disease Type C ("NPC"). The filing communication follows acceptance on a Priority Review basis by the FDA of Orphazyme’s NDA for arimoclomol in NPC and the agency’s establishment of the Prescription Drug User Fee Act ("PDUFA") target action date of March 17, 2021. Orphazyme stated that its receipt of the filing communication does not impact the FDA’s acceptance of its NDA, the target PDUFA action date or the Priority Review determination. Orphazyme’s disclosure notes that the filing communication constitutes preliminary notice from the FDA of potential review issues as part of its ordinary course review of the NDA and is not necessarily indicative of deficiencies that may be identified during the review. Orphazyme has stated that it intends to discuss the filing communication with the FDA.

In accordance with applicable securities laws, Orphazyme amended the registration statement on Form F-1 on file with the U.S. Securities and Exchange Commission. For further information concerning the FDA filing communication, we refer you to the "Recent Developments" section on Page 6 of Orphazyme’s amended Form F-1 filed on September 28, 2020.

CytRx will continue to provide updates that are relevant to its agreement with Orphazyme.

On September 30, 2020 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company focused on the development of female oncology products in the precision medicine metastatic breast cancer arena, reported a collaboration with Exactis Innovation, a pan-Canadian Network of Centres of Excellence (NCE) in precision medicine, expanding a Phase 2 clinical trial of Sermonix’s lead investigational drug, lasofoxifene, into Canada (Press release, Sermonix Pharmaceuticals, SEP 30, 2020, View Source [SID1234568153]).

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The NCE is a Canadian government initiative that funds partnerships between universities, industry, government and not-for-profit organizations to create large-scale research networks integrating precision oncology across Canada.

With the recent Health Canada agreement to proceed, the open-label, randomized Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1, NCT03781063) study will now include Exactis Network sites in Quebec, Ontario, Nova Scotia and New Brunswick. The study, which began U.S. enrollment in September 2019, is assessing the efficacy of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation and progression-free survival as the primary endpoint.

"Sermonix is honored to collaborate with Exactis Innovation, a truly esteemed international center of excellence in precision medicine," said David Portman, Sermonix founder and chief executive officer. "Our ELAINE trials are solely focused on women with ESR1 mutations, for whom there is such great need of targeted treatments that potentially can prolong and enhance their lives. Working with Exactis furthers that mission."

With exclusive global rights to develop and commercialize lasofoxifene in the oncological arena, Sermonix is also adding ELAINE 1 study sites in Israel, further providing important international data as the company looks to fulfill its global mission of addressing the unmet needs of women with metastatic breast cancer.

Personalize My Treatment

Personalize My Treatment (PMT) is Exactis’ active pan-Canadian, Research Ethics Board-approved cancer patient registry that collects clinical and molecular patient data to match sub-populations in precision oncology research. Exactis will utilize its PMT registry, pre-screening patients to identify ESR1 mutations to both inform genomic cancer profiling during the patient’s treatment journey and potentially identify candidates for the ELAINE trial participation.

Exactis Chief Medical Officer Dr. Gerald Batist will work closely with Sermonix on the PMT/ELAINE collaboration. Dr. Batist is currently professor and former chair of the Department of Oncology at McGill University and is director of both the McGill Centre for Translational Research in Cancer and the Segal Cancer Centre at Sir Mortimer B. Davis-Jewish General Hospital in Montreal.

"The synergy between Sermonix’s precision medicine focus – through its ELAINE 1 study of lasofoxifene – and the Exactis network and PMT registry creates an ideal collaborative opportunity," said Dr. Batist. "We look forward to identifying and enrolling Canadian women into this trial, extending the frontier of research in the ESR1-mutated breast cancer arena and offering Canadian patients participation in this very promising clinical trial."

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

On September 30, 2020 Theralase Technologies Inc. ("Theralase" or "Company") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDCs") and their associated drug formulations intended to safely and effectively destroy various cancers, reported that the Company proposes to extend the expiry date of 3,157,059 share purchase warrants, all of which are exercisable at $0.50 per share (collectively, the "Warrants") (Press release, Theralase, SEP 30, 2020, View Source [SID1234569760]).

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The Warrants were issued on October 3, 2018 pursuant to a private placement involving the issuance of 3,157,059 units of the Company. The Company proposes to extend the expiry date of the Warrants that remain outstanding from the original expiry date of October 3, 2020 to October 3, 2022.

All other terms and conditions of the Warrants will remain unchanged. The Warrant expiry date extension is subject to final acceptance by the TSX Venture Exchange.