On May 4, 2021 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that it will webcast its presentation at the BofA Securities 2021 Healthcare Conference at 8:00 a.m. PT on Wednesday, May 12, 2021 (Press release, Sana Biotechnology, MAY 4, 2021, View Source [SID1234584005]). The presentation will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer.

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The webcast will be accessible on the Investor Relations page of Sana’s website at www.sana.com. A replay of the presentation will be available at the same location for 30 days following the conference.

On May 4, 2021 eFFECTOR Therapeutics, Inc., a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, reported a $5.0 million cooperative agreement sponsored by the Defense Advanced Research Projects Agency (DARPA) and the Defense Health Agency (DHA) to fund a planned Phase 1b study of zotatifin (eFT226) as an anti-viral agent in an outpatient setting for those with mild to moderate COVID-19 disease (Press release, eFFECTOR Therapeutics, MAY 4, 2021, View Source [SID1234579502]). The agreement is a subaward of a DARPA research program awarded to the Quantitative Biosciences Institute (QBI) at University of California, San Francisco (UCSF), headed by Brian Shoichet, Ph.D., professor, department of pharmaceutical chemistry, to identify agents active against SARS-CoV-2 infections. eFFECTOR’s efforts will support the Phase 1b clinical study of zotatifin in patients with COVID-19 and related drug development activities.

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Zotatifin is an investigational small molecule inhibitor of eukaryotic initiation factor 4A (eIF4A), an enzyme that unwinds complex RNA structures important to producing key disease-driving proteins. SARS-CoV-2 is an RNA virus that hijacks the human cellular machinery—including eIF4A—to replicate. Research led by Nevan Krogan, Ph.D., director of QBI, and the QBI Coronavirus Research Group (QCRG) at UCSF, identified host factor vulnerabilities of SARS-CoV-2 replication published in Nature in April 2020. This research demonstrated that zotatifin was one of the most effective agents in blocking viral replication of SARS-CoV-2 out of 69 compounds evaluated.

"This research agreement allows us to evaluate zotatifin’s antiviral therapeutic potential in non-hospitalized patients suffering from mild to moderate SARS-CoV-2 infections," said Steve Worland, Ph.D., president and CEO of eFFECTOR. "Zotatifin may have broad utility against a number of coronaviruses, as in vitro studies have demonstrated that it is a potent inhibitor of SARS-CoV-2 and other coronavirus strains, including MERS-CoV."

Davide Ruggero, Ph.D., professor at the UCSF Helen Diller Cancer Center; an American Cancer Society Research Professor; and co-founder of eFFECTOR, added, "The interdisciplinary approach taken to establish zotatifin’s in vitro activity against SARS-CoV-2, which included proteomics to identify interactions between host and viral proteins and recognition of clinical-stage drug candidates that impacted the identified pathway, exemplifies the broad collaborative efforts taken by QCRG scientists around the world in response to COVID-19."

About Zotatifin (eFT226)
Zotatifin is a potent and sequence-selective inhibitor of eukaryotic translation initiation factor 4A (eIF4A) mediated translation. eIF4A is responsible for unwinding complex structures in the non-coding 5’ untranslated region of messenger RNA. Zotatifin is designed to inhibit the translation of mRNAs encoding several important oncogenes and survival factors, including receptor tyrosine kinases (RTKs), KRAS, Cyclin D, CDK4/6, and MYC. In vivo studies have shown potent in vivo tumor regression in multiple tumor models dependent on these factors, including non-small cell lung cancer and breast cancer. Since zotatifin inhibits the translation of mRNA in the non-coding region of mRNAs, it is not limited to any KRAS activating mutation subtypes. Zotatifin is currently being evaluated as an intravenous (IV) infusion in a Phase 1/2 clinical trial in patients with solid tumors.

Zotatifin will also be evaluated in a Phase 1b clinical trial in patients with mild to moderate COVID-19 infections pursuant to this grant sponsored by DARPA.

On May 4, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported that Chris Martin, Chief Executive Officer, will participate in a fireside chat at two virtual investor conferences in May (Press release, ADC Therapeutics, MAY 4, 2021, View Source [SID1234579059]).

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Details of the events are as follows:

·BofA Securities 2021 Virtual Health Care Conference on Tuesday, May 11, 2021, at 8:00 a.m. ET

·2021 RBC Capital Markets Global Healthcare Conference on Wednesday, May 19, 2021, at 9:45 a.m. ET

A live webcast of each fireside chat will be available via the Events & Presentations page in the Investors section of ADC Therapeutics’ website, ir.adctherapeutics.com. A replay of each webcast will be available for approximately 30 days.

On May 4, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported financial results for the first quarter ended March 31, 2021, and provided a corporate update (Press release, Deciphera Pharmaceuticals, MAY 4, 2021, View Source [SID1234579074]).

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"We are excited by the continuing successful commercial launch of QINLOCK in the U.S. as we solidify its position among GIST prescribers and patients and expand access to this important medicine globally. We also remain focused on realizing QINLOCK’s potential in earlier lines of therapy," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "We expect the INTRIGUE Phase 3 top-line results in the fourth quarter of this year and believe QINLOCK has the potential to transform the treatment of GIST for this larger, second-line patient population. Building on our commitment to fully explore the potential of QINLOCK to benefit patients with GIST, we are excited to announce today our plans to initiate a Phase 1b/2 study combining QINLOCK with binimetinib, an approved MEK inhibitor. Our enthusiasm for this combination is based on compelling pre-clinical data showing that this combination can induce apoptosis and has the potential to deepen and prolong responses."

Mr. Hoerter continued, "We remain very pleased with the progress and growth for the balance of our pipeline, including the upcoming initiation of the Phase 1 study for our potential first-in-class ULK kinase inhibitor, DCC-3116, in patients with cancers driven by mutant RAS or RAF genes. We look forward to presenting updated data from both the vimseltinib and rebastinib programs in the coming months and plan to finalize registration-enabling studies for both programs before the end of the year."

First Quarter 2021 Highlights and Upcoming Milestones

QINLOCK(ripretinib)
Recorded $20.0 million in QINLOCK net product revenue in the first quarter of 2021, including $19.3 million in U.S. net product revenue.
Received approval in China from the China National Medical Products Administration (NMPA) and from the Hong Kong Department of Health, via our collaboration with Zai Lab, for the treatment of adult patients with fourth-line gastrointestinal stromal tumors (GIST).
Expects potential approval from the European Medicines Agency (EMA) for QINLOCK in the fourth quarter of 2021.
Expects to announce top-line results from the INTRIGUE Phase 3 study in the fourth quarter of 2021.
Expects to present data for QINLOCK patients undergoing intra-patient dose escalation after disease progression in the INVICTUS Phase 3 study at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
Today announced that the Company plans to initiate a Phase 1b/2 study of QINLOCK in combination with binimetinib, an approved MEK inhibitor, to address one of the potential mechanisms of resistance to kinase inhibition, reactivation of the MAPK pathway, in post-imatinib GIST patients.
A publication supporting this approach was recently published online by Molecular Cancer Therapeutics. The results showed that treatment with QINLOCK in combination with MEK inhibitors effectively induced and enhanced apoptotic responses and prevented growth of resistant colonies in both imatinib-sensitive and -resistant GIST cell lines.
Vimseltinib
Expects to present updated data from the ongoing Phase 1/2 study in patients with tenosynovial giant cell tumor (TGCT) in the third quarter of 2021.
Plans to finalize the pivotal development plan for vimseltinib in TGCT in the second half of 2021.
Rebastinib
Expects to present updated data from the ongoing Phase 1b/2 study of rebastinib in combination with paclitaxel in the endometrial cancer cohort at the ASCO (Free ASCO Whitepaper) Annual Meeting in June.
Expects to present updated data from the ongoing Phase 1b/2 study of rebastinib in combination with paclitaxel in the platinum-resistant ovarian cancer cohort in the third quarter of 2021.
Plans to finalize the pivotal development plan for rebastinib in combination with paclitaxel in the second half of 2021.
DCC-3116
Expects to initiate the Phase 1, multicenter, open-label, first-in-human study of DCC-3116 in the second quarter of 2021. The study will evaluate DCC-3116 as a single agent and in combination with trametinib in patients with advanced or metastatic tumors with a mutant RAS or RAF gene. Currently, expansion cohorts are planned in patients with advanced or metastatic pancreatic ductal adenocarcinoma with KRAS or BRAF mutations, non-small cell lung cancer with KRAS, NRAS, or BRAF mutations, colorectal cancer with KRAS, NRAS, or BRAF mutations, and melanoma with NRAS or BRAF mutations.
Upcoming Scientific Congress Presentations

2021 ASCO (Free ASCO Whitepaper) Annual Meeting, June 4-8. E-poster presentations will be available on-demand via the ASCO (Free ASCO Whitepaper) Meeting Library beginning on Friday, June 4 at 9:00 AM ET.
QINLOCK
E-poster presentation: Intra-patient dose escalation (IPDE) of ripretinib after disease progression in patients with advanced gastrointestinal stromal tumor (GIST): Analyses from the phase 3 INVICTUS study.
Rebastinib
E-poster presentation: Open-label, multicenter, phase 1b/2 study of rebastinib in combination with paclitaxel to assess safety and efficacy in patients with advanced or metastatic endometrial cancer.
First Quarter Financial Results

Revenue: Total revenue for the first quarter of 2021 was $25.2 million, which includes $20.0 million of net product revenue from sales of QINLOCK and $5.2 million of collaboration revenue. Net product revenues for the first quarter of 2021 included U.S. sales of QINLOCK of $19.3 million and ex-U.S. sales of QINLOCK of $0.7 million. The Company also recognized $5.0 million in collaboration revenue under its license agreement with Zai Lab based on the approval of QINLOCK in China. In the first quarter of 2020, the Company did not generate product revenue.
Cost of Sales: Cost of sales were $0.2 million in the first quarter of 2021. There were no cost of sales in the first quarter of 2020 as no product sales were generated during that period. Cost of sales will not be significant until the initial pre-launch inventory is depleted, and additional inventory is manufactured and sold.
R&D Expenses: Research and development expenses for the first quarter were $55.7 million, compared to $51.4 million for the same period in 2020. The increase was primarily due to personnel and preclinical costs, partially offset by a decrease in clinical trial expenses related to the INTRIGUE Phase 3 study in second-line GIST and the INVICTUS Phase 3 study in fourth-line and fourth-line plus GIST. Non-cash, stock-based compensation was $5.0 million and $3.3 million for the first quarters of 2021 and 2020, respectively.
SG&A Expenses: Selling, general and administrative expenses for the first quarter of 2021 were $30.7 million, compared to $23.9 million for the same period in 2020. The increase was primarily due to personnel costs as well as external spend related to professional fees, including those associated with establishing a targeted commercial infrastructure in key European markets to support a potential launch of QINLOCK in Europe, if approved. Non-cash, stock-based compensation was $6.2 million and $3.7 million for the first quarters of 2021 and 2020, respectively.
Net Loss: For the first quarter of 2021, Deciphera reported a net loss of $61.3 million, or $1.06 per share, compared with a net loss of $72.8 million, or $1.36 per share, for the same period in 2020. The decrease in net loss was primarily a result of product sales during the first quarter of 2021, partially offset by an increase in R&D and SG&A expenses as described above.
Cash Position: As of March 31, 2021, cash, cash equivalents and marketable securities were $502.2 million, compared to $561.3 million as of December 31, 2020. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product and royalty revenues, but excluding any potential future milestone payments or other payments under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into the first half of 2023.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, May 4, 2021 at 4:30 PM ET. To access the live call by phone please dial (866) 930-5479 (domestic) or (409) 216-0603 (international); the conference ID is 5470938. A live audio webcast of the event may also be accessed through the "Investors" section of Deciphera’s website at www.deciphera.com. A replay of the webcast will be available for 30 days following the event.

On May 4, 2021, Invitae Corporation (the "Company") reported that entered into a Sales Agreement (the "Agreement") with Cowen and Company, LLC (the "Sales Agent") (Filing, 8-K, Invitae, MAY 4, 2021, View Source [SID1234579100]). The Agreement provides for the issuance and sale by the Company of common stock having an aggregate offering price of up to $400,000,000. Pursuant to the Agreement, the Company may offer and sell the shares in transactions deemed to be an "at-the-market" offering as defined in Rule 415(a)(4) of the Securities Act of 1933, which shares can be sold by the Company from time to time, depending upon market demand, with the Sales Agent acting as an agent for sales.

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The Company will pay the Sales Agent a commission of up to 3.0% of the gross proceeds from the sale of shares of common stock by it as agent under the Agreement. The Agreement provides that the Company will provide customary indemnification rights to the Sales Agent. The Company has no obligation to sell any shares of common stock pursuant to the Agreement and may at any time suspend sales pursuant to the Agreement. Either party may terminate the Agreement pursuant to the terms of the Agreement without liability of any party.

The shares of common stock will be sold pursuant to the Company’s automatic shelf registration statement on Form S-3 (File No. 333-230053), that was filed with the Securities and Exchange Commission and became automatically effective on March 4, 2019, including the related prospectus, dated March 4, 2019, as supplemented by the prospectus supplement dated May 4, 2021. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state.

Under the Agreement, the Company may also sell shares of common stock to the Sales Agent as principal for its own account, at a price to be agreed upon at the time of sale. If the Company sells shares to the Sales Agent as principal, the Company will enter into a separate terms agreement with the Sales Agent, and the Company will describe the agreement in a separate prospectus supplement or pricing supplement.

The foregoing description of the Agreement does not purport to be complete and is subject to and qualified in its entirety by reference to the Agreement, a copy of which is attached hereto as Exhibit 1.1 and is incorporated herein by reference.