BioCryst to Present at Upcoming Virtual Investment Conferences

On November 20, 2020 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported that the company will present at the Evercore ISI 3rd Annual HealthCONx on Wednesday, December 2, 2020 at 12:35 p.m. ET and at the Piper Sandler 32nd Annual Healthcare Conference (Press release, BioCryst Pharmaceuticals, NOV 20, 2020, https://biocryst.gcs-web.com/news-releases/news-release-details/biocryst-present-upcoming-virtual-investment-conferences [SID1234571475]). Both conferences are being conducted as virtual events.

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Piper Sandler is pre-recording company presentations at the conference and the pre-recorded presentation may be accessed on Monday, November 23, 2020 in the Investors section of BioCryst’s website at http://www.biocryst.com.

Links to a live audio webcast and replay of the presentation at the Evercore ISI conference may be accessed on December 2, 2020 in the Investors section of BioCryst’s website at http://www.biocryst.com.

Codiak BioSciences Reports Third Quarter 2020 Financial Results and Operational Progress

On November 20, 2020 Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage company focused on pioneering the development of exosome-based therapeutics, reported third quarter 2020 financial results and operational progress (Press release, Codiak Biosciences, NOV 20, 2020, View Source [SID1234571473]).

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"Codiak was founded to realize the potential of engineered exosomes as a new and important class of biologic medicines for the treatment of a broad range of diseases," said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. "The creativity, expertise, and execution of our team has enabled us to bring the field’s first two engineered exosome candidates into the clinic and we are on track to initiate a third clinical program next year. The recent successful completion of our initial public offering provides additional funding to progress our development programs, invest in our platform and sustain the positive momentum we have built."

Third Quarter 2020 and Recent Highlights

Closed initial public offering (IPO) in October 2020, raising $74.4 million in net proceeds
Initiated healthy volunteer dosing of exoIL-12 in a Phase 1 clinical trial designed to transition into patients with cutaneous T cell lymphoma (CTCL)
Initiated subject dosing in a Phase 1/2 clinical trial of exoSTING for the treatment of advanced/metastatic, recurrent and injectable solid tumors
Continued to advance exoASO-STAT6 for the intravenous treatment of myeloid-rich cancers through IND-enabling studies
Presented preclinical data on exoIL-12 and the engEx Platform at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Expanded executive team with addition of Yalonda Howze as Executive Vice President, Chief Legal Officer
Welcomed Jason Haddock to the Board of Directors and as Audit Committee Chairman
Anticipated Milestones and Events

Initial safety, tolerability and systemic exposure/pharmacokinetics data from the healthy volunteer portion of the exoIL-12 Phase 1 clinical trial are expected by year-end, with biomarker, safety and preliminary pharmacodynamics and efficacy data in CTCL patients expected by mid-2021
Safety and preliminary pharmacodynamics and efficacy data from exoSTING Phase 1/2 clinical trial in patients with solid tumors expected by mid-2021
Evercore ISI HEALTHCONx Virtual Conference, December 2, 2020
Third Quarter 2020 Financial Results
Total revenues for the quarter ended September 30, 2020 were $1.0 million, compared to $0.2 million for the same period in 2019. This increase was primarily due to an increase in collaboration revenue driven primarily by activities in connection with the collaboration with Sarepta.

Net loss for the quarter ended September 30, 2020 was $35.3 million, compared to a net loss of $20.7 million for the same period in 2019. Net loss for the quarter ended September 30, 2020 was driven primarily by clinical development, general and administrative, and personnel expenses, and ongoing development of the engEx Platform. The current quarter net loss was inclusive of a $15.0 million milestone payment to Kayla Therapeutics in connection with dosing of the first patient in the Phase 1/2 clinical trial of exoSTING.

Research and development expenses were $30.7 million for the quarter ended September 30, 2020 compared to $16.5 million for the same period in 2019. The increase was primarily driven by an increase in license milestones, personnel costs, and clinical development expenses related to the initiation of the exo-IL12 and exoSTING clinical trials in September 2020.

General and administrative expenses were $5.3 million for the quarter ended September 30, 2020 compared to $4.8 million for the same period in 2019. The increase was primarily driven by an increase in consulting and legal fees, personnel costs, and other administrative expenses in anticipation of operating as a public company.

As of September 30, 2020, Codiak had cash, cash equivalents, and marketable securities of $48.3 million. In October 2020, the completion of the IPO resulted in net proceeds of $74.4 million.

AIkido Pharma Inc. Announces Results of 2020 Annual Stockholder Meeting

On November 20, 2020 AIkido Pharma Inc. (the "Company" or "AIkido") (NASDAQ: AIKI) reported the results from the virtual 2020 Annual Meeting of Stockholders (the "Meeting") held on November 17, 2020 (the "Meeting") (Press release, AIkido Pharma, NOV 20, 2020, View Source [SID1234571472]).

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All proposals that were presented to the stockholders were approved at the Meeting, except for the proposal to amend the Company’s Amended and Restated Certificate of Incorporation, as amended, to effect a reverse stock split of the Company’s common stock (the "Common Stock") at a ratio of up to one-for-ten (the "Amendment Proposal"). Accordingly, the Company adjourned the Meeting to allow more time for stockholders to consider the Amendment Proposal. The adjournment of the Meeting will preserve the September 24, 2020 record date for the determination of stockholders entitled to receive notice of and vote at the upcoming adjourned meeting to be held at 12:00 p.m. on December 4, 2020.

The detailed voting results for the Meeting are provided in the Company’s Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission (the "SEC") on November 20, 2020.

The Company urges all stockholders who have not yet voted to vote in favor of the Amendment Proposal. Approval of the Amendment Proposal and the resulting reverse stock split is critical. The primary objective of the reverse stock split is to raise the per share trading price of the Common Stock to comply with the Nasdaq minimum share price listing rule to allow the Company to continue to list on Nasdaq. The higher stock price resulting from the reverse stock split and the listing of the Common Stock on Nasdaq is important for the marketability of the Common Stock to the financial community and investing public. If the reverse stock split is not effectuated, it could limit the number of potential buyers of the Common Stock as many institutional investors have policies prohibiting them from holding lower-priced stocks in their portfolios. Also, brokerage houses frequently have internal practices and policies that discourage individual brokers from dealing in lower-priced stocks. Top proxy advisory firms ISS and Glass Lewis, who together provide voting recommendations on stockholder meetings to a majority of institutional stockholders, both recommend a "FOR" vote for this proposal in order to maintain listing on Nasdaq.

We urge you to please vote your shares of AIkido today. You may do so by contacting MacKenzie Partners at 1-800-322-2885 (toll-free in the U.S.) or 212-929-5500.

MacKenzie Partners can also take your vote via email. To vote by email, simply send an email with your voting instructions to [email protected] . A sample email is below:

To: [email protected]
Cc: [email protected]:
Re: AIkido Pharma Inc. Annual Meeting

Dear Mr. Jaegers;

Please vote my shares of AIkido Pharma Inc. Common Stock for the 2020 Annual Meeting of Stockholders as follows:

FOR the amendment to effect reverse stock split
Proposals 2, 3a,3b,3c,3d, 3e, 3f, 4, 5, and 6 will be voted FOR in order to complete the proxy. Please be advised that these proposals have already passed at the shareholder meeting on November 17, 2020.

The shares are registered in the name of ___________

Thank you

Your vote is very important, regardless of the number of shares you own. Please take a moment to vote your shares by contacting MacKenzie Partners today.

Thank you for your support.

Important Information and Where to Find It
This communication may be deemed to be solicitation material in respect to the Meeting and the Proposals. On October 5, 2020, the Company initially filed the Definitive Proxy Statement with the SEC. The Company gave notice and mailed the Definitive Proxy Statement to certain stockholders on or about October 5, 2020. The Company may file other documents with the SEC in connection with the Meeting. BEFORE MAKING ANY VOTING DECISION, STOCKHOLDERS ARE URGED TO READ THESE MATERIALS CAREFULLY AND, IN THEIR ENTIRETY, BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY. Stockholders may obtain, free of charge, copies of the Definitive Proxy Statement and any other documents filed by the Company with the SEC in connection with the Meeting at the SEC’s website (View Source) and on the investor relations section of the Company’s website at www.aikidopharma.com. Investors and stockholders are urged to read the Definitive Proxy Statement and the other relevant materials before making any voting decision with respect to the Meeting and the Proposals.

Non-Solicitation
This communication does not constitute an offer to sell or solicitation of an offer to buy any securities, nor will there be any sale of securities 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.

Participants in the Solicitation
The Company and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of the Company in connection with the Meeting. Additional information regarding the directors and executive officers of the Company is included in the Company’s Definitive Proxy Statement relating to the Meeting, filed with the SEC on October 5, 2020. These documents are available free of charge from the sources indicated above.

Clovis Oncology to Present at the Piper Sandler 32nd Annual Healthcare Conference

On November 20, 2020 Clovis Oncology, Inc. (Nasdaq: CLVS) reported that a pre-recorded fireside chat with President and Chief Executive Officer Patrick J. Mahaffy will be available next week for replay as part of the Piper Sandler 32nd Annual Healthcare Conference (Press release, Clovis Oncology, NOV 20, 2020, View Source [SID1234571471]). The virtual conference, which takes place November 30 to December 3, 2020, incorporates a library of pre-recorded fireside chat presentations with presenting companies available on Monday, November 23, 2020 at 10:00 a.m. Eastern time.

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This conference is virtual and the pre-recorded presentation can be accessed through the investor relations section of the Company’s website at www.clovisoncology.com. The replay of the webcast will be available on the Company’s website for 30 days. The presentation was recorded on November 18, 2020, and statements made in the presentation speak only as of such date. Clovis Oncology does not undertake to update or revise any statements made therein.

ADC Therapeutics Announces FDA Accepts Biologics License Application and Grants Priority Review for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

On November 20, 2020 ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, reported that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for loncastuximab tesirine (Lonca) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and granted priority review status (Press release, ADC Therapeutics, NOV 20, 2020, View Source [SID1234571466]). The FDA has set a Prescription Drug User Fee Act ("PDUFA") target date of May 21, 2021.

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"The FDA’s acceptance of our BLA and granting of priority review for Lonca is a tremendous accomplishment that brings ADC Therapeutics one step closer to being able to offer patients with relapsed or refractory DLBCL a greatly needed new treatment option in 2021," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "We look forward to working with the FDA during its review of our BLA submission for Lonca. Our organization remains focused on robust planning for a successful launch next year."

The BLA submission is based on data from LOTIS 2, the pivotal Phase 2 multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL following two or more lines of prior therapy. In June 2020, the Company presented maturing data from LOTIS 2 at the virtual 25th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper). As of the April 6th cutoff date, Lonca demonstrated an overall response rate of 48.3% (70/145 patients) and a complete response rate of 24.1% (35/145 patients). The tolerability profile was manageable with the most common grade ≥3 treatment-emergent adverse events in ≥10% of patients being: neutropenia (25.5%) with low incidence of febrile neutropenia (3.4%), thrombocytopenia (17.9%), GGT increase (16.6%) and anaemia (10.3%).

Data from subgroup analyses of LOTIS 2 will be presented in a poster (abstract #1183) at the upcoming 62nd American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on Saturday, December 5, 2020.

About Loncastuximab Tesirine (Lonca)

Loncastuximab tesirine (Lonca, formerly ADCT-402) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, Lonca is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies.

Lonca, the Company’s lead product candidate, has been evaluated in a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that showed a 48.3% overall response rate (ORR), which exceeded the target primary endpoint. Lonca is also being evaluated in LOTIS 3, a Phase 1/2 clinical trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma, and LOTIS 5, a Phase 3 confirmatory clinical trial in combination with rituximab in patients with relapsed or refractory DLBCL.