On May 16, 2022 Factor Bioscience Inc., a Cambridge-based biotechnology company focused on developing mRNA and cell-engineering technologies, reported its participation in the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting to be held in Washington, D.C. from May 16-19, 2022, at which Factor will deliver four presentations (Press release, Factor Bioscience, MAY 16, 2022, View Source;cell-therapy-asgct-25th-annual-meeting-301547566.html [SID1234614684]):

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iPSC-Derived Monocytes Generate Functional M1 and M2 Macrophages with Enhanced Cytokine Secretion and Tumor Cell-Killing Activity
iPSC-Derived Monocytes Generate Functional M1 and M2 Macrophages with Enhanced Cytokine Secretion and Tumor Cell-Killing Activity
Factor to reveal mRNA-based iPS cell-derived macrophages for solid-tumor targeting

"iPSC-Derived Monocytes Generate Functional M1 and M2 Macrophages with Enhanced Cytokine Secretion and Tumor Cell-Killing Activity." -to be presented by Ian Hay on May 18 at 5:00 pm, Engineered Cell Therapies Oral Abstract Session, Room 206.

"Cytotoxic Lymphocytes Derived from B2M-Knockout iPSCs Show Enhanced Expansion and Cytokine-Controlled Cytotoxicity In Vitro." -to be presented by Mackenzie Parmenter on May 17 from 5:30-6:30 pm, Cell Therapies II Poster Session.

"The Immunosuppressive TTAGGG Motif Improves Homology-Directed Insertion of DNA Sequences in Human Primary and Induced Pluripotent Stem (iPS) Cells." -to be presented by Abigail Blatchford on May 17 from 5:30-6:30 pm, Oligonucleotide Therapeutics II Poster Session.

"Resveratrol Treatment Increases Homology-Directed Repair in Primary Human Cells." -to be presented by Taeyun Kim on May 18 from 5:30-6:30 pm, Gene Targeting and Gene Correction III Poster Session.
Digital presentations will be made available on the ASGCT (Free ASGCT Whitepaper) website on May 16, 2022. For more information about the American Society of Genetic & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, visit View Source

On May 16, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that it will host a virtual R&D Day for investors and analysts on Friday, June 10, 2022 at 10:00 am ET (Press release, SpringWorks Therapeutics, MAY 16, 2022, View Source [SID1234614711]). The program will include presentations by members of the SpringWorks executive leadership team as well as external thought leaders in the Company’s core development areas. A Q&A session will follow the presentations.

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To register for SpringWorks’ virtual R&D Day, please sign up here. The webcast will also be available under "Events and Presentations" in the Investors & Media section of the SpringWorks website at View Source A replay of the webcast will be available on the Company’s website for a limited period of time following the event.

On May 16, 2022, Inhibikase Therapeutics, Inc. (the "Company") reported that entered into an Equity Distribution Agreement (the "Agreement") with Piper Sandler & Co., as sales agent (the "Agent"), pursuant to which the Company may, from time to time, issue and sell shares of its common stock, par value $0.001 per share, in an aggregate offering price of up to $9,801,287 (the "Shares") through the Agent (Filing, 8-K, Inhibikase Therapeutics, MAY 16, 2022, View Source [SID1234614730]).

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The offer and sales of the Shares made pursuant to the Agreement, if any, will be made under the Company’s effective "shelf" registration statement on Form S-3 (File No. 333-262551) dated February 11, 2022, the base prospectus contained therein, and a prospectus supplement related to the offering of the Shares dated May 16, 2022.

Under the terms of the Agreement, the Agent may sell the Shares at market prices by any method that is deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act, as amended.

Subject to the terms and conditions of the Agreement, the Agent will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions. The Company has no obligation to sell any of the Shares, and may at any time suspend sales under the Agreement or terminate the Agreement in accordance with its terms. The Company has provided the Agent with customary indemnification rights, and the Agent will be entitled to a fixed commission of 3.0% of the aggregate gross proceeds from the Shares sold. The Agreement contains customary representations and warranties, and the Company is required to deliver customary closing documents and certificates in connection with sales of the Shares. The Company has agreed to reimburse the Agent for the fees and disbursements of its counsel, payable upon execution of the Equity Distribution Agreement, in an amount not to exceed $75,000 in connection with the establishment of this at-the-market offering program plus an additional amount of up to $15,000 for each quarterly period thereafter.

The legal opinion of McDermott Will and Emery LLP, counsel to the Company, relating to the Shares is filed as Exhibit 5.1 hereto.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which was filed as Exhibit 10.1 hereto and incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of any offer to buy the Shares, nor shall there be an offer, solicitation or sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state.

On May 16, 2022 Flamingo Therapeutics, a biotechnology company pioneering RNA-targeting therapies in oncology, reported that Mike Garrett, Chief Executive Officer, will present a company overview at the BioEquity Europe and Knowledge for Growth meetings, taking place May 16-18 in Milan, Italy and May 18-19 in Ghent, Belgium (Press release, Flamingo Therapeutics, MAY 16, 2022, View Source;utm_medium=rss&utm_campaign=flamingo-therapeutics-to-present-at-the-bioequity-europe-and-knowledge-for-growth-conferences-in-may-2022 [SID1234614588]). The Flamingo management team will also participate in one-on-one meetings with investors during both conferences.

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The presentations for both conferences will be available on-demand for registered attendees.

On May 16, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported first-quarter 2022 financial results and provided a corporate update (Press release, Ayala Pharmaceuticals, MAY 16, 2022, View Source [SID1234614637]).

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"We continued to execute on advancing our clinical programs during the first quarter of 2022," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "Our highest immediate priority is completing Part A of the RINGSIDE study evaluating AL102 in desmoid tumors and we are on target to announce initial interim data around mid-year. This will be followed by initiation of Part B, the randomized portion of the study, immediately thereafter. We are very encouraged by the positive feedback received from investigators in the study and by early signs of anti-tumor activity. Other important milestones expected this year include clinical updates from the ongoing ACCURACY trial of AL101 in adenoid cystic carcinoma and the planned initiation of a Phase 2 trial of AL102 in T-ALL."

First-quarter 2022 and Recent Business Highlights

Completed enrollment of Part A of the Phase 2/3 RINGSIDE study of AL102 in desmoid tumors: 42 patients have been enrolled in Part A of the RINGSIDE study, which is evaluating the safety and tolerability of AL102, as well as tumor volume by MRI at 16 weeks. Three dosing regimens of AL102 are being tested to determine the optimal dose regimen to advance forward.

Initiated "Window of Opportunity" study of AL101 in adenoid cystic carcinoma (ACC): The study, which is being conducted in collaboration with M.D. Anderson Cancer Center and the Adenoid Cystic Carcinoma (ACC) Research Foundation, is focused on determining the effects of AL101 for the treatment of ACC and other cancers. The goals of the study are to better understand the mechanism of AL101, determine the best treatment regimen and generate data for the future development strategy.
Upcoming Milestones

Initial interim data from pivotal Phase 2/3 RINGSIDE trial in desmoid tumors: Ayala expects to report an initial interim data read-out from Part A of Phase 2/3 RINGSIDE trial of AL102 in desmoid tumors around mid-2022. Part B of the study will be a double-blind placebo-controlled study enrolling up to 156 patients with progressive disease, randomized between AL102 or placebo. The study’s primary endpoint will be progression free survival with secondary endpoints including objective response rates, duration of response and patient reported quality of life measures.
Clinical data from Phase 2 ACCURACY trial of AL101 in ACC: The Phase 2 ACCURACY clinical trial is an open-label, single-arm, multi-center study to assess the clinical activity of AL101 using radiographic assessments of patients with R/M ACC demonstrating disease progression within 6 months prior to dosing. A poster at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting is expected to feature safety, efficacy, pharmacokinetics, and pharmacodynamics data from the 6mg AL101 cohort in the trial.
Initiate Phase 2 clinical trial evaluating AL102 in T-cell acute lymphoblastic leukemia (T-ALL): Ayala plans to begin a Phase 2 clinical trial evaluating AL101 in R/R T-ALL in the second half of 2022.
First-Quarter 2022 Financial Results

Cash Position: Cash and cash equivalents were $27.4 million as of March 31, 2021, as compared to $37.3 million at December 31, 2021.

Collaboration Revenue: Collaboration revenue was $0.4 million for the first quarter of 2022, as compared to $1.0 million for the corresponding quarter in 2021.

R&D Expenses: Research and development expenses were $7.5 million for the first quarter of 2022, compared to $6.9 million for the corresponding quarter in 2021.

G&A Expenses: General and administrative expenses were $2.4 million for the first quarter of 2022, compared to $2.3 million for the first quarter of 2021.

Net Loss: Net loss was $10.0 million for the first quarter ended March 31, 2022, resulting in basic and diluted net loss per share of $0.66. This compares with a net loss of $9.6 million for the first quarter ended March 31, 2021, or basic and diluted net loss per share of $0.74.

For further details on the company’s financial results, refer to form Quarterly Report on Form 10-Q for the three months ended March 31, 2022, filed with the SEC on May 16, 2022.