On May 6, 2022 Nykode Therapeutics AS (Euronext Growth (Oslo): NYKD), a clinicalstage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported to a Capital Markets Day for analysts and investors in Oslo, Norway, on May 12, from 2.00-4.00 p.m. CET / 8.00-10.00 a.m. ET (Press release, Nykode Therapeutics, MAY 6, 2022, View Source [SID1234613790]). The event will be hosted both with the possibility for physical attendance and as a live webcast from Nykode’s facilities in Oslo, Norway, and will take place in English.

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The Capital Markets Day will feature Nykode’s Executive Management Team who will provide updates on Nykode’s business, pipeline, and innovations. All sessions are webcasted live, and a replay will be made available on the investor section of nykode.com. The presentation material from the Capital Markets Day will also be available on the day from 8.00 a.m. CET on the investor section of nykode.com.

Topics of the Capital Markets Day will include:
• Nykode’s business status and journey
• Pipeline update – Overview of Nykode’s product candidate pipeline and clinical experience
• Research update – Deep dive into Nykode’s research and the ongoing technology projects
• Capital market strategy update, including potential uplisting to the main market of Oslo Stock
Exchange (Oslo Børs)
Physical attendance requires registration. To register for the physical event, please send an email to
[email protected] before May 11 at 3.00 p.m. CET.

On May. 6, 2022 Forma Therapeutics Holdings, Inc.(Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease, prostate cancer and other rare hematologic diseases and cancers, reported financial results for the first quarter ended March 31, 2022 (Press release, Forma Therapeutics, MAY 6, 2022, View Source [SID1234613762]). The company also highlighted recent progress and upcoming milestones for its pipeline programs.

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"The first quarter of 2022 was one of continued progress in enrolling ongoing trials of etavopivat and FT-7051, and also expansion into other areas where red blood cell health may play an important role," said Frank Lee, president and chief executive officer of Forma. "We also continue to strengthen our capabilities and focus on the patients we serve with the addition of talented leaders."

Key Business Updates

•Ifeyinwa (Ify) Osunkwo, M.D., MPH, joined Forma as the company’s inaugural chief patient officer and senior vice president. Dr. Osunkwo leads Forma’s efforts to be a trusted partner, collaborating with patients, advocates and healthcare providers who share a dedication to changing the care and treatment paradigm.
•Arturo Molina, M.D., elected to Board of Directors and R&D Committee. Dr. Molina is an internationally acclaimed clinician, hematology and oncology researcher, practicing physician and pioneer addressing healthcare inequities. He has over 25 years of experience in biopharma, hematology and oncology and currently serves as chief medical officer at Sutro Biopharma, where he is responsible for the clinical development of oncology and hematology therapeutics.
•Virtual Research and Development (R&D) Day to be held May 26, 2022. The company will provide an overview of its clinical development programs and research pipeline strategy, including the introduction of a new molecule currently undergoing IND-enabling studies. The live webcast will be available in the "News & Investors" section of Forma’s website.

Upcoming Milestones

•Patient enrollment in global pivotal Phase II/III trial of etavopivat for the treatment of SCD, the Hibiscus Study. The first interim analysis (IA1) in the Hibiscus Study is expected to be reached by the end of 2022. IA1 is designed to select the dose for the Phase III portion of the trial.

•Additional etavopivat development programs. Forma has initiated a Phase II trial in patients with either transfusion dependent SCD, transfusion dependent thalassemia, or non-transfusion dependent thalassemia, with initial results expected in late 2022. During 2022, Forma plans to begin clinical trials in pediatric SCD and lower-risk myelodysplastic syndrome (MDS).
•Update on FT-7051 clinical trial in mCRPC. Men with metastatic castration-resistant prostate cancer (mCRPC) continue to be enrolled in the Phase I trial. Forma plans to provide an update at its May R&D Day and further results later in 2022.
•Possibility of COVID-19 impact remains. The COVID-19 pandemic remains a factor in the successful completion of these milestones and ongoing clinical trials. Many clinical trials across the biopharma industry, including Forma’s, have been impacted by the COVID-19 pandemic. Clinical trial sites implementing new policies in response to COVID-19 have impacted enrollment of clinical trials and/or the ability to access sites participating in clinical trials.

Financial Results

•Cash Position: Cash, cash equivalents and marketable securities were $441.3 million as of March 31, 2022, as compared to $490.3 million as of December 31, 2021. Current cash runway is projected through the third quarter of 2024.

R&D Expenses: R&D expenses were $31.3 million for the quarter ended March 31, 2022, compared to $26.3 million for the quarter ended March 31, 2021. The increase was primarily attributable to an increase in research and development staff to support advancement of etavopivat and other programs, an increase in equity-based compensation, the conduct of our Phase II/III trial in SCD patients, and study start-up costs related to our trial in thalassemia.

General and Administrative (G&A) Expenses: G&A expenses were $13.1 million for the quarter ended March 31, 2022, compared to $9.9 million for the quarter ended March 31, 2021. The increase was primarily attributable to equity-based compensation, costs due to executive and staff hiring, and other related general and administrative costs.

Net Loss: Net loss was $44.1 million for the quarter ended March 31, 2022, compared to net loss of $36.0 million for the quarter ended March 31, 2021.

Forma will conduct a conference call and webcast May 6, 2022 at 8:00 a.m. Eastern Daylight Time (EDT) to discuss first quarter 2022 results and business updates. The call can be accessed by dialing (833) 301-1146 in the U.S., and (914) 987-7386 internationally, with conference ID 1879297.

The live webcast will be available in the "News & Investors" section of Forma’s website www.FormaTherapeutics.com.

On May 6, 2022 Palisade Bio, Inc. (Nasdaq: PALI) (the "Company" or "Palisade Bio"), a clinical-stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal complications, reported that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale in a registered direct offering of 3,646,690 shares of its common stock, at a purchase price of $0.55 per share (Press release, Seneca Biopharma, MAY 6, 2022, View Source [SID1234613792]).

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Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the offering.

The closings of the sale of the securities in the financing is expected to occur on or about May 10, 2022, subject to the satisfaction of customary closing conditions. Palisade Bio intends to use the net proceeds from the financing for working capital and general corporate purposes, including the development of the Company’s lead product candidate LB1148.

The Company also agreed to issue to the investors in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 3,646,690 shares of its common stock. The warrants have an exercise price of $0.7105 per share of common stock, will be exercisable 6 months after the date of issuance, and will expire five and a half years following the initial issuance date.

The shares of common stock (but not the warrants or the shares of common stock underlying such warrants) offered in the registered direct offering are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-263705), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission ("SEC") on April 26, 2022. The offering of the shares of common stock in the registered direct transaction are being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and accompanying base prospectus may also be obtained, when available, by contacting Ladenburg Thalmann & Co. Inc. at Attn: Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, NY 10019 or by e-mail at [email protected]..

The warrants (and the shares of common stock underlying such warrants) are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and/or Regulation D promulgated thereunder, and such securities have not been registered under the Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. Palisade Bio has agreed to file a registration statement with the SEC registering the resale of the shares of common stock issuable upon the exercise of the warrants.

This press release 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On May 6, 2022 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) and AK006 for the treatment of allergic and inflammatory diseases, reported financial results for the first quarter ended March 31, 2022 (Press release, Allakos, MAY 6, 2022, View Source [SID1234613776]).

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Recent Events

•Initiated a Phase 2 randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with moderate-to-severe atopic dermatitis in the fourth quarter of 2021.
•Hosted an Investor Day on February 15, 2022 to provide the results and learnings from the ENIGMA 2 and KRYPTOS studies as well as the next steps in the lirentelimab and AK006 development program. Additionally, we announced a restructuring plan with expected charges associated with exiting certain contractual obligations and reducing our workforce.
Upcoming Milestones

•Hold an End-of-Phase 2 meeting with the FDA during second quarter of 2022 to discuss the Phase 2/3 KRYPTOS data and the development path with subcutaneous lirentelimab in patients with eosinophilic esophagitis (EoE).
•Initiate a Phase 2b randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria in the middle of 2022.
•Report topline data from the Phase 3 EoDyssey study of lirentelimab in patients with eosinophilic duodenitis (EoD) in the third quarter of 2022.
•Complete IND-Enabling studies of AK006 during 2022 and initiate the first-in-human study in the first half of 2023.
First Quarter 2022 Financial Results

Research and development expenses were $176.8 million in the first quarter of 2022 compared to $38.9 million in first quarter of 2021. First quarter 2022 research and development expenses include $135.1 million in settlement costs to exit future manufacturing obligations and relating to employee severance and retention arrangements in connection with our reorganization plan. Research and development expenses in the first quarter of 2022 also include non-cash expenses for stock-based compensation of $4.4 million, compared to $5.1 million in same period of 2021, and depreciation of $0.2 million, compared to $0.3 million in the same period of 2021.

General and administrative expenses were $18.8 million in the first quarter of 2022 compared to $16.7 million in first quarter of 2021. First quarter 2022 general and administrative expenses include $4.3 million of costs relating to employee severance and retention arrangements in connection with our reorganization plan. General and administrative expenses also include non-cash expenses for stock-based compensation of $7.0 million, compared to $7.3 million in the same period of 2021, and depreciation of $1.9 million, compared to $0.1 million in the same period of 2021.

Allakos reported a net loss of $197.0 million in the first quarter of 2022 compared to $55.6 million in the same period in 2022. As disclosed at our February 15, 2022 Investor Day, we expected to incur approximately $150 million in settlement expenses to exit future manufacturing and other contractual obligations with vendors, as well as, employee severance and retention arrangements. During the first quarter 2022, we incurred $139.4 million in aggregate of these expenses as described above in the research development expense and general and administrative expense sections. We anticipate that approximately $5 million of the remaining estimated expenses will primarily be classified as research and development costs and will be incurred over the second and third quarters of 2022 with the remainder being incurred thereafter. Net loss per basic and diluted share was $3.60 for the first quarter of 2022 compared to $1.04 in the same period in 2021.

Allakos ended the first quarter of 2022 with $246.7 million in cash, cash equivalents and marketable securities.

On May 6, 2022 Amgen (NASDAQ:AMGN) reported that it will present at the 2022 Bank of America Healthcare Conference at 12:20 p.m. ET on Wednesday, May 11, 2022 (Press release, Amgen, MAY 6, 2022, View Source [SID1234613777]). David M. Reese, M.D., executive vice president of Research and Development and Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference . The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.