Abeona Therapeutics Announces Pricing of $25 Million Private Placement of Convertible Redeemable Preferred Stock

On April 29, 2022 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, reported that it has entered into a securities purchase agreement with certain institutional investors to purchase 1,000,006 shares of Series A convertible redeemable preferred stock and 250,005 shares of Series B convertible redeemable preferred stock (Press release, Abeona Therapeutics, APR 29, 2022, View Source [SID1234613238]). Each share of Series A and Series B preferred stock has a purchase price of $19.00, representing an original issue discount of 5% of the $20.00 stated value of each share. Each share of Series A and Series B preferred stock is convertible into shares of Abeona’s common stock at an initial conversion price of $0.45 per share. Shares of the Series A and Series B preferred stock are convertible at the option of the holder at any time following the Company’s receipt of stockholder approval for a reverse stock split of the Company’s common stock. Abeona will be permitted to redeem the Series A preferred stock at its option upon the fulfillment of certain conditions and subject to certain limitations. The Company and the holders of the Series A and Series B preferred stock will also enter into a registration rights agreement to register the resale of the shares of common stock issuable upon conversion of the Series A and Series B preferred stock. Total gross proceeds from the offerings, before deducting discounts, placement agent’s fees and other estimated offering expenses, is approximately $25 million.

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The Series A preferred stock permits the holders thereof to vote together with the holders of the Company’s common stock and any other shares of capital stock entitled to vote generally as a single class on all matters submitted to a vote of stockholders generally, including any proposal to effectuate a reverse stock split of the Company’s common stock at a special meeting of Company stockholders. The Series B preferred stock permits the holders thereof to vote on a proposal to effectuate a reverse stock split of the Company’s common stock at a special meeting of Company stockholders, together with the holders of common stock and Series A preferred stock. The Series B preferred stock permits the holder to cast 15,000 votes per share of Series B preferred stock on such proposal. Except as required by law or expressly provided by the certificate of designation, holders of the Series B preferred stock will not be permitted to vote on any other matters. The holders of the Series A and B preferred stock agreed not to transfer, offer, sell, contract to sell, hypothecate, pledge or otherwise dispose of their shares of preferred stock until after the special meeting. The holders of the Series A preferred stock agreed to vote their shares in favor of the reverse stock split proposal and the holders of the Series B preferred stock agreed to vote their shares in the same proportions as the shares of common stock and Series A preferred stock are voted on that proposal. The holders of the Series A and Series B preferred stock have the right to require the Company to redeem their shares of preferred stock for cash at 105% of the stated value of such shares commencing after the earlier of the Company’s stockholders’ approval of the reverse stock split and 60 days after the closing of the issuances of the Series A and Series B preferred stock and until 90 days after such closing. The Company has the option to redeem the Series A preferred stock for cash at 105% of the stated value commencing 90 days after the closing of the issuance of the Series A preferred stock, subject to the holders’ rights to convert the shares prior to a redemption at the option of the Company.

The closing of the offerings is expected to occur on or about May 2, 2022, subject to the satisfaction of customary closing conditions. Additional information regarding the securities described above and the terms of the offering will be included in a Current Report on Form 8-K to be filed with the United States Securities and Exchange Commission ("SEC").

A.G.P./Alliance Global Partners is acting as the sole placement agent in connection with the offering.

The Series A and Series B preferred stock and shares of common stock into which these preferred shares are convertible are being issued in reliance upon the exemption from the securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act") and/or Rule 506 of Regulation D as promulgated by SEC under the 1933 Act.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

PTC Therapeutics to Participate at Upcoming Investor Conferences

On April 29, 2022 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that management will present a company overview at the following conferences (Press release, PTC Therapeutics, APR 29, 2022, View Source [SID1234613233]):

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Bank of America Securities 2002 Healthcare Conference
Tuesday, May 10 at 5:20 p.m. PT

2022 RBC Capital Markets Global Healthcare Conference
Wednesday, May 18 at 2:05 p.m. ET

The presentation will be webcast live on the Events and Presentations page under the Investor section of PTC Therapeutics’ website at View Source and will be archived for 30 days following the presentation. It is recommended that users connect to PTC’s website several minutes prior to the start of the webcast to ensure a timely connection.

OncoSec Appoints Dr. Robert Arch as President and Chief Executive Officer

On April 29, 2022 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company focused on developing intratumoral immunotherapies to stimulate the body’s immune system to target and attack cancer, reported the appointment of Robert H. Arch, Ph.D., as President and Chief Executive Officer (Press release, OncoSec Medical, APR 29, 2022, View Source [SID1234613231]).

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Dr. Arch was previously Head of Research at Elpiscience Biopharma, Ltd. from October 2019 to June 2021, and Head of the Liver Disease Department at China Novartis Institutes for BioMedical Research from February 2017 to October 2019. Robert’s leadership roles have been focused on shaping strong teams and building diversified R&D pipelines with innovative assets, from ideas to late-stage clinical development programs. His career over 28 years extends from academia to the pharmaceutical industry, including positions at Novartis, Takeda, GlaxoSmithKline, and Pfizer. Robert’s expertise in basic research and drug development includes chronic liver disease, cancer, immuno-oncology, respiratory disease, and inflammatory disorders.

"On behalf of the Board of Directors, we are excited to welcome Robert to OncoSec and confident he will bring a focus on long-term value creation," remarked Kevin Smith, Board member of OncoSec. "Robert is uniquely qualified based on his executive experience in leading cross-functional pipeline strategy, and building and leading discovery teams across multiple geographic regions throughout his career."

"I am grateful for the opportunity to join OncoSec and excited to advance TAVO and the intratumoral platform technology," said Dr. Robert Arch. "I am honored to lead our team in our mission to bring truly novel immunotherapies to patients."

Dr. Arch earned his Ph.D. in Germany at the University of Wuerzburg and the German Cancer Research Center (DKFZ), Heidelberg. After postdoctoral training at the DKFZ and the University of Chicago, he started his independent career as a faculty member in the Departments of Medicine and Pathology & Immunology at Washington University in Saint Louis. Robert is an author on more than 40 publications and book chapters, and he is coinventor on several patents for clinical-stage assets.

Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
In connection with the hiring of Dr. Arch, the Compensation Committee of OncoSec’s Board of Directors granted to Dr. Arch non-qualified stock options to purchase 700,000 shares of OncoSec common stock as an inducement material to Dr. Arch entering into employment with OncoSec in accordance with Nasdaq Listing Rule 5635(c)(4), which grant shall be made outside of OncoSec’s 2011 Stock Incentive Plan. The stock options have an exercise price equal to the closing price of OncoSec’s common stock on May 2, 2022, and will vest quarterly commencing on the first completed calendar quarter after the date of grant, subject to the terms of grant. The vesting of shares of common stock underlying the non-qualified stock options are subject to Dr. Arch’s continuous service with OncoSec through each such vesting date.

Myovant Sciences Announces European Commission Approval for ORGOVYX® (relugolix) for the Treatment of Advanced Hormone-Sensitive Prostate Cancer

On April 29, 2022 Myovant Sciences (NYSE: MYOV) reported that the European Commission (EC) has approved the marketing authorisation application for ORGOVYX (relugolix, 120 mg) for the treatment of adult patients with advanced hormone-sensitive prostate cancer (Press release, Myovant Sciences, APR 29, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-european-commission-approval-orgovyxr [SID1234613230]). The approval is applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.

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"Now for the first time, patients in Europe have the ability to rapidly reduce testosterone without hormonal flare in a convenient oral form," said Juan Camilo Arjona Ferreira, Chief Medical Officer of Myovant Sciences, Inc. "This approval provides a valuable new treatment option for men with advanced hormone-sensitive prostate cancer in Europe and has the potential to change the standard of care over time."

"We’ve made significant progress in securing a business partner for the commercialization of ORGOVYX in Europe. We’ve had interest from multiple parties and anticipate an announcement in the upcoming weeks, in advance of the anticipated launches in European markets," said David Marek, Chief Executive Officer, Myovant Sciences, Inc.

This approval was supported by data from the Phase 3 HERO study, a randomized, open-label, parallel-group, multinational clinical study designed to evaluate the safety and efficacy of relugolix. The study compared relugolix to leuprolide in over 1,000 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. ORGOVYX received U.S. Food and Drug Administration (FDA) approval for the treatment of adult patients with advanced prostate cancer in December 2020.

In the HERO study, ORGOVYX met the primary endpoint and achieved sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in 96.7% (95% confidence interval [CI]: 94.9-97.9) of men, compared with 88.8% (95% CI: 84.6-91.8) of men receiving leuprolide acetate injections, the current standard of care. ORGOVYX also achieved several key secondary endpoints compared to leuprolide acetate, including suppression of testosterone to castrate levels at Day 4 and Day 15 (56% versus 0% and 99% versus 12%, respectively) and profound suppression of testosterone (< 20 ng/dL) at Day 15 (78% versus 1%). The most frequent adverse events reported in at least 10% of men in the ORGOVYX group were hot flush, musculoskeletal pain, fatigue, constipation, and mild to moderate diarrhea. The HERO data were previously presented in an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program, with simultaneous publication in The New England Journal of Medicine.

About Prostate Cancer
Prostate cancer is a leading cause of death in the European Union with about 65,200 men having died from the disease in 2016. The standardized death rate from prostate cancer stood at 38 deaths per 100,000 male inhabitants according to Eurostat.

Prostate cancer is considered advanced when it has spread or come back after initial treatment and may include biochemical recurrence (rising prostate-specific antigen in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels (< 50 ng/dL). Luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, are depot injections and the current standard of care for androgen deprivation therapy. However, LHRH receptor agonists may be associated with mechanism- of-action limitations, including the potentially detrimental initial surge in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery after the drug is discontinued.

About ORGOVYX (relugolix)
ORGOVYX (relugolix, 120 mg) is indicated in Europe for the treatment of adult patients with advanced hormone-sensitive prostate cancer. As a GnRH antagonist, ORGOVYX blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.

Leidos Holdings, Inc. Declares Quarterly Cash Dividend

On April 29, 2022 Leidos Holdings, Inc. (NYSE:LDOS) reported that its Board of Directors has declared a quarterly cash dividend of $0.36 per outstanding share of common stock of Leidos Holdings, Inc (Press release, Leidos, APR 29, 2022, View Source [SID1234613228]). The cash dividend is payable on June 30, 2022, to stockholders of record as of the close of business on June 15, 2022.

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