BeyondSpring To Host Virtual R&D Day to Discuss New Plinabulin Development Strategy for Cancer and Updates for SEED Therapeutics

On May 3, 2024 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, reported it will host a Research and Development (R&D) Day to discuss the current unmet medical needs and the potential of Plinabulin as a novel immunochemotherapeutic in drug combinations, and updates for SEED Therapeutics on Wednesday, May 15th, 2024 at 10:00 a.m. ET (Press release, BeyondSpring Pharmaceuticals, MAY 3, 2024, View Source;utm_medium=rss&utm_campaign=beyondspring-to-host-virtual-rd-day-to-discuss-new-plinabulin-development-strategy-for-cancer-and-updates-for-seed-therapeutics [SID1234642628]).

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The conference call and webinar will feature presentations by Key Opinion Leaders (KOLs) Trevor M. Feinstein, M.D. (Piedmont Cancer Institute), Alberto Chiappori, M.D. (Moffitt Cancer Center), and Steven Lin, M.D. (MD Anderson Cancer Center), who will discuss below topics:

Plinabulin history and development strategy for cancer
Plinabulin’s immunomodulatory activity as a DC maturation agent
Unmet needs after immune-checkpoint-inhibitor failure
Also featured will be a management discussion on technology platform and pipeline updates of SEED Therapeutics, BeyondSpring’s majority-owned molecular glue subsidiary.

The dial in numbers for the conference call are 1-877-407-0779 (U.S.) or 1-201-389-0914 (international). To register for the webinar, please click here. An archived replay of the webinar will be available following the presentation on BeyondSpring’s website www.beyondspringpharma.com under "Events and Presentations" in the Investors section.

Trevor M. Feinstein, M.D.
Dr. Feinstein is board certified in medical oncology and hematology. He joined Piedmont Cancer Institute in 2011 and is the Director of Research at Piedmont Fayette Hospital. Dr. Feinstein is actively involved in clinical trials focused on improved therapies for various cancers. He is a member of Georgia CORE’s research committee along with Georgia Society for Clinical Oncology Clinical Practice Committee. He also chairs the Lung Disease Group for the entire OneOncology network. He is a co-investigator on several peer-reviewed research projects and has authored numerous publications and abstracts in Hematology and Oncology. Dr. Feinstein graduated from the University of Illinois medical school and completed his residence and fellowships at the University of Pittsburgh.

Alberto Chiappori, M.D.

Dr. Chiappori is board certified in medical oncology. He serves as senior member of oncology and medicine for the Thoracic Oncology Program at the H. Lee Moffitt Cancer Center and Research Institute in Tampa and Florida. Dr. Chiappori is an active member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), the American Association for Cancer Research (AACR) (Free AACR Whitepaper), and the International Association for the Study of Lung Cancer (IASLC). Dr. Chiappori received his MD from the Universidad Peruana Cayetano Heredia in Lima, Peru, completed his residency at Southern Illinois University School of Medicine in Springfield, Illinois, and finished his fellowship and senior fellowship in medical oncology-hematology at Vanderbilt University School of Medicine in Nashville, Tennessee.

Steven Lin, M.D., Ph.D.
Dr. Lin is a Professor and Physician-Scientist at MD Anderson Cancer Center, with joint appointments in the Departments of Radiation Oncology and Experimental Radiation Oncology. Dr. Lin’s practice focuses on thoracic malignancies, and he oversees several clinical trials including the use of proton beam therapy for esophageal cancer and in the combination of immunotherapy with radiotherapy in lung and esophageal cancers. Dr. Lin runs a translational research team that evaluates biomarkers for treatment response and disease outcomes after cancer therapy. Dr. Lin acquired his M.D. and Ph.D. in the Medical Scientist Training Program at the University of California Irvine Medical School. He went on for residency training in Radiation Oncology at The Johns Hopkins Hospital.

Aileron Therapeutics Announces Closing of Underwritten Registered Direct Offering of up to Approximately $40 Million

On May 3, 2024 Aileron Therapeutics, Inc. ("Aileron") (NASDAQ: ALRN), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, reported the closing of its previously announced underwritten registered direct offering priced at-the-market under Nasdaq rules of 4,273,505 shares of its common stock and accompanying warrants to purchase an aggregate of 4,273,505 shares of common stock (Press release, Aileron Therapeutics, MAY 3, 2024, View Source [SID1234642625]). Each share of common stock and accompanying warrant were sold together at a combined public offering price of $4.68. The aggregate gross proceeds of the offering were approximately $20 million, before deducting underwriting discounts and commissions and other offering expenses payable by Aileron, and excluding any proceeds that may be received from exercise of the warrants.

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The accompanying warrants have an exercise price of $4.68 per share, are exercisable immediately and expire three years from the date of issuance. Aileron may call the warrants for cancellation during the ten trading day period after the date that is thirty (30) days following the public announcement by Aileron of the top-line results from the Phase 1b clinical trial of LTI-03 in patients with idiopathic pulmonary fibrosis, which announcement includes a statement that there were no drug-related adverse events that resulted in a discontinuation of the trial; provided that Aileron may only deliver such call notice if the volume-weighted average price of its shares of common stock exceeds the exercise price of the warrants on the trading day immediately prior to the date it delivers the call notice. Any warrant subject to such call for which a notice of exercise is not received will be cancelled ten trading days after the date of the call notice for consideration equal to $0.001 per warrant share.

Titan Partners Group, a division of American Capital Partners, acted as sole book-running manager for the offering.

The securities were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-265470) that was previously filed with and declared effective by the Securities and Exchange Commission (SEC) on June 16, 2022. The offering was made only by means of a prospectus supplement and the accompanying prospectus that form a part of the registration statement. A final prospectus supplement relating to the offering was filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained for free by contacting Titan Partners Group LLC, a division of American Capital Partners, LLC, 4 World Trade Center, 29th Floor, New York, NY 10007, by phone at (929) 833-1246 or by email at [email protected].

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

Agios to Present at the RBC Capital Markets Global Healthcare Conference on May 14, 2024

On May 3, 2024 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that the company is scheduled to present at the 2024 RBC Capital Markets Global Healthcare Conference on Tuesday, May 14, 2024, at 8:00 a.m. ET (Press release, Agios Pharmaceuticals, MAY 3, 2024, View Source [SID1234642624]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.

Abeona Therapeutics Announces Pricing of $75 Million Underwritten Offering of Common Stock and Pre-Funded Warrants

On May 3, 2024 Abeona Therapeutics Inc. (Nasdaq: ABEO) ("Abeona" or the "Company") reported the pricing of an underwritten offering of 12,285,056 shares of its common stock and, in lieu of common stock, pre-funded warrants to purchase 6,142,656 shares of its common stock, at an offering price of $4.07 per share, which is equal to the closing price on Thursday, May 2, 2024, or $4.0699 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.0001 per share exercise price for each pre-funded warrant (Press release, Abeona Therapeutics, MAY 3, 2024, View Source [SID1234642623]). The pre-funded warrants will be immediately exercisable at a nominal exercise price of $0.0001 per share and may be exercised at any time until the pre-funded warrants are exercised in full. The closing of the offering is expected to occur on or about May 7, 2024, subject to the satisfaction of customary closing conditions.

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The offering included participation from both new and existing investors, including Adage Capital Partners, L.P., Janus Henderson Investors, Nantahala Capital, Suvretta Capital, Vivo Capital, and other healthcare-dedicated investors.

Stifel is acting as the sole bookrunner for the offering.

The gross proceeds to Abeona from this offering are expected to be approximately $75 million, before deducting underwriting discounts and commissions and other offering expenses. Abeona intends to use the net proceeds from the offering primarily to fund preparations for resubmission of its BLA and for commercialization of its product candidate pz-cel, as well as for working capital and general corporate purposes.

The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-256850) that was filed with the Securities and Exchange Commission (the "SEC") on June 7, 2021 and amended on August 27, 2021 and October 19, 2021, and was declared effective by the SEC on October 22, 2021. When available, the prospectus supplement and the accompanying prospectus that form a part of the registration statement will be filed with the SEC and available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus may also be obtained when available by contacting Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected].

The securities described above have not been qualified under any state blue sky laws. This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Abeona being offered, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Clarity to present at three world leading conferences

On May 3, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that new data will be presented at the upcoming AUA, ASCO (Free ASCO Whitepaper) and SNMMI 2024 Annual Meetings, covering clinical results and trials in progress (Press release, Clarity Pharmaceuticals, MAY 3, 2024, View Source [SID1234642582]). The data showcases the extensive scope of Clarity’s Targeted Copper Theranostic (TCT) platform in developing multiple products for imaging and treating cancer patients, with focus on prostate cancer.

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Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The AUA, ASCO (Free ASCO Whitepaper) and SNMMI Annual Meetings are among the most prestigious conferences in urology, oncology and nuclear medicine, respectively. We are delighted that our data has been accepted for presentation at these world leading conferences. The abstracts accepted for presentations, including two oral presentations, highlight the exciting opportunities for our next-generation TCT radiopharmaceuticals as we continue to generate incredible data on what we strongly believe to be best in class assets for the treatment and diagnosis of cancer.

"We are looking forward to sharing this data as we continue to adhere to the highest standards of clinical research, work with world-class clinical sites and generate exciting results to date while expanding the platform into multiple indications. We are also looking forward to further developing our existing as well as novel TCT products as we get closer to our ultimate goal of improving treatment outcomes for children and adults with cancer."

Data to be presented at 2024 AUA, ASCO (Free ASCO Whitepaper) and SNMMI Annual Meetings
Product Abstract Title Conference
64Cu-SAR-bisPSMA CLARIFY: Positron Emission Tomography using 64Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy, a phase 3 diagnostic study AUA – Oral presentation
Session Date
Sunday, May 5th

Session Time
1:00-3:00 PM CT

Session Title
Clinical Trials in Progress—Cancer

64Cu-SAR-bisPSMA COBRA: Assessment of safety and efficacy of 64Cu-SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy ASCO – Poster presentation
Session Date
Sunday, June 2nd

Session Time
9:00 AM – 12:00 PM CT

Session Title/Track
Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track
Prostate Cancer–Local-Regional Disease

Abstract # 5100

Poster Bd # 506

64Cu-SAR-bisPSMA CLARIFY: Positron emission tomography using 64Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy (a phase 3 diagnostic study) ASCO – Poster presentation
Session Date
Sunday, June 2nd

Session Time
9:00 AM – 12:00 PM CT

Session Title/Track
Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track
Prostate Cancer–Local-Regional Disease

Abstract # TPS5129

Poster Bd # 524a

67Cu-SAR-bisPSMA SECuRE: A dose escalation/expansion study to assess the anti-tumor efficacy of 67Cu-SAR-bisPSMA in patients with metastatic castrate resistant prostate cancer

ASCO – Poster presentation
Session Date
Sunday, June 2nd

Session Time
9:00 AM – 12:00 PM CT

Session Title/Track
Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track
Prostate Cancer– Advanced/Castrate-Resistant

Abstract # TPS5116

Poster Bd # 517b

64Cu-SAR-bisPSMA COBRA: Assessment of safety and efficacy of 64Cu-SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy SNMMI – Oral presentation
Session Date
Tuesday, June 11th

Session Time
8:00 AM – 9:15 AM ET

Session Title
Prostate Cancer – Radiomics/Data Analysis

67Cu-SAR-bisPSMA SECuRE: A dose escalation/expansion study to assess the anti-tumor efficacy of 67Cu-SAR-bisPSMA in patients with metastatic castrate resistant prostate cancer SNMMI – Poster presentation
67Cu-SAR-BBN COMBAT: A study of 64Cu-SAR-BBN and 67Cu-SAR-BBN for identification and treatment of GRPr-expressing metastatic castrate resistant prostate cancer ineligible for therapy with 177Lu-PSMA-617 SNMMI – Poster presentation
64Cu-SAR-BBN SABRE: Assessment of safety and efficacy of 64Cu-SAR-BBN in PSMA-negative biochemical recurrent prostate cancer patients SNMMI – Poster presentation
Posters and presentations containing study results will be available on Clarity’s official website after their presentation at the 2024 AUA, ASCO (Free ASCO Whitepaper) and SNMMI Annual Meetings: claritypharmaceuticals.com/pipeline/scientific_presentations

Abstracts for the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting will be released on the 23rd of May at 5 PM ET and will be available at the conference website: conferences.asco.org/am/abstracts