On March 30, 2022 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported the pricing of its previously announced underwritten public offering of 53,333,334 shares of its common stock and pre-funded warrants to purchase 18,095,238 shares of its common stock, together with accompanying warrants to purchase 35,714,286 shares of its common stock (Press release, Geron, MAR 30, 2022, View Source [SID1234611167]). The combined offering price to the public of each share of common stock and accompanying warrant is $1.05. The combined offering price to the public of each pre-funded warrant and accompanying warrant is $1.049. The common stock and pre-funded warrants will be sold in combination with an accompanying warrant to purchase 0.5 of a share of common stock issued for each share of common stock or pre-funded warrant sold. The accompanying warrant has an exercise price of $1.45 per share and expires five years from the date of issuance; however, such term will be shortened upon achievement of a regulatory milestone.

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All of the securities in the offering are being sold by Geron. The gross proceeds to Geron from this underwritten public offering are expected to be approximately $75.0 million, before deducting the underwriting discount and other estimated offering expenses payable by Geron. The offering is expected to close on or about April 1, 2022, subject to the satisfaction of customary closing conditions.

Geron currently intends to use the net proceeds from this public offering, together with its existing cash, cash equivalents, restricted cash and marketable securities to fund potential regulatory filings in the United States and European Union for imetelstat in lower risk myelodysplastic syndromes (MDS), assuming top-line results in the IMerge Phase 3 clinical trial are supportive, and to support toward the completion of the IMpactMF clinical trial in refractory myelofibrosis and the planned exploratory studies in new indications, including IMproveMF and investigator-led trials in acute myeloid leukemia and higher risk MDS, the preclinical work in lymphoid malignancies and the discovery research program related to next generation telomerase inhibitors.

Stifel and Baird are acting as joint book-running managers for the offering. Needham & Company is acting as lead manager for the offering.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock, pre-funded warrants and accompanying warrants described above was previously filed with the Securities and Exchange Commission (SEC) and subsequently declared effective by the SEC. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the final prospectus supplement relating to the offering may also be obtained from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected] or Robert W. Baird & Co. Incorporated, Attention: Syndicate Department, 777 East Wisconsin Avenue, Milwaukee, Wisconsin 53202, by telephone at 800-792-2473 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will 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.

On March 30, 2022 Acacia Pharma Group plc ("Acacia Pharma" or the "Company") (EURONEXT: ACPH), reported that it will not publish its results for the full year to end December 2021 on 31 March 2022 as originally scheduled (Press release, Acacia Pharma, MAR 30, 2022, View Source [SID1234611190]).

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This comes as a result of the changes in regulatory requirements following Brexit. The Company is required under Belgian law to have its accounts audited by either an EU audit firm or a third country audit firm registered in Belgium. Following Brexit, the Company’s statutory auditor PwC UK ceased to be an EU audit firm on 30 June 2021.

The Company has been informed that there is currently no legal mechanism for PwC UK to register as a third country audit firm in Belgium; the Company is therefore required to also have its accounts audited by PwC Belgium. A new date for the publication of its results will be set and these will be released before the end of April 2022 as required under the applicable rules.

On March 30, 2022 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, reported that the first patient has been enrolled in the U.S. in the Phase 1 clinical trial for CS5001 (Press release, CStone Pharmaceauticals, MAR 30, 2022, View Source [SID1234611208]). This is a remarkable milestone for CStone’s Pipeline 2.0 strategy.

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CS5001 is a potential global best-in-class antibody-drug conjugate (ADC), targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1). As one of the three most advanced ROR1 ADCs worldwide, CS5001 has been approved for the initiation of a multi-regional clinical trial in the US and Australia. The China National Medical Products Administration (NMPA) has accepted the investigational new drug (IND) application of CS 5001. This first-in-human Phase 1 study aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS5001 in advanced B cell lymphomas and solid tumors.

ROR1 is an oncofetal protein with low or no expression in adult tissues but high expression in a variety of cancers including various forms of leukemia and non-Hodgkin lymphoma, breast, lung, and ovarian cancers, making it an ideal ADC target. Results from pre-clinical studies showed that CS5001 exhibited potent and selective cytotoxicity to a variety of ROR1-expressing cancer cell lines and demonstrated remarkable in vivo antitumor activity in both hematological and solid tumor xenograft models. The preclinical data were presented as a late-breaking abstract at the 33rd AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) 2021.

Dr. Archie Tse, Chief Scientific Officer of CStone, said: "We are very glad to have the first patient enrolled in the first-in-human study of CS5001. This potentially best-in-class ROR1 ADC contains a number of differentiated features which may translate into a wider therapeutic window against a variety of cancer types — a fully human antibody backbone, proprietary site-specific conjugation, and tumor-cleavable linker and prodrug technology. Results from the preclinical studies of CS5001 already showed its therapeutic potential in ROR1-expressing hematological and solid malignancies. We will swiftly execute the global development program of CS5001, starting with this Phase 1 study to characterize its safety and preliminary efficacy in the treatment of advanced B-cell lymphoma and selected solid tumors."

About CS5001（ROR1 ADC）

CS5001 is a clinical-stage antibody-drug conjugate (ADC) targeting ROR1 (receptor tyrosine kinase-like orphan receptor 1). CS5001 has uniquely designed and LCB’s proprietary tumor-cleavable linker and pyrrolobenzodiazepine (PBD) prodrug. Only after reaching the tumor, the linker and prodrug are cleaved to release the PBD toxin, resulting in lethal DNA cross-links in cancer cells. The use of the linker plus PBD prodrug effectively helps addressing the toxicity problem associated with traditional PBD payloads, leading to a better safety profile. Additionally, CS5001 utilizes site-specific conjugation for a precise drug antibody ratio of 2 which enables homogeneous production and large-scale manufacturing.

In October 2020, CStone signed a licensing agreement with LegoChem Biosciences, Inc. (LCB) for the development and commercialization of CS5001 which was originally generated by collaboration of LCB and ABL Bio, both South Korea-based leading biotech companies. Under the agreement, CStone obtains the exclusive global right to lead development and commercialization of CS5001 outside the Republic of Korea.

On March 30, 2022 KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a specialty pharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system (CNS) diseases, reported its financial results for the fourth quarter and year ended December 31, 2021 (Press release, KemPharm, MAR 30, 2022, View Source [SID1234611307]).

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"KemPharm advanced on multiple fronts during the fourth quarter of 2021 and into early 2022, cementing the past twelve months as the most substantial in KemPharm’s history," stated Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. "In January, we announced our strategic focus on developing and commercializing therapeutics targeting rare CNS and neurodegenerative conditions starting with KP1077. The data released earlier this month from the Phase 1 clinical trial exploring the safety and PK of ‘higher dose SDX,’ affirms the opportunity to develop multiple SDX-based drug candidates, led by KP1077 for the treatment of IH, a rare sleep disorder with limited treatment options. Our recent interactions with the FDA have confirmed that we may proceed with the submission of an IND application for KP1077, which we expect to file as early as the second quarter of 2022. Upon clearance of the IND, we plan to initiate a Phase 2 clinical trial of KP1077 in IH later this year with a second trial in narcolepsy targeted to begin as early as the second half of 2022. In addition, we remain active on the business development front with the goal of acquiring or licensing complimentary clinical stage assets in rare CNS and neurodegenerative diseases."

"As KemPharm focuses on advancing KP1077 and expanding our development pipeline, we remain bullish on the potential for the commercial success of AZSTARYS, which is now being commercialized nationally by Corium. There have been significant gains in payor access, and prescription volume is beginning to grow. If this growth continues along the same trajectory observed since the beginning of 2022, the potential to achieve the initial sales milestones provided in the licensing agreement with an affiliate of Gurnet Point Capital becomes more tangible."

"Supporting these strategic and product development efforts is our strong financial position. With $127.8 million in cash, cash equivalents and long-term investments as of December 31, 2021, our current capital resources enable us to advance our internal pipeline while also potentially seeking external opportunities. The strength of our capital position sets us apart from many other development-stage biopharmaceutical companies, particularly in this challenging capital market environment. Our existing $50 million share repurchase program, which extends through 2023, also provides a mechanism to return value to shareholders as we achieve success."

Q4 and Full-Year 2021 Financial Results:

KemPharm’s revenue for Q4 2021 was $2.6 million, as compared to Q4 2020 revenue of $2.4 million. Q4 2021 revenue was derived primarily from $2.0 million in service fee revenue, and approximately $0.6 million of various royalty payments under the license agreement which covers AZSTARYS. The contracts under which service fee revenue is derived will end on March 31, 2022, although some amount of service fee revenue is expected to continue beyond that date.

KemPharm’s net loss for Q4 2021 was ($2.7) million, or ($0.08) per basic and diluted share, compared to a net loss of ($4.9) million, or a loss of ($1.07) per basic and diluted share for the same period in 2020. Net loss for Q4 2021 was driven primarily by a loss from operations of ($2.8) million, partially offset by net interest and other income of $0.1 million. The net operating loss of ($2.8) million for Q4 2021 was a decrease of ($0.4) million compared to net operating loss of ($3.2) million in the same period in 2020.

For FY 2021, KemPharm reported revenue of $28.7 million, which was primarily driven by $20.6 million in milestone and royalty revenue received under the license agreement which covers AZSTARYS, and approximately $8.1 million derived under service fee arrangements and related reimbursements. FY 2020 revenue was $13.3 million.

KemPharm’s net loss attributable to common stockholders for FY 2021 was ($62.9) million, or ($2.11) per basic and diluted share, compared to net loss attributable to common stockholders of ($12.8) million, or ($3.21) per basic and diluted share for FY 2020. Net loss attributable to common stockholders for FY 2021 was driven primarily by aggregate non-cash deemed dividends of ($54.3) million, or ($1.83) per basic and diluted share, which were recognized as a result of the warrant inducement transactions completed in the first half of 2021, a non-cash net loss on extinguishment of debt of ($16.1) million, or ($0.54) per basic and diluted share related to the debt extinguishment in Q1 2021, partially offset by net income from operations of $7.7 million.

As of December 31, 2021, total cash, cash equivalents and long-term investments was $127.8 million, which was a decrease of $3.7 million compared to $131.5 million as of September 30, 2021, driven in part by share repurchases of $2.4 million which were settled during Q4 2021. Based on the Company’s current operating forecast, existing cash, cash equivalents and long-term investments are expected to be sufficient to continue operations through and beyond 2025.

Conference Call Information:

KemPharm will host a conference call and live audio webcast with slide presentation today at 5:00 p.m. ET, to discuss its corporate and financial results for the fourth quarter of 2021 and fiscal year of 2021.

Telephone Access: To access the conference call telephonically, interested participants and investors will be required to register via the following online form: View Source

Once registered, all individuals will be provided with participant dial-in numbers, a passcode, and a registrant ID, which can then be used to access the conference call.

Participants may register at any time. It is recommended that the registration process be completed at least 15 minutes prior to the start of the call.
Webcast Access: The live audio webcast with slide presentation will be accessible via the Investor Relations section of KemPharm’s website, View Source An archive of the webcast and presentation will be available for 90 days beginning at approximately 6:00 p.m. ET, on Wednesday, March 30, 2022.

On March 30, 2022 IGM Biosciences, Inc. (NASDAQ: IGMS) reported the pricing of its underwritten public offering of 8,695,653 shares of its non-voting common stock at a price to the public of $23.00 per share (Press release, IGM Biosciences, MAR 30, 2022, View Source [SID1234611125]). IGM expects to receive total gross proceeds of approximately $200.0 million from this offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by IGM. In addition, IGM has granted the underwriters a 30-day option to purchase up to an additional 1,304,347 shares of its voting common stock at the public offering price, less underwriting discounts and commissions. All of the shares in the offering will be sold by IGM. The offering is expected to close on or about April 1, 2022, subject to satisfaction of customary closing conditions.

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J.P. Morgan, BofA Securities, Stifel, and Guggenheim Securities are acting as joint book-running managers for the offering.

The securities in the offering will be offered by IGM pursuant to a Registration Statement on Form S-3, filed with the Securities and Exchange Commission (SEC) on August 9, 2021 and declared effective on August 19, 2021. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be accessed for free through the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at [email protected]; BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255, or via email: [email protected]; Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attn: Syndicate, or by phone at (415) 364-2720, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

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