On May 12, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the first quarter ended March 31, 2023 and provided an update on recent developments (Press release, IGM Biosciences, MAY 12, 2023, View Source [SID1234631597]).

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"We are pleased to be underway in our randomized clinical trial of IGM-8444 in combination with standard of care FOLFIRI chemotherapy and bevacizumab in second line metastatic colorectal cancer patients, and we look forward to presenting additional clinical data in the middle of 2023 from our non-randomized Phase 1 clinical study of 3 mg/kg of IGM-8444 plus FOLFIRI, with and without bevacizumab," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We are also looking forward to the start of clinical testing of imvotamab in autoimmune diseases, where we believe the clinical safety and efficacy profile of imvotamab positions us very well for the exciting new area of treating autoimmune disease with T cell engagers."

Pipeline Updates

IGM-8444 (DR5)

Clinical development of IGM-8444 advances. The Company continues to advance the clinical development of IGM-8444, the Company’s IgM agonist antibody targeting death receptor 5 (DR5).
Dosing ongoing in the randomized colorectal cancer clinical trial. The Company is currently treating patients in a randomized clinical trial of IGM-8444 plus FOLFIRI and bevacizumab in second line metastatic colorectal cancer. The Company plans to assess both the 3 mg/kg and 10 mg/kg dose levels of IGM-8444 with a primary endpoint of progression free survival and secondary endpoints of overall response rate and overall survival as compared to the current standard of care treatment arm.
Dosing ongoing in the venetoclax combination. The Company is currently treating patients with acute myeloid leukemia in its IGM-8444 plus venetoclax and azacytidine Phase 1 combination cohort.
Dosing ongoing in the fifth birinapant dose cohort. The Company is also currently treating patients in its fifth birinapant Phase 1 combination dose escalation cohort.
Additional clinical data expected in middle of 2023. The Company plans to present additional clinical data from the 3 mg/kg of IGM-8444 plus FOLFIRI cohort, with and without bevacizumab, of its non-randomized Phase 1 clinical trial in the middle of 2023.
Presented preclinical data. In April 2023, the Company presented preclinical data on IGM-8444 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data was featured in a poster presentation titled "Characterization of the synergistic tumor cytotoxicity of agonist DR5 IgM antibody IGM-8444 with chemotherapeutic agents".
Imvotamab (CD20 x CD3)

Advancing into multiple autoimmune clinical trials. The Company is planning to begin clinical testing of imvotamab in severe systemic lupus erythematosus and severe rheumatoid arthritis, subject to IND clearance.
Presented preclinical data. In April 2023, the Company presented preclinical data on imvotamab at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data was featured in a poster presentation titled "Depletion of tissue-resident B cells by a CD20xCD3 IgM bispecific T cell engager in cynomolgus monkeys demonstrates effective tissue penetration and potent target cell killing".
IGM-7354 (IL-15 x PD-L1)

Phase 1 trial. The Company continues enrolling patients in a Phase 1 clinical trial exploring the safety, efficacy and biomarker activity of IGM-7354, an IgM targeted immunostimulatory IL-15 cytokine, in the treatment of patients with solid tumors.
Presented preclinical data. In April 2023, the Company presented preclinical data on IGM-7354 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data was featured in a poster presentation titled "IGM-7354, an immunocytokine with IL-15 fused to an anti-PD-L1 IgM, induces NK and CD8+ T cell-mediated cytotoxicity of PD-L1-positive tumor cells".
IGM-2644 (CD38 x CD3)

Phase 1 trial. The Company is initiating a clinical trial exploring the safety and efficacy of IGM-2644, a CD38 x CD3 IgM T cell engaging antibody, in patients with recurrent or refractory multiple myeloma.
Presented preclinical data. In April 2023, IGM presented preclinical data evaluating IGM-2644 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data was featured in a poster presentation titled "Novel CD38xCD3 Bispecific IgM T Cell Engager, IGM-2644, Potently Kills Multiple Myeloma Cells Though Complement and T Cell Dependent Mechanisms".

First Quarter 2023 Financial Results

Cash and Investments: Cash and investments as of March 31, 2023 were $373.4 million, compared to $427.2 million as of December 31, 2022.
Collaboration Revenue: For the first quarter of 2023, collaboration revenues were $0.5 million, compared to no revenue for the same period in 2022.
Research and Development (R&D) Expenses: For the first quarter of 2023, R&D expenses were $50.9 million, compared to $38.9 million for the same period in 2022.
General and Administrative (G&A) Expenses: For the first quarter of 2023, G&A expenses were $13.0 million, compared to $13.1 million for the same period in 2022.
Net Loss: For the first quarter of 2023, net loss was $59.3 million, or a loss of $1.33 per share, compared to a net loss of $51.9 million, or a loss of $1.53 per share, for the same period in 2022.

2023 Financial Guidance

The Company expects full year 2023 GAAP operating expenses of $275 million to $285 million, including estimated non-cash stock-based compensation expense of approximately $45 million, and full year collaboration revenue of approximately $3 million related to the Sanofi agreement. The Company expects to end 2023 with a balance of more than $200 million in cash and investments, and for the balance to enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2024.

On May 12, 2023 Ensysce Biosciences, Inc. (NASDAQ:ENSC) (the "Company"), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, reported the closing of the previously announced public offering of an aggregate of 1,800,876 shares of its common stock (or pre-funded warrants in lieu thereof), Series A-1 warrants to purchase up to 1,800,876 shares of common stock and Series A-2 warrants to purchase 1,800,876 shares of common stock, at a combined public offering price of $3.887 per share (or pre-funded warrant in lieu thereof) and accompanying warrants (Press release, Ensysce Biosciences, MAY 12, 2023, View Source [SID1234631593]). The Series A-1 warrants have an exercise price of $3.637 per share, are exercisable immediately upon issuance and will expire five years from the date of issuance, and the Series A-2 warrants have an exercise price of $3.637 per share, are exercisable immediately upon issuance and will expire eighteen months from the date of issuance.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering were approximately $7 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for the further clinical development of their product candidates and for working capital and other general corporate purposes.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-271480), which was declared effective by the Securities and Exchange Commission (the "SEC") on May 9, 2023. The offering was made only by means of a prospectus which forms a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus will be filed with the SEC and may be obtained on the SEC’s website at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

In connection with the offering, the Company also has amended certain existing warrants to purchase up to an aggregate of 210,085 shares of the Company’s common stock that were previously issued in September 2021 through December 2022 at exercise prices ranging from $16.80 to $187.20 per share at an additional offering price of $0.125 per amended warrant. The amended warrants have a reduced exercise price of $3.637 per share.

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.

On May 12, 2023 Delcath Systems, Inc. (Nasdaq: DCTH) (Delcath or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and certain preliminary financial results for the first quarter ended March 31, 2023 (Press release, Delcath Systems, MAY 12, 2023, View Source [SID1234631592]).

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Recent Business Highlights

During and since the first quarter, Delcath:

Received an acknowledgement of Class 2 NDA resubmission from the U.S. Food and Drug Administration (FDA) for Hepzato Kit (melphalan hydrochloride for Injection/Hepatic Delivery System) with a Prescription Drug User Fee Act (PDUFA) goal date of August 14, 2023,

Completed a private placement of up to $85 million in gross proceeds, including the closing of initial upfront funding of $25 million. The financing was led by Vivo Capital with participation from Logos Capital, BVF Partners LP, Stonepine Capital Management LLC, and Serrado Capital LLC as well as existing investors including Rosalind Advisors,

Amended an existing loan agreement with Avenue Venture Opportunities Fund, L.P. to provide an interest only period spanning March 31, 2023, to September 30, 2023 thereby deferring $4.3 million in principal payments,
Appointed John R. Sylvester as Chairman of the Board, and
Announced that updated results from the CHOPIN phase 1B trial were published in the Journal Cardiovascular and Interventional Radiology. The article reported seven patients with advanced uveal melanoma treated with CHEMOSAT and ipilimumab plus nivolumab showed a median PFS of 29.1 months at a median follow-up of 29.1 months.

"With a critical financing behind us, the Company is focused on preparing to commercialize Hepzato if approved," said Gerard Michel, Chief Executive Officer of Delcath. Mr. Michel added, "Importantly, as we approach the August 14 PDUFA date, we continue to expand the list of institutions that have indicated their interest in becoming a treating center upon approval."

Preliminary First Quarter 2023 Financial Results

Delcath is in the process of completing its customary quarter-end close and review procedures, including certain valuation work associated with the issuance of warrants and preferred stock in Delcath’s previously announced private placement that closed on March 29, 2023, as of and for the quarter ended March 31, 2023, and the final results for this period could materially differ from the preliminary expected results disclosed in this press release. Delcath’s full first quarter 2023 financial results will be reflected in a Quarterly Report on Form 10-Q, which pursuant to Rule 12b-25, is expected to be filed no later than May 22, 2023. The financial performance measures presented in this press release for the first quarter of 2023 are forward-looking statements, preliminary estimates and unaudited, based on management’s initial review of the information presented, and are thus inherently uncertain and subject to change as Delcath completes its end-of-period reporting process and related activities for the first quarter of 2023. During the course of the review of Delcath’s condensed consolidated financial statements and related notes as of and for the quarter ended March 31, 2023, Delcath’s independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary estimates presented herein. Additional information and disclosures would be required for a more complete understanding of Delcath’s financial position and results of operations as of and for the quarter ended March 31, 2023. Accordingly, undue reliance should not be placed on this preliminary information.

Financial Highlights.

Revenue is expected to be approximately $0.6 million in revenue for the three months ended March 31, 2023, compared to $0.4 million for the three months ended March 31, 2022. The estimated increase in product revenue was due to the transition to direct sales in Europe which occurred in March 2022 as well as an approximately 37% increase in unit volume.

For the three months ended March 31, 2023, research and development expenses is expected to be relatively flat at approximately $4.5 million for both periods compared to the three months ended March 31, 2022.

As of March 31, 2023, the Company had cash, cash equivalents and restricted cash totaling $24.3 million, as compared to cash, cash equivalents and restricted cash totaling $11.8 million as of March 31, 2022. The increase in cash of $12.5 million was due to the proceeds from the private placement which closed on March 29, 2023, offset by the use of $4.3 million of cash in our operating activities and $6.3 million of principal payments toward the Company’s existing loan with Avenue.

Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

Event Date: Friday May 12, 2023

Time: 8:30 AM Eastern Time

Participant Numbers: Toll Free: 1-833-630-1960
International: 1-412-317-1841
Webcast: View Source

CONFERENCE REPLAY

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Replay Access Code: 2940240

End Date: May 19, 2023

On May 12, 2023 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company focused on discovering and developing medicines that are transformational for patients, reported its financial results and business highlights for the first quarter ended March 31, 2023 (Press release, Centessa Pharmaceuticals, MAY 12, 2023, View Source [SID1234631591]).

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"Centessa continued strong clinical momentum in the first quarter with multiple clinical milestones planned for the year," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "We are advancing the registration program for SerpinPC for the treatment of hemophilia B; dosing subjects in the ongoing Phase 1/2a clinical trial for LB101, our first LockBody molecule for the treatment of solid tumors; and, conducting IND enabling activities for our newest product candidate, ORX750, for the treatment of narcolepsy with potential expansion into other sleep disorders."

Dr. Saha continued, "We expect to rapidly drive our pipeline forward and anticipate a lower cash burn rate for the remainder of the year. We believe we are well positioned with a cash runway into 2026 to support multiple clinical readouts across our programs."

Recent Highlights
•In March, the first subject was dosed in the Phase 1/2a first-in-human clinical trial of LB101, a conditionally tetravalent PD-L1xCD47 bispecific monoclonal antibody from the Company’s LockBody technology platform for the treatment of solid tumors. LB101 is the Company’s first

LockBody candidate to enter the clinic. The Company announced clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to initiate the Phase 1/2a trial in January.
•In March, the Company announced ORX750, an orally administered, selective orexin receptor 2 (OX2R) agonist, as a product candidate for the treatment of narcolepsy with potential expansion into other sleep disorders.
•In February, the Company presented additional data from the open-label extension (OLE) of the ongoing Phase 2a study of SerpinPC for the treatment of hemophilia during an oral presentation at the 16th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD). With total exposure of over 40 patient-years across multiple dosing regimens, the Phase 2a data showed a continued favorable safety and tolerability profile for SerpinPC, as well as evidence of sustained efficacy, as measured by a reduction in the all-bleeds annualized bleeding rates (ABR). To date, no thromboembolic events and no treatment-related sustained elevations of D-dimer have been observed across the Phase 2a study.

Anticipated Upcoming Program Milestones
•Hemophilia (SerpinPC)- The registrational program for hemophilia B is ongoing. PRESent-5, an observational feeder study, is enrolling subjects and the Company expects to begin dosing in the PRESent-2 and PRESent-3 studies later this year. In addition, the Company plans to share data from Part 5 of the OLE of the Phase 2a study of SerpinPC, subject to completion, at a scientific meeting this year.
•Solid Tumors (PD-L1xCD47 LockBody LB101)- The Phase 1/2a first-in-human clinical study is ongoing.
•Narcolepsy and Other Sleep Disorders (ORX750)- ORX750 is in preclinical development and undergoing IND-enabling activities. The Company plans to share preclinical data at a scientific meeting later this year.

The Company has multiple earlier-stage programs, including MGX292 and other LockBody molecules such as PD-L1xCD3, and discovery-stage programs. Where applicable, the Company plans to provide updates on preclinical programs as they advance toward clinical studies.
First Quarter 2023 Financial Results

•Cash, Cash Equivalents and Short-term Investments: $346.2 million as of March 31, 2023, which the Company expects will fund operations into 2026, without drawing on the remaining available tranches under the Oberland credit facility.
•Research & Development Expenses: $32.8 million for the first quarter ended March 31, 2023, compared to $36.9 million for the first quarter ended March 31, 2022.
•General & Administrative Expenses: $16.1 million for the first quarter ended March 31, 2023, compared to $14.4 million the first quarter ended March 31, 2022.
•Net Loss Attributable to Ordinary Shareholders: $50.7 million for the first quarter ended March 31, 2023, compared to $54.5 million for the first quarter ended March 31, 2022.

On May 12, 2023 Bio-Techne Corporation (NASDAQ: TECH) reported that Jim Hippel, Executive Vice President and Chief Financial Officer, reported that it will present at the 2023 RBC Capital Markets Global Healthcare Conference on Tuesday, May 16, 2023, at 2:35 p.m. EDT (Press release, Bio-Techne, MAY 12, 2023, View Source [SID1234631589]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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