On April 28, 2023 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported recent progress in the business and announced financial results for the quarter ended March 31, 2023 (Press release, ImmunoGen, APR 28, 2023, View Source [SID1234630667]).

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"With a strong first full quarter of sales and continued momentum in FRα testing and market access, we have started the year making great strides towards establishing ELAHERE as the standard of care for FRα-positive ovarian cancer," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "Our commercial and medical teams have delivered exemplary performances in the first stages of the ELAHERE launch and we look forward to continued success with the appointment of Isabel Kalofonos as our new Chief Commercial Officer."

Enyedy continued, "With our goal of obtaining full approval for ELAHERE in the US and expanding into Europe, we expect to announce top-line data from our confirmatory MIRASOL trial in early May. In parallel, we advanced our broader development program to move into platinum-sensitive disease and position ELAHERE as the combination agent of choice in ovarian cancer. Turning to our second pivotal program, PVEK, we expect to complete enrollment in our pivotal CADENZA trial in frontline BPDCN by the end of the year. In addition, we anticipate reporting data from our expansion cohorts with the PVEK/VEN/AZA triplet in frontline AML at ASH (Free ASH Whitepaper) in December. We also advanced dose escalation with IMGN151, our second-generation ADC targeting FRα, and expect to report data for IMGC936 following an interim analysis. With meaningful clinical milestones coming, strong commercial uptake of ELAHERE, and a strengthened balance sheet following our recent non-dilutive term loan financing with Pharmakon, we are well positioned to create significant value for both patients and shareholders throughout the year."

RECENT PROGRESS

Generated $29.5 million in ELAHERE (mirvetuximab soravtansine-gynx) net sales for the quarter ended March 31, 2023, the first full quarter of launch following approval in November of 2022.
Reached requisite number of progression-free survival (PFS) events in the confirmatory MIRASOL trial.
Presented final overall survival and additional efficacy data from the SORAYA trial at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting.
Advanced dose escalation with IMGN151 and enrollment in the non-small cell lung cancer (NSCLC) expansion cohort for IMGC936.
Announced non-dilutive credit facility with Pharmakon Advisors, LP for up to $175 million; $75 million received upon execution.
Appointed Isabel Kalofonos as Senior Vice President and Chief Commercial Officer.
ANTICIPATED UPCOMING EVENTS

Report top-line data for MIRASOL trial in early May 2023.
Submit Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for ELAHERE in FRα-high platinum-resistant ovarian cancer (PROC) in the second half of 2023 to support approval and launch in Europe.
Submit supplemental Biologics License Application (sBLA) to the FDA in the second half of 2023 to support the conversion of the accelerated approval of ELAHERE to full approval.
Our partner, Huadong Medicine, to submit Biologics License Application (BLA) to the National Medical Products Administration (NMPA) of China for ELAHERE in FRα-high PROC in the second half of 2023 to support potential approval and launch.
Report on primary endpoint for PICCOLO, a single-arm Phase 2 trial of mirvetuximab in FRα-high platinum-sensitive ovarian cancer (PSOC), before the end of 2023.
Complete enrollment in the pivotal Phase 2 CADENZA trial this year.
Initiate combination cohort of pivekimab with magrolimab in relapsed/refractory (R/R) acute myeloid leukemia (AML) in collaboration with Gilead in the second half of 2023.
Report data from two cohorts evaluating the pivekimab triplet with Venclexta (venetoclax) and Vidaza (azacitidine) in frontline AML at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Report data from the IMGC936 NSCLC cohort following an interim analysis.
FINANCIAL RESULTS

Total revenues were $49.9 million for the quarter ended March 31, 2023, including $29.5 million of net product revenues from sales of ELAHERE for the first full quarter of launch following approval in November 2022, compared to $38.1 million in total revenue for the quarter ended March 31, 2022. The increase was primarily driven by ELAHERE net sales and recognition of a $15 million upfront fee received pursuant to a multi-target license and option agreement executed in the first quarter with Vertex Pharmaceuticals, partially offset by $30.8 million of license fees recorded as revenue in the prior year period pursuant to the Company’s collaboration and license agreements with Huadong Medicine and Eli Lilly.

Research and development expenses rose to $51.6 million for the quarter ended March 31, 2023 compared to $44.3 million for the quarter ended March 31, 2022. The increase was primarily driven by costs related to the addition of our medical affairs organization and clinical trial expenses.

Selling, general and administrative expenses were $40.0 million for the quarter ended March 31, 2023 compared to $16.6 million for the quarter ended March 31, 2022. The increase was due primarily to greater expenses in support of the US launch of ELAHERE, including costs related to the addition of our commercial organization and sales and marketing activities.

Net loss for the first quarter of 2023 was $41.0 million, or $0.16 per diluted share, compared to net loss of $24.1 million, or $0.10 per diluted share, for the first quarter of 2022.

ImmunoGen had $201.2 million in cash and cash equivalents as of March 31, 2023, compared with $275.1 million as of December 31, 2022. Cash used in operations was $73.7 million for the first three months of 2023 compared with cash used in operations of $41.4 million for the same period in 2022. Capital expenditures were $0.2 million and $0.3 for the first three months of 2023 and 2022, respectively. Earlier this month, the Company entered into a term loan credit facility for up to $175 million with entities managed by Pharmakon and drew the initial tranche of $75 million upon execution of the facility.

FINANCIAL GUIDANCE

ImmunoGen has updated its financial guidance for 2023 and now expects:

revenues, excluding product revenue from ELAHERE, between $45 million and $50 million; and
operating expenses between $320 million and $335 million.
ImmunoGen expects to provide ELAHERE product revenue guidance later this year. The increase in revenue guidance is a result of recognizing a $15 million upfront fee from Vertex in the first quarter as no deferral was required. Additionally, the Company increased its operating expense guidance to reflect greater spend in support of ELAHERE’s launch and expected growth trajectory.

ImmunoGen expects that its current cash, inclusive of the $75 million received pursuant to the term loan facility with Pharmakon, and combined with anticipated product and collaboration revenues, will fund operations into 2025.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, please register here. A dial-in and unique PIN will be provided to join the call. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

ABOUT ELAHERE

ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.

ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Eye problems are common with ELAHERE and can be severe. ELAHERE also can cause severe or life-threatening inflammation of the lungs that may lead to death and patients may develop nerve problems called peripheral neuropathy during treatment. Please see full Prescribing Information, including Boxed Warning, and Medication Guide for ELAHERE.

On April 28, 2023 Plus Therapeutics, Inc. (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, reported that the Company’s Board of Directors has approved a reverse stock split of its shares of common stock at a ratio of 1-for-15 (Press release, PLUS THERAPEUTICS, APR 28, 2023, View Source [SID1234630666]). The reverse stock split will become effective at 12:01 a.m. Eastern Time on May 1, 2023, and the Company’s common stock will open for trading on The Nasdaq Capital Market on a post-split basis on May 1, 2023 under the Company’s existing trading symbol, "PSTV." At such time, the Company’s common stock will also commence trading with a new CUSIP number, 72941H509.

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The reverse stock split is being implemented to increase the per share trading price of the Company’s common stock for the purpose of ensuring a share price high enough to comply with the minimum $1.00 bid price requirement for Continued listing on The Nasdaq Capital Market.

At the effective time of the reverse stock split, every fifteen (15) shares of Plus Therapeutics common stock issued and outstanding will be combined into one (1) share of common stock issued and outstanding, with no change to the par value of $0.001 per share. This will reduce the Company’s outstanding common stock from approximately 37,400,000 shares to approximately 2,493,333 shares. No fractional shares of common stock will be issued as a result of the reverse stock split and instead holders of Plus common stock will receive a cash payment in lieu of fractional shares to which they would otherwise be entitled. The shares underlying the Company’s outstanding equity awards and warrants will also be adjusted accordingly. The reverse stock split affects all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s common stock, except for adjustments that may result from the treatment of fractional shares.

The Company has retained its transfer agent, Broadridge Financial Services, Inc. ("Broadridge"), to act as its exchange agent for the reverse stock split. Stockholders with shares held in certificate form will receive from Broadridge instructions regarding the exchange of their certificates. Stockholders that hold shares in book-entry form or hold their shares in brokerage accounts are not required to take any action and will see the impact of the reverse stock split reflected in their accounts, subject to brokers’ particular processes. Beneficial holders of Plus Therapeutics common stock are encouraged to contact their bank, broker, custodian or other nominee with questions regarding procedures for processing the reverse stock split.

Additional information regarding the reverse stock split is available in the definitive proxy statement filed with the U.S. Securities and Exchange Commission on March 7, 2023 by the Company.

On April 28, 2023 ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the first quarter ended March 31, 2023, and provided an update on recent corporate activities (Press release, ASLAN Pharmaceuticals, APR 28, 2023, View Source [SID1234630665]).

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"We have made strong progress in the first quarter of the year by completing enrollment in our TREK-AD Phase 2b trial, testing eblasakimab as a novel treatment for moderate-to-severe atopic dermatitis (AD), and we look forward to reporting topline data from this study in early July 2023," said Dr Carl Firth, CEO, ASLAN Pharmaceuticals. "We have also advanced farudodstat into a Phase 2a, proof-of-concept study in alopecia areata (AA) expected to commence enrollment in the second quarter of 2023. AA is a common autoimmune disease that is associated with a severe psychological burden yet there are few effective treatments that are safe for long-term use. Farudodstat potently inhibits key drivers of AA disease pathophysiology and has the potential to be a novel, first-in-class treatment. This quarter we also announced strong support from BVF Partners and additional investors on a $20 million financing which we expect will enable sufficient runway for the company as we look forward to three possible clinical readouts in the next 12 months."

First quarter 2023 and recent business highlights

Q1 and recent clinical developments

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In January, ASLAN and Thermo Fisher Scientific Inc (NYSE: TMO) announced a partnership to manufacture a high concentration formulation of eblasakimab for Phase 3 clinical trials. Thermo Fisher will manufacture this formulation of eblasakimab that ASLAN has developed, allowing up to 400 mg to be administered in a single, subcutaneous injection and suitable for use with different devices.
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In February, the final patient was enrolled in the TREK-AD (Trials with EblasaKimab in Atopic Dermatitis) study, a Phase 2b, dose-ranging, randomized, double-blind, placebo-controlled clinical trial of eblasakimab in adults with moderate-to-severe AD. ASLAN expects to report topline data from the study that is evaluating the efficacy and safety of eblasakimab in biologic naïve AD patients over a 16-week treatment period in early July 2023.

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In February, ASLAN announced the advancement of its clinical program to investigate farudodstat in a Phase 2a, proof-of-concept trial as a potential first-in-class treatment for AA. Farudodstat is 30-fold more potent than approved drugs in its class and has demonstrated a well-tolerated safety profile. The trial will recruit around 60 AA patients in the US and enrollment is expected to begin in the second quarter of 2023. The interim, topline readout following the first 12-week treatment period is expected in the first quarter of 2024 and will inform the design of the subsequent, Phase 2b, dose-ranging study.
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In March, two abstracts showcasing new data on eblasakimab were accepted for poster presentation at the first meeting of the International Societies for Investigative Dermatology (ISID), taking place from May 10 to 13, 2023, in Tokyo, Japan. The abstracts published online in the Journal of Investigative Dermatology explore eblasakimab’s efficacy across different body regions in AD patients including difficult-to-treat areas, such as the head and neck, and its potential for alleviating the underlying itch and hypersensitized sensory nerve fibers through multiple molecular pathways in AD.
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In April, two additional late-breaker abstracts were accepted for presentation at the ISID meeting. The late-breaker abstract on eblasakimab and the differences between IL-13Rα1 and IL4R blockade on Type 2 and Type 1 signalling in AD was accepted for oral presentation and the late-breaker abstract on the role of farudodstat in a human ex vivo model of AA was accepted for poster presentation. Additional details from the late-breaker abstracts will be shared after presentation at the conference.
Corporate updates

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In February, ASLAN announced that it entered into a definitive purchase agreement (Purchase Agreement) to raise gross proceeds of approximately $20 million resulting from the sale of its ordinary shares (or pre-funded warrants) and accompanying purchase warrants, at a purchase price of $0.178 per ordinary share (or the equivalent of $4.45 per American Depositary Share ("ADS") after giving effect to the ADS Ratio Change described below) to BVF Partners, K2 HealthVentures and certain existing investors. In addition, ASLAN has the potential to receive up to an additional $80 million in proceeds if all purchase warrants issued in connection with the Purchase Agreement are fully exercised.
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In March, ASLAN’s management team hosted a virtual farudodstat Research and Development Day with Key Opinion Leader, Brett King, MD PhD, Associate Professor of Dermatology, Yale University School of Medicine, to discuss the unmet medical need in AA and the potential for farudodstat to be a novel, first-in-class treatment for AA patients. A replay of the event and presentation materials are available within the Investor Relations section of ASLAN’s website.
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In March, Alan Bianchi was appointed as Commercial Lead Advisor for eblasakimab. Alan is a biopharmaceutical marketing executive with extensive product commercialization and launch experience in dermatology and immunology. He held the role of Head, HCP marketing at Sanofi for the US launch of dupilumab and, most recently, was the Executive Director and US Marketing Lead for the global launch of tralokinumab at LEO Pharma.
Anticipated upcoming milestones

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New clinical and translational data on eblasakimab will be presented at the ISID Meeting in Tokyo, Japan, including a podium presentation for the late-breaker abstract. New translational data on farudodstat will be shared as a poster presentation. Posters will be available to view at the meeting from May 10, 2023, and will be uploaded to the "Publications" section of ASLAN’s website.

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The first patient is expected to be enrolled in the farudodstat Phase 2a, proof-of-concept study in AA in the second quarter of 2023.
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Topline data from the Phase 2b TREK-AD trial of eblasakimab is expected in early July 2023.
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Topline data from the TREK-DX trial of eblasakimab is expected in the first quarter of 2024.
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Topline interim data from the farudodstat Phase 2a, proof-of-concept study in AA is expected in the first quarter of 2024.
First quarter 2023 financial highlights

•
As of March 31, 2023, the Company had cash, cash equivalents and short-term investments of $57.5 million.
•
Cash used in operations for the first quarter of 2023 was $19.3 million compared to $7.2 million in the same period in 2022.
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Research and development expenses were $14.1 million in the first quarter of 2023 compared to $9.4 million in the first quarter of 2022. The increase was due to higher clinical development and manufacturing costs for the eblasakimab studies and activities to support the commencement of the farudodstat Phase 2a, proof-of concept study.
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General and administrative expenses were $4.0 million in the first quarter of 2023 compared to $2.5 million in the first quarter of 2022. The increase was mainly driven by costs related to financing activities completed in the first quarter and increase in corporate activities.
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Net loss attributable to stockholders for the first quarter of 2023 was $19.1 million compared to a net loss of $12.9 million for the first quarter of 2022.
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The weighted average number of ADSs outstanding in the computation of basic loss per share for the first quarter of 2023 was 14.8 million (representing 370.7 million ordinary shares) compared to 13.9 million (representing 348.7 million ordinary shares) for the first quarter of 2022.
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At the opening of trading on the Nasdaq Capital Market on March 13, 2023, the Company effected a change in the ratio of its ADSs to its ordinary shares from one (1) ADS representing five (5) ordinary shares to one (1) ADS representing twenty-five (25) ordinary shares (ADS Ratio Change). For the Company’s existing ADS holders, the ADS Ratio Change had the same effect as a one-for-five reverse ADS split. [Except as otherwise indicated, all information in this press release gives retroactive effect to the ADS Ratio Change.

On April 28, 2023 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, will report its first quarter 2023 financial results on Wednesday, May 3, 2023 (Press release, 2seventy bio, APR 28, 2023, View Source [SID1234630664]). 2seventy bio will host a conference call and webcast at 4:30 p.m. ET to discuss the results and provide a business update.

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Participants can access the conference call live via webcast which will be available on the investor page of the company’s website at View Source Participants who wish to ask a question may register here at https://register.vevent.com/register/BI458c3098c2a64310b49e967327a906e7 to receive dial-in numbers and a unique pin to join the call. It is recommended that participants join 10 minutes prior to the event’s start. A replay of the call will be available on the 2seventy bio website following the completion of the call.

On April 27, 2023 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), the only ASX-listed clinical stage cell therapy company, reported that the Indian Patent Office has issued a patent covering certain applications of chimeric antigen receptor (CAR) technology using chlorotoxin (CLTX), including Chimeric’s clinical-stage CAR T asset CHM 1101 and preclinicalstage CAR NK asset CHM 1301 (Press release, Chimeric Therapeutics, APR 28, 2023, View Source [SID1234630605]).

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The India patent has been granted under patent number IN 424963, entitled "Chimeric antigen receptors containing a chlorotoxin domain."

In addition, the Israel Patent Office has issued an Official Notification Prior to Acceptance, a notice of allowance, for application IL 258670.

Chimeric holds the exclusive worldwide license to develop and commercialize IN 424963, IL 258670, and related patent applications filed in other global territories. Chimeric’s CEO and Managing Director Jennifer Chow said: "We are delighted to have patent protection granted for CLTX CAR therapies in India and shortly in Israel as we continue to expand the robust intellectual property portfolio underpinning our CLTX CAR pipeline assets."

About CHM 1101:

CHM 1101 (CLTX CAR T) is a first in class CAR T therapy that has the potential to address the high unmet medical need of patients with recurrent or progressive glioblastoma, patients who have a poor prognosis, with limited treatment options and a median survival of less than 1 year (Gallego. Curr Oncol, 2015).

CHM 1101 cells uniquely utilize chlorotoxin (CLTX), a 36-amino acid peptide derived from deathstalkerscorpion venom, as the tumour-targeting component of the chimeric antigen receptor (CAR). In preclinical models, CHM 1101 CAR T cells have been shown to bind more broadly and specifically to GBM cells than other targeting domains like EGFR, HER-2 or IL-13. CHM 1101 cells also demonstrated potent antitumor activity against glioblastoma while not exhibiting any off-tumor recognition of normal human cells and tissues, indicating a potentially optimal safety and efficacy profile.

CHM 1101 is currently being studied in an ongoing phase 1A clinical trial in recurrent / progressive glioblastoma at City of Hope Cancer Centre in California. Outcomes from the initial two dose levels of the Phase 1A trial have been previously presented and demonstrated patient safety with a disease stability rate of approximately 70%.