On May 9, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported the acceptance of a poster presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting, to be held in-person on June 3-7, 2022, in Chicago, Illinois (Press release, Delcath Systems, MAY 9, 2022, View Source [SID1234613884]).

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Title: FOCUS Phase 3 Trial Results: Percutaneous Hepatic Perfusion (PHP) With Melphalan for Patients With Ocular Melanoma Liver Metastases (PHP-OCM-301/301A)
Session Title: Melanoma/Skin Cancers
Session Date and Time: June 6, 2022, 1:15-4:15 PM CDT (Display) and 4:30-6:30 PM CDT (Discussion)
Abstract Number: 9510
Presenter: Dr. Jonathan Zager, Director of Regional Therapies and Chief Academic Officer, Moffitt Cancer Center; Professor and Chair, Department of Oncologic Sciences, USF Morsani School of Medicine

For more information, visit the ASCO (Free ASCO Whitepaper) Annual Meeting website.

The poster will be available at View Source when the ASCO (Free ASCO Whitepaper) embargo is released on May 26, 2022, at 4:00 PM CDT.

On May 09, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported that its board of directors has authorized a share repurchase program to acquire up to $1 million of the Company’s common stock (Press release, Immix Biopharma, MAY 9, 2022, View Source [SID1234613883]). The Company may purchase common stock on the open market, through privately negotiated transactions, or otherwise, in compliance with the rules of the United States Securities and Exchange Commission and other applicable legal requirements. As of December 31, 2021, the Company had approximately $18 million of cash, cash equivalents and marketable securities. The Company had approximately 13.9 million shares of common stock outstanding as of April 15, 2022.

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"We are confident that with the $24.2 million gross proceeds raised in our recent IPO, ImmixBio is sufficiently capitalized to reach what we believe will be 2 upcoming inflection points: clinical data from IMX-110 monotherapy clinical trial, as well as clinical data from the IMX-110 combined with BeiGene anti-PD-1 tislelizumab clinical trial," said Ilya Rachman, MD PhD, CEO of ImmixBio. "The current market situation allows us to capture additional value for all shareholders through this measured buyback program. Our interests have always been, and continue to be, aligned with all IMMX shareholders."

The timing, amount of shares repurchased and prices paid for the stock under this program will depend on market conditions as well as corporate and regulatory limitations, including blackout period restrictions. The repurchase program does not obligate the Company to acquire any particular amount of shares, and the repurchase program may be suspended or discontinued at any time at the Company’s discretion.

On May 9, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported that the first participant has been treated in an investigator-sponsored Phase 1/2 study of bomedemstat in combination with atezolizumab (Tencentriq) during the maintenance phase of treatment in people newly diagnosed with extensive stage small cell lung cancer (ES-SCLC) (Press release, Imago BioSciences, MAY 9, 2022, View Source [SID1234613882]).

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The study is being conducted in Seattle and led by Rafael Santana-Davila, M.D., associate professor at the University of Washington School of Medicine and Joseph Hiatt, M.D., Ph.D., of Fred Hutchinson Cancer Center ("Fred Hutch"), and in collaboration with the National Cancer Institute (NCI) funded Fred Hutch Lung Specialized Project of Research Excellence.

Bomedemstat is an inhibitor of lysine-specific demethylase 1 (LSD1), an enzyme that plays a central role in cell growth. Atezolizumab is an anti-PD-L1 monoclonal antibody medication approved by the U.S. Food and Drug Administration (FDA) in 2021 as adjuvant treatment for non-small cell lung cancer. The Phase 1/2 open-label study will enroll approximately 34 participants diagnosed with ES-SCLC to establish the safety and tolerability of a combination treatment with bomedemstat and atezolizumab. Treatment cycles will last for 21 days, consisting of an oral administration of bomedemstat once daily and intravenous administration of atezolizumab on day 1. Participants are followed up after 30 days and every 12 weeks thereafter.

"We are excited to work with UW Medicine and Fred Hutch to explore the expanded use of bomedemstat in solid tumors," said Hugh Y. Rienhoff, Jr., M.D., Chief Executive Officer of Imago. "A combination of bomedemstat, which in some solid tumors enhances their immunogenicity, and atezolizumab, an established checkpoint inhibitor, represents a promising clinical opportunity in lung cancer treatment. This new regimen may provide more long-term disease management possibilities for patients who suffer from extensive stage small cell lung cancer."

In ongoing Phase 2 studies in bone marrow cancers, bomedemstat has been generally well-tolerated and has demonstrated significant symptom improvement for patients with essential thrombocythemia and advanced myelofibrosis.

Additional information about the study can be found at www.clinicaltrials.gov using the identifier NCT05191797.

On May 9, 2022 Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on developing innovative products for neuroendocrine and metabolic disorders, reported financial results for the quarter ended March 31, 2022 and provided a corporate update (Press release, Lipocine, MAY 9, 2022, View Source [SID1234613881]).

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Program Highlights

●TLANDO was approved and granted Market Exclusivity by the U.S. Food and Drug Administration ("FDA") for hypogonadism and our licensee expects commercial launch in second quarter of 2022

●Lipocine is currently enrolling subjects in a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhosis, with enrollment in the study expected to be complete by the end of the third quarter of 2022

●Lipocine has requested an End of Phase 2 meeting to discuss the Phase 3 study and confirmatory trial design for LPCN 1144 in non-cirrhotic non-alcoholic steatohepatitis ("NASH")

●An open label extension ("OLE") study in non-cirrhotic NASH has been completed and topline results are expected in May 2022

Board Appointments

The company appointed Jill M. Jene, Ph.D. and Spyros Papapetropoulos, M.D., Ph.D. to its board of directors in April 2022

First Quarter Ended March 31, 2022 Financial Results

Lipocine reported a net loss of $3.5 million or ($0.04 per diluted share), for the quarter ended March 31, 2022, compared with a net loss of $3.4 million, or ($0.04) per diluted share, in the quarter ended March 31, 2021.

Research and development expenses were $1.9 million for the quarter ended March 31, 2022, compared with $1.6 million for the quarter ended March 31, 2021. The increase in research and development expenses for the quarter ended March 31, 2022, was a result of increases in contract research organization expenses related to the ongoing Phase 2 clinical study for LPCN 1148, PK and food effect studies for LPCN 1107 and LPCN 1154, manufacturing scale up expenses for LPCN 1111, and an increase in personnel and other R&D expenses. These increases were offset by a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 LiFT Phase 2 clinical study and a decrease in costs related to TLANDO.

General and administrative expenses were $1.2 million for the quarter ended March 31, 2022, compared with $1.5 million for the quarter ended March 31, 2021. The decrease in general and administrative expenses for the quarter ended March 31, 2022, was primarily due to decreases in legal costs, personnel costs and other general and administrative costs. These decreases were offset by increases in professional fees related to various consulting and proxy solicitation services as well as an increase in corporate insurance expenses.

As of March 31, 2022, the company had $42.0 million of unrestricted cash, cash equivalents and marketable investment securities compared to $46.6 million as of December 31, 2021.

On May 9, 2022 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Adaptimmune, MAY 9, 2022, View Source [SID1234613880]).

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"We have four clear areas of focus this year: to file the BLA for afami-cel, continue to build our MAGE-A4 franchise, scale up our manufacturing capabilities, and continue to advance our allogeneic products. We have made good progress with each in 2022," said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. "We remain funded into early 2024 and will continue to execute across these objectives."

Roadmap to BLA submission for afami-cel1 in 2022 (first-generation product targeting MAGE-A4)

Adaptimmune is preparing the BLA and targeting submission to the US Food and Drug Administration (FDA) in Q4 2022 for the treatment of synovial sarcoma.
Updated data based on pooled analyses of characteristics associated with clinical responses from Cohort 1 of the SPEARHEAD-1 trial and the Phase 1 trial of afami-cel in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma to be presented in a poster at ASCO (Free ASCO Whitepaper).
Preclinical data at the American Society for Cell and Gene Therapy (ASGCT) (Free ASGCT Whitepaper) annual conference

Preclinical data from the next-generation SPEAR T-cell targeting MAGE-A4 incorporating IL-7 and CCL19 (ADP-A2M4N7X19), developed in collaboration with Noile-Immune, to be presented in a poster; the Company plans to file an IND for this next-generation SPEAR T-cell later this year.
Preclinical data from tumor-infiltrating lymphocytes (TILs) incorporating IL-7 (TIL-IL7), being developed in collaboration with the Center for Cancer Immune Therapy in Denmark, to be presented in a poster; a single-center clinical trial is planned for initiation in 2022.
Corporate
The Company appointed Dr. Joanna (Jo) Brewer as its Chief Scientific Officer effective May 4; Dr. Brewer previously served as the Company’s SVP Allogeneic Research.

Financial Results for the three months ended March 31, 2022

Cash / liquidity position: As of March 31, 2022, Adaptimmune had cash and cash equivalents of $89.5 million and Total Liquidity2 of $304.2 million, compared to $149.9 million and $369.6 million, respectively, as of December 31, 2021.
Revenue: Revenue for the three months ended March 31, 2022 was $3.6 million, compared to $0.4 million for the same period in 2021. Revenue has increased primarily due to an increase in development activities under our collaboration arrangements.
Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2022 were $36.8 million, compared to $24.5 million for the same period in 2021. R&D expenses increased due to an increase in the number of employees engaged in research and development, increases in subcontracted expenditures, increases in in-process research and development costs and a decrease in reimbursements receivable for research and development tax and expenditure credits.
General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2022 were $16.8 million, compared to $13.8 million for the same period in 2021 due to increases in employee-related costs and other corporate costs.
Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three months ended March 31, 2022 was $50.3 million ($(0.05) per ordinary share), compared to $37.8 million ($(0.04) per ordinary share) for the same period in 2021.
Financial Guidance
The Company believes that its existing cash, cash equivalents and marketable securities, together with the additional payments under the Strategic Collaboration and License Agreement with Genentech, will fund the Company’s current operations into early 2024, as further detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2022, to be filed with the Securities and Exchange Commission following this earnings release.

Conference Call Information
The Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EDT (1:00 p.m. BST) today, May 9, 2022. The live webcast of the conference call will be available via the Events page of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial (833) 652-5917 (US or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (6779362).