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Carisma Therapeutics Announces Investor Conference Participation

On November 16, 2019 Carisma Therapeutics Inc., a preclinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies based on engineered macrophages, reported that it will be participating in three upcoming investor conferences (Press release, Carisma Therapeutics, NOV 16, 2019, View Source [SID1234551403]).

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Stifel 2019 Healthcare Conference, November 19-20, 2019 – Carisma’s management will deliver a presentation on Wednesday, November 20, at 4:45 pm EDT and host one-on-one meetings at the venue. The conference will be held at the Lotte New York Palace Hotel, New York, NY.
Jefferies 2019 London Healthcare Conference, November 20-21, 2019 – Carisma will host one-on-one meetings on November 20 and 21 at the conference venue, at the Waldorf Hilton, London, UK.
Piper Jaffray 31st Annual Healthcare Conference, December 3-5, 2019 – Carisma’s management team will present on Tuesday, December 3, at 4:50 pm EDT. The company will host one-on-one meetings at the conference venue, at the Lotte New York Palace Hotel in New York, NY.
Carisma Therapeutics is pioneering the development of engineered macrophages to transform the treatment of cancer and other serious illnesses through the engagement of both the innate and adaptive immune responses. Carisma’s proprietary chimeric antigen receptor (CAR)-macrophage cell therapy platform is designed to address key challenges involved in the treatment of solid tumors by actively trafficking to the tumor, selectively killing tumor cells through phagocytosis, "warming up" the tumor microenvironment, and triggering a durable response from other immune cells.

Carisma’s first product in development is an autologous HER2-targeted CAR-macrophage expected to enter clinical studies in 2020. Additional CAR-macrophages targeting other solid tumor antigens are in early development.

Skyhawk’s $80M Celgene deal expands remit to autoimmune

On November 15, 2019 Skyhawk reported its fifth deal of the year, the company is moving into a new therapeutic area and adding $80 million to its cash reserve (Press release, Skyhawk Therapeutics, NOV 15, 2019, View Source [SID1234626570]). Skyhawk partnered with Celgene to discover and develop small molecules for autoimmune disease and cancer against hard-to-drug targets that have been clinically validated, or genetically associated with a disease.

Skyhawk Therapeutics Inc. uses its SkySTAR platform to discover and develop small molecules capable of modulating RNA splicing within the spliceosome, dictating which exons are included in the final mRNA transcript and offering drug developers a mechanism to control protein expression at the level of mRNA. The therapeutic approach can be applied broadly to indications where attempts at drugging a target at the protein level have been unsuccessful (see "Splice Time")

Interim Report – January to September 2019

On November 15, 2019 Affibody Medical AB (publ) ("Affibody" or "the Company"), a Swedish biotechcompany focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody molecules and Albumod, reported its Interim Report for the third quarter of 2019 (Press release, Affibody, NOV 15, 2019, View Source [SID1234575700]).

Financial Highlights

Revenue for the 3rd Quarter 2019 amounted to SEK 47.6 (25.6) m, and to 297.6 (85.1) m for the nine-month period
Operating result for the quarter amounted to SEK -17.5 (-58.0) m, and to 110.8 (-103.8) m for the nine-month period
Net result for the quarter amounted to SEK -6.0 (-57.7) m, and to 116.9 (-103.4) m for the nine-month period
Cash flow for the quarter amounted to SEK -27.9 (-30.6) m, and to 298.2 (-85.3) m for the nine-month period
Cash and cash equivalents at the end of the period amounted to SEK 389.2 (91.0) m.
Significant Events during the Reporting Period

In September Affibody announced its relocation to Campus Solna
In September a strategic collaboration with GE Healthcare to develop and commercialize Affibody-based PET imaging tracers, with initial focus on HER2 and PD-L1, was announced
In July, 2019 the completion of the planned 12 week interim analysis in the Company’s Phase 2 proof-of-concept study of its bispecific molecule ABY-035 for moderate-to-severe psoriasis ("AFFIRM-35") was announced.
Significant Events during the rest of the Year

The share issue was completed and fully subscribed in May and brought gross proceeds of SEK 147.4 m to the company
In March 2019, a partnership with Alexion Pharmaceuticals, Inc. to co-develop ABY-039, was announced. Under the terms of the agreement, Alexion has provided Affibody with an upfront payment of $25 million, with the potential for additional development- and sales-based milestones of up to $625 million and tiered low double-digit royalty payments. Alexion will lead joint clinical development of ABY-039 and commercialization activities. Affibody has the option to co-promote ABY-039 in the U.S. and will lead clinical development for an undisclosed indication
In February 2019, the Phase 2 proof-of-concept study of ABY-035 for moderate-to-severe psoriasis completed enrollment of patients.

LIDDS completes a direct share issue raising SEK 9.0 million

On November 15, 2019 The board of directors of LIDDS AB reported that it has decided to carry out a directed issue of 562,500 shares at a subscription price of SEK 16 per share (Press release, Lidds, NOV 15, 2019, View Source [SID1234555901]). LIDDS will through the directed share issue receive proceeds amounting to SEK 9.0 million, before transaction costs.

The board of directors of LIDDS has, based on the authorization given by the annual general meeting on May 16, 2019, decided to carry out a directed issue of 562.500 shares to new and current investors.

The subscription price in the Directed Share Issue is set to SEK 16,00 and has been determined by volume weighted average price during the last 20 business days with a discount of 5%. Through the Directed Share Issue, LIDDS will raise SEK 9.0 million before transaction costs. The Directed Share Issue entails a dilution of approximately 2.4 percent of the number of shares and the votes in the Company. Through the Directed Share Issue, the number of outstanding shares and votes will increase by 562,500 shares from 23,692,388 shares to 24,254,888 shares. The share capital will increase by SEK 29,812.50 from SEK 1,255,696.56 to SEK 1,285,509.07.

The reason for the deviation from the shareholders’ preferential rights, is to strengthen the shareholder base and to finance LIDDS’ exciting development projects. The Directed Share Issue will primarily be used to finance the NZ-TLR9 immuno-oncology project which includes an upcoming Phase I clinical trial.

Subscribers in the Directed Share Issue are new shareholders and existing shareholders.

Y-mAbs Announces Update on Omburtamab in DSRCT

On November 15, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported a clinical update on omburtamab for Desmoplastic Small Round Cell Tumor ("DSRCT"). Data was presented at the 2019 Connective Tissue Oncology Society ("CTOS") Annual Meeting in Tokyo, Japan on November 15, 2019, by Dr. Shakeel Modak from Memorial Sloan Kettering Cancer Center ("MSK") in New York (Press release, Y-mAbs Therapeutics, NOV 15, 2019, View Source [SID1234551395]).

DSRCT is an aggressive malignancy that typically presents as intraabdominal sarcomatosis in young males. Less than 100 patients are diagnosed each year in the US, and given this incidence, optimal treatment has not yet been defined. Patients with DSRCT have a very poor prognosis with limited five year survival. Even for those patients where Gross Total Resection ("GTR") is possible, five year Overall Survival ("OS") appears to be approximately 20%. Based on observations from MSK, Whole Abdominalpelvic Intensity-Modulated RadioTherapy ("WA-IMRT") may be advisable for all patients whose tumor can be resected.

Data reported by Dr. Modak was based on evaluation of 33 GTR patients treated at MSK from 2009 to 2017. A total of 24 patients from a Phase I study at MSK received WA-IMRT in combination with omburtamab Interperitoneal Radio Immunotherapy ("IP-RIT") and nine patients received WA-IMRT without omburtamab IP-RIT. The study showed a median OS of 41 months for the DSRCT patients who did not receive omburtamab IP-RIT and 59 months for those receiving omburtamab IP-RIT. The data presented at CTOS indicates that adding IP-RIT with iodinated omburtamab to the standard WA-IMRT treatment appears to be well tolerated. Furthermore, adding omburtamab IP-RIT to GTR improved the five year Kapplan Meier estimated OS from a historical rate of approximately 20% to approximately 40%. While this approach may not help patients who do not achieve GTR of DSRCT, we believe that it may help patients with microscopic disease and help prevent relapse. Lack of evaluable disease means that survival is the only relevant endpoint for these patients.

"We are excited to announce this update for omburtamab in DSRCT, and have recently started a Phase II trial at MSK. DSRCT represent a clear unmet medical need. We plan to advance omburtamab for the benefit of these patients. It is very encouraging to continue to witness omburtamab produce significant data in additional difficult indications, providing further evidence of omburtamab’s potential across B7-H3 positive solid tumors," said Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer further notes, "We are very pleased to see these survival data. This is good news for the DSRCT patients who typically are male teenagers and young adults. We believe that the data illustrates the width of compartmental use of radiolabeled omburtamab, which potentially could be applied to other peritoneal malignancies."