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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]).

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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."

Bavarian Nordic to Present at Jefferies 2019 London Healthcare Conference

On November 15, 2019 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that Paul Chaplin, President & CEO will provide a corporate presentation at the Jefferies 2019 London Healthcare Conference on Thursday, November 21, 2019 at 3:20 pm GMT (4:20 pm CET) (Press release, Bavarian Nordic, NOV 15, 2019, View Source [SID1234551394]).

A live and archived webcast of the presentation will be available at http://bit.ly/33G7FsV.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations & Communications. Phone +45 61 77 47 43
U.S.: Graham Morrell, Paddock Circle Advisors (US), Tel: +1 781 686 9600

AIM ImmunoTech Provides Business Update for the Third Quarter of 2019

On November 15, 2019 AIM ImmunoTech (NYSE American:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers and immune-deficiency diseases – such as severe chronic fatigue syndrome (CFS) – reported for the third quarter ended September 30, 2019, and has filed its form 10-Q with the U.S. Securities and Exchange Commission, which is available on the Company’s website (Press release, AIM ImmunoTech, NOV 15, 2019, View Source [SID1234551393]).

Recent Highlights

Reported positive safety data in Phase 1 stage 4 ovarian cancer clinical study using Ampligen
Announced the U.S. Department of Defense’s (DOD) $6.42M "Breakthrough Award" to Roswell Park Comprehensive Cancer Center to fund a clinical trial to study Ampligen as a potential synergistic agent in combination with several other immunotherapies, such as pembrolizumab, in the treatment of brain-metastatic breast cancer.
Announced a second DOD "Breakthrough Award" of $8.3 million to fund a similar Phase 2 clinical trial to study Ampligen as part of a new treatment for brain-metastatic breast cancer at the Moffitt Cancer Center
Received clearance from the FDA for exportation of Ampligen to Argentina for the treatment of severe chronic fatigue syndrome
AIM ImmunoTech CEO Thomas K. Equels commented: "We continue to rapidly progress our clinical activities, as illustrated by a number of major upcoming expected milestones. These include:

In as early as the end of the first quarter of 2020, publication of data from a Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer at University of Pittsburgh Medical Center.
In as early as 11 months, interim data from a follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin, pembrolizumab, plus Ampligen at University of Pittsburgh Medical Center.
In as early as five months, interim data from a Phase 2 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab, at Roswell Park Comprehensive Cancer Center.
In as early as one month, first enrollment in a Phase 1 study evaluating the safety and tolerability of a combination of Ampligen and celecoxib, with or without Intron A, when given along with chemotherapy in the treatment of patients with early-stage triple negative breast cancer.
In as early as three months, submission to the U.S. Food and Drug Administration of the protocol for two separate but parallel Phase 2 clinical trials to study Ampligen as a potential synergistic agent in combination with several other immunotherapies – including pembrolizumab and Intron A – in the treatment of brain-metastatic breast cancer (See details above in Recent Highlights).
Balance Sheet Highlights

As of September 30, 2019, AIM ImmunoTech had cash, cash equivalents and marketable securities of $11,730,000 compared with $1,825,000 as of December 31, 2019. The increase is primarily due to capital raises totaling approximately $10 million.

"The $10 million that we raised over the past few months provides us a substantial runway to support our activities while we await reportable data in the six ongoing immuno-oncology clinical trials studying Ampligen. Our role in these trials is solely to supply the Ampligen, as the trials are funded by grants from prestigious third parties directly to the clinical sites. We believe this third-party funding provides substantial validation of our platform and we look forward to providing further updates in the near-term. Meanwhile, we continue to carefully manage expenses in a way we believe will allow us to concentrate on near-term clinical goals, and as our short-term clinical trial manufacturing objectives are reached we expect to further reduce our burn rate."

Third Quarter Financial Highlights

Research and development-related expenses for the third quarter of 2019 were $1,190,000, compared with $1,595,000 million for the third quarter of 2018. Costs decreased primarily due to a general reduction in the level of Ampligen manufacturing and a decrease in clinical research costs.

General and administrative expenses for the third quarter of 2019 were $1,846,000, compared with $1,273,000 for the third quarter of 2018. The increase in G&A expenses during the current period was mainly due to an increase in stock-based compensation, an increase in public relations expenses, an increase in investment banking fees and an increase in legal fees.

The net loss from continuing operations for the third quarter of 2019 was $2,948,000, compared with $3,078,000 for the third quarter of 2018.