On March 17, 2020 DiaMedica Therapeutics Inc. (Nasdaq: DMAC) reported that its fourth quarter 2019 financial results will be released after the markets close on Monday, March 23rd (Press release, DiaMedica, MAR 17, 2020, View Source [SID1234555642]). DiaMedica will host a live conference call on Tuesday, March 24th at 7:00 AM Central Time to discuss its business update and financial results.

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Conference Call details:

Date:

Tuesday, March 24, 2020

Time:

7:00 AM CT / 8:00 AM ET

Web access:

View Source

Dial In:

(844) 557-8483 (domestic)

(825) 312-2381 (international)

Conference ID:

9270458

Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on our website, under investor events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until March 31, 2020, by dialing (800) 585-8367 (US Toll Free), (416) 621-4642 (International), replay passcode 9270458.

On March 17, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported a business update for the fourth quarter and full year 2019 (Press release, Cue Biopharma, MAR 17, 2020, View Source [SID1234555641]).

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"We continue to execute on our stated goals and objectives in a highly focused manner. The fourth quarter of 2019, as well as the beginning of 2020, has been marked by the successful opening of all 13 participating clinical centers and the associated enhancement of patient enrollment for our ongoing CUE-101 monotherapy Phase 1 trial," said Daniel Passeri, chief executive officer of Cue Biopharma. Mr. Passeri added, "Furthermore, we successfully accessed the capital markets in a highly effective and prudent manner through an At-the-Market ("ATM") instrument with Stifel Nicolaus & Company, Inc. ("Stifel") raising $49M, net of commissions paid, in the second half of the year through strategically placed blocks of shares with targeted fundamental institutional investors. As a result of our successful execution of clearly defined corporate initiatives, we are now well positioned to focus upon the next stages of our strategic corporate development plan."

According to Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma, "We continue to make significant progress across the R&D organization on many fronts including expanding our oncology pipeline assets, evolving our platform and generating key datasets to support application of our platform in autoimmune diseases. To the last point, we are very pleased to have Merck, our collaborator in autoimmune disease, recently present advances in the Immuno-STAT platform for selective modulation of pathologic T cells involved in autoimmune type 1 diabetes."

Fourth-Quarter 2019 Financial Results

The Company reported collaboration revenue of approximately $1.0 million and $0.3 million for the three months ended December 31, 2019 and 2018, respectively.

Research and development expenses were $6.9 million and $7.3 million for the three months ended December 31, 2019 and 2018, respectively. The decrease in research and development expenses of $0.4 million was primarily due to a decrease in manufacturing cost as our full clinical supply was manufactured during 2018. The decrease in these costs were offset by clinical trial expenses related to the CUE-101 monotherapy trial that was initiated in the latter part of the third quarter of 2019.

General and administrative expenses were $3.1 million and $5.3 million for the three months ended December 31, 2019 and 2018, respectively. The decrease in general and administrative expense of $2.2 million was primarily due to a decrease in stock-based compensation expense and legal and accounting fees incurred in the fourth quarter of 2019 as compared to the same period in 2018.

Full Year 2019 Financial Results

The Company reported collaboration revenue of approximately $3.5 million and $1.1 million for the years ended December 31, 2019 and 2018, respectively.

Research and development expenses were $27.5 million and $28.5 million for the years ended December 31, 2019 and 2018, respectively. The decrease in research and development expenses of $1.0 million was primarily due to a reduction in headcount and operational efficiencies realized during 2019.

General and administrative expenses were $12.7 million and $11.3 million for the years ended December 31, 2019 and 2018, respectively. The increase in general and administrative expense of $1.4 million was primarily due to an increase in headcount and legal fees related to our patent filings in 2019.

As of December 31, 2019, the Company had approximately $59.4 million in cash and cash equivalents compared with $39.2 million as of December 31, 2018.

Recent News & Business Updates

Extended cash runway through an ATM equity offering sales agreements for aggregate proceeds of $49 million, net of commissions paid, with Stifel, who acted as sales agent. As of December 31, 2019, the Company had sold 5,314,055 shares of common stock under the sales agreements.

Immuno-STAT (Selective Targeting and Alteration of T cells) platform was featured in a Merck presentation at the Antigen-Specific Immune Tolerance Drug Development Summit in February 2020. The presentation highlights an Immuno-STAT that was made to selectively deliver a PD-L1 inhibitory signal to CD4 T cells reactive to the proinsulin protein, which is associated with type 1 diabetes. This Immuno-STAT selectively inhibited the expansion of proinsulin reactive T cells isolated from the blood of type 1 diabetes patients, and also selectively inhibited the functional response of proinsulin-specific CD4 T cells when the Immuno-STAT was administered to transgenic mice.

Published research demonstrating the ability of the Company’s lead biologic candidate CUE-101 to activate tumor antigen specific antitumor immunity in the peer-reviewed medical journal Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The manuscript by Steven Quayle et al. is titled "CUE-101, a Novel HPV16 E7 pHLA-IL-2-Fc Fusion Protein, Enhances Tumor Antigen Specific T Cell Activation for the Treatment of HPV16-Driven Malignancies."

The research highlights the ability of our proprietary Immuno-STAT (Selective Targeting and Alternation of T cells) platform to selectively engage and modulate targeted T cells within the body. CUE-101 is the company’s lead drug candidate from the IL-2 based CUE-100 series designed to directly engage and activate T cells to target HPV16-driven recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

On March 17, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported the closing of its previously announced underwritten public offering of 8,333,334 ordinary shares at a price to the public of $9.00 per share (Press release, Compugen, MAR 17, 2020, View Source [SID1234555640]). The gross proceeds to Compugen from the offering were approximately $75 million, before deducting underwriting discounts and commissions and other offering expenses payable by Compugen. In addition, Compugen has granted the underwriters a 30-day option to purchase up to an additional 1,250,000 ordinary shares, at the public offering price less underwriting discounts and commissions, which has not yet been exercised. The offering closed on March 16, 2020.

SVB Leerink and Stifel acted as joint bookrunning managers for the offering. SunTrust Robinson Humphrey acted as lead manager for the offering and Oppenheimer & Co. acted as co-manager for the offering.

The securities described above were offered by Compugen pursuant to a shelf registration statement on Form F-3, including a base prospectus, that was previously filed by Compugen with the Securities and Exchange Commission (the "SEC") and that was declared effective on August 12, 2019. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at +1(800) 808-7525, ext. 6218, or by email at [email protected], or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at +1(415) 364-2720 or by email at [email protected].

This press release does not constitute an offer to sell or the 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.

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On March 17, 2020 Circle Pharma, Inc., a macrocycle drug discovery and development company focused on intractable cancer targets, reported that it has raised $45 million in a Series B financing (Press release, Circle Pharma, MAR 17, 2020, View Source [SID1234555639]).

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The financing was led by The Column Group, with participation by Nextech Invest. All investors from the prior round – ShangPharma, LifeForce Capital, and the Berkeley Catalyst Fund – joined the financing.

In conjunction with the financing, Peter Svennilson, founder and managing partner of The Column Group, and Thilo Schroeder, Ph.D., partner at Nextech Invest were appointed to the board. John Josey, Ph.D., formerly President and CEO of Peloton Therapeutics, was appointed to the board as Chairman.

Proceeds from the investment will be used to advance Circle’s work to develop inhibitors of Cyclin A and Cyclin E, and to expand the company’s pipeline.

"We are delighted to have these premier life science investors supporting our Series B financing" said David J. Earp, J.D., Ph.D., Circle’s President and CEO. "With this strong backing, we will expand our team, drive our cyclin targeted programs towards the clinic, and apply our macrocycle platform to additional intractable targets."

Circle’s new board appointments:

Peter Svennilson is the founder and managing partner of The Column Group. He was the chairman of Aragon Pharmaceuticals (acquired by Johnson & Johnson) and Seragon Pharmaceuticals (acquired by Roche / Genentech) and was a board director of Gritstone Oncology, NGM Biopharmaceuticals, Immune Design and Constellation Pharmaceuticals. He is currently a board director of ORIC Pharmaceuticals, Ribon Therapeutics and Carmot Therapeutics.

Thilo Schroeder, Ph.D., is a partner at Nextech Invest, a Zurich-based oncology-focused investment firm. He previously served on the board of Peloton Therapeutics (acquired by Merck) and Blueprint Medicines. He is currently a board director at IDEAYA Biosciences, Revolution Medicines, PMV Pharma, Silverback Therapeutics and a board observer at Black Diamond Therapeutics.

John Josey, Ph.D., served as the President, Chief Executive Officer, and member of the Board of Directors at Peloton Therapeutics from 2013 until its acquisition by Merck in 2019. From 2011 to 2013, he was President and Chief Scientific Officer at Peloton, and from 1998 to 2011, Vice President of Discovery Chemistry at Array Pharma.

The continuing members of Circle’s board of directors are Walter H. Moos, Ph.D., CEO of ShangPharma Innovation and Managing Director of Pandect Bioventures, Matthew P. Jacobson, Ph.D., Circle Pharma co-founder, chair of the department of pharmaceutical chemistry at U.C. San Francisco and also co-founder of Global Blood Therapeutics, Relay Therapeutics and Cedilla Therapeutics, and David J. Earp, J.D., Ph.D., President and Chief Executive Officer of Circle Pharma.

On March 17, 2020 Blue Earth Diagnostics, a Bracco company focused on molecular imaging diagnostics, reported that the first patient has been dosed in its Phase 3 LIGHTHOUSE clinical trial of rhPSMA-7.3 (18F), an investigational Prostate Specific Membrane Antigen-targeted radiohybrid PET imaging agent (Press release, Blue Earth Diagnostics, MAR 17, 2020, View Source [SID1234555638]). The LIGHTHOUSE study is a Phase 3, multi-center, single-arm imaging study being conducted in the United States and Europe to evaluate the safety and diagnostic performance of rhPSMA-7.3 (18F) PET imaging in men with newly diagnosed prostate cancer (NCT04186819). The primary objectives of the LIGHTHOUSE study are to assess the sensitivity and specificity of rhPSMA-7.3 (18F) PET for detecting pelvic lymph node metastases compared to surgical pathology on a patient level. The first patient in the LIGHTHOUSE study was dosed in Los Angeles, Calif. at RadNet’s Liberty Pacific Advanced Imaging Center in conjunction with Tower Urology.

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"We are excited to initiate this Phase 3 imaging trial of rhPSMA-7.3 (18F), with the hope that it may help address the needs of men with newly diagnosed prostate cancer," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "LIGHTHOUSE is part of our strategy to expand and advance a world-leading prostate cancer imaging portfolio, alongside our planned Phase 3 clinical trial investigating the use of rhPSMA-7.3 (18F) PET imaging in patients with an elevated Prostate-Specific Antigen (PSA) level after prior therapy. rhPSMA-7.3 (18F) and approved, commercially available Axumin (fluciclovine F 18) have unique and complementary mechanisms of action, and we believe both compounds may ultimately allow physicians and their patients flexibility in selecting the diagnostic agent most appropriate to each specific clinical situation."

"Effective staging of primary prostate cancer − determining its presence and whether it may have metastasized − is critical in assessing a patient’s prognosis and informing individual clinical management strategies," said Gerald L. Andriole, MD, the Robert K. Royce Distinguished Professor and Chief of Urologic Surgery at Washington University School of Medicine. "Up to 25% of prostate cancer patients may have detectable lymph node metastases, which are correlated with a risk for recurrence and associated overall survival. Conventional imaging techniques, such as MRI and CT, are limited in the information they may provide, particularly in high-risk primary prostate cancer, due to low sensitivity and specificity. Pelvic lymph node dissection (PLND), or pelvic lymphadenectomy, is considered the gold standard in assessing pelvic lesions, but its use is limited to the planned surgical area. An ideal staging technique for detecting metastatic disease should not only include the pelvic nodes but also more distant soft tissue and skeletal findings and be both sensitive and specific for identifying prostate cancer metastases. A number of investigational studies have reported promising diagnostic performance using PSMA-targeted PET agents, but none are approved and clinical use is limited to compassionate use and research protocols. The Phase 3 LIGHTHOUSE clinical study is designed to investigate the diagnostic performance of rhPSMA-7.3 (18F) PET imaging as a potential decision-making aid in assessing newly diagnosed disease."

"Prostate cancer is a leading cause of male cancer-related death worldwide, and we anticipate that eventually a large proportion of patients with prostate cancer may be eligible to undergo PSMA PET imaging to help stage their disease and inform subsequent treatment choices," said David Gauden, D.Phil., Chief Scientific Officer of Blue Earth Diagnostics. "Blue Earth Diagnostics acquired an exclusive license to a broad family of theranostic rhPSMA agents in 2018, which includes an exclusive option for therapeutic applications. Since that time, we have worked closely with the Technical University of Munich (TUM) and Scintomics to identify a lead imaging candidate for further development. We selected rhPSMA-7.3 (18F), a single isomer of rhPSMA-7 (18F), as the candidate for our Phase 3 imaging studies. In anticipation of imaging performance, production capacity and quality needs, we selected F18 as the radiolabeling isotope of choice for rhPSMA-7.3 PET imaging. The 110-minute half-life and energy of the F18 radioisotope enable high resolution PET scans; large batch production; consistent, centralized manufacturing; and efficient distribution and broad geographic availability independent of select individual hospitals – all of which are important considerations in facilitating broad availability of this cutting edge technology for prostate cancer patients."

"Results from the early clinical experience by TUM, including with rhPSMA-7.3 (18F) PET, in more than 1,000 prostate cancer patients were included in the Investigational New Drug (IND) submission for the LIGHTHOUSE trial," said Peter Gardiner, MB ChB, MRCP, FFPM, Chief Medical Officer of Blue Earth Diagnostics. "Some of that experience has recently been published online in the Journal of Nuclear Medicine. Retrospective analyses assessed the diagnostic performance, biodistribution and safety of rhPSMA-7 (18F) in primary prostate cancer and in biochemical recurrence after both radical prostatectomy and radiation therapy. Blue Earth Diagnostics is also conducting a Phase 1 clinical study in Finland to assess the safety, biodistribution and dosimetry of rhPSMA-7.3 (18F) in healthy volunteers and patients with prostate cancer."

About the LIGHTHOUSE Phase 3 Clinical Trial for rhPSMA-7.3 (18F)

The LIGHTHOUSE Phase 3 clinical trial is a prospective, Phase 3, multi-center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA-7.3 (18F) Positron Emission Tomography (PET) in men with newly diagnosed prostate cancer. The study will enroll approximately 375 evaluable patients at clinical sites in the United States and Europe. The primary endpoints of the LIGHTHOUSE study are to assess the sensitivity and specificity of rhPSMA-7.3 (18F) PET for detecting pelvic lymph node metastases compared to surgical pathology on a patient level. Secondary endpoints will assess the safety of rhPSMA-7.3 (18F) in patients and determine inter- and intra-reader agreement of rhPSMA-7.3 (18F) scan interpretations by blinded independent readers. Additional information about the Phase 3 LIGHTHOUSE trial is available at www.clinicaltrials.gov (NC04186819).

About rhPSMA

rhPSMA-7.3 (18F) consists of a radiohybrid Prostate-Specific Membrane Antigen (PSMA)-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and is labeled with the 18F radioisotope for PET imaging. rhPSMA compounds can also be labeled with radioisotopes such as 177Lu and 225Ac for therapeutic use. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA imaging technology from Scintomics in 2018, with an option to therapeutic rights. rhPSMA originated from the Technical University of Munich, Germany, and has been utilized clinically under German legislation at the Department of Nuclear Medicine there for the diagnostic imaging of men with both primary and recurrent prostate cancer. rhPSMA compounds have not received regulatory approval.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

This press release is intended to provide information about Blue Earth Diagnostics’ business in the United States and Europe. Please be aware that the approval status and product label for Axumin varies by country worldwide. For EU Axumin product information refer to: View Source;mid=WC0b01ac058001d124.

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION ABOUT AXUMIN
INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.