On August 23, 2021 Lightpoint Medical, a leading medical device company developing and marketing miniaturized imaging and sensing tools for minimally-invasive and robot-assisted surgery, repored that it has signed a strategic collaboration agreement with Telix Pharmaceuticals Limited (Press release, lightpoint medical, AUG 23, 2021, View Source [SID1234586832]). Under the agreement, the two companies will explore how Lightpoint and Telix technologies may be used together for real-time intra-operative cancer detection.

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SENSEI, Lightpoint Medical’s miniature surgical gamma probe, to be used with Telix’s imaging agent TLX599-CDx in prostate cancer surgery
SENSEI, Lightpoint Medical’s miniature surgical gamma probe, to be used with Telix’s imaging agent TLX599-CDx in prostate cancer surgery
Lightpoint has developed SENSEI, a miniaturized surgical gamma probe for minimally-invasive and robot-assisted cancer surgery, approved for sale in the US, EU, UK and Australia. SENSEI can be used with molecularly-targeted imaging agents, promising direct detection of cancer during surgery to help guide surgeons in the removal of cancer and the sparing of healthy, functional tissue.

Lightpoint and Telix will first evaluate the use of SENSEI with Telix’s investigational prostate cancer single photon emission computed tomography (SPECT) imaging agent TLX599-CDx (99mTc-HYNIC-iPSMA) for the intra-operative detection of cancerous pelvic lymph nodes. The objective of the collaboration is regulatory approval and commercialization of SENSEI and TLX599-CDx for prostate cancer surgery.

Lightpoint CEO, Graeme Smith said "This strategic partnership agreement with Telix marks an important milestone for Lightpoint Medical. The combination of our miniaturized surgical gamma probe, SENSEI, alongside Telix’s ground-breaking imaging agents is intended to create an extremely precise technique to help surgeons detect cancer that might not otherwise be found during surgery, or conversely, confirm the absence of disease to help surgeons retain healthy, functional tissue. The collaboration between our two companies has the potential to transform surgical outcomes for patients across a range of major cancer types, starting with prostate cancer."

Telix CEO, Dr. Christian Behrenbruch added "Bringing molecular imaging into the operating theatre is a key part of our portfolio strategy for urologic oncology, and the combination of Telix and Lightpoint technologies has the potential to transform treatment options for patients with cancer. This collaboration helps to reinforce Telix’s position as a leader in developing advanced surgical technologies using highly targeted imaging techniques."

About TLX599-CDx

TLX599-CDx is an investigational product being developed by Telix to facilitate patient access to advanced prostate cancer imaging in countries where SPECT imaging is predominant in healthcare facilities. Whereas Telix’s lead investigational product, Illuccix for prostate cancer imaging, utilises positron emission tomography (PET), TLX599-CDx employs SPECT, a diagnostic imaging technology that is more widely available in healthcare facilities throughout the world. In April 2021 Telix announced the launch of the NOBLE Registry[1], a global consortium of investigator-led studies exploring the clinical utility of TLX599-CDx, with the objective to generate data and facilitate the design of future formal registration clinical trials.

On August 23, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next generation antibody therapeutics, reported that the Company will participate in H.C. Wainright 23rd Annual Global Investment Conference taking place virtually from September 13-15, 2021 (Press release, PharmAbcine, AUG 23, 2021, https://www.prnewswire.com/news-releases/pharmabcine-to-participate-in-hc-wainright-23rd-annual-global-investment-conference-301359591.html [SID1234586831]).

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During the conference, Dr. Jin-San Yoo, CEO of PharmAbcine, will update PharmAbcine’s R&D progress via a presentation video, highlighting the Company’s core technology and pipelines such as olinvacimab, PMC-403, and PMC-309.

Olinvacimab, an anti-VEGFR2 (Vascular Endothelial Growth Factor Receptor 2) fully human antibody, is the Company’s leading pipeline and is undergoing multiple global clinical trials. Currently, a Phase II olinvacimab mono study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients is taking place at multiple sites in both US and Australia. Also, there are two Phase Ib olinvacimab and pembrolizumab combo trials in mTNBC and rGBM still ongoing in Australia.

PMC-403 is a novel TIE2-activating fully human antibody designed to stabilize and repair damaged blood vessels in a variety of diseases. PMC-403 is currently in development for treating AMD (Age-related Macular Degeneration), DME (Diabetic Macular Edema), and DR (Diabetic Retinopathy) which are common abnormal vascular-related eye diseases. The Company expects PMC-403 to enter global clinical trials for both ophthalmology and oncology in 2022.

PMC-309 is a novel anti-VISTA (V-domain Ig Suppressor of T cell Activation) antagonizing antibody in development for the treatment of various tumor types. VISTA plays a pivotal role in maintaining the immunosuppressive environment around the tumor cells and is expressed primarily on MDSC (Myeloid-Derived Suppressor Cells) and Tregs (regulatory T cells). Blocking VISTA pathways activates T cells’ immune responses and leads to better anti-tumor effects. PMC-309 is expected to enter a global clinical trial in 2022.

The Company will also join one-on-one meetings with institutional investors and private equity firms to seek investment opportunities.

The presentation video can be accessed at 7:00 AM (Eastern Standard Time) on Monday, September 13, 2021 and will be available for 90 days. For the webcasting link, request here.

About H.C. Wainwright & Co.

H.C. Wainwright is a full–service investment bank dedicated to providing corporate finance, strategic advisory and related services to public and private companies across multiple sectors and regions. H.C. Wainwright & Co. also provides research and sales and trading services to institutional investors. According to Sagient Research Systems, H.C. Wainwright’s team is ranked as the #1 Placement Agent in terms of aggregate CMPO (confidentially marketed public offering), RD (registered direct offering) and PIPE (private investment in public equity) executed cumulatively since 1998.

On August 23, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will release second quarter 2021 results on Wednesday, September 8, 2021, and host a conference call at 8:30 a.m. EDT to discuss financial results and recent corporate developments (Press release, Affimed, AUG 23, 2021, View Source [SID1234586830]).

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The conference call will be available via phone and webcast. To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference passcode 6156773 approximately 15 minutes prior to the call. To access the live audio webcast of the conference call please visit the "Investors" section of company’s website at View Source A replay of the call will be archived on the Affimed website for 30 days after the call.

On August 23, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported the publication of its Interim Report for the period January – June 2021 (Press release, Allarity Therapeutics, AUG 23, 2021, View Source [SID1234586829]). The report is available as an attached document and on the Company’s website.

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Steve Carchedi, CEO of Allarity Therapeutics, commented on the Company’s accomplishments during the period, stating , "In July, we successfully out-monetized our last remaining secondary pipeline program, irofulven. Shortly after our divestment of Irofulven, we, following positive results of our pre-clinical testing of stenoparib against numerous variants of the original Sars-CoV 2 strain, announced that we are initiating pre-clinical testing of stenoparib for activity against the delta variant (B.1.617.2). Also, in July, we announced that the U.S. Food and Drug Administration had provided a positive administrative acceptance and review notification for our pre-market approval application for our Dovitinib-DRP. Earlier, in June, we announced that our Rights Offering had been oversubscribed, netting approximately U.S. $12 million of crucial working capital. Lastly, in May, we announced that Allarity has entered into an agreement with 3i Fund for a U.S. $20 million investment to support Allarity’s recapitalization and reorganization into a U.S listed company."

Summary of the Interim Report for Q2 2021

Consolidated group revenue amounted to 0 MDKK (0 MDKK).
Consolidated group loss before depreciation amounted to -30.7 MDKK (-5.2 MDKK).
Consolidated group loss before net financials amounted to -89.8 MDKK (-5.5 MDKK).
Consolidated net result amounted to -92.1 MDKK (-3.5 MDKK).
Consolidated earnings per share (EPS) amounted to -0.37 DKK (-0.03 DKK).

2020 numbers in brackets.

Highlights during Q2 2021

April

On April 2, the Company submitted a Pre-Market Approval (PMA) application to the U.S. FDA for the DRP companion diagnostic for dovitinib.
On April 15, the Company published the minutes of the Annual General Meeting 2021.
On April 29, the Company announced that a Dovitinib-DRP e-Poster would be presented at the EACR 2021 Virtual Congress to be held from 9-12 June 2021.

May

On May 19, the Company announced that it would conduct a Rights Issue of new shares, and it had published a prospectus regarding the Rights Issue.
On May 21, the Company announced that it had secured an investment from 3i Fund for recapitalization, transition to listing on U.S. Nasdaq, and advancing the Company’s pipeline of priority oncology therapeutics.
On May 28, the Company published the Interim Report for the period January – March 2021

June

On June 9, the Company published an E-Poster detailing the molecular pathways covered by the Dovitinib-DRP companion diagnostic
On June 10, the Company announced that the rights issue had been oversubscribed
On June 14, it was announced that Allarity Therapeutics and Oncoheroes Biosciences had to partnered on pediatric cancer development of dovitinib and stenoparib
On June 24, the last day of trading with Allarity Therapeutics A/S BTU was announced

Highlights after the period

July

On July 5, the Company received an acceptance and review notification from U.S. FDA for Pre-Market Approval application for Dovitinib-DRP
On July 26, it was announced that the Company and Lantern Pharma entered into an agreement for Future Clinical Development of Irofulven
August

On August 5, the Company announced that its oral PARP inhibitor, stenoparib, had demonstrated pre-clinical antiviral activity against new variants of Coronavirus
On August 16, a notice to convene an Extraordinary General Meeting on August 31, 2021, was announced

On August 23, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, reported that it will report 2021 unaudited first half interim results after the closing of Hong Kong equity markets on August 30, 2021 (Press release, Everest Medicines, AUG 23, 2021, View Source [SID1234586828]). The Company will hold a live conference call at 9:00 AM on August 31, 2021, Beijing Time.

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Conference Call Information

A live conference call will be hosted on August 31, 2021 at 9:00 AM Beijing Time (August 30, 2021 at 9:00 PM U.S. Eastern Time). Participants must register in advance of the conference call. Details are as follows:

Registration Link: View Source

Conference ID: 5468938

All participants must use the link provided above to complete the online registration process in advance of the conference call. Upon registering, each participant will receive dial-in number, passcode and a unique registration ID, which can be used to join the conference call.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website at View Source