On May 14, 2021 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the first quarter ended March 31, 2021 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAY 14, 2021, View Source [SID1234580002]).

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"The start of 2021 has been marked by substantial progress across our portfolio of targeted nucleic cancer drugs which included both presented and published data in support of our DNAbilize platform," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We recently announced the successful completion of the safety run-in of Stage 2 of the Phase 2 clinical study of prexigebersen for the treatment of acute myeloid leukemia (AML) in combination with frontline therapies, decitabine and venetoclax. This was particularly important as the efficacy portion of this study will include de novo fragile AML patients for whom a clean safety profile will be critical."

"Last month, we were particularly pleased to have supportive preclinical data from our BP1002 program presented before an audience of world-leading cancer specialists at the AACR (Free AACR Whitepaper) Annual Meeting and to have published an analysis highlighting the potential of prexigebersen within the oligonucleotide drug delivery landscape in the peer-reviewed journal, Biomedicines. This presentation and publication significantly enhanced the oncology community’s awareness of the potential for our DNAbilize platform in a variety of hard to treat cancers and we look forward to building on this momentum throughout the remainder of this year," continued Mr. Nielsen.

Recent Corporate Highlights

Announced Publication in Biomedicines. In April, Bio-Path announced the publication of an analysis highlighting the potential of prexigebersen (BP1001) within the antisense oligonucleotide drug delivery landscape in the peer-reviewed journal, Biomedicines.

Presented BP1002 Data at 2021 AACR (Free AACR Whitepaper) Annual Meeting. In April, Bio-Path presented a poster highlighting preclinical BP1002 data at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with poor prognosis for patients diagnosed with AML. The data presented in the AACR (Free AACR Whitepaper) poster show that venetoclax-resistant cells are sensitive to the inhibitory effects of BP1002 combined with decitabine, suggesting that this combination is a potential treatment for patients who have relapsed from frontline venetoclax-based therapies.

Successfully Completed Safety Cohort of Triple Combination in Stage 2 of Phase 2 Clinical Trial in AML. In April, Bio-Path announced the successful completion of the safety run-in of Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of acute myeloid leukemia (AML), in combination with frontline therapies, decitabine and venetoclax, in acute myeloid leukemia (AML) patients. The safety run-in of Stage 2 of the Phase 2 clinical trial was comprised of six evaluable patients who were treated with the triple combination of prexigebersen, decitabine and venetoclax.
Raised $13.0 Million in Public Offering. In February, Bio-Path announced the closing of a public offering for 1,710,600 shares of common stock at a price of $7.60 per share, for aggregate gross proceeds to the Company of approximately $13.0 million, before deducting the fees and estimated offering expenses payable by the Company.

Received Third U.S. Patent Grant Related to Manufacture of Platform Technology. In February, Bio-Path announced that the United States Patent and Trademark Office granted U.S. Patent No. 10,898,506 titled, "P-ethoxy nucleic acids for liposomal formulation." The new patent builds on earlier patents granted that protect the platform technology for DNAbilize, the Company’s novel RNAi nanoparticle drug.
Financial Results for the First Quarter Ended March 31, 2021

The Company reported a net loss of $2.4 million, or $0.43 per share, for the three months ended March 31, 2021, compared to a net loss of $3.3 million, or $0.90 per share, for the three months ended March 31, 2020.

Research and development expense for the three months ended March 31, 2021 decreased to $1.3 million, compared to $2.0 million for the three months ended March 31, 2020 primarily due to decreased preclinical expense related to timing of activities for BP1003 as well as decreased clinical trial expense due to timing of activities for our Phase 2 clinical trial of prexigebersen in AML and our Phase 1 clinical trial of BP1002 in lymphoma.

General and administrative expense for the three months ended March 31, 2021 decreased to $1.2 million, compared to $1.3 million for the three months ended March 31, 2020 primarily due to decreased franchise tax expense.

As of March 31, 2021, the Company had cash of $30.8 million, compared to $13.8 million as of December 31, 2020. Net cash used in operating activities for the three months ended March 31, 2021 was $1.6 million compared to $2.5 million for the comparable period in 2020. Net cash provided by financing activities for the three months ended March 31, 2021 was $18.6 million.
Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these first quarter 2021 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 5064037. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On May 14, 2021 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the "Company") reported that members of the executive management team will participate in two upcoming investor conferences (Press release, Aurinia Pharmaceuticals, MAY 14, 2021, View Source [SID1234580001]):

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RBC Capital Markets Global Healthcare Conference on Wednesday, May 19, 2021 at 10:55 a.m. ET; and
Oppenheimer Rare & Orphan Disease Summit on Friday, May 21, 2021 at 10:45 a.m. ET.
In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

On May 14, 2021 Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, reported results for the first quarter of 2021 and provided a corporate update (Press release, AmpliPhi Biosciences, MAY 14, 2021, View Source [SID1234580000]).

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First Quarter 2021 and Recent Highlights:

Continued to advance the single ascending dose (SAD) cohort of the SWARM-P.a. Phase 1b/2a clinical trial evaluating AP-PA02 as a potential treatment for cystic fibrosis patients with chronic Pseudomonas aeruginosa airway infection
Progressed IND-enabling activities in preparation for a Phase 1b/2 clinical trial evaluating AP-SA02 as a potential treatment for Staphylococcus aureus bacteremia
Raised gross proceeds of $20.0 million through a securities purchase agreement with Innoviva Strategic Opportunities LLC, a wholly owned subsidiary of Innoviva, Inc., Armata’s largest shareholder
Subsequent to the end of the quarter, the Company earned a $750,000 payment from the Cystic Fibrosis (CF) Foundation for achieving a milestone related to the SWARM-P.a. study
"Despite the risks COVID-19 present to people with chronic lung infections, we are making progress with our SWARM-P.a. study as the pandemic’s negative impact on trial operations continues to improve," stated Todd R. Patrick, Chief Executive Officer of Armata. "As we have noted previously, the study is being funded in part by a Therapeutics Development Award from the CF Foundation and we are grateful for their support. At the same time, we continue to engage in IND-enabling activities in support of a Phase 1b/2 trial of our second candidate, AP-SA02, in Staphylococcus aureus bacteremia, which would give us line-of-sight to two programs in the clinic.

"Beyond these programs, we are working toward the initiation of additional clinical trials assessing our phage-based therapeutic candidates in other difficult to treat indications, including non-cystic fibrosis bronchiectasis, pneumonia and prosthetic joint infection.

"With our recent financing, we believe we are well funded to achieve multiple pre-clinical and clinical milestones over the next two years," Mr. Patrick concluded.

Anticipated 2021 and 2022 Milestones:

Complete the single ascending dose (SAD) cohort of the SWARM-P.a. Phase 1b/2a clinical trial evaluating AP-PA02 as a potential treatment for Pseudomonas aeruginosa infections in the coming months
Initiate and complete the multiple ascending dose (MAD) cohort of SWARM-P.a. trial in the fourth quarter of 2021 or first quarter of 2022
Initiate a Phase 1b/2 clinical trial evaluating AP-SA02 as a potential treatment for Staphylococcus aureus bacteremia
Initiate at least one additional clinical trial in a new indication
First Quarter Financial Results

Grant Revenue. The Company recognized grant revenue of $1.1 million for the three months ended March 31, 2021, which represents Medical Technology Enterprise Consortium (MTEC)’s share of the costs incurred for the Company’s AP-SA02 program for the treatment of Staphylococcus aureus bacteremia. The Company will receive a $15.0 million grant award from MTEC over a three-year period administered by the U.S. Department of Defense with funding from the Defense Health Agency and Joint Warfighter Medical Research Program. The Company recognized no grant revenue in the comparable period in 2020.

Research and Development. Research and development expenses for the three months ended March 31, 2021 were approximately $4.4 million as compared to $2.8 million for the comparable period in 2020. The increase was primarily related to the increase in clinical trial and personnel related expenses.

General and Administrative. General and administrative expenses for the three months ended March 31, 2021 and 2020 were $2.2 million in both years.

Loss from Operations. Loss from operations for the three months ended March 31, 2021 was $(5.4) million as compared to a loss from operations of $(4.9) million for the comparable period in 2020.

Cash and Equivalents. As of March 31, 2021, Armata held approximately $22.5 million of unrestricted cash and cash equivalents, as compared to $9.7 million as of December 31, 2020. During the first quarter, Armata completed a $20 million private placement financing with Innoviva Strategic Opportunities LLC, a wholly-owned subsidiary of Innoviva.

As of May 13, 2021, there were approximately 24.9 million shares of common stock outstanding.

On May 14, 2021 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF) ("ProMIS or the Company"), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the three months ended March 31, 2021 (Press release, ProMIS Neurosciences, MAY 14, 2021, View Source [SID1234579985]).

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In the first quarter of 2021, ProMIS, like much of society, started to emerge from "pandemic lockdown". Our most important milestone was securing a US $7MM round of financing from a prestigious group of Boston based investors, whose support will allow us to advance our core programs targeting neurodegenerative diseases.

In addition, in collaboration with Dr. David Wishart of the University of Alberta, we have enhanced and extended our unique technology platform. ProMIS Neurosciences has a unique antibody design capability, which not even the largest pharmaceutical companies have to the best of our knowledge based on ongoing discussions with them. We are able rapidly and cost effectively to design and create antibodies or therapeutic vaccines that only target toxic, mis-folded versions of proteins that otherwise play a normal healthy role. This capability has given ProMIS a growing portfolio of potential "best in class" monoclonal antibodies (or corresponding therapeutic vaccines), including our lead program PMN310, targeting toxic oligomers of amyloid in Alzheimer’s. In the Alzheimer’s field, positive results or regulatory steps were announced by Lilly, Cassava, and Biogen, all of which support the science suggesting PMN310 may be "best in class".

Corporate Highlights

In January 2021, we announced an outline of our strategic priorities and action plan for 2021. The priorities for 2021 fall into four key areas: near term focus on rare neurodegenerative diseases, especially ALS; use of our proprietary platform to support portfolio expansion; advancement of our PMN310 antibody lead program for Alzheimer’s disease (AD); COVID-19, further progress on serological assays.
In February 2021, we announced our perspectives on recent progress in the AD field.
Two important events occurred in January 2021, both of which we consider very positive for the AD field, for the updated amyloid hypothesis and for the Company. The Food & Drug Administration extended the Prescription Drug User Fee Act date for review of Biogen’s aducanumab from March 7 to June 7, 2021. Eli Lilly & Co. announced positive clinical results for their antibody, donanemab, on January 11, 2021, making it the third antibody with positive clinical results in AD, likely due to its targeting of aggregated amyloid-beta (not amyloid monomer). Both these events have positive implications for PMN310.
In March 2021, we completed a US$7.0 million (CDN$8.75 million) private placement of unsecured convertible debentures (Debentures). The Debentures are convertible into common shares at the option of the holder at a conversion price of US$0.10 per share and accrue interest at 1% per annum.
People

Johannes Minho Roth resigned from the ProMIS Board of Directors in February, taking on a senior executive position at UBS Group AG, a Swiss multinational investment bank and financial services company. We thank Johannes for his excellent contributions to the Board and in support of the Company’s progress.
Michael Grundman, MD, MPH, joins the ProMIS team as senior consultant medical advisor. Dr. Grundman is President and CEO of Global R&D Partners, LLC, a consulting firm that works closely with pharmaceutical and biotechnology companies to develop novel agents for the diagnosis and treatment of serious and life-threatening diseases. Dr. Grundman is Professor of Neurosciences at the University of California San Diego (UCSD). Prior to joining industry, Dr. Grundman was Associate Director of the Alzheimer’s Disease Cooperative Study (ADCS) at the University of California, San Diego (UCSD). He received his BA from New York University magna cum laude with Honors in Biochemistry. He obtained his MD and Neurology training at the Albert Einstein College of Medicine and a Master of Public Health degree from Columbia University.
Neil K. Warma, MBA, was appointed to the Board of Directors in May 2021. Neil Warma has been a successful healthcare entrepreneur for over 25 years having founded, managed and advised numerous biotech and pharmaceutical companies across the globe. Currently, Mr. Warma is the CEO/General Manager of I-Mab Biopharma U.S., (Nasdaq:IMAB) a publicly traded global biopharmaceutical company with offices and research labs in China (Shanghai, Beijing) and the U.S. (San Diego, Gaithersburg) that focuses on developing and commercializing novel immuno oncology drugs. Previously, as President and CEO of Opexa Therapeutics (Nasdaq:OPXA), a publicly traded biopharmaceutical company, Mr. Warma led the turnaround and rebuilding of the company’s cell therapy platform and oversaw its advance through clinical development in autoimmune and orphan diseases, expansion into China and its eventual merger with Acer Therapeutics (Nasdaq:ACER). Prior to Opexa, he was CEO of Viron Therapeutics, a private biotechnology company developing novel protein-based therapeutics for cardiovascular disease and transplantation.
Financial Results

Results of Operations – Three months ended March 31, 2021 and 2020

Net loss for the three months ended March 31, 2021 was $7,599,417, compared to a net loss of $1,761,919 in the three months ended March 31, 2020. Included in the net loss for the three months ended March 31, 2021 were non-cash expenses of 7,054,543, representing the change in the fair value of an embedded derivative associated with the Debenture financing, reversal of share-based compensation due to the forfeiture of unvested share options, foreign exchange loss, amortization of property and equipment and amortization of an intangible asset, compared to $213,737 for the three months ended March 31, 2020.

Operating loss before non-cash expenses for the three months ended March 31, 2021 was $582,331, as compared to $1,761,919 in the three months ended March 31, 2020. The decrease in the operating loss for the three months ended March 31, 2021 reflects decreased costs associated with external contract research organizations for internal programs, patent costs, share-based compensation due to the forfeiture of unvested share options, contracted salaries and associated costs and general corporate expenditures offset by an increase in professional fees.

Research and development expenses for the three months ended March 31, 2021 were $193,923, as compared to $973,586 in the three months ended March 31, 2020. The decrease in research and development expense for the three months ended March 31, 2021, compared to the same period ended March 31, 2020 reflects the conservation of cash resources and decreased costs associated with external contract research organizations for internal programs, reduced patent expense, share-based compensation due to the forfeiture of unvested share options, contracted research salaries and associated costs and external consulting expense.

General and administrative expenses for the three months ended March 31, 2021 were $388,408, as compared to $788,346 in the three months ended March 31, 2019. The decrease for the three months ended March 31, 2021, compared to the same period in 2020, is primarily attributable to a reduction in contracted corporate salaries and associated costs, share-based compensation and a decrease in foreign exchange losses expense offset by consulting and professional fees.

Outlook

Going forward ProMIS will focus on accelerating or re-initiating programs in our core business area, best in class therapeutics for neurodegenerative diseases. In addition, we will continue to expand the application of our unique discovery platform, with which we can "rationally design" antibodies or vaccines to be selective for only mis-folded, pathogenic proteins involved in disease.

In Alzheimer’s we will restart IND enabling work for PMN310, our antibody highly selective for toxic oligomers of amyloid. That selectivity may prove to give PMN310 significant competitive advantages in safety and efficacy over products from Biogen, Lilly, and Eisai that appear to provide benefit slowing the progression of Alzheimer’s disease. In addition, starting with the same proprietary technology that creates selective antibodies ("passive" immunotherapy), we are moving forward our program to create therapeutic vaccines ("active" immunotherapy) targeting toxic oligomers of amyloid. Therapeutic vaccines may be a preferred therapy for Alzheimer’s prevention; the ultimate goal in Alzheimer’s treatment is to detect disease in the ~20 year window before symptoms arise and treat to prevent symptoms of cognitive decline.

In ALS we will advance our program targeting toxic TDP-43 with further in vitro and in vivo validation, and we will build on the significant scientific advances we have made targeting RACK1 (Receptor for A Activated C Kinase 1). We will also further advance our alpha-synuclein program with further in vivo and in vitro validation, targeting diseases like Parkinson’s disease and Multiple System Atrophy.

On May 14, 2021 Prescient Therapeutics (PTX) reported a new research program with the Peter MacCallum Cancer Centre to advance its next-generation CAR-T programs (Press release, Prescient Therapeutics, MAY 14, 2021, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-asxptx-signs-new-research-agreement-with-peter-maccallum-cancer-centre [SID1234579984]).

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CAR-T is a type of cellular therapy that reprograms the immune cells of cancer patients to recognise and destroy cancerous cells.

As previously reported, PTX has an existing research agreement with Peter Mac focusing on cell therapy enhancement programs, which looks to improve the current CAR-T approaches.

This new agreement extends the relationship between the parties to include the development of the OmniCAR platform.

OmniCAR is a next-generation CAR T therapy platform that offers multiple advantages over its predecessor such as control, safety, flexibility and efficacy.

PTX is developing three OmniCAR programs, including next-generation CAR-T
therapies for acute myeloid leukaemia. Her2+ solid tumours and glioblastoma multiforme.

Under the terms of the research agreement, PTX will have access to the expertise and facilities of Peter Mac.

"We are delighted to deepen our ties with a world-class institute in Peter Mac. Prescient is committed to developing all three OmniCAR programs expediently, and to the highest standard," CEO and Managing Director Steven Yatomi-Clarke said.

"This latest research program with Peter Mac is an important part of Prescient’s development plans, which include institutional and commercial laboratories," he added.