Cardinal Health announces redemption of outstanding notes

On May 14, 2021 Cardinal Health (NYSE: CAH) reported that it is sending an irrevocable notice of early redemption to the holders of all of the Company’s 3.200% notes due June 2022 that are outstanding as of the early redemption date (aggregate principal amount of $237,558,000) and $262,442,000 in aggregate principal amount of the Company’s 2.616% notes due June 2022 (Press release, Cardinal Health, MAY 14, 2021, View Source [SID1234580004]). The early redemption date is set to June 15, 2021, pursuant to the June 2, 2008 indenture and the notes.

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

With respect to the 3.200% notes, in accordance with the terms and conditions set forth in the indenture and the notes, the 3.200% notes will be redeemed at a redemption price equal to the greater of (i) 100% of the principal amount or (ii) the sum of the present values of the remaining scheduled payments of principal and interest on the notes to be redeemed (exclusive of interest accrued to the date of redemption) discounted to the date of redemption on a semiannual basis (assuming a 360-day year consisting of twelve 30-day months) at the then current adjusted treasury rate (as defined in the notes) plus 25 basis points, plus, in either case, accrued but unpaid interest on the principal amount being redeemed to the redemption date.

With respect to the 2.616% notes, in accordance with the terms and conditions set forth in the indenture and the notes, the 2.616% notes will be redeemed at a redemption price equal to the greater of (i) 100% of the principal amount of the notes to be redeemed or (ii) the sum of the present values of the remaining scheduled payments of principal and interest on the notes to be redeemed that would be due if the notes of such series matured on May 15, 2022 (exclusive of interest accrued to the date of redemption) discounted to the date of redemption on a semiannual basis (assuming a 360-day year consisting of twelve 30-day months) at the then current adjusted treasury rate (as defined in the notes) plus 15 basis points, plus, in either case, accrued but unpaid interest on the principal amount being redeemed to the redemption date.

This press release shall not constitute a notice of redemption of the notes, and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of any securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Calliditas Therapeutics to host conference call to provide Business Update for the first quarter of 2021

On May 14, 2021 Calliditas Therapeutics AB (publ) ("Calliditas") reported that it will publish its financial report for the first quarter of 2021, and at 2.30 pm CET will host a conference call to present and discuss the results (Press release, Calliditas Therapeutics, MAY 14, 2021, https://www.calliditas.se/en/calliditas-therapeutics-to-host-conference-call-to-provide-business-update-for-the-first-quarter-of-2021-3521/ [SID1234580003]).

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The event will be hosted by the company’s CEO Renée Aguiar-Lucander and CFO Fredrik Johansson, and will be held in English. The presentation will be webcast live and will also be made available online on the Calliditas website after the call.

Webcast link: View Source

Bio-Path Holdings Reports First Quarter 2021 Financial Results

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.

Aurinia Pharmaceuticals to Participate in Two Upcoming Investor Conferences

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.

Armata Pharmaceuticals Announces First Quarter Results and Provides General Corporate Update

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.