SPRINT BIOSCIENCES PARTNER PETRA PHARMA GIVES AN UPDATE ON THE DEVELOPMENT OF THE PIP4K2 PROJECT

On March 9, 2020 Sprint Bioscience AB (publ) (Sprint) reported that it has received an update from the company’s partner Petra Pharma regarding the development of the PIP4K2 project (Press release, Sprint Bioscience, MAR 9, 2020, View Source [SID1234555296]). The ongoing pre-clinical program before the start of clinical trials continues to show good efficacy and safety, and according to Petra Pharma, the plan is to start a phase 1 trial in the second half of 2020.

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Sprint Bioscience and Petra Pharma signed a license agreement for Sprint Biosciences PIP4K2 inhibitors in 2016. The goal is to develop a new treatment for hematological diseases such as acute myeloid leukemia (AML).

Petra Pharma finances and is responsible for the continued development of the PIP4K2 project. Sprint Bioscience has now received a new update from Petra Pharma about the project’s development and according to this, the plan is to start clinical trials in the second half of 2020. Petra Pharma also announces that studies on primary samples from AML patients have shown very good effect at the same time. preliminary toxicological studies have shown good tolerability.

Petra Pharma has also successfully started scaling up the manufacture of the substance prior to the start of clinical trials.

"PIP4K2 is our most advanced project and thus one of our most valuable. The successes Petra Pharma reported further strengthens our belief in the project and we now look forward to the important transition from preclinical to clinical phase later this year. I note that our business model, where we generate and outlicenses innovative medicines programs for international pharmaceutical companies, continues to bear fruit. "Says Jessica Martinsson, CEO of Sprint Bioscience.

Under the licensing agreement, Sprint Bioscience can receive up to approximately USD 240 million in interim compensation, of which USD 5 million has been paid to date. In addition, Sprint Bioscience is entitled to royalty on the global turnover of any products generated within the collaboration. The next interim payment will be made at the start of the first clinical study (phase 1) within the project.

Aduro Biotech Provides Business Update and Reports Fourth Quarter and Full Year 2019 Financial Results

On March 9, 2020 Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Aduro Biotech, MAR 9, 2020, View Source [SID1234555318]).

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"2019 was a critical year for Aduro as we narrowed the focus of our STING program to squamous cell carcinoma of the head and neck and non-muscle invasive bladder cancer, and shifted the focus of our APRIL program to IgA nephropathy. In an effort to ensure we have the appropriate resources in place to advance these programs, we scaled down the company with the strategic reset in January 2019 and corporate restructuring in January 2020," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "Our strong cash position, which now takes us into 2023, enables us to execute on several key milestones in 2020 across our STING and APRIL programs."

Key Accomplishments in Fiscal Year 2019

STING

First patient dosed in Phase 2 clinical trial of ADU-S100 (MIW815) in combination with Keytruda (pembrolizumab), an approved anti-PD-1 antibody, as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma

Presented findings from the Phase 1b study of ADU-S100 (MIW815) in combination with spartalizumab (PDR001) in patients with advanced, metastatic treatment-refractory solid tumors or lymphomas in an oral presentation at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Presented nonclinical data on the role of TNF-alpha in suppressing the immunogenicity of STING agonists at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting

Presented three abstracts at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, including updated preclinical data on ADU-S100

APRIL

Completed treatment of all healthy volunteer dose cohorts in the single ascending dose and multiple ascending dose portions of the Phase 1 clinical trial of BION-1301 for the treatment of IgA nephropathy

Presented findings from the dose escalation portion of the Phase 1/2 study of BION-1301 in patients with relapsed or refractory multiple myeloma in two poster presentations at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting

Anti-CD27 Agonist Antibody

License partner, Merck & Co., Inc. (known as MSD outside the United States and Canada), presented findings from an ongoing Phase 1 clinical trial of MK-5890, the anti-CD27 agonist antibody licensed to Merck in 2014, in an oral presentation during the late breaking abstract session at the SITC (Free SITC Whitepaper) 34th Annual Meeting

Corporate

Appointed immuno-oncology drug development expert, Dimitry Nuyten, M.D., Ph.D., as chief medical officer

Appointed life sciences industry veterans, David H. Mack, Ph.D. and Frank Karbe, to the board of directors

Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $213.6 million at December 31, 2019, compared to $277.9 million at December 31, 2018.

Revenue – Revenue was $3.6 million for the fourth quarter of 2019 and $17.3 million for the year ended December 31, 2019, compared to $2.8 million and $15.1 million, respectively, for the same periods in 2018. For the fourth quarter and year ended December 31, 2019, the increase in revenue was primarily due to ratable recognition of the upfront milestone payment received under our Lilly collaboration in 2019. The increase was offset by a reduction in the revenue recognized for our Novartis collaboration in 2019 and by the milestone payment received under our license and collaboration agreement with Merck upon its initiation of a phase 1 trial in 2018.

Expenses –

Research and development expenses were $15.1 million for the fourth quarter of 2019 and $67.0 million for the year ended December 31, 2019, compared to $17.6 million and $75.8 million, respectively, for the same periods in 2018. For the fourth quarter and year ended December 31, 2019, costs decreased primarily due to reduced headcount and reduced stock-based compensation expense resulting from our strategic reset in January 2019. The reset also resulted in reduced spending towards deprioritized programs partially offset by higher spending towards our STING and APRIL programs.

General and administrative expenses were $9.0 million for the fourth quarter of 2019 and $34.8 million for the year ended December 31, 2019, compared to $9.0 million and $36.0 million, respectively, for the same periods in 2018. For the year ended December 31, 2019, costs decreased primarily due to reduced headcount and stock-based compensation expense resulting from our strategic reset in January 2019. The decrease in costs for the year was partially offset by higher professional services costs due to consulting services. The higher professional services costs also resulted in general and administrative expenses for the fourth quarter of 2019 remaining consistent with the 2018 period.

Loss on impairment of intangible assets was $5.0 million for the year ended December 31, 2019. This expense was recorded due to the discontinuation of one of our acquired early research programs.

Net Loss – Net loss for the fourth quarter of 2019 was $19.4 million or $0.24 per share and $82.4 million or $1.03 per share for the year ended December 31, 2019, compared to net loss of $26.3 million or $0.33 per share and $95.4 million or $1.21 per share, respectively, for the same periods in 2018.

Entry into a Material Definitive Agreement

On March 9, 2020, BridgeBio Pharma, Inc. ("BridgeBio") reported an aggregate of $550.0 million aggregate principal amount of its 2.50% Convertible Senior Notes due 2027 (the "Notes"), pursuant to an Indenture dated March 9, 2020 (the "Indenture"), between BridgeBio and U.S. Bank National Association, as trustee (the "Trustee"), in a private offering to qualified institutional buyers (the "Note Offering") pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Filing, 8-K, BridgeBio, MAR 9, 2020, View Source [SID1234555340]). The Notes issued in the Note Offering include $75.0 aggregate principal amount of Notes sold to the initial purchasers in (the "Initial Purchasers") pursuant to the exercise in full of the Initial Purchasers’ option to purchase additional Notes.

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The Notes are senior, unsecured obligations of BridgeBio and will accrue interest payable semiannually in arrears on March 15 and September 15 of each year, beginning on September 15, 2020, at a rate of 2.50 % per year. The Notes will mature on March 15, 2027, unless earlier converted or repurchased. The Notes are convertible into cash, shares of BridgeBio’s common stock or a combination of cash and shares of BridgeBio’s common stock, at BridgeBio’s election.

The net proceeds BridgeBio received from the Note Offering are equal to approximately $537.0 million, after deducting the Initial Purchasers’ discount and estimated offering expenses payable by BridgeBio. BridgeBio used approximately $49.3 million of the net proceeds from the Note Offering to pay the cost of the Capped Call Transactions described below, and approximately $75.0 million to pay the cost of Repurchases of shares of its common stock described below. BridgeBio intends to use the remainder of the net proceeds from the Note Offering for working capital and other general corporate purposes, including for its commercial organization and launch preparations. BridgeBio may also use any remaining net proceeds to fund possible acquisitions of, or investments in, complementary businesses, products, services and technologies. BridgeBio has not entered into any agreements or commitments with respect to any material acquisitions or investments at this time.

A holder of Notes may convert all or any portion of its Notes at its option at any time prior to the close of business on the business day immediately preceding December 15, 2026 only under the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on June 30, 2020 (and only during such calendar quarter), if the last reported sale price of BridgeBio’s common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; (2) during the five business day period after any five consecutive trading day period (the "measurement period") in which the "trading price" (as defined in the Indenture) per $1,000 principal amount of Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of BridgeBio’s common stock and the conversion rate on each such trading day; or (3) upon the occurrence of specified corporate events. On or after December 15, 2026 until the close of business on the second scheduled trading day immediately preceding the maturity date, a holder may convert all or any portion of its Notes at any time, regardless of the foregoing.

The conversion rate will initially be 23.4151 shares of BridgeBio’s common stock per $1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $42.71 per share of BridgeBio’s common stock). The conversion rate is subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date, BridgeBio will, in certain circumstances, increase the conversion rate for a holder who elects to convert its Notes in connection with such a corporate event.

BridgeBio may not redeem the Notes prior to the maturity date, and no sinking fund is provided for the Notes.

If BridgeBio undergoes a fundamental change (as defined in the Indenture), holders may require BridgeBio to repurchase for cash all or any portion of their Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus any accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

The Indenture contains customary terms and covenants, including that upon certain events of default occurring and continuing, either the Trustee or the holders of not less than 25% in aggregate principal amount of the Notes then outstanding may declare the entire principal amount of all the Notes plus accrued special interest, if any, to be immediately due and payable.

The Notes are BridgeBio’s general unsecured obligations and rank senior in right of payment to all of BridgeBio’s indebtedness that is expressly subordinated in right of payment to the Notes; equal in right of payment with all of BridgeBio’s liabilities that are not so subordinated; effectively junior to any of BridgeBio’s secured indebtedness to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of BridgeBio’s subsidiaries.

A copy of the Indenture and form of Note are filed as Exhibit 4.1 and Exhibit 4.2, respectively, to this Current Report on Form 8-K and are incorporated by reference herein. The foregoing description of the Indenture and Notes does not purport to be complete and is qualified in its entirety by reference to such exhibits.

BioLineRx to Report Annual 2019 Results on March 12, 2020

On March 6, 2020 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported it will release its audited financial results for the year ended December 31, 2019 on Thursday, March 12, 2020, before the US markets open (Press release, BioLineRx, MAR 6, 2020, View Source [SID1234555280]).

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The Company will host a conference call on Thursday, March 12, 2020 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer, and other members of the management team. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-888-668-9141 from the US or +972-3-918-0609 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until March 14, 2020; please dial +1-877-456-0009 from the US or +972-3-925-5927 internationally.

MedX Health Corp. Announces Closing of Non-Brokered Private Placement and Debt Settlement and Announces a New Non-Brokered Private Placement Offering

On March 6, 2020 MedX Health Corp. ("MedX" or the "Company") (TSX-V: MDX) is reported that further to the Conditional Approval from the TSX Venture Exchange for a non-brokered Private Placement to accredited investors of up to 25,000,000 units at $0.12 per unit ("Unit"), to raise up to $3,000,000 that was announced on January 30, 2020, and the closing of the first tranche of that placement, of 1,485,000 units, raising $178,200, on January 30, 2020, two further closings have taken place, on March 4, 2020, of 7,459,139 units, raising $895,096, and on March 5, 2020, of 2,000,000 units, raising $240,000. Each Unit is comprised of One (1) fully paid common share and One (1) Share Purchase Warrant, exercisable to purchase One (1) further Common Share at the price of $0.20, exercisable for a period of two years from the date of issue (Press release, MedX Health, MAR 6, 2020, View Source [SID1234555281]). The securities issued on January 30, 2020, March 4, 2020 and March 5, 2020, will be restricted from trading for four months from their respective dates of issue.

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The Company is also pleased to announce that on March 5, 2020, it closed the debt settlement announced in its Press Release dated March 3, 2020, pursuant to which is settled $372,071 of debt owed to an arm’s length trade creditor by issuance of 3,103,878 Units. The securities comprised in the Units issued on this debt settlement will be restricted from trading for four months from the date of issue.

In connection with the non-brokered private placement, agent’s warrants ("Agent’s Warrant(s)"), as described below, were also issued. Each Agent’s Warrant, which is non-transferable, is exercisable to acquire one Unit at $0.12 per Unit, at any time during the period of two years following the respective dates of issue. In connection with the January 30, 2020 Closing, a cash commission of $10,080 was paid and 84,000 Agent’s Warrants were issued. In connection with the March 4, 2020 Closing, a cash commission of $60,720 was paid and 506,000 Agent’s Warrants were issued. In connection with the March 5, 2020 Closing, a cash commission of $19,200 was paid.

The Company is further pleased to announce that it is proposing a further non-brokered Private Placement to accredited investors of up to 20,833,333 units at $0.12 per unit ("Unit"), to raise up to $2,500,000. Each Unit will be comprised of One (1) fully paid common share and One (1) Share Purchase Warrant, exercisable to purchase One (1) further Common Share at the price of $0.20, exercisable for a period of two years from the date of issue. Closing of the Placement, which will take place in tranches, will be subject to receipt of subscriptions and a number of other conditions, including without limitation the receipt of all relevant regulatory and Stock Exchange approvals or acceptances. Qualified Agents may receive commissions in respect of subscriptions introduced by them by way of cash equal to 8% of funds so introduced, and issuance of agent’s warrants ("Agent’s Warrant(s)") equal in number to 8% of the number of units so subscribed for. Each Agent’s Warrant, which is non-transferable, will be exercisable to acquire one Unit at $0.12 per Unit, at any time during the period of two years following the Closing.