On May 14, 2020 Isofol Medical AB’s (publ) (Nasdaq First North Premier Growth Market: ISOFOL) ("Isofol" or the "Company") Board of Directors reported on May 7, 2020, on a fully guaranteed new share issue of a maximum of 42,739,736 shares with preferential rights for the Company’s existing shareholders (the "Rights Issue") (Press release, Isofol Medical, MAY 14, 2020, View Source [SID1234561552]). Through the Rights Issue, the Company will receive approximately SEK 150 million before transaction costs related to the Rights Issue. In connection with the Rights Issue, the Company publishes a prospectus which today has been approved and registered by the Swedish Financial Supervisory Authority (Sw. Finansinspektionen).

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On May 14, 2020 CellProtect Nordic Pharmaceuticals reported that results from the first-in-human study ACP-001 was made public at the 2020 EHA (Free EHA Whitepaper) meeting (Press release, CellProtect Nordic Pharmaceuticals, MAY 14, 2020, View Source [SID1234561095]).

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Key findings from the study:

Overall survival (OS) 100% after a median follow-up time of 60 months
Median progression free survival (PFS) 34 months
No serious adverse events
The present study demonstrates that autologous NK cell-based immunotherapy is feasible and demonstrates clinical applicability with efficacy responses in an upfront autologous HSCT-setting in multiple myeloma (MM). The treatment strategy opens for usage of autologous NK cells in clinical settings where patients are not readily eligible for allogeneic NK cell-based treatments, including MRD and maintenance treatment in MM and other forms of malignancies.

On May 14, 2020 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported financial results for the first quarter ended March 31, 2020 and provided a corporate update (Press release, Regulus, MAY 14, 2020, View Source [SID1234561073]).

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"We have completed the second cohort and have initiated the dosing for the third and final cohort in the Phase 1 multiple ascending dose ("MAD") clinical study for RGLS4326" said Jay Hagan, CEO of Regulus. "Additionally, preparations for the Phase 1b study in patients with autosomal dominant polycystic kidney disease ("ADPKD") are well underway with plans to initiate in the second half of 2020."

Program Highlights

Initiated Dosing of the Third and Final Cohort in RGLS4326 Phase 1 for ADPKD: In April 2020, the Company initiated dosing of the third and final cohort of the MAD clinical study of RGLS4326, a novel oligonucleotide designed to inhibit miR-17 for the treatment of ADPKD. The Company expects to complete this study in mid-2020 with topline results available thereafter. The Company is planning to initiate a Phase 1b short-term dosing study in patients with ADPKD in the second half of 2020 to evaluate RGLS4326 for safety, pharmacokinetics, and biomarkers of pharmacodynamic activity.

Financial Results

Cash Position: As of March 31, 2020, Regulus had $28.1 million in cash and cash equivalents.

Research and Development (R&D) Expenses: R&D expenses were $3.1 million for the three months ended March 31, 2020, compared to $6.0 million for the same period in 2019. The aggregate decrease was driven by a $1.5 million reduction in personnel and internal expenses and a $1.0 million reduction in external development expenses, both of which were primarily attributable to a reduction in costs associated with the partial clinical hold of the RGLS4326 MAD study. In December 2019, the U.S. Food and Drug Administration ("FDA") lifted the partial clinical hold on the MAD study and it was recommenced in February 2020.

General and Administrative (G&A) Expenses: G&A expenses were $2.4 million for the three months ended March 31, 2020 compared to $3.5 million for the same period in 2019. These amounts reflect personnel-related and ongoing general business operating costs. The decrease is primarily attributable to continued cost reduction efforts subsequent to our corporate restructuring in the third quarter of 2018.

Revenue: Revenue was less than $0.1 million for the three months ended March 31, 2020. Revenue was $6.8 million for the three months ended March 31, 2019, attributable to revenue recognition of the upfront payments received under the 2018 Sanofi Amendment related to the transfer of the RG-012 program to Sanofi.

Net Loss: Net loss was $5.9 million, or $0.25 per share (basic and diluted), for the three months ended March 31, 2020, compared to $3.3 million, or $0.31 per share (basic and diluted), for the same period in 2019.

About ADPKD

ADPKD, caused by the mutations in the PKD1 or PKD2 genes, is among the most common human monogenic disorders and a leading cause of end-stage renal disease. The disease is characterized by the development of multiple fluid filled cysts primarily in the kidneys, and to a lesser extent in the liver and other organs. Excessive kidney cyst cell proliferation, a central pathological feature, ultimately leads to end-stage renal disease in approximately 50% of ADPKD patients by age 60.

About RGLS4326

RGLS4326 is a novel oligonucleotide designed to inhibit miR-17 and designed to preferentially target the kidney. Preclinical studies with RGLS4326 have demonstrated direct regulation of PKD1 and PKD2 in human ADPKD cyst cells, a reduction in kidney cyst formation, improved kidney weight/body weight ratio, decreased cyst cell proliferation, and preserved kidney function in mouse models of ADPKD. The RGLS4326 IND is currently on a Partial Clinical Hold for treatment of extended duration by the U.S. Food and Drug Administration until the second set of requirements outlined by FDA have been satisfactorily addressed. Information from the Phase 1 clinical studies, together with information from additional nonclinical studies, will be used to address the second set of requirements to support studies of extended duration.

On May 14, 2020 Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSXV:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, reported that it has commenced an overnight marketed public offering (the "Offering") of units (the "Units") of the Company (Press release, Tetra Bio Pharma, MAY 14, 2020, View Source [SID1234561072]). Each Unit is offered at a price of $0.26 per Unit (the "Issue Price") with each Unit consisting of one common share in the capital of Tetra (a "Common Share") and one common share purchase warrant (a "Warrant"). Each Warrant will entitle the holder thereof to acquire one Common Share at a price of $0.32 for a period of 36 months from the closing date of the Offering.

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The Offering will be conducted on a best efforts agency basis pursuant to the terms and conditions of an agency agreement to be entered into between the Company and Raymond James Ltd. and Canaccord Genuity Corp. as co-lead agents and joint bookrunners (collectively, the "Agents").

The size of the Offering will be determined in the context of the market at the time of entering into a definitive agency agreement between the Company and the Agents. The Company will also grant the Agents an option (the "Over-Allotment Option") to sell up to an additional 15% of the Units sold under the Offering, at the Issue Price. The Over-Allotment Option may be exercised in whole or in part to purchase Common Shares, Warrants or Units as determined by the Agents upon written notice to the Company at any time up to 30 days following the closing date of the Offering.

The Offering will be conducted pursuant to the Company’s Canadian base shelf prospectus dated April 1, 2020 (the "Base Shelf Prospectus"). A prospectus supplement (the "Prospectus Supplement") relating to the Offering will be filed in each of the provinces of Canada. Copies of the Prospectus Supplement and accompanying Base Shelf Prospectus will be available under the Company’s profile on SEDAR at www.sedar.com.

The Company intends to use the net proceeds of the Offering to continue the development of its clinical program, including Phase 2 and phase 3 clinical trials, toxicology, regulatory and manufacturing expenses related to QIXLEEF (PPP001).

The Offering is expected to close on or about May 22, 2020, subject to customary closing conditions.

Closing of the Offering is subject to certain conditions including, but not limited to, the receipt of all necessary approvals including the approval of the TSX Venture Exchange.

On May 14, 2020 TG Therapeutics, Inc. (the "Company") reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, Jefferies LLC, Evercore Group L.L.C. and Cantor Fitzgerald & Co., as representatives of the several underwriters named therein (the "Underwriters") (Filing, 8-K, TG Therapeutics, MAY 14, 2020, View Source [SID1234558238]). Pursuant to the Underwriting Agreement, the Company agreed to sell to the Underwriters, in a firm commitment underwritten public offering, 8,500,000 shares (the "Firm Shares") of the Company’s common stock, $0.001 par value per share ("Common Stock"), and, at the option of the Underwriters, up to an additional 1,275,000 shares of the Company’s common stock, par value $0.001 per share (the "Option Shares" and together with the Firm Shares, the "Shares"), less underwriting discounts and commissions. On May 15, 2020, the Underwriters exercised their option to purchase the full amount of the Option Shares.

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The offering was upsized from the previously announced offering size of 6,000,000 shares of Common Stock. The transactions contemplated by the Underwriting Agreement are expected to close on May 19, 2020, subject to the satisfaction of customary closing conditions. A copy of the Underwriting Agreement is attached hereto as Exhibit 1.1 and is incorporated by reference herein.

J.P. Morgan Securities LLC, Jefferies LLC, Evercore Group L.L.C. and Cantor Fitzgerald & Co. are acting as joint book-running managers for the offering. Ladenburg Thalmann & Co. Inc. and H.C. Wainwright & Co., LLC are acting as co-managers for the offering.

The gross proceeds to the Company are expected to be approximately $176 million before deducting underwriting discounts and commissions and estimated expenses payable by the Company associated with the offering.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended (the "Securities Act"), other obligations of the parties and termination provisions.

The offering is being made pursuant to the Company’s automatically effective "shelf" registration statement on Form S-3 (File No. 333-233636) (the "Registration Statement") filed with the Securities and Exchange Commission (the "SEC") on September 5, 2019, as supplemented by a preliminary prospectus supplement filed with the SEC on May 14, 2020 and a final prospectus supplement filed with the SEC on May 18, 2020, pursuant to Rule 424(b) under the Securities Act.

Alston & Bird LLP, counsel to the Company, delivered an opinion as to the validity of the Shares, a copy of which is attached hereto as Exhibit 5.1 and is incorporated by reference herein.

The foregoing summary description of the offering and the documentation related thereto, including without limitation, the Underwriting Agreement, does not purport to be complete and is qualified in its entirety by reference to such Exhibit.

The Underwriting Agreement has been included to provide investors and security holders with information regarding its terms. It is not intended to provide any other factual information about the Company. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties contemplated in such agreement, and may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures exchanged between the parties in connection with the execution of the Underwriting Agreement. The representations and warranties may have been made for the purposes of allocating contractual risk between the parties to the agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors are not third-party beneficiaries under the Underwriting Agreement and should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Underwriting Agreement, and this subsequent information may or may not be fully reflected in the Company’s public disclosures.