1stOncology™: Cancer Intelligence Service – Page 9969 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

HOOKIPA Pharma to Participate in Upcoming SVB Leerink Global Healthcare Conference

On February 16, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that HOOKIPA’s management team will participate in the upcoming virtual SVB Leerink Global Healthcare Conference (Press release, Hookipa Pharma, FEB 16, 2021, View Source [SID1234575131]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Fireside Discussion: Thursday, February 25, 2021 at 9:20 AM ET
The live audio webcast of the presentation will be available within the Investors & Media section of HOOKIPA’s website at View Source An archived replay will be accessible for 30 days following the event.

Cancer Genetics Announces Closing of $17.5 Million Common Stock Offering Priced At-the-Market under Nasdaq Rules

On February 16, 2021 Cancer Genetics, Inc. (the "Company") (Nasdaq: CGIX), a leader in drug discovery and preclinical oncology and immuno-oncology services, reported the closing of its previously announced registered direct offering with several healthcare-focused institutional investors of 2,777,778 shares of its common stock at a purchase price of $6.30 per share, priced at-the-market under Nasdaq rules (Press release, Cancer Genetics, FEB 16, 2021, View Source [SID1234575126]). The gross proceeds to the Company from the offering totaled approximately $17.5 million, before deducting placement agent fees and offering expenses.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including working capital and capital expenditures. The net proceeds are also expected to be available to the combined company once the previously announced merger with StemoniX closes, which is subject to stockholder approval.

The shares described above were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-239497) filed with the Securities and Exchange Commission (SEC) on June 26, 2020 and declared effective on July 21, 2020. The offering of the securities described herein was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered was filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or email at [email protected].

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

Entry into a Material Definitive Agreement

On February 16, 2021, Kadmon Holdings, Inc. (the "Company") reported that entered into an indenture (the "Indenture"), dated as of February 16, 2021, between the Company and U.S. Bank National Association, as trustee (the "Trustee"), relating to the issuance of $240,000,000 principal amount of the Company’s 3.625% Convertible Senior Notes due 2027 (the "Notes") in an offering conducted in accordance with Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Filing, 8-K, Kadmon, FEB 16, 2021, View Source [SID1234575125]). The Company granted the initial purchasers an option to purchase, for settlement within a period of 13 days from, and including, the date the Notes are first issued, up to an additional $40,000,000 principal amount of Notes. The initial purchasers have exercised this option in full. The net proceeds from the offering, after deducting the initial purchasers’ discounts, but before deducting estimated offering expenses (which include expenses related to the capped call transactions, as described below) were $232.8 million.

The Notes will bear interest at a rate of 3.625% per year. Interest will be payable semi-annually in arrears on February 15 and August 15 of each year, beginning on August 15, 2021. The Notes will mature on February 15, 2027, unless earlier repurchased, redeemed or converted. Before November 15, 2026, noteholders will have the right to convert their Notes only upon the occurrence of certain events. From and after November 15, 2026, noteholders may convert their Notes at any time at their election until the close of business on the second scheduled trading day immediately before the maturity date. The Company will settle conversions by paying or delivering, as applicable, cash, shares of its common stock or a combination of cash and shares of its common stock, at the Company’s election. The initial conversion rate is 143.7815 shares of common stock per $1,000 principal amount of Notes, which represents an initial conversion price of approximately $6.96 per share of common stock. The conversion rate and conversion price will be subject to customary adjustments upon the occurrence of certain events. In addition, if certain corporate events that constitute a "Make-Whole Fundamental Change" (as defined in the Indenture) occur, then the conversion rate will, in certain circumstances, be increased for a specified period of time.

The Company may not redeem the Notes at its option at any time before February 20, 2024. The Notes will be redeemable, in whole or in part, at the Company’s option at any time, and from time to time, on or after February 20, 2024 and on or before the 40th scheduled trading day immediately before the maturity date, at a cash redemption price equal to the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related redemption notice; and (ii) the trading day immediately before the date the Company sends such notice. In addition, calling any Note for redemption will constitute a Make-Whole Fundamental Change with respect to that Note, in which case the conversion rate applicable to the conversion of that Note will be increased in certain circumstances if it is converted after it is called for redemption.

If certain corporate events that constitute a "Fundamental Change" (as defined in the Indenture) occur, then, subject to a limited exception for certain cash mergers, noteholders may require the Company to repurchase their Notes at a cash repurchase price equal to the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. The definition of Fundamental Change includes certain business combination transactions involving the Company and certain de-listing events with respect to the Company’s common stock.

The Notes have customary provisions relating to the occurrence of "Events of Default" (as defined in the Indenture), which include, but are not limited to, the following: (i) certain payment defaults on the Notes (which, in the case of a default in the payment of interest on the Notes, will be subject to a 30-day cure period); (ii) the Company’s failure to send certain notices under the Indenture within specified periods of time; (iii) the Company’s failure to comply with certain covenants in the Indenture relating to the Company’s ability to consolidate with or merge with or into, or sell, lease or otherwise transfer, in one transaction or a series of transactions, all or substantially all of the consolidated assets of the Company and its subsidiaries, taken as a whole, to another person; (iv) a default by the Company in its other obligations or agreements under the Indenture or the Notes if such default is not cured or waived within 60 days after notice is given in accordance with the Indenture; (v) certain defaults by the Company or any of its significant subsidiaries with respect to indebtedness for borrowed money of at least $20,000,000; (vi)

certain defaults by the Company or any of its significant subsidiaries with respect to one or more final judgments of at least $25,000,000; and (vii) certain events of bankruptcy, insolvency and reorganization involving the Company or any of the Company’s significant subsidiaries.

If an Event of Default involving bankruptcy, insolvency or reorganization events with respect to the Company (and not solely with respect to a significant subsidiary of the Company) occurs, then the principal amount of, and any accrued and unpaid interest on, all of the Notes then outstanding will immediately become due and payable without any further action or notice by any person. If any other Event of Default occurs and is continuing, then, the Trustee, by notice to the Company, or noteholders of at least 25% of the aggregate principal amount of Notes then outstanding, by notice to the Company and the Trustee, may declare the principal amount of, and any accrued and unpaid interest on, all of the Notes then outstanding to become due and payable immediately. However, notwithstanding the foregoing, the Company may elect, at its option, that the sole remedy for an Event of Default relating to certain failures by the Company to comply with certain reporting covenants in the Indenture consists exclusively of the right of the noteholders to receive special interest on the Notes for up to 360 days at a specified rate per annum equal to 0.25% of the principal amount of the Notes for the first 180 days and, thereafter, at a rate per annum equal to 0.50% on the principal amount of the Notes.

The above description of the Indenture and the Notes is a summary and is not complete. A copy of the Indenture and the form of the certificate representing the Notes are filed as exhibits 4.1 and 4.2, respectively, to this Current Report on Form 8-K, and the above summary is qualified by reference to the terms of the Indenture and the Notes set forth in such exhibits.

Onconova Therapeutics, Inc. Announces Closing of $28.75 Million Public Offering of
Common Stock Including Full Exercise of the Over-Allotment Option

On February 16, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported the closing of its previously-announced underwritten public offering (Press release, Onconova, FEB 16, 2021, View Source [SID1234575124]). A total of 28,750,000 shares of its common stock were sold, including 3,750,000 shares of common stock following the exercise by the underwriters of their over-allotment option, at a public offering price of $1.00 per share. The gross proceeds of the offering to the Company are $28.75 million, before deducting the underwriting discounts and commissions and other estimated offering expenses.

Guggenheim Securities is acting as sole book-running manager. Maxim Group LLC and Noble Capital Markets, Inc. are acting as co-managers for the offering.

The securities described above were offered by Onconova pursuant to a shelf registration statement on Form S-3 (File No. 333-237844) which was initially filed by the Company with the Securities and Exchange Commission ("SEC") on April 24, 2020, amended on Form S-3/A that was filed with the SEC on May 15, 2020, and was declared effective by the SEC on May 18, 2020.

A preliminary prospectus supplement relating to the offering was filed with the SEC on February 10, 2021 and is available on the SEC’s website at View Source A final prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is also available on the SEC’s website at View Source Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or 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 jurisdiction.

Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2020 Financial Results and Provides a Corporate Update

On February 16, 2021 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, reported financial results for the fourth quarter and fiscal year ended November 30, 2020 and provided a corporate update (Press release, Nurix Therapeutics, FEB 16, 2021, View Source [SID1234575123]).

"We begin 2021 with a positive notification from the FDA that our first Phase 1 clinical trial of NX-2127 may proceed in patients with B cell malignancies, including chronic lymphocytic leukemia," said Arthur Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We look forward to a very exciting year as we generate clinical data that can support further development of NX-2127, a first-in-class targeted protein degrader of BTK, a highly validated target for hematologic malignancies."

Recent Business Highlights

Submitted first IND application for lead program NX-2127 and received clearance by the U.S. Food and Drug Administration (FDA). Nurix expects to dose the first patient in a Phase 1a/1b trial for NX-2127 in patients with relapsed or refractory B-cell malignancies in the first quarter of 2021 (expected timing of clinical trials here and throughout the press release are based on calendar year periods).

Expanded Sanofi collaboration: On January 7, 2021, Nurix announced that Sanofi exercised its option to increase the number of targets to a total of five, up from the original three targets in the strategic collaboration signed in December 2019. The option exercise triggered a one-time $22 million payment to Nurix, adding to the previously received $55 million upfront payment. As part of the multi-year collaboration, Nurix is using its proprietary drug discovery platform, DELigase, that integrates its DNA-encoded libraries (DEL) and its portfolio of E3 ligases to create small molecules designed to induce degradation of specified drug targets. Sanofi will have exclusive rights and be responsible for clinical development and commercialization of drug candidates resulting from the work while Nurix will retain the option to co-develop and co-promote up to two products in the United States under certain conditions.

Presented Preclinical Data Highlighting Pipeline Programs: In December 2020, the Company presented IND-enabling data from its NX-2127 program at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, including data in non-human primates demonstrating rapid and sustained degradation of BTK with once daily oral dosing. In October 2020, at the Targeted Protein Degradation Summit, data were presented from the Company’s NX-1607 program. NX-1607 is an inhibitor of Casitas B-lineage lymphoma proto-oncogene-B (CBL-B) that is being developed for immuno-oncology indications. The data demonstrated both single agent anti-tumor activity of NX-1607 and combination anti-tumor activity with an anti-PD-1 antibody in animal models.

Completed Initial Public Offering (IPO) in July 2020 raising approximately $238.5 million in gross proceeds: On July 23, 2020, Nurix announced the pricing of its IPO of 11,000,000 shares of common stock, at a public offering price of $19.00 per share. In addition, the underwriters subsequently exercised their option to purchase 1,550,000 additional shares of common stock. The net proceeds to Nurix from the offering were approximately $218.1 million, after deducting underwriting discounts, commissions and offering expenses.

Strengthened Leadership Team with Key Appointments. In 2020, the Company added Michael Lotze, M.D., as chief cellular therapy officer and Robert Brown, M.D., as vice president of clinical development to help advance protein modulating drug candidates and cell therapy programs into the clinic. The Company also enhanced the financial team with the addition of Jason Kantor, Ph.D., as senior vice president, finance and investment strategy.
Upcoming Program Highlights

NX-2127: The Company’s lead drug candidate from its protein degradation portfolio, NX-2127, is an orally available degrader of Bruton’s tyrosine kinase (BTK) with immunomodulatory drug (IMiD) activity for the treatment of relapsed or refractory B-cell malignancies. The Company has an open IND and anticipates dosing the first patient in a Phase 1a/1b trial for NX-2127 in the first quarter of 2021.

NX-1607: The Company’s lead drug candidate from its E3 ligase inhibitor portfolio, NX-1607, is an orally available inhibitor of CBL-B for immuno-oncology indications. The Company anticipates commencing a Phase 1 trial for NX-1607 in the second half of 2021.

NX-5948: The Company’s second drug candidate from its protein degradation portfolio, NX-5948, is an orally available BTK degrader designed without IMiD activity for certain B-cell malignancies, autoimmune diseases and related diseases such as graft-versus-host disease. The Company anticipates commencing a Phase 1 trial for NX-5948 in the second half of 2021.

DeTIL-0255: The Company’s lead candidate in its cellular therapy portfolio, DeTIL-0255, is a drug-enhanced adoptive cellular therapy. The Company anticipates commencing a Phase 1 trial for DeTIL-0255 in the second half of 2021.
Fiscal Fourth Quarter and Full Year 2020 Financial Results

Collaboration revenue for the three months and twelve months ended November 30, 2020 was $6.7 million and $17.8 million, respectively, compared with $1.9 million and $31.1 million for the three and twelve months ended November 30, 2019. The decrease in collaboration revenue for the full year was attributable to the termination of a collaboration agreement with Celgene Corporation in June 2019, which resulted in no revenue recognition in 2020, offset by revenue recognized related to the Company’s collaboration agreements with Gilead Sciences, Inc. and Sanofi S.A. that were established in July and December 2019, respectively.

Research and development expenses for the three months and twelve months ended November 30, 2020 were $20.4 million and $66.5 million, respectively, compared with $12.8 million and $45.0 million for the three and twelve months ended November 30, 2019. The increase was primarily related to increases in preclinical development activities and drug discovery research as well as increased expenses related to higher headcount.

General and administrative expenses for the three months and twelve months ended November 30, 2020 were $6.3 million and $16.3 million, respectively, compared with $2.6 million and $8.3 million for the three and twelve months ended November 30, 2019. The increase was primarily related to higher headcount and increased legal and accounting expenses associated with becoming a public company.

Net loss attributed to common stockholders for the three months and twelve months ended November 30, 2020 was $19.9 million or ($0.51) per share and $43.2 million or ($2.76) per share, respectively, compared with $13.5 million or ($3.55) per share and $21.7 million or ($6.59) per share, respectively, for the three and twelve months ended November 30, 2019.

Cash, Cash Equivalents and Investments: As of November 30, 2020, the Company had cash, cash equivalents and investments of $372.0 million, compared with $38.2 million as of November 30, 2019.