On November 20, 2019 Genprex, Inc.("Genprex" or the "Company") (NASDAQ: GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, reported a registered direct offering of 3,167,986 shares of its common stock at a price to the public of $0.40 per share, for gross proceeds of approximately $1.26 million prior to deduction of commissions and offering expenses payable by Genprex (Press release, Genprex, NOV 20, 2019, View Source [SID1234551522]). In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 3,167,986 shares of the Company’s common stock.

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Joseph Gunnar & Co. is acting as the exclusive placement agent.

The warrants will be exercisable 6 months from the issuance date, have an exercise price of $0.46 per share, and will expire 5 years from such date. The warrants will be exercisable for 100% of shares of common stock purchased by each investor in the registered direct offering. In addition, the Company has agreed to reduce the exercise price of an aggregate of 2,283,740 warrants held by the purchasers in the registered direct offering to $0.46, which warrants will not be exercisable for six months from the closing of the registered directed offering and the expiration date of the warrants will be extended by six months to January 27, 2024.

The Company intends to use the net proceeds of the offering for working capital and general corporate purposes. The closing of the offering is expected to take place on or about November 25, 2019, subject to the satisfaction or waiver of customary closing conditions.

The shares of common stock described above (but not the warrants or the shares of common stock underlying the warrants) are being offered pursuant to a "shelf" registration statement on Form S-3 (File No. 333-233774) that was filed by the Company with the Securities and Exchange Commission (SEC) and was declared effective on October 28, 2019. The Company will file a prospectus supplement with the SEC relating to such shares of common stock. Copies of the prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering may be obtained, when available, from Joseph Gunnar & Co., 30 Broad Street, 11th Floor, New York, NY 10004, or by email at [email protected]. In connection with the private placement, the Company has agreed to a file a registration statement registering for resale the shares of common stock issuable upon exercise of the warrants issued in the private placement within 45 days of the closing of the private placement.

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.

On November 20, 2019 Navrogen Inc. and Lonza Pharma & Biotech reported that they have entered a licensing agreement for the production of Navrogen’s biotherapeutics using Lonza’s GS Xceed Expression System (Press release, Navrogen, NOV 20, 2019, View Source [SID1234551520]).
Navrogen recently announced funding to develop biotherapeutics targeting Humoral Immuno-Oncology (HIO) factors to reverse their inhibitory activity against the pharmacologic effects of antibody-based therapies. Navrogen’s biological drugs involve novel protein and antibody-based configurations. Lonza’s GS Xceed toolbox includes GS PiggyBac, a unique and proven transposon-based technology suited for complex protein expression and bioprocessing that preferentially targets stable regions of the genome associated with highly expressed genes. This system will play a key role in advancing Navrogen’s novel therapeutic interventions from the laboratory bench to patient’s bedside.

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"We are pursuing novel targets, called HIO factors, produced by tumor cells that dampen the effect of a number of antibody-based therapeutics. To overcome the immuno-suppressive effects of these factors we developed a pipeline of uniquely engineered, biological-based compositions that may require optimized systems to facilitate their production at large scale for clinical trials", commented Dr. Luigi Grasso, Ph.D., co-founder and Chief Scientific Officer of Navrogen.

Dr. Nicholas Nicolaides, Ph.D., Navrogen’s co-founder and Chief Executive Officer said "Our collaboration with Lonza and their expertise will undoubtedly enable us to advance our pipeline of first-in-class products forward to meet our strategic initiatives and timelines. This partnership is one of many that we have formed with top-tiered vendors who have proven track records in supporting the development of biological-based therapies to support clinical trials and commercialization."

"Developing new technologies to enable production of increasingly complex and hard-to-express biological drugs is a priority for Lonza. Navrogen’s use of our GS PiggyBac system aligns the economics of bringing these first-in-class therapeutics to patients with current market needs", commented Dr Sarah Holland, Head of licensing, Lonza Pharma & Biotech.

On November 20, 2019 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported the pricing of its previously announced underwritten public offering (Press release, Checkpoint Therapeutics, NOV 20, 2019, View Source [SID1234551519]). Checkpoint is offering 13,400,000 shares of its common stock, par value $0.0001 per share, at a price to the public of $1.27 per share. In connection with the offering, Checkpoint has also granted the underwriters a 45-day option to purchase up to an additional 2,010,000 shares of common stock offered in the public offering, at the same public offering price per share, less underwriting discounts and commissions.

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National Securities Corporation, a wholly owned subsidiary of National Holdings Corporation (NasdaqCM: NHLD), is acting as sole book-running manager for the offering and H.C. Wainwright & Co., LLC is acting as lead manager for the offering. Lake Street Capital Markets, LLC is acting as financial advisor to Checkpoint.

The Company expects to receive gross proceeds from the offering of $17,018,000, before deducting underwriting discounts and commissions and other offering-related expenses. Assuming the full exercise of the underwriter’s option to purchase additional shares, gross proceeds would be $19,570,700.

Checkpoint intends to use the net proceeds from the offering primarily to support the continued development of cosibelimab, including an ongoing Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including ongoing cohorts intended to support one or more Biologics License Application submissions, and for general corporate purposes.

The offering is expected to close on or about November 22, 2019, subject to customary closing conditions.

A shelf registration statement on Form S‐3 (File. No. 333‐221493) (the "Registration Statement") relating to the shares of common stock being offered was filed with the U.S. Securities and Exchange Commission (SEC) and was declared effective on December 1, 2017. The offering is being made only by means of a prospectus. A preliminary prospectus supplement and accompanying prospectus describing the terms of the offering have been filed with the SEC. A final prospectus supplement to the base prospectus describing the final terms of the offering will be filed with the SEC and, when available, may be obtained from National Securities Corporation, Attn: Charles Wanyama, 200 Vesey Street, 25th Floor, New York, New York 10281, telephone: (212) 417-3634, or by email at [email protected]; or the on the SEC’s website at View Source

This press release shall not constitute an offer to sell or a solicitation of an offer to buy securities of the Company, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale is not permitted.

On November 20, 2019 Heat Biologics, Inc. (NASDAQ:HTBX), reported additional positive Phase 2 interim top line data from Cohort A of the Company’s Phase 2 trial of its T-cell activating cell-based therapy, HS-110, in combination with Opdivo (nivolumab) in advanced non-small cell lung cancer (NSCLC) at a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy on November 19, 2019 available at View Source (Press release, Heat Biologics, NOV 20, 2019, View Source [SID1234551518]). Cohort A enrolled only previously treated patients who have never received a checkpoint inhibitor (CPI).

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The Company reported median overall survival (mOS) of 16.9 months with 50% of patients censored with median follow up of 17 months. This compares favorably to the 12.2 months mOS reported in the Checkmate 057[i] study with Bristol-Myers Squibb’s nivolumab (Opdivo) alone in a similar patient population. The Company also reported an objective response rate (ORR) per iRECIST of 22%, and a disease control rate (DCR) of 48%, with tumor shrinkage observed in 46% of patients.

Moreover, mOS of patients experiencing dermal injection site reactions (ISR) was 42.1 months. Statistically significant improvement in progression-free survival (PFS) and mOS was observed compared to those without ISR (Hazard Ratio = 0.51, p=0.042 and Hazard Ratio = 0.14, p <0.0001, respectively).

Jeff Hutchins, Ph.D., Heat’s Chief Scientific and Operating Officer commented, "The data from Cohort A is extremely encouraging and builds upon our recently announced data in Cohort B, a population consisting of patients who previously progressed on a checkpoint inhibitor and were re-challenged with HS-110 plus nivolumab. Of special interest in Cohort A is a prospectively defined subset of PD-L1 positive patients who achieved a median overall survival of 42.1 months (95% CI; 15.8 – 42.1). This is particularly compelling when compared to overall survival rates in published literature of 1st or 2nd line checkpoint inhibitor monotherapy."

Highlights for Cohort A patients are presented below:

Median Overall Survival of 16.9 months (50% of patients still alive with median follow up of 17 months)
Median overall survival of ISR positive patients was 42.1 months (95% CI; 15.8 – 42.1) vs. an ISR negative mOS of 5.9 months (95% CI; 1.4 – 11.6) (Hazard Ratio = 0.14, p <0.0001)
A prospectively defined analysis of PD-L1 negative vs. PD-L1 positive showed a difference in mOS of 16.9 months (95% CI; 5.5 – unk) to 42.1 months (95% CI; 1.6 – 42.1), respectively
Objective Response Rate by iRECIST of 22% and DCR of 48%
Tumor shrinkage in 46% of patients
Patients who achieved stable disease or better showed statistically significant decreases in peripheral blood T cell subsets from baseline while on combination treatment
Jeff Wolf, Heat’s CEO, commented, "We are strongly encouraged by this latest data release and believe the data from both Cohorts A and B will be helpful as we advance partnership and collaboration discussions."

On November 20, 2019 XOMA Corporation (Nasdaq: XOMA) ("XOMA" or the "Company") reported its intent to commence a rights offering pursuant to which the Company would raise approximately $22 million through the distribution of subscription rights to holders of its common stock ("Common Stock"), Series X preferred stock ("Series X Preferred") and Series Y preferred stock ("Series Y Preferred"), which will entitle the holders to purchase shares of XOMA’s Common Stock at $22.00 per share (the "Rights Offering") (Press release, Xoma, NOV 20, 2019, View Source [SID1234551514]). The Rights Offering will be fully backstopped by BVF Partners L.P., the Company’s largest stockholder, or its assignee/transferee, which has agreed to purchase at a minimum its as-converted pro rata share of the offering amount, plus an additional amount of securities that are not subscribed for by other purchasers in the Rights Offering for a total of up to $22 million.

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Under the proposed Rights Offering, the Company plans to distribute non-transferable subscription rights to purchase a portion of a share of Common Stock for each share of Common Stock outstanding and for each share of Common Stock issuable upon conversion of the Company’s outstanding shares of Series X Preferred and Series Y Preferred, at a subscription price per share of $22.00, to its stockholders of record as of the close of business on November 29, 2019 (the "Record Date"). The subscription rights will be exercisable for an aggregate of 1,000,000 shares of Common Stock, with participation to be allocated among holders of its Common Stock, Series X Preferred and Series Y Preferred on a pro rata basis (assuming full conversion of the Series X Preferred and Series Y Preferred into shares of Common Stock), subject to the aggregate offering threshold and ownership limitations. The subscription rights are non-transferable and may be exercised only during the anticipated subscription period of Monday, December 2, 2019, through 5:00 PM EDT on Wednesday, December 18, 2019, unless extended. Any participant in the Rights Offering that, by exercise of its subscription right would become a holder of greater than 9.9% of the outstanding number of shares of Common Stock of the Company following the Rights Offering may elect to instead purchase Series Z Preferred Stock ("Series Z Preferred") of the Company. The Company intends to sell the Series Z Preferred at $22,000 per share, and any such holder so electing would have a right to purchase one one-thousandth of a share of Series Z Preferred for each share of Common Stock it had a right to purchase under the subscription rights. Each share of Series Z Preferred will, subject to certain limitations, be convertible into 1,000 shares of Common Stock at the election of the holder. The Series Z Preferred will generally have no voting rights, except as required by law, and will participate pari passu, on an as-converted basis, with any distribution of proceeds to holders of Common Stock in the event of the Company’s liquidation, dissolution or winding up.

The Rights Offering will be made pursuant to the Company’s effective shelf registration statement on file with the Securities and Exchange Commission and only by means of a prospectus supplement and accompanying prospectus. The Company expects to mail subscription certificates evidencing the subscription rights and a copy of the prospectus supplement and accompanying prospectus for the Rights Offering shortly following the Record Date.

This press release is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities in any jurisdiction, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

BVF Partners L.P., the Company’s largest shareholder, currently owning approximately 20.5% of the Company’s outstanding Common Stock (and 53.6% on an as-converted basis), will backstop the Rights Offering and has agreed to purchase up to $22 million of Common Stock at a subscription price per share of $22.00, subject to approval by Nasdaq, or Series Z Preferred at a price of $22,000 per share in a private placement promptly at the conclusion of the Rights Offering, with the dollar amount to be purchased in such private placement reduced by the dollar amount sold by the Company (including to BVF Partners L.P., and its affiliates) in the Rights Offering.