Oncternal Therapeutics Announces $6.2 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules

On July 20, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it has entered into definitive agreements with existing institutional investors and other accredited investors, for the purchase and sale of 2,581,867 shares of its common stock, at a purchase price of $2.3825 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Oncternal Therapeutics, JUL 20, 2020, View Source [SID1234562137]). Oncternal also agreed to issue to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 1,290,933 shares of its common stock. The closing of the offering is expected to occur on or about July 21, 2020, subject to the satisfaction of customary closing conditions.

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

The warrants have an exercise price of $2.32 per share, will be exercisable immediately upon issuance and will expire five and one-half years from the date of issuance.

The gross proceeds from this offering are expected to be approximately $6.2 million, before deducting placement agent’s fees and other estimated offering expenses. Oncternal intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical development of cirmtuzumab and TK216, preclinical development of our ROR1 CAR-T program and other preclinical programs, and for working capital.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock will be 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 shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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

Histogen Inc. Announces Common Stock Purchase Agreement for up to $10 Million with Lincoln Park Capital Fund, LLC
Includes an Initial Investment of $1 Million

On July 20, 2020 Histogen Inc. ("Histogen" or the "Company") (NASDAQ: HSTO), a regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, reported that it has that it has entered into a common stock purchase agreement for up to $10 million with Lincoln Park Capital Fund, LLC ("Lincoln Park"), a Chicago-based institutional investor (Press release, Conatus Pharmaceuticals, JUL 20, 2020, View Source [SID1234562135]). Upon execution of the purchase agreement, Lincoln Park made an initial purchase of $1.0 million of common stock.

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Under the terms of the purchase agreement, the Company will have the right, in its sole discretion, to sell shares of its common stock to Lincoln Park over the 24-month term of the purchase agreement. Any common stock sold to Lincoln Park will occur at a purchase price that is based on the prevailing prices of the common stock at the time of each sale. The Company will control the timing and amount of any shares of common stock sold to Lincoln Park, and Lincoln Park is obligated to make purchases at quantities and prices in accordance with the purchase agreement. Histogen’s sale of common stock is subject to various limitations including those set forth in the purchase agreement and the listing rules of Nasdaq.

The Company intends to use any proceeds it receives under the purchase agreement for working capital and general corporate purposes. There are no warrants, limitations on use of proceeds, financial or business covenants, rights of first refusal, participation rights, penalties or liquidated damages in the purchase agreement.

As part of the agreement, Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Company’s common stock. In consideration for Lincoln Park entering into the purchase agreement, Histogen issued shares of its common stock to Lincoln Park as a commitment fee. The purchase agreement may be terminated by the Company at any time, at its sole discretion, without any cost or penalty.

Additional information regarding the purchase agreement is set forth in a Current Report on Form 8-K, which Histogen filed today with the SEC.

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

Can-Fite Completes Development of an Assay to Identify Clinically Active Cannabis Derived Compounds

On July 20, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported it has completed the development of a biological cell-based in vitro assay which can identify clinically active cannabis derived compounds that bind to and activate the A3 adenosine receptor (A3AR), thus enabling the development of pharmaceuticals that use a specific cannabis derived compound to treat a variety of diseases (Press release, Can-Fite BioPharma, JUL 20, 2020, View Source [SID1234562134]). Numerous studies published in peer reviewed scientific journals demonstrate that cannabis derived compounds bind to the Gi protein-coupled A3AR, which is over-expressed in pathological cells and tissues.

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As a global leader in discovering and developing drugs which target A3AR, Can-Fite is utilizing its platform technology to develop cannabis derived compounds for the treatment of unmet medical needs. Can-Fite has a strategic partnership with Univo Pharmaceuticals, a medical cannabis company.

In addition to using its assay in the development of its own cannabis derived compound-based therapeutics, Can-Fite plans to market the assay on a ‘fee for service’ basis to researchers and other cannabis companies worldwide.

"This new assay, combined with our unparalleled expertise in the development of therapeutics that target A3AR, enable Can-Fite to contribute to unlocking the vast potential of cannabis derived compounds for the effective treatment of specific diseases," stated Can-Fite CEO Dr. Pnina Fishman.

According to Adroit Market Research, the medical cannabis market is projected to grow at a CAGR of 29% to $56.7 billion by 2026.

Molecular Templates, Inc. Raises $43 Million in Gross Proceeds Through Its At-the-Market Facility

On July 20, 2020 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," "MTEM" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported that it has raised gross proceeds of approximately $43 million through its At-the-Market facility ("ATM") with participation based on interest received from Consonance Capital Management (Press release, Molecular Templates, JUL 20, 2020, View Source [SID1234562130]). The Company sold approximately 3.6 million shares of the Company’s common stock at a purchase price of $12.00, the market price at the time of sale. Cantor Fitzgerald & Co. is acting as the sales agent for the ATM.

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The additional funds raised through the ATM will be used to advance the Company’s pipeline, including the development of MT-3724, MT-5111, TAK-169, MT-6402, as well as for working capital and other general corporate purposes.

The shares of common stock described above were sold by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-228975) previously filed and effective on February 13, 2019.

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

Pieris Pharmaceuticals Announces Partial Clinical Hold On PRS-343

On July 20, 2020 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported that its phase 1 studies of PRS-343 have been placed on partial clinical hold by the U.S. Food and Drug Administration (FDA) while Pieris conducts an additional in-use and compatibility study requested by the Agency (Press release, Pieris Pharmaceuticals, JUL 20, 2020, View Source [SID1234562128]). Currently-enrolled patients may continue to receive treatment, although no new patients can be enrolled until resolution of this partial hold.

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The partial hold follows discussions with FDA regarding the Company’s in-use study supporting the technical setup for clinical administration of PRS-343. Specifically, FDA has requested that Pieris conduct an additional in-use and compatibility study of PRS-343 with various infusion materials under specific conditions to confirm suitability of PRS-343 for administration in clinical settings. In its telephonic communication, the Agency did not cite any adverse events in connection with its request. In-use and compatibility studies are laboratory-based studies typically conducted to evaluate the impact of product handling on a drug candidate’s behavior, including effects of dilution media, hold times, and adsorption to materials such as tubing and infusion bags before administration to patients. As part of the development of PRS-343, Pieris conducted in-use and compatibility studies prior to phase 1 and thereafter, the results of which were shared with the Agency.

Separately, the Company has received a written response from the Agency to its Type C meeting request related to the planned phase 2 proof of concept study of PRS-343 in combination with ramucirumab and paclitaxel. Based on this response, Pieris continues to believe it can initiate this clinical study later this year, pending successful completion of the requested in-use and compatibility study.

"We share FDA’s commitment to product quality and will continue to engage with the Agency to initiate and complete the requested in-use and compatibility study with the highest priority," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "Pending satisfactory completion of this laboratory study, we remain committed to continuing the development of PRS-343, including the initiation of a phase 2 study in second-line gastric cancer in combination with the standard of care this year, as previously communicated. We also remain on track to present comprehensive data from both the monotherapy and atezolizumab combination phase 1 studies at a medical conference later this year."

About PRS-343:

PRS-343 is a 4-1BB/HER2 fusion protein comprising a 4-1BB-targeting Anticalin protein and a HER2-targeting antibody. The drug candidate is currently in development for the treatment of HER2-positive solid tumors. Ongoing phase 1 studies of PRS-343 include a monotherapy study and a combination study with atezolizumab. Based on encouraging initial results from both studies, which demonstrated clinical benefit and biomarker data indicative of a 4-1BB-driven mechanism of action, the Company is actively working towards initiating a phase 2 study of PRS-343 in combination with ramucirumab and paclitaxel for the treatment of HER2-positive gastric cancer in a second line setting later this year.