On November 8, 2021 Idera Pharmaceuticals, Inc. ("Idera," the "Company," "we," "us," or "our") (Nasdaq: IDRA) reported its financial and operational results for the third quarter ended September 30, 2021 (Press release, Idera Pharmaceuticals, NOV 8, 2021, View Source [SID1234594796]).

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"We are maintaining our focus on identifying new development or commercial-stage assets for Idera’s portfolio and we are encouraged by the opportunities presented to us," stated Vincent Milano, Idera’s Chief Executive Officer. "As a number of these prospects advance and as we continue to preserve cash, we remain optimistic in Idera’s future potential."

Added Mr. Milano, "Studies also continue in patients with microsatellite-stable colorectal cancer (ILLUMINATE-206) and, in partnership with AbbVie, in patients with head and neck squamous cell carcinoma. We expect to share results from the second stage of ILLUMINATE-206, which involves tilsotolimod in combination with Bristol Myers Squibb’s nivolumab and ipilimumab, by the end of the year."

Third Quarter Financial Results
Our cash position as of September 30, 2021 was $36.6 million. Research and development expenses for the three months ended September 30, 2021 totaled $3.5 million, compared to $4.8 million for the same period in 2020. General and administrative expense for the three months ended September 30, 2021 totaled $2.3 million, compared to $2.7 million for the same period in 2020. Restructuring costs for the three months ended September 30, 2021 totaled approximately $0.1 million and relate to a reduction in force initiated in April 2021 to better align our workforce to our ongoing operational and business development activities. No such costs were incurred during the three months ended September 30, 2020. Additionally, during the three months ended September 30, 2020, we recorded $0.7 million and $12.4 million non-cash warrant revaluation loss and non-cash future tranche right revaluation loss, respectively, related to securities issued in connection with our December 2019 private placement transaction. No such non-cash losses were recognized in the three months ended September 30, 2021.

As a result of the factors above, net loss applicable to common stockholders for the three months ended September 30, 2021 was $6.0 million or $0.11 per basic and diluted share compared to net loss applicable to common stockholders of $20.6 million or $0.59 per basic and diluted share for the same period in 2020. Excluding the non-cash loss of approximately $13.1 million for the three months ended September 30, 2020 related to the securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $7.5 million.

On November 8, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it has entered into a strategic agreement with Kukbo Co. Ltd. (Kospi: 001140) ("Kukbo"), a South Korean corporation, for the sale of RedHill’s American Depositary Shares ("ADSs") in a private placement of up to $10 million at a 20% premium to the prior 30 trading days’ volume weighted average price ("VWAP") (Press release, RedHill Biopharma, NOV 8, 2021, View Source [SID1234595344]).

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Kukbo’s strategic investment in RedHill is to be made in two tranches, with the first tranche of $5 million already paid and the second tranche of $5 million to follow within six months, subject to satisfaction of certain conditions. As part of the first tranche, RedHill is to issue 827,586 ADSs at a purchase price of $6.04, representing a 20% premium based on the VWAP of RedHill’s ADS on NASDAQ over the 30 trading days ending on the effective date. All ADSs are to be issued with a 180-day transfer restriction.

In addition, under the terms of the agreement, RedHill has agreed to grant Kukbo a right of first offer, for a period of six months, for a license with respect to one or more of RedHill’s late-stage clinical assets, opaganib, RHB-107 (upamostat)1 and Talicia, for one or more of the territories of South Korea, Japan, Indonesia, Vietnam, Thailand and Malaysia. Kukbo has the right to elect not to purchase the ADSs in the second tranche if no such license agreement is executed within six months of the closing of the first tranche.

Dror Ben-Asher, RedHill’s CEO said: "We are rapidly advancing with opaganib’s COVID-19 data package submissions to regulators in several territories including the U.S., EU and others, ahead of planned regulatory advice. We are pleased with the addition of Kukbo as a committed strategic investor and look forward to evaluating opportunities for opaganib, RHB-107 and Talicia in South Korea and other territories in Asia where large unmet medical needs exist."

"As Kukbo proceeds in its planned strategic expansion into healthcare, we believe that RedHill’s opaganib, RHB-107 and Talicia, if approved, hold substantial promise in South Korea and other Asian countries and are eager to leverage our local expertise and network in those territories," said Hyun Ha, Kukbo’s CEO.

Nexpedia Holdings Co., Ltd. and Network 1 Financial Securities, Inc. facilitated the introduction between the parties.

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

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

On November 8, 2021 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) reported that the board of directors has resolved on a directed new share issue of 1,612,904 shares at a price of SEK 62 per share, corresponding to in total approximately SEK 100 million (Press release, Xspray, NOV 8, 2021, View Source [SID1234649574]).

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The board of directors of Xspray Pharma has, based on the authorisation granted by the annual general meeting on 20 May 2021, resolved on a directed new share issue of 1,612,904 shares. The subscription price in the directed new share issue is set to SEK 62 per share, which has been determined based on the volume-weighted average share price of Xspray Pharma’s share on Nasdaq Stockholm during the five-day period ending on 5 November 2021. The company receives approximately SEK 100 million through the directed new share issue.

The shares have been subscribed by Flerie Invest, a Swedish investment company in biotechnology and pharmaceuticals, founded by Thomas Eldered. As Xspray Pharma has chosen to increase its focus on the improved version of dasatinib, Dasynoc , the proceeds from the share issue will mainly be used to strengthen the development of the company’s presence in the US, primarily with the strategic marketing resources needed for the market launch of Dasynoc. Resources will also be invested in accelerating the development of the fast-growing portfolio.

"Xspray Pharma has a very promising and growing product portfolio where Dasynoc is now facing the application for market approval at the same time as HyNap-Nilo will undergo studies and registration-based studies. Several products in the early phase will also reach the clinical development stage within the next year. It is of course very gratifying that Flerie Invest, in this important phase for Xspray Pharma, chooses to invest in the company. Flerie Invest is a specialized and long-term investor whose management has a deep and broad competence and experience in commercial pharmaceutical production. They also have a very strong network of contacts in the global pharmaceutical industry. Flerie Invest will be a very valuable addition to Xspray Pharma’s shareholder base", says Per Andersson, CEO of Xspray Pharma.

"We have been following Xspray Pharma for a long time and are impressed with the potential in the company’s unique technology. The recently decided focus on improved PKIs, and not pure generics, makes the company even more interesting. The improved drugs have the potential to provide fewer side effects and better effects and thus constitute essential therapies for affected patients. We therefore look forward to being involved in the company’s continued development", comments Thomas Eldered, founder and board member of Flerie Invest.

The board of directors has resolved on the issue by utilizing the authorisation granted by the annual general meeting and the reason for the deviation from the shareholders’ preferential rights is that the board of directors considers that the investment from Flerie Invest is for Xspray Pharma, and thus for its shareholders, the most advantageous way to raise capital in a time and cost-efficient manner and in the meanwhile onboarding a reputable, specialized and a long-term investor.

In its deliberations, the board of directors has further taken into account that there are no time- and cost-effective ways to successfully carry out a rights issue on terms favorable to the company, that the subscription price negotiated with Flerie Invest at arm’s length is not discounted but has been based on the volume-weighted average price of Xspray Pharma’s share during the five-day period ending on 5 November 2021, the last trading day before the issue resolution, and that Flerie Invest is not previously a shareholder in Xspray Pharma. The board of directors’ overall assessment is thus that there are good reasons to deviate from the preferential rights and carry out a directed new share issue.

Flerie Invest has, in connection with the share issue, agreed not to sell any shares in Xspray Pharma during a lock-up period of 360 days, subject to customary exceptions. In connection with the share issue, Xspray Pharma has agreed to a lock-up undertaking, with customary exceptions, on future share issuances for a period of 90 days.

Through the directed new share issue, the total number of shares and votes will increase by 1,612,904, from 19,067,504 to 20,680,408, which corresponds to a dilution of approximately 7.8 percent based on the total number of shares and votes in Xspray Pharma after the directed new share issue. The share capital increases with SEK 1,612,904, from SEK 19,067,504 to SEK 20,680,408.

Xspray Pharma has, in connection with the directed new share issue, appointed Advokatfirman Vinge as legal advisor.

On November 8, 2021 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the initiation of a proof-of-concept Phase Ib clinical trial to assess the safety and efficacy of mitazalimab in combination with MesoPher, an experimental dendritic cell vaccine, in patients with pancreatic cancer (Press release, Alligator Bioscience, NOV 8, 2021, View Source [SID1234594700]). The trial will be led by investigators at Erasmus MC University Medical Center Rotterdam, The Netherlands.

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The first patient has been dosed in the phase I proof-of-concept study trial, REACtiVe-2, that will enroll up to 18 patients with pancreatic cancer. REACtiVe-2 will assess the safety and efficacy of Alligator´s second generation CD40 agonist, mitazalimab in combination with the investigational cancer vaccine MesoPher, which is comprised of autologous dendritic cells loaded with allogeneic tumor lysate (PheraLys), in patients with progressive metastatic pancreatic cancer. Mitazalimab is currently in Phase II trial in pancreatic cancer patients in combination with chemotherapy. MesoPher, under development by Amphera B.V., is currently in a Phase III trial in mesothelioma and a phase II trial in pancreatic cancer. The investigator sponsored trial, REACtiVe-2, will be performed at Erasmus MC University Medical Center Rotterdam.

The clinical study is supported by strong preclinical data that was recently published in the high-ranking peer-reviewed journal "Journal of Immunotherapy of cancer" (Lau SP, et al. J Immunother Cancer 2020). This study demonstrates that CD40 agonists in combination with dendritic cells loaded with allogeneic tumor lysate mediates powerful and significant anti-tumor effects in pancreatic cancer models.

"This new trial is an important step forward in expanding the potential of mitazalimab in a patient population with high medical needs," said Alligator’s CEO, Søren Bregenholt. "Erasmus MC University Medical Center Rotterdam is the ideal partner for the clinical evaluation of mitazalimab´s ability to enhance the response of a promising cancer vaccine in pancreatic cancer."

On November 8, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT) ("Corcept") a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported that it has commenced a modified Dutch Auction tender offer for the purchase of up to 10 million shares of Corcept’s common stock, par value $0.001 per share (each, a "Share," and collectively, "Shares") or such lesser number of Shares as are properly tendered and not properly withdrawn, at a price not greater than $23.75 per Share nor less than $20.75 per Share, to be paid to the seller in cash less any applicable withholding taxes (Press release, Corcept Therapeutics, NOV 8, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-commencement-tender-offer [SID1234594716]). The tender offer is made in accordance with the terms and subject to the conditions described in the offer to purchase, the related letter of transmittal and other related materials, as each may be amended or supplemented from time to time.

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The closing price of the Shares on The Nasdaq Stock Market on November 5, 2021, the last full trading day before the start of the tender offer, was $20.68 per Share. The tender offer is scheduled to expire one minute after 11:59 P.M., New York City Time, December 7, 2021, unless the offer is extended or terminated.

Corcept believes that the repurchase of Shares pursuant to the tender offer is consistent with its long-term goal of maximizing stockholder value and that the tender offer is an efficient way to give stockholders the opportunity to receive a return of their investment by tendering some or all of their Shares.

The tender offer is contingent upon at least three million Shares being tendered. The tender offer is also subject to terms and conditions, which are described in detail in the offer to purchase. Specific instructions and a complete explanation of the terms and conditions of the tender offer are contained in the offer to purchase, the related letter of transmittal and other related materials, which will be mailed to stockholders of record promptly.

None of Corcept, the members of its Board of Directors, the dealer manager, the financial advisor, the information agent or the depositary for the tender offer makes any recommendation as to whether or not any stockholder should participate in the tender offer or as to the purchase price or purchase prices at which stockholders may choose to tender their Shares.

The sole dealer manager for the tender offer is Truist Securities, Inc. D.F. King is serving as the information agent for the tender offer and Continental Stock Transfer & Trust Company is serving as the depositary. Canaccord Genuity LLC is serving as a financial advisor. For all questions relating to the tender offer, please contact the information agent, D.F. King & Co., Inc. at [email protected] or call toll-free at 1 (800) 431-9646, or call the dealer manager, Truist Securities, Inc. at 1 (404) 926-5832.