On April 27, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing novel therapeutics that combine both targeted and immune-mediated mechanisms, reported a $15 million private investment in public equity (PIPE) financing from the sale of 3,149,912 shares of its common stock at a price per share of $2.36 and, in lieu of shares of common stock, pre-funded warrants to purchase up to 3,206,020 shares of its common stock at price per pre-funded warrant of $2.359 to EcoR1 Capital, LLC and Versant Venture Capital (Press release, Tempest Therapeutics, APR 27, 2022, View Source [SID1234613049]). Gross proceeds from the PIPE financings total approximately $15.0 million, before deducting offering expenses.

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"We are very pleased to have a top investor such as EcoR1 recognize the value in Tempest, and we strongly appreciate Versant’s continued support of the Company, which has been consistent since our inception," said Stephen R. Brady, chief executive officer of Tempest. "Given the current capital markets environment, we are also pleased with the equivalent value between the securities, and will continue to diligently execute towards the development of meaningful therapies for patients."

The closing of the PIPE financing is subject to customary closing conditions and is expected to close by April 29, 2022.

The securities sold in this private placement, including the shares of common stock underlying the pre-funded warrants, have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the U.S. except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Tempest Therapeutics has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in this private placement and the shares of common stock underlying the pre-funded warrants.

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.

On April 27, 2022 Heat Biologics, Inc. (NYSE American: HTBX) (to be renamed "NightHawk Biosciences"), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported to shareholders that its Elusys Therapeutics subsidiary has finalized a contract with the Canadian government to deliver ANTHIM (obiltoxaximab for injection), a treatment for inhalation anthrax, for use against a potential anthrax attack (Press release, NightHawk Biosciences, APR 27, 2022, View Source [SID1234613048]).

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ANTHIM will be delivered to Canada’s National Emergency Strategic Stockpile under a procurement contract totaling CAD $7.9 millioni. The goal of this program is to establish a Canadian supply of Anthim for use as a medical countermeasure against natural and man-made anthrax biothreats.

Jeff Wolf, CEO of Nighthawk and its Elusys subsidiary, commented, "We are excited to announce this first international contract to supply ANTHIM to Canada, which is particularly timely given the growing global geopolitical uncertainty and emerging threats. This agreement follows our recent acquisition of Elusys, which complements our broader biodefense initiatives. We are focused on expanding sales of ANTHIM, abroad and this first international contract is an important validation of our strategy."

According to the United States Centers for Disease Control and Prevention (CDC), if a bioterrorist attack were to happen, bacillus anthracis, the bacteria that causes anthrax, would be one of the biological agents most likely to be used, since these spores are easily found in nature, can be produced in a lab, and may remain in the environment for a prolonged period. In recent Congressional testimony, Gerald Parker, Associate Dean of Texas A&M’s College of Veterinary Medicine & Biomedical Sciences, indicated that the top three bioterrorist threats were "anthrax, anthrax, and anthrax."

Elusys has previously established a successful track record collaborating with U.S. government agencies including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), the Strategic National Stockpile (SNS) and the Department of Defense (DOD). To date, Elusys has been awarded over $400 million in research and development grants, contracts and procurement orders from BARDA and SNS through ongoing, multi-year partnerships with the U.S. government.

This latest award follows NightHawk’s recent announcement of its planned 500,000+ square foot biodefense-focused biologics biomanufacturing facility in Manhattan, Kansas, which is being designed to scale production of ANTHIM, among other uses.

About ANTHIM
Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.

ANTHIM (obiltoxaximab for injection) is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs. ANTHIM is indicated for post-exposure prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax.

On April 27, 2022 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported that it has agreed to sell 953,834 of its common shares at a price of $26.21 per share to Pfizer for gross proceeds of $25.0 million (the "Transaction") (Press release, Zentalis Pharmaceuticals, APR 27, 2022, View Source [SID1234613047]). The common shares were offered and sold to Pfizer in a registered direct offering conducted without an underwriter or placement agent. The offering is expected to close on or about April 29, 2022, subject to customary closing conditions. Zentalis intends to use the net proceeds of the offering to help fund ongoing and planned clinical trials, including studies of ZN-c3, its Wee1 inhibitor, and ZN-d5, its BCL-2 inhibitor, and for working capital and general corporate purposes. With prioritization of the clinical development of ZN-c3 and ZN-d5, budget reallocation and Pfizer’s investment, the Company extends current cash runway into Q1 2024.

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Pfizer also expects to leverage its global development capabilities and expertise to enhance Zentalis’ clinical development program. The parties have entered into an agreement to collaborate to advance the clinical development of ZN-c3, a selective Wee1 inhibitor designed to induce synthetic lethality in cancer cells.

Zentalis will maintain full economic ownership and control of ZN-c3 and the rest of its pipeline.

Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis, commented, "Given Pfizer’s deep expertise in developing treatments for genitourinary cancers, we are proud not only to receive capital support but to partner with them to develop a potential treatment option for patients living with cancer. We look forward to advancing our promising therapeutics to hopefully realize the full potential of our internally discovered oncology pipeline."

"We are proud to support Zentalis and to assist in the clinical advancement of its pipeline," said Chris Boshoff, M.D., Ph.D., FMedSci, Chief Development Officer, Pfizer Oncology. "We believe Zentalis’ commitment to developing innovative treatments holds promise, and we are looking forward to continuing our relationship to potentially help better the lives of people with cancer."

In addition, Adam Schayowitz, Ph.D., MBA, Vice President & Medicine Team Group Lead for Breast Cancer, Colorectal Cancer and Melanoma, Pfizer, will join Zentalis’ Scientific Advisory Board. Dr. Schayowitz will work closely with Zentalis’ senior management team to provide input on the Company’s clinical strategy.

The securities described above were offered by means of a prospectus supplement dated April 26, 2022, and accompanying prospectus dated May 4, 2021, forming a part of the Company’s effective shelf registration statement (File No. 333-255769). The prospectus supplement and accompanying prospectus relating to this offering will be filed with the U.S. Securities and Exchange Commission (the "SEC") and will be available on the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the common shares, nor shall there be any sale of the common shares 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.

On April 27, 2022 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that it will report first quarter 2022 financial results after the close of U.S. financial markets on Wednesday, May 4, 2022 (Press release, Kura Oncology, APR 27, 2022, View Source [SID1234613046]). Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

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The live call may be accessed by dialing (844) 826-3035 for domestic callers and (412) 317-5195 for international callers and entering the conference code: 10166202. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.

On April 27, 2022 ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the first quarter ended March 31, 2022, and provided an update on recent corporate activities (Press release, ASLAN Pharmaceuticals, APR 27, 2022, View Source [SID1234613045]).

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"We have made strong progress in the first quarter of the year with the initiation of TREK-AD, the global Phase 2b trial of eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor, and welcoming new team members to support the late-stage development of eblasakimab," said Dr Carl Firth, CEO, ASLAN Pharmaceuticals. "Following the presentation of the positive data from our proof-of-concept study in the late-breaker session at the American Academy of Dermatology meeting, we plan to publish new data from this study in the coming months to support the potential of eblasakimab as a differentiated therapy for patients with moderate-to-severe AD. By targeting the receptor, and blocking signaling of both IL-13 and IL-4 through the Type 2 receptor, eblasakimab may be effective in a range of other Type 2-driven comorbidities, which is very important in this patient population."

First quarter 2022 and recent business highlights

Q1 and recent clinical developments

In January, the TREK-AD (TRials with EblasaKimab in Atopic Dermatitis) Phase 2b trial was initiated to evaluate the efficacy and safety of eblasakimab in patients with moderate-to-severe AD. The randomized, double-blind, placebo-controlled, multi-center, dose-ranging clinical trial is evaluating five treatment arms (four active treatment arms and one placebo arm) and is expected to enroll approximately 300 patients across sites in North America, Europe and Asia Pacific. Topline data from the study is expected in the first half of 2023.
In January, results of an interim analysis of the completed Phase 1b proof-of-concept study of eblasakimab in AD were accepted for poster presentation at the 2022 Winter Clinical Dermatology Conference – Hawaii.
In January, the Company hosted the second episode in its series of Key Opinion Leader (KOL) webinars, the "A4 (Aspects of Atopic Dermatitis and ASLAN004) Series: Dialogues with International Thought Leaders in Dermatology". Dr April Armstrong, MD MPH, discussed the key clinical study parameters likely to impact patient responses and clinical trial outcomes in AD. Replay for the webinar is available here. The replays can also be found on the "Events and Presentations" section in ASLAN’s Investor Relations website.
In March, key efficacy and safety data from the completed Phase 1b proof-of-concept study that demonstrated eblasakimab’s potential to offer a differentiated treatment option for patients were presented in a late-breaker oral session at the 2022 American Academy of Dermatology Annual Meeting. These data confirmed that eblasakimab’s inhibition of the IL-13 receptor, blocking signaling of both IL-13 and IL-4 through the Type 2 receptor, can contribute significantly to reducing inflammation in AD. ASLAN believes that this ‘dual blockade’ may not only offer a differentiated treatment option for patients in terms of safety and dosing regimen, but may also address other allergic comorbidities that many of these patients suffer from.
Corporate updates

In March, Alex Kaoukhov, MD, was appointed as Chief Medical Officer based in the Company’s U.S. office. Alex has more than 20 years of global drug development experience in the U.S. and Europe, and was most recently Head of Clinical Development, Senior Vice President at Bioniz Therapeutics, where he established and managed a team responsible for the development of therapeutic assets for the treatment of skin and gastrointestinal autoimmune diseases. Prior to this, Alex served as Head of Global Development at Almirall, where he oversaw global clinical and non-clinical development programs. He also was responsible for business development activities including the in-licensing of lebrikizumab for Europe. Prior to Almirall, Alex was Associate Vice President of Clinical Development at Allergan and served in clinical development leadership roles at Novartis and Galderma.
Anticipated upcoming milestones

Initiation of Phase 2 study of farudodstat, also known as ASLAN003, in inflammatory bowel disease is planned for the first half of 2022.
New data on biomarkers and patient reported outcome measures from the Phase 1b proof-of-concept study of eblasakimab expected in the second half of 2022.
Topline data from the Phase 2b TREK-AD study of eblasakimab is expected in the first half of 2023.
First quarter 2022 financial highlights

As of March 31, 2022, the Company had cash, cash equivalents and short-term investments of $87.4 million.
Cash used in operations for the first quarter of 2022 was US$7.2 million compared to US$7.6 million in the same period in 2021.
Research and development expenses were US$9.4 million in the first quarter of 2022 compared to US$3.8 million in the first quarter of 2021. The increase was driven by clinical development expenses and manufacturing costs related to eblasakimab and the TREK-AD Phase 2b trial.
General and administrative expenses were US$2.5 million in the first quarter of 2022 compared to US$3.1 million in the first quarter of 2021. The decrease was due to financing costs incurred in the first quarter of 2021.
Net loss attributable to stockholders for the first quarter of 2022 was US$12.9 million or $0.19 per ADS compared to a net loss of US$6.7 million or $0.13 per ADS for the first quarter of 2021.
The weighted average number of American Depositary Shares (ADSs) outstanding in the computation of basic loss per share for the first quarter of 2022 was 69.7 million (representing 348.7 million ordinary shares) compared to 51.4 million (representing 257.2 million ordinary shares) for the first quarter of 2021. One ADS is the equivalent of five ordinary shares.