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]).

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!

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.

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!

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.

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!

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]).

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!

"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.

On April 27, 2022 Alkermes plc (Nasdaq: ALKS) reported financial results for the first quarter of 2022 (Press release, Alkermes, APR 27, 2022, View Source [SID1234613044]).

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!

"Our strong first quarter results reflect continued momentum across the business, and a sharp operational focus that provides a solid foundation to drive further growth of our proprietary products and advance our pipeline of development programs in 2022. As we execute on our launch strategy for LYBALVI, we are particularly encouraged by early utilization trends and feedback from healthcare providers that underscore LYBALVI’s value proposition in the oral antipsychotic market," said Richard Pops, Chief Executive Officer of Alkermes. "With our focus on disciplined allocation of capital, strong corporate governance, and our commitment to long-term profitability targets, we are delivering on our commitment to efficiently drive growth and actively managing the business to create value for our shareholders in 2022 and beyond."

Quarter Ended March 31, 2022 Financial Results

Revenues

– Total revenues for the quarter were $278.5 million, compared to $251.4 million for the same period in the prior year.

– Net sales of proprietary products for the quarter were $171.3 million, compared to $130.0 million for the same period in the prior year.

Net sales of VIVITROL were $84.9 million, compared to $74.5 million for the same period in the prior year, representing an increase of approximately 14%.
Net sales of ARISTADAi were $72.5 million, compared to $55.4 million for the same period in the prior year, representing an increase of approximately 31%.
Net sales of LYBALVI were $13.9 million, following its commercial launch in October 2021.
– Manufacturing and royalty revenues for the quarter were $105.2 million, compared to $119.8 million for the same period in the prior year.

Royalty revenues from INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA (the long-acting INVEGA products) were $37.1 million, compared to $61.6 million for the same period in the prior year. This includes approximately one month of royalty payments related to sales of the long-acting INVEGA products in the United States (U.S.), compared to three months in the same period in the prior year. This decrease was driven primarily by Janssen Pharmaceutica N.V.’s (Janssen) partial termination of the license agreement related to sales of long-acting INVEGA products in the U.S., which took effect starting in February of 2022.
° In April 2022, the company commenced binding arbitration proceedings related to, among other things, Janssen’s partial termination of the license agreement in the U.S. and Janssen’s royalty and other obligations under the agreement.

Manufacturing and royalty revenues from RISPERDAL CONSTA were $17.4 million, compared to $14.2 million for the same period in the prior year.
Manufacturing and royalty revenues from VUMERITY were $30.6 million, compared to $13.4 million for the same period in the prior year.
Costs and Expenses

– Total operating expenses for the quarter were $305.1 million, compared to $267.9 million for the same period in the prior year, primarily reflecting increased investment to support the commercial launch of LYBALVI.

Cost of Goods Manufactured and Sold were $55.2 million, compared to $41.0 million for the same period in the prior year.
Research and Development (R&D) expenses were $96.0 million, compared to $92.3 million for the same period in the prior year.
Selling, General and Administrative (SG&A) expenses were $145.1 million, compared to $125.2 million for the same period in the prior year.
– Other Expense, Net for the quarter included a reduction of $19.1 million in the fair value of contingent consideration related to increased risk of non-payment of certain milestone payments by Baudax Bio, Inc. in light of its disclosures regarding its ability to continue as a going concern.

Profitability

– Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $35.9 million for the quarter, or a basic and diluted GAAP loss per share of $0.22. This compared to GAAP net loss of $22.4 million, or a basic and diluted GAAP loss per share of $0.14, for the same period in the prior year.

– Non-GAAP net income was $19.6 million for the quarter, or a non-GAAP basic and diluted earnings per share of $0.12. This compared to non-GAAP net income of $17.8 million for the quarter, or a non-GAAP basic and diluted earnings per share of $0.11, for the same period in the prior year.

Balance Sheet

– At March 31, 2022, the company recorded cash, cash equivalents and total investments of $758.7 million, compared to $765.7 million at Dec. 31, 2021. The company’s total debt outstanding as of March 31, 2022 was $295.2 million.

"Our first quarter results demonstrate the strength of our proprietary commercial product portfolio and our continued focus on efficient management of our cost structure. We are in a strong financial position to execute on our strategic priorities and work toward achievement of our long-term profitability targets," commented Iain Brown, Chief Financial Officer of Alkermes. "Today, we are reiterating our financial expectations for 2022, as we focus on efficiently driving growth of LYBALVI, ARISTADA and VIVITROL, and advancing our development pipeline."

Financial Expectations for 2022

Alkermes reiterates its financial expectations for 2022, and the assumptions underlying such expectations, as set forth in its press release dated Feb. 16, 2022.

Recent Events:

Oncology

In February 2022, the company presented new data from the ongoing phase 1/2 ARTISTRY-1 clinical trial for nemvaleukin alfa (nemvaleukin), the company’s novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium. The presentation included updated data from the monotherapy arm of ARTISTRY-1 in patients with advanced renal cell carcinoma (RCC), including patients who were checkpoint inhibitor-pretreated.
In March 2022, the company presented nemvaleukin data from ARTISTRY-1 in patients with platinum-resistant ovarian cancer (PROC) in an oral plenary session at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting on Women’s Cancer. The company also presented a trial-in-progress poster from the ongoing phase 3 ARTISTRY-7 global study evaluating the efficacy, safety and tolerability of IV nemvaleukin in combination with pembrolizumab compared to investigator’s choice chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer.
Psychiatry

In April 2022, the company presented new research from its psychiatry portfolio at the 2022 Congress of the Schizophrenia International Research Society (SIRS). The presentations included detailed results from the recently completed ENLIGHTEN-Early study of LYBALVI (olanzapine and samidorphan), a phase 3b study that evaluated the effect of LYBALVI compared to olanzapine on body weight in young adult patients (ages 16 to 39; mean age: 26 years) with schizophrenia, schizophreniform disorder or bipolar I disorder who were early in their illness.
Other

In April 2022, the company commenced binding arbitration proceedings related to, among other things, Janssen’s partial termination of two license agreements with the company in the U.S. and Janssen’s royalty and other obligations under the agreements. Under these agreements, Janssen received access and rights to Alkermes’ small particle pharmaceutical compound technology, known as NanoCrystal Technology, which enabled the development and commercialization of a number of successful products, such as INVEGA SUSTENNA, INVEGA TRINZA, INVEGA HAFYERA and CABENUVA. Janssen partially terminated these agreements in the United States effective as of February 2022.
Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, April 27, 2022, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Wednesday, April 27, 2022, through Wednesday, May 4, 2022, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13727838.