On December 15, 2021 Helix BioPharma Corp. (TSX: "HBP"), ("Helix" or the "Company"), a clinical-stage biopharmaceutical company developing unique therapies in the field of immuno-oncology based on its proprietary technological platform DOS47, reported fiscal 2022 first quarter results for the period ending October 31, 2021 (Press release, Helix BioPharma, DEC 15, 2021, View Source [SID1234597368]).

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OVERVIEW
The Company reported a net loss and total comprehensive loss for the three-month period ended October 31, 2021, of $1,813,000 (2020-$222,000). Net loss and comprehensive loss for the three-month period ending October 31, 2020, included a gain from loss of control in Helix Immuno-Oncology S.A. ("HIO") of $2,162,000. Clinical development

 Phase I combination therapy study in lung cancer (LDOS001):
 Final clinical study report expected to be completed by the end of December 2021;
 Phase II combination therapy trial in lung cancer (LDOS003):  Final clinical study report expected to be completed in March 2022 provided the Company settles a contractual disagreement with the clinical research organization engaged to oversee the study.

 The Company ceased patient enrolment into the trial in 2020 and proceeded to data analysis.  As previously announced, the Company will not be advancing the randomized portion of the study without third-party partner funding. To date, no third-party partner has been identified.  Phase Ib/II combination trial in pancreatic cancer (LDSOS006):  On November 15, 2021, the Company applied for a revision to the clinical protocol to the U.S. Food and Drug Administration ("FDA").

 L-DOS47 immunotherapy chemo combination study in lung cancer:  The Company engaged key opinion leaders on the feasibility and design of a possible immunotherapy chemo combination clinical study. The Company is not currently in a position to make a submission to the FDA regarding the potential clinical study.  Clinical drug product strategic review:  The Company hired biotechnology consults to assess the Company’s drug product candidate with a focus on identifying value propositions and positioning strategies that would enable clinical adoption of L-DOS47. This engagement includes input from key opinion leaders on the positioning of possible combination therapies and the prioritization of current and/or any additional clinical indications. The Company expects the consulting firm’s report to be finalized by the end of December 2021. Corporate development

 On August 19, 2021, the Company announced that Dr. Krzysztof Saczek had been appointed as a member of the board of directors of the Company (the "Board") effective immediately in connection with the resignation of Dr. Heman Chao as CEO, CSO and as a member of the Board. Mr. Chao’s resignation became effective on September 1, 2021 and assumed the position of Chair of the Company’s Scientific Advisory Board on the same date.

1  On September 20, 2021, the Company announced the appointment of the company’s Chairman, Dr. Slawomir Majewski, as Interim Chief Executive Officer to hold office while the Board worked to identify and evaluate potential candidates as permanent CEO. Research and development Research & development expenses for the three-month period ended October 31, 2021, totalled $1,249,000 (2020 – $1,084,000). Research and development expenditures in the three-month period ended October 31, 2021, when compared to the three-month period ended October 31, 2020, were higher by $165,000.

The increase is mainly the result of higher third-party research and development consulting services of $163,000 in addition to higher contact manufacturing services of $267,000 which were offset by lower clinical operations spend of $213,000. The Company hired biotechnology consults to assess the Company’s drug product candidate with a focus on identifying value propositions and positioning strategies that would enable clinical adoption of L-DOS47. This engagement includes broad clinical development key opinion leader input on the positioning of possible combination therapies and the prioritization of current and/or any additional clinical indications. The Company expects the consulting firm’s report to be finalized by the end of December 2021. The increase in manufacturing spend is the result of new production lot of Polysorbate 80 and increased stability and assay activity from recently repolished old drug substance and lyophilization of new drug product. Lower clinical operations spend is mainly the result of analytical method development spend incurred in the comparative prior year’s quarter related to LDOS006, the Company’s Phase Ib/II combination trial for pancreatic cancer. Operating, general and administration Operating, general and administration expenses for the three-month period ended October 31, 2021, totalled $447,000 (2020-$1,303,000).

Operating, general and administration expenditures in the three-month period ended October 31, 2021, when compared to the three-month period ended October 31, 2020, were lower by $856,000. The decrease is mainly the result of expenses associated with various third-party advisory services such as legal, accounting and investment banking of $210,00 incurred in the comparative prior year’s quarter related to the Company’s attempt to raise additional capital as part of a qualifying transaction to list on the Nasdaq; lower investor relations spend of $287,000 as a result of the termination of the agreement on October 21, 2020 the Company had in place with ACM Alpha Consulting Management EST ("ACMest"); and lower stock-based compensation expense of options granted to directors of the Company over their vesting period of $355,000.

2 LIQUIDITY AND CAPITAL RESOURCES
The Company reported a net loss and total comprehensive loss for the three-month period ended October 31, 2021, of $1,813,000 (2020-$222,000). As at October 31, 2021 the Company had working capital deficiency of $1,493,000, shareholders’ deficiency of $2,730,000 and a deficit of $190,367,000. As at July 31, 2021, the Company had working capital of $144,000, shareholders’ deficiency of $1,393,000, a deficit of $188,554,000. In order for the Company to advance the currently planned preclinical and clinical research and development activities, its collaborative scientific research programs and pay for its overhead costs, the Company will need to raise approximately $15,000,000 through to the end of fiscal 2023.

The Company’s cash reserves of $1,873,000 as at October 31, 2021 are insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months, nor are they sufficient to see planned research and development initiatives through to completion. To the extent that the Company does not believe it has sufficient liquidity to meet its current obligations, management considers securing additional funds, preferably through the issuance of equity securities of the Company, to be critical for its development needs. The Company may also consider other forms of raising funds, such as the issuance of debt which may or may not include a conversion of equity in the Company. The Company’s long-term liquidity depends on its ability to raise funds from various sources, which depends substantially on the success of its ongoing research and development programs, economic conditions and the state of the biotech industry

On December 15, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that it has completed its previously announced initial public offering (STAR Offering) on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange (SSE) (Press release, BeiGene, DEC 15, 2021, View Source [SID1234597365]). The shares offered in the STAR Offering were issued to and subscribed for by permitted investors in the People’s Republic of China (PRC) in Renminbi (RMB Shares). The RMB Shares began trading on the STAR Market under the stock code "688235" on December 15, 2021, China time, making BeiGene the first triple-listed biotechnology company on NASDAQ, the Hong Kong Stock Exchange (HKEx), and the STAR Market.

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The total number of shares offered in the STAR Offering is 115,055,260 ordinary shares, par value $0.0001 per share, which represents 8.62% of BeiGene’s total outstanding ordinary shares as of October 31, 2021, after giving effect to the shares offered. The public offering price of the RMB Shares is RMB192.60 per ordinary share, which equates to HK$234.89 per ordinary share and US$391.68 per American Depositary Share (ADS), based on an assumed exchange rate of RMB0.81996 to HK$1.00 and RMB6.3924 to US$1.00. Each ADS represents 13 ordinary shares.

The gross proceeds to BeiGene from the STAR Offering, before deducting underwriting commissions and other estimated offering expenses, are approximately RMB22.2 billion, or approximately US$3.5 billion, based on an assumed exchange rate of RMB6.3924 to US$1.00.

China International Capital Corporation Limited and Goldman Sachs Gao Hua Securities Company Limited acted as joint sponsors and joint bookrunners for the STAR Offering. J.P. Morgan Securities (China) Company Limited, CITIC Securities Co., Ltd. and Guotai Junan Securities Co., Ltd. acted as joint bookrunners for the STAR Offering.

BeiGene has granted China International Capital Corporation Limited a 30-day overallotment option for up to 17,258,000 additional RMB Shares. If the over-allotment option is fully exercised, the total number of shares offered in the STAR Offering will be 132,313,260 Shares, which represents 9.79% of BeiGene’s total outstanding ordinary shares as of October 31, 2021, after giving effect to the shares offered.

BeiGene expects to use the net proceeds from the STAR Offering to fund its research and clinical development, construction of its research and development centers and a manufacturing plant in China, sales and marketing force expansion in China, and for working capital and general corporate purposes.

In accordance with applicable PRC laws and regulations, the STAR Offering is conducted solely within the PRC and only to permitted investors who are eligible to participate in the STAR Offering in accordance with applicable PRC securities laws and regulations, and rules promulgated by the SSE and the China Securities Regulatory Commission (CSRC). The STAR Offering is conducted pursuant to a prospectus and other offering materials prepared by BeiGene in Chinese language and as approved by and registered with the SSE and the CSRC, which are only permitted to be used within the PRC. No part of the STAR Offering is intended to involve a public offering or sale of the RMB Shares into or in the United States or any other jurisdiction outside of the PRC. In addition, although the RMB Shares are of the same class and have the same rights as the Company’s existing ordinary shares listed on the HKEx, the RMB Shares will not be fungible with the ordinary shares listed on the HKEx or the Company’s ADSs representing its ordinary shares listed on the NASDAQ Global Select Market (NASDAQ), and in no event will any RMB Shares be able to be converted into ordinary shares listed on the HKEx or ADSs listed on NASDAQ, or vice versa.

An automatically effective shelf registration statement on Form S-3 was filed with the Securities and Exchange Commission (SEC) on May 11, 2020. A prospectus supplement relating to and describing the key terms of the STAR Offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. The purpose of the prospectus supplement is to register all RMB Shares offered in the STAR Offering under the Securities Act of 1933, as amended (Securities Act) to ensure that the offer and sale of the RMB Shares, if any, to permitted investors who are U.S. persons (as defined in Regulation S under the Securities Act) in transactions outside the United States will not violate the registration requirements under Section 5 of the Securities Act.

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 offer or sale of these securities in any state or 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 jurisdiction. This press release is being issued pursuant to, and in accordance with, Rule 134 under the Securities Act.

On December 15, 2021 Eli Lilly and Company (NYSE: LLY) reported that extensive updates across its research and development (R&D) programs to highlight the company’s strong pipeline and potential for future growth (Press release, Eli Lilly, DEC 15, 2021, View Source [SID1234597298]). At an investment community meeting today, the company is sharing key information across its four therapeutic areas – including pipeline updates and future R&D investments – along with 2022 financial guidance and updated 2021 guidance.

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The company is on track to meet its goal of launching 20 new medicines over the 10-year period from 2014 to 2023. Over the last eight years, Lilly has delivered 16 new medicines and plans to launch five more medicines over the next two years, if approved, including tirzepatide, donanemab, pirtobrutinib, lebrikizumab and mirikizumab. These potential launches contribute to the company’s expectations for top-tier, volume-driven growth over the next decade, as the number of people that can benefit from Lilly’s innovative new medicines continues to increase.

"Lilly’s accomplishments in recent years are impressive, but it’s where we are going that most excites us. We’ve driven results over the last four years, successfully launched new medicines, and invested in high-impact R&D that has set us up for a truly exciting new era," said David A. Ricks, Lilly’s chairman and CEO. "Bringing new practice-changing medicines to patients is our top priority. We have a remarkable opportunity ahead of us to make life better for millions more people around the world."

The company is providing details on its diabetes and obesity, immunology, oncology and neuroscience R&D programs, sharing a number of new pipeline updates and previously undisclosed data. Lilly also will provide insight into its ongoing R&D investments that reflect the company’s conviction around key emerging trends in biopharma innovation.

"I’m very optimistic about the future for Lilly and the patients we serve. In addition to our promising late-stage pipeline, our labs are making new discoveries to bring life-changing medicines to patients who need them," said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories. "Lilly has significantly improved our development speed and clinical success rates and will continue to apply this focus as we work to maximize the impact of our existing medicines and create new ones.

"Genetic medicines, including modalities such as RNA therapeutics and viral-delivered gene therapies, are poised to contribute to the next generation of breakthrough treatments for a wide array of diseases," Skovronsky continued. "Today, Lilly will share more about our new capabilities and increased investment in this space, along with new preclinical and clinical data for genetic medicines in our neuroscience and cardiovascular disease research portfolios."

Diabetes and Obesity
Building on its historic foundation of helping people with diabetes, Lilly is expanding its strategic focus to breakthrough medications that disrupt the disease cascade caused by obesity and type 2 diabetes progression, highlighted by tirzepatide and supported by several early-phase incretin assets.

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Lilly’s New Drug Application and Marketing Authorization Application, respectively, for tirzepatide for the treatment of adults with type 2 diabetes. Lilly also submitted tirzepatide to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and in six additional markets. Lilly plans to initiate additional tirzepatide studies that include phase 3 studies in obesity related outcomes and obstructive sleep apnea, as well as a phase 2 mechanism of action study in kidney disease.

Lilly is disclosing new data from several assets in its robust early-phase incretin platform focused on obesity. The company’s incretin platform is focused on delivering therapeutics with bariatric surgery-like weight loss with related metabolic benefits and developing convenient, easy-to-use oral incretins.

As it has for nearly 100 years, Lilly continues to work to transform diabetes care through insulin innovation. Lilly’s novel weekly insulin is on track to progress to phase 3 studies in 2022, and the company is advancing a new generation of insulin medicines with its pre-clinical efforts in glucose-sensing insulin.

Immunology
Over the last decade, Lilly has established a presence in immunology, with Taltz and Olumiant addressing patient needs across dermatology and rheumatology. Positive late-stage readouts in 2021 for mirikizumab in moderate-to-severely active ulcerative colitis and lebrikizumab in moderate-to-severe atopic dermatitis provide the potential to help even more patients suffering from disease.

In addition, Lilly has built a deep early-and mid-stage portfolio of novel immunology opportunities that represent potential first-in-class or best-in-class assets from both internal and external innovation. Lilly is sharing new data from several of these molecules, including proof of concept phase 1b atopic dermatitis data for its IL-2 conjugate, in collaboration with Nektar Therapeutics, and is announcing plans to move into additional phase 2 studies.

Oncology
Propelled by the acquisition of Loxo Oncology, Lilly has established a renewed presence in oncology, with a portfolio focused on high-conviction assets. The company’s oncology portfolio, including Verzenio, Retevmo and pirtobrutinib, has the potential to deliver meaningful growth over the course of the decade.

Lilly initiated a rolling submission to the FDA for pirtobrutinib, seeking accelerated approval in mantle cell lymphoma, with expectations to complete the submission in 2022 and regulatory action anticipated in early 2023. Lilly continues to invest to maximize the potential of Verzenio for patients, and intends to initiate a phase 3 study to evaluate earlier treatment of prostate cancer in mid-2022.

The company also is providing an overview of several promising early-phase and pre-clinical programs that are expected to deliver new data and potential new trials starting in 2022.

Neuroscience
Lilly is an established leader in neuroscience with a more than 30-year commitment to advancing Alzheimer’s disease research. The company is focused on its work to slow, then halt and eventually prevent age-related neurodegeneration in the decades ahead.

Lilly is providing new biomarker data from donanemab from the phase 2 TRAILBLAZER-ALZ study. Lilly initiated a rolling submission for donanemab to the FDA for accelerated approval in early Alzheimer’s disease, which it expects to complete in the coming months, likely by the end of the first quarter.

The company is also sharing phase 1 data from its next-generation amyloid-lowering antibody, N3PG-IV, noting plans to move this antibody into pivotal trials in 2022. The company has a number of early phase and pre-clinical programs for Alzheimer’s and other neurodegenerative diseases with novel targets and new modalities and is highlighting the significant growth in its early pain pipeline.

Strong Financial Outlook Fueled by New Innovative Medicines
"We believe the continued uptake of our key growth products – which we expect will account for more than two-thirds of core business revenue in 2022 – coupled with our anticipated upcoming launches will allow Lilly to deliver top-tier, volume-driven revenue growth through at least 2030," said Anat Ashkenazi, Lilly senior vice president and chief financial officer. "Lilly remains committed to prioritizing long-term growth, as we maintain significant investment in our exciting pipeline, fund new launches to ensure we can reach more patients in the coming years and continue to expand operating margin."

Updated 2021 Financial Guidance
The company has updated certain elements of its 2021 financial guidance on both a reported and non-GAAP basis. Earnings per share for 2021 are now expected to be in the range of $6.18 to $6.23 on a reported basis and $8.15 to $8.20 on a non-GAAP basis. The company’s 2021 financial guidance reflects adjustments shown in the reconciliation table below.

On December 15, 2021 Almac Discovery , the research driven drug discovery company, is delighted that Debiopharm, a Swiss biopharmaceutical company, reported that it has launched a dose escalation trial to assess the safety and preliminary anti-tumour activity of Debio 0123 as a monotherapy in patients with advanced solid tumours (NCT05109975) (Press release, Almac, DEC 15, 2021, View Source [SID1234597285]). Debio 0123 is an oral, potent and highly selective WEE1 inhibitor initially discovered by Almac Discovery and in-licensed by Debiopharm in 2017.

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Part of an emerging new class of drugs working within the DNA damage response (DDR) pathway, the compound’s anti-tumour capacity has been evaluated in several preclinical studies along with the ongoing phase I study in combination with carboplatin-based chemotherapy. This new trial’s primary objective is to identify the maximum tolerated dose and/or recommended phase II dose in a¬¬dults with advanced solid tumours that have recurred or progressed after prior therapy and/or for whom no standard therapy of proven benefit is available.

The evaluation of Debio 0123 as monotherapy could help to better characterize the safety and efficacy profile of the compound in a clinical setting and define the parameters for eventual phase II research. Pre-clinical research highlights its potential for efficacy in cancer patients, particularly in combination with DNA damaging agents such as chemo- and radiotherapy. Debiopharm plans to advance the clinical program while simultaneously negotiating potential partnerships, such as during the upcoming JP Morgan 2022 conference, with larger pharmaceutical companies for eventual commercialization.

Dr Stephen Barr, Managing Director & President, Almac Discovery commented, "Since the discovery of our highly selective WEE1 inhibitor, now known as Debio 0123, we have looked forward with anticipation to understanding its potential therapeutic benefit for cancer patients across the globe. We are therefore delighted that, in addition to the ongoing combination clinical study, Debio 0123 is also being evaluated as a monotherapy in the treatment of advanced solid tumours. We look forward to seeing further progress from this ongoing clinical research."

"We’re intrigued to learn more about the clinical benefits that WEE1 inhibition with Debio 0123 alone could offer cancer patients. We believe that this new modality can effectively exploit the genomic instability and malfunctioning of the DNA repair process in cancer cells in hopes that ultimately tumour progression is halted and patient survival is improved," added Dr. Esteban Rodrigo Imedio, Senior Medical Director, Oncology Research & Development, Debiopharm. "As Debio 0123 is highly selective against WEE1, in time, ongoing clinical research could confirm Debio 0123’s potential best-in-class status."

On December 15, 2021 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio" or the "Company"), a biopharmaceutical company pioneering Tissue Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported the pricing of its initial public offering of 4,200,000 shares of its common stock at a public offering price of $5.00 per share, for gross proceeds of $21,000,000 before deducting underwriting discounts, commissions and offering expenses (Press release, Immix Biopharma, DEC 15, 2021, View Source [SID1234597262]). In addition, ImmixBio has granted the underwriters a 45-day option to purchase up to an additional 630,000 shares of common stock solely to cover over-allotments. The shares of common stock are expected to begin trading on the Nasdaq Capital Market under the ticker symbol "IMMX" on December 16, 2021. The offering is expected to close on December 20, 2021, subject to satisfaction of customary closing conditions.

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The net proceeds from the initial public offering will be used to fund a planned IMX-110 Phase 2a clinical trial in soft tissue sarcoma and IMX-110 + tislelizumab Phase 1b combination trial, for IND-enabling studies for IMX-111 (colorectal cancer) and IMX-120 (inflammatory bowel disease), and for working capital and other general corporate purposes.

ThinkEquity is acting as the sole book-running manager for the offering.

The registration statement on Form S-1 (file No. 333-259591) relating to the shares being sold in this offering has been filed with the U.S. Securities and Exchange Commission and became effective on December 15, 2021. A final prospectus related to the proposed offering will be filed and made available on the SEC’s website at View Source The offering is being made only by means of a prospectus. Electronic copies of the final prospectus may be obtained, when available, from ThinkEquity, 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 and by email at [email protected].

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 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.