On February 28, 2022 ​Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), reported that Hugh Y. Rienhoff, Jr., M.D., Imago’s Chief Executive Officer, will participate in the Cowen 42nd Annual Health Care Conference, taking place March 7-9, 2022 (Press release, Imago BioSciences, FEB 28, 2022, View Source [SID1234609130]).

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Dr. Rienhoff is scheduled to participate in the "Leukemias and Myeloproliferative Neoplasms" corporate panel discussion, on Monday, March 7, at 10:30 a.m. Eastern Time.

Interested parties can access the live webcast for this conference from the Investor Relations section of the company’s website at www.imagobio.com. The webcast replay will be available after the conclusion of the panel discussion for approximately 30 days.

On February 28, 2022 Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called "cytokine storm" with its lead drug candidate, lenzilumab, reported financial results for the year ended December 31, 2021, and announced corporate objectives for 2022 (Press release, Humanigen, FEB 28, 2022, View Source [SID1234609129]).

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Cameron Durrant, chairman and chief executive officer of Humanigen stated, "We initiated the development of lenzilumab, or LENZ, in May 2020 as a treatment for hypoxic COVID-19 patients. The virus and the treatment landscape continue to evolve. We believe that COVID-19 will become a serious endemic disease and will continue to impact society, healthcare systems and patients and that, if authorized or approved by regulatory agencies, LENZ, a variant-agnostic immunomodulatory antibody, could address a significant unmet need in COVID-19 for the foreseeable future. Humanigen made significant progress in developing lenzilumab over the last year, highlighted by the completion of our phase 3 study of lenzilumab in COVID-19, LIVE-AIR, and the publication of positive results from the study in The Lancet Respiratory Medicine, a world-renowned, peer-reviewed journal."

"We look forward to the announcement of the topline data from a second phase 2/3 study of lenzilumab in COVID-19, the ACTIV-5/BET-B study conducted by the National Institutes of Health, in late Q1 or early Q2. If results from ACTIV-5/BET-B in patients with a baseline C-reactive protein level less than 150mg/L build on the data from LIVE-AIR published in The Lancet, we plan to prepare and submit an amendment to our application for emergency use authorization for lenzilumab in hospitalized COVID-19 patients to the FDA, as well as regulatory submissions in the European Union and United Kingdom," Dr. Durrant continued.

Lenzilumab is an investigational product and is not currently authorized or approved in any country.

Highlights over the past year include:

Lenzilumab in COVID-19 patients

Completed the LIVE-AIR study, which showed that patients who received lenzilumab and other treatments, including steroids and/or remdesivir, had a 54% greater relative likelihood of survival without the need for invasive mechanical ventilation compared with patients receiving standard of care and placebo.
Positive results of the LIVE-AIR study were published in The Lancet Respiratory Medicine, https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00494-X/fulltext. The Lancet publication concluded that lenzilumab treatment of patients with COVID-19 can improve the likelihood of survival without the need for mechanical ventilation, with a safety profile comparable to placebo.
Completed enrollment of the Phase 2/3 ACTIV-5/BET-B study, sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and enrolled over 400 patients in the primary analysis population (patients with a C-reactive protein level at baseline of less than 150mg/L).
FDA has guided that, if the trial is successful, the company can include the results from ACTIV-5/BET-B in an amended Emergency Use Authorization (EUA) submission for lenzilumab for the treatment of patients with COVID-19.
Lenzilumab in DLBCL, NHL, aGvHD, and CMML

Announced positive data from the Phase 1b portion of ZUMA-19, evaluating the efficacy and safety of lenzilumab in patients treated with CAR-T in diffuse large B-cell lymphoma (DLBCL). At the recommended Phase 2 dose of lenzilumab, the overall response rate (ORR) was 100% and no patient experienced severe neurotoxicity (NT) or severe cytokine release syndrome (CRS).
FDA provided guidance on the registration pathway for lenzilumab for the prevention of CAR-T therapy related toxicities including Immune Effector Cell-Associated Neurotoxicity (ICANS), which Humanigen intends to study in the registrational Phase 3 SHIELD study.
Planning to enroll the first patient in the first half of 2022 in a Phase 2/3, potentially registrational study (the RATinG study) to evaluate lenzilumab in the treatment of aGvHD at IMPACT Partnership stem cell transplant centers across the UK.
First patient dosed in Phase 2 study of lenzilumab (the PREACH-M study) in patients with Chronic Myelomonocytic Leukemia (CMML), sponsored by the company’s Australian partners.
2022 Objectives Include:

Announcing topline results from ACTIV-5/BET-B in COVID-19
Filing amended EUA with FDA for lenzilumab in COVID-19 in the US
Responding to MHRA requests for additional information on lenzilumab for the CMA in COVID-19 in the UK
Filing CMA for lenzilumab in COVID-19 under Accelerated Approval with EMA in the EU
Commencing shipments under LenzMAP, the lenzilumab managed access program for COVID-19 in the UK and multiple European countries
Continuing enrollment in the PREACH-M CMML study in Australia
Initiating the SHIELD Phase 3 registrational CAR-T study in the US
Initiating the RATinG Phase 2/3 potentially registrational aGvHD study in the UK
Initiating the C-SMART (COVID in cancer patients) study in Australia
Year Ended December 31, 2021 Financial Results

Net loss for the year ended December 31, 2021 was $236.6 million or $4.04 per share as compared to $89.5 million or $2.42 per share for the year ended December 31, 2020. The increase in net loss for the year was due to an increase in total expenses, mainly Research and Development (R&D) expense. R&D expense increased $140.4 million from $72.7 million for the year ended December 31, 2020, to $213.1 million for the year ended December 31, 2021. The increase is primarily due to an increase of $143.9 million in lenzilumab manufacturing costs, including consulting fees, and a $1.7 million increase in internal costs, primarily compensation-related, partially offset by a $5.2 million reduction in clinical trial expenses for lenzilumab.

Cash and Cash Equivalents

Net cash used in operating activities, net of balance sheet changes, was $184.0 million for the year ended December 31, 2021. During the year ended December 31, 2021, the company raised net proceeds of $65.7 million from the sale of shares of common stock under its At-the-Market offering program, drew $25.0 million under its credit facility with Hercules Capital, which provided net proceeds of $24.4 million, and completed a public offering of common stock with net proceeds of $94.2 million. As of December 31, 2021, the company had cash and cash equivalents of $70.0 million. Subsequent to December 31, 2021, the company raised net proceeds of approximately $3.7 million under its At-the-Market offering program.

A summary of key financial highlights as of and for the years ended December 31, 2021 and 2020 is as follows ($ in thousands):

On February 28, 2022 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported financial results for the three and twelve months ended December 31, 2021 and highlighted recent corporate updates (Press release, Heron Therapeutics, FEB 28, 2022, View Source [SID1234609128]).

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Recent Corporate Updates

Acute Care Franchise

ZYNRELEF:

The ZYNRELEF (bupivacaine and meloxicam) extended-release solution New Drug Application (NDA) was approved by the U.S. Food and Drug Administration (FDA) in May 2021. In December 2021, the FDA approved our supplemental New Drug Application (sNDA) for ZYNRELEF, which significantly expanded the indication statement, now covering approximately 7 million procedures annually. ZYNRELEF is currently indicated for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. The FDA also agreed to Heron’s proposal for a second sNDA, planned for later this year, designed to further expand the indication statement.

ZYNRELEF became commercially available in the U.S. on July 1, 2021, and net product sales for the three and twelve months ended December 31, 2021 were $0.8 million and $2.9 million, respectively.

During the first two quarters of commercial launch ended December 31, 2021, over 300 unique accounts purchased ZYNRELEF with 70% of those accounts reordering the product. ZYNRELEF end-user (hospitals and ambulatory surgical centers (ASC)) demand units’ volume sales increased by 126% in the fourth quarter over the prior quarter.

As of February 25, 2022, ZYNRELEF has received 260 formulary approvals, with over a 90% hospital approval rate, and over 60% of formulary approvals have been for unrestricted use. Over 100 additional formulary review meetings are scheduled through March 31, 2022.

Multiple commercial and Medicaid payers covering over 120 million lives have agreed to reimburse ZYNRELEF outside of the surgical bundle payment for surgeries performed in ASCs, with many of these covered lives also having their hospital outpatient procedures reimbursed outside the surgical bundle payment. Commercial and Medicaid payers represent more than 80% of our target patients in the outpatient setting. On November 2, 2021, we were issued a specific C-code (C9088) for separate reimbursement in the ASC setting of care effective January 1, 2022.

In the fourth quarter of 2021, Heron received FDA approval of two manufacturing supplements to the NDA for ZYNRELEF to add a large-scale secondary supplier of our proprietary polymer and to add larger-scale manufacturing of ZYNRELEF. These approvals will allow for the manufacturing of millions of doses of ZYNRELEF annually at a significantly reduced cost of products sales.

NDA Submission for HTX-019 for Prevention of PONV in Adults Under Review: A 505(b)(2) NDA for HTX-019 for the prevention of postoperative nausea and vomiting (PONV) in adults was submitted to the FDA in November 2021. The FDA accepted the NDA for filing and set a Prescription Drug User Fee Act (PDUFA) goal date of September 17, 2022.
Oncology Care Franchise

2021 Oncology Care Franchise Net Product Sales: For the three and twelve months ended December 31, 2021, oncology care franchise net product sales were $19.9 million and $83.4 million, respectively, compared to $20.6 million and $88.6 million, respectively, for the same periods in 2020. During 2021, Heron’s oncology care franchise net product sales have stabilized with moderate growth expected in 2022.
CINVANTI

Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and twelve months ended December 31, 2021 were $17.4 million and $73.5 million, respectively, compared to $20.3 million and $87.8 million, respectively, for the same periods in 2020.

In the fourth quarter of 2021, Heron received FDA approval of a manufacturing supplement to the NDA for CINVANTI to add larger-scale manufacturing of CINVANTI. This approval will significantly reduce the cost of products sales.
SUSTOL

Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and twelve months ended December 31, 2021 were $2.5 million and $9.9 million, respectively, compared to $0.3 million and $0.8 million, respectively, for the same periods in 2020.

2022 Oncology Care Franchise Net Product Sales Guidance: Heron currently expects the first quarter of 2022 net product sales for the oncology care franchise in the range of $20 million to $22 million. The Company is not providing full-year 2022 financial guidance at this time due to the uncertainty around the COVID-19 pandemic and its impact on patient care.
"2021 was a tremendous year for Heron. The approval and successful commercial launch of ZYNRELEF was a game-changing milestone for patients, healthcare providers, and pain management. We are extremely pleased with the very positive feedback from patients and surgeons about the benefits of ZYNRELEF, which has resulted in a high reorder rate. With our new broader label for ZYNRELEF and the recent rapid decline of COVID, we expect to significantly expand ZYNRELEF’s commercial footprint this year," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "In oncology care, our CINV portfolio has stabilized and is poised for sales growth in 2022."

Financial Results

Net product sales for the three and twelve months ended December 31, 2021 were $20.7 million and $86.3 million, respectively, compared to $20.6 million and $88.6 million, respectively, for the same periods in 2020.

Heron’s net loss for the three and twelve months ended December 31, 2021 was $54.6 million and $220.7 million, or $0.54 per share and $2.24 per share, respectively, compared to $62.3 million and $227.3 million, or $0.68 per share and $2.50 per share, respectively, for the same periods in 2020. Net loss for the three and twelve months ended December 31, 2021 included non-cash, stock-based compensation expense of $12.9 million and $46.9 million, respectively, compared to $16.0 million and $50.2 million, respectively, for the same periods in 2020.

As of December 31, 2021, Heron had cash, cash equivalents and short-term investments of $157.6 million, compared to $208.5 million as of December 31, 2020. Net cash used for operating activities for the year ended December 31, 2021 was $203.4 million, compared to $184.8 million for the same period in 2020. The increase in our net cash used for operating activities was primarily due to changes in working capital related to the launch of ZYNRELEF in July 2021, including manufacturing of commercial inventory. We expect net cash used for operating activities of $44 million to $48 million in the first quarter of 2022. We anticipate that our net cash usage will continue to moderate lower throughout 2022 as net product sales increase and we realize cost savings from anticipated larger-scale manufacturing.

Conference Call and Webcast

Heron will host a conference call and webcast on February 28, 2022 at 4:30 p.m. ET. The conference call can be accessed by dialing 877-311-5906 for domestic callers and 281-241-6150 for international callers. Please provide the operator with the passcode 9276143 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron’s website for 60 days following the call.

About ZYNRELEF for Postoperative Pain

ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first modified-release local anesthetic to be classified by the FDA as an "extended-release" product because ZYNRELEF is also the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF’s indication. ZYNRELEF is now indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. In September 2020, the European Commission granted a marketing authorization for ZYNRELEF for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. As of January 1, 2021, ZYNRELEF is approved in 31 European countries including the countries of the European Union and European Economic Area and the United Kingdom.

Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.

About HTX-019 for PONV

HTX-019 is an IV injectable emulsion formulation designed to directly deliver aprepitant, the active ingredient in EMEND (aprepitant) capsules, which is the only substance P/neurokinin-1 (NK1) receptor antagonist (RA) to be approved in the U.S. for the prevention of PONV in adults. The FDA-approved dose of oral EMEND is 40 mg for PONV prevention, which is given within 3 hours prior to induction of anesthesia for surgery. In a Phase 1 clinical trial, 32 mg of HTX-019 as a 30-second IV injection was demonstrated to be bioequivalent to oral aprepitant 40 mg. The NDA for HTX-019 for PONV was submitted in November 2021 and the FDA set a PDUFA goal date of September 17, 2022.

About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL for CINV Prevention

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

On February 28, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) reported financial results for the three months and full-year ended December 31, 2021 and provided an update on key milestones (Press release, Lexicon Pharmaceuticals, FEB 28, 2022, View Source [SID1234609127]).

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"We remain focused on advancing sotagliflozin for the millions of people suffering from heart failure and living with type 2 diabetes on a daily basis. We announced today that we voluntarily withdrew the sotagliflozin NDA to correct a technical issue that we recently identified, and we plan to promptly resubmit early in the second quarter of 2022," said Lonnel Coats, Lexicon’s chief executive officer. "In addition, we are looking forward to completing and announcing top-line results in the coming months from our two proof-of-concept Phase 2 studies of LX9211 in diabetic peripheral neuropathic pain and post-herpetic neuralgia."

Fourth Quarter Highlights

Sotagliflozin

Lexicon submitted a New Drug Application (NDA) to the FDA at the end of the fourth quarter of 2021 seeking approval for the marketing and sale of sotagliflozin, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular ejection fraction. Today, Lexicon announced its voluntary withdrawal and planned near-term resubmission of the NDA to correct a technical issue with the submission recently identified by the company.
A new analysis evaluating the clinical benefit of sotagliflozin in heart failure and blood glucose control across the full range of kidney function was presented at the American Heart Association Scientific Sessions 2021. Sotagliflozin significantly reduced total cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure, as well as decreased hemoglobin A1c, across the full range of kidney function studied, including individuals with moderate-to-severe chronic kidney disease.
LX9211

Patient enrollment continued in two ongoing Phase 2 clinical studies of LX9211: RELIEF-DPN-1 for the treatment of diabetic peripheral neuropathic pain and RELIEF-PHN-1 for the treatment of post-herpetic neuralgia. Lexicon anticipates completing recruitment this week for RELIEF-DPN-1 and expects top-line results for the study by the end of the second quarter of 2022. Top-line results for RELIEF-PHN-1 are expected in the third quarter of 2022.
Fourth Quarter and Full-Year 2021 Financial Highlights

Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2021 compared to the fourth quarter and full year of 2020.

Revenues: Revenues were negligible for the fourth quarters of 2021 and 2020. Full-year revenues were negligible in 2021 as compared to $24.0 million for 2020, primarily due to the absence of product revenues in 2021 as a result of Lexicon’s sale of its XERMELO product and related assets to TerSera Therapeutics LLC during the third quarter of 2020.

Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2021 increased to $16.5 million from $1.0 million for the corresponding period in 2020. The R&D expense in the fourth quarter of 2020 reflected a reduction in external clinical development cost estimates primarily related to sotagliflozin R&D expenses. Full-year R&D expenses decreased to $55.0 million in 2021 from $153.6 million in 2020, primarily due to lower sotagliflozin clinical external research expenses, partially offset by higher LX9211 clinical external research expenses.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2021 increased to $8.8 million from $6.4 million for the corresponding period in 2020, primarily due to higher legal fees during the quarter. Full-year SG&A expenses for 2021 decreased to $32.3 million from $47.2 million, primarily due to lower salaries and benefits and marketing costs.

Gain on Sale of XERMELO: A gain of $132.6 million was recognized during 2020 from the sale of XERMELO and related assets to TerSera in September 2020.

Net Income (Loss): Net loss for the fourth quarter of 2021 was $25.6 million, or $0.17 per share, as compared to a net loss of $5.5 million, or $0.04 per share, in the corresponding period in 2020. For the fourth quarter of 2021 and 2020, net loss included non-cash, stock-based compensation expense of $2.2 million and $2.7 million, respectively. Net loss for the full-year was $87.8 million, or $0.60 per share, in 2021 as compared to a net loss of $58.6 million, or $0.53 per share, in 2020. For the full years of 2021 and 2020, net loss included non-cash, stock-based compensation expense of $10.6 million and $13.3 million, respectively.

Cash and Investments: As of December 31, 2021, Lexicon had $86.7 million in cash and investments, as compared to $152.3 million as of December 31, 2020.

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 8:00 am ET / 7:00 am CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 8051406. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.

On February 28, 2022 Heidelberg Pharma AG (FSE: HPHA) and Huadong Medicine Co., Ltd., Hangzhou, China, (SZ 000963; Huadong) reported that the companies have entered into a strategic partnership with the signing of an exclusive licensing agreement as well as an investment agreement (Press release, Heidelberg Pharma, FEB 28, 2022, View Source [SID1234609125]). The agreements were concluded with wholly owned subsidiaries of Huadong, one of the leading pharmaceutical companies in China with a focus on oncology and ADC research, development and commercialization.

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Dr. Jan Schmidt-Brand, CEO and CFO of Heidelberg Pharma, commented: "We are excited to enter this major partnership with Huadong. Through this strategic collaboration, we will gain another valuable and reliable long-term investor who fully supports our strategy to become a global ADC player, and we will be able to speed up our product development and broaden our pipeline. We are convinced that our partner’s strong development and commercialization expertise and knowledge of Asia will both shorten the time to market and maximize the commercial opportunity for our ATAC products in this important territory."

Mr. Liang Lu, Chairman of the Board and CEO of Huadong Medicine, added: "Heidelberg Pharma is an emerging leader in the ADC space. We are pleased to partner with Heidelberg Pharma and bring the best ADC products to the cancer patients in Asia. The collaboration further strengthens Huadong’s ADC portfolio and expands our ADC R&D capabilities. Huadong will contribute Asian patients to global clinical trials to help accelerate products development. We are also committed to supporting Heidelberg Pharma to 1 Asia (excluding Japan, India, Pakistan, Sri Lanka): People’s Republic of China, Hong Kong, Macao, Taiwan, South Korea, Indonesia, Singapore, The Philippines, Thailand, Bangladesh, Bhutan, Brunei, Myanmar, Cambodia, Laos, Malaysia, Maldives, Mongolia, Nepal and Vietnam 2 dievini Hopp BioTech holding GmbH & Co. KG 2/4 become a world ADC leader, by the substantial equity investment and access to Huadong’s ADC ecosystem."

Prof. Dr. Christof Hettich, Chairman of the Supervisory Board of Heidelberg Pharma and Managing Partner of dievini, said: "I am delighted that the Heidelberg Pharma team has entered into this strategic partnership with a strong Asian partner and new shareholder who shares the Company’s vision. We have been supporting Heidelberg Pharma since 2004 and are happy to see that their legacy assets have been developing nicely through partnerships and the new ATAC projects have been generating high interest from pharma companies. The dievini team is looking forward to the clinical development of the pipeline with the goal of bringing new, much-needed treatment options to cancer patients."

The strategic partnership includes the following agreements:

ATAC licensing agreement
• Heidelberg Pharma has granted Huadong exclusive development and commercialization rights for HDP-101 (BCMA-ATAC) and HDP-103 (PSMA-ATAC) for Asia1 and is eligible to receive an upfront payment of USD 20 million (EUR 17.5 million) and milestone payments of up to USD 449 million (EUR 400 million), as well as tiered royalties ranging from single to low double digit percentages for each candidate.
• Heidelberg Pharma has granted Huadong an exclusive option for the pre-IND research candidates HDP-102 (CD37-ATAC) and HDP-104 (undisclosed target) in Asia1 with a total deal value of up to USD 461 million (EUR 410 million), plus tiered royalties ranging from single to low double digit percentages for each candidate.
• Huadong also has right of first negotiation to license the next two ATAC candidates for Asia1.
• Huadong becomes the strategic partner in Asia for Heidelberg Pharma’s product development.

Investment agreement
• Huadong intends to make an equity investment in Heidelberg Pharma totaling EUR 105 million, representing 35% of total shares outstanding after the transaction, consisting of a rights issue and a share transfer as outlined below, has taken place.
• Heidelberg Pharma is planning a capital increase in the form of a rights issue of up to EUR 80 million, issuing up to 12,408,649 shares at EUR 6.44 per share, the price of the last funding round in April 2021. The rights issue will be based on a prospectus and use authorized capital. The approval of the prospectus for the rights offering by BaFin3 will be published in connection with the granting of all other necessary regulatory approvals. Further details of the capital increase will be published in due time. 3 Bundesanstalt für Finanzdienstleistungsaufsicht (Federal Financial Supervisory Authority) 3/4
• Huadong plans to acquire up to 26% of Heidelberg Pharma shares outstanding in the context of the rights issue. To achieve this percentage, the main shareholder dievini and related entities have agreed to transfer their subscription rights to Huadong, and Huadong will assume any unsubscribed shares in the rights issue. Huadong will purchase the necessary number of existing shares from dievini to reach 35% of total shares outstanding following the capital increase.
• The acquisition of shares by Huadong is subject to certain closing conditions, such as foreign trade clearance, Huadong’s exemption from the obligation to make a mandatory offer by BaFin, as well as foreign direct investment (ODI) approval required under Chinese law.
• The closing conditions must generally be satisfied until 27th August 2022 (Long Stop Date). If the necessary public approvals have not been granted by 27th July 2022, Huadong is entitled to extend the Long Stop Date until 27th October 2022, provided that Huadong grants a 12-month loan to the Company in the amount of EUR 10 million at the prevailing market interest rate. dievini would also grant a loan to the Company with the same terms as the loan from Huadong, under the framework of the financing commitment by dievini announced on 17th February 2022.
• If the approvals are not granted by the Long Stop Date, then no shares will be issued to or acquired by Huadong. However, dievini might consider participating in the rights issue and exercise a part of its subscription rights to fulfil partly or in full its financing commitment announced on 17th February 2022.

Conference call invitation
Heidelberg Pharma will host a conference call and live audio webcast to discuss the new partnership on Monday, 28th February 2022, at 1:00 pm CET, which will include a Q&A session. Participants may ask questions by phone or online via the Q&A chat window.