On May 6, 2021, ORIC Pharmaceuticals, Inc. (the "Company") reported that it entered into an Open Market Sale AgreementSM (the "Sales Agreement") with Jefferies LLC as the Company’s sales agent (the "Agent"), pursuant to which the Company may offer and sell from time to time through the Agent up to $150 million of shares (the "Shares") of the Company’s common stock, par value $0.0001 per share ("Common Stock"), in such share amounts as the Company may specify by notice to the Agent, in accordance with the terms and conditions set forth in the Sales Agreement (Filing, 8-K, ORIC Pharmaceuticals, MAY 6, 2021, View Source [SID1234579369]).

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Sales, if any, of the Shares pursuant to the Sales Agreement may be made in negotiated transactions or transactions that are deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on The Nasdaq Stock Market. Under the Sales Agreement, the Company will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. The Company is not obligated to sell any Shares under the Sales Agreement.

The Shares will be offered and sold pursuant to the Company’s shelf registration statement on Form S-3 ASR which was automatically effective upon filing with the Securities and Exchange Commission (the "Commission") on May 6, 2021. The Company filed a prospectus supplement, dated May 6, 2021, with the Commission in connection with the offer and sale of the Shares. The Company may terminate the Sales Agreement upon written notice to the Agent for any reason or by the Agent upon written notice to us for any reason or at any time under certain circumstances, including but not limited to the occurrence of a material adverse change in the Company.

The Sales Agreement contains customary representations, warranties and agreements by us, and indemnification rights and obligations of the parties. The Sales Agreement provides that the Agent will be entitled to compensation for its services at a commission rate of up to 3.0% of the gross sales price per share of all shares sold through the Agent under the Sales Agreement. Under the terms of Sales Agreement, the Company agreed to indemnify the Agent against certain specified types of liabilities, including liabilities under the Securities Act, to contribute to payments the Agent may be required to make in respect of these liabilities, and to reimburse the Agent for certain expenses. In the ordinary course of business, the Agent or its respective affiliates from time to time have provided and may in the future provide various investment banking, commercial banking and financial advisory services to the company and/or its affiliates, for which it has received or may receive customary compensation.

The Company intends to use the net proceeds from the sale, if any, of the securities offered in the offering, together with the Company’s existing cash, cash equivalents and short-term investments, to fund the development of ORIC-101, to fund the development of ORIC-533, to fund the development of ORIC-944, to fund the development of ORIC-114, to fund other research and development activities, including the potential acquisition of and drug development activities related to new programs, as well as for working capital and other general corporate purposes. The Company does not have agreements or commitments for any specific acquisitions or strategic transactions at this time.

The above summary of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the Sales Agreement, a copy which is attached as Exhibit 1.1 to this Current Report on Form 8-K and incorporated herein by reference. The legal opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation relating to the shares of Common Stock being offered pursuant to the Sales Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.

On May 6, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that that it plans to host a conference call on Thursday, May 13, 2021, at 8:30 a.m. ET to discuss its financial results for the quarter ended March 31, 2021 and provide a business update (Press release, Selecta Biosciences, MAY 6, 2021, https://selectabio.gcs-web.com/news-releases/news-release-details/selecta-biosciences-host-conference-call-and-webcast-discuss-4 [SID1234579385]).

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Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10147801. Investors and the public can access the live and archived webcast of this call and a copy of the presentation via the Investors & Media section of the company’s website, www.selectabio.com.

On May 6, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported financial results for the first quarter ended March 31, 2021 and provided business updates (Press release, ADC Therapeutics, MAY 6, 2021, View Source [SID1234579403]).

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"We are off to an exciting start to the year with the recent accelerated FDA approval of ZYNLONTA, bringing a new and differentiated treatment option to patients with relapsed or refractory diffuse large B-cell lymphoma," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "ZYNLONTA is approved for a broad population of r/r DLBCL patients, including DLBCL NOS, DLBCL arising from low grade lymphoma and also high-grade B-cell lymphoma. This reflects the real world population of patients enrolled in our LOTIS-2 pivotal trial including transplant eligible and ineligible patients, heavily pre-treated patients and patients with difficult-to-treat disease. In addition, we continue to advance our pipeline of next-generation ADCs for patients with difficult-to-treat hematologic and solid tumor cancers."

"On the occasion of the commercial launch of ZYNLONTA, it has been impressive to see the high quality of talented and experienced commercial and medical affairs professionals at ADC Therapeutics fully prepared for an early FDA approval," said Ron Squarer, Chairman of the Board and an advisor to the Company. "This team is executing on its launch plan and is well equipped to support the treating community in adopting an important new option with a broad label which included tough to treat patients in third-line plus DLBCL."

Recent Highlights

ZYNLONTA (loncastuximab tesirine-lpyl)

FDA accelerated approval and launch: ZYNLONTA was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on April 23, 2021, as a single-agent for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma, a key point of differentiation on the label. ZYNLONTA became commercially available last week and the commercial launch is fully underway.
Added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: As of May 5, 2021, ZYNLONTA was added to the NCCN guidelines with a category 2A recommendation for third-line plus DLBCL, including DLBCL arising from low-grade lymphoma such as follicular lymphoma (FL) and marginal zone lymphoma (MZL).
Ongoing trials progressing:
The Phase 3 LOTIS-5 clinical trial is evaluating ZYNLONTA in combination with rituximab in second-line patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant. This trial will fulfill the post-marketing approval requirement with the FDA for a confirmatory study.
The pivotal Phase 2 LOTIS-3 clinical trial of ZYNLONTA in combination with ibrutinib for relapsed or refractory DLBCL patients is intended to support the submission of a supplemental Biologics License Application (BLA) for ZYNLONTA in combination with ibrutinib.
Additional planned trials in 2021 to potentially expand the ZYNLONTA opportunity:
Pivotal Phase 2 clinical trial in follicular lymphoma (FL).
Clinical trial to evaluate ZYNLONTA in combination with multiple other drugs in B-cell non-Hodgkin lymphoma (NHL).
Dose-finding study of ZYNLONTA in combination with R-CHOP in frontline DLBCL.
Camidanlumab Tesirine (Cami)

Ongoing trials progressing:
The pivotal Phase 2 clinical trial evaluating the efficacy and safety of Cami in patients with relapsed or refractory Hodgkin lymphoma (HL) has completed enrollment and is continuing to follow patients. The Company will present data from this study at an upcoming congress.
The Phase 1b clinical trial of Cami in combination with pembrolizumab in selected advanced solid tumors is an open-label, dose-escalation and dose-expansion trial evaluating the safety, tolerability, pharmacokinetics and antitumor activity of Cami in combination with pembrolizumab, a checkpoint inhibitor.
2021 Expected Milestones

ZYNLONTA

Initiate a pivotal Phase 2 clinical trial of ZYNLONTA in FL in the second quarter of 2021.
Report updated data from the Phase 1 clinical trial of ZYNLONTA in combination with ibrutinib in relapsed or refractory DLBCL in the second quarter of 2021.
Initiate the dose-finding study of ZYNLONTA in first-line DLBCL with R-CHOP in the second half of 2021.
Initiate the clinical trial to evaluate ZYNLONTA in multiple combinations in B-cell non-Hodgkin lymphoma in the second half of 2021.
Complete enrollment in the pivotal Phase 2 trial of ZYNLONTA in combination with ibrutinib in the second half of 2021.
Complete safety lead-in of the Phase 3 LOTIS-5 confirmatory study of ZYNLONTA in combination with rituximab in the second half of 2021.
Cami

Report interim results from the pivotal Phase 2 clinical trial of Cami in HL in the second quarter of 2021.
Earlier-Stage Pipeline

File Investigational New Drug (IND) application for ADCT-901, targeting KAAG1 in the second quarter of 2021.
Initiate a Phase 1b combination study of ADCT-601, targeting AXL, in multiple solid tumors in the first half of 2022.
First Quarter 2021 Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $383.1 million as of March 31, 2021, compared to $439.2 million as of December 31, 2020. In the coming days, the Company will be drawing down $50 million associated with its Convertible Credit Facility with Deerfield, which was contingent upon ZYNLONTA approval.

Research and Development (R&D) Expenses

R&D expenses were $39.2 million for the quarter ended March 31, 2021, compared to $35.4 million for the same quarter in 2020. R&D expenses increased due to investments to explore the potential of ZYNLONTA in earlier lines of treatment and histologies and advance the portfolio. As a result of these initiatives, employee headcount and share-based compensation expense increased.

Selling and Marketing (S&M) Expenses

During the first quarter of 2021, S&M expenses were $13.9 million as compared to $2.6 million for the same quarter in 2020. The increase in S&M expenses related to the build-out of the Company’s commercial organization and preparation activities for the anticipated launch of ZYNLONTA in 2021. Prior to December 31, 2020, S&M expenses were reported within General and Administrative ("G&A") expenses within the condensed consolidated interim statement of operations. The period ended March 31, 2020 has been recast to conform to the current year presentation.

G&A Expenses

G&A expenses were $17.6 million for the quarter ended March 31, 2021, compared to $5.9 million for the same quarter in 2020. G&A expenses increased due to higher headcount to support the commercial launch, increased share‐based compensation expense and higher costs of being a public company.

Net Loss and Adjusted Net Loss

Net loss was $51.5 million, or a net loss of $0.67 per basic and diluted share, for the quarter ended March 31, 2021, compared to $43.5 million, or a net loss of $0.85 per basic and diluted share, for the same quarter in 2020. The net loss for the quarter ended March 31, 2021 includes a $21.2 million non-cash gain related to the changes in fair value of derivatives associated with the convertible loans under the Convertible Credit Facility with Deerfield. The decrease in fair value was driven by the decrease in the Company’s share price from December 31, 2020. In addition, net loss included share-based compensation expense of $14.0 million for the quarter ended March 31, 2021, compared to $3.8 million for the same quarter in 2020.

Adjusted net loss was $56.8 million, or an adjusted net loss of $0.74 per basic and diluted share, for the quarter ended March 31, 2021, compared to $39.7 million, or an adjusted net loss of $0.78 per basic and diluted share, for the same quarter in 2020. The increase in adjusted net loss was primarily driven by the expansion of the organization, investment in the expanding clinical portfolio and the preparation for the anticipated launch of ZYNLONTA.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss first quarter 2021 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the live call, please dial 888-771-4371 (domestic) or +1 847-585-4405 (international) and provide confirmation number 50158735. A live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

On May 6, 2021 Isofol Medical AB (publ) ("Isofol"), (Nasdaq First North Premier Growth Market: ISOFOL) reported its primary recruitment objective with the recruitment of 440 patients in the global phase III AGENT study (Press release, Isofol Medical, MAY 6, 2021, View Source [SID1234579419]). Today the company announces that it has completed the recruitment of Japanese patients in accordance with the regulatory requirements by the PMDA (the Japanese Medicines Agency) to reach market approval in Japan. As previously communicated, Isofol expects the top line results for the AGENT study to be available during H1 2022.

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Following today’s announcement of the completion of recruitment of Japanese patients, the full patient population, including the entire Japanese cohort, will be included in PMDA’s assessment for a potential market approval in Japan. For a market approval in Japan, the PMDA set a specific requirement for the number of participating Japanese patients of a total of 56 Japanese patients (of which 14 Japanese patients were already included in the primary recruitment of 440 patients) in the AGENT study. The rationale for the specific requirement from PMDA is e.g. that the metabolism of Japanese patients tends to differ from patients in other countries, which is why the effect and potential side effects must be investigated separately.

For the rest of the world, the original 440 patients will be analyzed for efficacy, but the full patient population will be analyzed for safety purposes.

"I am satisfied that we now have completed the recruitment of the Japanese patients, an important step on the way to receive market approval in Japan, the second largest oncology market worldwide. We are now looking forward to continue working with Solasia on the development and registration of arfolitixorin to bring a new treatment option to patients living with mCRC in Japan", said Ulf Jungnelius, M.D, CEO of Isofol.

Solasia Pharma ("Solasia") will fund and supervise clinical development activities in Japan and will be responsible for registrational filing, and following potential regulatory approvals, Solasia will, as the Market Authorization holder, be responsible for the commercialization of arfolitixorin in Japan. Isofol remain the global sponsor of the AGENT study.

"We are very pleased to have completed the recruitment of the target number of patients in Japan in the AGENT study and contributed to the global development of arfolitixorin. I would like to thank all the patients and investigators participating in the study, the CRO in charge of conducting the study, and Isofol, our partner and the sponsor of the AGENT study, for supporting us achieve this important goal. Patient recruitment was completed earlier than expected, and Solasia, together with Isofol, will further proceed development of arfolitixorin for market approval in Japan with the aim of becoming a new treatment option for mCRC patients", said Yoshihiro Arai, President & CEO of Solasia.

Arfolitixorin is evaluated in the AGENT study for the treatment of patients with first-line metastatic colorectal cancer (mCRC). The study is currently being conducted in the U.S., Canada, Europe, Australia and Japan in more than 90 clinics.

The information was submitted for publication, through the agency of the contact person set out above, at 08:30 CET on May 6, 2021.

About the AGENT study

The Phase III AGENT study is a randomized, controlled, multi-centre study assessing the efficacy and safety of arfolitixorin, [6R]-5,10-methylene-THF acid (MTHF), compared to leucovorin, both used in combination with 5- FU, oxaliplatin, and bevacizumab, in first-line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumour cells. The study is designed to show superiority for arfolitixorin over leucovorin. The study is ongoing at approximately 90 sites in the U.S., Canada, Europe, Australia and Japan. In December 2020, the last of the AGENT study’s 440 patients was recruited, which is the basis in the statistical analysis plan. Recruitment has since continued in Japan to reach 56 Japanese patients. Isofol is now focusing on completing the ongoing AGENT study where the patients receive first-line standard treatment for metastatic colorectal cancer (mCRC). The company expects that the results of the AGENT study will be available during H1 2022.Further information about the study, including patient eligibility requirements, is available at www.clinicaltrials.gov id: NCT03750786.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On May 6, 2021 Hope Medicine reported the completion of a Series B financing US$56 million (Press release, Hope Medicine, MAY 6, 2021, View Source [SID1234632778]). This round of financing was jointly led by Qiming Venture Partners and Grand Flight Investment. HighLight Capital (HLC) co-invested with Sinovation Ventures. The Series A investor，Trust Bridge Partners，continued to subscribe. HaoYue Capital acted as the exclusive financial advisor for this round of financing.

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HopeMed is a global science-driven innovative biopharmaceutical company with R&D bases and offices in Nanjing, Shanghai, and Beijing, China. The company was founded by Professor Rui-Ping Xiao, the dean of the College of Future Technology of Peking University, and an associate editor of New England Journal of Medicine. HopeMed has always followed the founding philosophy of In China, For Global, and has built an international multi-disciplinary team dedicated to global unmet medical needs with first-in-class medicines.

HopeMed focuses on the three major disease areas of women’s health, endocrine, and cardiovascular diseases, and aims at the unmet medical needs, through an independent R&D as well as license-in models, to further establish and enrich our research and development pipelines.

Previously, HopeMed has signed a world-wide exclusive license agreement with Bayer AG on the development and commercialization of a human antibody (HMI-115) targeting the prolactin (PRL) receptor for the treatment of male and female pattern hair loss, endometriosis and other chronic diseases with dysregulated PRL signaling. Under the terms of the license agreement, Hope Medicine will develop and globally commercialize the novel PRL receptor antibody based on intellectual property from Bayer. At present, HMI-115 has completed phase I clinical trials in the European Union, with positive safety results. The global multi-center phase II clinical trials for androgenic alopecia and endometriosis will soon be launched.

‘We have built a world-class professional team and strong global intellectual property rights to develop the best pharmaceuticals for the global market. China’s innovative pharmaceutical research and development have now entered an exciting new era of ‘dare to do, can do, and must do’. The diseases in women health, endocrinology, and cardiovascular fields are our primary battlefields. We will not forget our original purpose and strive for first-in-class medicines with disruptive innovation to benefit patients worldwide. Here we would like to express our sincere thanks to our new and old investors for their precious recognition and trust in HopeMed. This round of financing will provide strong support for the company’s upcoming MRCT international phase II clinical studies and commercial product development.’ Said Rui-Ping Xiao, Founder, and CEO of HopeMed.

Amy Tang, a venture partner with Qiming Venture Partners, said, "China’s innovative drug R&D sector is maturing. As a science-driven innovative drug R&D company, Hope Medicine has formed solid cooperations with world-class scientific research and development platform, such as IMM. The company develops first-in-class drugs to target unmet clinical needs and push forward with this goal. We are honored to cooperate with the visionary company, which is also effective at execution. Qiming hopes to explore the huge R&D potential of Hope Medicine and help their pipeline to go to market as soon as possible, to benefit the patients."

Mr. Jun Yang, Managing Partner of Grand Flight Investment said that they are very optimistic about the development of China’s biomedical industry and are convinced that China’s domestic grown innovative pharmaceutical companies can achieve more First-in-Class innovations. The HopeMed team led by Professor Xiao has a global vision and experience and is committed to the research and development of First-in-Class innovative medicines based on a deep understanding of translational medicine. HopeMed’s HMI-115 antibody has shown very significant effects in the natural NHP model, and human clinical trials have also shown positive safety results. Grand Flight is very optimistic about its follow-up clinical advancement and the expansion of more indications. HopeMed’s innovative pipelines in other disease fields also enrich the company’s future product layout.

‘After ten years of accumulation, the research and development of innovative pharmaceuticals in China has entered the spring of rapid development. We are very excited about the development of China’s medical and healthcare industry in recent years and its long-term prospects, and we are willing to accompany the growth of truly original pharmaceutical companies. HopeMed is a First-in-Class pharmaceutical research and development practice based in China and aiming at the world. Trust Bridge Partners is honored to be the founding investor and partner of HopeMed. This investment is in line with our vision to develop and provide international standard medical products for the Chinese and global markets.’ Said Mr. Feng Ge, the Managing Partner of Trust Bridge Partners.

Mr. Richard Yang, Partner of Sinovation Ventures commented that HopeMed is founded on the remarkable achievements in advanced translational medicine accumulating years of domain know-how led by Professor Xiao. The company develops competitive pipelines in multiple therapeutic areas with the world’s leading research and experiment platforms. Sinovation Ventures is honored to work with Professor Xiao’s team, and is highly confident that HopeMed will create great commercial value and social impact.

Mr. Liu Hao, Founder and CEO of HaoYue Capital, said that ‘we are honored to assist HopeMed in completing this round of financing. HopeMed has a world-class R&D team, including basic research, clinical translation, and CMC manufacturing. HopeMed always focuses on unmet clinical needs and refuses to follow others. HaoYue Capital is also committed to serving the best R&D team and the most innovative biopharmaceutical company in the world. We believe that HopeMed can provide patients with products with true clinical value.’