Calithera Biosciences and Antengene Enter Worldwide License Agreement for Development & Commercialization of CB-708

On May 17, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, and Antengene Corporation, Ltd. (SEHK: 6996.HK), a leading clinical-stage R&D driven biopharmaceutical company focused on innovative medicines for oncology and other life-threatening diseases, reported an exclusive, worldwide license agreement for the development and commercialization of CB-708, Calithera’s small molecule inhibitor of CD73 (Press release, Calithera Biosciences, MAY 17, 2021, View Source [SID1234606789]).

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"This agreement validates the capabilities of our drug discovery engine and represents a significant milestone for our CD73 program," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "Antengene brings significant enthusiasm and proven global capabilities to the development and future commercialization of CB-708, a potential best-in-class oral small molecule CD73 inhibitor. This licensing agreement enables the continued advancement of this promising program, while allowing Calithera to focus our resources on our more advanced clinical programs evaluating telaglenastat in non-small cell lung cancer and CB-280 in cystic fibrosis."

CB-708 is a highly potent, selective, orally-bioavailable small molecule inhibitor of CD73. Preclinical data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and the 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting demonstrated that CB-708 has immune-mediated, single agent activity in syngeneic mouse tumor models. In preclinical studies, CB-708 was well-tolerated and showed enhanced anti-tumor activity when combined with either an anti-PD-L1 immunotherapy or with chemotherapeutic agents, such as oxaliplatin or doxorubicin. CB-708 has completed GLP toxicology studies and is poised to advance into clinical development.

"We are excited to continue the advancement of CB-708 through our deep experience in global clinical development and extensive track record in commercialization in major markets around the world," said Dr. Jay Mei, Founder and Chief Executive Officer of Antengene. "CB-708 is a highly differentiated oral small molecule CD73 inhibitor with best-in-class potential. Antengene will continue to complete the GMP manufacturing of CB-708 and advance it into clinical trials for the treatment of multiple cancers including solid tumors and hematologic malignancies. This agreement brings a great addition to our synergistic portfolio of 12 assets with combinatory potential, is a testament to our abilities in accelerating global development, and represents another step in realizing our mission of treating patients beyond borders."

Under the terms of the license agreement, Calithera will receive an upfront payment and potential development, regulatory and sales milestones of up to $255.0 million. Additionally, Calithera is eligible to receive tiered royalties on sales of the licensed product up to low double-digits. Antengene Investment Ltd, a wholly owned subsidiary of Antengene Corporation, will receive exclusive, worldwide rights to develop and commercialize CB-708.

iBio Reports Fiscal Third Quarter 2021 Financial Results and Provides Corporate Update

On May 17 2021 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a biotech innovator and biologics contract manufacturing organization, reported its financial results for the fiscal quarter ended March 31, 2021 (Press release, iBioPharma, MAY 17, 2021, View Source [SID1234585484]).

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"Our focus on strategy execution was reflected in our third quarter results as we advanced our second-generation COVID-19 vaccine candidate, defended our intellectual property rights, and achieved strong year-over-year revenue growth while adding new development services clients," said Tom Isett, Chairman & CEO of iBio. "Also, more recently, we saw continued progress on new product and pipeline additions, including line extensions to our Bioanalytical Services offering, and a planned investment in the establishment of a new Drug Discovery team. Importantly, we believe that when our new discovery capabilities are installed, we will be able to more fully leverage the many ‘speed-to-clinic’ advantages conveyed by our proprietary FastPharming System."

Fiscal Third Quarter and Recent Business Developments:

Vaccines

In May 2021, iBio reported on development of IBIO-202, a subunit vaccine candidate that targets the nucleocapsid protein ("N protein") of SARS-CoV-2. Using its FastPharming System, iBio has successfully expressed N protein antigens and has initiated both intramuscular and intranasal preclinical studies to evaluate antigen-adjuvant combinations that may provide strong T-cell memory and immune responses. Initial results are expected in early Q1 FY2022.
The Company also announced that IBIO-201, its COVID-19 vaccine candidate combining antigens derived from the spike protein ("S protein") fused with its patented LicKM Immunostimulator, had completed IND-enabling toxicology studies, with no adverse effects observed at low or high doses.
In support of approval for production of its lead animal health product candidate, IBIO-400, the Company submitted an "Outline of Production" and facility documentation to the U.S. Department of Agriculture for review.
Therapeutics

Today, iBio announced its plans to establish drug discovery capabilities in the San Diego, CA, area, with an initial focus upon monoclonal antibodies for use in oncology.
The Company continued pre-clinical development of IBIO-100, with initiation of IND-enabling studies expected in FY 2022.
Contract Development and Manufacturing ("CDMO") Services

In May 2021, iBio announced that it concluded its lawsuit with Fraunhofer USA, Inc. ("Fraunhofer USA") as described in full detail in the Company’s Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on May 4, 2021.
Today, iBio announced an expanded menu of Bioanalytical Services, including intact protein analysis, new proteomic assays and middle-down characterization for monoclonal antibodies. The Company’s Bioanalytical Services were previously available only to FastPharming Development and Manufacturing Services clients, but are now available to biologics developers using alternative protein expression systems.
Research & Bioprocess Products

iBio continues to make progress towards launching certain cytokines and growth factors as part of a new catalog of products for research and further manufacturing uses.
"We are excited about the advancement of a differentiated second-generation COVID-19 vaccine candidate," said Mr. Isett. "Additionally, we are pleased with the protection of – and compensation for – our IP in plant-based biologics, as we further develop our FastPharming Technologies. Moreover, we continue to see increased demand from new and existing customers for our CDMO Services, even while we are in the midst of our transformation."

With reference to the Company’s planned establishment of in-house drug discovery capabilities, Mr. Isett commented, "We believe that our investment in fast, translatable drug discovery activities will enable us to optimally leverage our FastPharming System to create a robust pipeline of truly innovative molecules and fast-followers, particularly in the field of oncology."

Fiscal Third Quarter and Recent Corporate Developments:

Fiscal year to-date, iBio increased staffing by approximately 21% to 57 employees.
During the fiscal third quarter, iBio further strengthened its leadership team with the additions of Dr. Martin B. Brenner as Chief Scientific Officer and Mr. Robert M. Lutz as Chief Financial & Business Officer, effective January 18 and March 4, 2021, respectively.
"The key additions of Martin and Rob – along with the recruitment of many talented new employees to our R&D and Operations functions – reflect the ongoing rapid and successful transformation of iBio," said Mr. Isett. "By further expanding the capabilities of our team this quarter, we delivered new pipeline candidates, new service products and continued to advance other key initiatives. Clearly, our ability to execute and deliver value to shareholders has been further elevated this quarter, and we expect that the investment in the new Drug Discovery Team will yield significant returns as we seek to make the FastPharming System the bioprocess platform-of-choice."

Financial Results:

For the fiscal quarter ended March 31, 2021, iBio reported revenues of approximately $0.8 million, an increase of $0.7 million from $0.1 million in the fiscal quarter ended March 31, 2020.

To further clarify the results of its operations for investors, from this quarter forward, iBio will include Cost of Goods Sold ("COGS") and Gross Profit line items in its financial statements. For the three-months ended March 31, 2021, iBio reported COGS of approximately $0.5 million and gross profit of $0.3 million, compared to COGS of $0.1 million and gross profit that was not significant for the three months ended March 31, 2020. Since iBio’s revenue is currently derived from a small number of contracts, and revenue recognition from development and manufacturing services is generally subject to volatility due to timing, the Company expects that gross profit and gross profit percentage may fluctuate significantly from quarter to quarter.

R&D expenses for the fiscal quarter ended March 31, 2021 were approximately $2.2 million, compared with approximately $1.1 million in the same period of 2020. The increase in R&D expense of approximately $1.1 million was primarily related to increases in personnel and other expenses to support the Company’s development of a portfolio of proprietary therapeutics and vaccines.

G&A expenses for the fiscal quarter ended March 31, 2021 were approximately $5.3 million, compared with approximately $3.0 million in the same period of 2020. The increase of approximately $2.3 million resulted primarily from increased headcount and increased operations to support the growth of the business.

Net loss attributable to iBio stockholders for the fiscal quarter ended March 31, 2021 was approximately $7.7 million, or $0.04 per share. This compared with a net loss of approximately $4.7 million, or $0.06 per share, in the same period of 2020.

iBio had $103.9 million in cash, cash equivalents and debt investments as of March 31, 2021. The Company further strengthened its financial position through the aforementioned settlement of litigation with Fraunhofer USA. The Company believes it will have sufficient resources to fund its planned operations at least through March 31, 2023, inclusive of its planned investment in the FastPharming Discovery Platform and potential in-licensing activities.

Webcast and Conference Call

iBio management will host a webcast and conference call at 8:00 a.m. Eastern Time today, May 17, 2021, to discuss these results and provide a corporate update.

The live and archived webcast may be accessed on the Company’s website at www.ibioinc.com under "News and Events" in the Investors section. The live call can be accessed by dialing (833) 672-0651 (domestic) or (929) 517-0227 (international) and referencing conference code: 3085726.

Concert Pharmaceuticals Announces Sale of VX-561 Milestones to Vertex for $32 Million

On May 17, 2021 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) has purchased the potential future milestones under the companies’ 2017 asset purchase agreement relating to VX-561 (deutivacaftor) for $32 million (Press release, Concert Pharmaceuticals, MAY 17, 2021, View Source [SID1234584685]).

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"This transaction provided an opportunity to secure non-dilutive capital and strengthens our balance sheet as we continue to advance CTP-543, our lead asset for alopecia areata, through its Phase 3 program," stated Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. "By receiving these proceeds, we now expect our cash, cash equivalents and investments to fund the Company into the second quarter of 2022."

Under the asset purchase agreement, Vertex acquired worldwide development and commercialization rights to VX-561 (formerly known as CTP-656) and other assets related to the treatment of cystic fibrosis. VX-561 is an investigational cystic fibrosis transmembrane conductance regulator (CFTR) potentiator that has the potential to be used as part of future once-daily combination regimens of CFTR modulators that treat the underlying cause of cystic fibrosis. In 2017, Concert received a one-time cash payment of $160 million upon closing the asset purchase, with the potential for $90 million in future milestones. Following receipt of the $32 million, no further milestone obligations remain.

Chestnut Securities, Inc. acted as exclusive financial advisor to Concert in this transaction.

Black Diamond Therapeutics to Host Webcast Presentation of Data From Phase 1 Dose-Escalation Portion of MasterKey-01 Clinical Trial

On May 17, 2021 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, MasterKey therapies, reported that it will host a webcast presentation on Wednesday, May 19, 2021 at 6:00 PM ET to discuss pharmacokinetic, safety, and preliminary efficacy data from the Phase 1 dose-escalation portion of the MasterKey-01 trial of BDTX-189 in patients with advanced solid tumors, which will also be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 4-8, 2021 (Press release, Black Diamond Therapeutics, MAY 17, 2021, View Source [SID1234584641]).

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Conference Call and Webcast Event

A live webcast presentation will be available on the News & Events section of the Black Diamond website at www.blackdiamondtherapeutics.com. To access the presentation, please dial 833-730-3983 (United States) or 720-405-2158 (international) and reference the conference ID 1979666. A replay of the webcast will be available on the Black Diamond website following the presentation.

Abstract Details:

Title: Safety and Preliminary Efficacy from the Phase 1 Portion of MasterKey-01: A First-in-Human Dose-Escalation Study to Determine the Recommended Phase 2 Dose (RP2D), Pharmacokinetics (PK), and Preliminary Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB mutations, in Patients with Advanced Solid Malignancies
Session Type: Poster Session
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date and Time: Friday, June 4, 2021 at 9:00 AM ET
Abstract ID: 3086

Title: Clinical pharmacokinetics of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies in MasterKey-01 study
Session Type: Poster Session
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date and Time: Friday, June 4, 2021 at 9:00 AM ET
Abstract ID: 3097

Full abstracts will be published online at 5:00 PM ET on May 19, 2021 on the ASCO (Free ASCO Whitepaper) website at www.asco.org.

About BDTX-189
BDTX-189 is an orally available, irreversible, and ATP competitive small molecule inhibitor that is designed to block the function of a family of oncogenic epidermal growth factor receptor (EGFR) and ErbB-2 (epidermal growth factor receptor 2 [HER2]) proteins across a range of tumor types. BDTX-189 is designed as a MasterKey inhibitor targeting a family of previously undrugged and functionally similar oncogenic mutations in a tumor-agnostic manner. These mutations include extracellular domain allosteric mutations of HER2, as well as EGFR and HER2 kinase domain Exon 20 insertions, and additional activating oncogenic drivers of ErbB. The ErbB receptors are a group of receptor tyrosine kinases involved in key cellular functions, including cell growth and survival. BDTX-189 is also designed to spare normal, or wild-type, EGFR, which we believe has the potential to improve upon the toxicity profiles of current ErbB kinase inhibitors. Currently, there are no medicines approved by the U.S. Food and Drug Administration (FDA) to target all of these oncogenic mutations with a single therapy.

BDTX-189 is currently being evaluated in a Phase 1/2 clinical trial (MasterKey-01) in adult patients with advanced solid tumors expressing a range of alterations of ErbB receptors, including oncogenic MasterKey mutations, HER2-WT amplification, HER3 mutation, EGFR exon 19 deletion, and L858R mutation who have no standard therapy available or for whom standard therapy is considered unsuitable or intolerable. In July 2020, the FDA granted Fast Track designation to BDTX-189 for the treatment of adult patients with solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 Exon 20 insertion mutation who have progressed following prior treatment and who have no satisfactory treatment options.

Miravo Healthcare™ Announces First Quarter 2021 Results

On May 17, 2021 Nuvo Pharmaceuticals Inc. (TSX: MRV) (OTCQX: MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three months ended March 31, 2021 (Press release, Nuvo Pharmaceuticals, MAY 17, 2021, View Source [SID1234580427]). For further details on the results, please refer to Miravo’s Management, Discussion and Analysis (MD&A) and Condensed Consolidated Interim Financial Statements for the three months ended March 31, 2021, which are available on the Company’s website (www.miravohealthcare.com). All figures are in Canadian dollars, unless otherwise noted.

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Key Developments
Three months ended March 31, 2021 include the following:

Adjusted total revenue(1) was $14.5 million, a decrease of 23% compared to $18.9 million for the three months ended March 31, 2020.
Adjusted EBITDA(1) was $4.4 million, a decrease of 45% compared to $8.0 million for the three months ended March 31, 2020.
Revenue related to Blexten and Cambia was $5.6 million, a decrease of 7% compared to revenue of $6.0 million for the three months ended March 31, 2020. Total Canadian prescriptions of Blexten and Cambia increased by 22% and 9% compared to the three months ended March 31, 2020.
The Company repaid $3.6 million (US$2.9 million) of the Amortization Loan to Deerfield Management Company, L.P. (Deerfield).
As at March 31, 2021, cash and cash equivalents were $23.8 million.
(1) Non-International Financial Reporting Standards (IFRS) financial measure defined by the Company below.

Business Update

As a result of the COVID-19 pandemic, the Company has made changes to operations to promote a healthy and safe environment for its employees, while the business continues to supply global partners, wholesalers, pharmacies, and ultimately patients, with its healthcare products. The possibility of future supply disruptions resulted in forward buying linked to the COVID-19 pandemic, which increased revenue in the three months ended March 31, 2020. It is anticipated that the COVID-19 pandemic may continue to impact the timing of revenue in future quarters and the Company will monitor market dynamics accordingly.
In April 2021, the Company filed and obtained a receipt for a final base shelf prospectus with the securities regulatory authorities in each of the provinces of Canada (the Prospectus). The Company has filed the Prospectus to maintain financial flexibility and to have the ability to offer the securities on an accelerated basis pursuant to the filing of prospectus supplements. The Prospectus is valid for a 25-month period, during which time the Company may offer and issue, from time-to-time, common shares, preferred shares, debt securities, warrants and subscription receipts, or any combination thereof, having an aggregate offering value of up to $40 million.
In February 2021, Nuvo Pharmaceuticals (Ireland) DAC trading as Miravo Healthcare (Miravo Ireland) entered into an exclusive license and supply agreement (the License Agreement) with The Mentholatum Company for the right to commercialize the Resultz formula and technology in the United States under the Mentholatum brand. Miravo Ireland will earn revenue from The Mentholatum Company pursuant to the License Agreement. It is anticipated that The Mentholatum Company will launch Resultz during the summer of 2021. Resultz is currently manufactured by the Company’s contract manufacturing partner in Europe.
In January 2021, the Company launched NeoVisc ONE 4 mL and NeoVisc + 2 mL in Canada. Both NeoVisc+ and NeoVisc ONE were issued a Medical Device License by Health Canada in September 2020 for the treatment of pain and improvement of joint functionality in patients affected by degenerative (age-related changes) or mechanical arthropathy (related to overuse) of the knee.
In January 2021, the Company’s exclusive partner for Pennsaid 2% in Switzerland, Gebro Pharma AG (Gebro Pharma), launched the product into the Swiss market, generating net sales and related royalty revenue for Miravo.
"Our key promoted brands, Blexten and Cambia, continued their solid performance and demonstrated year-over-year gains in prescription growth. New prescriptions of Blexten (a measure of new patients to the product) grew by 17% compared to Q1 2020. Wholesaler and pharmacy buying patterns reverted to more traditional levels, as we did not see a repeat of the forward buying that occurred in Q1 2020 in response to the uncertainty around the COVID-19 pandemic. Our recently launched Suvexx and NeoVisc brands are performing according to plan and are already achieving meaningful market share. Feedback from healthcare providers and patients in relation to both products has been encouraging. In a recent market research study conducted for our marketing team, 95% of physicians surveyed, expect to increase the number of Suvexx prescriptions for their migraine patients," said Jesse Ledger, Miravo’s President & CEO. "We remain optimistic that with the accelerated roll out of COVID-19 vaccination programs across Canada and around the world, patients will gain improved access to healthcare providers during the remainder of the year and we anticipate this will result in demand for products across all our business segments."

First Quarter 2021 Financial Results
Adjusted total revenue was $14.5 million for the three months ended March 31, 2021 compared to $18.9 million for the three months ended March 31, 2020. For the three months ended March 31, 2021, the decrease in the Licensing and Royalty Business segment was primarily due to a $2.2 million decrease of the royalty earned on U.S. net sales of Vimovo due to a competitor launching a generic version of Vimovo in March 2020. During the three months ended March 31, 2021, the Company received a royalty of 10% based on U.S. net sales of Vimovo. In subsequent quarters, this royalty is anticipated to decrease to 5% of U.S. net sales of Vimovo due to a royalty step-down provision in Miravo Ireland’s license agreement with Horizon Therapeutics plc that is anticipated to be triggered as a result of continued generic competitor market share gains. Adjusted total revenue attributable to the Commercial Business segment declined during the three months ended March 31, 2021, as an increase in sales related to certain promoted products was more than offset by a decline in revenue from the segment’s mature products. During the comparative quarter, the possibility of future supply disruptions resulted in forward buying linked to the COVID-19 pandemic, which increased revenue in the Company’s Commercial Business segment in the three months ended March 31, 2020. The Production and Service Business segment revenue decreased as a result of a decline in the Company’s Resultz product sales.

Adjusted EBITDA was $4.4 million for the three months ended March 31, 2021 compared to $8.0 million for the three months ended March 31, 2020. The decrease in the current quarter was primarily attributable to a decrease in gross profit and an increase in sales and marketing expenses, slightly offset by a decrease in general and administrative expenses.

Non-IFRS Financial Measures
The Company discloses non-IFRS measures (such as adjusted total revenue, adjusted EBITDA, adjusted EBITDA per share and cash value of loans) that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company’s financial performance and in interpreting the effect of the Aralez Transaction and the Deerfield Financing on the Company. Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies.

Adjusted Total Revenue
The Company defines adjusted total revenue as total revenue, plus amounts billed to customers for existing contract assets, less revenue recognized upon recognition of a contract asset. Management believes adjusted total revenue is a useful supplemental measure to determine the Company’s ability to generate cash from its customer contracts used to fund its operations.

The following is a summary of how adjusted total revenue is calculated:

Adjusted EBITDA
EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery). The Company defines adjusted EBITDA as EBITDA, plus amounts billed to customers for existing contract assets, inventory step-up expenses, stock-based compensation expense, Other Expenses (Income), less revenue recognized upon recognition of a contract asset and other income. Management believes adjusted EBITDA is a useful supplemental measure to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

The following is a summary of how EBITDA and adjusted EBITDA are calculated:

1) The Company’s derivative liabilities are measured at fair value through profit or loss at each reporting date. As a result of the increase in the share price in the current quarter and an increase in the volatility of the Company’s shares, amongst other inputs, the value of the Company’s derivative liabilities increased and the Company recognized a net non-cash $18.4 million loss on the change in fair value of derivative liabilities for the three months ended March 31, 2021.

Virtual Annual Meeting of Shareholders
Miravo’s 2021 Annual Meeting of Shareholders (Meeting) will be held as an online meeting only. The Meeting will take place on Monday, May 17, 2021 (today) at 9:00 a.m. Registered shareholders can attend the Meeting online, vote shares electronically if they have not voted by proxy in advance of the Meeting in accordance with the proxy instructions, and submit questions during the Meeting. You will need to have your 16-digit Control Number (the Control Number) to participate in the Meeting. If you are a shareholder and do not have a Control Number or if you are not a Miravo shareholder, you can attend the Meeting as a guest, but you will not be able to vote at the Meeting.

The link to participate in the Meeting is: www.virtualshareholdermeeting.com/mrv2021. If you encounter any difficulties accessing the virtual meeting during the check-in or meeting time, please call the technical support number that will be posted on the Virtual Shareholder Meeting log in page.