On August 9, 2021 PharmaCyte Biotech, Inc. (NASDAQ: PMCB) (PharmaCyte or Company), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that the Company’s common stock is expected to begin trading on The Nasdaq Capital Market on August 10, 2021, under the symbol "PMCB (Press release, PharmaCyte Biotech, AUG 9, 2021, View Source [SID1234586155])." The Company also announced the pricing of its previously announced underwritten public offering.

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The offering consists of 3,529,412 shares of its common stock (or pre-funded warrants to purchase common stock in lieu of common stock) and warrants to purchase up to an aggregate of 3,529,412 shares of common stock. Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with one warrant to purchase one share of common stock at an effective combined public offering price of $4.25 per share of common stock and accompanying warrant, less underwriting discounts and commissions. The warrants have an exercise price of $4.25 per share, are exercisable immediately, and will expire five years following the date of issuance. PharmaCyte expects to receive gross proceeds from the underwritten public offering of approximately $15 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

H.C. Wainwright is acting as sole book-running manager for the offering.

In addition, PharmaCyte has granted the underwriter a 30-day option to purchase up to an additional 529,411 shares of common stock and/or warrants to purchase up to an additional 529,411 shares of common stock at the public offering price, less the underwriting discounts and commissions.

All the securities being sold in the offering are being offered by PharmaCyte. The offering is expected to close on or about August 12, 2021, subject to satisfaction of customary closing conditions.

The securities described above are being offered by PharmaCyte pursuant to a shelf registration statement on Form S‑3 (File No. 333-255044) that was previously filed with and subsequently declared effective by the U.S. Securities and Exchange Commission (SEC) on April 14, 2021. The securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying base prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the offering will be filed with the SEC and, when available, will be on the SEC’s website at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Avenue, New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and the accompanying prospectus forming a part of the registration statement.

On August 9, 2021 Targovax ASA (OSE: TRVX) reported that it will announce its second quarter and first half 2021 results on Wednesday 18 August 2021 (Press release, Targovax, AUG 9, 2021, View Source [SID1234586067]). An online presentation by Targovax’s management to investors, analysts and the press will take place at 10:00 am CET.

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The results report and the presentation will be available at www.targovax.com in the Investors section from 07:00 am CET.

Presentation

As a consequence of the Corona situation, there will only be a virtual presentation of the results with a live webcast 18 August at 10.00 am CET. You can join the webcast here. It will be possible to ask questions during the presentation.

On August 9, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported financial results for the second quarter ended June 30, 2021 and provided an update on its recent corporate activities and outlook (Press release, Halozyme, AUG 9, 2021, View Source [SID1234586107]).

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"Our excellent start to 2021 continued in the second quarter with strong quarterly growth resulting in record quarterly revenues from royalties and the signing of our eleventh collaboration and license agreement," said Dr. Helen Torley, president and chief executive officer. "Our recently announced collaboration with ViiV Healthcare demonstrates the potential for our ENHANZE technology to meet evolving patients’ needs by creating long-acting drugs that facilitate rapid, large volume subcutaneous injections of small molecule drugs. This collaboration also highlights the potential for ENHANZE in new disease areas like infectious disease. As a result of this new collaboration and our strong results to date, we are pleased to share that we are raising our guidance for revenues and earnings for the year."

Recent Partner Highlights:

In July 2021, Janssen received U.S. Food and Drug Administration (FDA) approval for DARZALEX FASPRO (daratumumab and hyaluronidase – fijh) in combination with pomalidomide and dexamethasone for patients with multiple myeloma after first or subsequent relapse, marking the sixth indication for DARZALEX FASPRO in the treatment of multiple myeloma.
In June 2021, Halozyme announced a global collaboration and license agreement with ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc. This license gives ViiV exclusive access to Halozyme’s ENHANZE technology for four specific small and large molecule targets for the treatment and prevention of HIV. Under the terms of the agreement, Halozyme received an upfront payment of $40 million and ViiV is obligated to make potential future payments of up to $175 million in development and commercial milestones per target, subject to achievement of specified development and commercial milestones, including certain specified sales milestones. Halozyme will also be entitled to receive mid-single digit royalties on sales of commercialized medicines using the ENHANZE technology.
In June 2021, Janssen was granted two marketing authorizations by the European Commission (EC) for DARZALEX (daratumumab) SC in two new indications in the European Union. The first authorization was for use in combination with cyclophosphamide, bortezomib and dexamethasone (D-VCd) in newly diagnosed adult patients with systemic light chain (AL) amyloidosis marking the first approved therapy for AL amyloidosis in Europe. The second authorization was for use in combination with pomalidomide and dexamethasone (D-Pd) in adult patients with relapsed or refractory multiple myeloma.
In June 2021, Bristol Myers Squibb enrolled the first patient in a Phase 3 study of nivolumab using ENHANZE technology for patients with advanced or metastatic clear cell renal cell carcinoma.
Recent Corporate Highlights:

During the second quarter, the Company repurchased approximately 1.0 million shares of common stock for $48.8 million at an average price per share of $47.05, achieving its target for share repurchases in 2021 with a total of $125 million at an average price per share of $44.43.
Second Quarter Financial Highlights

Revenue for the second quarter was $136.5 million compared to $55.2 million for the second quarter of 2020. The year-over-year increase was primarily driven by $60.0 million in milestone revenues, including $40 million from ViiV and $20 million from Janssen that was earned upon achievement of a commercial milestone related to subcutaneous DARZALEX, an increase in royalty revenue primarily attributable to subcutaneous DARZALEX and an increase in product sales. Revenue for the quarter included $45.8 million in royalties, an increase of 189% compared to $15.8 million in the prior year period.
Cost of product sales for the second quarter was $23.0 million, compared to $5.7 million for the second quarter of 2020. The year-over-year increase was primarily driven by higher product sales, principally the sales of bulk rHuPH20 to the Company’s partners.
Research and development expenses for the second quarter were $8.1 million, compared to $9.0 million for the second quarter of 2020. The decrease in expenses was due to the discontinuation of some development related activities for PEGPH20 and closure of the Company’s oncology operations, partially offset by an increase in costs to support additional ENHANZE targets.
Selling, general and administrative expenses for the second quarter were $12.3 million, compared to $11.0 million for the second quarter of 2020. The increase was primarily due to an increase in compensation expense, including stock compensation, for personnel to support additional ENHANZE targets entering clinical development.
Operating Income: On a GAAP basis in the second quarter of 2021, operating income was $93.0 million, compared to an operating income of $29.6 million in the second quarter of 2020.
Net Income: On a GAAP basis in the second quarter of 2021, net income was $91.5 million, compared with net income of $25.8 million in the second quarter of 2020. Non-GAAP net income was $97.8 million in the second quarter of 2021, compared with Non-GAAP net income of $33.6 million in the second quarter of 2020.1
Earnings per Share: On a GAAP basis in the second quarter of 2021, diluted earnings per share was $0.62, compared with $0.19 in the second quarter of 2020. On a Non-GAAP basis diluted earnings per share was $0.66, compared with diluted earnings per share of $0.24 in the second quarter of 2020.1
Cash, cash equivalents and marketable securities were $755.3 million on June 30, 2021, compared to $368.0 million on December 31, 2020.
During the second quarter, the Company repurchased 1.0 million shares of common stock for $48.8 million at an average price of $47.05, bringing the total for share repurchases since the announcement of the Company’s three-year share repurchase program to $475.0 million at an average price of $23.27.
Financial Outlook for 2021

Based on the recent signing of a new collaboration and license agreement and strong year-to-date results as well as the latest information from collaboration partners and planned expenditures for the year, the Company is raising guidance for 2021 and now expects:

Revenues of $425 million to $445 million, representing year-over-year growth of 59%-66%, and up from prior guidance of $375 to $395 million;
GAAP Operating Income of $260 million to $280 million, representing year-over-year growth of 80%-94%;
GAAP Net Income of $235 million to $255 million, representing year-over-year growth of 82%-98% and Non-GAAP Net Income of $280 million to $300 million, representing year-over-year growth of 75%-87%;1
GAAP Diluted Earnings per Share of $1.55 to $1.70, representing year-over-year growth of 70%-86%, up from prior guidance of $1.25 to $1.40; and
Non-GAAP Diluted Earnings per Share of $1.85 to $2.00, representing year-over-year growth of 65%-78%, up from prior guidance of $1.55 to $1.70.1
Webcast and Conference Call

Halozyme will webcast its Quarterly Update Conference Call for the second quarter of 2021 today, Monday, August 9, 2021, at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To register for this conference call, please use this link: View Source After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, please register a day in advance or at minimum 10 minutes before the start of the call.

On August 9, 2021 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), reported financial results for the second quarter and six months ended June 30, 2021 and highlighted recent corporate progress (Press release, Avidity Biosciences, AUG 9, 2021, View Source [SID1234586123]).

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"The FDA clearance to proceed with our AOC 1001 Phase 1/2 MARINA trial in adults with myotonic dystrophy (DM1) is a huge milestone for Avidity and our AOC platform. AOC 1001 will be the first program based on our novel technology to enter clinical development. This also marks an important step forward for the DM1 community who have no approved therapies and so desperately needs therapeutic options," said Sarah Boyce, president and chief executive officer. "In addition, over the past quarter we made significant advances in our pipeline including nominating AOC 1044 as the clinical development candidate for our lead DMD program. We remain on track for both AOC 1044 and our AOC FSHD program to advance into the clinic in 2022."

"We are well funded with $280 million at the end of Q2’21, along with an additional $155 million in estimated net proceeds from our successful financing in August 2021. Our strong financial position allows us to further progress our late stage programs while continuing to invest in our skeletal muscle pipeline and our AOC platform," said Mike MacLean, chief financial officer.

AOC Platform and Pipeline Highlights

Received FDA clearance to proceed with clinical studies for AOC 1001 in adults with DM1.

Avidity recently received clearance to proceed with the Phase 1/2 MARINA trial of AOC 1001 in adults with DM1, under its Investigational New Drug application (IND). Avidity continues to be on track to initiate the Phase 1/2 MARINA clinical trial this year. In the second half of 2022, the Company plans to conduct a preliminary assessment of safety, tolerability and key biomarkers.

Detailed information on the MARINA study was presented during Volume 2 of Avidity’s virtual investor and analyst event series. Volume 2 featured presentations on AOC 1001, the MARINA study and a presentation on the clinical impact of DM1 by Nicholas E. Johnson, MD, MSCI, FAAN, an associate professor, division chief of neuromuscular, and vice chair of research in the department of neurology at Virginia Commonwealth University. The event also featured a live Q&A session with Avidity’s management team and Dr. Johnson. Volume 2 in the series follows Volume 1 which was focused on the years of engineering underpinning Avidity’s AOC platform and AOC 1001. Replays of Volume 1 and Volume 2 can be found on the events page in the investors section of the Avidity website.

In July, the FDA granted Orphan Drug Designation for AOC 1001 for the treatment of DM1. The FDA grants Orphan Drug Designation to novel drugs that seek to treat a rare disease or condition and, if the drug is approved for the designated orphan indication, provides 7 years of market exclusivity, along with certain financial incentives, including tax credits, opportunities for grant funding towards clinical trial costs and FDA user-fee waivers.

In May, Avidity reported results from its IND-enabling toxicology study of AOC 1001. Results from the study showed the highest dose tested was the maximum feasible dose and was the no-observed adverse effect level (NOAEL). The Company did not observe any treatment-related histopathologic toxicity or any changes in safety pharmacology parameters (cardiac, respiratory and neurological). All dose levels in the study produced a greater than 80% reduction in the expression of dystrophy myotonic protein kinase (DMPK) across multiple skeletal muscles, demonstrating that pharmacology was essentially saturated even at the lowest dose tested.
Progressed Skeletal Muscle Pipeline including nominating AOC 1044 to move into IND-enabling studies.

AOC 1044 was recently nominated as the clinical development candidate for the DMD program targeting Exon 44. AOC 1044 is entering into IND-enabling studies and is on track with plans to advance into the clinic in 2022.

Data from the AOC FSHD program targeting facioscapulohumeral muscular dystrophy (FSHD) was presented at the 28th Annual FSHD Society International Research Congress (IRC) in June. The data demonstrated promising preclinical activity in both in vitro and in vivo experiments in the cells of patients with FSHD.
Second Quarter 2021 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities totaled $279.5 million as of June 30, 2021, compared to $328.1 million as of December 31, 2020.
Collaboration Revenue: Collaboration revenue, including reimbursable expenses, primarily relates to Avidity’s partnership with Eli Lilly and Company and totaled $2.6 million for the second quarter of 2021 compared with $1.5 million for the second quarter of 2020, and $5.3 million for the first six months of 2021 compared with $2.9 million for the first six months of 2020.
Research and Development (R&D) Expenses: R&D expenses include external and internal costs associated with research and development activities. These expenses were $22.7 million for the second quarter of 2021 compared with $9.0 million for the second quarter of 2020, and $43.4 million for the first six months of 2021 compared with $14.5 million for the first six months of 2020. The increases were primarily driven by the advancement of AOC 1001, AOC 1044 and our AOC FSHD program, as well as costs related to the expansion of our overall research capabilities.
General and Administrative (G&A) Expenses: G&A expenses primarily consist of employee-related expenses, professional fees, insurance costs, and patent filing and maintenance fees. These expenses were $6.3 million for the second quarter of 2021 compared with $2.9 million for the second quarter of 2020, and $12.2 million for the first six months of 2021 compared with $4.9 million for the first six months of 2020. The increases were primarily due to higher personnel costs (including noncash stock-based compensation), professional fees and insurance costs related to being a public company.

On August 9, 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 and six months ended June 30, 2021 (Press release, Nuvo Pharmaceuticals, AUG 9, 2021, View Source [SID1234586139]). 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 and six months ended June 30, 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 June 30, 2021 include the following:

Adjusted total revenue(1) was $19.9 million, an increase of 11% compared to $18.0 million for the three months ended June 30, 2020.
Adjusted EBITDA(1) was $7.4 million, a decrease of 3% compared to $7.6 million for the three months ended June 30, 2020.
Revenue related to Blexten and Cambia was $9.2 million, an increase of 46% compared to revenue of $6.3 million for the three months ended June 30, 2020. Total Canadian prescriptions of Blexten and Cambia increased by 26% and 17% respectively compared to the three months ended June 30, 2020.
The Company repaid $3.0 million (US$2.5 million) of the Amortization Loan to Deerfield Management Company, L.P. (Deerfield).
As at June 30, 2021, cash and cash equivalents were $27.3 million.
Six months ended June 30, 2021 include the following:

Adjusted total revenue(1) was $34.5 million, a decrease of 7% compared to $37.0 million for the six months ended June 30, 2020.
Adjusted EBITDA(1) was $11.7 million, a decrease of 25% compared to $15.6 million for the six months ended June 30, 2020.
Revenue related to Blexten and Cambia was $14.8 million, an increase of 21% compared to revenue of $12.2 million for the six months ended June 30, 2020. Canadian prescriptions of Blexten and Cambia increased by 25% and 13% respectively compared to the six months ended June 30, 2020.
The Company repaid $6.6 million (US$5.4 million) of the Amortization Loan to Deerfield.
(1) Non-International Financial Reporting Standards (IFRS) financial measure defined by the Company below.

Business Update

In July 2021, Nuvo Pharmaceuticals (Ireland) DAC trading as Miravo Healthcare (Miravo Ireland) entered into an exclusive license and supply agreement with SK Chemicals Co., Ltd. (SK Chemicals) for the exclusive right to commercialize Suvexx in the Republic of South Korea. Miravo Ireland will receive up to €1.1 million in upfront consideration, regulatory and sales-based milestone payments, as well as royalties on net sales of Suvexx in South Korea and revenue pursuant to the supply of product.
In May 2021, the Company announced the appointment of Mary Ritchie to its Board of Directors. Ms. Ritchie is the President and Chief Executive Officer of Richford Holdings Ltd., an accounting and investment advisory services firm based in Edmonton, Alberta. Ms. Ritchie has over 30 years of experience in both the public, private and not-for-profit sectors and is a Fellow of CPA Alberta. She is a member of the board of directors and audit committees of Alaris Royalty Corp. (TSX) and EnWave Corporation (TSXV). She has been a past director on a number of boards, including the Canada Pension Plan Investment Board, Industrial Alliance Insurance, Financial Services Inc. (TSX), iA Financial Corporation Inc. (TSX) and IPL Plastics Inc. (TSX) and a past member of the RBC Global Asset Management’s independent oversight committee.
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.
"Our key promoted brands, Blexten and Cambia, continued their solid performance and demonstrated year-over-year gains in prescription and revenue growth. New Blexten prescriptions now represent 1 in 4 new antihistamine prescriptions nationally, and 1 in 3 new antihistamine prescriptions in Ontario, Alberta, and British Columbia. Our recently launched Suvexx and NeoVisc brands are performing according to plan and are steadily growing market share," said Jesse Ledger, Miravo’s President & CEO. "Our international business also continues to expand with our recently announced Suvexx licensing agreement for South Korea. This represents our first Suvexx license partner for Asia and, once approved, will introduce Suvexx as a treatment option in a rapidly growing acute migraine market. This transaction is another example of our team executing on our business development objectives."

Second Quarter 2021 Financial Results
Adjusted total revenue was $19.9 million and $34.5 million for the three and six months ended June 30, 2021 compared to $18.0 million and $37.0 million for the three and six months ended June 30, 2020. The $1.9 million increase in adjusted total revenue in the current quarter was primarily attributable to an increase of $4.3 million in the Commercial Business segment and an increase of $0.7 million of revenue from the Production and Service Business segment, slightly offset by a decrease of $3.1 million of revenue in the Licensing and Royalty Business segment. Adjusted total revenue attributable to the Commercial Business segment increased during the current quarter due to an increase in sales of the Company’s promoted products (Blexten, Cambia, Suvexx and Neovisc), as well as an increase in sales of the Company’s mature products. The Production and Service Business segment adjusted total revenue increased as a result of an increase in the Company’s Pennsaid product sales, slightly offset by the strengthening of the Canadian dollar against the U.S. dollar, which decreased the value of U.S. denominated sales compared to the three months ended June 30, 2020. Adjusted total revenue decrease in the Licensing and Royalty Business segment as a result of a decrease in royalty earned on U.S. net sales of Vimovo due to a competitor launching a generic version of Vimovo in March 2020, as well as a decrease in amounts billed to customers for existing contract assets. In the comparative quarter, the Company received a $2.4 million (US$1.8 million) milestone from Takeda Pharmaceutical Co., Ltd. related to the use of its Yosprala intellectual property in Japan.

Adjusted EBITDA was $7.4 million and $11.7 million for the three and six months ended June 30, 2021 compared to $7.6 million and $15.6 million for the three and six months ended June 30, 2020. During the three months ended June 30, 2021, increases in gross profit from the Company’s Commercial Business and Production and Service Business segments was more than offset by an increase in general and administrative expenses, as well as a decrease in the contribution from the License and Royalty Business segment due to a decline in the U.S. Vimovo royalty and a decrease in amounts billed to customers for existing contract assets.

Non-IFRS Financial Measures
The Company discloses non-IFRS measures (such as adjusted total revenue and adjusted EBITDA) 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. 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. These measures should be considered as supplemental in nature and not as a substitute for related financial information prepared in accordance with IFRS.

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.

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:

Management to Host Conference Call/Webcast
Management will host a conference call to discuss the results today (Monday, August 9, 2021) at 11:00 a.m. ET. To participate in the conference call, please dial 416 764 8688 or 1 888 390 0546. Please call in 15 minutes prior to the call to secure a line. You will be put on hold until the conference call begins.

A taped replay of the conference call will be available two hours after the live conference call and will be accessible until midnight on August 16, 2021 by calling 416 764 8677 or 1 888 390 0541 / replay passcode: 457561#.

A live audio webcast of the conference call will be available through www.miravohealthcare.com. Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to hear the webcast.