On September 1, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) reported an agreement with Jounce Therapeutics, Inc. (Nasdaq: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, to exclusively license its JTX-1811 program (Press release, Gilead Sciences, SEP 1, 2020, View Source [SID1234564227]).

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JTX-1811 is a monoclonal antibody designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory (TITR) cells. The target of JTX-1811 is CCR8, a chemokine receptor enriched on TITR cells. When JTX-1811 binds to CCR8, it targets TITR cells for depletion by enhanced antibody-dependent cellular cytotoxicity mechanism. The antibody remains on track for filing an Investigational New Drug (IND) application in the first half of 2021.

"We are very pleased to add, upon closing of the transaction, JTX-1811 to our pipeline of investigational immuno-oncology therapies that have the potential to transform care for patients with cancer," said William A. Lee, PhD, Executive Vice President of Research at Gilead Sciences. "JTX-1811 is complementary to our other oncology candidates and has the potential to be first in a new class of therapies as a treatment for people with both solid tumors and hematological malignancies."

"Gilead’s investment in Jounce and, specifically, JTX-1811 reinforces the value of our Translational Science Platform and differentiated and sustainable approach to novel immuno-oncology programs, focused on patients with cancer who have yet to benefit from immunotherapy. We look forward to seeing JTX-1811 progress to the clinic," said Richard Murray, PhD, Chief Executive Officer and President of Jounce Therapeutics. "Our mission to deliver the right immunotherapy to the right patient population for meaningful and long-lasting benefit remains at the core of our discovery and clinical development work. Our JTX-1811 program is a prime example of these efforts."

Terms of the Agreement

Under the terms of the agreement, Gilead will make a $85 million upfront payment to, and a $35 million equity investment at a premium in, Jounce upon closing. In addition, Jounce may receive up to an additional $685 million in future clinical, regulatory and commercial milestone payments. Jounce will also be eligible to receive royalties ranging from high single digit to mid-teens based upon worldwide sales, subject to certain adjustments.

Jounce will lead development of JTX-1811 through IND clearance, and thereafter, Gilead will have the sole right to develop JTX-1811. JTX-1811 is not approved anywhere globally. Its efficacy and safety have not been established.

This transaction, which is expected to close in the second half of 2020, is subject to applicable antitrust clearance under the Hart-Scott Rodino Antitrust Improvements Act and other customary closing conditions.

On September 1, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported financial results for the first quarter of fiscal 2021, ended July 31, 2020 (Press release, Avid Bioservices, SEP 1, 2020, View Source [SID1234564226]).

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Highlights Since April 30, 2020

"Fiscal 2021 is off to a strong start as a result of the accomplishments of the first quarter," stated Nicholas Green, president and chief executive officer of Avid Bioservices. "During the quarter, the company achieved revenues of $25.4 million and net income of $4.7 million. And though revenue for the quarter was supplemented as a result of our completion of runs deferred from the third and fourth quarters of fiscal 2020, we are optimistic that future demand will support our growth trajectory. During the period, our business development team signed three new customers as well as project expansion orders with several existing customers. The visibility we currently have into the industry, as well as our customer projections point to continued growth in production demand throughout the year, and it is our priority to be well-positioned to support that demand.

"In recent weeks, the company also made progress with several important operational projects. As reported previously, the company experienced an equipment issue that interrupted several production runs during the third and fourth quarters of fiscal 2020. I am pleased to report that the remediation activities conducted were validated during the first quarter of fiscal 2021 by completing multiple successful revenue-generating production campaigns using this equipment. Avid also recently initiated its planned annual preventative facility maintenance program. This effort is proceeding well, with work largely completed in the Franklin facility and work on our Myford facility well underway. Lastly, during the first quarter, we made further progress with our expansion plans. As we continue to see growth in customer demand, this anticipated expansion will be important to sustaining strong future growth. We continue to dedicate significant time and resources to design, review and pre-engineering activities and look forward to updating you on our plans in the near future.

"I was very pleased to officially join the company in late July, and my first month has only strengthened my belief that Avid is a state-of-the art business with significant opportunity for growth. This is especially true given our focus on biologics, which is one of the fastest growing sectors of the industry. As I return to the United States from my time abroad, I can’t help but feel that Avid is well positioned to benefit from some of the industry trends we have seen developing recently. Given the broad and deep talent of our employees, our quality facilities and systems, and the expertise and commitment to excellence that fuels our work here at Avid, I am confident that the company will continue to thrive. As I begin what I believe will be an exciting and successful time at Avid, I wish to thank my predecessor, Rick Hancock, for his contributions over the last year. Under Rick’s leadership, Avid has evolved into the growth organization it is today, and I thank him and the board for entrusting me with the future of the company."

Financial Highlights and Guidance

The company is confirming revenue guidance for the full fiscal year 2021 of $76 million to $81 million.

Revenues for the first quarter of fiscal 2021 were $25.4 million, a 66% increase compared to revenues of $15.3 million recorded during the first quarter of fiscal 2020. The increase in revenue was primarily attributable to growth in the number and scale of in-process and/or completed manufacturing runs during the quarter, including $4.3 million from the completion of all batches that had been deferred from the third and fourth quarters of fiscal 2020 due to a previously reported equipment issue, and $3.1 million in fees received from a customer that reached its inventory requirements with fewer than expected runs, therefore not utilizing all their reserved capacity that had been scheduled for third quarter of fiscal 2021. Avid expects demand for high quality biologics capacity to continue, and it remains on track to achieve the stated revenue guidance for fiscal 2021. However, the company cautions against using its first quarter revenues as a new benchmark, as the deferred batches from the third and fourth quarters of fiscal 2020 and the fees associated with a customer’s unused capacity contributed to the top line during the period.

As of July 31, 2020, revenue backlog was $60 million, compared to $65 million at the end of the fourth quarter of fiscal 2020. The company expects to recognize the majority of this backlog during fiscal 2021.

Gross margin for the first quarter of fiscal 2021 was 34%, a significant increase compared to a gross margin of 7% for the first quarter of fiscal 2020. The increase in gross margin for the fiscal 2021 quarter was primarily attributable to increased manufacturing revenue from the growth in the number and scale of manufacturing runs and the aforementioned fees associated with a customer’s unused capacity.

Selling, general and administrative expenses ("SG&A") for the first quarter of fiscal 2021 were $3.8 million versus $4.5 million recorded for the first quarter of fiscal 2020. The decrease in SG&A was primarily attributed to a decrease in separation related expenses and other general SG&A expenses, partially offset by a net increase in payroll and benefits costs.

For the first quarter of fiscal 2021, the company recorded a consolidated net income attributable to common stockholders of $3.3 million or $0.06 per basic and diluted share, as compared to a consolidated net loss attributable to common stockholders of $4.6 million or $0.08 per basic and diluted share, for the first quarter of fiscal 2020.

Avid reported $28.2 million in cash and cash equivalents as of July 31, 2020, compared to $36.3 million as of the prior fiscal year ended April 30, 2020.
More detailed financial information and analysis may be found in Avid Bioservices’ Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Recent Corporate Developments

Expanded the company’s customer base with the addition of three new customers and executed multiple project expansion orders with existing customers representing additional net revenue backlog of $20 million during the first quarter. The company’s new customers include Iovance Biotherapeutics, Inc., Oragenics, Inc., and Mapp Biopharmaceutical, Inc. These new customers will take advantage of the range of capabilities at Avid including technical transfer, process development and scale-up, all with a view to future GMP manufacture.

Entered into a co-marketing agreement with Argonaut Manufacturing Services to support drug product manufacturing. This partnership is designed to offer customers Avid’s upstream and downstream process development and drug substance manufacturing services in tandem with Argonaut’s parenteral drug product fill-finish services, to support the efficient delivery of CGMP parenteral drug products for use in clinical studies. Through the collaborations signed with Aragen Bioscience during Q4 fiscal 2020, and with Argonaut in Q1 fiscal 2021, Avid has strategically established an end-to-end option for customers seeking support from early cell line development through drug product manufacturing.

Continued the pre-engineering, design and permitting work required to allow the company to break ground on a facility expansion at the appropriate time. While a specific kick-off date has not yet been established for this expansion, the company believes that continued strong customer demand will require additional capacity and Avid is proactively working to prepare for this growth.
Conference Call

Avid will host a conference call and webcast this afternoon, September 1, 2020, at 4:30 PM EDT (1:30 PM PDT).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source

On September 1, 2020 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that management will participate in the following upcoming virtual investor conferences (Press release, Aclaris Therapeutics, SEP 1, 2020, View Source [SID1234564225]):

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H.C. Wainwright & Co. 22nd Annual Global Investment Conference. On Tuesday, September 15, 2020 at 12:30 p.m. ET, Dr. Neal Walker, the President and CEO of Aclaris, will present a company overview. Management will be available September 15th throughout the day for virtual one-on-one meetings with investors who are registered to attend the conference.

Cantor Virtual Global Healthcare Conference. On Thursday, September 17, 2020 at 10:40 a.m. ET., Dr. Walker will participate in a fireside chat. Management will be available September 17th throughout the day for virtual one-on-one meetings with investors who are registered to attend the conference.
A live audio webcast of each presentation may be accessed through the Events page under the Investors section of Aclaris’ website, www.aclaristx.com. An archived version of each webcast will be available for 30 days.

On September 1, 2020 Kintara Therapeutics, Inc. ("Kintara" or the "Company") (Nasdaq: KTRA) reported the final closing of its previously announced private placement of Series C Convertible Preferred Stock (the "Preferred Stock") to accredited investors (Press release, Kintara Therapeutics, SEP 1, 2020, View Source [SID1234564222]). Including the previously announced closings, Kintara received aggregate gross proceeds of approximately $25 million before deducting placement agent fees and other offering expenses payable by the Company.

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The capital raised from existing and new investors is expected to facilitate Kintara’s strategic initiative to become a recognized leader in developing therapies for rare and difficult to treat oncology indications. The Company intends to use the net proceeds from the offering primarily to fund the previously announced registration study for VAL-083 in newly diagnosed and recurrent glioblastoma multiforme (GBM) and the 15-patient REM-001 confirmatory lead-in study that is designed to seamlessly transition into a Phase 3 pivotal study for cutaneous metastatic breast cancer (CMBC) as well as for working capital. As previously disclosed, the VAL-083 GBM registration study will be executed through the Company’s partnership with Global Coalition for Adaptive Research (GCAR) through the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study, the world’s first global adaptive clinical trial platform for GBM with regulatory support as a registrational study.

"This is a transformational event for the Company as we believe it validates the combined portfolio of assets from the recently completed acquisition of Adgero," commented Saiid Zarrabian, President and Chief Executive Officer of Kintara. "Furthermore, and perhaps most importantly, we believe this financing provides sufficient capital to achieve meaningful value generating milestones for multiple clinical stage programs over the next 12-24 months. We look forward to enrolling the first patient into the VAL-083 arm of the GBM AGILE study in the fourth quarter of 2020 and plan to initiate the 15 patient REM-001 confirmatory study in the second quarter of 2021, with planned data results from this study as early as the fourth quarter of 2021."

The private placement offering consisted of the issuance of an aggregate of 25,028 shares of the Company’s Series C Convertible Preferred Stock (the "Preferred Stock") at a purchase price of $1,000 per share priced at-the-market under the rules of the Nasdaq Stock Market. The Preferred Stock was issued in three separate series, 19,587 shares of Series C-1 Preferred Stock, which are convertible into 16,885,345 shares of the Company’s common stock at a conversion price of $1.16 per share, 2,185 shares of Series C-2 Preferred Stock, which are convertible into 1,799,835 shares of the Company’s common stock at a conversion price of $1.214 per share and 3,256 shares of Series C-3 Preferred Stock, which are convertible into 2,831,304 shares of the Company’s common stock at a conversion price of $1.15 per share. The Preferred Stock also accrues dividends as previously disclosed.

"The strong investor response to this private placement is confirmation of the attractiveness of Kintara’s unique corporate profile and diversified late-stage oncology product pipeline targeting rare, unmet medical needs," commented Adam Stern, Chief Executive Officer of SternAegis Ventures. "With the addition of new capital, the Company is now in a strong position to expedite the advancement of two potential therapeutic candidates into late-stage clinical trials."

SternAegis Ventures acted as the exclusive placement agent for the private placement.

The shares of Preferred Stock described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and, along with the common shares issuable upon their conversion or payable as dividends pursuant to the Preferred Stock, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

On September 1, 2020 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, reported financial results for the second quarter ended June 30, 2020, as well as recent clinical progress (Press release, Akari Therapeutics, SEP 1, 2020, View Source [SID1234564221]).

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"Akari continues to make good clinical progress, and since the beginning of the year has successfully completed its Phase II BP program and now has a clear pathway towards U.S. regulatory approval from the FDA. The HSCT-TMA program is set to commence recruitment in the fourth quarter of 2020 and we have initiated a COVID-19 pneumonia clinical program across multiple countries that leverages the unique dual C5 and LTB4 inhibition of nomacopan," said Clive Richardson, Chief Executive Officer of Akari Therapeutics.

Second Quarter 2020 and Recent Clinical Highlights

Akari’s lead programs are in BP, HSCT-TMA, COVID-19 pneumonia and AKC. These diseases have no approved treatments.

Patients with COVID-19 pneumonia

Clinical studies both underway and planned for patients with COVID-19 pneumonia in the U.S., U.K., and Brazil. In the U.S., a proposed multi-center randomized clinical program is in regulatory submission following the current treatment of patients via expanded access programs. In Brazil, patient recruitment has been completed for a proof of principle clinical study; potential progression into a follow-on randomized study is expected in early fourth quarter 2020. In the UK, nomacopan has been selected by the AGILE COVID-19 clinical trial initiative, and in addition data from approximately 50 COVID-19 pneumonia patients are expected in early fourth quarter 2020 from an observational study focused on identifying potential therapeutic biomarkers for optimizing use of nomacopan.
Nomacopan has been shown in clinical trials to inhibit both complement C5 activation and leukotriene B4 (LTB4), and has significant potential to simultaneously inhibit both microthrombi as well as block multiple cytokines (the cytokine storm) which together drive COVID-19 pneumonia and associated organ damage.
Phase II clinical trial in patients with BP

In August 2020, Akari announced a successful end-of-Phase II meeting with the U.S Food and Drug Administration (FDA) regarding its proposed pivotal Phase III program for the treatment of BP, which is now expected to start in the first half of 2021. The FDA has agreed to a two-part pivotal trial with Part A and Part B having the same structure, duration, endpoints and target population of moderate and severe BP patients. This follows positive topline results from Akari’s fully recruited Phase II study of nomacopan in BP patients previously announced in May 2020. The study achieved no reported drug-related serious adverse events. Seven of the nine treated patients showing a rapid and clinically significant reduction in Bullous Pemphigoid Disease Area Index (BPDAI) score, which measures the body surface area affected by blisters. Of the seven responders, three showed an 80%+ reduction in BPDAI score and three an approximately 40% reduction in BPDAI score within six weeks of starting nomacopan.
The European Medicines Agency (EMA) and the FDA have granted orphan drug designation for nomacopan for the treatment of BP.
Phase III clinical trial in pediatric patients with HSCT-TMA

During the first quarter of 2020, Akari initiated a pivotal Phase III trial for HSCT-TMA with nomacopan following the opening of an Investigational New Drug (IND) application by the FDA. As a result of the COVID-19 pandemic, site initiations were delayed and Akari expects enrollment to now commence in the fourth quarter of 2020. Akari has both FDA fast track for pediatric HSCT-TMA patients and orphan drug designation status for this program.
Phase I/II clinical trial in patients with AKC

As previously disclosed, enrollment into Part B of this study was paused due to the COVID-19 crisis. The study has now been unblinded to help evaluate next steps. Of the 12 patients recruited, a complete data set was available on 10 patients – two from Part A and eight from Part B. In Part B, of the eight patients recruited, six were placebo (four AKC patients and two other surface of the eye diagnosis) and two were treated with nomacopan (two AKC patients).
As a first-in-eye Phase I/II study, the primary endpoint measure was safety. Aggregating data from the eight AKC patients from Part A and Part B shows no ocular treatment emergent serious adverse events during the eight-week treatment period. Nomacopan is delivered topically without preservatives and is pH neutral. A comfort score measured after each eye drop installation showed the drug was comfortable and well tolerated. In all four efficacy categories (signs, symptoms, visual acuity and tear film break up) the four nomacopan treated AKC patients achieved a higher improved mean score than the four placebo AKC patients, however, the patient numbers are too small to show statistical significance on efficacy measures between the two treatment groups.
The interim data are encouraging and show that nomacopan eyedrops are safe and comfortable. Subject to operational constraints created by COVID-19, Akari aims to collect additional patient data with topical nomacopan. Akari recently received FDA approval for an IND for treatment with topical nomacopan which opens up the potential to broaden our topical ophthalmological program.
Second Quarter 2020 Financial Results

As of June 30, 2020, the Company had cash of approximately $12.7 million, compared to cash of $5.7 million as of December 31, 2019. Subsequent to the end of the second quarter of 2020, the Company received an additional $3.4 million in research & development tax credits.
On June 30, 2020, the Company entered into a securities purchase agreement with Aspire Capital Fund, LLC (Aspire Capital) which provides that Aspire Capital is committed to purchase up to an aggregate of $30.0 million of the Company’s ADSs, with each ADS representing one hundred ordinary shares, during a 30-month term of the purchase agreement. As of June 30, 2020, $30.4 million remains available under the facility together with a facility entered into with Aspire in 2018.
Research and development (R&D) expenses in the second quarter of 2020 were approximately $3.0 million, as compared to approximately $3.6 million in the same quarter the prior year. This decrease was primarily due to lower drug manufacturing costs and reductions of discretionary clinical expenses due to the COVID-19 outbreak delaying certain ongoing trials.
General and administrative (G&A) expenses in the second quarter of 2020 were approximately $2.9 million, as compared to approximately $2.4 million in the same quarter last year. This increase was primarily due to a one-time non-cash financing expense of $900,000 related to the 2020 purchase agreement with Aspire Capital. Higher expenses for insurance were partially offset by lower expenses for stock-based compensation, office rent and legal fees.
Total other expense for the second quarter of 2020 was approximately $2.4 million, as compared to total other income of $1.9 million in the same period the prior year. This change of $4.3 million was primarily due to approximately $4.3 million of loss related to the change in the fair value of the options and warrants liabilities in the second quarter of 2020 compared to the same period in 2019.
Net loss for the second quarter of 2020 was approximately $8.3 million, compared to a net loss of approximately $4.1 million for the same period in 2019. The increase in net loss was primarily due to higher Total Other Expense in 2020 and the aforementioned one-time non-cash financing expense related to the 2020 purchase agreement with Aspire Capital.
Important Message Regarding COVID-19

Akari’s clinical trial sites are based in areas currently affected by the global outbreak of the coronavirus, and public health epidemics such as this can adversely impact the Company’s business as a result of disruptions, such as travel bans, quarantines, and interruptions to access the trial sites and supply chains, which could result in material delays and complications with respect to research and development programs and clinical trials. Moreover, as a result of coronavirus, there is a general unease of conducting unnecessary activities in medical centers. As a consequence, the Company’s ongoing trials have been halted or disrupted. For example, the Phase I/II clinical trial in patients with AKC study has been halted and the Company expects that recruitment in the Phase III clinical trial in pediatric patients with HSCT-TMA will be delayed until the fourth quarter of 2020. It is too early to assess the full impact of the coronavirus outbreak on trials for nomacopan, but coronavirus is expected to affect Akari’s ability to complete recruitment in the original timeframe. The extent to which the coronavirus impacts operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and continued severity of the outbreak, and the actions that may be required to contain the coronavirus or treat its impact. In particular, the continued spread of the coronavirus globally, could adversely impact the Company’s operations and workforce, including research and clinical trials and the ability to raise capital, could affect the operations of key governmental agencies, such as the FDA, which may delay the development of the Company’s product candidates and could result in the inability of suppliers to deliver components or raw materials on a timely basis or at all, each of which in turn could have an adverse impact on the Company’s business, financial condition and results of operation.