On August 13, 2020 Acacia Pharma Group plc ("Acacia Pharma" or the "Company" and, together with its subsidiaries, the "Group") (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or chemotherapy, reported its unaudited interim results for the six-month period ended 30 June 2020 (Press release, Acacia Pharma, AUG 13, 2020, View Source [SID1234568514]).

Mike Bolinder, CEO of Acacia Pharma, said: "The first half of 2020 was truly a transformative period for the Company. We were delighted to gain FDA approval for our first product, BARHEMSYS, in February. We identified and developed this product through an extensive and successful clinical trials program and it is testament to the founders and employees of the company for achieving this significant milestone.

"The in-licensing and subsequent US approval of BYFAVO added a second product to strengthen our portfolio targeting the anesthesiology market. We are now focused on building the optimal commercial organization to launch both products in the US, where we believe there is significant need for our new products.

"The coronavirus has created many challenges for the global healthcare system and supply chains. We believe it has also created opportunity for our products, and that we will see strong demand for both products given that they are designed in part to improve procedural throughput to help address the current surgical backlogs in hospitals and surgical centres that exist as a result of the pandemic. We also believe that in making these new products available, we can satisfy the demand for products addressing PONV and procedural sedation owing to shortages of supply that currently exist for the current standard-of-care drugs for these indications.

"Our focus is now wholly on executing a successful launch of BARHEMSYS and BYFAVO in 2H 2020, which will further accelerate our transition from an R&D-led company into a commercial business bringing much needed treatments to patients in the US. We look forward to an exciting time ahead and to providing further updates on our progress."

Operating Highlights (including post-period updates)

On 26 February 2020, the US Food and Drug Administration (FDA) approved the New Drug Application (NDA) for BARHEMSYS (amisulpride injection), the Company’s first product approval, allowing its commercialization in the US for the treatment and prevention of postoperative nausea and vomiting (PONV).
The label is the first to include rescue treatment in patients who have failed prior prophylaxis, and also includes combination prophylaxis with other antiemetics in higher risk patients, the two key commercial unmet needs.
On 27 July 2020, FDA approved a second supplier for the active pharmaceutical ingredient (API) for BARHEMSYS, supporting the Group’s ability to provide a continuous, high-quality product supply to meet the anticipated ongoing demand.
On 2 July 2020, FDA approved the NDA for the Group’s second product, BYFAVO (remimazolam), a rapid onset/offset IV benzodiazepine sedative for injection, for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less, such as colonoscopy and bronchoscopy.
BYFAVO was in-licensed on 10 January 2020 from Cosmo Technologies Limited (Cosmo) as part of a strategic agreement that also involved Cosmo making an equity investment in Acacia Pharma and providing a debt facility to the Group to finance the US commercialization of BARHEMSYS and BYFAVO.
On 1 June 2020, the Company announced that €10m of the overall Cosmo debt facility had been replaced by a €10m equity investment.
With effect from 7 August 2020, the Group was assigned the US license to BYFAVO by Cosmo with the consent of PAION UK Limited, thereby establishing a direct relationship between the originator of remimazolam and the Group as its US commercialization partner.
US infrastructure established in preparation for launch of BARHEMSYS and BYFAVO in 2H 2020.
The Company has assembled a highly experienced commercial leadership team with proven success in commercializing specialty pharmaceutical products to anaesthetists, surgical teams and directors of pharmacy – the target customers for BARHEMSYS and BYFAVO.
With both products approved, the Company is advancing its plans to build an initial hospital sales force and support staff ahead of launch in the 2H 2020.
The Company believes that the procedural backlogs and standard-of-care drug shortages, as a result of the coronavirus situation, have created potential pent-up demand for drugs such as BARHEMSYS and BYFAVO.
The Company announced changes to its senior management team and Board of Directors during 1H 2020 as part of its planned transition into a commercial-stage company.
With effect from 1 March 2020, Gary Gemignani was appointed Chief Financial Officer, succeeding Christine Soden who stepped down from the role and retired from the Board of Directors.
At the Annual General Meeting (AGM) on 7 April 2020, Scott Byrd was elected Chairman and Alessandro Della Chà, Chief Executive Officer and Director of Cosmo, was elected as a Non-Executive Director.
Patrick Vink (former Chairman), Pieter van der Meer and Johan Kördel (both former Non-Executive Directors) previously announced their intentions not to stand for re-election and stepped down from the Board at the AGM.

Financial Highlights

Cash and cash equivalents were $24.6m at 30 June 2020 (31 December 2019: $17.0m, 30 June 2019: $22.7m).
Operating loss for the period remained flat at $12.8m (1H 2019: $12.8) as the Group transitions from an R&D-led business towards the launch and commercialization of BARHEMSYS and BYFAVO.
G&A costs increased $2.2m in 1H 2020 to $4.4m (1H 2019: $2.2m) as a result of increased legal and other costs mainly related to the transactions with Cosmo Pharmaceuticals.
R&D costs in the 1H 2020 decreased to $0.6m (1H 2019: $2.5m) due to costs in the prior year attributed to activities preparing the NDA for BARHEMSYS.
Basic loss per share $0.24 (H1 2019: $0.25).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On August 13, 2020 Acacia Pharma Group plc ("Acacia Pharma" or the "Company") (EURONEXT: ACPH), a commercial stage biopharmaceutical company reported that focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or chemotherapy, intends to issue new ordinary shares of a nominal value of £0.02 (the "New Ordinary Shares") raising gross proceeds of approximately EUR 25m ($30m), by means of an accelerated bookbuild offering (the "Placing") (Press release, Acacia Pharma, AUG 13, 2020, View Source [SID1234568513]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The price at which the New Ordinary Shares will be issued (the "Placing Price") and the total number of New Ordinary Shares to be issued in the Placing will be determined by way of an accelerated bookbuild process (the "Bookbuild"). The Company believes that using the flexibility provided by a non-pre-emptive placing is the most appropriate structure for the Company at this time, allowing it to raise capital in a timely and cost-effective manner and to diversify the shareholder base.

Jefferies International Limited ("Jefferies") and Guggenheim Securities, LLC ("Guggenheim Securities") are acting as Joint Global Coordinators and Joint Bookrunners and Bank Degroof Petercam SA/NV ("Degroof Petercam") is acting as Joint Bookrunner and Listing Agent (Jefferies, Guggenheim Securities and Degroof Petercam together, the "Joint Bookrunners" or the "Banks") in connection with the Placing.

The Bookbuild will start immediately following this announcement. Pricing and allocation of the New Ordinary Shares in the Placing is expected to take place before beginning of trading on Euronext Brussels at 09:00 CEST on 14 August 2020. The exact timing of closing of the Bookbuild, pricing and allocation is at the discretion of the Company and the Joint Global Coordinators and Joint Bookrunners. The Company will announce the outcome of the Placing after closing of the Bookbuild in a subsequent announcement.

The Company has requested the Belgian Financial Services and Markets Authority ("Belgian FSMA") to suspend trading in Acacia Pharma’s shares on Euronext Brussels during the Bookbuild. Trading in the shares is expected to resume following the publication of the results of the Placing.

The Company has separately announced today its interim results for the six months ended 30 June 2020 (the "Interim Results Announcement"). This announcement should be read in conjunction with the Interim Results Announcement.

The net proceeds of the Placing are intended to be used for:
(i) the recruitment of an initial sales force of approximately 30, with an additional ten support staff; NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN AND SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE SUCH PUBLICATION, DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR OTHER MEASURES
2 (ii) payment of marketing costs relating to BARHEMSYS and BYFAVO including brand development and engagement with key opinion leaders, healthcare professionals and medical conference and speaker programmes;
(iii) the implementation of post-approval research and development commitments including paediatric studies for BARHEMSYS and BYFAVO and a renal study for BARHEMSYS;
(iv) satisfaction of interest and capital payments under existing loan agreements; and
(v) general corporate purposes relating to ongoing commercial activities as well as supplementing existing stock of both BARHEMSYS and BYFAVO.

In connection with the Placing, the Company has agreed, pursuant to a lock-up undertaking, not to issue additional shares for a period of 90 days following settlement of the Placing. In addition, in connection with the Placing, senior managers and directors of the Company as well as Cosmo Technologies Limited, a substantial shareholder in the Company, have agreed not to sell any shares in Acacia Pharma for a period of 90 days following the settlement of the Placing, subject to customary exceptions.

Your attention is drawn to the detailed terms and conditions of the Placing described in Appendix I to this announcement (which form part of this announcement). The attention of investors is drawn in particular to the "Conditions of the Placing and Termination of the Placing Agreement" section of Appendix I (including the condition that no Material Adverse Change can have occurred immediately prior to the Closing Date and, in respect of termination of the Placing Agreement, the various applicable force majeure events set out therein).

Capitalised terms used but not otherwise defined in the text of this announcement are defined in Appendix II of this announcement.

On August 13, 2020 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA) (the Company or Ayala), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported financial results for the second quarter ended June 30, 2020 and highlighted recent progress and upcoming milestones for its pipeline programs (Press release, Ayala Pharmaceuticals, AUG 13, 2020, View Source [SID1234563990]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our successful IPO in the second quarter represents an important step for Ayala as we work to make meaningful strides across our exciting programs. With a well-capitalized foundation on which to further develop our novel pipeline of therapies for genetically defined cancers, we are poised to execute across multiple milestones in the remainder of 2020 and through the first half of 2021," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "We are looking forward to presenting new interim data from our Phase 2 ACCURACY study of AL101 for the treatment of ACC in September 2020, while also continuing to dose patients in the 6mg dose cohort of the study. Now more than ever, the need for innovation and drug development is evident and we are pleased by the additional clinical progress we have made to-date. This quarter our IND was accepted for our Phase 2 TENACITY study of AL101 monotherapy in patients with recurrent or metastatic triple negative breast cancer who have undergone up to three prior lines of therapy and we are on track to begin dosing patients this year."

Key Business and Clinical Highlights

Phase 2 TENACITY Study of AL101 For Treatment of Triple Negative Breast Cancer: In April 2020, the U.S. Food and Drug Administration (FDA) accepted the investigational new drug application (IND) for the Phase 2 TENACITY study of AL101 for the treatment of Triple Negative Breast Cancer (TNBC). The FDA approved the dosing to commence at 6mg in a monotherapy study to evaluate TNBC patients bearing Notch activating mutations who have undergone 3 or fewer prior lines of therapy. Ayala has opened its first U.S. clinical site for the study.
Upcoming Milestones

New Interim Data from Phase 2 ACCURACY Study of AL101 for the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma to be Presented at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020: Ayala will provide an oral presentation of new interim data from its ongoing Phase 2 ACCURACY study of AL101 for the treatment of recurrent/metastatic adenoid cystic carcinoma (R/M ACC) harboring Notch activating mutations at the upcoming ESMO (Free ESMO Whitepaper) Virtual Congress 2020 on September 18, 2020, at 03:55 CEST.

On Track to Begin Patient Dosing in Phase 2 TENACITY Study of AL101 for the Treatment of TNBC: Ayala expects to initiate patient dosing before year-end 2020 in the Phase 2 TENACITY study of AL101 for the treatment of TNBC harboring Notch activating mutations.

On Track to Initiate Two Phase 2 Clinical Trials in 2021:

Phase 2 Study of AL102 for the Treatment of Desmoid Tumors: Ayala expects to initiate a Phase 2 study of AL102, a potent, selective, oral gamma secretase inhibitor, in patients with desmoid tumors, a category of rare, disfiguring and often debilitating soft tissue tumors, in the first half of 2021.

Phase 2 Study of AL101 for the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia: Based on findings from Ayala’s Phase 1 study of AL101 and supporting data from its preclinical studies, Ayala expects to initiate a Phase 2 study of AL101 for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (R/R T-ALL), an aggressive and rare form of T-cell specific leukemia, in the first half of 2021.
Second Quarter 2020 Financial Results

Cash Position: Cash and cash equivalents were $57.4 million as of June 30, 2020, as compared to $16.7 million as of December 31, 2019. Ayala expects its existing cash balance to fund operations through multiple potential key clinical and development milestones into the second half of 2022.

Collaboration Revenue: Collaboration revenue was $1.0 million for the second quarter of 2020 compared to $0.9 million for the same period in 2019. The increase in revenue was attributed to the advancement of Ayala’s collaboration with Novartis for the development of AL102 in combination with Novartis’ anti-B-cell maturation antigen agent.

R&D Expenses: Research and development expenses were $5.1 million for the second quarter of 2020, compared to $3.4 million for the same period in 2019. The increase was primarily driven by additional costs in connection with the advancement of AL101 trials and other preclinical development.

G&A Expenses: General and administrative expenses were $1.5 million for the second quarter of 2020, compared to $1.0 million for the same period in 2019. The increase was primarily related to higher professional services and personnel costs to support the growth of the Company.

Net Income/Loss: Net loss was $6.7 million, or $0.74 loss per share, for the second quarter of 2020, compared to $3.8 million, or $0.76 loss per share, for the same period in 2019, mainly attributable to the advancement of the clinical trials and other preclinical development.

On August 13, 2020 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of rare primary and metastatic cancers of the liver, announces financial results for the quarter ended June 30, 2020, and will host an earnings call on August 13, 2020 at 4:30 p.m.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Corporate Highlights:

Completed a $22 million public offering, led by healthcare-focused investors, to allow completion of the Company’s Phase 3 registration trial of Melphalan/HDS in liver-dominant metastatic ocular melanoma (mOM) and refiling of a New Drug Application (NDA) with FDA.

Uplisted to the NASDAQ Capital Market.

Announced management and board transitions.

Initiated pre-commercialization work for Melphalan/HDS in mOM.

Initial physician and payer surveys have highlighted the high-unmet medical need in mOM as well as the expectation of ultra-orphan oncology pricing dynamic for Melphalan/HDS.
Expected Milestones:

Late 2020/early 2021 – COVID-19 has affected clinical trials globally, including our Phase 3 FOCUS registration trial for Melphalan/HDS in liver-dominant ocular melanoma. Importantly, however, throughout these months, the trial protocol remained intact and ongoing trial patients continued to receive treatments. While access to clinical sites for data entry and monitoring was severely restricted during the quarter, the majority of the study’s European and US sites began to ease these restrictions subsequent to quarter end. In addition, we implemented a number of steps to increase data monitoring efforts in light of the impact of the pandemic. Based on the current trajectory of site access, management is focused on delivering top-line results by year-end 2020/early 2021.

Mid-2021– New Drug Application (NDA) submission of Melphalan/HDS in liver-dominant mOM. During the quarter management took steps to ensure progress on key elements of our NDA submission. Those included, among other things, required non-clinical studies and Chemistry, Manufacturing and Controls (CMC) work to ensure that any potential COVID-19 clinical data delays would not affect our timelines to NDA submission.

Initiation of additional clinical studies for Melphalan/HDS in liver-dominant orphan cancers of high unmet-medical need. During the quarter, in-line with the overall restructuring efforts, management initiated a comprehensive review of the multitude of potential pipeline opportunities available for the Company to pursue, as potential label-expansion, beyond mOM. The analysis comprises available clinical evidence, based on the European commercial experience, where Melphalan/HDS is approved as a device-only configuration under the brand name CHEMOSAT, as well as the potential US commercial opportunity. Based on the conclusions of this analysis Delcath expects to initiate at least one additional clinical development program of Melphalan/HDS in coming quarters.
John Purpura, interim CEO of Delcath commented, "Q2 was a transformational quarter for Delcath. The recent $22 million public offering along with our NASDAQ uplisting have been the culmination of a strategic restructuring achieved over the last year. With $51.5 million raised in the 12-month period ended June 30, 2020, led by fundamental healthcare focused investors, Delcath has been restructured, recapitalized and refocused. Our current cash resources, along with expected cash milestones from our European commercialization partner, medac GmBH, provide us with a sufficient runway through multiple value inflection points. These include completion of our Phase 3 FOCUS trial in metastatic ocular melanoma and the refiling of a New Drug Application (NDA) with FDA by mid-2021."

Mr. Purpura added, "Working towards the possibility of having Melphalan/HDS available as a treatment for mOM patients, who have limited therapeutic options, is Delcath’s top priority. With Melphalan/HDS set for potential FDA approval in the second half of 2021, as the only labelled mOM-specific therapy in the US, Delcath has begun pre-commercialization activities which it intends to accelerate in coming quarters. Initial work has highlighted oncologists’ perceptions of the high-unmet medical need of mOM patients, the potential front-line positioning of Melphalan/HDS in this setting and the expectation of attractive ultra-orphan pricing dynamics for our therapy."

Mr. Purpura concluded, "Interventional Oncology has become, in recent years, an integrated, fast-growing segment of cancer care. We believe that Melphalan/HDS is uniquely positioned as a potentially well differentiated, high-value, interventional oncology treatment paradigm targeting orphan and ultra-orphan indications of high unmet medical need. Beyond mOM, Delcath is currently looking to initiate additional studies in one or more liver-dominant metastatic indications for which Melphalan/HDS could be applicable. We expect the next 12 months to be transformational for Delcath and are looking forward to providing updates on our progress throughout."

Second Quarter 2020 Financial Results:

Income Statement Highlights. Product revenue for the three months ended June 30, 2020 was approximately $262 thousand, compared to $221 thousand for the prior year period from our sales of CHEMOSAT procedures in Europe. Selling, general and administrative expenses were approximately $2.3 million compared to $2.7 million in the prior year quarter. Research and development expenses for the second quarter were $2.2 million compared to $1.7 million in the prior year quarter. Total operating expenses for the second quarter were $4.5 million compared with $4.4 million in the prior year quarter.

We recorded a net loss for the three months ended June 30, 2020, of $4.3 million, compared to a net loss of $6.0 million for the same period in 2019.

Balance Sheet Highlights. At June 30, 2020, we had cash, cash equivalents and restricted cash totaling $16.2 million, as compared to cash, cash equivalents and restricted cash totaling $10.2 million at December 31, 2019 and $1.4 million at June 30, 2019. During the three months ended June 30, 2020 and June 30, 2019, we used $7.9 million and $3.2 million, respectively, of cash in our operating activities. In Q2 we made a number of one-time cash payments not indicative of the usual cash usage trend totaling approximately $3.3 million, including compensation payable subsequent to resignations of executives and a director, and past-due payables.

We believe our cash resources and anticipated milestone payments, are adequate to fund our operating activities into mid-year 2021.

Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the Delcath Second Quarter Conference Call when reaching an operator.

On August 13, 2020 Mission Bio, Inc., the pioneer in high-throughput single-cell DNA and multi-omics analysis, reported $70 million in its Series C financing led by Novo Growth, the growth equity arm of Novo Holdings (Press release, Mission Bio, AUG 13, 2020, View Source [SID1234563630]). Soleus Capital also joins the round, along with earlier investors Mayfield, Cota, and Agilent, bringing the company’s total funding to more than $120 million. To support Mission Bio’s rapid growth, the funds will scale its single-cell multi-omics technology, the Tapestri Platform, to expand the company’s reach in more effective clinical trials for novel cancer treatments, as well as characterization for cell and gene therapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As part of this announcement, Robert Ghenchev, Senior Partner and Head of Novo Growth, has joined Mission Bio’s board of directors. "In Novo Growth, our strategy is to support companies developing cutting edge science that has significant potential to positively impact patients and society. Single-cell analysis has proven highly valuable in cancer research, and we are confident the technology will be used increasingly to unlock key insights into blood cancers, as well as solid tumor indications. We further see a clear opportunity in drug development, where the technology can bring great impact to patients’ lives," said Ghenchev. "We are impressed with Mission Bio’s innate approach to data integration at the single-cell level and are excited to contribute more than capital by activating our broad life science network to support their mission to greatly impact the success and economics of precision therapy development."

Over the past year, Mission Bio has advanced its efforts to support drug development through clinical trials and the translation of research into novel biomarkers with its growing install base in NCI cancer centers and key biopharma companies. The Tapestri Platform is the first-ever single-cell multi-omics platform capable of detecting DNA and protein changes simultaneously from the same cell — a capability necessary for the development of more impactful precision therapies. The award-winning technology has been adopted by Agios, LabCorp, Onconova Therapeutics, and other companies to optimize clinical trials and improve the likelihood of success. Leading cancer centers, including Stanford, MD Anderson Cancer Center, the University of California at San Francisco, and Memorial Sloan Kettering Cancer Center, have leveraged the Tapestri Platform to support their work in therapeutic resistance and treatment response monitoring.

"We are on a mission to help our customers eliminate cancer. With access to multiple layers of the cellular profile, the Tapestri Platform can help identify novel biomarkers in diseased cells, monitor therapy resistance and response, and accelerate novel therapies through clinical trials," said Charlie Silver, CEO, and Co-founder of Mission Bio. "We are delighted to partner with Novo Holdings to advance our impact in drug development and cell and gene therapy."