On August 11, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported corporate updates and financial results for the first quarter fiscal year 2020 (Press release, Myovant Sciences, AUG 11, 2020, View Source [SID1234563441]).

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"I am very proud of the many recent accomplishments achieved by Myovant, including positive results from our second Phase 3 study in women with endometriosis, publication of our advanced prostate cancer data in the New England Journal of Medicine, and progress in our commercial readiness, particularly now that relugolix is under Priority Review by the FDA for advanced prostate cancer and the NDA for relugolix combination therapy for uterine fibroids has been submitted for review," said Lynn Seely, M.D., chief executive officer of Myovant Sciences. "The additional financial commitment from Sumitomo Dainippon Pharma and our commercial collaboration agreement with Sunovion we expect will further advance our vision to potentially provide one pill, once-a-day treatment options to the women and men with these common diseases."

First Quarter Fiscal Year 2020 and Recent Corporate Updates

Relugolix Phase 3 Clinical Programs

Prostate cancer: In June 2020, the U.S. Food and Drug Administration (FDA) accepted for Priority Review Myovant’s New Drug Application (NDA) for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer, setting a target action date of December 20, 2020. In May 2020, efficacy and safety data from the Phase 3 HERO study of relugolix in men with advanced prostate cancer were simultaneously published in the New England Journal of Medicine and presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program. In July 2020, these data were also presented in an oral presentation during the American Urological Association (AUA)’s 2020 Virtual Experience.

Uterine fibroids: In May 2020, Myovant submitted an NDA for once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of women with heavy menstrual bleeding associated with uterine fibroids. In July 2020, Myovant presented additional data from the Phase 3 LIBERTY program showing improvement in patient-reported outcomes and in hemoglobin levels in women with anemia, as well as detailed data from a separate ovulation inhibition study, at the European Society of Human Reproduction and Embryology (ESHRE)’s virtual 36th Annual Meeting.

Endometriosis: In April 2020, Myovant announced that the SPIRIT 2 Phase 3 study evaluating the efficacy and safety of once-daily, oral relugolix combination therapy in women with pain associated with endometriosis met the co-primary efficacy endpoints with 75.2% and 66.0% of women achieving clinically-meaningful reductions in dysmenorrhea and non-menstrual pelvic pain, respectively. In June 2020, Myovant announced that the replicate SPIRIT 1 Phase 3 study also met the co-primary efficacy endpoints with 74.5% and 58.5% of women achieving clinically-meaningful reductions in dysmenorrhea and non-menstrual pelvic pain, respectively. Relugolix was generally well-tolerated and resulted in minimal bone mineral density loss over 24 weeks in both studies.
Corporate

On August 5, 2020, Myovant announced an additional USD 200 million low-interest, five-year term loan commitment from Sumitomo Dainippon Pharma, which, subject to the negotiation of a definitive agreement, will bring its total financing support for Myovant to USD 600 million, further bolstering Myovant’s cash and committed funding, and increasing Myovant’s financing flexibility as it prepares for multiple potential product launches.

On August 5, 2020, Myovant also announced that it entered into a three-year commercial collaboration agreement with Sunovion Pharmaceuticals Inc. (Sunovion). Under the agreement, Sunovion will provide third-party logistics, trade and retail distribution, contract operations, and market access account management services to Myovant and will become a non-exclusive distributor of relugolix for prostate cancer and the exclusive distributor of relugolix combination tablet for uterine fibroids and endometriosis in the U.S.

In June 2020, Myovant partnered with BlackDoctor.org, Evidation Health, and Movember to launch Forward Momentum, a cross-sector coalition working on innovative projects to increase diversity in research and develop new digital resources for men with prostate cancer.
COVID-19 Pandemic Environment

Myovant’s priorities during the COVID-19 pandemic are protecting the health and safety of its employees while continuing its mission to redefine care for women and for men. To date the impact of the COVID-19 pandemic on Myovant’s ability to advance its clinical studies, regulatory activities, and preparation for the potential commercialization of its product candidates has been limited and all of Myovant’s publicly announced milestones remain on track. However, if the COVID-19 pandemic persists, and depending on the further evolution of the pandemic and its effects on Myovant’s activities, Myovant may experience more significant impacts on its business operations.
Expected Upcoming Milestones

Castration-resistance free survival data for prostate cancer expected in the third quarter of calendar year 2020.

Data from the uterine fibroids cohort in the prospective observational bone mineral density study expected in the third quarter of calendar year 2020.

Relugolix monotherapy tablet for advanced prostate cancer target action date of December 20, 2020.

Data from the LIBERTY randomized withdrawal study expected in the first quarter of calendar year 2021.

One-year efficacy and safety data from the SPIRIT extension study expected in the first quarter of calendar year 2021.
First Quarter Fiscal Year 2020 Financial Summary

License and milestone revenue in the three months ended June 30, 2020, was $33.3 million and represents the partial recognition of revenue associated with the $40 million upfront payment and a $10 million regulatory milestone payment under the Development and Commercialization Agreement Myovant entered into with Gedeon Richter (Richter) in March 2020. Myovant recognizes revenue as it satisfies its performance obligation to Richter. There were no such amounts in the comparable prior year period.

Research and development (R&D) expenses in the three months ended June 30, 2020, were $44.2 million compared to $51.1 million for the comparable prior year period. The decrease in R&D expenses reflects a decrease in clinical study costs as a result of the completion and wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies. This decrease was partially offset by an increase in other R&D expenses related predominantly to regulatory activities in connection with regulatory submissions for relugolix combination tablet and relugolix monotherapy tablet, including NDA submission fees of $5.8 million, expenses associated with the build out of Myovant’s medical affairs organization in connection with preparations for Myovant’s anticipated commercial launches, as well as increases in personnel-related expenses.

General and administrative (G&A) expenses in the three months ended June 30, 2020, were $22.8 million compared to $14.2 million for the comparable prior year period. The increase was primarily due to increases in expenses related to commercial operations activities in advance of potential future regulatory approvals of relugolix combination tablet and relugolix monotherapy tablet, personnel-related expenses, and other general overhead, administrative, and information technology expenses to support Myovant’s organizational growth.

Interest expense was $2.2 million in the three months ended June 30, 2020, related to the Sumitomo Dainippon Pharma Loan Agreement compared to $3.8 million in the comparable prior year period, related to Myovant’s previously outstanding financing arrangements with NovaQuest and Hercules. The decrease in interest expense was driven by a lower interest rate associated with the Sumitomo Dainippon Pharma Loan Agreement as compared to the previously outstanding obligations to NovaQuest and Hercules, which were repaid in December 2019. Myovant expects its interest expense to increase in future periods as a result of further anticipated draws under the Sumitomo Dainippon Pharma Loan Agreement.

Interest income in the three months ended June 30, 2020, was $0.1 million compared to $0.8 million for the comparable prior year period. The decrease was primarily due to decreases in interest rates and lower balances in cash equivalents and marketable securities.

Other income, net in the three months ended June 30, 2020, was $3.6 million compared to $0.7 million for the comparable prior year period. This increase was primarily the result of a foreign currency exchange gain on Myovant’s outstanding balance under the Sumitomo Dainippon Pharma Loan Agreement.

Net loss for the quarter ended June 30, 2020, was $32.9 million compared to $67.9 million for the comparable prior year period. The decrease in the net loss for the quarter was driven primarily by the recognition of $33.3 million of license and milestone revenue from the Gedeon Richter Development and Commercialization Agreement. On a per common share basis, net loss was $0.37 and $0.89 for the quarters ended June 30, 2020, and 2019, respectively.

Capital resources: Cash, cash equivalents, marketable securities, and committed funding from Sumitomo Dainippon Pharma totaled $306.0 million as of June 30, 2020, and consisted of $99.7 million of cash, cash equivalents, and marketable securities and $206.3 million of available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement. Additional funds may be drawn down by Myovant once per calendar quarter, subject to certain terms and conditions, including consent of Myovant’s Board of Directors. In July 2020, Myovant borrowed an additional $60.0 million under the Sumitomo Dainippon Pharma Loan Agreement. On August 5, 2020, Myovant announced a USD 200 million, low-interest, five-year term loan commitment from Sumitomo Dainippon Pharma, which, subject to negotiation of a definitive agreement, will bring its total financing support for Myovant to USD 600 million.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testicular testosterone, a hormone known to stimulate the growth of prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under development for women with uterine fibroids and for women with endometriosis. Relugolix monotherapy tablet (120 mg once daily) is under regulatory review in the U.S. for men with advanced prostate cancer.

On August 11, 2020 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the second quarter ended June 30, 2020 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, AUG 11, 2020, View Source [SID1234563440]).

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"By developing targeted alpha therapies (TATs), Fusion is taking a precision medicine approach to radiation therapy," said Chief Executive Officer John Valliant, Ph.D. "In addition to our lead program, FPI-1434, which is currently in a Phase 1 clinical trial, Fusion’s research and development capabilities, manufacturing and supply chain expertise, and our Fast-Clear linker technology provide a platform for creating new TATs and growing our pipeline."

Dr. Valliant continued, "Following a successful initial public offering in June, and achieving a regulatory milestone that triggered the second tranche of our Series B financing in May, we are well-positioned to reach significant inflection points in our clinical programs, expand our pipeline, and invest in our platform to create potent TATs."

"Our near-term priority is to initiate the multi-dosing portion of our Phase 1 trial of FPI-1434, and we are pleased to have received notice from both Health Canada and the U.S. Food and Drug Administration (FDA) that we are able to move forward with these plans," Dr. Valliant concluded.

Recent Highlights and Future Milestones

FPI-1434 Monotherapy

Fusion has completed enrollment, dosing and the dose-limiting toxicity (DLT) evaluation period for the third patient cohort in the ongoing Phase 1 clinical trial of FPI-1434. Fusion plans to convene a Safety Review Committee (SRC) meeting in the third quarter of 2020 to evaluate the safety of the third patient single-dose cohort of 40kBq/kg (cohort three). Fusion anticipates Phase 1 single-dose safety and imaging data to be available in the fourth quarter of 2020.

Fusion received notice from the FDA in May 2020 and a "No Objection Letter" from Health Canada in July 2020 indicating that investigation of the multiple-dose administration in the Phase 1 clinical trial of FPI-1434 may begin.

Fusion anticipates reporting Phase 1 multiple-dose safety and imaging data, and the recommended Phase 2 dose/schedule, approximately nine to eighteen months after the commencement of this portion of the study.

FPI-1434 Combination Therapy

Fusion is currently evaluating FPI-1434 in preclinical studies in combination with approved checkpoint and DNA damage response inhibitors, including PARP inhibitors, and believes the synergies observed could expand the addressable patient populations for FPI-1434 and allow for potential use in earlier lines of treatment.

Fusion anticipates initiating Phase 1 combination studies six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.

FPI-1966

FPI-1966 is designed to target and deliver Actinium to tumor sites expressing FGFR3, a protein that is overexpressed in head and neck and bladder cancers. Following the completion of pre-clinical studies, the Company expects to submit an IND for FPI-1966 approximately six to twelve months after the Company fully resumes preclinical activities following interruptions caused by COVID-19.

Corporate Updates

In June 2020, Fusion completed an initial public offering of 12,500,000 common shares at a public offering price of $17.00 per share. Gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Fusion, were $212.5 million.

In May 2020, upon acceptance of the clinical trial protocol amendment to move from the single- to multiple-dose regimen of FPI-1434, the Company achieved a regulatory milestone associated with the Class B financing which triggered the closing of the second tranche of $62.5 million in gross proceeds.

Impact of COVID-19

Fusion is closely monitoring how the spread of COVID-19 is affecting the Company’s employees, business, preclinical studies and clinical trials. In response to the COVID-19 pandemic, most employees have transitioned to working remotely and travel has been restricted.

While Fusion has completed enrollment, dosing and the DLT evaluation period for the third patient cohort in the ongoing Phase 1 clinical trial of FPI-1434, the Company may not be able to enroll additional patient cohorts on the planned timeline due to disruptions at clinical trial sites. Additionally, while certain preclinical activities have restarted, Fusion is currently unable to predict when the Company will fully resume all preclinical activities.

Although the single dose Phase 1 clinical trial has not been materially affected by the COVID-19 pandemic as of June 30, 2020, at this time, there is significant uncertainty relating to the trajectory of the pandemic. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in difficulties or delays in initiating, enrolling, conducting or completing the planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The impact of COVID-19 on future results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.

Second Quarter 2020 Financial Results

Cash Position: As of June 30, 2020, Fusion held cash of $318.9 million, compared to cash of $65.3 million as of December 31, 2019. Fusion expects its cash as of June 30, 2020 will enable the Company to fund its operations into 2024.

R&D Expenses: Research and development expenses for the second quarter of 2020 were $3.3 million, compared to $2.1 million for the same period in 2019. The increase was primarily due to costs related to our Phase 1 clinical trial of FPI-1434, as well as other development and personnel-related costs.

G&A Expenses: General and administrative expenses for the second quarter of 2020 were $4.0 million, compared to $1.8 million for the same period in 2019. The increase was primarily due to an increase in professional fees, personnel-related costs and other costs including general corporate, insurance and facilities costs.

Net Loss: For the second quarter of 2020, Fusion reported a net loss of $44.7 million, or $18.91 per share, compared with a net loss of $3.5 million, or $1.79 per share, for the same period in 2019. During the second quarter of 2020, Fusion recorded a non-cash charge of $31.6 million for the final fair value measurement of the Company’s Class B preferred share tranche right liability. The fair value increased in the quarter due primarily to an increase in the fair value of the Class B preferred shares as a result of achieving specified milestones underlying the preferred share tranche rights. Fusion also recorded a non-cash charge of $6.1 million during the second quarter of 2020 for the final fair value measurement of the Company’s Class B preferred share warrant liability. The fair value increased in the quarter due primarily to an increase in the fair value of the underlying Class B preferred shares resulting from the IPO. The tranche right liability and the warrant liability were reclassified to shareholders’ equity during the second quarter of 2020. Excluding these non-cash charges, for the second quarter of 2020 net loss on a non-GAAP adjusted basis was $7.1 million.

Upcoming Events

Fusion will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12 at 9:10am EDT.

Fusion will participate in a virtual "fireside chat" presentation at Morgan Stanley’s 18th Annual Global Healthcare Conference on Thursday, September 17 at 11:00am EDT.

On August 11, 2020 Nascent Biotech, Inc. (OTCQB:NBIO) reported that It has significantly reduced its liabilities through stock conversion and payment of accrued liabilities (Press release, Nascent Biotech, AUG 11, 2020, View Source [SID1234563439]). The reduction was achieved through the conversion of $1,600,000 in debt to equity and the payment of over $200,000 of liabilities.

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Nascent’s CFO Lowell Holden stated, "I believe the Company has continued to be undervalued and the debt reduction allows the Company to invest funds into opening the clinical trials for brain cancer.

Nascent’s CEO Sean Carrick added," Shareholder confidence in the Senior Management team and the Company’s asset along with this significantly reduce of Company debt will help to move our assets forward. This reduction of debt should result in a positive market impact, as Nascent continues to monetize its assets."

On August 11, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported financial results for the six months ended June 30, 2020 (Press release, Kitov Pharmaceuticals , AUG 11, 2020, View Source [SID1234563438]).

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"The first half of 2020 represented a transformative period for Kitov, with multiple commercial, clinical and corporate milestones achieved," said Isaac Israel, Chief Executive Officer. "Importantly, we have successfully completed our evolution to an oncology-focused biotechnology company with the acquisition of CM24, an inhibitor of CEACAM1, and our strong cash balance at the end of the first half of the year of over $60 million positions us well to continue building a pipeline of attractive oncology assets. Moreover, our emerging oncology pipeline continued to advance expeditiously in the first half of the year and we expect to achieve multiple key upcoming catalysts."

"For CM24, we presented positive Phase 1 results at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program indicating that CM24 at higher doses warrants further evaluation in a larger clinical study, and we look forward to the anticipated initiation of our Phase 1/2 clinical trial to evaluate the combination of CM24 with nivolumab (OPDIVO), to be conducted in collaboration with Bristol Myers Squibb Company (BMS), in the second half of this year," continued Mr. Israel. "We were excited to receive U.S. Food and Drug Administration (FDA) acceptance of our Investigational New Drug (IND) application to conduct the Phase 1/2 clinical trial that will evaluate NT219 as a monotherapy treatment for advanced solid tumors and in combination with cetuximab for the treatment of recurrent or metastatic solid tumors and head and neck cancer or colorectal adenocarcinoma."

"In addition, we achieved a significant milestone in May 2020 with the U.S. commercial launch of CONSENSI, a fixed-dose combination of celecoxib and amlodipine besylate, designed for the simultaneous treatment of hypertension and osteoarthritis pain. We believe that our strong balance sheet of $63 million in cash at the end of the first half of 2020, which provides us runway beyond 2024, furnishes us with the financial support for our continued development efforts aimed at further advancing CM24 and NT219, and allows us the flexibility to enhance our growth through potential acquisitions and/or in-licensing activity in our core focus area of oncology," concluded Mr. Israel.

Recent Corporate Highlights

CM24: a monoclonal antibody targeting CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways:

Presented the positive results of a previously reported Phase 1 trial at the ASCO (Free ASCO Whitepaper) 2020 Virtual Scientific Program. These encouraging Phase 1 results indicate that CM24 at higher doses warrants further evaluation in a larger clinical study. Importantly, pharmacokinetic (PK) modelling suggests that higher doses of CM24 of up to 20mg/kg administered every two weeks would be required for target saturation.
Received a notification from the European Patent Office to grant a patent for Kitov’s application entitled "Humanized antibodies against CEACAM1," covering protein and DNA sequences pertaining to humanized antibodies capable of specific binding to human CEACAM1 molecules, including its lead monoclonal antibody, CM24, pharmaceutical compositions comprising these antibodies, as well as methods for their use in treating and diagnosing cancer and other conditions.
Currently advancing preparations to initiate a Phase 1/2 clinical trial of CM24 in combination with nivolumab (OPDIVO) in patients with non-small cell lung cancer, and in combination with nivolumab in addition to standard of care chemotherapy, in patients with pancreatic cancer. The trial will be conducted under a clinical collaboration agreement with BMS, and is expected to begin in the second half of 2020.
NT219: a dual inhibitor, novel small molecule targeting IRS1/2 and STAT3, important oncogenic drivers and major drug resistance pathways in many hard-to-treat cancers:

Expanded planned Phase 1/2 clinical trial of NT219 with cetuximab trial in patients with recurrent or metastatic head and neck cancer, to also include evaluation of NT219 as monotherapy treatment in patients with advanced solid tumors, based on significant compelling preclinical evidence generated in various studies with NT219.
Presented promising preclinical data demonstrating the anti-tumor activity of NT219 as both a monotherapy and in combination with cetuximab, an EGFR blocking monoclonal antibody, at the 2020 Multidisciplinary Head and Neck Cancers Symposium.
Presented preclinical data at the American Association of Cancer Research Virtual Meeting II in a presentation entitled "NT219, a novel dual inhibitor of STAT3 and IRS1/2, demonstrates anti-tumor activity with and without cetuximab in pembrolizumab-resistant head and neck cancer PDX models." Using multiple patient derived xenograft (PDX) models of subjects with head and neck squamous cell carcinoma, NT219 demonstrated growth inhibition, both as monotherapy as well as in combination with cetuximab or pembrolizumab (KEYTRUDA), a PD-1 inhibitor .
The FDA accepted Kitov’s IND to conduct a Phase 1/2 clinical trial of NT219. The primary objectives of the open-label Phase 1/2 trial are to evaluate safety, assess PK, identify the appropriate dose to be studied in the Phase 2 portion, and establish preliminary efficacy of NT219. We initiated the study in July and expect to activate up to eight sites in the U.S. and Canada over the next few months.
CONSENSI: a fixed-dose combination of celecoxib and amlodipine besylate, designed for the simultaneous treatment of hypertension and osteoarthritis pain:

Announced the U.S. commercial launch of CONSENSI by Burke Therapeutics, the marketing partner of Kitov’s U.S. distributor, Coeptis Pharmaceuticals. Burke Therapeutics’ sales team is growing steadily, and is expected to include approximately 50 sales representatives, with plans to increase this number further.
According to our agreement with Coeptis for CONSENSI, Kitov is eligible to receive up to $99.5 million in milestone and reimbursement payments, in addition to royalties.
Kitov expects to receive aggregate milestone and royalty revenues of between $28 million and $36 million from 2020 through 2022.
Financing Activities

Raised an aggregate of approximately $54.5 million in gross proceeds from registered direct, public offering, and PIPE transactions.
Received an additional $13.9 million of gross cash proceeds from the exercise of warrants.
Financial Results for the Six Months Ended June 30, 2020

Revenues
Total revenues for the six months ended June 30, 2020, were $1.0 million, the same as compared to the same period of 2019. The revenue for the six months ended June 30, 2020, included a milestone payment related to the CONSENSI launch from Coeptis Pharmaceuticals.

Research & Development (R&D) Expenses
R&D expenses for the six months ended June 30, 2020, were $3.1 million, an increase of $1.4 million, or 85.6%, compared to $1.7 million in the same period of 2019. The increase was due to preparations related to the anticipated initiation of the CM24 and NT219 clinical trials.

Selling, General & Administrative (SG&A) Expenses
SG&A expenses for the six months ended June 30, 2020, were $2.2 million, compared to $3.3 million in the same period of 2019. The decrease was due to a decrease in professional and legal fees, user fees to the FDA and a one-time settlement fee in the first half of 2019.

Operating Loss
Operating loss for the six months ended June 30, 2020, was $4.3 million, an increase of $0.6 million, or 20.7%, compared to $3.6 million in the same period of 2019.

On a non-IFRS basis (as reconciled below), adjusted operating loss for the six months ended June 30, 2020, was $3.5 million, an increase of $0.5 million from $3.1 million for the six months ended June 30, 2019.

Net Loss
Net loss for the six months ended June 30, 2020, was $27.8 million, or $0.46 per basic and diluted share, compared to a net loss of $2.6 million, or $0.14 per basic and diluted share, in the comparable period of 2019. The increase was due to an increase in expenses related to warrants in the amount of $24.6 million. Adjusted net loss for the first half of 2020 was $3.5 million, compared to $3.1 million in the same period of 2019. The increase of $0.4 million was due to an increase in R&D expenses related to the Company’s preparations for the planned initiation of two clinical studies, offset by a decrease in SG&A expenses. .

Cash & Cash Equivalents
As of June 30, 2020, we had cash and cash equivalents of $63.0 million, compared to $4.4 million at December 31, 2019. We believe that our cash and cash equivalents will provide sufficient resources for our current ongoing needs through fiscal year 2024.

On August 11, 2020 BridgeBio Pharma, Inc. (Nasdaq: BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases and cancers with clear genetic drivers, reported its financial results for the second quarter ending June 30, 2020 and provided an update on the company’s operations (Press release, BridgeBio, AUG 11, 2020, View Source [SID1234563437]).

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Since the beginning of 2020, BridgeBio has initiated four company-sponsored clinical trials, progressed its additional 11 ongoing clinical trials, submitted three Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA), and completed the rolling submission of its first New Drug Application (NDA) with the FDA. During the quarter, BridgeBio strengthened its corporate governance by adding three world-class independent directors to its board. In addition, it recently entered into a partnership with Perceptive Advisors-founded company LianBio, expanding BridgeBio’s global reach into China.

BridgeBio remains on track with each of its four core value drivers – acoramidis (formerly AG10, TTR stabilizer) for ATTR cardiomyopathy, low-dose infigratinib (FGFRi) for achondroplasia, AAV5 gene therapy for congenital adrenal hyperplasia (CAH), and encaleret (CaSRi) for autosomal dominant hypocalcemia type 1 (ADH1) – and the company believes it is adequately financed through key readouts for each of these programs. Notably, BridgeBio dosed the first child in its Phase 2 clinical trial of infigratinib in achondroplasia in July.

The strategic collaboration with LianBio will initially focus on targeted oncology. BridgeBio’s near-term economics includes a total of $26.5 million in upfront and milestone payments. BridgeBio will additionally receive up to $505 million in future milestone payments, tiered royalty payments ranging from single- to double-digits and increase its equity interest via investment in LianBio. BridgeBio CEO Neil Kumar has also been appointed to the LianBio board of directors.

Across the company, BridgeBio’s drug engineering platform continues to deliver. Strengthening its ability to discover new targets, it established collaboration agreements with Johns Hopkins University and University of Florida and continues to assess a wide variety of new programs in the genetic disease space. BridgeBio’s pre-clinical platform has expanded to include additional modalities such as antisense oligonucleotides and deepened expertise in critical areas such as molecular modeling and novel statistical approaches to genetics. Its clinical platform has grown and now encompasses more than 350 trial sites in over 25 countries.

"On a risk-adjusted basis we are in a great position to produce meaningful medicines for patients and meaningful returns to investors over the next 18 to 24 months. This is exemplified by our disease-modifying, first or best-in-class therapeutic candidates for ATTR, achondroplasia, ADH1, and CAH. We intend to deliver on this goal by expanding our industry-leading target identification and research engine and global clinical development infrastructure, and look forward to delivering our medicines, once approved, to patients through our growing commercial organization," said BridgeBio CEO and founder Neil Kumar, Ph.D.

Recent pipeline progress and corporate updates:

Low-dose infigratinib – Selective FGFR inhibitor for achondroplasia: Dosed first child in the Phase 2 clinical program (PROPEL 2) (NCT04265651).
BBP-418 – Glycosylation substrate pro-drug for LGMD2i: Dosed first subject in Phase 1 clinical trial in healthy volunteers.
Expansion into China through partnership with LianBio: BridgeBio entered into a strategic collaboration with Perceptive Advisors-founded LianBio, expanding its reach into China and other major Asian markets. The initial focus of the collaboration will be targeted oncology. Under the terms of the agreements, LianBio receives commercial rights in China and selected Asian markets and will participate in clinical development activities for BridgeBio’s Phase 3 FGFR inhibitor infigratinib and Phase 1-ready SHP2 inhibitor BBP-398. BridgeBio’s near-term economics includes a total of $26.5 million in upfront and milestone payments. BridgeBio will additionally receive up to $505 million in future milestone payments, tiered royalty payments ranging from single- to double-digits and increase its equity interest via investment in LianBio. BridgeBio CEO Neil Kumar has also been appointed to the LianBio board of directors.
Three new independent directors added to BridgeBio’s board:
○ Brent Saunders, former Allergan CEO and biopharma deal-maker
○ Randy Scott, Ph.D., genomics pioneer and entrepreneur
○ Andrew Lo, Ph.D., renowned economist and BridgeBio co-founder
New academic partnerships: Established collaboration agreements with Johns Hopkins University and University of Florida to accelerate the development of new medicines in genetically driven diseases.
BridgeBio Pharma R&D Day: BridgeBio will hold a virtual R&D Day on Tuesday, Sept. 29, 2020 from 8:30 am ET – noon. The event will be webcast, with a link available on the event calendar at View Source
Major milestones anticipated over the next 18-24 months for BridgeBio’s four core value drivers:

Acoramidis (formerly AG10) – TTR stabilizer for ATTR: Remain on track to complete enrollment in the Phase 3 ATTRibute-CM study in ATTR cardiomyopathy (ATTR-CM) in the first half of 2021, with topline data expected in the first half of 2022. Acoramidis is a potentially best in class TTR stabilizer for ATTR-CM, a large and growing disease affecting >400K patients globally, and one of the first drug candidates to arise from BridgeBio’s drug engineering platform.
Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia: Remain on track to report initial data from the ongoing Phase 2 dose ranging study by YE2021. Achondroplasia is the most common form of genetic short stature and one of the most commonly-known genetic diseases, with >55K cases in the US and EU. Low-dose infigratinib is the only known therapy in development for achondroplasia that targets the disease at its genetic source and the only orally administered product candidate in clinical stage development.
Encaleret – CaSR antagonist for Autosomal Dominant Hypocalcemia Type 1 (ADH1): Remain on track to initiate the planned Phase 2 study in 2020, with potential proof-of-concept data available in 2021. If the development program is successful, encaleret would be the first approved therapy for ADH1, a condition caused by gain of function variants in the calcium-sensing receptor gene estimated to be carried by 12k individuals in the US.
BBP-631 – AAV5 gene therapy candidate for congenital adrenal hyperplasia (CAH): IND-enabling studies for AAV gene therapy proceeding. Remain on track to initiate a first in human Phase 1/2 study and report initial data in 2021. CAH is one of the most prevalent genetic diseases thought to be addressable with AAV gene therapy, with >75K cases in the US and EU.
Second quarter 2020 financial results:

Cash, Cash Equivalents and Marketable Securities

Cash, cash equivalents and marketable securities, excluding restricted cash, totaled $840.9 million as of June 30, 2020 compared to $577.1 million at December 31, 2019. The net change in cash balance of $263.8 million reflects $537.0 million in net proceeds received from the issuance of our 2.50% Convertible Senior Notes due 2027, $24.1 million in net proceeds received from Eidos’ at-the-market issuance of shares, offset by payment of $75.0 million to repurchase BridgeBio shares, $49.3 million payment related to capped call option and the remaining payment of $173.0 million primarily related to operating expenses.

Operating Expenses

Operating expenses for the second quarter and first half of 2020 were $124.6 million and $227.1 million, as compared to $69.3 million and $133.1 million, respectively, for the same periods in the prior year. The increases in operating expenses of $55.2 million and $94.0 million during the periods were attributable to the increase in external-related costs and increase in headcount to support the progression in our research and development programs, including our increasing research pipelines, and overall growth of our operations.

Our research and development expenses have not been significantly impacted by the global outbreak of COVID-19 for the periods presented. While we have experienced some initial delays in certain of our clinical enrollment and trial commencement activities, we continue to adapt in this unprecedented time to enable alternative site, telehealth and home visits, at home drug delivery, as well as mitigation strategies with our contract manufacturing organizations. The longer-term impact of COVID-19 on our operating expenses is currently unknown.