On April 1, 2020 Stealth BioTherapeutics Corp (NASDAQ: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, reported financial results for the year ended December 31, 2019 and announced recent business highlights (Press release, Stealth Biologics, APR 1, 2020, View Source [SID1234556081]).

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"We are off to a strong start in 2020, having honed our focus on Barth and our planned expansion into other rare metabolic cardiomyopathies, while continuing to execute on the significant promise of our ophthalmic and other pipeline programs. By decisively reducing expenses in January, our cash and cash equivalents are sufficient through key Barth regulatory interactions in the second half of 2020, bringing us closer to a potential approval with an opportunity for a rare pediatric voucher and expedited regulatory review," said Reenie McCarthy, Chief Executive Officer at Stealth. "We hope to complete enrollment of our Phase 2b study in dry AMD during the second half of this year, keeping us on-track for a second half of 2021 top-line read-out. We are actively planning development initiatives in other rare metabolic cardiomyopathies, on which we hope to engage with the FDA this year. We are also rapidly advancing our pipeline of novel mitochondrial medicines, with SBT-272 being assessed in a Phase 1 clinical trial, preclinical data read-outs expected this year for SBT-272 in amyotrophic lateral sclerosis and multiple system atrophy and SBT-259 in Charcot-Marie-Tooth, and lead optimization underway for our SBT-550 series, targeting the ferroptosis pathway of cell death implicated in neurodegenerative diseases such as Parkinson’s."

Fourth Quarter 2019 and Recent Highlights

Announced Barth rare pediatric designation. In March 2020, the Company announced receipt of Rare Pediatric Disease (RPD) designation from the U.S. Food and Drug Administration (FDA) for elamipretide for the treatment of Barth syndrome. Under this program, upon FDA priority review and approval of elamipretide for Barth syndrome, the Company would be eligible for a voucher that can be used to obtain priority review for a subsequent drug application.
Announced positive Barth data from natural history efficacy study. In February 2020, the Company announced positive results from its SPIBA-001 natural history comparative control efficacy study in Barth patients, demonstrating a greater than 80 meter improvement in the primary endpoint of 6 Minute Walk Test at one year compared to natural history controls (p=0.0005).
Expanded clinical pipeline. In January 2020, the Company initiated a first-in-human Phase 1 clinical trial evaluating its second-generation pipeline compound, SBT-272, in healthy subjects. The Company anticipates that preclinical data expected later this year in models of amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA) will help inform SBT-272’s clinical development pathway for rare neurodegenerative diseases.
Implemented strategic repositioning. In January 2020, the Company implemented strategic actions to reduce costs and reposition its focus on Barth and other rare metabolic cardiomyopathies, in addition to its ophthalmic and pipeline neurology programs following 2019 year-end announcement of the Company’s MMPOWER-3 clinical study results.
Announced improvement in cardiac function in Barth. In October 2019, data presented at the American Society of Human Genetics (ASHG) 2019 Annual Meeting showed that treatment with elamipretide was associated with a significant increase in average cardiac stroke volume, or the amount of blood pumped by the heart’s left ventricle per contraction, in Barth subjects, measured from the trial baseline (40.8 mL) to week 36 (51.8 mL) of the open-label extension (p<0.01).
Alexion collaboration. In October 2019, the Company announced an option agreement with Alexion, in connection with which it received gross proceeds of $30 million. Although Alexion has declined to exercise this option, the gross proceeds provided the Company with flexibility to consider its strategic financing options and develop a Barth regulatory path.
Key Upcoming Milestones

Anticipated guidance from FDA meeting on Barth expected midyear 2020.
Complete enrollment of Phase 2b clinical trial in dry AMD expected second half of 2020.
Pre-clinical data for SBT-272 in ALS and MSA and for SBT-259 in CMT expected by year-end.
2019 Financial Results

Revenue: In 2019, the Company recognized $21.1 million in revenue associated with the Alexion arrangement. The revenue represents the portion of the non-refundable upfront payments that were recognized in full upon the delivery of the topline data for the Company’s MMPOWER-3 trial. Alexion terminated the arrangement and as such, no additional revenue will be recognized.

Research and Development (R&D) Expenses: R&D expenses decreased by $8.5 million to $44.6 million for the year ended December 31, 2019, from $53.1 million for the year ended December 31, 2018. This decrease was primarily from a net decrease of $8.5 million in clinical trial costs due to the timing of trials that ended in 2018, a $2.8 million decrease in contract manufacturing, and a $0.9 million decrease in discovery related expenses due to timing of activities. These decreases were offset in part by increases of $3.6 million in employee and consultant related expenses driven by continued build-out of clinical, medical affairs and regulatory functions and $0.1 million in other costs.

General and Administrative (G&A) Expenses: G&A expenses increased by $0.1 million to $22.3 million for the year ended December 31, 2019, from $22.2 million for the year ended December 31, 2018. The increase was primarily attributable to a net $2.3 million increase in pre-commercial activities including building market disease awareness, a $1.8 million increase in professional services for activities attributable to operating as a public company, an increase of $3.2 million in employee related costs offset by a decrease of $6.7 million in costs associated with 2018 financing efforts and a decrease in IP legal fees of $0.5 million.

Other Expenses: Other expenses increased by $4.5 million to $25.9 million for the year ended December 31, 2019 from $21.4 million for the year ended December 31, 2018. The increase in other expenses is primarily attributable to a $22.7 million loss on extinguishment of debt recorded with respect to convertible debt conversion into ordinary shares in conjunction with the Company’s 2019 initial public offering and a $0.7 million change period over period in the fair value adjustments of the warrant liability. These increases were offset by a $3.4 million change in period over period fair value adjustments of the derivative liability associated with the convertible debt, a decrease in interest expense mostly related to the convertible debt of $14.7 million and an increase in interest income of $0.8 million.

Cash Position: Cash and cash equivalents were $50.8 million at December 31, 2019, compared to $10.9 million at December 31, 2018.

Conference Call

Management will host a conference call today at 8:30 am ET to discuss the financial results and provide a general business update. The call can be accessed by dialing (877) 407-0989 or (201) 389-0921 (international) and referencing conference ID 13701108. A live audio webcast of the event can be accessed by visiting the Investors & News section of Stealth’s Investor website, https://investor.stealthbt.com/. A replay of the webcast will be archived on Stealth’s website for 30 days following the event.

On April 1, 2020 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported the achievement of key milestones reflecting portfolio-wide progress against the company’s 2020 goals (Press release, Blueprint Medicines, APR 1, 2020, View Source [SID1234556080]). These milestones include the compilation of top-line data for pralsetinib in patients with RET-mutant medullary thyroid cancer (MTC), supporting plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the second quarter of 2020.

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"As our company and the communities we serve face the COVID-19 pandemic, I am exceptionally proud of our team’s nimbleness and persistency in advancing multiple therapies across our portfolio for the patients who need them," said Andy Boral, M.D., Ph.D., Chief Medical Officer at Blueprint Medicines. "I am particularly encouraged that we have advanced pralsetinib toward registration across multiple tumor types and have made strong progress on the avapritinib program, with a compelling dataset in patients with systemic mastocytosis reported last month. The top-line data announced today demonstrate the potential of pralsetinib to be a best-in-class therapy for patients with RET-altered thyroid cancers, with deep and durable responses in both the first-line and relapsed settings."

Top-line Data from Phase 1/2 ARROW Trial in RET-Altered Thyroid Cancers

Top-line results announced today support Blueprint Medicines’ plans to submit an NDA for pralsetinib in patients with RET-mutant MTC previously treated with an approved multi-kinase inhibitor (MKI) in the second quarter of 2020. The registration endpoints are overall response rate (ORR) and duration of response (DOR), based on independent central radiology and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria.

Top-line efficacy data were reported for patients treated with pralsetinib who were evaluable for response assessment per RECIST 1.1, as determined by blinded independent central review. All patients received the proposed indicated dose of 400 mg once daily (QD). All results were as of a data cutoff date of February 13, 2020.

In 53 patients with RET-mutant MTC previously treated with cabozantinib or vandetanib, the ORR was 60 percent (95% CI: 46-74%) with one response pending confirmation. Nearly all patients (98 percent) had tumor shrinkage. The median DOR was not reached (95% CI: not estimable, not estimable), and the 18-month DOR rate was 90 percent (95% CI: 77-100%).

In addition, the top-line data showed robust clinical activity in treatment-naïve patients, supporting the potential of pralsetinib across lines of therapy. In 19 patients with RET-mutant MTC who had not received prior systemic treatment, the confirmed ORR was 74 percent (95% CI: 49-91%), and all patients had tumor shrinkage. The median DOR was not reached (95% CI: 7 months, not estimable), with 12 of 14 responders remaining in response for up to 15 months as of the data cutoff date.

In nine patients with RET fusion-positive thyroid cancer, the confirmed ORR was 89 percent (95% CI: 52-100%), and all patients had tumor shrinkage. The median DOR was not reached (95% CI: 8 months, not estimable), with seven of eight responders remaining in response for up to 20 months as of the data cutoff date.

Top-line safety data were consistent with those previously reported. Pralsetinib was well-tolerated, and most treatment-related adverse events (AEs) were Grade 1 or 2. Across all patients enrolled in the ARROW trial treated at the proposed indicated dose of 400 mg QD (N=438), only 4 percent discontinued treatment with pralsetinib due to treatment-related AEs.

Blueprint Medicines plans to present the full data at a scientific meeting this year.

NDA Submission for Pralsetinib for RET Fusion-Positive NSCLC

Blueprint Medicines completed the rolling NDA submission for pralsetinib for RET fusion-positive non-small cell lung cancer (NSCLC). Blueprint Medicines requested priority review for the application, which, if granted, could result in a six-month review process.

Top-line Data from Phase 3 VOYAGER Trial in Third-Line GIST

Blueprint Medicines plans to lock the VOYAGER trial database in April and provide top-line data to the FDA for avapritinib in third-line gastrointestinal stromal tumor (GIST), to enable the FDA to take action on the proposed fourth-line GIST indication by the May 14, 2020 PDUFA date.

Submission of IND Application for BLU-263

Blueprint Medicines submitted an investigational new drug (IND) application to the FDA for BLU-263, a next-generation KIT inhibitor, for the treatment of patients with indolent systemic mastocytosis (SM). With its drug candidates avapritinib and BLU-263, Blueprint Medicines is pursuing a comprehensive strategy to address a broad population of patients with SM and other mast cell disorders.

About RET-Altered Solid Tumors

RET activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and MTC. RET fusions are implicated in approximately 1 to 2 percent of patients with NSCLC and approximately 10 to 20 percent of patients with papillary thyroid cancer, while RET mutations are implicated in approximately 90 percent of patients with advanced MTC. In addition, oncogenic RET alterations are observed at low frequencies in colorectal, breast, pancreatic and other cancers, and RET fusions have been observed in patients with treatment-resistant EGFR-mutant NSCLC.

Currently, there are no approved therapies that selectively target RET-driven cancers, although there are several approved MKIs with RET activity being evaluated in clinical trials. To date, clinical activity attributable to RET inhibition has been uncertain for these approved MKIs, likely due to insufficient inhibition of RET and off-target toxicities. There is a need for precision therapies that provide durable clinical benefit by selectively targeting RET alterations and anticipated resistance mutations.

About Pralsetinib

Pralsetinib is an investigational, once-daily oral precision therapy specifically designed for highly potent and selective targeting of oncogenic RET alterations. Blueprint Medicines is developing pralsetinib for the treatment of patients with RET-altered NSCLC, MTC and other solid tumors. The FDA has granted Breakthrough Therapy Designation to pralsetinib for the treatment of RET fusion-positive NSCLC that has progressed following platinum-based chemotherapy, and RET mutation-positive MTC that requires systemic treatment and for which there are no acceptable alternative treatments.

Pralsetinib was designed by Blueprint Medicines’ research team, leveraging the company’s proprietary compound library. In preclinical studies, pralsetinib consistently demonstrated sub-nanomolar potency against the most common RET fusions, activating mutations and predicted resistance mutations. In addition, pralsetinib demonstrated markedly improved selectivity for RET compared to pharmacologically relevant kinases, including approximately 90-fold improved potency for RET versus VEGFR2. By suppressing primary and secondary mutants, pralsetinib has the potential to overcome and prevent the emergence of clinical resistance. Blueprint Medicines believes this approach will enable durable clinical responses across a diverse range of RET alterations, with a favorable safety profile.

Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of pralsetinib and certain other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for pralsetinib in the rest of the world.

On April 1, 2020 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported preliminary unaudited worldwide revenue for the quarter ended March 31, 2020 and the withdrawal of its full year 2020 financial guidance issued on February 25, 2020 (Press release, Nevro, APR 1, 2020, View Source [SID1234556079]). In addition, the Company provided an update on the actions it is taking in response to the COVID-19 pandemic.

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First Quarter 2020 Update
Preliminary unaudited first quarter 2020 worldwide revenue is expected to be in the range of $86.4 to $86.9 million, a 5-6% increase compared to $82.1 million in the first quarter of 2019. First quarter 2020 revenue was negatively impacted by a rapid deceleration in March due to COVID-19 shelter-in-place policies and restrictions on elective surgical procedures around the world.

Preliminary unaudited first quarter 2020 U.S. revenue is expected to be $74.9 to $75.2 million, a 14% increase compared to $65.8 million in the prior year period. Year-over-year, U.S. trial growth was 6% and permanent implant growth was 12% during the first quarter of 2020. U.S. trial growth was 20% and permanent implant growth was 29% for the two months ended February 29, 2020, compared to the prior year period. Cases totaling approximately $16.5 million were cancelled during the month of March 2020.

Preliminary unaudited first quarter 2020 international revenue is expected to be $11.5 to $11.7 million, a decrease of 29% to 30% as reported, compared to $16.3 million in the prior year period. The decrease in international revenue was primarily due to the impact of COVID-19 related government restrictions on elective procedures implemented in Europe and Australia during the latter half of the quarter.

Preliminary unaudited first quarter 2020 operating expenses are expected to be at or below approximately $90 million.

Full Year 2020 Financial Guidance
Due to the rapidly evolving environment and continued uncertainties resulting from the impact of COVID-19, Nevro is withdrawing its previously announced annual guidance for 2020, which was issued on February 25, 2020. At this date, Nevro cannot predict the extent or duration of the impact of the COVID-19 virus on its financial and operating results, but the Company believes the shelter-in-place policies and suspension of elective procedures worldwide will substantially impact revenue in the second quarter of 2020. As of December 31, 2019, Nevro had approximately $238 million in cash, cash equivalents and short-term investments. Nevro intends to maintain the strength of its commercial organization in preparation for what the Company believes could be an active recovery period in the second half of 2020 and early 2021. Nevro plans to provide additional information, to the extent practicable, during its first quarter earnings call in early May.

COVID-19 Updates
"We are grateful to the healthcare professionals around the world who are tirelessly caring for patients on the front lines of this pandemic, and our thoughts go out to all who have been affected," said D. Keith Grossman, Chairman, CEO and President of Nevro. "During this challenging time, we have proactively implemented multiple initiatives to support our customers, patients and employees as well as preserve our future business growth opportunities. Prior to COVID-19, our sales in the first two months of the year were ahead of our expectations and we believe the initiatives we’ve put in place will enable us to reemerge from this global health crisis in a position of strength. We expect that our unique ability to capture patient scheduling and outcomes data with NevroCloud will enable us to proactively support our patients’ progress for our customers throughout this crisis. More than 3,000 patients have recently had trials in the U.S. with the Company’s products and many of those patients are now awaiting permanent implants. We stand ready to help our customers return to growth as soon as the ability to perform elective procedures is restored."

As a medical device company that provides implantable devices and on-site support to physicians in hospitals, surgery centers and private practices, Nevro’s highest priority is the health and safety of healthcare professionals, patients and employees. In response to this global pandemic, the Company has quickly responded in recent weeks to help protect its communities while continuing to support customers and maintain its business:

Health and Safety. To protect the health and safety of Nevro customers, their patients and employees, the Company has implemented the latest recommendations from public health authorities worldwide. The Company has restricted business-related travel and has asked all employees who can work from home to do so until further notice.
Maintaining Nevro’s ‘Patient First’ Commitment. Nevro remains fully committed to helping patients who suffer from chronic debilitating pain, as well as its physician customers who care for them. The Company has built an effective patient care infrastructure with phone-based therapy support specialists, field-based sales and clinical support teams. All of the Company’s patient-support teams remain available to support customers and patients, while following applicable restrictions, safety precautions and procedures.
Operating Nevro’s Business. Nevro believes its fundamental business opportunity remains unchanged and that the strong momentum from its growth drivers, such as its proprietary HF10 therapy and the recent Senza Omnia product launch, will be regained when the ability to perform elective procedures returns. The Company remains focused on managing expenses and driving operating efficiency in our business. Future growth drivers such as the current trials to support expanded use in PDN (Painful Diabetic Neuropathy) and NSRBP (Non-Surgical Refractory Back Pain) will continue to move forward as well.

On April 1, 2020 Nevro Corp. ("Nevro") (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported that it has commenced a proposed underwritten public offering of 1,625,000 shares of its common stock (the "common stock offering") and $165,000,000 aggregate principal amount of its convertible senior notes due 2025 (the "notes") (the "notes offering") (Press release, Nevro, APR 1, 2020, View Source [SID1234556078]). All of the shares of common stock to be sold in the common stock offering will be offered by Nevro. In addition, Nevro expects to grant the underwriters of the offerings a 30-day option to purchase an additional (a) 243,750 shares of its common stock at the public offering price, less underwriting discounts and commissions and (b) $24,750,000 aggregate principal amount of the notes, less underwriting discounts and commissions and solely to cover over-allotments with respect to the notes offering. Neither the completion of the common stock offering nor the notes offering is contingent on the completion of the other. The offerings are subject to market and other conditions, and there can be no assurance as to whether or when the offerings may be completed, or as to the actual size or terms of the offerings.

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The notes will be senior, unsecured obligations of Nevro, bearing interest semi-annually and are expected to mature on April 1, 2025, unless earlier converted or repurchased. Prior to the close of business on the business day immediately preceding October 1, 2024, the notes will be convertible at the option of holders only in certain circumstances and during certain periods, and thereafter, the notes will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date, in either case into cash, shares of Nevro’s common stock or a combination thereof, at Nevro’s election. Holders of the notes will have the right to require Nevro to repurchase all or any portion of their notes at 100% of their principal amount, plus any accrued and unpaid interest to, but excluding, the fundamental change repurchase date, upon the occurrence of certain fundamental changes. The interest rate, conversion rate and other terms of the notes will be determined at the time of pricing of the notes offering.

In connection with the offering of the notes, Nevro expects to enter into privately-negotiated convertible note hedge transactions with one or more of the underwriters and/or their respective affiliates and/or other financial institutions (the "option counterparties"). These transactions will cover, subject to customary anti-dilution adjustments, the number of shares of Nevro’s common stock that will initially underlie the notes, and are expected generally to reduce the potential equity dilution, and/or offset any cash payments in excess of the principal amount due, as the case may be, upon conversion of the notes.

Nevro also expects to enter into separate, privately-negotiated warrant transactions with the option counterparties at a higher strike price relating to the same number of shares of Nevro’s common stock, subject to customary anti-dilution adjustments, pursuant to which Nevro will sell warrants to the option counterparties. The warrants could have a dilutive effect on Nevro’s common stock to the extent that the price of Nevro’s common stock exceeds the strike price of those warrants.

If the underwriters exercise their option to purchase additional notes, Nevro expects to enter into additional convertible note hedge transactions and additional warrant transactions with the option counterparties, which will initially cover the number of shares of Nevro’s common stock that will initially underlie the additional notes sold to the underwriters.

Morgan Stanley is acting as bookrunning manager for the offerings.

Nevro has been advised that in connection with establishing their initial hedges of the convertible note hedge and warrant transactions, the option counterparties or their respective affiliates expect to enter into various derivative transactions with respect to Nevro’s common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Nevro’s common stock or the notes at that time. The option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Nevro’s common stock and/or purchasing or selling Nevro’s common stock or other securities of Nevro in secondary market transactions following the pricing of the notes and prior to maturity of the notes (and are likely to do so during any observation period related to a conversion of the notes).

The potential effect, if any, of these transactions and activities on the market price of Nevro’s common stock or the notes will depend in part on market conditions and cannot be ascertained at this time, but any of these activities could adversely affect the value of Nevro’s common stock, which could affect the ability to convert the notes, the value of the notes and the amount of cash, if any, and the number of and value of the shares of Nevro’s common stock, if any, holders would receive upon conversion of the notes.

Nevro intends to use a portion of the net proceeds from the common stock offering and notes offering to pay the cost of the convertible note hedge transactions (after such cost is partially offset by the proceeds to Nevro from the sale of the warrants). Nevro expects to use the remainder of the net proceeds from the common stock offering and notes offering for general corporate purposes, including to repurchase and retire its outstanding 1.75% senior convertible notes due 2021 (the "existing convertible notes") in separate, privately negotiated transactions effected by one or more of the underwriters or their affiliates concurrently with these offerings. If the underwriters exercise their option to purchase additional notes, then Nevro intends to use a portion of the net proceeds from the sale of additional notes, together with the proceeds from the sale of additional warrants, to enter into additional convertible note hedge transactions with the option counterparties and Nevro intends to use the remaining net proceeds from the sale of such additional notes for general corporate purposes and/or the repurchase or other retirement of additional existing convertible notes.

In connection with the issuance of the existing convertible notes, Nevro entered into convertible note hedge transactions (the "existing convertible note hedge transactions") and warrant transactions (the "existing warrant transactions" and, together with the existing convertible note hedge transactions, the "existing call spread transactions") with certain financial institutions (the "existing option counterparties"). In connection with Nevro’s intended repurchase of the existing convertible notes, Nevro expects to enter into agreements with the existing option counterparties to terminate a portion of such existing call spread transactions, in each case, in a notional amount corresponding to the amount of such existing convertible notes repurchased, if any. In connection with any termination of existing call spread transactions and the related unwinding of the existing hedge position of the existing option counterparties with respect to such transactions, such existing option counterparties and/or their respective affiliates will sell shares of Nevro’s common stock in secondary market transactions, and/or enter into or unwind various derivative transactions with respect to Nevro’s common stock. In particular, in connection with Nevro’s intended repurchase of the existing convertible notes concurrently with the offerings, Nevro will terminate a corresponding portion of the existing call spread transactions, and Nevro expects the existing option counterparties to sell shares of Nevro’s common stock in the open market for some period of time beginning as early as five scheduled trading days after the offerings. This activity could decrease (or reduce the size of any increase in) the market price of Nevro’s common stock at that time and it could decrease (or reduce the size of any increase in) the market value of the notes. Nevro may enter into further agreements with the existing option counterparties to terminate any remaining portion of the existing call spread transactions in connection with any subsequent repurchase of its existing convertible notes.

Nevro also expects that those holders of the existing convertible notes that sell their existing convertible notes to Nevro may enter into or unwind various derivatives with respect to Nevro’s common stock and/or purchase or sell shares of Nevro’s common stock in the market to hedge their exposure in connection with these transactions. In particular, Nevro expects that many holders of the existing convertible notes employ a convertible arbitrage strategy with respect to the existing convertible notes and have a short position with respect to Nevro’s common stock that they would close, through purchases of Nevro’s common stock, in connection with Nevro’s repurchase of their existing convertible notes. This activity could increase (or reduce the size of any decrease in) the market price of Nevro’s common stock or the notes at that time.

The common stock offering and the notes offering will be made pursuant to an automatic shelf registration statement on Form S-3 (including a base prospectus) filed with the Securities and Exchange Commission ("SEC"), which automatically became effective. Preliminary prospectus supplements related to each of the common stock offering and the notes offering (together with such base prospectus, each a "prospectus"), will be available on the SEC’s website located at www.sec.gov. Copies of the prospectus relating to the common stock offering and the notes offering may be obtained, when available, from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On April 1, 2020 MedGenome, the leading genetic diagnostics, research and data company focused on expanding access for populations in South Asia and other emerging markets reported an investment of USD 55m led by LeapFrog Investments, a leading specialist investor in emerging markets. Existing investors Sofina and Sequoia also participated in the round (Press release, MedGenome, APR 1, 2020, View Source [SID1234556077]).

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Sam Santhosh, the CEO and Founder of MedGenome, said, "Genomics and personalized medicine are the future of healthcare, but emerging markets remain significantly under-penetrated. As the largest player in India in applied genomics, we are well-positioned to fill this gap." The subcontinent contributes around 20% of the world’s population, while the DNA sequences of its people make up only around 0.2% of global genetic databases.

MedGenome has already built the largest database of South Asian genetic variants through its leadership in genetic diagnostics in India, research partnerships and work as a co-founding member with GenomeAsia 100K. MedGenome has completed over 200,000 genomic tests to date and obtains samples from more than 550 hospitals and 6,000 clinicians across India. This investment will expand the clinical genomic testing market by expanding access in Tier-II and Tier-III towns and cities across India and accelerate the company’s drug discovery programs.

Sam added, "Genetics is having a transformational impact on families through early disease risk detection, inherited disease prevention, health care personalization, and new therapy development. MedGenome strives to deliver these benefits to India and Emerging Markets, where the burden of many inherited and complex diseases is even higher than in western markets. We are excited about partnering with the LeapFrog team, who share our focus on profit with purpose, and look forward to leveraging their network and expertise to accelerate achievement of our goals."

The MedGenome transaction was led by Dr. Felix Olale, Global Co-Lead for healthcare investments at LeapFrog. Dr. Olale said, "We are very excited to partner with MedGenome to increase access to affordable and high-quality genetic testing for emerging consumers in Asia and Africa. Genomic sequencing will anchor the future of medicine and we must include other underrepresented genomes not only because it drives access, but also because it improves the accuracy for everyone. As the leading player in its field, we believe that our investment will enable MedGenome to rapidly consolidate its position in Asia and become a significant player in the global market for drug discovery and precision medicine. Our investment will also drive the development of new drug discovery platforms that will have an enormous impact on cancer and cardiovascular disease.This investment is in line with LeapFrog’s consumer health approach and will be a key addition to the portfolio in terms of both returns and impact. Furthermore, it is a strong fit for LeapFrog’s impact mandate via increasing the availability of essential diagnostics in emerging markets and creation of new drug targets for intractable diseases globally."

The company’s latest research findings about Asian populations, in partnership with GenomeAsia 100K, was published as a cover article in the December 2019 issue of Nature magazine1. The paper is now a strong reference base and discussion point for scientists working globally on genomics. The increased diversity captured in MedGenome’s genetic datasets will drive discovery of new gene-disease associations, drug targets, and novel therapies.

The investment in MedGenome will seek to capitalise on the favourable dynamics in both the domestic and international markets for genetic diagnostics. The Indian genetic diagnostics market is expected to expand at 42% CAGR over the next five years. Globally, the market is expected to grow from USD 13bn in 2019 to USD 28.5bn by 2026 driven by improving penetration, affordability and increasing consumer awareness.