MeiraGTx (MGTX) $200M deal with Hologen AI for Parkinson's therapy

 

 

 

 

 

 

IPO: June 8, 2018

Hologen AI commits up to $430M to help take MeiraGTx's Parkinson's gene therapy through phase 3 and beyond

MeiraGTx will partner with Hologen AI to leverage its multimodal generative AI (genAI) models to accelerate Phase III development of the biotech's AAV-GAD gene therapy for Parkinson’s disease. 

The therapy, dubbed AAV-GAD, delivers a gene that codes for the enzyme that makes the neurotransmitter GABA, which is implicated in the characteristic motor dysfunction of Parkinson’s. A small-scale phase 2 readout last October showed that AAV-GAD was able to improve patients' motor ability and quality of life.

Details of the agreement 

MeiraGTx will receive an upfront cash payment of $200 million from Hologen, and together, the partners will launch a joint venture called Hologen Neuro AI. The genAI firm will also contribute $230 million in funding for the JV, which will shepherd AAV-GAD through development to commercialisation. The capital will help support other early-stage clinical programmes targeting the central nervous system (CNS), such as AAV-BDNF for genetic obesity. 

MeiraGTx will retain 30% ownership in Hologen Neuro AI and take the lead on all clinical development and manufacturing. It will form exclusive clinical and commercial manufacturing supply agreements with the JV. 

In turn, Hologen will use its genAI tech to optimise MeiraGTx's manufacturing practices, while gaining a minority stake in the manufacturing subsidiary and contributing to annual funding. 

About Hologen 

Hologen Limited is a world-leading developer of generative AI capabilities for clinical medicine and pharmaceutical drug development. 

The company emerged as a spin-out from University College London and Kings College London. It is privately held.

For more information, please visit www.hologen.ai

===ADT (ADT ) reported earnings on Thur 27 Feb 25 (b/o)

 

 ADT reports EPS in-line, beats on revs; guides FY25 EPS in-line, revs in-line; announces new $500 mln share repurchase plan

• Reports Q4 (Dec) earnings of $0.20 per share, excluding non-recurring items, in-line with the two analyst estimate of $0.20; revenues rose 7.5% year/year to $1.26 bln vs the $1.23 bln single analyst estimate.
• Co issues in-line guidance for FY25, sees EPS of $0.77-0.85, excluding non-recurring items, vs. $0.81 two analyst estimate; sees FY25 revs of $5.025-5.225 bln vs. $5.04 bln two analyst estimate.
• On Feb. 27, 2025, the Company's Board of Directors announced a share repurchase plan. pursuant to which the Company is authorized to repurchase, through April 30, 2026, up to a maximum aggregate amount of $500 million of shares of Common Stock.

GeneDx (WGS) reported earnings on Tue 18 Feb 25 (b/o)

** charts after earnings ** 

Strong Beat, Guidance: This provider of exome and genome tests is a play on the shift toward personalized medicine and earlier intervention.

During the fourth quarter, GeneDx earned an adjusted 77 cents per share, obliterating forecasts for 16 cents, according to FactSet. Earnings flipped from a year-earlier loss of 49 cents. Sales grew almost 65% to $95.6 million, well ahead of calls for $82.2 million.

GeneDx also guided to $350 million to $360 million in full-year sales. The low end of the outlook easily beat analysts' forecast for $340.4 million.

GeneDx uses AI to provide genomics-related diagnostic testing.

GeneDx provides whole genome and exome sequencing to help identify rare diseases, primarily in children. The genome includes all the DNA in the body, while reading the exome involves looking at only the protein-coding genes.

When performed early, genetic testing can lead to answers that help avoid what Chief Executive Katherine Stueland calls a "diagnostic odyssey." The company only tests for diseases where there is a solution — a clinical study, a dietary change or a treatment.

Long trade : REKR +20% (12/24)

 

===Protara Therapeutics (TARA) : Positive results from Phase 2 ADVANCED-2 trial of TARA-002 in patients with NMIBC

• TARA-002 demonstrates 72% six-month landmark complete response rate and 70% complete response rate at any time across BCG exposures
• 100% six-month landmark complete response rate and 80% complete response rate at any time observed in BCG-Unresponsive patients
• 64% six-month landmark complete response rate and 67% complete response rate at any time observed in BCG-Naïve patients
• 80% reinduction salvage rate and compelling durability observed with 100% of patients maintaining a complete response from three months to six months across BCG exposures
• Favorable safety and tolerability profile with no Grade 2 or greater treatment-related adverse events

 

Company Profile

• Protara Therapeutics
• Industry: Health Care
• Website: https://artaratx.com/

===Esperion Therapeutics (ESPR) : new drug submissions in Canada for NEXLETOL treatments

Co announced that it has filed New Drug Submissions to Health Canada for NEXLETOL and NEXLIZET, once-daily, accessible, oral non-statin medications that reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.

 

Ecovyst (ECVT) reported earnings on Thur 31 Oct 24 (b/o)

The company was formerly known as PQ Group Holdings Inc. and changed its name to Ecovyst Inc. in August 2021.

• Sector(s): Basic Materials
• Industry: Specialty Chemicals
• Full Time Employees: 911
• Founded in 1831 
• Headquartered in Malvern, Pennsylvania
• https://www.ecovyst.com

** charts 1 day after earnings **

Long trade : WEN +10% (10/24)

•  A:  Thur Oct 10: #3, 4, 11, 12, 22, 29, 30, 38, 60, 61, 82, 83

Blend Labs (BLND) : 3-year performance

• Sector(s): Technology
• Industry: Software - Application
• Full Time Employees: 881
• Incorporated in 2012 
• Headquartered in San Francisco, California
• https://blend.com

ticker: BLND

EHang (EH) reported earnings on Thur 22 Aug 24 (b/o)

• Quarterly Revenues Up 919.6% YoY, Highest Growth Rate in Company History
• Sizeable New Orders in China (Shanxi, Zhejiang and Hong Kong)
• Pilotless eVTOL Air Operator Certificate Applications Accepted by CAAC
• Partnered with China Southern Airlines General Aviation for Collaborative eVTOL Operation
• Strategic Collaboration with MLG and ADIO in UAE, Debut Flights in UAE and Saudi Arabia
• Partnered with GBT to Develop Ultra-Fast/eXtreme Fast Charging Battery Solutions

 ** charts after earnings **

** The following day **

GUANGZHOU, China, Aug. 22, 2024 (GLOBE NEWSWIRE) -- EHang Holdings Limited (Nasdaq: EH), the world’s leading Urban Air Mobility (“UAM”) technology platform company, today announced its unaudited financial results for the second quarter ended June 30, 2024.

Financial and Operational Highlights for the Second Quarter 2024

• Sales and deliveries of EH216 series products1 were 49 units, the highest quarterly delivery volume in the Company’s history, compared with 5 units in the second quarter of 2023, and 26 units in the first quarter of 2024.
• Total revenues reached a record high of RMB102.0 million (US$14.0 million), representing an increase of 919.6% from RMB10.0 million in the second quarter of 2023, and an increase of 65.3% from RMB61.7 million in the first quarter of 2024.
• Gross margin was 62.4%, representing a 2.2 percentage points increase from 60.2% in the second quarter of 2023, and a 0.5 percentage points increase from 61.9% in the first quarter of 2024.
• Operating loss was RMB77.4 million (US$10.7 million), representing a slight increase of 2.8% from RMB75.3 million in the second quarter of 2023 and an increase of 17.6% from RMB65.8 million in the first quarter of 2024.
• Adjusted operating loss2 (non-GAAP) was RMB4.7 million (US$0.6 million), representing a 90.9% improvement from RMB51.3 million in the second quarter of 2023, and a 62.9% improvement from RMB12.6 million in the first quarter of 2024.

==Sarepta Therapeutics (SRPT) : expanded FDA approval of ELEVIDYS to Duchenne Muscular Dystrophy patients

 

Sarepta Therapeutics announces expanded FDA approval of ELEVIDYS to Duchenne Muscular Dystrophy patients

• FDA grants traditional approval to ELEVIDYS for ambulatory Duchenne patients. FDA grants accelerated approval to ELEVIDYS for non-ambulatory Duchenne patients.
• Consistent with the accelerated approval pathway, Sarepta has committed to conduct and submit the results of a randomized, controlled trial to verify and confirm the clinical benefit of ELEVIDYS in patients with Duchenne muscular dystrophy who are non-ambulatory. ENVISION (Study SRP-9001-303), a global, randomized, double-blind, placebo-controlled Phase 3 study of ELEVIDYS in non-ambulatory and older ambulatory individuals with Duchenne, is underway and intended to serve as this postmarketing requirement.

Comtech Telecommunications (CMTL) reported earnings on Tue 18 June 24 (b/o)

** charts after earnings ** 

 

CHANDLER, Ariz. (AP) — CHANDLER, Ariz. (AP) — Comtech Telecommunications Corp. (CMTL) on Tuesday reported fiscal third-quarter earnings of $2.8 million.

On a per-share basis, the Chandler, Arizona-based company said it had net loss of 4 cents. Earnings, adjusted for one-time gains and costs, came to 20 cents per share.

The results beat Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research was for earnings of 8 cents per share.

The communications company posted revenue of $128.1 million in the period, which fell short of Street forecasts. Four analysts surveyed by Zacks expected $136.4 million.

Long trade : REPL +50% (6/23)

•  Wed 6/5; vol. 950K

 

 

==CareDx Inc. (CDNA) reported earnings on Thur 9 May 24 (a/h)

 

CareDx beats by $0.44, beats on revs; raises FY24 revenue guidance above consensus

• Reports Q1 (Mar) loss of $0.03 per share, $0.44 better than the FactSet Consensus of ($0.47); revenues fell 6.9% year/year to $72 mln vs the $63.13 mln FactSet Consensus. 
• Revenue for Testing Services of $53.8 million, an increase of 15% as compared to the fourth quarter 2023. 
• Co raises guidance for FY24, sees FY24 revs of $274-$282 mln vs. $266.97 mln FactSet Consensus

Auna S.A. (AUNA) began trading on the NYSE on Fri 22 Mar 24

 Auna S.A., a healthcare service provider, operates hospitals and clinics in Mexico, Peru, and Colombia. The company provides prepaid healthcare plans in Peru; and dental and vision plans in Mexico. 

• Sector(s): Healthcare
• Industry: Medical Care Facilities
• Full Time Employees: 14,734
• Founded in 1989 
• HQ in Luxembourg, Luxembourg
• https://aunainvestors.com

 AUNA Auna S.A. (NYSE) priced 30.0 mln share IPO at $12.00 per share, below the expected

$13-15 range

Opened at $9.51 

Jumia Technologies AG (NYSE:JMIA) reported earnings on Tue 7 May 24 (b/o)

 ** charts after earnings **

 

 

LAGOS, NIGERIA / ACCESSWIRE / May 7, 2024 / Jumia Technologies AG (NYSE:JMIA) ("Jumia" or the "Company") announced today its financial results for the first quarter ended March 31, 2024.

Results highlights for the first quarter 2024

• Revenue of $49 million, up 19% year-over-year, and up 57% in constant currency.
• GMV of $181 million, up 5% year-over-year, and up 39% in constant currency.
• Operating loss of $8 million compared to $28 million in the first quarter of 2023, down 71% year-over-year, and down 79% in constant currency.
• Adjusted EBITDA loss of $4 million as compared to a loss of $25 million in the first quarter of 2023, down 83% year-over-year, and down 94% in constant currency.
• Loss before Income tax from continuing operations in the first quarter of 2024, was up 36% year-over-year and up 12% in constant currency largely driven by a $11 million increase in net foreign exchange losses, mostly without a cash impact, as a result of currency devaluations in Nigeria and Egypt and an increase in finance costs related to Jumia's treasury and investment portfolio management activities.
• Liquidity position of $101 million, a decrease of $19 million in the first quarter of 2024 as compared to a decrease of $22 million in the first quarter of 2023.
• Net cash flows from operating activities of $4 million as compared to net cash flows used in operating activities of $19 million in the first quarter of 2023.

-=Torrid (CURV) reported earnings on Thur 28 March 24 (a/h)

 

Torrid beats by $0.04, beats on revs; guides Q1 revs below consensus; guides FY24 revs mostly above consensus

• Reports Q4 (Jan) loss of ($0.04A) per share, $0.04 better than the FactSet Consensus of ($0.08); revenues fell 2.6% year/year to $293.54 mln vs the $276.2 mln FactSet Consensus.
• Co issues downside guidance for Q1 (Apr), sees Q1 revs of $277-282 mln vs. $296.22 mln FactSet Consensus.
• Co issues in-line guidance for FY24, sees FY24 revs of $1.135-1.155 bln vs. $1.14 bln FactSet Consensus.

==XPO, Inc. (XPO) reported earnings on Wed 7 Feb 24 (b/o)

 

XPO, Inc. beats by $0.15, beats on revs

• Reports Q4 (Dec) earnings of $0.77 per share, excluding non-recurring items, $0.15 better than the FactSet Consensus of $0.62; revenues rose 6.0% year/year to $1.94 bln vs the $1.92 bln FactSet Consensus.

Long trade : ADAP +20% (1/24)

•  Mon Jan 29: #1; vol. 562K

==Science Applications (SAIC) reported earnings on Mon 4 Dec 23 (b/o)

 

Science Applications beats by $0.58, beats on revs; raises FY24 EPS above consensus, revs above consensus

• Reports Q3 (Oct) earnings of $2.27 per share, $0.58 better than the FactSet Consensus of $1.69; revenues fell 0.7% year/year to $1.9 bln vs the $1.79 bln FactSet Consensus.
• Co issues upside guidance for FY24, sees EPS of $7.70-7.90 vs. $7.42 FactSet Consensus and above prior guidance of $7.20-7.40; sees FY24 revs of $7.33-7.35 bln vs. $7.24 bln FactSet Consensus and above prior guidance of $7.20-7.25 bln.