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Monday, November 8, 2021

BEAM-101 IND Cleared for Evaluation for Sickle Cell Disease

  Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today reported recent business and pipeline updates, as well as third quarter 2021 financial results.

As part of today’s update, Beam announced that its Investigational New Drug (IND) application for BEAM-101 for the treatment of sickle cell disease was cleared by the U.S. Food and Drug Administration (FDA). BEAM-101, the company’s lead ex vivo base editing product candidate, is a patient-specific, autologous hematopoietic investigational cell therapy which incorporates base edits that mimic single nucleotide polymorphisms seen in individuals with hereditary persistence of fetal hemoglobin (HPFH) to potentially alleviate the effects of mutations causing sickle cell disease or beta-thalassemia. This is the first open IND for base editing technology, a next-generation form of CRISPR capable of making single base changes without creating double strand breaks in the DNA. Beam is preparing to initiate a Phase 1/2 clinical trial designed to assess the safety and efficacy of BEAM-101 for the treatment of sickle cell disease, which Beam refers to as the BEACON-101 trial.

“We are thrilled to share that the FDA has cleared our first IND. BEAM-101 has the potential to offer a one-time treatment for patients with sickle cell disease, and this clearance enables the important transition from a preclinical to a clinical-stage company, bringing us closer to our ultimate goal of helping patients,” said John Evans, chief executive officer of Beam. “As leaders in the field of base editing, this milestone underscores the expertise of our team and the significant potential of our technology. We are grateful to the team members who have dedicated countless hours to this effort, and we look forward to this program’s continued evaluation in the clinic. As we look toward 2022, we believe we are well-positioned both financially and organizationally to execute on our vision.”

EHealth cuts guidance; Q3 call info

 2021 Guidance

Based on information available as of November 8, 2021, we are revising guidance for the full year ending December 31, 2021 previously provided on July 29, 2021. These expectations are forward-looking statements and we assume no obligation to update these statements. Actual results may be materially different and are affected by the risk factors and uncertainties identified in this press release and in eHealth's annual and quarterly reports filed with the Securities and Exchange Commission.

The following guidance is for the full year ending December 31, 2021:
•Total revenue is expected to be in the range of $535.0 million to $575.0 million compared to our previous guidance of $660.0 million to $700.0 million.
•GAAP net loss is expected to be in the range of $(43.0) million to $(63.0) million compared to our previous guidance of GAAP net income of $42.0 million to $57.0 million.
•Adjusted EBITDA(1)(2) is expected to be in the range of $(20.0) million to $0.0 million compared to our previous guidance of $110.0 million to $125.0 million.
•Cash used in operations is expected to be in the range of $125.0 million to $135.0 million compared to our previous guidance of $85.0 million to $95.0 million, and cash used for capital expenditures is expected to be in the range of $21.0 million to $24.0 million compared to our previous guidance of $24.0 million to $27.0 million.
•Non-GAAP net loss per diluted share(1) is expected to be in the range of $(0.45) to $(1.13) compared to our previous guidance of non-GAAP net income per diluted share of $2.77 to $3.26 per share.
•Revenue from the Medicare segment is expected to be in the range of $471.0 million to $509.0 million compared to our previous guidance of $601.0 million to $639.0 million. Revenue from the Individual, Family and Small Business segment is expected to be in the range of $64.0 million to $66.0 million compared to our previous guidance of $59.0 million to $61.0 million.
•Medicare segment profit (loss)(3) is expected to be in the range of $(5.0) million to $16.0 million compared to our previous guidance of $130.0 million to $146.0 million, and Individual, Family and Small Business segment profit is expected to be in the range of $41.0 million to $43.0 million compared to our previous guidance of $36.0 million to $38.0 million.
•Corporate(4) shared service expenses, excluding stock-based compensation, depreciation and amortization expense, and restructuring and reorganization charges, is expected to remain consistent with our previous guidance of $56.0 million to $59.0 million.
•GAAP net loss attributable to common stockholders per diluted share is expected to be in the range of $(2.26) to $(2.99) compared to our previous guidance of GAAP net income attributable to common stockholder of $0.84 to $1.39 per share.
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(1)See Non-GAAP Financial Information for definitions of our non-GAAP financial measures.
(2)During the first quarter of 2021, we revised the calculation of segment profit (loss) and adjusted EBITDA by excluding amortization of capitalized software development costs to enhance comparability of our financial metrics with peer companies. See the Revised Segment Profit Summary and Revised Adjusted EBITDA Reconciliation for additional information. Amortization of capitalized software development costs excluded from adjusted EBITDA is $10.0 million, which is comprised of $9.0 million and $1.0 million for the Medicare segment and the Individual, Family and Small Business segment, respectively.
(3)Segment profit (loss) is calculated as revenue for the applicable segment less marketing and advertising, customer care and enrollment, technology and content and general and administrative operating expenses, excluding stock-based compensation expense, depreciation and amortization, restructuring and reorganization charges, and amortization of intangible assets, that are directly attributable to the applicable segment and other indirect marketing and advertising, customer care and enrollment and technology and content operating expenses, excluding stock-based compensation expense, depreciation and amortization, restructuring and reorganization charges, and amortization of intangible assets, allocated to the applicable segment based on usage.
(4)Corporate consists of other indirect general and administrative operating expenses, excluding stock-based compensation and depreciation and amortization expense, which are managed in a corporate shared services environment and, since they are not the responsibility of segment operating management, are not allocated to the reportable segments.


Webcast and Conference Call Information
A webcast and conference call will be held today, Monday, November 8, 2021 at 8:30 a.m. Eastern / 5:30 a.m. Pacific Time. The live webcast and supporting presentation slides will be available on the Investor Relations section of eHealth's website at http://ir.ehealthinsurance.com. Individuals interested in listening to the conference call may do so by dialing (877) 930-8066 for domestic callers and (253) 336-8042 for international callers. The participant passcode is 2061569. A telephone replay will be available two hours following the conclusion of the call for a period of seven days and can be accessed by dialing (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. The call ID for the replay is 2061569. The live and archived webcast of the call will also be available on eHealth's website at http://www.ehealthinsurance.com under the Investor Relations section.

Alcon to Buy Glaucoma Surgery Device Maker Ivantis for Initial $475M

 Alcon Inc. on Monday said it agreed to buy privately held Ivantis Inc., maker of the Hydrus Microstent minimally invasive glaucoma surgery device, for an initial $475 million.

The Swiss eye-care company said the deal also includes additional contingent payments subject to the achievement of certain regulatory and commercial milestones.

Alcon said the addition of the Hydrus device, which is designed to lower intraocular pressure for open-angle glaucoma patients in connection with cataract surgery, expands its portfolio across cataract, refractive, retina and glaucoma.

Alcon said it expects to complete the acquisition of Ivantis, based in Irvine, Calif., in the first quarter of 2022.

https://www.marketscreener.com/quote/stock/ALCON-INC-56976364/news/Alcon-to-Buy-Glaucoma-Surgery-Device-Maker-Ivantis-for-Initial-475-Million-36938077/

EU to advise on Merck's COVID-19 pill in 'shortest possible' time

 


 The European Union's medicines regulator said on Monday it will give region-wide recommendations for the COVID-19 antiviral pill jointly developed by Merck and Ridgeback Biotherapeutics in the "shortest possible" time-frame.

The European Medicines Agency (EMA) said it was reviewing the available data as the watchdog seeks to help member states before possible approval.

https://www.marketscreener.com/news/latest/EU-to-advise-on-Merck-s-COVID-19-pill-in-shortest-possible-time--36943367/

CytoDyn Submits Breakthrough Application for Leronlimab for Triple-Negative Breast Cancer

 Ongoing analysis of data from 28 mTNBC patients following 12 months of treatment with leronlimab is very encouraging given little-to-no effective treatment options currently

CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it has submitted to the U.S. Food and Drug Administration (“FDA”) an application for Breakthrough Therapy designation (“BTD”) for leronlimab as a potential treatment for mTNBC. This BTD application is based on the data analysis reported by the Company on November 3, 2021.

The Company’s Chief Medical Officer, Scott Kelly, M.D., shared early findings from this study with the medical and scientific communities at the Triple-Negative Breast Cancer Drug Development Digital Summit in April 2021. Dr. Nitya Ray, CytoDyn’s COO and CTO, has led the BTD effort in collaboration with experts in Oncology, Biostatistics, and Regulatory affairs.

As previously reported, these findings represent the analysis of data from 28 pooled patients, 16 from our Compassionate Use Study, 10 from the Phase 1b/2 Study, and 2 from the Basket Study. All subjects received ≥1 dose of leronlimab (range 1-51 doses) subcutaneously in conjunction with standard of care (SOC) systemic chemotherapy. Of the 28 subjects, 9 subjects received 350mg weekly dose and 19 subjects received 525mg or 700mg weekly dose (4 subjects had dose escalation from 350mg to 525mg and were included in the higher dose cohort). The median age of the subjects was 52 years (range 33-84 years). All subjects were diagnosed with Stage IV mTNBC. Of the 28 subjects, 17 (61%) subjects started with visceral metastases, 6 (21%) subjects started with brain metastases, and 3 (11%) had bone-only metastases.

https://finance.yahoo.com/news/cytodyn-submits-breakthrough-therapy-designation-110000722.html

Endo to Supply Vasopressin Vials Essential for COVID-19 Care

 Endo International plc (NASDAQ: ENDP) today announced that its Par Sterile Products business will supply VASOSTRICT®, vasopressin injection, USP, vial presentations to healthcare providers through Premier's Premier ProRx® program, helping to maintain supply continuity for a medication needed in critical care, including some of the most acute cases of COVID-19.

https://finance.yahoo.com/news/endo-announces-agreement-premier-supply-123000575.html

Bristol: Opdivo Plus Chemo Improves Event-Free Survival in Non-Small Cell Lung Cancer in Phase 3

 CheckMate -816 is the first Phase 3 trial with an immunotherapy-based combination to demonstrate improved event-free survival and pathologic complete response in the neoadjuvant setting of non-small cell lung cancer

Positive results reinforce the improved efficacy seen with Opdivo-based treatments in four Phase 3 clinical trials in earlier-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma

Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -816 trial met the primary endpoint of improved event-free survival (EFS) in patients with resectable stage IB to IIIA non-small cell lung cancer (NSCLC). In a prespecified interim analysis, Opdivo (nivolumab) plus chemotherapy showed a statistically significant and clinically meaningful improvement in EFS compared to chemotherapy alone when given before surgery. This combination previously showed a significant improvement of pathologic complete response (pCR), the trial’s other primary endpoint. The safety profile of Opdivo plus chemotherapy was consistent with previously reported studies in NSCLC.

https://finance.yahoo.com/news/neoadjuvant-opdivo-nivolumab-plus-chemotherapy-115900324.html