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Heathcare and Biotech Updates

Investors Seeing Green as FDA Approves Second Sight Medical’s Argus 2s Retinal Prosthesis System

Source: Streetwise Reports   03/05/2021

Second Sight Medical Products shares trade more than 400% higher after the company reported that the FDA granted approval for its Argus 2s Retinal Prosthesis System designed to deliver useful artificial vision to blind individuals diagnosed with retinitis pigmentosa.

Developer of implantable visual prosthetics Second Sight Medical Products Inc. (EYES:NASDAQ), which is striving to create an artificial form of useful vision for blind individuals, today announced that “the U.S. Food and Drug Administration (FDA) has approved the Argus 2s Retinal Prosthesis System, a redesigned set of external hardware (glasses and video processing unit) initially for use in combination with previously implanted Argus II systems for the treatment of retinitis pigmentosa (RP).”

The firm indicated that it anticipates that the Argus 2s system will be incorporated into the external system for the next generation Orion Visual Cortical Prosthesis System, which the company stated is presently undergoing development.

Second Sight Medical Products pointed out that the Argus 2s system now comes with significantly greater processing power that offers the potential for enhanced video processing capabilities. The firm noted that the system has also been designed to provide additional ergonomic improvements.

Matthew Pfeffer, acting CEO of Second Sight Medical, commented, “We are very pleased to have received this approval, as it presents an opportunity to offer external hardware that we believe enhance comfort and aesthetics compared with the legacy Argus II system.”

The company advised that it plans to continue working together with Pixium Vision on production of the newly FDA approved hardware. The two firms are currently in discussions as to how best to structure the joint production efforts and to establish a timeline for when production will commence. Second Sight indicated that if the business management combination details are worked out then the firms will proceed with evaluating the best path forward with the Argus 2s Retinal Prosthesis System and other products in development.

Second Sight Medical Products is a developer and marketer of implantable visual prosthetics based in Los Angeles, Calif. The company’s products are designed to deliver functional artificial vision to blind people. The firm specializes in the area of creating neuromodulation devices and developing new neurostimulation technologies to treat the broadest population of sight-impaired individuals. The firm is focused initially on individuals who have lost vision due to retinitis pigmentosa (RP), but there are also potential applications for other eye diseases and injuries including glaucoma, diabetic retinopathy, optic nerve injury or disease, cancer and trauma.

The company noted that its Argus II system is the first artificial retina to have received widespread commercial approval. The firm explained that “the Argus II Retinal Prosthesis System provides electrical stimulation that bypasses the defunct retinal cells and stimulates remaining viable cells inducing visual perception in individuals with severe to profound RP and works by converting images captured by a miniature video camera mounted on the patient’s glasses into a series of small electrical pulses, which are transmitted wirelessly to an array of electrodes implanted on the surface of the retina.”

Second Sight indicated that “the Orion Visual Cortical Prosthesis System is an implanted cortical stimulation device intended to provide useful artificial vision to individuals who are blind due to a wide range of causes, including glaucoma, diabetic retinopathy, optic nerve injury or disease, and eye injury.” Orion works by converting video captured images into a series of small electrical pulses. The wearable device is a miniature camera embedded into eyeglasses that bypasses the injured or diseased eye and wirelessly transmits electrical impulses to electrodes implanted on the brain’s visual cortex surface where patterns of light are detected and perceived.

The firm stated that an early feasibility study of Orion is now being conducted in six individual subjects at the Ronald Reagan UCLA Medical Center and the Baylor College of Medicine.

Second Sight Medical Products started off the day with a relatively small market capitalization of around $33.2 million with approximately 23.21 million shares outstanding and a short interest of about 1.3%. EYES shares opened 60% higher today at $2.29 (+$0.86, +60.14%) over yesterday’s $1.43 closing price and then soared to a new 52-week high price this morning of $9.89 on greater than 400 times average 200-day trading volume. The stock has traded today between $2.07 to $9.89 per share and is currently trading at $7.44 (+$6.01, +420.28%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Amgen Offers $1.9 Billion to Acquire Five Prime Therapeutics

Source: Streetwise Reports   03/04/2021

Five Prime Therapeutics shares traded 78% higher after the company reported it entered into a definitive agreement to be acquired by biotech giant Amgen for $38 per share in cash.

This morning prior to the open of U.S. markets, clinical-stage biotechnology company Five Prime Therapeutics Inc. (FPRX:NASDAQ), which is focused on the development of immune modulators and targeted treatment for solid tumor cancers, announced that it entered into an agreement to be acquired by Amgen Inc (AMGN:NASDAQ) for $38.00 per share in cash, which represents an equity value of about $1.9 billion.

The report indicated that the merger will serve to incorporate Five Prime’s pipeline with Amgen’s extensive oncology portfolio. Five Prime Therapeutics stated that “its leading asset bemarituzumab is a first-in-class, Phase 3 ready anti-FGFR2b antibody with positive data from a randomized, placebo-controlled Phase 2 study in frontline advanced gastric or gastroesophageal junction (GEJ) cancer.” The company noted that in the Phase 2 FIGHT study, treatment with bemarituzumab showed “clinically meaningful improvements in progression-free survival (PFS), overall survival (OS) and overall response rate (ORR) in the frontline treatment of patients with advanced gastric or GEJ cancer.” The firm added that the data from the trial suggests that there may be additional correlations and benefits in treatment of other epithelial cancers, such as ovarian, breast, lung and other cancers.

The firms noted that the Five Prime acquisition fits well with Amgen’s international expansion strategy. As gastric cancer is classified as one of the world’s most common cancer types and is much more prevalent in the Asia-Pacific region, this area is well aligned with Amgen’s strategy to grow sales in that region in coming years. Amgen will also benefit immediately from owning the existing royalties from future net sales in Greater China under the co-development and commercialization agreement that is already in place between Five Prime and Zai Lab Co. Ltd.

Amgen’s Chairman and CEO commented, “The acquisition of Five Prime offers a compelling opportunity for Amgen to strengthen our oncology portfolio with a promising late-stage, first-in-class global asset to treat gastric cancer…We look forward to welcoming the Five Prime team to Amgen and working with them to leverage our best-in-class monoclonal antibody manufacturing capabilities to supply additional clinical materials, as well as expanded production quantities, to realize the full potential of bemarituzumab for even more patients around the world as quickly as possible.”

Five Prime Therapeutics’ President and CEO Tom Civik remarked, “This is an exciting day for patients who may one day benefit from the promise of bemaritizumab and our full pipeline. I’m so proud of the Five Prime team and the science we’ve pioneered…We see tremendous complementarity between the two companies. Amgen has global reach, world-class resources, and they share our deep passion for science and commitment to patients. I have full confidence that Amgen is the right company to work with us to bring our innovative cancer treatments to patients and to achieve our mission to rewrite cancer.”

The report advised that the transaction has already been approved by the Boards of Directors of both companies and is expected to close by the end of Q2/21. For its part Amgen will make a cash tender offer of $38 per share to acquire 100% of Five Prime’s outstanding common shares. The transaction remains subject to majority stockholder approval from Five Prime shareholders, customary closing conditions and regulatory approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

The company explained that “bemarituzumab (anti-FGFR2b) is a first-in-class targeted antibody that blocks fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression.”

The company stated that gastric (stomach) cancer and GEJ cancer accounts for the third highest cause of cancer deaths worldwide. The firm indicated that globally more than 1 million new cases are diagnosed each year.

Five Prime Therapeutics is a clinical-stage biotechnology company based in South San Francisco, Calif. The firm is engaged in research and development of immuno-oncology and targeted cancer therapies that can be paired with companion diagnostics to identify patients who might be benefit from treatment with its drug candidates.

Amgen is one of the world’s largest biotechnology firms with a market cap of around $130 billion. The company is the owner of numerous patented medicines including Enbrel, Prolia, XGEVA, Neulasta and Aranesp.

Five Prime Therapeutics began the day with a market cap of around $933.3 million with approximately 43.9 million shares outstanding and a short interest of about 5.5%. FPRX shares opened nearly 79% higher today at $38.00 (+$16.74, +78.74%) over yesterday’s $21.26 closing price and reached a new 52-week high this morning of $38.1727. The stock has traded today between $37.70 and $38.18 per share and is currently trading at $37.82 (+$16.56, +77.89%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

FDA Grants Expanded Use in General Surgery for Asensus Surgical’s Robotic Laparoscopic Platform

Source: Streetwise Reports   03/03/2021

Asensus Surgical shares traded 16.5% higher after the company reported it received clearance from the U.S. Food & Drug Administration for its Senhance© Surgical System for use in general surgical procedures.

Medical surgical device company Asensus Surgical Inc. (TRXC:NYSE.American), developer of a Performance-Guided Surgery™ platform that digitizes the interface between the surgeon and patient, today announced that it has “received an additional FDA clearance for the Senhance Surgical System which allows for indication expansion in general surgery in the U.S.”

The company advised that its Senhance® Surgical System technology platform “is the first of its kind digital laparoscopic platform that leverages augmented intelligence to provide unmatched performance and patient outcomes through machine learning.”

Asensus Surgical explained that the Senhance system offers numerous features well beyond other commercially available surgical robotic systems. The firm stated that its system incorporates haptic feedback and allows for eye-tracking camera control and 3D visualization. The company additionally pointed out that the system permits use of the smallest 3 mm instruments available in the world that can be integrated for use on its robotic laparoscopic surgical platform.

The company’s President and CEO Anthony Fernando commented, “The expansion into general surgery for the Senhance Surgical System is a major milestone for the growth and clinical applicability of our technology…General surgery is, by far, the largest area of manual laparoscopy which can benefit from the precision and insight of Performance-Guided Surgery. The indication expansion allows Senhance to be used in many high-value, complex reconstructive surgeries such as those used to treat reflux and obesity. Including previous indications granted, the Senhance Surgical System can now be utilized in over 2.7 million general surgical procedures performed in the U.S. annually.”

Dr. Sabino Zani, assistant professor of surgery at Duke University and an investigator in the clinical studies submitted for indication expansion, remarked, “Many of the procedures we perform in general surgery require complex reconstruction throughout a wide surgical field…Senhance can now be seen as a widely applicable tool for general surgeons across the broad range of procedures that may be performed from deep in the pelvis to the upper abdomen.”

The company explained that the Senhance Surgical System is designed to accurately control laparoscopic instruments during surgical procedures. The system facilitates visualization and allows for endoscopic manipulation of tissue when grasping, cutting, retracting and suturing during medical procedures.

The firm noted that the Senhance Surgical System is intended for use in adult patients in laparoscopic gynecological surgery, cholecystectomy colorectal surgery and inguinal hernia repair and now many other common general surgical procedures.

Asensus Surgical is a medical device company headquartered in Morrisville, N.C. The firm stated that “it is digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery by unlocking the Clinical Intelligence to enable consistently superior outcomes and a new standard of surgery.” The firm notted that its Senhance® Surgical System is presently available for sale in the EU, Japan, Russia and the U.S.

Asensus Surgical started the day with a market cap $546.1 million with approximately 139.3 million shares outstanding and a short interest of about 4.8%. TRXC shares opened 26% higher today at $4.95 (+$1.03, +26.28%) over yesterday’s $3.92 closing price. The stock has traded today between $4.50 and $5.30 per share and is currently trading at $4.57 (+$0.65, +16.58%).

 

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Analyst: All Systems Are Go for Testing, Testing and More Testing

Source: Streetwise Reports   02/24/2021

This Dawson James report explains why ProPhase Labs is perfectly positioned to benefit from expanded COVID testing.

In a Feb. 22 research note, Dawson James analyst Jason Kolbert stated that ProPhase Labs Inc. (PRPH:NASDAQ) is well positioned to benefit from the several new federal initiatives to expand COVID-19 testing.

Kolbert listed the Biden administration’s recent efforts to increase COVID-19 testing, all of which bode well for ProPhase Labs. The Department of Health and Human Services will partner with the Department of Defense to expand testing for schools and underserved congregate settings through coordination hubs with a $650 million investment. Domestic manufacturing of testing supplies and raw materials will be boosted; $815 million will be directed toward that effort. The Centers for Disease Control and Prevention plans to “increase genomic sequencing of the virus to better prepare for the threat
of variants and slow the spread of disease. CDC plans “to invest nearly $200 million to expand genomic sequencing capabilities, including bioinformatics, reporting, and modeling, to increase sequencing three-fold per week.

Kolbert noted that even a small piece of the multimillion-dollar market for COVID tests “has the ability to be transformative to a company such as ProPhase.”

“Recognizing the opportunity, the company acquired a CLIA lab (October 2020) capable of processing 1,000 samples in 24 hours (& now expanded to 10k/day). We visited the newest facility in Garden City, which is set to come on-line with the capability to process up to 50,000 samples per day,” the analyst explained.

Previously, ProPhase generated revenue solely from sales of its T.K. dietary supplements line and from contract manufacturing of over-the-counter cold/flu and other health products. Those earnings will offset expenses incurred from its new operations, laboratory testing services.

“We see this as a good business and one where the management team, particularly the CEO, has demonstrated the ability to turn around both a falling business and a company,” Kolbert wrote. “With that said, we see this business as a means to an end, with the end being diagnostics.”

Dawson James has a Buy rating on ProPhase Labs and a target price of $25. The stock is currently trading at around $8.28.

 

Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures for Dawson James Securities, ProPhase Labs, February 22, 2021

The Firm does not make a market in the securities of the subject company(s). The Firm has engaged in investment banking relationships with the subject company in the prior twelve months, as a manager or co-manager of a public offering and has received compensation resulting from those relationships. The Firm may seek compensation for investment banking services in the future from the subject company(s). The Firm has not received other compensation from the subject company(s) in the last 12 months for services unrelated to managing or co-managing of a public offering.

Neither the research analyst(s) whose name appears on this report nor any member of his (their) household is an officer, director or advisory board member of these companies. The Firm and/or its directors and employees may own securities of the company(s) in this report and may increase or decrease holdings in the future. As of January 31, 2021, the Firm as a whole did not beneficially own 1% or more of any class of common equity securities of the subject company(s) of this report. The Firm, its officers, directors, analysts or employees may affect transactions in and have long or short positions in the securities (or options or warrants related to those securities) of the company(s) subject to this report. The Firm may affect transactions as principal or agent in those securities.

Analysts receive no direct compensation in connection with the Firm’s investment banking business. All Firm employees, including the analyst(s) responsible for preparing this report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of the Firm and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.

Analyst Certification: The analyst(s) whose name appears on this research report certifies that 1) all of the views expressed in this report accurately reflect his (their) personal views about any and all of the subject securities or issuers discussed; and 2) no part of the research analyst’s compensation was, is, or will be directly or indirectly related to the specific recommendations or views expressed by the research analyst in this research report; and 3) all Dawson James employees, including the analyst(s) responsible for preparing this research report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of Dawson James and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.

Pandion Shares Trade Up 134% on $1.85 Billion Acquisition by Merck

Source: Streetwise Reports   02/25/2021

Pandion Therapeutics shares reached a new 52-week high after the company reported it agreed to be acquired by pharmaceutical giant Merck & Co. in an all cash transaction for $60 per share.

Clinical-stage biopharmaceutical company Pandion Therapeutics Inc. (PAND:NASDAQ), which focuses on developing modular therapeutics for treating autoimmune and inflammatory diseases, today announced that it entered into a definitive agreement to be acquired by a wholly owned subsidiary of Merck & Co. Inc. (MRK:NYSE) for $60 per share in cash. The firms advised that this price equates to a total equity value of approximately $1.85 billion.

Merck Research Laboratories’ President Dr. Dean Y. Li commented, “This acquisition builds upon Merck’s strategy to identify and secure candidates with differentiated and potentially foundational characteristics…Pandion has applied its TALON technology to develop a robust pipeline of candidates designed to re-balance the immune response with potential applications across a wide array of autoimmune diseases.”

Pandion noted that “it is advancing a pipeline of precision immune modulators targeting critical immune control nodes and that its lead candidate, PT101, is an engineered IL-2 mutein fused to a protein backbone designed to selectively activate and expand regulatory T cells (Tregs) for the potential treatment of ulcerative colitis and other autoimmune diseases.”

Pandion Therapeutics’ CEO Dr. Rahul Kakkar stated, “Pandion grew out of our founders’ personal and scientific mission to change the way patients living with autoimmune diseases are treated. In just a few years, we have taken that mission from idea to clinical proof of mechanism with PT101, our lead IL-2 mutein. We are proud that Merck has recognized our team’s innovation and drive in creating a pipeline of diverse candidates that activate natural immune regulatory mechanisms and thereby have the potential to achieve better clinical responses for patients…We believe Merck is well positioned to bring our novel approach to the millions of those living with autoimmune diseases, and we look forward to seeing these molecules progress in the clinic.”

The companies advised that according to the terms of the purchase agreement, Merck will initiate a tender offer of $60 per share to acquire all of the outstanding shares of Pandion through a subsidiary company. In order to go forward at least one half of the shares held by Pandion investors must tendered in the offer.

The transaction is expected to close in H1/21 following the successful completion of the tender offer, though the transaction remains subject to customary closing conditions and regulatory approvals including the expiration of the waiting period as mandated under the Hart-Scott-Rodino Antitrust Improvements Act.

Merck & Co., Inc. is headquartered in Kenilworth, N.J., and is one of the world’s largest global healthcare companies with a market cap of around $190 billion. The firm is known as MSD outside of the U.S. and Canada. The company provides healthcare services and develops, manufactures and markets animal health products, biologic therapies, prescription medicines and vaccines worldwide.

Pandion Therapeutics is a clinical-stage biopharmaceutical company based in Watertown, Mass. The firm is engaged in developing novel innovative modular therapeutics to meet unmet medical needs in the area of autoimmune and inflammatory diseases. The company noted that “its TALON (Therapeutic Autoimmune reguLatOry proteiN) drug design and discovery platform enables the company to create a pipeline of product candidates using immunomodulatory effector modules, with the ability to also combine an effector module with a tissue-targeted tether module in a bifunctional format.”

Pandion Therapeutics began the day with a market cap of around $756.6 million with approximately 29.52 million shares outstanding. PAND shares opened more than 130% higher today at $59.39 (+33.76, +131.72%) compared to yesterday’s closing price of $25.63. The stock has traded today between $59.21 and $60.38 per share and is currently trading at $60.06 (+$34.43 +134.35%).

 

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Owens & Minor Shares Soar 36% After Firm Reports Record Q4 Earnings and Positive 2021 Outlook

Source: Streetwise Reports   02/24/2021

Shares of Owens & Minor Inc. soared to a new 52-week high after the company reported Q4/20 and FY/20 financial results that were boosted by a 58% gain in global products revenue and increases in elective medical procedures.

Global healthcare solutions firm Owens & Minor Inc. (OMI:NYSE) today announced financial results for the fourth quarter and full year of 2020 ended December 31, 2020.

The company’s President and CEO Edward A. Pesicka remarked, “The monumental effort of the Owens & Minor teammates in 2020 along with their relentless focus on serving our customers has reinforced our position in the healthcare industry as a trusted partner…I am very proud of how our teammates delivered on our mission of ‘Empowering Our Customers to Advance Healthcare’ and exemplified our IDEAL values in our swift response to the Covid-19 pandemic.”

“We delivered exceptional financial results for the quarter and full year through strong execution…Our productivity gains along with favorable product mix drove our margin improvement and significant earnings growth. During the year we successfully deleveraged our balance sheet while continuing to reinvest in our businesses. We have established a solid foundation for long-term profitable growth and enhanced financial flexibility,” Pesicka added.

The company reported that total revenue in Q4/20 grew by 8% year-over-year to $2.362 billion, compared to $2.191 billion in Q4/19. The firm listed that Q4/20 Global Solutions revenue grew to $1.95 billion, which represented a 1% increase over Q4/20 and a 5% increase over Q3/20. During the same period, Global Products revenue increased to $575 million, representing a 58% increase from Q4/19 and a 21% boost versus Q3/20.

Owens & Minor advised that the strong growth in Q4/20 revenue was largely driven by increased demand for personal protective equipment (PPE) through its medical distribution channel as well as through its direct to customers home healthcare business.

The company stated that net income in Q4/20 was $50.7 million, compared to a net loss of $5.4 million in Q4/19. The company reported that in Q4/20 GAAP earnings per share (EPS) was $0.72 per share and adjusted EPS was $1.14, which represented growth of nearly 400% compared to adjusted EPS of $0.23 in Q4/19.

The firm noted that the significant increase in Q4/20 year-over-year earnings was achieved by a combination of sales growth, operating efficiencies and product mix. The company stated that its gross margin expanded by 390 basis points which contributed to a 204% increase in adjusted operating income.

The company highlighted that it “delivered over 12 billion units of PPE to healthcare workers in the fight against Covid-19, of which approximately 5 billion units were produced with materials manufactured in its American factories or Owens & Minor owned facilities, since January 2020.” The firm added that that it has been actively partnering with both U.S. federal and state agencies to respond to the pandemic by making further investments in PPE manufacturing capacity and distributing PPE to frontline medical personnel and is doing its part to aid in replenishing the country’s strategic national stockpile.

The company offered some forward guidance and stated that for FY/21 it expects adjusted net income will be $3.00-3.50 per share, which represents growth in the range of 33-55% compared to FY/20. Owens & Minor stated that the FY/20 estimates are based upon achieving increased PPE capacity and manufacturing efficiencies during 2021. In addition, the firm projects that pass through of exam glove cost increases will add $300-$500 million to top line, but will only have a minimal impact on profitability. The firm also advised that it anticipates that the strength in the number of elective medical procedures undergone in Q4/20 will continue thru H1/21.

Owens & Minor indicated that its Board of Directors has approved a dividend for Q1/21 in the amount of $0.0025 per share, which is payable to shareholders of record as of March 15, 2021, on March 31, 2021.

Owens & Minor is a global healthcare solutions company based in Richmond, Va. The company employs about 15,000 people and markets its products and services to greater than 4,000 healthcare industry customers in around 70 countries. The firm provides a broad spectrum of integrated technologies, products, services and logistical support to healthcare providers and manufacturers across the continuum of care. At present, the company is highly focused on reliably supplying its self-manufactured surgical and PPE products and portfolio of products representing 1,200 branded suppliers to medical facilities. The company has production and distribution operations, customer service centers and sales offices located across Asia-Pacific, Europe, Latin America, and North America.

Owens & Minor started the day with a market cap of around $1.9 billion with approximately 73.51 million shares outstanding and a short interest of about 7.6%. OMI shares opened 14% higher today at $29.03 (+$3.60, +14.16%) over yesterday’s $25.43 closing price and reached a new 52-week high this morning of $35.73. The stock has traded today between $28.50 and $35.73 per share and is currently trading at $34.54 (+$9.11, +35.82%).

 

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Telehealth Tech Company Continues Rapid Growth in COVID-Changed Landscape

Source: Streetwise Reports   02/24/2021

Reliq Health introduces iUGO Home services and just added a care management network in California with 50 clinics and over 500 physicians.

Not only does Reliq Health Technologies Inc. (RHT:TSX.V; RQHTF:OTCQB; A2AJTB:WKN) continue to add innovative and advanced virtual care solutions for community-based healthcare—care outside the hospital setting—it also is growing the network of providers using its technology.

COVID has changed the healthcare landscape. “The pandemic has certainly accelerated the adoption of virtual care technology by over a decade,” Dr. Lisa Crossley, CEO of Reliq Health Technologies, told Streetwise Reports. “Medicare and Medicaid have validated that using virtual care technologies prevents patients from going into hospital or going into the ER and therefore significantly reduces the cost of care for these patients. We’re at a point now where there’s a lot of market pull for our platform.”

“This is really going to be the breakout year for us,” Dr. Crossley added.

She noted that the company hadn’t had a lot of interest from skilled nursing facilities prior to the pandemic, but “now they are one of our most rapidly growing segments. Their business was hard hit by the pandemic, but transitional care, remote monitoring and remote annual wellness visits are new revenue streams for them and a way to maintain some continuity of care, without having patients in a residential setting where the risk of catching COVID is so high.”

More than 37 million Medicare and Medicaid patients have two or more chronic diseases, Dr. Crossley noted. “That’s a $100 billion market for us right there.” The company is also getting interest from private insurers.

The company just added a care management network in California with 50 clinics and over 500 physicians. “The network delivers culturally customized, technology-enabled health care to senior citizens in the Asian-American community across California,” the company advised.

“We are very pleased to be expanding on the West Coast, and in particular to be leveraging our customizable, multilingual iUGO Care and iUGO Home solutions to meet the needs of Medicare, Medicaid and privately insured patients in the Asian-American community in California,” said Dr. Crossley.

“Using our highly scalable iUGO Care platform, physicians serving this community will be able to manage complex patients in their own homes and in their preferred language, offering multilingual Remote Patient Monitoring (RPM), Chronic Care Management (CCM) and Behavioral Health Integration (BHI) services,” Dr. Crossley explained.

“iUGO Care allows complex patients to receive high quality care at home, improving health outcomes, enhancing quality of life for patients and families and reducing the cost of care delivery,” the company stated. Remote patient monitoring allows people to monitor their health status anywhere using medical devices, and the system notifies the care team if a patient’s condition starts to deteriorate.

“With iUGO Home, case managers in the network can support seniors aging in place, allowing them to live safely and independently by providing multilingual personal emergency response services, fall detection, medication reminders and geofencing,” Dr. Crossley said. The company expects to begin onboarding patients in California in March, with revenue averaging US$40/patient/month.

Reliq’s iUGO Home system uses a wearable device, either a watch or a pendant, that connects a patient with its care team. The system facilitates two-way audio communication, fall detection, medication reminders and fencing alerts if the patient wanders beyond a defined area. The device connects either by cellular or Wi-Fi, and also connects with Bluetooth-enabled medical devices that the patient is using.

The company signed its first contract for iUGO Home at the end of January, with a long-term care facility in Texas that will supply iUGO Home to its patients, and expects to add 3,000 iUGO Home patients in North Texas this year. The average revenue is expected to be $30 USD per patient per month. “Many of these patients will also be using other iUGO Care products including Remote Patient Monitoring, Chronic Care Management, Transitional Care Management and Behavioral Health Integration, with an average additional revenue per patient of $40 USD/patient/month,” the company stated.

Reliq has also launched iUGO Well to address people’s physical and mental needs. In October, Reliq announced an agreement with the University of Notre Dame Australia, a school with 12,000 students. “iUGO Well is a digital health solution that delivers preventative health and wellbeing programs via mobile and web applications,” the company explained. “With iUGO Well,” Dr. Crossley explained, “we’re mostly focusing on the university students, although also on the faculty and staff, looking at reducing stress in general and making positive lifestyle changes. Australia is a really good market for that kind of product, because the government actually penalizes employers if they have employees who are either hospitalized for a mental health conditions if it’s related to stress at work, or if they committed suicide.”

“Just this year we are working in new geographies, we’ve got new technologies that are allowing us to access different patient populations, so we are diversified geographically as well as in our product lines,” Dr. Crossley concluded. “We are ramping up the first half of this year, and we expect to see truly explosive growth the second half of the year as COVID vaccinations alleviate a lot of the acute, urgent demands on our clients, and allow them to focus on more proactive approaches to care.”

Disclosure:
1) Patrice Fusillo conducted this interview for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. She owns, or members of her immediate household or family own, shares of the following companies mentioned in this article: None. She is, or members of her immediate household or family are, paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this interview are billboard sponsors of Streetwise Reports: Reliq Health Technologies. Click here for important disclosures about sponsor fees. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) The interview does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
4) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Reliq Health Technologies, a company mentioned in this article.

Digital Therapeutics Leader DarioHealth Makes a Critical Acquisition

Source: Matt Badiali for Streetwise Reports   02/17/2021

Independent financial analyst Matt Badiali discusses DarioHealth’s latest acquisition and what it means for the company’s growth.

On January 27, DarioHealth Corp. (DRIO:NASDAQ) bought Upright Technologies. Upright is a leader in musculoskeletal (MSK) treatment using a similar digital platform to DarioHealth’s. This is a “force multiplier” for DarioHealth because it broadens the treatment options for the company’s popular app.

Upright Technologies’ system complements DarioHealth’s platform. Upright won the 2016 Convergence MEDy award for excellence in medical entrepreneurship and Best Medical App 2016 at MEDICA. The platform reduced back pain over a period of 18 months. It has the largest patient-reported outcome in the musculoskeletal space, with over 57,000 participants.

Upright’s platform offers a data driven solution to back pain. It has sensors that collect data, biofeedback, and coaching. And the two companies share a user-centric philosophy. They both aim for real, positive outcomes on chronic conditions.

DarioHealth’s platform assists users in managing pre-diabetes, diabetes, obesity and hypertension. It captures, monitors and communicates personalized health data and metrics, like a smartwatch. The company’s team uses that data to supply high-quality, personalized coaching to help users succeed.

And once the two platforms integrate, it will significantly increase the company’s revenue.

That’s because DarioHealth’s platform focuses on diabetes and requires buy-in by participants. When a company signs up with DarioHealth, roughly 1 in 10 employees will be a potential customer for its diabetes and hypertension system. However, 4 in 10 employees will be interested in the MSK. The result of the acquisition is that DarioHealth’s platform will now be able to serve a much larger customer base.

DarioHealth might be the best new digital therapeutics companies in the sector. CEO Erez Raphael continues to stand by his philosophy and grow the company in a smart, deliberate manner.

Livongo’s acquisition by Teledoc for $18.5 billion left a vacuum at the top of the sector. DarioHealth is clearly one of the favorites to fill that void. The market took notice. As you can see in the chart below, DarioHealth’s shares are up more than 200% in a year.

DRIO chart

But with just a $394 million market cap, the company still offers a huge value opportunity for new investors. Livongo’s takeover set a new standard for companies like DarioHealth. And DarioHealth’s cross-functional system combines life sciences, behavioral science and technology to create a unique and successful new tool for health.

The one promise from management that we haven’t seen is a true nameplate payer. Once we see the company land a large insurance company, the stock should rip higher.

Good Investing,

–Matt Badiali

Reach Matt Badiali at www.mattbadiali.net.

Matt Badiali is a geologist and independent financial analyst. He spent fifteen years researching and writing about great investments inside the natural resources sectors. He can be reached at www.mattbadiali.net.

 

Streetwise Reports Disclosure:
1) Matt Badiali: I, or members of my immediate household or family, own shares of the following companies mentioned in this article: DarioHealth. I personally am, or members of my immediate household or family are, paid by the following companies mentioned in this article: I am a consultant to DarioHealth. I determined which companies would be included in this article based on my research and understanding of the sector.
2) The following companies mentioned in the article are sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) Statements and opinions expressed are the opinions of the author and not of Streetwise Reports or its officers. The author is wholly responsible for the validity of the statements. The author was not paid by Streetwise Reports for this article. Streetwise Reports was not paid by the author to publish or syndicate this article. Streetwise Reports requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Streetwise Reports relies upon the authors to accurately provide this information and Streetwise Reports has no means of verifying its accuracy.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

Nektar Therapeutics Planning Phase 2/3 Studies with Merck and SFJ Pharma for Head and Neck Cancer

Source: Streetwise Reports   02/17/2021

Nektar Therapeutics shares traded 14% higher after the company reported it plans to conduct a Phase 2/3 study of bempegaldesleukin in combination with Merck’s KEYTRUDA® in patients with squamous cell carcinoma of the head and neck and is partnering on a second Phase 2/3 study with SFJ Pharmaceuticals that will provide $150 million to fund development.

Biopharmaceutical company Nektar Therapeutics (NKTR:NASDAQ), which is employs new chemistry approaches to create medicines to treat cancer and auto-immune disease, today announced that “it has entered into a clinical trial collaboration and supply agreement with Merck & Co. Inc. (MRK:NYSE) for a Phase 2/3 study of bempegaldesleukin (NKTR-214, BEMPEG).”

The company stated that “BEMPEG is its investigational IL-2 pathway agent, in combination with Merck’s KEYTRUDA® (pembrolizumab) for first-line treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck (SCCHN) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1).” The firm advised that it plans to begin the Phase 2/3 study in H2/21.

Nektar Therapeutics’ Chief R&D Officer Jonathan Zalevsky, Ph.D., commented, “We are excited to advance the combination of BEMPEG plus KEYTRUDA to a Phase 2/3 study in first-line squamous cell carcinoma of the head and neck…Earlier studies of BEMPEG in combination with immune checkpoint inhibitors, also known as ICIs, evaluated in patients with immune-sensitive cancers have shown the potential to increase and deepen treatment responses as compared to historical rates for ICIs alone. This collaboration with Merck will enable us to further explore the combination of BEMPEG with the leading checkpoint inhibitor therapy in the setting of advanced head and neck cancer.”

The company advised that according to the terms of the agreement with Merck, it will responsible for conducting the Phase 2/3 trial. The study calls for the enrollment of 500 patients with metastatic or recurrent SCCHN with PD-L1 expressing tumors who will be randomized to receive pembrolizumab alone or a combination of BEMPEG plus pembrolizumab.

The firm stated that an interim analysis is scheduled to be performed during the Phase 2 portion of the trial based upon the overall response rate (ORR) of the first 200 trial participants after they have each undergone at least four months of treatment and follow up. The company indicated that if this first cohort of 200 patients displays positive ORR results, then it will proceed into the Phase 3 portion of the study with the remaining 300 enrolled patients. Nektar stated that the Phase 2/3 study’s primary endpoints of the trial are ORR and overall survival (OS) and that a secondary endpoint has been defined as progression free survival (PFS).

Nektar Therapeutics also announced today that it entered into “a financing and co-development collaboration with SFJ Pharmaceuticals to support the development of bempegaldesleukin (BEMPEG), an investigational CD122-preferential IL-2–pathway agonist.” The firm noted that SFJ Pharmaceuticals Group is a global drug development firm that is backed by Abingworth and Blackstone Life Sciences.

Nektar’s President and CEO Howard Robin remarked, “This innovative collaboration with SFJ provides Nektar with substantial non-dilutive funding to broaden the registrational program for BEMPEG…SFJ’s global drug development and clinical trial management expertise, coupled with a track record of success in accelerating and advancing late-stage development programs for global pharmaceutical companies, make them an ideal partner.”

The company noted that the agreement provides that SFJ will fund up to a total of $150 million for the Phase 2/3 head and neck cancer study through the trial’s completion. Nektar in return will be required to make success-based annual milestone payments to SFJ over a period of seven to eight years. The firm noted that the milestone payments are strictly contingent upon receiving specific U.S. regulatory approvals for certain indications for BEMPEG that may result from a head and neck study projected to be completed in 2024. The company stated that it will only be required to make the future payments to SFJ for indications treated with BEMPEG that are granted regulatory approval and will not owe any payments for any unapproved indications.

“We are excited to be partnering with Nektar under this novel financing and co-development agreement…Based on the strength of the clinical data generated to date for BEMPEG in melanoma and other tumor types, and following an extensive diligence process conducted in conjunction with our partners at Blackstone Life Sciences and Abingworth, we believe that BEMPEG has great potential to help cancer patients. We look forward to supporting the Phase 3 study and working closely with the Nektar team,” stated Bob DeBenedetto, CEO of SFJ.

The company explained that squamous cell carcinoma (SCCHN) of the head and neck is the sixth most common cancer worldwide and that according to The Global Cancer Observatory there were more than 850,000 cases of SCCHN that resulted in 440,000 deaths worldwide in 2020.

Nektar Therapeutics is headquartered in San Francisco, Calif. and has other offices in Huntsville, Ala. and Hyderabad, India. The company’s wholly owned research pipeline includes investigational medicines in immunology, oncology and virology. In addition, Nektar’s portfolio includes several other approved partnered medicines.

The company noted that SFJ Pharmaceuticals is a global drug development group that offers a highly customized co-development partnering model for biotechnology and pharmaceutical companies. SFJ is unique in that it is able to provide at-risk funding along with global clinical development management and expertise required to successfully navigate and submit promising drug development applications through the regulatory submission process.

Nektar Therapeutics started the day with a market cap of around $4.0 billion with approximately 179.4 million shares outstanding and a short interest of about 12.75%. NKTR shares opened 11.31% higher today at $25.00 (+$2.54, +11.31%) over yesterday’s $22.46 closing price and reached a new 52-week high price this morning of $26.75. The stock has traded today between $23.81 and $26.75 per share and is currently trading at $25.59 (+$3.13, +13.94%).

 

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

ImmunoGen Shares Rise 30% After Firm Reports FY20 Earnings and 2021 Outlook

Source: Streetwise Reports   02/12/2021

Shares of ImmunoGen Inc. reached a new 52-week high after the company announced Q4/20 and FY/20 business operating and financial results.

Biotechnology company ImmunoGen Inc. (IMGN:NASDAQ), which concentrates its efforts on generating targeted antibody-drug conjugates (ADCs) therapies for the treatment of cancer, today provided a report detailing its recent business activities and announced financial results for the fourth quarter and year ended December 31, 2020.

The company’s President and CEO Mark Enyedy commented, “Despite the challenges of the pandemic, 2020 was a transformative year for ImmunoGen…Within our portfolio, we advanced accrual in the pivotal SORAYA and confirmatory MIRASOL trials for mirvetuximab soravtansine in patients with ovarian cancer to support our projected timelines for top-line data and regulatory submissions. In addition, we established a second registration program with our CD123-targeting ADC, IMGN632, for which we received Breakthrough Therapy designation and aligned with FDA on a path to full approval in BPDCN. Furthermore, we began dosing patients in the Phase 1 study of IMGC936, our first-in-class ADAM9-targeting ADC for solid tumors, and transitioned IMGN151, our next-generation FRα-targeting ADC, into preclinical development. Finally, through a combination of business development and activity under our ATM facility, we added over $140 million to our balance sheet in the fourth quarter.”

“Taken together, our pivotal programs, experienced management team, and strong balance sheet position us well to execute on our strategy and transition ImmunoGen to a fully-integrated oncology company with two products on the market in 2022,” Enyedy added.

The company discussed many of the highlights and its achievements during 2020. The company noted that it had continued patient enrollment in the pivotal SORAYA and confirmatory MIRASOL trials. The firm noted also that it was successful in advancing its partnership with Huadong Medicine and had received acceptance of the investigational new drug (IND) application for mirvetuximab in China from the National Medical Products Administration (NMPA).

The company indicated that it also worked closely with the U.S. Food and Drug Administration (FDA) to formulate “a clear path to full approval for IMGN632 by amending its ongoing 801 Phase 1/2 study with a new pivotal cohort of up to 20 frontline blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients.”

The company stated that with enrollment complete in the SORAYA trial the first top-line pivotal data is expected to be available in Q3/21. The firm estimated that it will be a position to submit the biologics license application (BLA) before the end of December 2021 that will support potential accelerated approval in 2022. The firm further noted that the top-line data from the MIRASOL study should become available in H2/22.

The company reported that total revenues in Q4/20 increased to $85.8 million, compared to $44.9 million in Q4/19 and that for FY/20 total revenues were $132.3 million, versus $82.3 million for FY/19.

The firm stated that these revenues consisted of revenues from license and milestone fees and non-cash royalty revenue. A major component of these revenues totaling $62.4 million was recorded in Q4/20 as the company recognized $60.5 million of the upfront fee previously received under it collaboration agreement with Jazz Pharmaceuticals and $3.2 million in upfront fees received previously from other collaborative partners.

The firm indicated that in Q4/20, net income was $31.4 million, or $0.16 per diluted share, compared $4.8 million, or $0.03 per diluted share in Q4/19. The company additionally reported that for FY/20, it posted a net loss of $44.4 million, or $0.25 per diluted share, compared to a net loss of $104.1 million, or $0.70 per diluted share for FY/19.

ImmunoGen pointed out that in Q4/20, through its At-the-Market (ATM) facility, it sold approximately 20 million shares of its common stock, which generated around $100 million in gross proceeds. Similarly, the firm advised that it sold 4.5 million additional shares generating gross proceeds of around $35 million in January 2021.

ImmunoGen provided some forward guidance and stated that for FY/21 it expects total revenues in the range of $65-75 million with operating expenses in the range of $200-210 million and projects that at year-end 2021 it will have cash and cash equivalents on its balance sheet in the amount of $140-150 million.

ImmunoGen, Inc., based in Waltham, Mass., advised that it is “developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients.” The firm endeavors to generate targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles in order to disrupt the progression of cancer giving patients many more good days.

ImmunoGen started the day with a market cap of around $1.6 billion with approximately 194.7 million shares outstanding and a short interest of about 14.0%. IMGN shares opened nearly 6% higher today at $8.54 (+$0.46, +32.67%) over yesterday’s $8.08 closing price and reached a new 52-week high price this morning of $10.88. The stock has traded today between $8.43 and $10.88 per share and closed at $10.53 (+$2.45, +30.32%).

 

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.