Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Potential Breakthroughs In Xenotransplantation. The journal Nature has published a preclinical study by Eledon’s research collaborator detailing genetic changes to porcine (pig) cells and the results of their transplantation to monkeys. In September, the second successful transplant of an engineered pig heart to a human patient used Eledon’s tegoprubart for immune suppression. Both developments have overcome many technological barriers and could make trans-species organ transplantation a clinical reality.
Publication Details Some Of The Changes To Make Xenotransplants Compatible. Transplanting organs from a non-human species has many additional challenges than transplantation from one human to another (allografts). The Nature article, from Eledon’s collaborator eGenesis, describes the design, creation, and function of kidney grafts from a genetically engineered porcine transplant into a cynomolgus monkey model. The article describes 69 genomic edits to the donor tissue, addition of 7 human genes, and inactivation of endogenous retroviruses. The transplanted monkeys survived up to 758 days (108 weeks).
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Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.
Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Meeting Held October 12, 2023. In an October 13th filing, Baudax Bio reported that proposals submitted to shareholders for a Special Meeting of Shareholders passed. In particular, the Series X convertible preferred stock conversion to common shares was approved. The preferred shares were issued in conjunction with the TeraImmune merger announcement in June. In the merger agreement, Baudax Bio issued 1.212 million shares of common stock, and 27,089.719 shares of Series X convertible preferred to TeraImmune shareholders, with each preferred share convertible into 1,000 shares of common stock.
Amended and Restated Articles of Incorporation Approved. Shareholders also approved an amendment to effect a reverse stock split to be determined by the Board of Directors at any time in the next year, at the Board’s discretion. The Board can set the reverse split within a range of 1:10 to 1:40.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Shares of clinical-stage biotech Prothena Corp skyrocketed over 20% on Monday amid reports the company is exploring strategic options including a potential sale. Prothena specializes in developing therapies for neurodegenerative diseases like Alzheimer’s, making it a hot target for larger pharmaceutical firms hungry for new assets in this space.
Based in Ireland and spun off from Elan Corp in 2012, Prothena focuses on protein misfolding disorders. Its pipeline features several promising programs targeting proteins believed to play a key role in Alzheimer’s and other neurological conditions with high unmet need.
Prothena’s lead candidate is birtamimab, an antibody-based therapy for AL amyloidosis in late-stage studies. Results expected later this year or in early 2024 could support regulatory filings. Beyond amyloidosis, the company is going all-in on Alzheimer’s research.
The most advanced Alzheimer’s asset is PRX012, an antibody targeting amyloid beta proteins thought to drive disease progression. Prothena is also developing a dual vaccine dubbed PRX012/PRX123 against amyloid beta and tau proteins. Reducing both proteins simultaneously may provide better clinical benefit.
These programs have already attracted partnership interest. Prothena has neuroscience collaborations with pharmaceutical giants Bristol Myers Squibb, Roche, and Novo Nordisk. Just this month, Bristol Myers exercised an option to license PRX005, Prothena’s anti-tau antibody, for nearly $60 million upfront.
But Prothena may seek an acquirer willing to buy the entire company outright. The potential payoff from Alzheimer’s success is massive given the huge unmet need. With late-stage data upcoming, now may be the optimal time for a sale.
Any acquirer would gain full access to Prothena’s Alzheimer’s pipeline, along with its programs for Parkinson’s disease and other neurodegenerative disorders. Adding these diverse assets to an existing neuroscience portfolio could create exciting synergistic opportunities.
Prothena’s small size also makes it financially digestible for big pharma buyers. The company’s market cap sits around $2.5 billion, presenting a worthwhile gamble for majors like Roche or Bristol Myers with scores of billions in annual revenue.
News of the company exploring strategic options sent Prothena shares surging 25% on nearly 6x normal volume. Investors are betting a buyout could be announced in coming months. Prothena’s pipeline progress makes it an alluring target.
Upcoming clinical results will prove whether Prothena’s Alzheimer’s bet pays off scientifically. But from a business perspective, the stars may be aligning for a near-term acquisition. Cash-rich pharmas need new prospects to bolster aging portfolios, and Prothena boasts some of the most exciting neurological assets out there.
If Prothena’s Alzheimer’s programs demonstrate strong efficacy, bidding wars could drive the buyout price sky-high. With biotech valuations rebounding from lows, management may see now as the perfect time to capitalize on these assets. Whether via sale, partnership or remaining independent, Prothena’s future direction should become clearer soon.
Pharmaceutical giant Pfizer stunned investors on Friday by making drastic reductions to its 2023 earnings and revenue guidance, driven entirely by rapidly declining demand for its COVID-19 vaccine and treatment.
The company now expects full-year sales of $58-61 billion, far below its previous projection of $67-70 billion. Adjusted earnings per share were cut even more drastically, from an expected $3.25-3.45 down to just $1.45-1.65.
The huge forecast reduction was prompted by a projected $7 billion drop in sales of Pfizer’s COVID treatment Paxlovid and a $2 billion decline for its Comirnaty vaccine. This comes amidst clear signs of “COVID fatigue” as vaccination rates slow and cases become milder.
Pfizer’s update led to a sell-off of its stock on Friday. Rival vaccine maker Moderna’s shares also dropped on the news, reflecting similar downbeat trends for COVID products industrywide.
However, Pfizer regained some losses after executives held a call on Monday to outline plans for weathering the abrupt COVID revenue downturn. This includes a new cost-cutting program aiming to deliver $1 billion in savings this year and $2.5 billion by 2024.
The planned cuts will touch all business segments and regions, though details remain scarce. Pfizer says one-time costs to implement the reductions will be approximately $3 billion, including severance charges and other expenses.
This belt-tightening comes after Pfizer hinted in August it was prepared to trim expenses if COVID product sales continued to deteriorate. “We are in the middle of the COVID fatigue. Nobody wants to speak about COVID,” acknowledged CEO Albert Bourla.
Indeed, uptake for Pfizer’s updated Omicron booster has been lackluster since launching last month. Logistical hurdles and lack of awareness around eligibility have hampered rollout. Waning concern over infections has also lowered demand.
Paxlovid prescriptions have similarly collapsed as immunity from vaccines and prior disease leaves most cases mild. Bourla said this means the remaining demand is coming from the minority focused on prevention and protection.
Looking beyond COVID products, Pfizer still expects to complete its pending $12 billion acquisition of cancer detection leader Seagen on schedule. Executives said the belt-tightening and forecast revisions will not impact those plans.
Pfizer is not alone in adapting to new COVID realities. Moderna has delayed advancing new boosters and vaccines meant to target emerging variants. Merck has paused production of its Molnupiravir antiviral.
But Pfizer’s aggressive pandemic investments leave it most exposed to lasting changes in demand. The company marshaled its resources early on to supply over 3.5 billion vaccine doses worldwide, along with millions of Paxlovid courses.
Now, the record revenues these products delivered are evaporating almost overnight. And as the market leader, Pfizer’s woes signal a new chapter for the entire vaccine and antiviral space.
Of course, the pandemic is not over, and COVID will remain a threat demanding vaccines and treatments. But with most people vaccinated, reinfected, or both, demand and profits are inevitable casualties absent a dangerous new variant.
For pharmaceutical firms like Pfizer and Moderna, the cash windfall from COVID spending is clearly drawing to a close. With customers, cash flows and share prices dropping, a reckoning has arrived. Massive cost cuts offer one path forward, with layoffs and restructuring the vaccines’ unintended side effect.
With the recent rise in mergers and acquisitions in the biotech sector, some analysts believe that now is an opportune time for investors to start positioning themselves in small and microcap biotech stocks. Though these smaller companies have been out of favor with investors in the post-pandemic environment, the current conditions suggest their fortunes may soon change.
The biotech sector saw a surge of interest during the pandemic, as companies raced to develop vaccines, treatments and diagnostics for COVID-19. Many smaller biotechs saw their values skyrocket on the hope that they would come up with a breakthrough. However, once the initial rush of COVID-related products came to market, investors began rotating out of pandemic darlings and into recovery plays. This led to a dramatic decline in the valuations of micro and small cap biotechs.
Despite this negative sentiment, mergers and acquisitions in biotech have been increasing over the past year. Pharma giants have been scooping up smaller firms to replenish their drug pipelines. While the big deals have gotten all the headlines, analysts say more deal-making is starting to occur further down the market cap scale. This suggests that the fundamentals of select smaller biotechs remain strong, though valuations do not yet reflect it.
Take Eledon Pharmaceuticals (ELDN) for example. This clinical stage biotech has a market cap of only $35 million, which is about half its cash on their 6/30/23 balance sheet . Though its lead drug candidate is in Phase 2 trials for several indications, the company’s stock price has languished. However, with ample cash to support ongoing trials and an approved IND for another preclinical asset, Eledon seems significantly undervalued based on peers.
In fact, many small biotechs appear mispriced today based on the potential of their underlying technology and pipelines. These companies are developing innovative new platforms and drug candidates across therapeutic areas like oncology, rare diseases, neurology, and ophthalmology. While risks are high during the R&D process, achieving clinical milestones and a path to successful commercialization could drive exponential growth.
Consider the market opportunity for breakthrough platforms like CRISPR gene editing or cell therapy. Many smaller firms are advancing novel applications of these cutting-edge technologies. If proven successful in clinical studies, even niche indications could generate billions in peak annual sales.
Additionally, smaller firms tend to be more targeted in their R&D approach. Rather than spreading efforts across numerous indications, microcaps often concentrate on 1-2 assets with large treatment populations. This focused strategy allows them to achieve key milestones more economically. Partnerships with larger biopharma companies can also help offset expenses in later stage development.
The current biotech environment shares some similarities with pandemic euphoria. Today’s misery and fear echoes the extreme euphoria felt by investors three years ago. Just as sentiment eventually turned negative on pandemic darlings, the same could occur for today’s recovery favorites. Already, tech giants like Meta, Nvidia and Tesla have fallen substantially from their highs, suggesting a potential peak.
While rotating out of pandemic favorites made sense as reopening plays gained momentum, the economic backdrop is cloudier now. High inflation, rising rates, geopolitical tensions and recession fears have driven significant equity declines and increased market volatility this year. This has led some investors to question whether stocks still offer favorable risk-reward profiles.
With bonds and equity markets declining in tandem, some investors have turned to cash equivalents like money market funds. While these instruments can provide principal protection, their yields could still lag inflation, given its uncertain outlook. Accounting for taxes owed on interest earned further reduces the chances of a real return. Therefore, holding too much cash during periods of high inflation could erode purchasing power over time.
Rather than accept guaranteed, but potential negative real returns in cash, investors may want to revisit beaten-down assets with asymmetric upside, like small cap biotech stocks. Some of these companies offer innovative technologies that could drive explosive growth if their development and commercialization efforts prove successful, and investor sentiment in this sector turns around.
To identify promising opportunities in the space, investors need to educate themselves on individual companies, study various ideas and leverage resources like Channelchek. While risks for small biotech stocks are always high, those able to discern winners from losers can potentially generate substantial outsized gains.
After years of hype around pandemic favorites, optimism needs to be rekindled for forgotten pockets of the market like micro and small cap biotech stocks. For investors with the appropriate time horizon and risk tolerance, now could be the ideal time to start building positions. If M&A activity continues apace, it likely will not be long before positive fundamentals translate into rising valuations.
IRVINE, Calif., Oct. 13, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that the Company will present a poster at the American Society of Nephrology’s upcoming Kidney Week 2023 Annual Meeting taking place in Philadelphia, PA from November 2-5, 2023. The poster will highlight new data from Eledon’s ongoing open-label Phase 1b trial evaluating tegoprubart for the prevention of rejection in kidney transplantation.
Details on the poster presentations are below:
Title: Tegoprubart for the prevention of rejection in kidney transplant: update of emerging data from an ongoing trial Presenter: Steve Perrin, Ph.D., President and Chief Scientific Officer, Eledon Pharmaceuticals Poster Number: TH-PO835 Session Title: Transplantation: Clinical – I [PO2102-1] Session Date and Time: November 2, 2023 from 10:00 AM to 12:00 PM EDT
About Eledon Pharmaceuticals and Tegoprubart (formerly AT-1501)
Eledon Pharmaceuticals is a clinical stage biotechnology company with immunology expertise that is developing therapies to protect and prevent rejection of transplanted organs, as well as to treat amyotrophic lateral sclerosis (ALS). The Company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand (also called “CD154”), a well-validated biological target with broad therapeutic potential. Eledon is headquartered in Irvine, California. For more information, please visit the company’s website at www.eledon.com.
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OptimizeRx Corp. announced Thursday it will acquire Scottsdale-based Medicx Health for $95 million, expanding its platform reach to healthcare consumers.
The deal combines OptimizeRx’s solutions focused on healthcare providers (HCPs) with Medicx’s consumer-centric technologies. Together, the companies can engage over 2 million HCPs and a majority of U.S. healthcare consumers.
“Our acquisition of Medicx is expected to be a major business accelerator for us,” said OptimizeRx CEO Will Febbo.
For OptimizeRx, the acquisition enhances its digital health platform that helps life sciences companies educate and engage HCPs and patients. Medicx brings new omnichannel marketing and analytics capabilities aimed at consumers.
Reaching Healthcare’s Key Stakeholders
OptimizeRx’s lead solution is a digital point-of-care network enabling pharma marketing and engagement integrated within EHR and e-prescribing workflows. This allows drug makers to reach HCPs through digital touchpoints at the point of care.
Medicx has developed a Micro-Neighborhood® Targeting Platform using advanced identity resolution to reach healthcare consumers. Combining both solutions offers an end-to-end way for pharma companies to connect with HCPs and patients—healthcare’s two most important stakeholders.
“Coupling consumer and HCP marketing strategies is a natural next step for many of our customers,” said OptimizeRx Chief Commercial Officer Steve Silvestro.
Profitable Addition to Fuel Growth
The acquisition is expected to significantly benefit OptimizeRx’s growth and profitability. Medicx is a highly profitable company that will immediately add to revenue, EBITDA, and earnings per share.
On a combined basis, the deal will bring OptimizeRx’s revenue run-rate close to $100 million. Medicx also opens substantial new opportunities for customer penetration and cross-selling.
“I’m extremely proud of the leading patient-focused omnichannel platform the Medicx team has built,” said Medicx CEO Michael Weintraub. “Integrating with a leading HCP-focused enterprise provides numerous efficiencies.”
Weintraub added the combined platforms can now inform and educate patients and HCPs in a cohesive way no single company has done before.
Funded for Growth
OptimizeRx will pay $95 million in total consideration to acquire Medicx. The deal will be funded through OptimizeRx’s cash on hand, short-term investments, and a new $40 million credit facility from Blue Torch Capital.
Certain members of Medicx’s management will invest approximately $10.5 million of their proceeds into OptimizeRx common stock.
The acquisition is expected to close in Q4 2023. Medicx will operate as a subsidiary under its current management team.
Strong Quarterly Performance
In tandem with the acquisition announcement, OptimizeRx preannounced strong third quarter 2023 results.
The company expects Q3 revenue between $15.2-$15.5 million, ahead of consensus estimates. Non-GAAP net income is projected at $0.6-$1 million.
OptimizeRx saw accelerated organic growth in messaging driven by its recently enhanced Dynamic Audience Activation Platform.
The deal marks OptimizeRx’s largest acquisition to date as it leverages M&A to expand its platform. Medicx’s addition is expected to be immediately accretive while funding future growth.
Harmony Biosciences aims to expand its pipeline into rare neuropsychiatric disorders through the acquisition of Zynerba Pharmaceuticals and its innovative cannabinoid gel technology.
Harmony, known for its narcolepsy drug Wakix, announced Monday that it will acquire Zynerba in a deal worth up to $200 million. The buyout provides Harmony with Zynerba’s lead asset, Zygel, a synthetic cannabidiol gel in mid-stage trials for Fragile X syndrome and 22q11.2 deletion syndrome.
Zygel could become the first FDA-approved drug for managing Fragile X if it succeeds in pivotal trials. Harmony sees the drug as a way to expand beyond sleep disorders while tackling high unmet needs in orphan neuropsychiatric conditions.
Fragile X affects 80,000 in the U.S., causing intellectual disability and behavioral challenges. Zynerba’s focus aligns with Harmony’s mission in rare neurological diseases, said Harmony CEO Jeffrey Dayno, M.D. in Monday’s announcement.
“With Harmony’s scale, resources and proven commercial excellence, they are well positioned to potentially bring to market the first pharmaceutical product indicated for the treatment of behavioral symptoms of Fragile X syndrome and to maximize the value of Zygel,” added Zynerba Chairman and CEO Armando Anido.
No FDA-Approved Options Today
Fragile X syndrome stems from mutations in the FMR1 gene which codes for FMRP, a protein vital for synaptic function and neural connections. The lack of FMRP causes cognitive impairments. Around 60% of Fragile X patients don’t produce any FMRP due to methylation.
While Fragile X affects tens of thousands in the U.S. alone, there are no FDA-approved treatments. Patients rely on behavioral interventions and off-label drug use.
Zynerba’s Zygel aims to modulate the endocannabinoid system impacted by the loss of FMRP. The gel contains synthetic cannabidiol, absorbing through the skin to avoid first-pass metabolism.
Zygel already secured FDA orphan drug status for both Fragile X and 22q deletion syndrome. It also won Fast Track designation for Fragile X.
Now in pivotal Phase 3 trials, Zygel showed positive Phase 2 data in both indications. Harmony believes the drug can help patients manage behavioral symptoms if approved.
Betting Up to $200M on Approval
Under the acquisition terms, Harmony will pay $60 million upfront for Zynerba’s shares, or $1.1059 per share in cash. Zynerba shareholders will also receive one contingent value right (CVR) worth up to $2.5444 per share more.
The CVR payments depend on Zygel hitting clinical, regulatory and sales milestones:
$15M for completing Phase 3 Fragile X trial
Up to $30M for Phase 3 data (timing-based)
$35M for FDA approval in Fragile X
$15M for approval in a second indication
Up to $45M for reaching sales milestones
Altogether, the deal is valued at up to $200 million if Zygel secures FDA approval and reaches peak sales targets. Harmony expects the buyout to close in Q4 2023.
“Innovative potential new therapeutic option for rare/orphan neuropsychiatric disorders with high unmet medical needs,” said Harmony CEO Dayno.
Doubling Down on Rare Diseases
The acquisition aligns with Harmony’s focus on innovative treatments for overlooked neurological diseases. Zynerba’s work in underserved neuropsychiatric disorders complements Harmony’s leading drug in narcolepsy.
Harmony markets Wakix, a first-in-class H3 receptor antagonist that hit $230 million in net sales over the twelve months ending June 30, 2022. But the company sees untapped growth opportunities in adjacent rare diseases.
The Zynerba deal provides pipeline diversification into high-value orphan drug development. Harmony now has new opportunities in gene mutation disorders like Fragile X and 22q deletion syndrome.
With a profitable commercial engine already built, Harmony is betting its expertise and $430 million cash position can maximize Zygel’s impact if approved. The company sees Zynerba’s cannabinoid therapy as both a strategic fit and a long-term growth driver if milestones are met.
For shareholders, the buyout provides Harmony an approved orphan drug asset with potential peak sales upside. And for patients, it brings hope for the first therapy to address Fragile X symptoms.
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Good News For A Program Where No News Was Expected. Ocugen announced that its OCU500 nasal vaccine for COVID-19 has been chosen to start Phase 1 clinical trials run by the National Institute for Allergy and Infectious Disease, a division of the National Institutes of Health. We see this as a positive development for the vaccine program since Ocugen had no plans to develop OCU500 without obtaining non-dilutive funding. We have no revenues for the vaccine programs in our models, and we see the selection by NIAID for Phase 1 clinical trials as upside for the company.
We See The Selection By NIAID As A Technology Validation. OCU500 was developed to stimulate immunity in the nasal passages and lungs where the virus enters the body and the infection begins. This is intended to prevent both the initial infection and transmission of the virus to others. We see the OCU500 selection as a validation to the Ocugen inhaled vaccine technology, which currently includes OCU500 for COVID-19, OCU510 for influenza, and OCU520 for both COVID-19 and influenza. The carrier technology can be used to develop other vaccines as well.
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NIAID is conducting early phase clinical trials on select next generation vaccine candidates with the intent to identify the most effective platforms and delivery routes
OCU500 will be tested as both inhaled and intranasal vaccine candidates
Clinical trials scheduled to start in early 2024
MALVERN, Pa., Oct. 10, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health, will conduct a trial comparing the administration of Ocugen’s mucosal vaccine candidate, OCU500, via two different mucosal routes, inhalation into the lungs and as a nasal spray.
Ocugen is developing a novel anti-viral mucosal vaccine platform initially targeting COVID-19 and influenza (flu). The intent is to provide protection against severe disease, increase durability and prevent transmission of viral threats. OCU500 is based on a novel chimpanzee adenovirus-vectored (ChAd) technology. Earlier clinical studies to prevent COVID-19 employing a similar vector administered via inhalation demonstrated increased mucosal antibodies, systemic antibodies, and durable immune response up to one year using one fifth (1/5) of the dose compared to the same vaccine given via intramuscular administration. Additionally, Ocugen believes that this vaccine can be rapidly scaled-up as new variants emerge.
“We believe our novel mucosal vaccine platform technology has the potential to prevent infection and spread of COVID-19, and improve durability for an annualized vaccine similar to flu,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “This is the first vaccine candidate using our inhaled platform technology, which we hope to expand in order to address multiple respiratory threats, including flu. We have benefited from a strong collaborative relationship with NIAID and BARDA since the start of Project NextGen and we look forward to participating in this initiative.”
NIAID will be conducting clinical trials to evaluate several early stage vaccine candidates. The study involving Ocugen’s vaccine will be administered via both intranasal and inhaled routes and is designed to help answer an important question – does an inhaled COVID-19 vaccine provide greater immune response than the same vaccine administered through a nasal spray. Upon completion of the trial NIAID and Ocugen will assess the results and determine next steps for OCU500.
Project NextGen is a $5 billion multi-government agency initiative to develop the next generation of vaccines and therapeutics to combat the spread of COVID-19. NIAID, with funding from Project NextGen, will cover the full cost of the clinical trials, including operations and related analysis. Ocugen will be responsible for providing clinical trial materials and upon completion will have full right of reference to the findings, which Ocugen believes will provide clinical evidence to support the further development of the Company’s lead mucosal vaccine candidate.
The announced collaboration comes at a time when COVID-19 infection rates are rising with the emergence of new variants. Durability of existing vaccines continues to be of concern with antibody protection waning several months following vaccination while vaccine compliance rates have declined since the initial wave. According to a recent Harris poll, 66% of Americans would prefer to have more vaccine options. The poll also found that 52% of Americans would be more open to getting an intranasal or inhaled, versus injectable COVID-19 vaccine.
Ocugen looks forward to this important next step in the development of its novel mucosal vaccine platform and further supporting the Company’s commitment to advancing public health.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Medical technology firm Haemonetics Corporation recently announced a definitive agreement to acquire OpSens, Inc. in an all-cash deal valued at approximately $253 million. OpSens is a medical device company specializing in innovative fiber optic sensor technology for interventional cardiology applications. This strategic acquisition allows Haemonetics to expand its hospital business into the high-growth interventional cardiology market estimated at $1 billion.
Haemonetics, based in Boston, offers a suite of products for blood and plasma collection, the surgical suite, and hospital transfusion services. With the addition of OpSens’ sensor-guided guidewire and pressure guidewire products for transcatheter aortic valve replacement (TAVR) and percutaneous coronary intervention (PCI), Haemonetics bolsters its portfolio with clinically validated technology to improve patient outcomes.
OpSens’ core offerings include the SavvyWire, the first sensor-guided guidewire for TAVR procedures which enables shorter hospital stays, and the OptoWire, a pressure guidewire used to aid coronary artery disease diagnosis by measuring key parameters like fractional flow reserve (FFR). OpSens leverages proprietary optical technology across its sensor solutions for medical devices and critical industrial applications.
According to Stewart Strong, President of Global Hospital at Haemonetics, this acquisition expands Haemonetics’ leadership in interventional cardiology while providing a foundation for additional growth. By combining OpSens’ innovative technology with Haemonetics’ commercial infrastructure and hospital relationships, there is tremendous potential to increase adoption and improve patient care globally.
Strategically, Haemonetics gains several advantages from the purchase:
Access to a $1 billion total addressable market in interventional cardiology, a specialty area witnessing increasing procedure volume. OpSens’ competitive, clinically validated offerings are well-positioned for long-term growth.
The ability to accelerate OpSens product adoption leveraging Haemonetics’ existing commercial footprint and depth of penetration in U.S. hospitals for its VASCADE vascular closure portfolio.
Expanded product breadth and enhanced diversification into adjacent applications like industrial sensors. OpSens technology can be leveraged across Haemonetics’ hospital business and new markets.
Opportunities for continued R&D, clinical study efforts, and other business development activities to augment internal product development. Haemonetics aims to expand its hospital division via organic and inorganic investments.
Financially, Haemonetics expects the deal will be immediately accretive to revenue growth. On an adjusted basis, earnings per share is also expected to be accretive right away. Due to one-time integration costs, GAAP earnings per share may be slightly dilutive in the first full fiscal year before turning accretive.
Haemonetics will finance the transaction through existing cash balances and its revolving credit facility. This will result in a manageable rise in the company’s net debt to EBITDA ratio to around 2.1x. The purchase is anticipated to close by January 2024, subject to customary approvals.
In summary, the acquisition of OpSens for $253 million in cash strengthens Haemonetics’ position in the attractive interventional cardiology space while providing new technologies, commercial synergies, and earnings accretion over the long-term. It signals a bold move to supplement organic growth with value-enhancing strategic M&A, as Haemonetics looks to deliver innovation and drive better patient outcomes through continued expansion.
ATLANTA, GA, October 9, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/584,231 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40).” The allowed claims generally cover GeoVax’s vector platform for expressing Marburg virus antigens in virus-like particles (VLPs) utilizing an MVA viral vector.
A recent presentation of data from nonhuman primate studies demonstrated that immunization with GeoVax’s vaccine candidate, GEO-MM01, conferred 80% survival in cynomolgus macaques following a lethal dose of Marburg virus. Vaccination protected from viremia, weight loss and death following challenge with a lethal Marburg virus dose. Evaluation of immune responses following vaccination demonstrated the presence of both neutralizing antibodies and functional T cells, indicating a breadth of responses that combine for optimal protection. GeoVax is currently evaluating study designs to assess the potential for administering different dose levels of the vaccine and different routes of vaccine delivery to optimize utility and efficacy.
David Dodd, GeoVax President and CEO, commented, “While our focus and development priorities continue to be our next-generation COVID-19 vaccine and cancer immunotherapy programs, developing vaccines against lethal hemorrhagic fever viruses represents our commitment to addressing highly fatal endemic threats throughout the world. Our team is committed to supporting the successful advancement of such a vaccine, as we recognize the critically important medical and biodefense need, reflected by the inclusion of Marburg virus in the FDA Priority Review Voucher program. This patent allowance adds to our growing portfolio of wholly owned, co-owned, and in-licensed intellectual property, now standing at over 115 granted or pending patent applications spread over 24 patent families.”
About Marburg Virus
Marburg virus (MARV) is a hemorrhagic fever virus of the Filoviridae family, which also includes Ebola virus, and causes severe human disease with up to a 90% fatality rate. The Marburg virus is transmitted to people from fruit bats, and human-to-human transmission occurs through direct contact with bodily fluids, or contaminated surfaces and materials. MARV is rated by the World Health Organization (WHO) as a Risk Group 4 Pathogen. In the United States, the NIH/National Institute of Allergy and Infectious Diseases ranks it as a Category A Priority Pathogen and the Centers for Disease Control and Prevention lists it as a Category A Bioterrorism Agent. MARV typically appears in sporadic outbreaks throughout Africa and the virus continues to pose potential public health and biodefense threats. There are currently no licensed vaccines or therapeutics against the diseases caused by MARV.
About the GV-MVA-VLPTM Platform
GeoVax’s GV-MVA-VLPTM vaccine platform utilizes modified vaccinia Ankara (MVA), a large virus capable of carrying several vaccine antigens, that expresses proteins that assemble into virus-like particles (VLP) immunogens in the person receiving the vaccine. The production of VLPs in the person being vaccinated can mimic the virus production that occurs in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP derived vaccines can elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Pharma giant Bristol Myers Squibb (BMY) announced today that it will acquire clinical-stage biotech Mirati Therapeutics (MRTX) for $58 per share in an all-cash deal totaling $4.8 billion. Mirati stockholders will also receive a contingent value right worth up to $12 per share, bringing the total potential deal value to $5.8 billion.
The acquisition will expand Bristol Myers Squibb’s oncology portfolio and pipeline. Mirati’s lead asset is KRAZATI (adagrasib), the first and only FDA-approved drug targeting the KRAS G12C mutation. KRAS mutations occur in about 13% of non-small cell lung cancers (NSCLC) and are linked to poor prognosis.
KRAZATI was granted accelerated approval in October 2022 as a second-line treatment for KRAS G12C-mutated NSCLC. It is also being tested in combination with a PD-1 inhibitor as a potential first-line NSCLC therapy. Beyond lung cancer, KRAZATI has shown promise in colorectal and pancreatic cancers.
“With multiple targeted oncology assets including KRAZATI, Mirati is another important step forward in our efforts to grow our diversified oncology portfolio,” said Bristol Myers CEO Giovanni Caforio. The company aims to leverage its global commercial infrastructure to maximize KRAZATI’s reach.
Mirati’s earlier-stage pipeline includes MRTX1719, an innovative PRMT5 inhibitor, as well as several KRAS-targeted agents. MRTX1719 could be the first targeted therapy for MTAP-deleted tumors, which represent about 10% of cancers.
“Bristol Myers Squibb’s global scale, resources and commitment to innovation will enable Mirati’s therapeutics to benefit more patients, faster,” said Mirati CEO Charles Baum.
Strategic Fit
Lung cancer is the most common cancer and leading cause of cancer death globally. The addition of KRAZATI establishes Bristol Myers as a leader in developing targeted lung cancer therapies. Mirati also expands Bristol Myers’ presence in colorectal and pancreatic cancers.
The acquisition builds on Bristol Myers’ recent deals for Turning Point Therapeutics and Eisai’s oncology business. As patents expire for the pharma giant’s top-selling cancer immunotherapy Opdivo, it aims to refill its oncology pipeline.
“With a strong strategic fit, great science and clear value creation opportunities for our shareholders, the Mirati transaction is aligned with our business development goals,” said Caforio.
Broader Biopharma Implications
The blockbuster Mirati acquisition also has significant implications for the broader biotech and biopharma sector. As large pharmas look to replenish pipelines, M&A activity has intensified. The deal shows that promising clinical-stage biotechs with innovative oncology pipelines continue to be attractive buyout targets.
Analysts note the 52% buyout premium Bristol Myers paid as a sign of their urgency to tap into Mirati’s next-gen oncology science. For startup biotechs pursuing novel approaches in high-value areas like oncology, it underscores the possibility of commanding large premium buyouts from “big pharma” acquirers.
However, smaller players also face the risk of being squeezed out as consolidation accelerates. The Mirati deal exemplifies the scaling up required to compete in cutting-edge areas like targeted cancer therapies. Smaller biotechs could find it increasingly difficult to independently develop and commercialize new drugs in the future.
That said, smaller biotechs may also benefit from big pharma’s growing appetite for M&A. The premiums being offered for innovative science and pipelines create lucrative exit opportunities for startups. And the influx of capital from buyouts can fund the next generation of biotech innovation.
Under the definitive agreement, Bristol Myers will pay $58 per share for Mirati’s outstanding common stock. This represents a 52% premium over Mirati’s 30-day volume-weighted average price. Including Mirati’s $1.1 billion cash balance, the total equity value comes to $4.8 billion.
Each Mirati shareholder will also receive a CVR worth up to $12 per share. This contingent value right payment is triggered if Mirati’s MRTX1719 is approved within 7 years as a NSCLC therapy after two or fewer systemic treatments. The CVR adds up to $1 billion in potential additional value.
The transaction is expected to close in the first half of 2024, pending approval from regulators and Mirati shareholders. Bristol Myers anticipates the deal will be dilutive to its non-GAAP earnings through 2025 as it integrates Mirati. It plans to finance the acquisition through cash and debt offerings.
Caforio stated: “With a strong strategic fit, great science and clear value creation opportunities for our shareholders, the Mirati transaction is aligned with our business development goals.” The deal furthers Bristol Myers Squibb’s transformation into a leading oncology-focused biopharma.
