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SALE OF the Assets of Ohana Biosciences, Inc.

Gerbsman Partners – http://gerbsmanpartners.com  has been retained by OBS (ABC), LLC (“Assignee or “Seller”) the assignee for the benefit of creditors of Ohana Biosciences, Inc. (“Ohana”) to solicit interest for the acquisition of all or substantially all of the Ohana assets, including its Intellectual Property (“IP”), in whole or in part (collectively, the “Ohana Assets”).  Please see detailed sales information letter attached, (Exhibit A), NDA, (Exhibit B) Patent information and Trademark information (Exhibit C).

On June 3, 2021, Ohana Biosciences, Inc., a Delaware corporation, as Assignor, made a General Assignment for the Benefit of Creditors (the “Assignment”) to “OBS (ABC), LLC”, a Delaware limited liability company, as Assignee, pursuant to Delaware state law. Please note that with the exception of the relationship created by the Assignment, and despite their similarity in name, Assignor and Assignee have no corporate affiliation to each other. Pursuant to the Assignment, Assignor transferred ownership of all of its rights in tangible and intangible assets (collectively, the “Assets”) to Assignee for sale. Assignee shall sell the Assets and distribute the net proceeds to creditors of Assignor.

Ohana was founded to develop a sperm biology platform that combines single-cell sequencing, cell surface profiling, and computational biology to analyze large libraries of genetic and molecular information from individual sperm cells. Through this, Ohana scientists applied these insights to product opportunities across reproductive health.

Disclaimer 

This Enterprise Offering contains information regarding certain operations and the business of Ohana Biosciences, Inc., and the information contained herein has been assembled for the purpose of providing interested parties with general information to assist in their evaluation of a possible acquisition of the Company or assets of the Company. Nothing contained in this Enterprise Offering is, or shall be relied upon as, a promise or representation as to the past, present or future performance of the Company or its product or as providing any assurances of any kind regarding the Company’s intellectual property or other assets.  In furnishing this Enterprise Offering, neither the Company, Gerbsman Partners nor Assignee undertakes any obligation to (and each expressly reserves the right not to) provide the recipient with access to any additional information of any kind with respect to the Company or any of its assets or operations.

Assignee has retained the services of Gerbsman Partners and certain former employees to assist with the sale of the assets. This group of individuals are available to assist with due diligence and the transition of assets.

As Seller, OBS (ABC), LLC will oversee the process and select the winning bidder(s). This will be a closed bidding process whereby the names of the bidders and the bids will not be disclosed to the other parties. 

Ohana Investment to Date:

Ohana was founded by Flagship Pioneering in 2016.  Since that time, approximately $58.2 Million has been invested, a majority of which was from Flagship Pioneering.  An additional $18.0 Million of senior secured notes was also infused into the company by Oxford Finance LLC.

Ohana has 2 issued patents, and 25 patents pending.

IMPORTANT LEGAL NOTICE:  

The information in this memorandum does not constitute the whole or any part of an offer or a contract.

The information contained in this memorandum relating to the Ohana Assets has been supplied by third parties and obtained from a variety of sources. It has not been independently investigated or verified by Assignee or Gerbsman Partners or their respective agents.  


Potential purchasers should not rely on any information contained in this memorandum or provided by Assignee or Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.


Assignee and Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reason of Assignee’s or Gerbsman Partners’ negligence or otherwise. 

Any sale of the Ohana Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of Assignee or Gerbsman Partners. Without limiting the generality of the foregoing, Assignee and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the Assignee Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

Ohana History and Background

Ohana Biosciences, founded in 2016, was conceived in the setting of a broader technological leap forward in biomedical research. Ohana Biosciences was created through Flagship Pioneering’s origination process. The emergence of single-cell sequencing allowed researchers to study the individual cells composing various tissues with a precision previously not possible, and scientists flocked to study the complex composition of organ systems and tumors. 

David Berry, general partner at Flagship Pioneering, took a different view, focusing on how single-cell sequencing technology could analyze the differences between sperm and egg cells compared with other cells in the body. Berry’s exploration, supported by a team of scientists at Flagship Pioneering’s VentureLabs innovation team, discovered a breakthrough. Put simply, science had vastly underestimated the role of sperm. Berry and his team identified sperm’s role in setting the health trajectory of a person from embryo development through early childhood, and in dictating health outcomes for pregnant women. Ohana was founded to build upon these learnings, developing a sperm biology platform to combine single-cell sequencing, cell surface profiling, and computational biology to analyze large libraries of genetic and molecular information from individual sperm cells. Through this, Ohana scientists applied these insights to product opportunities across reproductive health, including its most advanced program called SPERTILITY.

Details for the key points below are outlined in the attached Ohana detail sales letter.

• The world has changed, yet reproductive medicine has largely stayed the same. 

•The global trend toward delayed age of parenthood and its impact to health. 

•Rising rates of infertility around the world.

•The overlooked role of sperm: inordinate burden on women and men with few treatment options.

•Growing rates of fertility preservation and ART (Assisted Reproductive Technology) point to explosive growth potential.

•Ohana has discovered previously unknown insights into sperm, unlocking a breadth of ways to influence reproductive health  

•Not all sprm are equal as evidenced in the chart below.

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Figure 1.  Ohana analyzed a publicly available dataset of de novo mutations in 70 fraternal twins, demonstrating an increase in de novo mutations with age of father as well as variation in de novo mutations between twins from different sperm. Each pair of data points in the left panel represents the number of de novo mutations detected in each set of twins. The right panel shows the difference in number of de novo mutations between twins, ranging from 1 to 21. Original data from Goldmann et al, “Parent-of-origin-specific signatures of de novo mutations, Nat Genetics 201610.

•Sperm are specialized cells, fit-for-purpose.

•Sperm present a unique opportunity for therapeutic intervention.

Key Attributes: 

Ohana Biosciences, Inc. believes its assets are attractive for multiple reasons:

  • SPERTILITY is the first product designed to mimic sperm activation in natural conception, in an IVF and IUI setting.  It is an ex-vivo sperm cell treatment that improves sperm function, and has shown the potential to increase the number of high-quality embryos yielded per cycle and improve pregnancy outcomes for anyone undergoing ART.
  • Clinical study completed in late 2020 demonstrated:
  • 32% increase in rate of high-quality euploid blastocysts (HQEB’s) when using SPERTILITY.  HQEB is a clinically meaningful endpoint.
  • 24% increase in the average number of HQEB’s per couple.
  • 40% decrease in the odds of not getting a HQEB on SPERTILITY
  • 68% increase in the odds of having a top-ranked embryos on SPERTILITY  

The clinical study was a randomized, prospective, double-blinded, multicenter, split oocytes and split insemination pilot study in conventional IVF.   

  • Ex-vivo treatment provides fast 510(k) regulatory opportunity
  • Strong patent protection, with 2 granted U.S. patents broadly covering technology and 25 patents pending
  • Contract manufacturer in place
  • Company also had a contraception program

Intellectual Property

Ohana’s platform leverages distinctive features of sperm biology to rapidly generate therapeutic opportuniti

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Figure 2. Ohana’s sperm biology platform integrates in-depth characterization of sperm function, genetic, and epigenetic characteristics and sperm surface to yield novel insights about sperm biology and support development of products to enhance sperm function to improve reproductive outcomes and block sperm function as novel, non-hormonal contraceptives.

Targeting sperm to block or enhance function can yield transformative products 

The application of advanced data analysis to Ohana’s continually growing sperm cell library yields dynamic, actionable insights  

Fertility Disease Overview 

Infertility prevalence is growing with significant implications for society 
Addressing infertility may be one of the most important challenges for developed nations in the coming decades. Infertility, defined as failure to establish a clinical pregnancy after 12 months of trying, is a common and growing public health problem. The prevalence of infertility in the U.S. is estimated to be 10-15% of women, and growing over time (Stephen 1998, Boivin 2007, ASRM 2020).  Applying these statistics, it can be construed that 1 in 8 couples have trouble getting pregnant or sustaining a pregnancy.  Unfortunately, of these ~7 million women and couples suffering, many go untreated (CDC 2010). 

The global prevalence of infertility is trending upwards as people delay parenthood until later in life. Increased age is a significant contributor to reduced fertility in women, as well as declining sperm counts in men. Several studies add to the mounting research showing that declining sperm count (a 50-60% decline over the past four decades) as well as reduction in sperm quality (50% global reduction in quality since 1938) are highly correlated with infertility trends (Levine 2017, Lengupta 2017).

In developed nations, Assisted Reproductive Technology (ART) is considered to be the most effective treatment option for infertility, but with only an average success rate of ~30% (Gnoth 2011). In the U.S., only ~300,000 of 7 million are accessing ART, leaving more than 90% of those who may benefit untreated as an example of the unmet need that exists.

Births per Woman Declining Over Time: Historical and Projected

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Sources: Clarion Healthcare Partners 2019, World Bank 2019

The Patient Journey to seek treatment is long and often unresolved
To be able to address the high unmet need and low treatment rates, we need to understand the patient journey. The infertility diagnosis and treatment journey present patients with a complicated path of multiple doctor visits with different specialists, unclear and cumbersome treatment recommendations and considerable financial costs.  Many patients end up not seeking or undergoing treatment due to cost, low perceived efficacy of IVF, need for multiple treatment cycles, time, and physical/emotional burden. For those that do pursue treatment, at least 30% drop out after just one cycle. (Boivin 2007).

Female patients with infertility may seek help from their primary care physicians, their OBGYNs or may go straight to a fertility specialist (reproductive endocrinologist).  The majority of women experiencing infertility see an OBGYN for diagnosis and assessment and are then referred to a fertility specialist. At each referral point there is significant drop-out (see Patient Journey chart) resulting in very few who go through with treatment at fertility clinics.  Men on the other hand, rarely seek diagnosis or treatment.  It is usually only at the Fertility clinics when a semen analysis is done that the male part of the equation is considered or that infertility is assessed

Infertility Patient Journey: Summary of Patient Experience and Dropout

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Sources: Clearview Healthcare 2019

Emotional impact of infertility
Infertility can take a heavy psychological and emotional toll on both women and men (Hassanpoor Azghdy 2014, NYTimes 2019).

Many experience anxiety, grief, anger and frustration as they experience the loss of control over something that is a life goal and easy for so many of their peers (Harvard 2009). 

  • A study of 488 American women who filled out a standard psychological questionnaire concluded that women with infertility felt as anxious or depressed as those diagnosed with cancer, hypertension, or recovering from a heart attack (Domar 1993).
  • Men are often in the role of supporter, but they also experience low self-esteem, stigma and depression similar to women when they are part or all of the cause of the infertility.

Market Size & Dynamics of ART

There is a significant but under-penetrated patient population
More than 4 million IVF cycles are performed globally, with approximately 265,000 IVF cycles in the U.S. (2019 SART) and almost 850,000 in Europe (IQVIA 2019, ESHRE 2018, Allied Market Research 2019).  In the U.S. this equates to ~4% utilization of ART.

Across Europe and Japan utilization rates are significantly higher due to broad universal coverage of ART.  Only 86 cycles of ART per 100,000 population are performed each year in the U.S. By comparison, ART is utilized over twice as frequently per capita in France and over five times as much per capita in Japan (IFFS 2019). This leaves the U.S. substantially behind in providing ART as a key tool in addressing infertility, with much room to grow.

Despite the U.S.’s relatively low utilization of ART compared with other developed nations, the U.S. IVF market size is substantial; IVF services in the U.S. accounts for over $4.9B USD per year in revenue and expected to reach $5.6B USD by 2027 (Allied Market Research 2019). 

Infertility and Volume of ART Cycles per Year (US)

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Sources: IQVIA 2019; Malizia 2009, Allied Market Research 2019.

Lack of payor coverage has historically limited ART use in U.S., but fertility benefits are improving rapidly

The rise should translate to a significant increase in the covered population and drive more patients to ART who otherwise would not have had access (Canaccord Genuity ART Report 2019).

FBM’s offer employers a carve-out benefit for fertility by contracting with fertility clinics and service providers to negotiate the costs of cycles and reduce risk to employers. Though each benefit manager employs different business models, all aim to increase employees’ access to infertility treatments, improve clinical outcomes, and reduce costs. These trends of expanding coverage will have a significant impact on people’s ability to access treatment including ART.

An additional benefit many employers are adding is fertility preservation such as egg freezing services. As women delay having children, there is growing need for women to freeze younger, higher quality eggs to use for future pregnancies, which necessitates the use of IVF later in life.

As a result of these ongoing and rapidly changing benefits and preservation trends, the number of IVF cycles performed per year is predicted to double by 2027, exceeding 500,000 cycles per year in the U.S. (Allied Market Research 2019). As fertility benefit plans seek to provide the highest quality ART products with highest possibility of success, a product like Spertility, which has the potential to decrease the number of cycles needed to achieve pregnancy, may have a positive impact to the cost-benefit analysis attractive to such payers and employers.

Current Treatment Options and Limitations

Across the treatment landscape, a key leverage point for improving success of IVF cycles is related to the ability to generate high quality embryos.  Today, despite a plethora of pharmaceutical drugs, devices and other tools, there is very little that gives a women/couples a better chance to have enough embryos to improve likelihood of having a live birth.

The historic context of infertility as a female problem is clearly seen in the treatment focus today.   Although infertility due to female factors is only about 30% of cases, most of the focus in treatment is on the female.

Despite male factors contributing between 30-50% of the issue, there are almost no treatments available to improve the function of sperm. Usually IUI or IVF is recommended to overcome male factor infertility but is not a direct treatment to address the underlying issue.

Infertility in men is typically evaluated once a couple goes to a fertility clinic.  The evaluation focuses on a semen analysis in which the number of sperm (concentration), motility (movement), and morphology (shape) are assessed by a specialist urologist.  These diagnostics have not advanced in almost 100 years and may miss additional ways the sperm is compromised (Andrade-Rocha 2017).

Assisted Reproductive Technology (ART) 

The most commonly used methods of reproductive assistance include:

·         Intrauterine insemination (IUI). During IUI, millions of healthy sperm are placed inside the uterus close to the time of ovulation. However, success rates are low, around 10% per cycle (Tomlinson 1996, Harris 2009). 

·         Invitro fertilization (IVF): This involves retrieving mature eggs from a woman, fertilizing them with sperm, then transferring the embryos into the uterus after fertilization. IVF is the most effective assisted reproductive technology. An IVF cycle takes several weeks and requires frequent blood tests and daily hormone injections. 

There are two ways that an egg may be fertilized by IVF: conventional and ICSI (Intracytoplasmic Sperm Injection). In conventional IVF, sperm prepared and isolated from a semen specimen are placed with the egg in a laboratory dish. Fertilization occurs when one of the sperm enters into the cytoplasm of the egg. In the ICSI process, a tiny needle, called a micropipette, is used to inject a single sperm into the center of the egg. With either conventional IVF or IVF/ICSI, once fertilization occurs, the fertilized egg (now called an embryo) grows in a laboratory from 3 (cleavage stage) to 5 and sometimes 6 days (blastocyst stage embryo)  before it is transferred to the woman’s uterus.  

Graphical user interface, text, application

Description automatically generatedThe IVF Process

Sources: Fertility IQ, Ohana Biosciences

Limitations of current treatment with ART 
Today limitations and burden associated with ART leave many people unable to address their desire to have children. Success of IVF is often dependent on the number of high-quality embryos at the end of a stimulation cycle. Achieving a sufficient number of high-quality embryos is often a challenge and follows an age-dependent decline (Ubaldi 2019). In general, multiple individual embryo transfer procedures are required to achieve a pregnancy and live birth. If one cycle does not yield enough embryos, multiple stimulation/retrieval cycles are needed, imposing additional burden on patients. 

High Treatment burden

While medical interventions offer much-needed help and hope, studies suggest that they may also add to the stress, anxiety, and grief that patients are already experiencing from infertility itself (Hassanpoor-Azghdy 2014, NYTimes 2019, Harvard 2009).

Challenging medication side effects 

Drugs and hormones can often cause psychological side effects including mood swings, anxiety, irritability in women as well as physical impact of multiple injections a day (de Klerk 2008).

Financial strain  

Costs of infertility treatments are significant. The average cost for an IVF cycle using fresh embryos is approximately $24,000 with slight variances in geography. This includes $3,000 to $7,000 per cycle for fertility drugs. Clinics may also offer and patients opt for ICSI ($1,000-$3,000) and preimplantation genetic testing (PGT-A: $3,000-$6,000) adding to the cost per cycle. Many patients will need several cycles which can result in >$50,000 in cost, which is often paid out of pocket due to reimbursement issues discussed (Fertility IQ).

Low success rates

IVF success rates are approximately 33% for women under 35 but are much lower for older women. (Malizia 2009).

  • Average of 2.5 IVF cycles for a 50% chance of having a baby; 27% for women 40+ (Smith 2015)
  • On average, even after 6 cycles, the chance of having  a baby is only 65% 
  • 30% of the few who do access ART stop after one cycle due to the high cost and burden (Smith 2015) 

Reliance on high quality embryos

Increasing the number of high-quality embryos enables higher probability of successful pregnancies and outcomes using fewer egg retrieval cycles. Ohana’s Spertility aims to increase the number of high-quality embryos yielded per single egg retrieval procedure.  

  • Higher quality embryos are more likely to result in a successful live birth; 90% of women who had a baby did so as a result of an embryo graded high quality (Van den Abbeel 2013)
  • Utilizing a high-quality embryo doesn’t guarantee pregnancy; 50% of embryo transfers result in a live birth and 50% do not (Zhao 2018)
  • More high-quality embryos provides more opportunities to have a baby and an increased opportunity to have a second child from the same egg retrieval at a later date

Limited options for improving sperm in IVF 

The role of sperm in reproductive outcomes has lacked significant research and focus in clinical practice. Yet sperm contribute significantly to the ability for fertilization, good embryo development, and the health of the child. Since ICSI was first performed over 30 years ago, there has been no meaningful innovation in addressing sperm’s role. Regardless of infertility in a male, female or both, all sperm utilized for IVF must attain the proper metabolic state that supports embryo development.  The current processes used to prepare sperm do little to activate sperm or influence function. 

Spertility has the potential to address each of these current limitations of IVF.  The potential for a product to increase the number of available embryos for transfer may alleviate the financial, emotional, and physical burden associated with multiple egg retrievals and transfer cycles. Spertility also does not add burden to the patient as it is utilized in the lab.

Current sperm preparation products

Most current sperm preparation methodologies and the products used in fertility labs are based on incomplete understanding of the role of sperm in fertilization and embryo development. Preparations are primarily used to isolate viable sperm cells from other semen fractions, debris, and non-viable sperm cells with the goal of increasing the odds that viable sperm reach an egg for fertilization in a lab dish. There are no products available specifically aimed at improving sperm metabolism and function to optimize fertilization and positively influence embryo development.  

Of current products, none activate the natural metabolic pathway of the female reproductive tract during natural conception. We believe this mechanism is critical to the IVF process, and the basis for developing Spertility. If cleared for commercial use, Spertility has the potential to become a new standard of care for sperm treatment, addressing significant unmet needs expressed by patients, physicians, and payors, as well as advancing the untapped field of sperm-targeted approaches in ART. 

SPERTILITY 

Product Overview

SPERTILITY to improve ART Outcomes

Ohana developed SPERTILITY, an ex-vivo sperm cell treatment that improves sperm function, and has shown the potential to increase the number of high-quality embryos yielded per cycle and improve pregnancy outcomes for anyone undergoing ART. Spertility was designed to enhance ART outcomes by mimicking the natural in utero environment sperm encounter during natural fertilization, which is lacking in the laboratory setting, yet essential in facilitating the activation of key metabolic pathways critical to sperm function.

Ohana has conducted a wide variety of pre-clinical and ex-vivo human sperm studies that provided data supporting clinical development of Spertility as a sperm treatment that has potential to improve fertilization and embryo development (ASRM 2020).  

A pilot clinical study (SPRING) was recently completed for Spertility.  Results from the study are outlined further below, but in summary the study showed:

·         Higher rate of implantable embryos (“high-quality euploid blastocysts” or HQEB’s)

·         More top-ranked embryos selected by embryologist for IVF transfer

·         More couples with at least 1 HQEB for transfer

·         No safety signals reported

Spertility’s product profile addresses a key area of unmet need in ART: improvement of sperm function resulting in higher rates of fertilization and development of high-quality embryos.

Compared to how IVF cycles are performed in fertility labs today, Spertility will replace the current sperm preparation including 3 steps, which when performed in sequence influence and improve the metabolism required for embryo development.

Ohana’s SPERTILITY in the IVF Lab Process

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Sources: Fertility IQ, Ohana Biosciences

Each Spertility kit is intended to be used for one IVF cycle and contains three vials of media applied sequentially to activate the sperm before the fertilization step.  Preparing sperm using the Spertility protocol takes approximately two hours more than the current process as the timing of the steps in the protocol is a key component to success.

SPERTILITY: Designed to Mimic the Activation Stages of Sperm

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Source: Ohana Biosciences

Regulatory 

Ohana was preparing to pursue regulatory clearance for SPERTILITY in the U.S. through the FDA’s 510(k) pathway, as the product is considered a medical device in the eyes of the FDA.  As such, the clinical study performed by Ohana was not completed to support the intended filing.  

The 510(k) approach provides a more expeditious review process, which the company believed would help get this important new treatment to patients in need in the most efficient way possible, while still having the benefit of rigorous FDA review. 

The 510(k) approach provides a more time sensitive and predictable review process.

In making that determination, the FDA will conclude a device is substantially equivalent to a marketed device if:

  1. It has the same intended use as the predicate device and the same technological characteristics.
  2. Or it has the same intended use as the predicate device, has different technological characteristics, does not raise new questions of safety and effectiveness and the applicant can show that the device is at least as safe and effective as the marketed device.

The constituents in Spertility are found in commercial media used in IVF labs and therefore one can consider this to be of equivalent technological characteristics.

Ohana holds patents for Spertility based on its energy depletion with subsequent staged reintroduction of different energy sources.  This staging of energy sources has been evaluated in both the preclinical and clinical settings demonstrating Spertility is at least as safe and as effective to marketed devices

There is room to have a differentiated product, while still using the 510K (the easiest) pathway to the US market.

SRING Clinical Study – available for review in due diligence room

Manufacturing

The Company relies on a third-party CMO for its Spertility manufacturing needs.

Former Management Team

Amber Salzman, PhD
President & Chief Executive Officer

Dr. Salzman was the President and CEO of Ohana Biosciences. She previously served as the President and CEO at Adverum Biotechnologies, and was a Co-Founder of Annapurna Therapeutics SAS where she served as its President and CEO prior to its merger with Avalanche Biosciences to create Adverum Biotechnologies.

Prior to her role at Adverum Biotechnologies, Dr. Salzman served as President and CEO of Cardiokine, Inc. until it was acquired by Cornerstone Therapeutics. Prior to that, she was a member of the GlaxoSmithKline (GSK) research and development executive team, where she was responsible for operations for medicine development across therapeutic areas, including planning and managing drug development projects and clinical trials with over 30,000 active patients around the world.

Alka Batycky, PhD
Chief Development Officer

Dr. Batycky was VP, Clinical Strategy & Operations, and was involved in overseeing Ohana’s clinical pipeline.

Dr. Batycky is a leader in driving efficient drug development spanning drug discovery, IND enabling studies and phase 1-4 clinical trials. She has broad therapeutic experience, which has included developing treatments for oncology, CNS disorders, inflammatory diseases, and women’s health. She also has experience in developing small molecules, biologics, devices and combination products. Marketed products she has worked on include Feraheme®, MuGard™, Vivitrol® as well as the AIR™ technology that is the basis of Inbrija™.

Ramiro Castro-Santamaria, MD, MPH, MBA
Chief Medical Officer

Dr. Ramiro Castro-Santamaria is a urologist and family medicine physician with nineteen years of experience in clinical research and drug development. He has worked in various companies (Pharmacia, Pfizer, Boehringher Ingelheim and GSK), across different therapeutic areas including urology and women’s health, in different cultures and countries (Spain, Germany, UK, US) and delivered various worldwide regulatory files, drug approvals and product launches.

Lance Colwell, BS
Chief Operating Officer

Mr. Colwell was Chief Operating Officer and led a range of functions, including program and portfolio management, technical operations, medical affairs, corporate affairs, and business development.

Mr. Colwell is a proven global pharmaceutical executive with a nearly 30-year track record of consistently delivering sustainable growth through multiple business cycles. He joined Ohana from Biogen, where he was most recently the Vice President of the Rare Disease Group and responsible for the successful launch of SPINRAZA® in the U.S. During his 14-year tenure at Biogen, Mr. Colwell led or supported several drug launches and held a range of leadership roles, including Vice President of Global Commercial Excellence and Operations, Austrian Country Head, Global Head of Medical Affairs Operations, Head of Commercial Training and Development, and a variety of marketing/brand leadership responsibilities for TYSABRI®, AVONEX®, MS franchise, and German affiliate marketing.

Caren B. Deardorf, BS, MBA
Chief Commercial Officer

Ms. Deardorf was Chief Commercial Officer and led the building of a commercial organization and capabilities, to bring Ohana’s pipeline of products to patients.

Prior to joining Ohana, Ms. Deardorf was at Biogen, where she was Vice President and Global Lead for SPINRAZA and the SMA Portfolio. In her role at Biogen, she led the global launch of SPINRAZA in over 40 countries, overseeing the regulatory, market access and commercial launch planning and execution.

Eric Furfine, PhD
Chief Scientific Officer

Dr. Furfine was Chief Scientific Officer and led on research and development strategies, with a specific focus on the company’s antibody contraceptive program.

Previously, Dr. Furfine was at Eleven Biotherapeutics, where his roles included Chief Scientific Officer and President of Research and Development. During his tenure, he led the discovery and early development of EBI-031, an IL-6 inhibitory antibody for the treatment of posterior ocular inflammatory diseases. Prior to Eleven Biotherapeutics, Dr. Furfine served as the Senior Vice President of Research and Preclinical Development of Adnexus Therapeutics, Inc., a Bristol-Myers Squibb research and development company, where his group discovered Adnectins, which advanced into clinical development. Prior to that, he was Vice President of Preclinical Development at Regeneron, where he led the non-clinical development and clinical pharmacology of ARCALYST®, EYLEA®, and ZALTRAP®. Dr. Furfine began his career in the pharmaceutical industry at Burroughs Welcome, which became GlaxoSmithKline, where he was the inventor of LEXIVA.

David McManus, BBA, CPA
Vice President of Finance

Mr. McManus was Vice President of Finance, Treasurer and Secretary, and led all aspects of the company’s finance and accounting, IT, and facilities operations. Over his career, he has raised over $100 million of financing across companies at various stages, and had a significant role in leading multiple companies through successful acquisitions.

Prior to joining Ohana, Mr. McManus was Executive Director of Finance and Corporate Controller at Good Start Genetics. At Good Start, he led finance and operational functions from early development through commercial launch and accelerated growth, and ultimate acquisition by Invitae in 2017. Previously, Mr. McManus was Controller at VisEn Medical, a Flagship Pioneering company that developed and commercialized transformative in vivo molecular imaging systems and reagents for cancer, cardiovascular, skeletal, and pulmonary applications. At VisEn, he was part of the leadership team that executed on record commercial growth and the acquisition of the company by PerkinElmer, Inc. in 2010.

Kathleen Seyb, PhD
Vice President of Research

Dr. Seyb was Vice President of Research and led the Biology team in developing and testing new ideas and moving projects from research to development.

Previously, Dr. Seyb led the biology and translational science efforts at Ra Pharmaceuticals, a biotech company with a platform technology to identify novel, synthetic macrocyclic peptides that combine the specificity of antibodies with the pharmacological properties of small molecules. Dr. Seyb was the Biology Lead through discovery, pre-clinical, and early clinical development of zilucoplan, a macrocyclic peptide inhibitor of complement C5 for treatment of complement-mediated autoimmune disorders. At Ra, Dr. Seyb also served as Alliance Manager and Program Manager for a collaboration with Merck on a cardiovascular target which advanced into clinical development.

Brendan St. Amant, JD, MPP
Vice President of Legal

Mr. St. Amant was Vice President, Legal, to lead the legal function at Ohana.

Mr. St. Amant comes to Ohana from Vertex Pharmaceuticals, where he was Director, Senior Counsel in the Legal Department and advised multiple functions on a broad array of risk, litigation, and employment matters. His previous professional experience includes serving as an associate then partner with Donnelly, Conroy & Gelhaar where he focused on commercial controversies and government enforcement. Mr. St. Amant was previously an associate with Goodwin and worked as a judicial clerk for a federal judge. In the legal community, Mr. St. Amant is Second Vice President and Trustee at the Massachusetts Continuing Legal Education, Inc., and has served in leadership roles on several committees for the Boston Bar Association. Brendan received his B.A. in History, magna cum laude, from Cornell University and his J.D./M.P.P. from Harvard Law School and the Harvard Kennedy School of Government.

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a nondisclosure agreement (in the form attached hereto as Exhibit A) to have access to key members of Ohana’s former management, intellectual capital and the due diligence “war room” documentation (the “Due Diligence Access”). Each interested party, upon obtaining Due Diligence Access, shall be deemed to acknowledge and represent that (i) it is bound by the bidding procedures described herein; (ii) it has an opportunity to inspect and examine the Ohana Assets and to review all pertinent documents and information with respect thereto; (iii) it is not relying upon any written or oral statements, representations, or warranties of Assignee or Gerbsman Partners, or any of their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of such interested party, and neither Assignee nor Gerbsman Partners (nor any of their respective, staff, agents, or attorneys) make any representations as to the accuracy or completeness of the same.  

TERMS AND CONDITIONS TO SALE

Assignee, which is managed by Rock Creek Advisors, will oversee the sales process for the Ohana Assets and select the winning bidder(s).  This will be a closed bidding process whereby the names of the bidders and the bids will not be disclosed to the other interested parties.

Assignee has retained the services of Gerbsman Partners and certain former employees to assist with the sale of the assets. This group of individuals is available to assist with due diligence and the transition of assets.

The contemplated transaction will be an asset sale using a standard Asset Purchase Agreement (“APA”). Please note that the general terms under which the assets will be sold, and key terms include:

  • Sell and convey assets on an “as-is, where-is” basis with all faults;
  • Sell and convey assets with limited representations or warranties; and
  • No indemnity for the purchaser of assets and the purchaser will indemnify the Seller from any liabilities relating to the use of the assets after the closing date.

Due diligence will begin immediately.  Gerbsman will provide access to an online data room to interested parties provided that a valid confidentiality and non-disclosure agreement (NDA) is put in place.  The information contained in this Offering Memorandum has been provided to Gerbsman and Assignee by the former management of Assignor. Neither Assignee, Gerbsman Partners nor Assignor represent that any of the information contained in this Offering Memorandum is a statement of opinion or fact.  Interested parties are solely responsible for performing their own due diligence to determine the value and status of the assets being offered through independent investigation by themselves and their legal and/or financial advisors.  

Dates and Deadlines –Based on the submitted indications of interest or otherwise, qualifying parties (which meet the requirements established by the Assignee in its sole and absolute discretion) will be asked to prepare and submit  binding Letters of Intent in the form of an executed Asset Purchase Agreement (an “APA”) substantially in the form to be provided by Gerbsman containing the required information set forth in the paragraph below).  Such Letters of Intent must be received no later than Friday, July 9, 2021 at 5:00 pm Eastern Daylight Time (the “Offer Deadline”), or they may not be considered by the Assignee in its sole and absolute discretion.  The Assignee anticipates rendering a decision shortly after the Offer Deadline and communicating such decision to the parties submitting Letters of Intent.

Notwithstanding the deadlines set forth above, Letters of Intent may be presented to Gerbsman and the Assignee at any time during the due diligence period by email.   Letters of Intent must include the name of the purchasing entity, the purchase price, the assets to be purchased, any contingencies to closing, and any variation from the standard terms and conditions of the APA (such variations shall be noted by submitting a “redline” version against the form APA provided by the Assignee).  A form APA will be provided upon request.  Interested Parties should be aware that any significant material changes to the form APA may jeopardize the transaction and cause the Assignee to reject any such Letters of Intent and reopen the bidding process.  The sale will be an “AS IS”“WHERE IS” sale, with no representations or warranties whatsoever provided by the Assignee or Ohana Biosciences, Inc. as to merchantability, fitness or use, and the assets shall be subject to any and all encumbrances and related obligations that are not expressly released by the holder(s) thereof.  Oxford Finance has consented to this sales process and agreed that it will release its security interest in the Ohana Assets so as to permit them to be sold free and clear to the buyer(s) resulting from this process.

Former senior employees will also be available to host in-person and web presentations by teleconference to help the sales process.

Once the announcement has been made that the bidding has ended, the successful bidder (“Buyer”) will be required to close and fund promptly. Exclusivity will not be granted.

Seller reserves the right to accelerate, delay, cancel or alter the bidding process immediately with or without notifying other bidders, and to withdraw any or all assets from this sale process in its sole discretion. Therefore, Interested parties are encouraged to complete due diligence and submit offers as soon as practicable.

All Indications of Interest/Letters of Intent should be submitted to steve@gerbsmanpartners.com and hlipton@rockcreekfa.com

We appreciate your sincere interest in this opportunity and this exciting offering for the assets of the Ohana Biosciences, Inc.  We look forward to engaging with you and your due diligence teams.

SPECIAL PURPOSE ENTITY DISCLOSURE

OBS (ABC), LLC which is the Assignee for the Benefit of Creditors of Ohana Biosciences, Inc. is a special purpose entity manage by Rock Creek Advisors 1738 Belmar Blvd., Belmar, New Jersey 07719.  United States

For additional information, please see below and/or contact:

Steven R. Gerbsman                                                          

Gerbsman Partners

steve@gerbsmanpartners.com                         

ken@gerbsmanpartners.com

SALE OF the Assets of Ohana Biosciences, Inc.

Gerbsman Partners – http://gerbsmanpartners.com  has been retained by OBS (ABC), LLC (“Assignee or “Seller”) the assignee for the benefit of creditors of Ohana Biosciences, Inc. (“Ohana”) to solicit interest for the acquisition of all or substantially all of the Ohana assets, including its Intellectual Property (“IP”), in whole or in part (collectively, the “Ohana Assets”).  Please see detailed sales information letter attached, (Exhibit A), NDA, (Exhibit B) Patent information and Trademark information (Exhibit C).

On June 3, 2021, Ohana Biosciences, Inc., a Delaware corporation, as Assignor, made a General Assignment for the Benefit of Creditors (the “Assignment”) to “OBS (ABC), LLC”, a Delaware limited liability company, as Assignee, pursuant to Delaware state law. Please note that with the exception of the relationship created by the Assignment, and despite their similarity in name, Assignor and Assignee have no corporate affiliation to each other. Pursuant to the Assignment, Assignor transferred ownership of all of its rights in tangible and intangible assets (collectively, the “Assets”) to Assignee for sale. Assignee shall sell the Assets and distribute the net proceeds to creditors of Assignor.

Ohana was founded to develop a sperm biology platform that combines single-cell sequencing, cell surface profiling, and computational biology to analyze large libraries of genetic and molecular information from individual sperm cells. Through this, Ohana scientists applied these insights to product opportunities across reproductive health.

Disclaimer

This Enterprise Offering contains information regarding certain operations and the business of Ohana Biosciences, Inc., and the information contained herein has been assembled for the purpose of providing interested parties with general information to assist in their evaluation of a possible acquisition of the Company or assets of the Company. Nothing contained in this Enterprise Offering is, or shall be relied upon as, a promise or representation as to the past, present or future performance of the Company or its product or as providing any assurances of any kind regarding the Company’s intellectual property or other assets.  In furnishing this Enterprise Offering, neither the Company, Gerbsman Partners nor Assignee undertakes any obligation to (and each expressly reserves the right not to) provide the recipient with access to any additional information of any kind with respect to the Company or any of its assets or operations.

Assignee has retained the services of Gerbsman Partners and certain former employees to assist with the sale of the assets. This group of individuals are available to assist with due diligence and the transition of assets.

As Seller, OBS (ABC), LLC will oversee the process and select the winning bidder(s). This will be a closed bidding process whereby the names of the bidders and the bids will not be disclosed to the other parties.

Ohana Investment to Date:

Ohana was founded by Flagship Pioneering in 2016.  Since that time, approximately $58.2 Million has been invested, a majority of which was from Flagship Pioneering.  An additional $18.0 Million of senior secured notes was also infused into the company by Oxford Finance LLC.

Ohana has 2 issued patents, and 25 patents pending.

IMPORTANT LEGAL NOTICE:  

The information in this memorandum does not constitute the whole or any part of an offer or a contract.

The information contained in this memorandum relating to the Ohana Assets has been supplied by third parties and obtained from a variety of sources. It has not been independently investigated or verified by Assignee or Gerbsman Partners or their respective agents.  


Potential purchasers should not rely on any information contained in this memorandum or provided by Assignee or Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.


Assignee and Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reason of Assignee’s or Gerbsman Partners’ negligence or otherwise. 

Any sale of the Ohana Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of Assignee or Gerbsman Partners. Without limiting the generality of the foregoing, Assignee and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the Assignee Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

Ohana History and Background

Ohana Biosciences, founded in 2016, was conceived in the setting of a broader technological leap forward in biomedical research. Ohana Biosciences was created through Flagship Pioneering’s origination process. The emergence of single-cell sequencing allowed researchers to study the individual cells composing various tissues with a precision previously not possible, and scientists flocked to study the complex composition of organ systems and tumors.

David Berry, general partner at Flagship Pioneering, took a different view, focusing on how single-cell sequencing technology could analyze the differences between sperm and egg cells compared with other cells in the body. Berry’s exploration, supported by a team of scientists at Flagship Pioneering’s VentureLabs innovation team, discovered a breakthrough. Put simply, science had vastly underestimated the role of sperm. Berry and his team identified sperm’s role in setting the health trajectory of a person from embryo development through early childhood, and in dictating health outcomes for pregnant women. Ohana was founded to build upon these learnings, developing a sperm biology platform to combine single-cell sequencing, cell surface profiling, and computational biology to analyze large libraries of genetic and molecular information from individual sperm cells. Through this, Ohana scientists applied these insights to product opportunities across reproductive health, including its most advanced program called SPERTILITY.

Details for the key points below are outlined in the attached Ohana detail sales letter.

• The world has changed, yet reproductive medicine has largely stayed the same.

•The global trend toward delayed age of parenthood and its impact to health.

•Rising rates of infertility around the world.

•The overlooked role of sperm: inordinate burden on women and men with few treatment options.

•Growing rates of fertility preservation and ART (Assisted Reproductive Technology) point to explosive growth potential.

•Ohana has discovered previously unknown insights into sperm, unlocking a breadth of ways to influence reproductive health 

•Not all sprm are equal as evidenced in the chart below.

Figure 1.  Ohana analyzed a publicly available dataset of de novo mutations in 70 fraternal twins, demonstrating an increase in de novo mutations with age of father as well as variation in de novo mutations between twins from different sperm. Each pair of data points in the left panel represents the number of de novo mutations detected in each set of twins. The right panel shows the difference in number of de novo mutations between twins, ranging from 1 to 21. Original data from Goldmann et al, “Parent-of-origin-specific signatures of de novo mutations, Nat Genetics 201610.

•Sperm are specialized cells, fit-for-purpose.

•Sperm present a unique opportunity for therapeutic intervention.

Key Attributes:

Ohana Biosciences, Inc. believes its assets are attractive for multiple reasons:

  • SPERTILITY is the first product designed to mimic sperm activation in natural conception, in an IVF and IUI setting.  It is an ex-vivo sperm cell treatment that improves sperm function, and has shown the potential to increase the number of high-quality embryos yielded per cycle and improve pregnancy outcomes for anyone undergoing ART.
  • Clinical study completed in late 2020 demonstrated:
    • 32% increase in rate of high-quality euploid blastocysts (HQEB’s) when using SPERTILITY.  HQEB is a clinically meaningful endpoint.
    • 24% increase in the average number of HQEB’s per couple.
    • 40% decrease in the odds of not getting a HQEB on SPERTILITY
    • 68% increase in the odds of having a top-ranked embryos on SPERTILITY 

The clinical study was a randomized, prospective, double-blinded, multicenter, split oocytes and split insemination pilot study in conventional IVF.  

  • Ex-vivo treatment provides fast 510(k) regulatory opportunity
  • Strong patent protection, with 2 granted U.S. patents broadly covering technology and 25 patents pending
  • Contract manufacturer in place
  • Company also had a contraception program

Intellectual Property

Ohana’s platform leverages distinctive features of sperm biology to rapidly generate therapeutic opportunities

Figure 2. Ohana’s sperm biology platform integrates in-depth characterization of sperm function, genetic, and epigenetic characteristics and sperm surface to yield novel insights about sperm biology and support development of products to enhance sperm function to improve reproductive outcomes and block sperm function as novel, non-hormonal contraceptives.

Targeting sperm to block or enhance function can yield transformative products

The application of advanced data analysis to Ohana’s continually growing sperm cell library yields dynamic, actionable insights 

Fertility Disease Overview

Infertility prevalence is growing with significant implications for society
Addressing infertility may be one of the most important challenges for developed nations in the coming decades. Infertility, defined as failure to establish a clinical pregnancy after 12 months of trying, is a common and growing public health problem. The prevalence of infertility in the U.S. is estimated to be 10-15% of women, and growing over time (Stephen 1998, Boivin 2007, ASRM 2020).  Applying these statistics, it can be construed that 1 in 8 couples have trouble getting pregnant or sustaining a pregnancy.  Unfortunately, of these ~7 million women and couples suffering, many go untreated (CDC 2010).

The global prevalence of infertility is trending upwards as people delay parenthood until later in life. Increased age is a significant contributor to reduced fertility in women, as well as declining sperm counts in men. Several studies add to the mounting research showing that declining sperm count (a 50-60% decline over the past four decades) as well as reduction in sperm quality (50% global reduction in quality since 1938) are highly correlated with infertility trends (Levine 2017, Lengupta 2017).

In developed nations, Assisted Reproductive Technology (ART) is considered to be the most effective treatment option for infertility, but with only an average success rate of ~30% (Gnoth 2011). In the U.S., only ~300,000 of 7 million are accessing ART, leaving more than 90% of those who may benefit untreated as an example of the unmet need that exists.

Births per Woman Declining Over Time: Historical and Projected

Sources: Clarion Healthcare Partners 2019, World Bank 2019

The Patient Journey to seek treatment is long and often unresolved
To be able to address the high unmet need and low treatment rates, we need to understand the patient journey. The infertility diagnosis and treatment journey present patients with a complicated path of multiple doctor visits with different specialists, unclear and cumbersome treatment recommendations and considerable financial costs.  Many patients end up not seeking or undergoing treatment due to cost, low perceived efficacy of IVF, need for multiple treatment cycles, time, and physical/emotional burden. For those that do pursue treatment, at least 30% drop out after just one cycle. (Boivin 2007).

Female patients with infertility may seek help from their primary care physicians, their OBGYNs or may go straight to a fertility specialist (reproductive endocrinologist).  The majority of women experiencing infertility see an OBGYN for diagnosis and assessment and are then referred to a fertility specialist. At each referral point there is significant drop-out (see Patient Journey chart) resulting in very few who go through with treatment at fertility clinics.  Men on the other hand, rarely seek diagnosis or treatment.  It is usually only at the Fertility clinics when a semen analysis is done that the male part of the equation is considered or that infertility is assessed

Infertility Patient Journey: Summary of Patient Experience and Dropout

Sources: Clearview Healthcare 2019

Emotional impact of infertility
Infertility can take a heavy psychological and emotional toll on both women and men (HassanpoorAzghdy 2014, NYTimes 2019).

Many experience anxiety, grief, anger and frustration as they experience the loss of control over something that is a life goal and easy for so many of their peers (Harvard 2009).

  • A study of 488 American women who filled out a standard psychological questionnaire concluded that women with infertility felt as anxious or depressed as those diagnosed with cancer, hypertension, or recovering from a heart attack (Domar 1993).
  • Men are often in the role of supporter, but they also experience low self-esteem, stigma and depression similar to women when they are part or all of the cause of the infertility.

Market Size & Dynamics of ART

There is a significant but under-penetrated patient population
More than 4 million IVF cycles are performed globally, with approximately 265,000 IVF cycles in the U.S. (2019 SART) and almost 850,000 in Europe (IQVIA 2019, ESHRE 2018, Allied Market Research 2019).  In the U.S. this equates to ~4% utilization of ART.

Across Europe and Japan utilization rates are significantly higher due to broad universal coverage of ART.  Only 86 cycles of ART per 100,000 population are performed each year in the U.S. By comparison, ART is utilized over twice as frequently per capita in France and over five times as much per capita in Japan (IFFS 2019). This leaves the U.S. substantially behind in providing ART as a key tool in addressing infertility, with much room to grow.

Despite the U.S.’s relatively low utilization of ART compared with other developed nations, the U.S. IVF market size is substantial; IVF services in the U.S. accounts for over $4.9B USD per year in revenue and expected to reach $5.6B USD by 2027 (Allied Market Research 2019).

Infertility and Volume of ART Cycles per Year (US)

Sources: IQVIA 2019; Malizia 2009, Allied Market Research 2019.

Lack of payor coverage has historically limited ART use in U.S., but fertility benefits are improving rapidly

The rise should translate to a significant increase in the covered population and drive more patients to ART who otherwise would not have had access (Canaccord Genuity ART Report 2019).

FBM’s offer employers a carve-out benefit for fertility by contracting with fertility clinics and service providers to negotiate the costs of cycles and reduce risk to employers. Though each benefit manager employs different business models, all aim to increase employees’ access to infertility treatments, improve clinical outcomes, and reduce costs. These trends of expanding coverage will have a significant impact on people’s ability to access treatment including ART.

An additional benefit many employers are adding is fertility preservation such as egg freezing services. As women delay having children, there is growing need for women to freeze younger, higher quality eggs to use for future pregnancies, which necessitates the use of IVF later in life.

As a result of these ongoing and rapidly changing benefits and preservation trends, the number of IVF cycles performed per year is predicted to double by 2027, exceeding 500,000 cycles per year in the U.S. (Allied Market Research 2019). As fertility benefit plans seek to provide the highest quality ART products with highest possibility of success, a product like Spertility, which has the potential to decrease the number of cycles needed to achieve pregnancy, may have a positive impact to the cost-benefit analysis attractive to such payers and employers.

Current Treatment Options and Limitations

Across the treatment landscape, a key leverage point for improving success of IVF cycles is related to the ability to generate high quality embryos.  Today, despite a plethora of pharmaceutical drugs, devices and other tools, there is very little that gives a women/couples a better chance to have enough embryos to improve likelihood of having a live birth.

The historic context of infertility as a female problem is clearly seen in the treatment focus today.   Although infertility due to female factors is only about 30% of cases, most of the focus in treatment is on the female.

Despite male factors contributing between 30-50% of the issue, there are almost no treatments available to improve the function of sperm. Usually IUI or IVF is recommended to overcome male factor infertility but is not a direct treatment to address the underlying issue.

Infertility in men is typically evaluated once a couple goes to a fertility clinic.  The evaluation focuses on a semen analysis in which the number of sperm (concentration), motility (movement), and morphology (shape) are assessed by a specialist urologist.  These diagnostics have not advanced in almost 100 years and may miss additional ways the sperm is compromised (Andrade-Rocha 2017).

Assisted Reproductive Technology (ART)

The most commonly used methods of reproductive assistance include:

  • Intrauterine insemination (IUI). During IUI, millions of healthy sperm are placed inside the uterus close to the time of ovulation. However, success rates are low, around 10% per cycle (Tomlinson 1996, Harris 2009).
  • Invitro fertilization (IVF): This involves retrieving mature eggs from a woman, fertilizing them with sperm, then transferring the embryos into the uterus after fertilization. IVF is the most effective assisted reproductive technology. An IVF cycle takes several weeks and requires frequent blood tests and daily hormone injections.

There are two ways that an egg may be fertilized by IVF: conventional and ICSI (Intracytoplasmic Sperm Injection). In conventional IVF, sperm prepared and isolated from a semen specimen are placed with the egg in a laboratory dish. Fertilization occurs when one of the sperm enters into the cytoplasm of the egg. In the ICSI process, a tiny needle, called a micropipette, is used to inject a single sperm into the center of the egg. With either conventional IVF or IVF/ICSI, once fertilization occurs, the fertilized egg (now called an embryo) grows in a laboratory from 3 (cleavage stage) to 5 and sometimes 6 days (blastocyst stage embryo)  before it is transferred to the woman’s uterus. 

Graphical user interface, text, application

Description automatically generatedThe IVF Process

Sources: Fertility IQ, Ohana Biosciences

Limitations of current treatment with ART
Today limitations and burden associated with ART leave many people unable to address their desire to have children. Success of IVF is often dependent on the number of high-quality embryos at the end of a stimulation cycle. Achieving a sufficient number of high-quality embryos is often a challenge and follows an age-dependent decline (Ubaldi 2019). In general, multiple individual embryo transfer procedures are required to achieve a pregnancy and live birth. If one cycle does not yield enough embryos, multiple stimulation/retrieval cycles are needed, imposing additional burden on patients.

High Treatment burden

While medical interventions offer much-needed help and hope, studies suggest that they may also add to the stress, anxiety, and grief that patients are already experiencing from infertility itself (Hassanpoor-Azghdy 2014, NYTimes 2019, Harvard 2009).

Challenging medication side effects 

Drugs and hormones can often cause psychological side effects including mood swings, anxiety, irritability in women as well as physical impact of multiple injections a day (de Klerk 2008).

Financial strain  

Costs of infertility treatments are significant. The average cost for an IVF cycle using fresh embryos is approximately $24,000 with slight variances in geography. This includes $3,000 to $7,000 per cycle for fertility drugs. Clinics may also offer and patients opt for ICSI ($1,000-$3,000) and preimplantation genetic testing (PGT-A: $3,000-$6,000) adding to the cost per cycle. Many patients will need several cycles which can result in >$50,000 in cost, which is often paid out of pocket due to reimbursement issues discussed (Fertility IQ).

Low success rates

IVF success rates are approximately 33% for women under 35 but are much lower for older women. (Malizia 2009).

  • Average of 2.5 IVF cycles for a 50% chance of having a baby; 27% for women 40+ (Smith 2015)
  • On average, even after 6 cycles, the chance of having  a baby is only 65%
  • 30% of the few who do access ART stop after one cycle due to the high cost and burden (Smith 2015)

Reliance on high quality embryos

Increasing the number of high-quality embryos enables higher probability of successful pregnancies and outcomes using fewer egg retrieval cycles. Ohana’s Spertility aims to increase the number of high-quality embryos yielded per single egg retrieval procedure. 

  • Higher quality embryos are more likely to result in a successful live birth; 90% of women who had a baby did so as a result of an embryo graded high quality (Van den Abbeel 2013)
  • Utilizing a high-quality embryo doesn’t guarantee pregnancy; 50% of embryo transfers result in a live birth and 50% do not (Zhao 2018)
  • More high-quality embryos provides more opportunities to have a baby and an increased opportunity to have a second child from the same egg retrieval at a later date

Limited options for improving sperm in IVF

The role of sperm in reproductive outcomes has lacked significant research and focus in clinical practice. Yet sperm contribute significantly to the ability for fertilization, good embryo development, and the health of the child. Since ICSI was first performed over 30 years ago, there has been no meaningful innovation in addressing sperm’s role. Regardless of infertility in a male, female or both, all sperm utilized for IVF must attain the proper metabolic state that supports embryo development.  The current processes used to prepare sperm do little to activate sperm or influence function.

Spertility has the potential to address each of these current limitations of IVF.  The potential for a product to increase the number of available embryos for transfer may alleviate the financial, emotional, and physical burden associated with multiple egg retrievals and transfer cycles. Spertility also does not add burden to the patient as it is utilized in the lab.

Current sperm preparation products

Most current sperm preparation methodologies and the products used in fertility labs are based on incomplete understanding of the role of sperm in fertilization and embryo development. Preparations are primarily used to isolate viable sperm cells from other semen fractions, debris, and non-viable sperm cells with the goal of increasing the odds that viable sperm reach an egg for fertilization in a lab dish. There are no products available specifically aimed at improving sperm metabolism and function to optimize fertilization and positively influence embryo development. 

Of current products, none activate the natural metabolic pathway of the female reproductive tract during natural conception. We believe this mechanism is critical to the IVF process, and the basis for developing Spertility. If cleared for commercial use, Spertility has the potential to become a new standard of care for sperm treatment, addressing significant unmet needs expressed by patients, physicians, and payors, as well as advancing the untapped field of sperm-targeted approaches in ART.

SPERTILITY

Product Overview

SPERTILITY to improve ART Outcomes

Ohana developed SPERTILITY, an ex-vivo sperm cell treatment that improves sperm function, and has shown the potential to increase the number of high-quality embryos yielded per cycle and improve pregnancy outcomes for anyone undergoing ART. Spertility was designed to enhance ART outcomes by mimicking the natural in utero environment sperm encounter during natural fertilization, which is lacking in the laboratory setting, yet essential in facilitating the activation of key metabolic pathways critical to sperm function.

Ohana has conducted a wide variety of pre-clinical and ex-vivo human sperm studies that provided data supporting clinical development of Spertility as a sperm treatment that has potential to improve fertilization and embryo development (ASRM 2020). 

A pilot clinical study (SPRING) was recently completed for Spertility.  Results from the study are outlined further below, but in summary the study showed:

  • Higher rate of implantable embryos (“high-quality euploid blastocysts” or HQEB’s)
  • More top-ranked embryos selected by embryologist for IVF transfer
  • More couples with at least 1 HQEB for transfer
  • No safety signals reported

Spertility’s product profile addresses a key area of unmet need in ART: improvement of sperm function resulting in higher rates of fertilization and development of high-quality embryos.

Compared to how IVF cycles are performed in fertility labs today, Spertility will replace the current sperm preparation including 3 steps, which when performed in sequence influence and improve the metabolism required for embryo development.

Ohana’s SPERTILITY in the IVF Lab Process

Sources: Fertility IQ, Ohana Biosciences

Each Spertility kit is intended to be used for one IVF cycle and contains three vials of media applied sequentially to activate the sperm before the fertilization step.  Preparing sperm using the Spertility protocol takes approximately two hours more than the current process as the timing of the steps in the protocol is a key component to success.

SPERTILITY: Designed to Mimic the Activation Stages of Sperm

Source: Ohana Biosciences

Regulatory

Ohana was preparing to pursue regulatory clearance for SPERTILITY in the U.S. through the FDA’s 510(k) pathway, as the product is considered a medical device in the eyes of the FDA.  As such, the clinical study performed by Ohana was not completed to support the intended filing. 

The 510(k) approach provides a more expeditious review process, which the company believed would help get this important new treatment to patients in need in the most efficient way possible, while still having the benefit of rigorous FDA review. 

The 510(k) approach provides a more time sensitive and predictable review process.

In making that determination, the FDA will conclude a device is substantially equivalent to a marketed device if:

  1. It has the same intended use as the predicate device and the same technological characteristics.
  2. Or it has the same intended use as the predicate device, has different technological characteristics, does not raise new questions of safety and effectiveness and the applicant can show that the device is at least as safe and effective as the marketed device.

The constituents in Spertility are found in commercial media used in IVF labs and therefore one can consider this to be of equivalent technological characteristics.

Ohana holds patents for Spertility based on its energy depletion with subsequent staged reintroduction of different energy sources.  This staging of energy sources has been evaluated in both the preclinical and clinical settings demonstrating Spertility is at least as safe and as effective to marketed devices

There is room to have a differentiated product, while still using the 510K (the easiest) pathway to the US market.

SRING Clinical Study

Manufacturing

The Company relies on a third-party CMO for its Spertility manufacturing needs.

Former Management Team

Amber Salzman, PhD
President & Chief Executive Officer

Dr. Salzman was the President and CEO of Ohana Biosciences. She previously served as the President and CEO at Adverum Biotechnologies, and was a Co-Founder of Annapurna Therapeutics SAS where she served as its President and CEO prior to its merger with Avalanche Biosciences to create Adverum Biotechnologies.

Prior to her role at Adverum Biotechnologies, Dr. Salzman served as President and CEO of Cardiokine, Inc. until it was acquired by Cornerstone Therapeutics. Prior to that, she was a member of the GlaxoSmithKline (GSK) research and development executive team, where she was responsible for operations for medicine development across therapeutic areas, including planning and managing drug development projects and clinical trials with over 30,000 active patients around the world.

Alka Batycky, PhD
Chief Development Officer

Dr. Batycky was VP, Clinical Strategy & Operations, and was involved in overseeing Ohana’s clinical pipeline.

Dr. Batycky is a leader in driving efficient drug development spanning drug discovery, IND enabling studies and phase 1-4 clinical trials. She has broad therapeutic experience, which has included developing treatments for oncology, CNS disorders, inflammatory diseases, and women’s health. She also has experience in developing small molecules, biologics, devices and combination products. Marketed products she has worked on include Feraheme®, MuGard™, Vivitrol® as well as the AIR™ technology that is the basis of Inbrija™.

Ramiro Castro-Santamaria, MD, MPH, MBA
Chief Medical Officer

Dr. Ramiro Castro-Santamaria is a urologist and family medicine physician with nineteen years of experience in clinical research and drug development. He has worked in various companies (Pharmacia, Pfizer, Boehringher Ingelheim and GSK), across different therapeutic areas including urology and women’s health, in different cultures and countries (Spain, Germany, UK, US) and delivered various worldwide regulatory files, drug approvals and product launches.

Lance Colwell, BS
Chief Operating Officer

Mr. Colwell was Chief Operating Officer and led a range of functions, including program and portfolio management, technical operations, medical affairs, corporate affairs, and business development.

Mr. Colwell is a proven global pharmaceutical executive with a nearly 30-year track record of consistently delivering sustainable growth through multiple business cycles. He joined Ohana from Biogen, where he was most recently the Vice President of the Rare Disease Group and responsible for the successful launch of SPINRAZA® in the U.S. During his 14-year tenure at Biogen, Mr. Colwell led or supported several drug launches and held a range of leadership roles, including Vice President of Global Commercial Excellence and Operations, Austrian Country Head, Global Head of Medical Affairs Operations, Head of Commercial Training and Development, and a variety of marketing/brand leadership responsibilities for TYSABRI®, AVONEX®, MS franchise, and German affiliate marketing.

Caren B. Deardorf, BS, MBA
Chief Commercial Officer

Ms. Deardorf was Chief Commercial Officer and led the building of a commercial organization and capabilities, to bring Ohana’s pipeline of products to patients.

Prior to joining Ohana, Ms. Deardorf was at Biogen, where she was Vice President and Global Lead for SPINRAZA and the SMA Portfolio. In her role at Biogen, she led the global launch of SPINRAZA in over 40 countries, overseeing the regulatory, market access and commercial launch planning and execution.

Eric Furfine, PhD
Chief Scientific Officer

Dr. Furfine was Chief Scientific Officer and led on research and development strategies, with a specific focus on the company’s antibody contraceptive program.

Previously, Dr. Furfine was at Eleven Biotherapeutics, where his roles included Chief Scientific Officer and President of Research and Development. During his tenure, he led the discovery and early development of EBI-031, an IL-6 inhibitory antibody for the treatment of posterior ocular inflammatory diseases. Prior to Eleven Biotherapeutics, Dr. Furfine served as the Senior Vice President of Research and Preclinical Development of Adnexus Therapeutics, Inc., a Bristol-Myers Squibb research and development company, where his group discovered Adnectins, which advanced into clinical development. Prior to that, he was Vice President of Preclinical Development at Regeneron, where he led the non-clinical development and clinical pharmacology of ARCALYST®, EYLEA®, and ZALTRAP®. Dr. Furfine began his career in the pharmaceutical industry at Burroughs Welcome, which became GlaxoSmithKline, where he was the inventor of LEXIVA.

David McManus, BBA, CPA
Vice President of Finance

Mr. McManus was Vice President of Finance, Treasurer and Secretary, and led all aspects of the company’s finance and accounting, IT, and facilities operations. Over his career, he has raised over $100 million of financing across companies at various stages, and had a significant role in leading multiple companies through successful acquisitions.

Prior to joining Ohana, Mr. McManus was Executive Director of Finance and Corporate Controller at Good Start Genetics. At Good Start, he led finance and operational functions from early development through commercial launch and accelerated growth, and ultimate acquisition by Invitae in 2017. Previously, Mr. McManus was Controller at VisEn Medical, a Flagship Pioneering company that developed and commercialized transformative in vivo molecular imaging systems and reagents for cancer, cardiovascular, skeletal, and pulmonary applications. At VisEn, he was part of the leadership team that executed on record commercial growth and the acquisition of the company by PerkinElmer, Inc. in 2010.

Kathleen Seyb, PhD
Vice President of Research

Dr. Seyb was Vice President of Research and led the Biology team in developing and testing new ideas and moving projects from research to development.

Previously, Dr. Seyb led the biology and translational science efforts at Ra Pharmaceuticals, a biotech company with a platform technology to identify novel, synthetic macrocyclic peptides that combine the specificity of antibodies with the pharmacological properties of small molecules. Dr. Seyb was the Biology Lead through discovery, pre-clinical, and early clinical development of zilucoplan, a macrocyclic peptide inhibitor of complement C5 for treatment of complement-mediated autoimmune disorders. At Ra, Dr. Seyb also served as Alliance Manager and Program Manager for a collaboration with Merck on a cardiovascular target which advanced into clinical development.

Brendan St. Amant, JD, MPP
Vice President of Legal

Mr. St. Amant was Vice President, Legal, to lead the legal function at Ohana.

Mr. St. Amant comes to Ohana from Vertex Pharmaceuticals, where he was Director, Senior Counsel in the Legal Department and advised multiple functions on a broad array of risk, litigation, and employment matters. His previous professional experience includes serving as an associate then partner with Donnelly, Conroy & Gelhaar where he focused on commercial controversies and government enforcement. Mr. St. Amant was previously an associate with Goodwin and worked as a judicial clerk for a federal judge. In the legal community, Mr. St. Amant is Second Vice President and Trustee at the Massachusetts Continuing Legal Education, Inc., and has served in leadership roles on several committees for the Boston Bar Association. Brendan received his B.A. in History, magna cum laude, from Cornell University and his J.D./M.P.P. from Harvard Law School and the Harvard Kennedy School of Government.

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a nondisclosure agreement (in the form attached hereto as Exhibit A) to have access to key members of Ohana’s former management, intellectual capital and the due diligence “war room” documentation (the “Due Diligence Access”). Each interested party, upon obtaining Due Diligence Access, shall be deemed to acknowledge and represent that (i) it is bound by the bidding procedures described herein; (ii) it has an opportunity to inspect and examine the Ohana Assets and to review all pertinent documents and information with respect thereto; (iii) it is not relying upon any written or oral statements, representations, or warranties of Assignee or Gerbsman Partners, or any of their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of such interested party, and neither Assignee nor Gerbsman Partners (nor any of their respective, staff, agents, or attorneys) make any representations as to the accuracy or completeness of the same.  

TERMS AND CONDITIONS TO SALE

Assignee, which is managed by Rock Creek Advisors, will oversee the sales process for the Ohana Assets and select the winning bidder(s).  This will be a closed bidding process whereby the names of the bidders and the bids will not be disclosed to the other interested parties.

Assignee has retained the services of Gerbsman Partners and certain former employees to assist with the sale of the assets. This group of individuals is available to assist with due diligence and the transition of assets.

The contemplated transaction will be an asset sale using a standard Asset Purchase Agreement (“APA”). Please note that the general terms under which the assets will be sold, and key terms include:

  • Sell and convey assets on an “as-is, where-is” basis with all faults;
  • Sell and convey assets with limited representations or warranties; and
  • No indemnity for the purchaser of assets and the purchaser will indemnify the Seller from any liabilities relating to the use of the assets after the closing date.

Due diligence will begin immediately.  Gerbsman will provide access to an online data room to interested parties provided that a valid confidentiality and non-disclosure agreement (NDA) is put in place.  The information contained in this Offering Memorandum has been provided to Gerbsman and Assignee by the former management of Assignor. Neither Assignee, Gerbsman Partners nor Assignor represent that any of the information contained in this Offering Memorandum is a statement of opinion or fact.  Interested parties are solely responsible for performing their own due diligence to determine the value and status of the assets being offered through independent investigation by themselves and their legal and/or financial advisors. 

Dates and Deadlines –Based on the submitted indications of interest or otherwise, qualifying parties (which meet the requirements established by the Assignee in its sole and absolute discretion) will be asked to prepare and submit  binding Letters of Intent in the form of an executed Asset Purchase Agreement (an “APA”) substantially in the form to be provided by Gerbsman containing the required information set forth in the paragraph below).  Such Letters of Intent must be received no later than Friday, July 9, 2021 at 5:00 pm Eastern Daylight Time (the “Offer Deadline”), or they may not be considered by the Assignee in its sole and absolute discretion.  The Assignee anticipates rendering a decision shortly after the Offer Deadline and communicating such decision to the parties submitting Letters of Intent.

Notwithstanding the deadlines set forth above, Letters of Intent may be presented to Gerbsman and the Assignee at any time during the due diligence period by email.   Letters of Intent must include the name of the purchasing entity, the purchase price, the assets to be purchased, any contingencies to closing, and any variation from the standard terms and conditions of the APA (such variations shall be noted by submitting a “redline” version against the form APA provided by the Assignee).  A form APA will be provided upon request.  Interested Parties should be aware that any significant material changes to the form APA may jeopardize the transaction and cause the Assignee to reject any such Letters of Intent and reopen the bidding process.  The sale will be an “AS IS”, “WHERE IS” sale, with no representations or warranties whatsoever provided by the Assignee or Ohana Biosciences, Inc. as to merchantability, fitness or use, and the assets shall be subject to any and all encumbrances and related obligations that are not expressly released by the holder(s) thereof.  Oxford Finance has consented to this sales process and agreed that it will release its security interest in the Ohana Assets so as to permit them to be sold free and clear to the buyer(s) resulting from this process.

Former senior employees will also be available to host in-person and web presentations by teleconference to help the sales process.

Once the announcement has been made that the bidding has ended, the successful bidder (“Buyer”) will be required to close and fund promptly. Exclusivity will not be granted.

Seller reserves the right to accelerate, delay, cancel or alter the bidding process immediately with or without notifying other bidders, and to withdraw any or all assets from this sale process in its sole discretion. Therefore, Interested parties are encouraged to complete due diligence and submit offers as soon as practicable.

All Indications of Interest/Letters of Intent should be submitted to steve@gerbsmanpartners.com and hlipton@rockcreekfa.com

We appreciate your sincere interest in this opportunity and this exciting offering for the assets of the Ohana Biosciences, Inc.  We look forward to engaging with you and your due diligence teams.

Special Purpose Entity Disclosure

OBS (ABC), LLC which is the Assignee for the Benefit of Creditors of Ohana Biosciences, Inc. is a special purpose entity manage by Rock Creek Advisors 1738 Belmar Blvd., Belmar, New Jersey 07719.  United States

For additional information, please see below and/or contact:

Steven R. Gerbsman                                                          

Gerbsman Partners

                                                          

steve@gerbsmanpartners.com                        

Kenneth Hardesty

Gerbsman Partners

ken@gerbsmanpartners.com