Humacyte to Go Public via Merger with Alpha Healthcare Acquisition Corp. (AHAC)

February 17, 2021 7:02 AM EST

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Alpha Healthcare Acquisition Corp. (Nasdaq: AHAC) (“AHAC”), a special purpose acquisition company led by Mr. Rajiv Shukla, today announced execution of definitive business combination agreement along with a fully committed PIPE financing agreement with Humacyte, Inc. (“Humacyte”), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale. Upon closing of the transaction, AHAC will be renamed Humacyte, Inc. (the “Combined Company”) and will be led by Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. The Combined Company’s common stock is expected to be listed on the Nasdaq Capital Market under the ticker symbol “HUMA.”

  • Humacyte aims to transform medicine with off-the-shelf, universally implantable, bioengineered human tissue available at commercial scale.
  • Transaction values Humacyte at a pre-money valuation of $800 million with existing Humacyte shareholders rolling over 100% of their equity into equity of the Combined Company. Following transaction closing, Humacyte is expected to have a market capitalization of $1.1 billion.
  • Transaction is expected to provide up to $255 million of cash proceeds, including a fully committed $175 million PIPE and up to $100 million of cash held in the AHAC trust account assuming no redemptions. As a result of outsized demand, the PIPE offering was oversubscribed and upsized.
  • The PIPE was raised from a broad group of health care investors and thought leaders. These include Fresenius Medical Care, OrbiMed, Monashee Investment Management, Alexandria Venture Investments, UBS O’Connor, Morgan Creek Capital, and a number of unnamed health care focused funds. Most of the Company’s existing investors participated in the PIPE.
  • Transaction is expected to close in the second quarter, with the Combined Company expected to trade on the Nasdaq Capital Market under the symbol “HUMA.”

A group of leading investors has committed to participate in a common stock PIPE of approximately $175 million at $10.00 per share that will close simultaneously with the business combination. The Combined Company will also receive up to $100 million held in AHAC’s trust account at closing of the transaction, subject to any redemptions by existing AHAC shareholders. Additionally, existing Humacyte investors will be subject to a 12-month lockup with 50% eligible for sale after 6 months if the 20-day VWAP over any 30-day period equals or exceeds $15.00.

Humacyte Highlights

1. Clinical-stage biotechnology platform company with multiple potential products

  • Universally implantable: no need for donor tissue matching or a lifetime of immunosuppression.
  • Off-the-shelf: eliminate waiting time for donor tissue or the need to harvest tissue through surgical excision of the patient often dealing with existing morbidity.
  • Highly resistant to infection: based on evidence from clinical trials to date.
  • Regenerative and self-healing: expected to transform into the patient’s own tissue by repopulating with the patient’s own cells and undergoing angiogenesis.

2. Potential life-saving innovations

  • It is estimated that 3.5 million patients worldwide require hemodialysis every year. Each patient needs safe and repeatable arteriovenous (AV) access for dialysis. Humacyte’s Human Acellular Vessel (HAV), if approved, will provide a potential alternative to synthetic grafts and AV fistulas.
  • Over a million patients suffer from type 1 diabetes in the U.S. alone. Humacyte’s BioVascular pancreas, if approved, could be implanted in an outpatient procedure, potentially eliminating the need for continuous glucose monitoring and exogenous insulin therapy.
  • Half a million coronary access bypass grafts (CABG) are placed every year in the U.S. alone, most requiring the harvesting of a vein from the patient’s leg for the bypass conduit. Humacyte’s HAVs may potentially provide long-lasting revascularization with an off-the-shelf vessel, potentially eliminating the need for a second surgery to harvest a vein from the patient.
  • Vascular trauma affects tens of thousands of patients per year in the U.S., and can lead to amputation, infection and loss of life. Humacyte’s HAV is designed to potentially restore blood flow to injured limbs without waiting for vein tissue harvest.
  • Peripheral arterial disease is a growing health care problem, with over 100,000 procedures per year in the U.S. to treat the disease. Humacyte’s HAV may provide an alternative to vein stripping or artificial plastic implants for treatment of this disease which, if left untreated, can lead to infection, amputation and death.

3. Significant body of clinical evidence

  • 5 Phase II clinical trials completed: in hemodialysis access and peripheral arterial disease.
  • 3 Phase III clinical trials ongoing: vascular trauma and AV access trials expected to be complete by 2023.
  • 430+ patients treated with HAVs to date in clinical trials, no immunological rejections to date.
  • 800+ patient-years of clinical data with the HAVs implanted to date.

4. Extensive intellectual property rights

  • 87 patents granted and 21 patents pending.
  • Proprietary human cell bank and biomanufacturing processes.
  • Considerable manufacturing know-how and trade secrets.
  • Over 300 publications by Humacyte Executive Team on regenerative and vascular medicine.

5. $150+ billion in estimated total size of markets targeted by Humacyte’s products, if approved

  • Nearly $90 billion in market size for potential vascular products.
  • Over $65 billion in market size for potential non-vascular products.

6. $12+ billion in potential annual peak sales from Humacyte’s products, if approved

  • Multibillion-dollar peak sales potential from hemodialysis AV access, vascular trauma, peripheral arterial disease, diabetes and CABG products.
  • Substantial additional opportunities under development include bioengineered lung, trachea, urinary conduit and esophagus.

7. Well-defined regulatory pathway

  • Fast Track designation granted by the U.S. FDA in 2014.
  • First company to receive Regenerative Medicine Advanced Therapy (RMAT) designation, granted by the U.S. FDA in 2017.

8. In-house commercial-scale manufacturing with room for modular expansion

  • Proprietary biomanufacturing process that can operate at commercial scale.
  • Extensive automation and process monitoring and controls, designed for GMP compliance.
  • Current facility with scale-out expansion capability up to 40,000+ HAVs per year.

9. Nearly $480 million in financing raised to date, including $150M equity investment from Fresenius Medical Care

  • Commercial partnership with Fresenius Medical Care for the use of Humacyte’s HAV in dialysis AV access and peripheral arterial disease, a collaboration that includes vascular trauma in markets outside the U.S.
  • Fresenius Medical Care is the world's leading provider of products and services for individuals with renal diseases and in surgical care centers.

“Humacyte is a global leader in developing bioengineered tissues for use in regenerative medicine,” said Dr. Niklason. “We are very pleased to have support from top-tier investors, and access to the U.S. capital markets following the closing of this proposed transaction, which will leave Humacyte well-capitalized to provide first-in-class therapies to treat several life-threatening diseases. Our innovative platform has the potential to support tissue repair, reconstruction and replacement without the limitations of existing standards of care. Humacyte’s bioengineered tissues can be produced at commercial scale and, after regulatory approval, are designed to be stored in hospitals and other surgical centers, and immediately available to surgeons whenever needed.”

Said Rajiv Shukla, Chairman & CEO of AHAC, “Humacyte’s innovative biotechnology platform is aimed at solving intractable medical problems for (1) Patients: potential for lower risk of amputation and tissue rejection, elimination of waiting times, and reduced need for immunosuppression and additional surgeries; (2) Physicians: potential for better clinical outcomes and ease of use; (3) Payors: potential cost savings by avoiding amputations and infections, additional surgeries, medication and re-hospitalizations.”

Humacyte has assembled a seasoned team of 130 employees, consisting of scientists, clinical, manufacturing, regulatory and commercial experts. Following the closing of the transaction, Dr. Niklason and Mr. Shukla will be joined by certain board members of Humacyte to form the Combined Company’s board of directors.

Transaction OverviewUnder the terms of the proposed transaction, Humacyte’s shareholders will receive an aggregate of 80 million shares of AHAC’s Class A common stock (the “Class A Shares”) in exchange for their existing Humacyte shares, as contemplated by the terms of the business combination agreement. Current shareholders of Humacyte will exchange their shares of Humacyte for Class A Shares on a one for one basis. In addition, Humacyte’s shareholders may receive (i) an additional 7,500,000 Class A Shares if the 20-day VWAP of the Class A Shares over any 30-day period equals or exceeds $15.00 and (ii) an additional 7,500,000 Class A Shares if the 20-day VWAP of the Class A Shares over any 30-day period equals or exceeds $20.00. In addition to the $100 million held in AHAC’s trust account (assuming no redemptions), an additional group of top-tier healthcare investors has committed to participate in the transaction through a common stock PIPE of $175 million at $10.00 per share. Assuming that no AHAC shareholders elect to redeem their shares, it is estimated that the current shareholders of Humacyte will own approximately 73% of the issued and outstanding shares in the Combined Company at closing. The Combined Company is expected to receive gross proceeds of approximately $255 million at the closing of the transaction assuming no redemptions. The transaction is expected to close in the second quarter of 2021.

The transaction has been approved by each of AHAC’s and Humacyte’s Board of Directors. The transaction is subject to the approval of AHAC and Humacyte shareholders and other customary conditions and is expected to close in the second quarter of 2021.

Additional information about the transaction will be provided in a Current Report on Form 8-K that will contain an investor presentation to be filed by AHAC with the Securities and Exchange Commission (“SEC”) and will be available at www.sec.gov. In addition, AHAC intends to file a registration statement on Form S-4 with the SEC, which will include a proxy statement/prospectus, and will file other documents regarding the proposed transaction with the SEC.

AdvisorsPiper Sandler & Co. acted as lead placement agent and financial advisor to AHAC. Exos acted as co-placement agent and financial advisor to AHAC. Oppenheimer and Lake Street Capital Markets acted as financial advisors to AHAC. Goodwin Procter LLP acted as legal counsel to AHAC. DLA Piper acted as legal counsel to the placement agents. Covington & Burling LLP acted as legal counsel to Humacyte in the transaction.

Webcast DetailsA pre-recorded presentation discussing the business combination and PIPE agreements, and associated presentation materials, can be accessed at the following links with the passcode “AHAC”:URL: https://dealroadshow.comDirect link: https://dealroadshow.com/e/AHAC

About Humacyte Humacyte, Inc., is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues and organs designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries and chronic conditions. Humacyte’s initial opportunity, a portfolio of human acellular vessels (HAVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease. Pre-clinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s HAVs were the first product to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) expedited review designation and received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.



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