legal-opinion-issuers-counsel.docx

1013-00002 · Client 1013 · Closing

legal-opinion-issuers-counsel.docx DOCUMENT Capital Markets

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CALDERWOOD & HARKNESS LLP Attorneys at Law 600 California Street, 40th Floor San Francisco, CA 94108 Telephone: (415) 782-6000 Facsimile: (415) 782-6001 www.calderwoodharkness.com

April 22, 2024

Pinnacle BioVentures Fund III, L.P. 101 Federal Street, 26th Floor Boston, MA 02110

Cormorant Health Capital Partners, L.P. 375 Park Avenue, Suite 3201 New York, NY 10152

Alder Creek Life Sciences Fund II, L.P. 555 Mission Street, Suite 2800 San Francisco, CA 94105

(each, a "Purchaser" and collectively, the "Purchasers")

Ladies and Gentlemen:

We have acted as counsel to Genome Dx Therapeutics Inc., a corporation organized and existing under the laws of the State of Delaware (the "Company"), in connection with the Note Purchase Agreement dated as of April 9, 2024 (as the same may be amended, supplemented, or otherwise modified from time to time, the "Purchase Agreement"), by and among the Company and the Purchasers named therein. The Purchase Agreement provides for the issuance by the Company of an aggregate principal amount of Forty Million Dollars ($40,000,000) of senior unsecured convertible promissory notes (individually, a "Note" and collectively, the "Notes") to the Purchasers, allocated as follows:

(a) a Note in the principal amount of Twenty-Two Million Dollars ($22,000,000) issued to Pinnacle BioVentures Fund III, L.P.;

(b) a Note in the principal amount of Twelve Million Dollars ($12,000,000) issued to Cormorant Health Capital Partners, L.P.; and

This opinion letter is being delivered to the Purchasers pursuant to Section 6.2(e) of the Purchase Agreement in connection with the closing of the transactions contemplated thereby on the date hereof (the "Closing Date"). This opinion letter relates to Calderwood & Harkness LLP client matter number 1013-00002.

In connection with this opinion, we have examined and are familiar with such documents and matters of law and fact as we have considered necessary or appropriate for the purpose of rendering the opinions set forth herein, as more particularly described below.

1. DEFINED TERMS AND DOCUMENTS EXAMINED

1.1 Defined Terms

As used in this opinion letter, the following terms have the meanings indicated:

"Bylaws" means the Amended and Restated Bylaws of the Company, as currently in effect.

"Company" means Genome Dx Therapeutics Inc., a Delaware corporation.

"Disclosure Schedules" means the disclosure schedules delivered by the Company to the Purchasers in connection with the Purchase Agreement.

"Notes" means the senior unsecured convertible promissory notes issued pursuant to the Purchase Agreement in an aggregate principal amount of Forty Million Dollars ($40,000,000).

"Purchase Agreement" means the Note Purchase Agreement dated as of April 9, 2024, by and among the Company and the Purchasers.

"Regulation D" means Regulation D promulgated under the Securities Act, including Rules 501 through 508 thereunder, as in effect on the date hereof.

"Restated Certificate" means the Restated Certificate of Incorporation of the Company, as filed with the Secretary of State of the State of Delaware.

"Securities Act" means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

"Transaction Documents" means, collectively, the Purchase Agreement, the Notes, the Disclosure Schedules, and each other agreement, certificate, or instrument delivered by the Company or the Purchasers pursuant to or in connection with the Purchase Agreement.

Capitalized terms used but not otherwise defined in this opinion letter have the meanings ascribed to them in the Purchase Agreement.

1.2 Documents Examined

In rendering the opinions set forth below, we have examined originals or copies (certified or otherwise identified to our satisfaction) of the following documents:

(a) The Purchase Agreement, executed as of April 9, 2024, including the Disclosure Schedules delivered by the Company in connection therewith;

(b) The Notes, each dated as of April 22, 2024, in the respective principal amounts set forth above;

(c) The Restated Certificate of Incorporation of the Company, as filed with the Secretary of State of the State of Delaware, Delaware file number 6347821;

(d) The Amended and Restated Bylaws of the Company, as currently in effect;

(e) The Written Consent of the Board of Directors of the Company in Lieu of Meeting, dated as of April 5, 2024, approving and authorizing the transactions contemplated by the Purchase Agreement (the "Board Written Consent");

(f) The Officers' Certificate, dated as of April 22, 2024, executed by Dr. Marcus Avellino, Ph.D., MBA, in his capacity as Chief Executive Officer of the Company, and Diane Kowalski, CPA, in her capacity as Chief Financial Officer of the Company;

(g) The Secretary's Certificate, dated as of April 22, 2024, executed by Priya Raghunathan, J.D., in her capacity as General Counsel and Corporate Secretary of the Company, certifying as to the incumbency and authority of certain officers, and attaching thereto true, correct, and complete copies of the Restated Certificate, the Bylaws, and the Board Written Consent;

(h) A Certificate of Good Standing of the Company issued by the Secretary of State of the State of Delaware, dated on or about April 22, 2024 (the "Delaware Good Standing Certificate"), which certificate was obtained as a refreshed certificate in connection with the delayed closing of the transactions;

(i) A Certificate of Good Standing (Certificate of Status) of the Company issued by the Secretary of State of the State of California, dated on or about April 22, 2024 (the "California Good Standing Certificate");

(j) Accredited investor questionnaires completed and executed by each of the Purchasers in connection with the transactions contemplated by the Purchase Agreement; and

(k) Such other documents, certificates, corporate records, and instruments as we have deemed necessary or appropriate for the purposes of this opinion, including records of proceedings of the Board of Directors of the Company relating to the transactions contemplated by the Purchase Agreement.

2. ASSUMPTIONS

In rendering the opinions set forth herein, we have, with your consent and without independent investigation or verification, assumed the following:

(a) All signatures on documents examined by us are genuine, and all documents submitted to us as originals are authentic and complete. All documents submitted to us as copies, whether certified or uncertified, conform in all material respects to the originals thereof, and all such originals are authentic and complete.

(b) Each natural person executing any document reviewed by us in connection with this opinion had, at the time of such execution, the legal capacity to do so.

(c) Each Purchaser has the requisite legal power, authority, and capacity to execute, deliver, and perform its obligations under the Purchase Agreement and each other Transaction Document to which it is a party, and has duly and validly authorized, executed, and delivered the Purchase Agreement and each such other Transaction Document.

(d) Each Purchaser is an "accredited investor" as that term is defined in Rule 501(a) of Regulation D promulgated under the Securities Act, as represented by each such Purchaser in the Purchase Agreement and as confirmed in the accredited investor questionnaires delivered to us.

(e) The Purchase Agreement constitutes a valid, binding, and enforceable obligation of each Purchaser in accordance with its terms, subject to applicable bankruptcy, insolvency, and similar laws affecting creditors' rights generally and to general principles of equity.

(f) The information contained in all certificates, documents, and other materials delivered to us by officers, directors, and representatives of the Company is complete, true, accurate, and has not been modified, superseded, or revoked as of the date hereof. We have relied upon such certificates and documents as to all factual matters encompassed thereby without independent verification.

(g) The Company will file a Form D notice with the United States Securities and Exchange Commission (the "SEC") within fifteen (15) days of the first sale of securities as required by Rule 503 of Regulation D. The Company has represented to us that such filing will be made on or before April 24, 2024. In addition, the Company will make applicable blue sky filings and notices in the States of California, New York, Massachusetts, and Delaware as required by the securities laws of such states.

(h) No form of general solicitation or general advertising (within the meaning of Rule 502(c) of Regulation D) has been used by the Company, or by any person acting on its behalf, in connection with the offering, issuance, or sale of the Notes.

(i) The number of purchasers of the Notes does not exceed the numerical limitations set forth in Rule 506(b) of Regulation D, and no non-accredited investors (as defined in Regulation D) are participating in the offering or have been offered an opportunity to purchase the Notes.

3. OPINIONS

Based upon and subject to the foregoing, and subject further to the qualifications and limitations set forth in Section 4 below, we are of the opinion that:

Opinion 3.1 — Due Organization and Good Standing (Delaware)

The Company is a corporation duly incorporated, validly existing, and in good standing under the laws of the State of Delaware. In rendering this opinion, we have relied upon our review of the Restated Certificate of Incorporation of the Company on file with the Secretary of State of the State of Delaware under Delaware file number 6347821, the Delaware Good Standing Certificate, and the Secretary's Certificate delivered by the Company on the date hereof. Based on our review of such documents, the Company was originally incorporated in the State of Delaware on March 14, 2017. The Company's registered agent in the State of Delaware is Capitol Registered Agents, Inc., with a registered office located at 1209 Orange Street, Suite 200, Wilmington, Delaware 19801. As of the date of the Delaware Good Standing Certificate, the Company is in good standing with the Secretary of State of the State of Delaware, having paid all franchise taxes and filed all annual reports currently due and owing.

Opinion 3.2 — Foreign Qualification (California)

The Company is duly qualified to transact business as a foreign corporation and is in good standing in the State of California. In rendering this opinion, we have relied upon our review of the California Good Standing Certificate issued by the Secretary of State of the State of California. The Company's California entity number is C4085629. The Company initially filed for qualification to transact intrastate business as a foreign corporation in the State of California on April 3, 2017. The Company's principal executive office is located at 450 Pinnacle Drive, Suite 300, South San Francisco, California 94080. As of the date of the California Good Standing Certificate, the Company is in good standing with the Secretary of State of the State of California, and all applicable statements of information and related filings appear to have been made in a timely manner. We express no opinion as to the qualification of the Company to transact business in any jurisdiction other than the State of California.

Opinion 3.3 — Corporate Power and Authority

The Company has all requisite corporate power and authority under the Delaware General Corporation Law and the Restated Certificate and Bylaws to execute, deliver, and perform its obligations under each of the Transaction Documents to which it is a party, including, without limitation, the power and authority to issue the Notes in the aggregate principal amount of Forty Million Dollars ($40,000,000) to the Purchasers on the terms and conditions set forth therein. Additionally, the Company has all requisite corporate power and authority to own, lease, and operate its properties and assets and to carry on its business as presently conducted. In rendering this opinion, we have reviewed the Restated Certificate, the Bylaws, the Board Written Consent, and the other organizational documents of the Company, and nothing has come to our attention that would indicate that the Company lacks the corporate power or authority described in this paragraph.

Opinion 3.4 — Due Authorization, Execution, and Delivery

The execution and delivery by the Company of each Transaction Document to which it is a party, and the performance by the Company of its obligations thereunder, including the issuance and delivery of the Notes, have been duly authorized by all necessary corporate action on the part of the Company. The Board of Directors of the Company duly adopted the Board Written Consent, dated as of April 5, 2024, authorizing the transactions contemplated by the Purchase Agreement, including specifically: (i) approving the form, terms, and conditions of the Purchase Agreement and the Notes; (ii) authorizing the issuance and sale of the Notes to the Purchasers; (iii) designating Dr. Marcus Avellino, Ph.D., MBA, in his capacity as Chief Executive Officer, and Diane Kowalski, CPA, in her capacity as Chief Financial Officer, as authorized signatories with authority to execute and deliver, on behalf of the Company, the Transaction Documents and all related agreements, certificates, and instruments; and (iv) directing the officers of the Company to take all actions and execute and deliver all documents necessary or desirable to consummate the transactions contemplated by the Purchase Agreement.

We note that Jonathan Merriweather, in his capacity as Chair of the Board of Directors and in his separate capacity as Managing Director of Pinnacle BioVentures (the investment advisor or general partner affiliate of Pinnacle BioVentures Fund III, L.P., the lead investor and a Purchaser under the Purchase Agreement), recused himself from participation in the deliberation and vote of the Board of Directors with respect to the transactions contemplated by the Purchase Agreement, due to his actual and potential conflict of interest arising from Pinnacle's role as lead investor and Purchaser. The Board Written Consent was duly adopted by the affirmative written consent of the remaining members of the Board of Directors, who constituted a quorum for the transaction of business under the Bylaws and the Delaware General Corporation Law, in the absence of Mr. Merriweather. Based on our review of the Board Written Consent and the Bylaws, we are of the opinion that the recusal and abstention of Mr. Merriweather were properly effected and did not impair the validity of the corporate action taken.

Each Transaction Document to which the Company is a party has been duly executed and delivered by the Company by officers duly authorized to execute and deliver such documents on behalf of the Company.

Opinion 3.5 — Enforceability

Each of the Purchase Agreement and the Notes constitutes the legal, valid, and binding obligation of the Company, enforceable against the Company in accordance with its respective terms, except as such enforceability may be limited by the Enforceability Exceptions (as defined and described in Section 4.2 below), which include, without limitation:

(a) applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance, fraudulent transfer, and other similar laws of general applicability relating to or affecting the rights and remedies of creditors generally, as from time to time in effect;

(b) general principles of equity, including principles of commercial reasonableness, good faith, and fair dealing, whether applied in a proceeding at law or in equity; and

(c) the discretion of the court before which any proceeding for enforcement may be brought with respect to the availability of specific performance, injunctive relief, and other equitable remedies, which remedies are subject to the discretion of the court before which any such proceeding may be brought.

We note for informational purposes that the Notes bear interest at the rate of six percent (6.0%) per annum, calculated on the basis of simple interest and payable in kind by addition to the outstanding principal amount. The Notes mature on April 12, 2027 and are convertible into equity securities of the Company upon the occurrence of a Qualified Financing or other conversion events, in each case on the terms and conditions more fully set forth in the Notes. The Transaction Documents are governed by, and are to be construed in accordance with, the laws of the State of Delaware, without regard to conflicts-of-law principles that would result in the application of the laws of any other jurisdiction.

Opinion 3.6 — No Conflicts

The execution, delivery, and performance by the Company of the Transaction Documents to which it is a party, and the issuance and delivery of the Notes to the Purchasers, do not and will not:

(a) violate, conflict with, result in a breach of, or constitute a default under, or require any consent or approval not previously obtained under, the Restated Certificate of Incorporation or the Bylaws of the Company;

(b) to our knowledge, violate, conflict with, result in a breach of, or constitute a default under (or an event that, with notice or lapse of time or both, would constitute a default under), or result in the termination or acceleration of (or give any party the right to terminate, accelerate, or modify), any material agreement, contract, indenture, mortgage, lease, license, permit, or other instrument to which the Company is a party or by which the Company or any of its properties or assets are bound, in each case to the extent such agreement or instrument has been listed in or provided to us through the Disclosure Schedules to the Purchase Agreement;

(c) result in the creation or imposition of any lien, charge, encumbrance, pledge, security interest, or other claim upon any of the properties or assets of the Company under any such agreement or instrument described in clause (b) above; or

(d) violate any applicable order, judgment, injunction, writ, decree, or ruling of any court, arbitral tribunal, or governmental authority known to us to be binding upon the Company or any of its properties or assets.

This opinion is limited in scope to our review of the agreements and instruments listed in or delivered to us through the Disclosure Schedules to the Purchase Agreement, and does not extend to any agreements, instruments, or obligations not so provided to us for review. In rendering this opinion, we have relied upon the representations and warranties of the Company in the Purchase Agreement and in the Officers' Certificate regarding the completeness of the Disclosure Schedules.

Opinion 3.7 — Securities Law Exemption

The offer, issuance, sale, and delivery of the Notes to the Purchasers as contemplated by the Purchase Agreement are exempt from the registration requirements of Section 5 of the Securities Act pursuant to Section 4(a)(2) thereof and Rule 506(b) of Regulation D promulgated thereunder. In rendering this opinion, we have, in addition to our assumptions set forth in Section 2 above, relied upon the following factual matters, among others:

(a) Each of the Purchasers is an "accredited investor" as defined in Rule 501(a) of Regulation D, as represented by each Purchaser in the Purchase Agreement and as confirmed through the accredited investor questionnaires executed and delivered by each Purchaser;

(b) No form of general solicitation or general advertising (within the meaning of Rule 502(c) of Regulation D) was used by the Company or any person acting on its behalf in connection with the offering, issuance, or sale of the Notes;

(c) The Notes are being issued and sold to three (3) Purchasers, all of which are existing investors of the Company and have a pre-existing substantive relationship with the Company;

(d) The Notes are "restricted securities" within the meaning of Rule 144 under the Securities Act and each Note bears an appropriate restrictive legend substantially in the form set forth in Section 4.6 of the Purchase Agreement, stating that the Notes have not been registered under the Securities Act and may not be offered, sold, pledged, or otherwise transferred except in compliance with the registration requirements of the Securities Act or pursuant to an applicable exemption therefrom;

(e) The Company has made available to the Purchasers all information reasonably requested by them concerning the Company, its financial condition, and the terms and conditions of the offering of the Notes, including access to such information as would be required to be provided in a registration statement on Form S-1 under the Securities Act; and

(f) The sale of the Notes is made to the Purchasers, each of which has represented in the Purchase Agreement that it is acquiring the Notes for investment purposes only, for its own account, and not with a view to the distribution thereof within the meaning of the Securities Act.

This opinion regarding the availability of the exemption from registration under Section 4(a)(2) of the Securities Act and Rule 506(b) of Regulation D is premised upon the accuracy and completeness of the foregoing factual matters and the assumptions set forth in Section 2 above, and upon the Company's compliance with the requirements of Regulation D, including the filing of a Form D notice with the SEC within the time period prescribed by Rule 503 of Regulation D.

Opinion 3.8 — No Governmental Approvals Required

No consent, approval, authorization, order, license, permit, registration, qualification, or filing with any federal, state, or local governmental authority, agency, commission, or regulatory body is required for the execution, delivery, and performance by the Company of the Transaction Documents to which it is a party or for the offer, issuance, sale, and delivery of the Notes to the Purchasers, except for:

(a) the filing of a Form D notice with the SEC pursuant to Rule 503 of Regulation D, which the Company has represented to us will be filed within fifteen (15) days of the first sale of securities, and in no event later than April 24, 2024; and

(b) applicable state securities law (blue sky) filings and notices, including: (i) a notice filing pursuant to Section 25102(f) of the California Corporations Code with the California Department of Financial Protection and Innovation (or its successor agency); and (ii) state notice filings in the States of New York, Massachusetts, and Delaware as required by the securities laws of such states, which filings are to be made concurrently with or promptly following the Closing Date, in accordance with the applicable deadlines prescribed by the laws of such states.

4. QUALIFICATIONS AND LIMITATIONS

The opinions expressed herein are subject to the following qualifications and limitations:

4.1 Scope of Law Covered

The opinions expressed in this opinion letter are limited solely to the federal laws of the United States of America, the General Corporation Law of the State of Delaware (Title 8, Chapter 1 of the Delaware Code), and the laws of the State of California, in each case as in effect on the date hereof. We express no opinion as to the laws of any other state or jurisdiction, or as to the laws of any foreign country or any political subdivision thereof. We express no opinion as to any statute, rule, regulation, ordinance, order, or other law of any county, city, municipality, or other local governmental authority.

With respect to matters of Delaware law, we have relied upon our review of applicable statutory provisions and reported judicial decisions interpreting such provisions. We note that we are not admitted to practice law in the State of Delaware and do not hold ourselves out as experts in the laws of the State of Delaware; however, based on our review of the General Corporation Law of the State of Delaware and applicable judicial authorities, we believe that our opinions with respect to such matters are reasonable and well-founded as of the date hereof. To the extent that the laws of any jurisdiction other than those specified above are relevant to the opinions expressed herein, we have assumed, without investigation, that such laws are identical in all respects to the laws of the State of California.

4.2 Enforceability Exceptions

The opinions set forth in Section 3.5 above with respect to the enforceability of the Transaction Documents are subject to, and limited by, the following exceptions (collectively, the "Enforceability Exceptions"):

(a) Applicable bankruptcy, insolvency, reorganization, moratorium, receivership, conservatorship, arrangement, fraudulent transfer, fraudulent conveyance, preference, and other similar laws of general applicability now or hereafter in effect relating to or affecting the rights and remedies of creditors generally, including, without limitation, the United States Bankruptcy Code (Title 11, United States Code), as amended;

(b) General equitable principles (whether considered in a proceeding in equity or at law), including, without limitation, principles and concepts of materiality, reasonableness, good faith, and fair dealing, and the possible unavailability of specific performance, injunctive relief, or other equitable remedies, regardless of whether enforceability is considered in a proceeding in equity or at law;

(c) The power of a court of competent jurisdiction to deny enforcement of specific remedial provisions contained in the Transaction Documents where the enforcement thereof would be unreasonable under the circumstances then prevailing, or would violate principles of public policy, including provisions relating to the payment of penalties, forfeitures, or liquidated damages that a court may determine to constitute a penalty;

(d) The possible unenforceability, in whole or in part, of provisions relating to indemnification, contribution, or exculpation, to the extent that such provisions may be limited or rendered unenforceable by applicable federal or state law (including applicable securities laws) or by public policy considerations underlying such laws; and

(e) The enforceability of choice-of-law provisions and forum selection clauses contained in the Transaction Documents, which is subject to applicable principles and limitations under the laws of the forum state, including the requirements of Section 187 of the Restatement (Second) of Conflict of Laws.

4.3 Reliance on Certificates and Factual Matters

We have relied, without independent investigation or verification, upon certificates of officers and representatives of the Company and upon certificates and other communications of public officials as to certain factual matters relevant to the opinions expressed herein. We have also relied upon the representations and warranties of the Company and the Purchasers contained in the Transaction Documents and upon information obtained through due diligence inquiries addressed to the Company's officers and employees. We have assumed the accuracy, completeness, and currency of all information so obtained, and we have not undertaken any independent investigation to verify such information.

The opinions expressed in Sections 3.1 and 3.2 with respect to the good standing of the Company in the States of Delaware and California are based solely upon the Delaware Good Standing Certificate and the California Good Standing Certificate, respectively, each of which is dated as of a recent date prior to the date hereof. Such certificates speak only as of their respective dates, and we express no opinion as to the good standing of the Company at any time subsequent to the dates of such certificates.

We have not independently verified and do not opine upon the accuracy, completeness, or adequacy of the representations and warranties of the Company set forth in the Transaction Documents. In particular, and without limiting the generality of the foregoing, we have not independently verified the information set forth in the Disclosure Schedules to the Purchase Agreement.

4.4 No Opinion on Certain Matters

We express no opinion as to any of the following matters:

(a) The financial condition, solvency, creditworthiness, or value of the Company, its assets, or its business;

(b) The fairness of the terms of the Transaction Documents or the Notes from a financial point of view, to any party or any other person;

(c) The treatment of the Transaction Documents, the Notes, or the transactions contemplated thereby under any applicable tax law, including any federal, state, local, or foreign income, franchise, excise, property, transfer, or other tax law, or the tax consequences to any party or any other person of the transactions contemplated by the Transaction Documents;

(d) Compliance by the Company with any federal or state regulatory requirements applicable to the Company's business, including, without limitation, regulations and requirements administered by the United States Food and Drug Administration ("FDA"), the Drug Enforcement Administration ("DEA"), or any comparable state or foreign regulatory authority, clinical trial requirements, Good Manufacturing Practice ("GMP") regulations, or any other healthcare, pharmaceutical, or biotechnology laws, rules, or regulations;

(e) intellectual property matters, including without limitation the validity, enforceability, scope, or ownership of any patent, patent application, trademark, trade name, service mark, copyright, trade secret, or other intellectual property right, or any license or other agreement relating thereto;

(f) The validity or enforceability of any provision of the Transaction Documents that purports to waive, or that has the effect of waiving, the right to trial by jury in any litigation arising under or in connection with the Transaction Documents; and

(g) Any securities law matter other than the exemption from registration specifically addressed in Opinion 3.7 above, including, without limitation, any opinion as to the availability of exemptions under state blue sky or securities laws, the application of the antifraud provisions of federal or state securities laws, or compliance with any other provision of the Securities Act, the Securities Exchange Act of 1934, as amended, or the rules and regulations promulgated thereunder.

4.5 Limitation on Conversion Mechanics

We express no opinion as to whether, at the time of any future conversion of the Notes into equity securities of the Company, the Company will have a sufficient number of authorized and unissued shares of any class or series of stock available for issuance upon such conversion, or as to the terms, conditions, pricing, or other characteristics of any future equity financing that may constitute a "Qualified Financing" as such term is defined in the Transaction Documents. We note, for informational purposes only, that:

(a) Upon conversion of the Notes at the Valuation Cap Price of Four Dollars and Fourteen and 51/100 Cents ($4.1451) per share (calculated based on a pre-money valuation cap of Two Hundred Million Dollars ($200,000,000) divided by 48,250,000 shares on a fully diluted basis as determined in accordance with the provisions of the Notes), the Notes would convert into approximately 9,650,906 shares of equity securities of the Company (assuming conversion of the full aggregate principal amount and all accrued and unpaid interest thereon at such Valuation Cap Price); and

(b) Upon conversion of the Notes at a discount to the price per share in a Qualified Financing (as provided in the Notes), additional shares of equity securities may be issuable by the Company.

Notwithstanding the foregoing, we express no opinion as to the Company's future ability to authorize, reserve, or issue such shares, or as to whether the conversion of the Notes will require an amendment to the Restated Certificate to increase the Company's authorized share capital, or as to the anti-dilution, pre-emptive, or other rights of existing stockholders that may be affected by or relevant to any such conversion.

5. RELIANCE AND OTHER MATTERS

5.1 Reliance

This opinion letter is furnished solely to the Purchasers, and is solely for the benefit of the Purchasers, in connection with the transactions contemplated by the Purchase Agreement. This opinion letter may not be relied upon by, quoted to, or delivered to any other person or entity, or used for any other purpose, without our prior express written consent in each instance. Notwithstanding the foregoing, Whitfield, Greer & Cavanaugh LLP, in its capacity as legal counsel to the Purchasers, may rely on this opinion letter as if it were addressed directly to such firm, solely in connection with the transactions contemplated by the Purchase Agreement and solely for the purpose of rendering its own advice to the Purchasers.

5.2 No Undertaking to Update

This opinion letter speaks only as of the date hereof. We undertake no obligation, and hereby expressly disclaim any obligation, to advise the Purchasers, Whitfield, Greer & Cavanaugh LLP, or any other person of any change of law, fact, or circumstance that may come to our attention after the date of this opinion letter, even though such change may affect the legal analysis or the opinions expressed herein. Without limiting the foregoing, we disclaim any obligation to update this opinion letter to reflect any facts or circumstances arising after the date hereof or any changes in applicable law occurring after the date hereof.

5.3 Governing Law of This Opinion

The interpretation of this opinion letter shall be governed by, and this opinion letter shall be interpreted in accordance with, the Legal Opinion Accord of the Section of Business Law of the American Bar Association (the "Accord"), to the extent that the provisions of the Accord are applicable to the opinions expressed herein. In the event of any inconsistency between the Accord and the express provisions of this opinion letter, the express provisions of this opinion letter shall control.

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SIGNATURE PAGE TO LEGAL OPINION OF CALDERWOOD & HARKNESS LLP

Very truly yours,

CALDERWOOD & HARKNESS LLP

By: ________

Name: Theodore Langston

Title: Partner

CALDERWOOD & HARKNESS LLP 600 California Street, 40th Floor San Francisco, CA 94108 Telephone: (415) 782-6000 Facsimile: (415) 782-6001

Enclosures

cc: Priya Raghunathan, J.D., General Counsel and Corporate Secretary, Genome Dx Therapeutics Inc. Whitfield, Greer & Cavanaugh LLP (Purchasers' Counsel)

CALDERWOOD & HARKNESS LLP Attorneys at Law 600 California Street, 40th Floor San Francisco, CA 94108 Telephone: (415) 782-6000 Facsimile: (415) 782-6001 www.calderwoodharkness.com
April 22, 2024
Pinnacle BioVentures Fund III, L.P. 101 Federal Street, 26th Floor Boston, MA 02110
Cormorant Health Capital Partners, L.P. 375 Park Avenue, Suite 3201 New York, NY 10152
Alder Creek Life Sciences Fund II, L.P. 555 Mission Street, Suite 2800 San Francisco, CA 94105
(each, a "Purchaser" and collectively, the "Purchasers")
Ladies and Gentlemen:
We have acted as counsel to Genome Dx Therapeutics Inc., a corporation organized and existing under the laws of the State of Delaware (the "Company"), in connection with the Note Purchase Agreement dated as of April 9, 2024 (as the same may be amended, supplemented, or otherwise modified from time to time, the "Purchase Agreement"), by and among the Company and the Purchasers named therein. The Purchase Agreement provides for the issuance by the Company of an aggregate principal amount of Forty Million Dollars ($40,000,000) of senior unsecured convertible promissory notes (individually, a "Note" and collectively, the "Notes") to the Purchasers, allocated as follows:
(a) a Note in the principal amount of Twenty-Two Million Dollars ($22,000,000) issued to Pinnacle BioVentures Fund III, L.P.;
(b) a Note in the principal amount of Twelve Million Dollars ($12,000,000) issued to Cormorant Health Capital Partners, L.P.; and
(c) a Note in the principal amount of Six Million Dollars ($6,000,000) issued to Alder Creek Life Sciences Fund II, L.P.
This opinion letter is being delivered to the Purchasers pursuant to Section 6.2(e) of the Purchase Agreement in connection with the closing of the transactions contemplated thereby on the date hereof (the "Closing Date"). This opinion letter relates to Calderwood & Harkness LLP client matter number 1013-00002.
In connection with this opinion, we have examined and are familiar with such documents and matters of law and fact as we have considered necessary or appropriate for the purpose of rendering the opinions set forth herein, as more particularly described below.
1. DEFINED TERMS AND DOCUMENTS EXAMINED
1.1 Defined Terms
As used in this opinion letter, the following terms have the meanings indicated:
"Bylaws" means the Amended and Restated Bylaws of the Company, as currently in effect.
"Company" means Genome Dx Therapeutics Inc., a Delaware corporation.
"Disclosure Schedules" means the disclosure schedules delivered by the Company to the Purchasers in connection with the Purchase Agreement.
"Notes" means the senior unsecured convertible promissory notes issued pursuant to the Purchase Agreement in an aggregate principal amount of Forty Million Dollars ($40,000,000).
"Purchase Agreement" means the Note Purchase Agreement dated as of April 9, 2024, by and among the Company and the Purchasers.
"Regulation D" means Regulation D promulgated under the Securities Act, including Rules 501 through 508 thereunder, as in effect on the date hereof.
"Restated Certificate" means the Restated Certificate of Incorporation of the Company, as filed with the Secretary of State of the State of Delaware.
"Securities Act" means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
"Transaction Documents" means, collectively, the Purchase Agreement, the Notes, the Disclosure Schedules, and each other agreement, certificate, or instrument delivered by the Company or the Purchasers pursuant to or in connection with the Purchase Agreement.
Capitalized terms used but not otherwise defined in this opinion letter have the meanings ascribed to them in the Purchase Agreement.
1.2 Documents Examined
In rendering the opinions set forth below, we have examined originals or copies (certified or otherwise identified to our satisfaction) of the following documents:
(a) The Purchase Agreement, executed as of April 9, 2024, including the Disclosure Schedules delivered by the Company in connection therewith;
(b) The Notes, each dated as of April 22, 2024, in the respective principal amounts set forth above;
(c) The Restated Certificate of Incorporation of the Company, as filed with the Secretary of State of the State of Delaware, Delaware file number 6347821;
(d) The Amended and Restated Bylaws of the Company, as currently in effect;
(e) The Written Consent of the Board of Directors of the Company in Lieu of Meeting, dated as of April 5, 2024, approving and authorizing the transactions contemplated by the Purchase Agreement (the "Board Written Consent");
(f) The Officers' Certificate, dated as of April 22, 2024, executed by Dr. Marcus Avellino, Ph.D., MBA, in his capacity as Chief Executive Officer of the Company, and Diane Kowalski, CPA, in her capacity as Chief Financial Officer of the Company;
(g) The Secretary's Certificate, dated as of April 22, 2024, executed by Priya Raghunathan, J.D., in her capacity as General Counsel and Corporate Secretary of the Company, certifying as to the incumbency and authority of certain officers, and attaching thereto true, correct, and complete copies of the Restated Certificate, the Bylaws, and the Board Written Consent;
(h) A Certificate of Good Standing of the Company issued by the Secretary of State of the State of Delaware, dated on or about April 22, 2024 (the "Delaware Good Standing Certificate"), which certificate was obtained as a refreshed certificate in connection with the delayed closing of the transactions;
(i) A Certificate of Good Standing (Certificate of Status) of the Company issued by the Secretary of State of the State of California, dated on or about April 22, 2024 (the "California Good Standing Certificate");
(j) Accredited investor questionnaires completed and executed by each of the Purchasers in connection with the transactions contemplated by the Purchase Agreement; and
(k) Such other documents, certificates, corporate records, and instruments as we have deemed necessary or appropriate for the purposes of this opinion, including records of proceedings of the Board of Directors of the Company relating to the transactions contemplated by the Purchase Agreement.
2. ASSUMPTIONS
In rendering the opinions set forth herein, we have, with your consent and without independent investigation or verification, assumed the following:
(a) All signatures on documents examined by us are genuine, and all documents submitted to us as originals are authentic and complete. All documents submitted to us as copies, whether certified or uncertified, conform in all material respects to the originals thereof, and all such originals are authentic and complete.
(b) Each natural person executing any document reviewed by us in connection with this opinion had, at the time of such execution, the legal capacity to do so.
(c) Each Purchaser has the requisite legal power, authority, and capacity to execute, deliver, and perform its obligations under the Purchase Agreement and each other Transaction Document to which it is a party, and has duly and validly authorized, executed, and delivered the Purchase Agreement and each such other Transaction Document.
(d) Each Purchaser is an "accredited investor" as that term is defined in Rule 501(a) of Regulation D promulgated under the Securities Act, as represented by each such Purchaser in the Purchase Agreement and as confirmed in the accredited investor questionnaires delivered to us.
(e) The Purchase Agreement constitutes a valid, binding, and enforceable obligation of each Purchaser in accordance with its terms, subject to applicable bankruptcy, insolvency, and similar laws affecting creditors' rights generally and to general principles of equity.
(f) The information contained in all certificates, documents, and other materials delivered to us by officers, directors, and representatives of the Company is complete, true, accurate, and has not been modified, superseded, or revoked as of the date hereof. We have relied upon such certificates and documents as to all factual matters encompassed thereby without independent verification.
(g) The Company will file a Form D notice with the United States Securities and Exchange Commission (the "SEC") within fifteen (15) days of the first sale of securities as required by Rule 503 of Regulation D. The Company has represented to us that such filing will be made on or before April 24, 2024. In addition, the Company will make applicable blue sky filings and notices in the States of California, New York, Massachusetts, and Delaware as required by the securities laws of such states.
(h) No form of general solicitation or general advertising (within the meaning of Rule 502(c) of Regulation D) has been used by the Company, or by any person acting on its behalf, in connection with the offering, issuance, or sale of the Notes.
(i) The number of purchasers of the Notes does not exceed the numerical limitations set forth in Rule 506(b) of Regulation D, and no non-accredited investors (as defined in Regulation D) are participating in the offering or have been offered an opportunity to purchase the Notes.
3. OPINIONS
Based upon and subject to the foregoing, and subject further to the qualifications and limitations set forth in Section 4 below, we are of the opinion that:
Opinion 3.1 — Due Organization and Good Standing (Delaware)
The Company is a corporation duly incorporated, validly existing, and in good standing under the laws of the State of Delaware. In rendering this opinion, we have relied upon our review of the Restated Certificate of Incorporation of the Company on file with the Secretary of State of the State of Delaware under Delaware file number 6347821, the Delaware Good Standing Certificate, and the Secretary's Certificate delivered by the Company on the date hereof. Based on our review of such documents, the Company was originally incorporated in the State of Delaware on March 14, 2017. The Company's registered agent in the State of Delaware is Capitol Registered Agents, Inc., with a registered office located at 1209 Orange Street, Suite 200, Wilmington, Delaware 19801. As of the date of the Delaware Good Standing Certificate, the Company is in good standing with the Secretary of State of the State of Delaware, having paid all franchise taxes and filed all annual reports currently due and owing.
Opinion 3.2 — Foreign Qualification (California)
The Company is duly qualified to transact business as a foreign corporation and is in good standing in the State of California. In rendering this opinion, we have relied upon our review of the California Good Standing Certificate issued by the Secretary of State of the State of California. The Company's California entity number is C4085629. The Company initially filed for qualification to transact intrastate business as a foreign corporation in the State of California on April 3, 2017. The Company's principal executive office is located at 450 Pinnacle Drive, Suite 300, South San Francisco, California 94080. As of the date of the California Good Standing Certificate, the Company is in good standing with the Secretary of State of the State of California, and all applicable statements of information and related filings appear to have been made in a timely manner. We express no opinion as to the qualification of the Company to transact business in any jurisdiction other than the State of California.
Opinion 3.3 — Corporate Power and Authority
The Company has all requisite corporate power and authority under the Delaware General Corporation Law and the Restated Certificate and Bylaws to execute, deliver, and perform its obligations under each of the Transaction Documents to which it is a party, including, without limitation, the power and authority to issue the Notes in the aggregate principal amount of Forty Million Dollars ($40,000,000) to the Purchasers on the terms and conditions set forth therein. Additionally, the Company has all requisite corporate power and authority to own, lease, and operate its properties and assets and to carry on its business as presently conducted. In rendering this opinion, we have reviewed the Restated Certificate, the Bylaws, the Board Written Consent, and the other organizational documents of the Company, and nothing has come to our attention that would indicate that the Company lacks the corporate power or authority described in this paragraph.
Opinion 3.4 — Due Authorization, Execution, and Delivery
The execution and delivery by the Company of each Transaction Document to which it is a party, and the performance by the Company of its obligations thereunder, including the issuance and delivery of the Notes, have been duly authorized by all necessary corporate action on the part of the Company. The Board of Directors of the Company duly adopted the Board Written Consent, dated as of April 5, 2024, authorizing the transactions contemplated by the Purchase Agreement, including specifically: (i) approving the form, terms, and conditions of the Purchase Agreement and the Notes; (ii) authorizing the issuance and sale of the Notes to the Purchasers; (iii) designating Dr. Marcus Avellino, Ph.D., MBA, in his capacity as Chief Executive Officer, and Diane Kowalski, CPA, in her capacity as Chief Financial Officer, as authorized signatories with authority to execute and deliver, on behalf of the Company, the Transaction Documents and all related agreements, certificates, and instruments; and (iv) directing the officers of the Company to take all actions and execute and deliver all documents necessary or desirable to consummate the transactions contemplated by the Purchase Agreement.
We note that Jonathan Merriweather, in his capacity as Chair of the Board of Directors and in his separate capacity as Managing Director of Pinnacle BioVentures (the investment advisor or general partner affiliate of Pinnacle BioVentures Fund III, L.P., the lead investor and a Purchaser under the Purchase Agreement), recused himself from participation in the deliberation and vote of the Board of Directors with respect to the transactions contemplated by the Purchase Agreement, due to his actual and potential conflict of interest arising from Pinnacle's role as lead investor and Purchaser. The Board Written Consent was duly adopted by the affirmative written consent of the remaining members of the Board of Directors, who constituted a quorum for the transaction of business under the Bylaws and the Delaware General Corporation Law, in the absence of Mr. Merriweather. Based on our review of the Board Written Consent and the Bylaws, we are of the opinion that the recusal and abstention of Mr. Merriweather were properly effected and did not impair the validity of the corporate action taken.
Each Transaction Document to which the Company is a party has been duly executed and delivered by the Company by officers duly authorized to execute and deliver such documents on behalf of the Company.
Opinion 3.5 — Enforceability
Each of the Purchase Agreement and the Notes constitutes the legal, valid, and binding obligation of the Company, enforceable against the Company in accordance with its respective terms, except as such enforceability may be limited by the Enforceability Exceptions (as defined and described in Section 4.2 below), which include, without limitation:
(a) applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance, fraudulent transfer, and other similar laws of general applicability relating to or affecting the rights and remedies of creditors generally, as from time to time in effect;
(b) general principles of equity, including principles of commercial reasonableness, good faith, and fair dealing, whether applied in a proceeding at law or in equity; and
(c) the discretion of the court before which any proceeding for enforcement may be brought with respect to the availability of specific performance, injunctive relief, and other equitable remedies, which remedies are subject to the discretion of the court before which any such proceeding may be brought.
We note for informational purposes that the Notes bear interest at the rate of six percent (6.0%) per annum, calculated on the basis of simple interest and payable in kind by addition to the outstanding principal amount. The Notes mature on April 12, 2027 and are convertible into equity securities of the Company upon the occurrence of a Qualified Financing or other conversion events, in each case on the terms and conditions more fully set forth in the Notes. The Transaction Documents are governed by, and are to be construed in accordance with, the laws of the State of Delaware, without regard to conflicts-of-law principles that would result in the application of the laws of any other jurisdiction.
Opinion 3.6 — No Conflicts
The execution, delivery, and performance by the Company of the Transaction Documents to which it is a party, and the issuance and delivery of the Notes to the Purchasers, do not and will not:
(a) violate, conflict with, result in a breach of, or constitute a default under, or require any consent or approval not previously obtained under, the Restated Certificate of Incorporation or the Bylaws of the Company;
(b) to our knowledge, violate, conflict with, result in a breach of, or constitute a default under (or an event that, with notice or lapse of time or both, would constitute a default under), or result in the termination or acceleration of (or give any party the right to terminate, accelerate, or modify), any material agreement, contract, indenture, mortgage, lease, license, permit, or other instrument to which the Company is a party or by which the Company or any of its properties or assets are bound, in each case to the extent such agreement or instrument has been listed in or provided to us through the Disclosure Schedules to the Purchase Agreement;
(c) result in the creation or imposition of any lien, charge, encumbrance, pledge, security interest, or other claim upon any of the properties or assets of the Company under any such agreement or instrument described in clause (b) above; or
(d) violate any applicable order, judgment, injunction, writ, decree, or ruling of any court, arbitral tribunal, or governmental authority known to us to be binding upon the Company or any of its properties or assets.
This opinion is limited in scope to our review of the agreements and instruments listed in or delivered to us through the Disclosure Schedules to the Purchase Agreement, and does not extend to any agreements, instruments, or obligations not so provided to us for review. In rendering this opinion, we have relied upon the representations and warranties of the Company in the Purchase Agreement and in the Officers' Certificate regarding the completeness of the Disclosure Schedules.
Opinion 3.7 — Securities Law Exemption
The offer, issuance, sale, and delivery of the Notes to the Purchasers as contemplated by the Purchase Agreement are exempt from the registration requirements of Section 5 of the Securities Act pursuant to Section 4(a)(2) thereof and Rule 506(b) of Regulation D promulgated thereunder. In rendering this opinion, we have, in addition to our assumptions set forth in Section 2 above, relied upon the following factual matters, among others:
(a) Each of the Purchasers is an "accredited investor" as defined in Rule 501(a) of Regulation D, as represented by each Purchaser in the Purchase Agreement and as confirmed through the accredited investor questionnaires executed and delivered by each Purchaser;
(b) No form of general solicitation or general advertising (within the meaning of Rule 502(c) of Regulation D) was used by the Company or any person acting on its behalf in connection with the offering, issuance, or sale of the Notes;
(c) The Notes are being issued and sold to three (3) Purchasers, all of which are existing investors of the Company and have a pre-existing substantive relationship with the Company;
(d) The Notes are "restricted securities" within the meaning of Rule 144 under the Securities Act and each Note bears an appropriate restrictive legend substantially in the form set forth in Section 4.6 of the Purchase Agreement, stating that the Notes have not been registered under the Securities Act and may not be offered, sold, pledged, or otherwise transferred except in compliance with the registration requirements of the Securities Act or pursuant to an applicable exemption therefrom;
(e) The Company has made available to the Purchasers all information reasonably requested by them concerning the Company, its financial condition, and the terms and conditions of the offering of the Notes, including access to such information as would be required to be provided in a registration statement on Form S-1 under the Securities Act; and
(f) The sale of the Notes is made to the Purchasers, each of which has represented in the Purchase Agreement that it is acquiring the Notes for investment purposes only, for its own account, and not with a view to the distribution thereof within the meaning of the Securities Act.
This opinion regarding the availability of the exemption from registration under Section 4(a)(2) of the Securities Act and Rule 506(b) of Regulation D is premised upon the accuracy and completeness of the foregoing factual matters and the assumptions set forth in Section 2 above, and upon the Company's compliance with the requirements of Regulation D, including the filing of a Form D notice with the SEC within the time period prescribed by Rule 503 of Regulation D.
Opinion 3.8 — No Governmental Approvals Required
No consent, approval, authorization, order, license, permit, registration, qualification, or filing with any federal, state, or local governmental authority, agency, commission, or regulatory body is required for the execution, delivery, and performance by the Company of the Transaction Documents to which it is a party or for the offer, issuance, sale, and delivery of the Notes to the Purchasers, except for:
(a) the filing of a Form D notice with the SEC pursuant to Rule 503 of Regulation D, which the Company has represented to us will be filed within fifteen (15) days of the first sale of securities, and in no event later than April 24, 2024; and
(b) applicable state securities law (blue sky) filings and notices, including: (i) a notice filing pursuant to Section 25102(f) of the California Corporations Code with the California Department of Financial Protection and Innovation (or its successor agency); and (ii) state notice filings in the States of New York, Massachusetts, and Delaware as required by the securities laws of such states, which filings are to be made concurrently with or promptly following the Closing Date, in accordance with the applicable deadlines prescribed by the laws of such states.
4. QUALIFICATIONS AND LIMITATIONS
The opinions expressed herein are subject to the following qualifications and limitations:
4.1 Scope of Law Covered
The opinions expressed in this opinion letter are limited solely to the federal laws of the United States of America, the General Corporation Law of the State of Delaware (Title 8, Chapter 1 of the Delaware Code), and the laws of the State of California, in each case as in effect on the date hereof. We express no opinion as to the laws of any other state or jurisdiction, or as to the laws of any foreign country or any political subdivision thereof. We express no opinion as to any statute, rule, regulation, ordinance, order, or other law of any county, city, municipality, or other local governmental authority.
With respect to matters of Delaware law, we have relied upon our review of applicable statutory provisions and reported judicial decisions interpreting such provisions. We note that we are not admitted to practice law in the State of Delaware and do not hold ourselves out as experts in the laws of the State of Delaware; however, based on our review of the General Corporation Law of the State of Delaware and applicable judicial authorities, we believe that our opinions with respect to such matters are reasonable and well-founded as of the date hereof. To the extent that the laws of any jurisdiction other than those specified above are relevant to the opinions expressed herein, we have assumed, without investigation, that such laws are identical in all respects to the laws of the State of California.
4.2 Enforceability Exceptions
The opinions set forth in Section 3.5 above with respect to the enforceability of the Transaction Documents are subject to, and limited by, the following exceptions (collectively, the "Enforceability Exceptions"):
(a) Applicable bankruptcy, insolvency, reorganization, moratorium, receivership, conservatorship, arrangement, fraudulent transfer, fraudulent conveyance, preference, and other similar laws of general applicability now or hereafter in effect relating to or affecting the rights and remedies of creditors generally, including, without limitation, the United States Bankruptcy Code (Title 11, United States Code), as amended;
(b) General equitable principles (whether considered in a proceeding in equity or at law), including, without limitation, principles and concepts of materiality, reasonableness, good faith, and fair dealing, and the possible unavailability of specific performance, injunctive relief, or other equitable remedies, regardless of whether enforceability is considered in a proceeding in equity or at law;
(c) The power of a court of competent jurisdiction to deny enforcement of specific remedial provisions contained in the Transaction Documents where the enforcement thereof would be unreasonable under the circumstances then prevailing, or would violate principles of public policy, including provisions relating to the payment of penalties, forfeitures, or liquidated damages that a court may determine to constitute a penalty;
(d) The possible unenforceability, in whole or in part, of provisions relating to indemnification, contribution, or exculpation, to the extent that such provisions may be limited or rendered unenforceable by applicable federal or state law (including applicable securities laws) or by public policy considerations underlying such laws; and
(e) The enforceability of choice-of-law provisions and forum selection clauses contained in the Transaction Documents, which is subject to applicable principles and limitations under the laws of the forum state, including the requirements of Section 187 of the Restatement (Second) of Conflict of Laws.
4.3 Reliance on Certificates and Factual Matters
We have relied, without independent investigation or verification, upon certificates of officers and representatives of the Company and upon certificates and other communications of public officials as to certain factual matters relevant to the opinions expressed herein. We have also relied upon the representations and warranties of the Company and the Purchasers contained in the Transaction Documents and upon information obtained through due diligence inquiries addressed to the Company's officers and employees. We have assumed the accuracy, completeness, and currency of all information so obtained, and we have not undertaken any independent investigation to verify such information.
The opinions expressed in Sections 3.1 and 3.2 with respect to the good standing of the Company in the States of Delaware and California are based solely upon the Delaware Good Standing Certificate and the California Good Standing Certificate, respectively, each of which is dated as of a recent date prior to the date hereof. Such certificates speak only as of their respective dates, and we express no opinion as to the good standing of the Company at any time subsequent to the dates of such certificates.
We have not independently verified and do not opine upon the accuracy, completeness, or adequacy of the representations and warranties of the Company set forth in the Transaction Documents. In particular, and without limiting the generality of the foregoing, we have not independently verified the information set forth in the Disclosure Schedules to the Purchase Agreement.
4.4 No Opinion on Certain Matters
We express no opinion as to any of the following matters:
(a) The financial condition, solvency, creditworthiness, or value of the Company, its assets, or its business;
(b) The fairness of the terms of the Transaction Documents or the Notes from a financial point of view, to any party or any other person;
(c) The treatment of the Transaction Documents, the Notes, or the transactions contemplated thereby under any applicable tax law, including any federal, state, local, or foreign income, franchise, excise, property, transfer, or other tax law, or the tax consequences to any party or any other person of the transactions contemplated by the Transaction Documents;
(d) Compliance by the Company with any federal or state regulatory requirements applicable to the Company's business, including, without limitation, regulations and requirements administered by the United States Food and Drug Administration ("FDA"), the Drug Enforcement Administration ("DEA"), or any comparable state or foreign regulatory authority, clinical trial requirements, Good Manufacturing Practice ("GMP") regulations, or any other healthcare, pharmaceutical, or biotechnology laws, rules, or regulations;
(e) intellectual property matters, including without limitation the validity, enforceability, scope, or ownership of any patent, patent application, trademark, trade name, service mark, copyright, trade secret, or other intellectual property right, or any license or other agreement relating thereto;
(f) The validity or enforceability of any provision of the Transaction Documents that purports to waive, or that has the effect of waiving, the right to trial by jury in any litigation arising under or in connection with the Transaction Documents; and
(g) Any securities law matter other than the exemption from registration specifically addressed in Opinion 3.7 above, including, without limitation, any opinion as to the availability of exemptions under state blue sky or securities laws, the application of the antifraud provisions of federal or state securities laws, or compliance with any other provision of the Securities Act, the Securities Exchange Act of 1934, as amended, or the rules and regulations promulgated thereunder.
4.5 Limitation on Conversion Mechanics
We express no opinion as to whether, at the time of any future conversion of the Notes into equity securities of the Company, the Company will have a sufficient number of authorized and unissued shares of any class or series of stock available for issuance upon such conversion, or as to the terms, conditions, pricing, or other characteristics of any future equity financing that may constitute a "Qualified Financing" as such term is defined in the Transaction Documents. We note, for informational purposes only, that:
(a) Upon conversion of the Notes at the Valuation Cap Price of Four Dollars and Fourteen and 51/100 Cents ($4.1451) per share (calculated based on a pre-money valuation cap of Two Hundred Million Dollars ($200,000,000) divided by 48,250,000 shares on a fully diluted basis as determined in accordance with the provisions of the Notes), the Notes would convert into approximately 9,650,906 shares of equity securities of the Company (assuming conversion of the full aggregate principal amount and all accrued and unpaid interest thereon at such Valuation Cap Price); and
(b) Upon conversion of the Notes at a discount to the price per share in a Qualified Financing (as provided in the Notes), additional shares of equity securities may be issuable by the Company.
Notwithstanding the foregoing, we express no opinion as to the Company's future ability to authorize, reserve, or issue such shares, or as to whether the conversion of the Notes will require an amendment to the Restated Certificate to increase the Company's authorized share capital, or as to the anti-dilution, pre-emptive, or other rights of existing stockholders that may be affected by or relevant to any such conversion.
5. RELIANCE AND OTHER MATTERS
5.1 Reliance
This opinion letter is furnished solely to the Purchasers, and is solely for the benefit of the Purchasers, in connection with the transactions contemplated by the Purchase Agreement. This opinion letter may not be relied upon by, quoted to, or delivered to any other person or entity, or used for any other purpose, without our prior express written consent in each instance. Notwithstanding the foregoing, Whitfield, Greer & Cavanaugh LLP, in its capacity as legal counsel to the Purchasers, may rely on this opinion letter as if it were addressed directly to such firm, solely in connection with the transactions contemplated by the Purchase Agreement and solely for the purpose of rendering its own advice to the Purchasers.
5.2 No Undertaking to Update
This opinion letter speaks only as of the date hereof. We undertake no obligation, and hereby expressly disclaim any obligation, to advise the Purchasers, Whitfield, Greer & Cavanaugh LLP, or any other person of any change of law, fact, or circumstance that may come to our attention after the date of this opinion letter, even though such change may affect the legal analysis or the opinions expressed herein. Without limiting the foregoing, we disclaim any obligation to update this opinion letter to reflect any facts or circumstances arising after the date hereof or any changes in applicable law occurring after the date hereof.
5.3 Governing Law of This Opinion
The interpretation of this opinion letter shall be governed by, and this opinion letter shall be interpreted in accordance with, the Legal Opinion Accord of the Section of Business Law of the American Bar Association (the "Accord"), to the extent that the provisions of the Accord are applicable to the opinions expressed herein. In the event of any inconsistency between the Accord and the express provisions of this opinion letter, the express provisions of this opinion letter shall control.
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SIGNATURE PAGE TO LEGAL OPINION OF CALDERWOOD & HARKNESS LLP
Very truly yours,
CALDERWOOD & HARKNESS LLP
By: ________
Name: Theodore Langston
Title: Partner
CALDERWOOD & HARKNESS LLP 600 California Street, 40th Floor San Francisco, CA 94108 Telephone: (415) 782-6000 Facsimile: (415) 782-6001
Enclosures
cc: Priya Raghunathan, J.D., General Counsel and Corporate Secretary, Genome Dx Therapeutics Inc. Whitfield, Greer & Cavanaugh LLP (Purchasers' Counsel)

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